YP-2000

INFANT INCUBATOR
Operator’s Manual

[Link]
 EMC INFORMATION

This section is special precautions regarding EMC. The equipment should be installed and put into
service according to EMC information of this section.

ELECTROMAGNETIC COMPATIBILITY PRECAUTIONS

1. The equipment intend to use in the professional healthcare facility environment.
2. Equipment cannot be operated or exposed in RFID, X-RAY, MRI environments.
3. Pay attention to the electromagnetic environment at the scene, because the equipment may be
affected by the electromagnetic environment at the scene.
4. Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
5. Equipment should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, the equipment should be observed to verify normal operation in the
configuration in which it will be used.
6. If the essential performance is lost or degraded due to EM disturbances, the user might need to
take mitigation measures, such as relocating or re-orienting the equipment.
7. Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.

CABLES SUPPLIED BY THE MANUFACTURER

NAME MAXIMUM LENGTHS OF CABLES

Power cord 3 meters

Skin temperature sensor 1.5 meters

Page 1 of 6
 ESSENTIAL PERFORMANCE
1. With an INFANT INCUBATOR working in the BABY CONTROLLED INCUBATOR mode with
horizontal MATTRESS orientation ， the temperature as measured by the SKIN TEMPERATURE
SENSON shall not differ from the CONTROL TEMPERATURE by more than 0.7℃ in STEADY
TEMPERATURE CONDITICN.
2. With an INFANT INCUBATOR or operating as an AIR CONTROLLED INCUBATOR, the
AVERAGE INCUBATOR TEMPERATURE shall not differ from the CONTROL INCUBATOR by more
than±1.5℃.
3. After STEADY TEMPERATURE CONDITIONS of an AIR CONTROLLED INCUBATOR have
been achieved, any sensed temperature deviation of the displayed air temperature exceeding ±3℃
compared with the CONTROL TEMPERATURE shall cause an auditory and visual alarm to operate.
4. After STEADY TEMPERATURE CONDITIONS of a BABY CONTROLLED INCUBATOR have
been achieved, any deviation of the displayed SKIN TEMAPERATURE exceeding ±1℃ compared with
the CONTROL TEMPERATURE shall cause an auditory and visual alarm to operate.

Page 2 of 6
 Guidance and manufacturer’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic emission

The Infant Incubator is intended for use in the electromagnetic environment specified below. The
customer of the user of the Infant Incubator should assure that it is used in such and environment.
Emission test Compliance
RF emissions
Group 1
CISPR 11
RF emission
Class A
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
Complies
IEC 61000-3-3
NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or
re-orienting the equipment.

Page 3 of 6
 Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic immunity

The Infant Incubator is intended for use in the electromagnetic environment specified below. The
customer or the user of Infant Incubator should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level
Electrostatic discharge (ESD) 8 kV contact 8 kV contact
IEC 61000-4-2 15 kV air 15 kV air
Electrical fast transient/burst 2 kV for power supply lines 2 kV for power supply lines
IEC 61000-4-4
Surge 1 kV differential mode 1 kV differential mode
IEC 61000-4-5 2 kV common mode 2 kV common mode
0 % UT; 0,5 cycle 0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315° 225°, 270° and 315°
Voltage dips, short interruptions
and voltage variations on power 0 % UT; 1 cycle and 0 % UT; 1 cycle and
supply input lines
IEC 61000-4-11 70 % UT; 25 cycles 70 % UT; 25 cycles
Single phase: at 0° Single phase: at 0°

0 % UT; 250cycle 0 % UT; 250 cycle

Power frequency magnetic field
（50/60HZ） 30A/m 30A/m
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

Page 4 of 6
 Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic immunity

The Infant Incubator is intended for use in the electromagnetic environment specified below. The
customer or the user of Infant Incubator should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level

3Vrms
150 kHz to 80 MHz 3 Vrms
Conducted RF
IEC 61000-4-6

6 Vrms
150 kHz to 80 MHz 6 Vrms
in ISM bands

Radiated RF 10 V/m
10V/m
IEC 61000-4-3 80 MHz to 2.7 GHz

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to
6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70
MHz.
b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the
frequency range 80 MHz to 2.5GHz are intended to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas. For this reason, an additional factor of 10/3 is used in calculating the recommended
separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Infant Incubator is used exceeds the applicable RF
compliance level above, the Infant Incubator should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the Infant Incubator.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Page 5 of 6
 Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
IMMUNITY to proximity fields from RF wireless communications equipment

The ENCLOSURE PORT of ME EQUIPMENT and ME SYSTEMS shall be tested as specified in

Table 9 using the test methods specified in IEC 61000-4-3..
Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment
Test Maximum IMMUNITY
Band a) Distance
frequency Service a) Modulation b) Power TEST LEVEL
(MHZ) (m)
(MHZ) (W) (v/m)
Pulse
385 380-390 TETRA 400 modulation b) 1,8 0,3 27
18 Hz
FM c)
GMRS 460,
450 430-470 ±5 kHz deviation 2 0,3 28
FRS 460
1 kHz sine
710 Pulse
LTE
745 704-787 modulation b) 0,2 0,3 9
Band13, 17
780 217 Hz
GSM
810
800/900,TE
Pulse
870 TRA 800,
800-960 modulation b) 2 0,3 28
iDEN 820,
18 Hz
930 CDMA 850,
LTE Band 5
GSM 1800;
1720
CDMA 1900;
Pulse
1700- GSM 1900;
1845 modulation b) 2 0,3 28
1990 DECT; LTE
217 Hz
Band 1, 3, 4,
1970
25; UMTS
Bluetooth,
WLAN,
Pulse
2400- 802.11
2450 modulation b) 2 0,3 28
2570 b/g/n,
217 Hz
RFID 2450,
LTE Band 7
5240 Pulse
5100- WLAN
5500 modulation b) 0,2 0,3 9
5800 802.11 a/n
5785 217 Hz
NOTE If necessary to achieve the IMMUNITY TEST LEVEL , the distance between the transmitting
antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is
permitted by IEC 61000-4-3.
a)
For some services, only the uplink frequencies are included.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it
does not represent actual modulation, it would be worst case.

Page 6 of 6
 MANUAL FOR INFANT INCUBATOR

WARRANTY
The product being described in this manual is warranted against defects in materials or
workmanship for one year from the date of shipment, with the following exceptions.
1. All consumable and disposable products are guaranteed to be free from defects upon
shipment only.
2. Calibrations are considered normal maintenance and are not included in the 1-year
warranty.
During the warranty period any defective parts other than those listed above will be replaced
at no charge to the customer.
This warranty is rendered void and our company cannot be held liable for conditions resultant
therefrom if:
1. Damage to the unit is incurred as a result of mishandling.
2. The customer fails to maintain the unit in a proper manner.
3. The customer uses any parts, accessories, or fittings not specified or sold by our company.
4. Sale or service is performed by the non-certified service/dealer agency.
5. For related technical instructions, please refer to the maintenance manual.
This warranty is in lieu of all other warranties, expressed or implied, and our company shall in
no event be liable for incidental or consequential damages including loss of use, property damage,
or personal injury resulting from breach of warranty.
The Accreditation Manual for Hospitals requires each piece of equipment to be tested prior to
initial use and at least annually thereafter. To comply with this standard, we recommend that you
participate in our accreditation Testing compliance Program during the warranty period. This
service can be performed through our company and authorized dealers.

SERVICE
For optimal performance, product service should be performed only by qualified service
personnel who is authorized by manufacturer. Please contact the local agency or the After-Sales
of our company to get more technical information about maintenance.

i
I5
 MANUAL FOR INFANT INCUBATOR

OPERATING PRECAUTIONS
1. INFANT INCUBATOR (incubator) belongs to high risk medical device which can endanger

infant's life. Therefore please use the device only in neonate nursing room, children nursing room,

pediatric intensive care unit or similar sickroom in hospital. Operators for the device should be

special trained and operate the device under the instruction of medical practitioner.

2. The operator must keep observing the patient's condition while the device is working.

Supervise and record baby's temperature regularly to check whether the temperature of the

patient is over high/low or any other unusual conditions happen. Suggest motoring the baby

temperature at least I time every half hour.

3. Please stop using the device when failure or malfunction appears. Turn off the power and

transfer the patient out from the device, then inform our company or our authorized agency for

service. DO NOT ask for service from person who's not been authorized by our company.

4. Direct radiation from sunlight or other infrared source could cause overheating of the infant

without activating the Over Temperature Alarm. DO NOT leave the INCUBATOR in direct sunlight

or near other sources of radiant heat.

5. DO NOT leave the INCUBATOR in the presence of flammable anaesthetic gases or other

flammable materials, such as some types of cleaning fluids.

6. DO NOT leave the INCUBATOR in the presence of strong electromagnetic field. Portable and

mobile RF communication devices may have an impact on this device.

7. Devices which are easily interfered by magnetic field should not be used near the INCUBATOR

because they may interfered by the INCUBATOR.

8. The incubator does not equip the air cleaner, to make sure the good air quality inside hood, the

incubator should be used in the environment with clean air.

9. Please DO NOT use the INCUBATOR under working environment not stipulated in table 1.1,

or else, it may cause the failure or the INCUBATOR can not reach the requirements.

10. To prevent harm to the infant, the hood should not be raised while leads are connected to the

infant or if the mattress tilted.

11. There should be no need to raise the hood at any time while the infant is cared for in the

incubator. All necessary access to the infant can be achieved by means of the Access Panel and

Access Doors.

ii
I5
 MANUAL FOR INFANT INCUBATOR

12. When the Front and Back Access Panels are open, the temperature from the air temperature

indicator maybe not the real temperature inside incubator. Therefore, do not leave the Access

Panels open in a long period.

13. All access panel‘s latch should be firm plugged, in case accidental open.

14. For infant safety, DO NOT leave the infant unattended when the Front and Back Access

Panels are open.

15. Other accessories within the incubator which can alter the air flow pattern may affect

temperature uniformity and temperature variability. In addition,we suggest the incubator run on

skin temperature mode. Otherwise, according to the baby temperature measurement result, the

incubator temperature set value must be reduced.

16. Patient safety and incubator performance may be compromised if air flow passages are not

kept clear from obstructions (blankets, stuffed animals, etc.) during clinical usage.

17. Do not place surgical covers or blankets over the infant and warm air curtain or side vents

simultaneously. This may cause heat induced injury and burns.

18. The incubator should be moved by at least two personnel who have certain power, the handle

located on both side of the incubator can be used as hands handle when moving. Please pull out

all power cords before moving.

19. To prevent the harm on patient for accidental movement, please lock the casters during

usage.

20. To prevent accidental disconnection, secure all patient leads, infusion lines and ventilator

tubing to the mattress with sufficient excess length to allow for the full range of mattress height

adjustment.

21. To avoid water over flow from water chamber, and keeping the most stable position of infant

incubator, before moving all of accessories should be fixed to the right position and let out all of

the water.

22. Do not switch on for longer time than essential, when the machine not connected to the power

supply, otherwise, power supply failure alarm will be activated and the internal battery current

waste.

23. When using X-Ray tray via incubator hood, the shadow of hood will reflect on the X-ray

negative. That maybe influence the doctor’s diagnose.

24. Do not place any article higher than incubator’s caster under its VHA stand which may affect

the stabilization of VHA stand.

iii
I5
 MANUAL FOR INFANT INCUBATOR

25. When operating the VHA stand, support the incubator with one hand on to prevent it from

unbalance.

26. In nursing operation, the operator can not touch the other charged equipment at the same

time, may bring shock hazard to patients.

27. Only the authorized and qualified maintenance personnel can replace the fuse according to

the specification. When replace the fuse, you should disconnect the power supply of the incubator

first, and can not touch the patients and metal parts at the same time.

28. The device must be fully cleaned and sterilized for the first time for initial use, after nursing for

one baby, after used it for one week or there's dirt in the incubator. Cleaning and sterilizing

methods please refer to Section 5.

29. Please use the registered neutral detergent/ disinfectant. Other disinfectant (like alcohol) will

destroy some parts of the incubator. Please follow the instruction for detergent usage.

30. After cleaning the incubator by combustible cleaning solvent should airing the incubator

completely. The residual a handful of the flammable solvent (such as ethyl ether, ethanol or

similar cleaning solvent) in the incubator can cause a fire.

31. Please only use skin temperature sensor, rechargeable battery,power cord or other accessories

provided by our company. Otherwise, it may reduce the safety of the equipment.

32. The lifetime of incubator internal rechargeable battery is usually 3 years. Before using it every

time, we should inspect the status of internal rechargeable battery according to the requirement in

section 5.3. If it isn't getting through the inspection or the battery has been used more than three

years, it must be replaced. The internal rechargeable battery should be replaced by authorized

qualified service personnel.

33. The device should not be close to or use with other device. If have to, please observed to

verify that in its use of configuration can run normally or not.

34. Damages will be easily caused if using the incubator after it reached its lifetime. Previous

capability guideline and requirement cannot be reached as well.

35. The life period of incubator is 8 years. The device, accessories and the packaging have to be

disposed of waste correctly at the end of the usage. Please follow Local Ordinances or

Regulations for disposal.

ELECTRICAL PRECAUTIONS
1. This equipment must only be connected to a supply mains with protective earth. If any doubt

exists as to the grounding connection, do not operate the equipment.

iv
I5
 MANUAL FOR INFANT INCUBATOR

2. An electric shock hazard exists within the Controller and VHA stand assembly when the cover

is removed. Servicing should be performed only by qualified personnel with appropriate service

documentation.

3. To prevent equipment damage or accidental power disconnection, Do NOT connect an

Incubator power cord directly to an ac wall socket. Always provide power to the Incubator using

the power cord coming directly form the VHA stand.

4. Make sure the building power source is compatible with the electrical specifications shown on

the rear center column of the VHA stand.

5. Power of incubator is supplied by the net power from VHA stand. Please unplug the power

cable when stop using or maintain incubators.

6. Improbably using of the assistant device will cause the decrease of our device’s safety. The

safety of auxiliary devices shall comply with the general requirements for safety according to

IEC60601-1, and have acquired the certificate by relative institution.

7. Equipment provided an integral multiple socket-outlet, If connecting the auxiliary equipment on

this interface, the maximum power of the auxiliary equipment shall not exceed the prescribed load

limit, The assembly of ME SYSTEMS and modifications during the actual service life require

evaluation to the requirements of IEC60601-1, clause 16. Anybody connecting additional

equipment to medical electrical equipment configures a medical system and is therefore

responsible that the system complies with the requirements for medical electrical systems.

Attention is drawn to the fact that local laws take priority over the above mentioned requirements.

If in doubt, consult your local representative or the technical service department.

8. When the incubator is installed with the VHA, for, the device will use the power plug and socket

as the way to insulate the device from the main power supply for safety. Please ensure that the

plug is easy to operate.

9. General Power switch used as isolation device from the mains supply. When the operator want

to safely terminate operation of Me Equipment, please cut off the General Power switch.

Equipment should be placed where it is easy to operate.

10. Any parts are not serviced or maintained while in use with the patient.

11. When selecting the ancillary equipment must insure that the equipment had tested according

to the requirements in IEC60601-1 or other relevant standard, and acquire the safety certificate.

v
I5
 MANUAL FOR INFANT INCUBATOR

HUMIDITY PRECAUTIONS
1. The incubator is with the humidity controller, it can increase the Humidity of incubator

according to the clinical demands.

2. Higher relative humidity will, at any given time, decrease an infant’s evaporative water loss and

may cause an increase in infant temperature. Monitor the infant’s temperature as required.

3. Use only distilled water to fill or refill the Reservoir. Tap water may contain organisms that may

flourish in the heated water of the humidifier.

4. Make sure all hood access door gaskets and tubing ports are properly installed. Any open gaps

in the incubator hood will reduce the incubator’s internal relative humidity.

5. Fill the humidity chamber to the bottom of the MAXIUM LIMIT line. DO NOT OVERFILL. Or

else water spillage may result.

6. At high humidity levels within the incubator hood (typically more than 80%RH), condensation

may form on the inside walls of the hood.

7. When there is much more difference between the humidity setting value and the humidity of

environment, it is very difficult to reach the needed control value of the humidity inside of the

incubator.

8. Following the doctor’s advice when setting the relative humidity.

OXYGEN PRECAUTIONS
1. This incubator is with oxygen control system, please use medical oxygen when feeding oxygen.

2. Abusing of supplemental oxygen may result in serious aftereffects which include blindness,

brain damage, even death. Therefore, keeping to the main doctor's direction strictly and

monitoring the oxygen supplement condition for the patient in a regularly time.

3. If it is necessary to administer Oxygen in an emergency, notify the attending physician

immediately.

4. When supplementing the oxygen, calibrated oxygen analyzer must be turned on for monitoring

the oxygen concentration.

5. Oxygen feeding may increase the noise level inside the hood.

6. As Oxygen use increases the danger of fire. To ensure the device safety, make all flammable

material far away from incubator, and auxiliary equipment producing sparks should not be placed

near incubator.

vi
I5
 MANUAL FOR INFANT INCUBATOR

7. When the oil, grease, other fat substance and the compressed oxygen meet, it will self-ignite

seriously, therefore, try to avoid the oxygen pressure reducing valve/adjustment valve, valve for

oxygen cylinder, pipe, connector containing these substance.

8. Do not use combustible material like aether, alcohol etc. because once even a little aether,

alcohol, or other combustible material mixed with oxygen in the incubator, it’ll cause fire.

9. When modulating the oxygen flux every time, please leave 30min. at least for the incubator

regaining the new oxygen concentration.

10. There’s a pressurize device filling with potassium hydroxide electrolyte installed inside the

oxygen sensor. If the sensor leaks, please stop using and chuck it. If the leaking electrolyte

touches skin or clothes, please wash with clean water immediately. If the leaking electrolyte

touches eyes, please wash eyes with clean water for 15 min. and keep them open, notify the

doctor immediately.

11. Seasonal check the gas and the oxygen transporting parts to see if they are eroded or broken.

12. Seasonal check the battery of oxygen sensor to if they are leaking or aging. Replace them if it

is necessary.

13. To operate the auxiliary oxygen equipment together with incubator,please refer to the

corresponding instruction manual.

14. Under 100% oxygen concentration the oxygen sensor service life is up to 10000 hours.

WEIGHING PRECAUTIONS
1. The electrical scale installed in the bassinet must work after 30 minutes’ warm-up in the

incubator, that is to say the electrical scale can’t work until being put in the incubator which is set

the using temperature and begins working for at least 30min. Or else, the number read on the

scale will surpass the regulated value.

2. Please keep the patient horizontal and in the middle of the bassinet while weighing.

3. The maximum weighing weight of Infant scale is 8kg, please don’t over loading, or else the

scale will be damaged.

4. Lay the bassinet with infant scale gently when loading or unloading, don’t press surface of the

bassinet to avoid damage the weight sensor inside the bassinet.

5. The displayed weighing value is just for reference.

vii
I5
 MANUAL FOR INFANT INCUBATOR

SEASONAL SAFETY CHECK

1. Please clean the plug of power cord at least once a year. Too much dust on plug may cause
the fire.
2. The air sensor should be calibrated every half year, and only the authorized qualified service
personnel can do that.
3. The following safety checks should be performed at least every 12 months by a qualified
person who has adequate training, knowledge, and practical experience to perform these tests.
The data should be recorded in an equipment log.
1 . Inspect the equipment and accessories for mechanical and functional damage.
○
2 . Inspect the safety relevant labels for legibility.
○
3 . Inspect the fuse to verify compliance with rated current and breaking characteristics.
○
4 . Verify that the device functions properly as described in the instructions for use.
○
5 . Test the protection earth resistance according IEC 60601-1:2005+[Link] Limit 0.1Ω
○
(including Power line: Limit 0.2Ω).
6 . Test the earth leakage current according IEC60601-1:2005+[Link] Limit: NC 5mA,
○
SFC: 10mA.
7 . Test the enclosure leakage current according to IEC 60601-1:2005+[Link] Limit: NC
○
100μA, SFC: 500μA.
8 . Test the patient leakage current according IEC 60601-1:2005+[Link] Limit: for a.c.:
○
100μA (BF), for d.c.: 10μA (BF).
9 . Test the patient leakage current under single fault condition with mains voltage on the
○
applied part according IEC 60601-1:2005+[Link] Limit: for a.c.:500μA (BF), for d.c.: 50μA (BF).
10 . According to the test methods of IEC 60601-1:2005+A1:2012, the patient leakage current
○
(net voltage should be added on the applied part) of the testing device must less than 5000μA.
11 . Test the patient auxiliary leakage current according IEC 60601-1:2005+[Link] Limit:
○
NC for a.c.: 100μA (BF), for d.c.: 10μA (BF).SFC for a.c.: 500μA (BF), for d.c.: 50μA (BF).
4. The essential performance should be verified at least once a year by qualified service
personnel who gets trained and obtain written authorization of the company. The essential
performance verification method shall meet the requirements of clause [Link],
[Link], [Link].1ee) and [Link].1dd) of IEC60601-2-19:2016.

TABLE OF DEFINITIONS AND SYMBOLS

TECHNICAL DEFINITIONS
SKIN TEMPERATURE SENSOR: A sensing device including the link with the equipment
intended to measure the infant’s skin temperature.
INCUBATOR TEMPERATURE: Air temperature at a point 10cm above and centered over the
mattress surface.

viii
I5
 MANUAL FOR INFANT INCUBATOR

CONTROL TEMPERATURE: The temperature set at the temperature control.

AVERAGE INCUBATOR TEMPERATURE: The average of the maximum and minimum
Incubator temperatures achieved during Temperature Condition.
STEADY TEMPERATURE CONDITION: A condition which is reached when the temperature
does not vary by more than 1℃ over a period of 1 hour.
TEMPERATURE ALARM CHECKOUT STATE: The difference between real temperature and
control temperature is within ±0.5℃. The equipment must stay in such state when check up the
alarm about temperature
TEMPERATURE UNIFORMITY: The amount by which the average temperature at each of four
points 10cm above the mattress surface differs from the Average incubator Temperature at
steady Temperature Condition. The four points are the centers of four quadrants formed by lines
that divide the width and length of the mattress surface.
TEMPERATURE VARIABILITY ： The variability of the Incubator Temperature that will be
observed over a one hour period after Incubator Temperature Equilibrium has been reached.
TEMPERATURE RISING TIME: The time required for the Incubator Temperature to rise 11℃,
when the Air Control Temperature is at least 12℃ above ambient.
STEADY HUMIDITY CONDITION: A condition that the disparity between the indicated humidity
value and control value is less than ±5%RH, and maintains over 1 min.
LIFETIME OF PRODUCT: The period from sell-by date to the date of discarding as useless.
VHA STAND: Abbreviation of vertical height adjustment stand.

NOTE, IMPORTANT, CAUTION AND WARNING

NOTE: A note is inserted in text to point out procedures or conditions, which may otherwise be

misinterpreted or overlooked. A note may also be used to clarify apparently contradictory or

confusing situations.

IMPORTANT: Similar to a Note but be used where greater emphasis is required.

CAUTION: A caution is inserted in text to call attention of a procedure which, It not followed

exactly, can lead to damage or destruction of the equipment.

WARNING: A warning is inserted in text to call attention to dangerous or hazardous conditions

inherent to the operation, cleaning, and maintenance of the equipment which may result in

personal Injury or death of the operator or patient.

ix
I5
 MANUAL FOR INFANT INCUBATOR

SYMBOLS

General warning sign Follow instructions for use

CLASS I Class I equipment Type BF Applied part

Main power on Main power off

On (only for a part of equipment) Off (only for a part of equipment)

User-Defined key Keypad lock

Set temperature up key Set temperature down key

Silence /Reset Key RS232 RS232 Connector

Socket for skin temperature 1 Socket for skin temperature 2

High water level Low water level

Warning; Hot surface Mattress tilt direction

Low High

The VHA stand rising key The VHA stand falling key

220-230V~
AC Power 220-230V/50Hz F 6.3AH/250V F Type Fuse 6.3AH/250V
50Hz
220-230V~
50Hz Assistant net power outlet, MAX: 3A No heavy load
MAX:3A

SN Serial Number Date of manufacture

Authorized representative in the

Manufacturer
European community

CE Marking Baby scale socket

x
I5
 MANUAL FOR INFANT INCUBATOR

TABLE OF CONTENTS

SECTION PAGE
1. GENERAL INFORMATION…………………………………………………………………………1-1
1.1 INTRODUCTION……………………………………………………………………………………1-1
1.2 PRODUCT CONTRAINDICATIONS………………………………………………………………1-1
1.3 INTENDED USE……………………………………………………………………………………1-1
1.4 COMPOSITION OF PRODUCTS…………………………………………………………………1-1
1.5 DESCRIPTION………………………………………………………………………………………1-1
1.6 SPECIFICATIONS…………………………………………………………………………………1-3

2. INSTALLATION………………………………………………………………………………………2-1
2.1 GENERAL……………………………………………………………………………………………2-1
2.2 UNPACKING…………………………………………………………………………………………2-1
2.3 INSTALLATION…………………………………………………………………………………… 2-1

3. FUNCTION DESCRIPTION…………………………………………………………………………3-1
3.1 OVERALL FUNCTIONAL DESCRIPTION………………………………………………………3-1
3.2 TEMPERATURE CONTROL PRINCIPLE………………………………………………………3-1
3.3 DATA COMMUNICATION CONNECTOR………………………………………………………3-2
3.4 ALARMING AND SYSTEM INDICATION INFORMATION……………………………………3-3

4. OPERATION…………………………………………………………………………………………4-1
4.1 GENERAL……………………………………………………………………………………………4-1
4.2 POWER SUPPLY CONNECTION AND SWITCH CONTROL…………………………………4-1
4.3 OPERATIONAL CHECKOUT PROCEDURE……………………………………………………4-8
4.4 GENERAL OPERATION PROCEDURE………………………………………………………4-17

5. CLEANING AND MAINTENANCE…………………………………………………………………5-1

5.1 GENERAL……………………………………………………………………………………………5-1
5.2 CLEANING…………………………………………………………………………………………5-1
5.3 MAINTENANCE……………………………………………………………………………………5-9
5.4 TROUBLE SHOOTING……………………………………………………………………………5-9

6. OXYGEN CONCENTRATION MONITORING/CONTROL SYSTEM…………………………6-1

6.1 GENERAL……………………………………………………………………………………………6-1
6.2 INSTALLATION OF OXYGEN SENSOR…………………………………………………………6-1
6.3 FUNCTIONAL DESCRIPTION……………………………………………………………………6-2

xi
I5
 MANUAL FOR INFANT INCUBATOR

6.4 CONNECTION OF OXYGEN INPUT CONNECTOR……………………………………………6-2

6.5 OXYGEN SYSTEM OPERATIONAL CHECKOUT PROCEDURE……………………………6-3
6.6 USING OF OXYGEN SUPPLY SYSTEM…………………………………………………………6-5
6.7 MAINTENANCE……………………………………………………………………………………6-9

7. HUMIDITY CONTROL SYSTEM……………………………………………………………………7-1

7.1 GENERAL……………………………………………………………………………………………7-1
7.2 FUNCTIONAL DESCRIPTION……………………………………………………………………7-1
7.3 OPERATION AND CALIBRATION PROCEDURES……………………………………………7-1
7.4 USING THE HUMIDITY CONTROL SYSTEM…………………………………………………7-2
7.5 MAINTENANCE……………………………………………………………………………………7-6

8. WEIGHT SYSTEM……………………………………………………………………………………8-1
8.1 GENERAL……………………………………………………………………………………………8-1
8.2 INSTALLATION……………………………………………………………………………………8-1
8.3 FUNCTION DESCRIPTION………………………………………………………………………8-2
8.4 OPERATION AND CALIBRATION PROCEDURES……………………………………………8-2
8.5 OPERATION OF WEIGHING SYSTEM…………………………………………………………8-5
8.6 MAINTENANCE……………………………………………………………………………………8-5

9. PARTS LIST…………………………………………………………………………………………9-1

NOTE: The product composition maybe different from this manual, but it does not affect
product function. Please understand.

xii
I5
 MANUAL FOR INFANT INCUBATOR

SECTION 1
GENERAL INFORMATION
1.1 INTRODUCTION
This manual provides instructions for installation, debugging, operation, cleaning and
maintenance of Infant Incubator (incubator). We are not responsible for the malfunction which is
caused due to not following the instruction on our manual.
The operator should read and understand of the content of this manual.
This manual should be put together with the device so as to the client to check at any
moment.
Monitoring tray, manually mattress tilt function, Panel damping system, oxygen concentration
control system and the weighing system are optional. We also provide Disposable skin
temperature sensor for your choice. You can ignore the relative contents if you do not purchase
them.
1.2 PRODUCT CONTRAINDICATIONS
It is not clear now.
1.3 INTENDED USE
The Infant Incubator is intended to provide a controlled thermal environment and isolation
from ambient air for premature and neonatal infants. The infant incubator is not intended for the
transport of infants.
1.4 COMPOSITION OF PRODUCTS
The infant incubator consists of four components: the double wall hood, the base, the VHA
stand, and the controller. The sponge based mattress positions centrally within the confines of the
hood.
1.5 DESCRIPTION
The following diagram shows the main parts of the Infant Incubator.

Monitoring shelf
I.V. Pole

Shelf Baby compartment

Controller

Base

Mobile Cabinet

1-1
I5
 MANUAL FOR INFANT INCUBATOR

DESCRIPTION OF PART EXPLANATION

A kind of bearing part, which is used for hanging the infusion bottle.
I.V. pole
Max. Load: 2Kg

The core part with two kinds of temperature control modes: air
mode, baby mode, moreover, it also have the function of weighing,
humidity control and oxygen concentration controlling system
which are used for auto-control the heat output and the humidity
Controller
and oxygen concentration in the incubator. The detail operation to
temperature please refer to the section 4, to oxygen concentration
please refer to the section 6, to humidity please refer to the section
7, to weighing please refers to the section 8.

A kind of bearing part, which is used for putting some small objects.
Shelf
Max. Load: 3.5Kg

A kind of bearing part, which is used for putting Infant monitor

Monitoring shelf system.
Max. Load: 8Kg

It is used for placing the infant inside, including the Double-wall

Acrylic hood, bassinet, and so on. Panel damping system is
optional for the front access panel. The bassinet can be tilted at the
Baby compartment request of clinical needs. The baby scale is optional part, and the
Max. Load of bassinet is 10 Kg.
Max. Load of mattress with weighing system configuration: 8kg.
Size of mattress: 740mm×376mm

An important part of Infant Incubator, which is mainly composed of

Base
the oxygen device, humidity chamber, air filter, and so on.

A part which can support the main body of Infant Incubator.

Cabinets are supplied in VHA stand which include large and small
storage compartment.
Mobile Cabinet
Big storage compartment Max. load: 4 Kg.
Small storage compartment Max. load: 2 Kg.
Storage cover Max. load: 1 Kg.

The max. Load of tray and the other accessories is the value in the list, not
overloaded, so as not to damage to the accessories.

NOTE: Size of Infant Incubator: L1270× W650×H1500mm ~L1270× W650×H1650mm.

Distance from the bassinet to the floor: 950mm ~ 1100mm.
Weight of Infant Incubator: 117Kg.

1-2
I5
 MANUAL FOR INFANT INCUBATOR

1.6 SPECIFICATIONS
This product’s classification as follows:
By the electric shock protection type classification: Type I equipment.
By the degree of shock proof classification: Type BF application part
By the specified of IEC60529 for liquid protection degree classification:IPX0.
By the manufacturers recommended disinfection and sterilization method classification: Use
neutral disinfection solvents or solution to clean. The tank can use steam sterilization.
By the air mixer of flammable gas or with oxygen or nitrous oxide mixture of flammable
anaesthetic gas safety degree classification: It should not use in air mixer of flammable gas or
with oxygen or nitrous oxide mixture of flammable anaesthetic gas.
By operational mode classification: Continuous operation.
Specifications for the Infant Incubator are provided in table 1.1.
TABLE 1.1 SPECIFICATIONS

Power Requirements…………………………………………………AC220V-230V/50Hz, 1300VA

Maximum Heater Power Output………………………………………………………350W/240V
Auxiliary Mains Power Output………………………AC220V-230V/50Hz, MAX. CURRENT 3A
Heater power display……………………………………0 to 100%, adjustable in 10% increments
Temperature control modes…………………………………………………………………Air mode
Baby mode
Air Temperature Control range………………….………………………………………25℃~37℃
37℃~39℃(override mode)
Baby Temperature Control range……………………………..…………………………34℃~37℃
37℃~38℃(override mode)
Temperature sensor display range……………………………………………………5℃~65℃
Temperature rise Time* (environment temperature is +22℃) ……………….…….… ≤40min
Temperature variability*…………………………………………………………………………≤0.5℃
Temperature Uniformity* (level mattress) …………………………………………………≤0.8℃
Temperature Uniformity* (Tilt mattress) ……………………………………………………≤1.0℃
The difference between average incubator temperature with the control temperature
………………………………………………………………………………………………………≤1.0℃
Skin temperature sensor precision………………………………………………………±0.2℃

ALARM(See 3.4 section)

General alarm……………………………………………………………Power failure alarm
Fan motor alarm
Sensor failure alarm
Deviation alarm
Over temperature alarm
The sensor box position alarm
Tank position alarm
Water shortage alarm

1-3
I5
 MANUAL FOR INFANT INCUBATOR

TABLE 1.1 SPECIFICATIONS（continued）

System alarm………………………………………………………………ROM failure alarm

Internal system failure Alarm
SRAM failure Alarm
EEPROM failure Alarm
Real time clock failure alarm
Communication failure alarm
ADC failure alarm
Key- board failure alarm
Battery failure alarm
LCD display failure alarm
Temperature heater failure alarm
Humidity heater failure alarm

HUMIDITY CONTROLLING
Running time after the Reservoir filled by distilled water……Humidity<70%RH, 24h at least
Reservoir’s cubage…………………………………….......……………………………………1200ml
Humidity display range……………..………..………………………………………0%RH～99%RH
Humidity control range…………………………………. 0%～90%（adjustable in 1% each time）
Humidity control precision……………………………………………………………………±5%RH
Humidity display precision（ENVI TEM. 25℃, ENVI humidity 45% RH±5% RH）……±5%RH
NOTE: In the surrounding of high humidity, it may not control the humidity to a relatively
low level.

OXYGEN CONCENTRATION CONTROLLING

Oxygen concentration display range……………………………………………………0%～99%
Oxygen concentration display resolution………………………………………………………1%
Oxygen concentration display precision……………………………………………………………
±2%O2（Oxygen concentration set value is below 25% ）
±3%O2（Oxygen concentration set value is above 25% ）
Oxygen concentration control precision……………Within ±4% oxygen Volume concentration
Oxygen concentration setting range…………………20%～60%（adjustable in 1% each time）
Life time of oxygen sensor………………………….……………10000h MAX. with 100% oxygen

WEIGHING DISPLAY
Weight range………………………………………………………………………………100～8000g
Weight display resolution…………………………………………………………………………1g
Weight display precision…………………………………………………………………………±1%

1-4
I5
 MANUAL FOR INFANT INCUBATOR

TABLE 1.1 SPECIFICATIONS（continued）

ENVIRONMENT TEMP (Not to use in the environment exceed specified)

Operating range……………………………………………………………………………+20～+30℃
Transport and storage range……………………………………………………………-20～+55℃

ENVIRONMENT HUMIDITY
Operating range……………………………………………………………………….30%～75%RH
Transport and storage range……………………………………………………………… ≤93%RH

ATMOSPHERIC PRESSURE
Shipment and Store atmospheric pressure range……………………………500hPa～1060hPa
Operating atmospheric pressure range………………………………………800hPa～1060hPa

Application environment altitude……………………………………..……………………≤2000m

Overvoltage category……………………………………..……………………………………………II
Pollution degree…………………………………………………………………………………………2

AIR FLOW RATE

Ambient air movement rate……….…………………………………………………………<0.3m/s

OTHER SPECIFICATION
Noise inside hood…………………………………Under the steady temperature condition ≤45dB(A)
under other conditions ≤50dB(A)
[Ambient noise: ≤35dB(A)]
Carbon dioxide(CO2) concentration within the hood…………Less than 0.5% when a mixture
CO2 is delivered at 750ml/min at a
Point 10cm above the center of the mattress
Air Flow rate above Mattress…………………………………………………………………≤0.35m/s

*Refer to Table of Definitions and Symbols

NOTE: If opening the front Access Panel or Access door or using infant bed, supplies or
other equipment within incubator can alter the air flow pattern so as to affect the
temperature uniformity, temperature variability, the correlation of the incubator
temperature reading to center mattress temperature and skin temperature.

1-5
I5
 MANUAL FOR INFANT INCUBATOR

SECTION 2
INSTALLATION
2.1 GENERAL
This section provides installing procedures about Infant Incubator.
2.2 UNPACKING
Generally, the Infant Incubator is usually packed to two cartons: main body and VHA stand.
When taking out the equipment from the cartons, take care not to damage the spare parts of the
Infant Incubator.
2.3 INSTALLATION
Before installation, checking if the surface of structure parts attached is adequate. At least two
professionals are required to do the installation of the Infant Incubator with spanners.
A. Install the main body onto the VHA stand
Mount the main body on the VHA stand using the four hexangular bolts M6X45, spring washer
M6, flat washer M6 by the equipment provided figured as 2.1.

ENLARGED ILLUSTRATION I

Flat Washer M6

Spring Washer M6

Hexangular Bolt M6X45

TEMPERATURE CONTROLLER
POWER PLUG

I5 2-1
 MANUAL FOR INFANT INCUBATOR

Insert the temperature controller power

WHEEL UNLOCKED WHEEL LOCKED Cord to the socket.
NOTE: The Pedestal front locking casters must be facing down to be locked indicated by
arrow 1. The Pedestal front locking casters must be facing down to be unlocked
indicated by arrow 2.
FIGURE 2.1
IMPORTANT: The main body can be installed on the VHA stand only if the power cord of
temperature controller from the VHA stand is located on the same side with
the temperature controller.

WARNING: 1. The incubator must be attached to the VHA stand using the bolts provided.
Failure to do so could result in the incubator separating from the VHA stand
if the VHA stand is tilted, particularly when the hood is open.
2. To prevent the incubator from sliding when fixed on an incline, the front
locking caster for the VHA stand must be facing down the incline and locked.

B. Install the I.V. Pole

Seat for the monitor shelf

Step 1: Fix the seat for monitoring shelf on the right and left sides of the main body with the inner
hexagon bolts.

2-2 I5
 MANUAL FOR INFANT INCUBATOR

I.V. Pole
Support pole for I.V. Pole

Clamp seat

Support pole for I.V. Pole

Step 2: Fix the I.V. Pole on the Seat for the monitor Step 3: Adjust the proper height of I.V.
shelf with latch seat and the inner hexagon Pole, and tighten it as the arrow
bolts as the arrow indicates. indicates.
FIGURE 2.2

C. Install Shelf
As figure 2.3 indicates, Use inner hexagon bolt and fix seat1 to fix the shelf on the I.V.
support.

Shelf

Inner Hexagon Bolts

Fix Seat 1

FIGURE 2.3

The side with note label of shelf must be installed in front of the incubator.

D. Install Monitoring Shelf

See figure 2.4, using the method of fixing support pole for I.V. pole, fix the support pole for

shelf on the seat for monitoring. Insert the one terminal of tray with hole into the hole of support

pole of monitor, and fasten it with inner hexagon bolt tightly.

I5 2-3
 MANUAL FOR INFANT INCUBATOR

Monitoring Shelf

The support pole for monitoring shelf

The inner hexagon bolts M5×30

FIGURE 2.4

E. Install the storage

Put Φ6 spring washer, Φ6 flat washer and Φ6 outer sawtooth tighten washer onto the four
inner hexagon bolt M6X20 by turn as figure 2.5 shows. Then fix the small storage and big storage
to both sides of VHA stand separately by inner hexagon spanner.

Inner hexagon bolt

Storage bracket

FIGURE 2.5

F. Connect the sensor

Connect the sensor connector with sensor socket which is on the side of the incubator’s main
body as figure 2.6 directed. Then tighten the bolt in the connector.
NOTE：Connection between the sensor connector and socket should in the right orientation
for these two parts have their own direction.

Fixed bolt

Sensor connector
FIGURE 2.6

G. Install oxygen sensor

Refer to the section 6 to see the detail.

2-4 I5
 MANUAL FOR INFANT INCUBATOR

H. Install weighing system

Refer to the section 8 to see the detail.

I. Insert the power cord

Insert the power cord into the socket of general power supply.
Check the INCUBATOR according to the instruction in section 4.3.

NOTE：The main power switch of the incubator is located in the VHA stand, not to position
incubator to make it difficult to operate the power switch.

I5 2-5
 MANUAL FOR INFANT INCUBATOR

SECTION 3
FUNCTIONAL DESCRIPTION
3.1 OVERALL FUNCTION DESCRIPTION
The Infant Incubator adopts temperature control system (Air Mode and Baby Mode),
humidity controlling system, and oxygen concentration controlling system and weighing system (if
it is applicable).
Heat output control in Air Mode: It will control the heater’s output automatically according to
the Air temperature sensor; see instruction in section [Link];
Heat output control in Baby Mode: It will control the heater’s output automatically according
to the Skin temperature sensor, see instruction in section [Link].
Oxygen input control：Auto control the valve according to the oxygen concentration in the
incubator which detected by the oxygen concentration sensor. Please refer the section 6 to see
the details.
Reservoir humidifying output control：Auto control the humidifier according to the humidity
in the incubator which detected by the humidity sensor. Please refer the section 7 to see the
details.
The LCD screen of the controller shows the temperature of the air temperature and the
temperature measured by the skin temperature sensor and their setting values, as well as the
measured values of humidity and oxygen concentration. At the same time, the LCD screen also
shows the selected control mode 2,4,8,12 and 24 hours curve trend, among which,the curve trend
measured by the weighing system can be shown from 1 week to 7 weeks.
To indicate which parameter (air or skin) is controlling, the rotating wheel in the air or skin soft
key designator of display (figure 4.2 A) rotates.

3.2 TEMPERATURE CONTROL PRINCIPLE

The control of temperature, humidity and oxygen concentration inside hood is achieved by
means of the forced air circulation system as shown in Figure 3.1.
When the oxygen control function is off, the outside air is filtered, it will flow through the heater
which can heat the air, and then the air enters into the hood through the inlet port under the drive
of fan motor, after then, it will be cycled back to the fan motor through the inlet port to form the heat
air cycle flow. And this heat air flow will come to the top of water tank and enter into the hood with
the vapor above the water.

I5 3-1
 MANUAL FOR INFANT INCUBATOR

When turning on the oxygen control function, oxygen flow through the oxygen input connector,
then passes the electromagnetism valve and enters into the air-oxygen separating device through
the oxygen input connector, after then, it enters into the heat air cycle flow under the drive of the
fan motor to supply the oxygen in the incubator.

FIGURE 3.1

3.3 DATA COMMUNICATION CONNECTOR

The incubator is equipped with RS232 data communication connector and used for data
terminal output. The RS-232 communication connector is expected to connect with POS
microprinter to achieve one-way data transmission and print temperature, alarm and other data
stored in the chip of the device. The POS microprinter, when used in the infant incubator, shall
comply with IEC or ISO safety standards.

1. If connecting the auxiliary equipment on this interface, the assembly of ME SYSTEMS

and modifications during the actual service life require evaluation on the requirements of
IEC60601-1, clause 16.
2. Everyone should be responsible for the safety of the whole system requirements.
3. Only the equipment provided by our company can be connected with RS232 data
communication connector. When using, must ensure the reliable connection.
4. The service department should be responsible for the maintenance of data
communication connector, and inspect the data communication every year.
5. The connection and usage of the data communication must be performed by special
trained medical personnel, and the personnel should clear and definite the risk of data
communication.
6. Do not touch RS232 data communication connector and patient simultaneously.
7. If have any question, please contact with the agency or the service department of our
company.

3-2 I5
 MANUAL FOR INFANT INCUBATOR

3.4 ALARMING AND SYSTEM INDICATION INFORMATION

STATE
1. Alarm information
High priority: The most urgent information, red alarm light flashing, alarm sounds more than
65dB; alarm in five tones order, ring twice, and every 2.5 seconds to repeat again.
Note: The sound of power failure alarm whose sound source is a single buzzer which is
different from other high priority alarms.
Medium priority: Medium priority information, yellow alarm light flashing, alarm sounds more
than 65dB; alarm in three tones order , and every 7.5 seconds to repeat again.
Low priority: Low priority information, the yellow alarm light is continuously on, alarm sounds
more than 65dB; alarm in two tones order , and every 20 seconds to repeat again.
2. The alarm preference is arranged according to the alarm serial number, the bigger the serial
number is, the lower level it is. When various failures appear, the alarm prompts according to
the priority, the sound is different too.

ALARM INTRODUCTION
Alarm
Alarm Alarm Alarm activation Control Heater Alarm
Alarm character delay
no. information conditions mode state level
time
Power failure
Turn on the switch
Power failure alarm light High
1 when without All Off <5s
alarm flashing, sound priority
power supply
alarm start
Red alarm light
flashes, the
Alarm sensor
indicator shows Sensor box is High
2 box is placed All Off <5s
“Alarm Sensor box placed wrong priority
wrong
is placed wrong”,
sound alarm start
Red alarm light Short-circuit,
flashes, the open circuit or
Alarm error air indicator shows bad connection High
3 All Off <5s
sensor “Alarm Air Sensor inside the air priority
Fault”, sound temperature
alarm start sensor
Red alarm light Short-circuit,
flashes, the open circuit or
Alarm error indicator shows bad connection High
4 All Off <5s
isolated sensor “Alarm Isolated inside the isolated priority
Sensor Fault”, temperature
sound alarm start sensor
Red alarm light
flashes, the The difference
Alarm air
indicator shows between air
sensor is High
5 “Alarm Air Sensor sensor and All Off <2min
different from priority
is different from isolated sensor
isolated sensor
Isolated sensor ”, above 0.8℃
sound alarm start

I5 3-3
 MANUAL FOR INFANT INCUBATOR

ALARM INTRODUCTION（continued）

Alarm
Alarm Alarm Alarm activation Control Heater Alarm
Alarm character delay
no. information conditions mode state level
time
Red alarm light
Short-circuit, open
Alarm error flashes, the indicator
circuit or bad
air flow shows “Alarm Air High
6 connection inside All Off <5s
temp. flow temp. sensor priority
the air flow
sensor Fault”, sound alarm
temperature sensor
start

Red alarm light Short-circuit, open

flashes, the indicator circuit or bad
Alarm error Baby High
7 shows “Alarm error connection inside the Off <5s
skin sensor 1 mode priority
Skin Sensor 1”, skin temperature
sound alarm start sensor 1

Temperature of
incubator is not
Red alarm light
over 38℃(set
flashes, the indicator
Alarm over temperature is less High
8 shows “Alarm Over All Off <5s
temperature than 37℃), or not priority
Temperature”, sound
over 39.5℃(set
alarm start
temperature is
more than 37℃)

Temperature
measured by
Red alarm light
airflow sensor is
flashes, the indicator
over 45℃ (set
Alarm error shows “Alarm Air High
9 temperature is less All Off <5s
air flow flow Temp. Over priority
than 37℃), or over
Fault”, sound alarm
47℃ (set
start
temperature is
more than 37℃)

The temperature
measured by skin
sensor 1 is always
Red alarm light
lower 2℃ than set
Alarm skin flashes, the indicator
temperature, the
sensor 1 is shows “Alarm Skin Baby High
10 temperature On <15min
placed sensor 1 is placed mode priority
measured by air
wrong wrong”, sound alarm
sensor is lower
start
between 3.5℃ and
4.5℃ than set
temperature

Red alarm light

Motor stopped
flashes, the indicator
Alarm error running or the High
11 shows “Alarm Motor All Off <15s
motor speed is lower than priority
Fault”, sound alarm
800r/m
start

3-4 I5
 MANUAL FOR INFANT INCUBATOR

ALARM INTRODUCTION（continued）

Alarm Alarm
Alarm Alarm Control Heater Alarm
Alarm character activation delay
no. information mode state level
conditions time

Display
temperature is Air High
Off <5s
3℃ higher than mode priority
set temperature

Display
temperature is Air High
On <5s
3℃ lower than mode priority
Red alarm light flashes, set temperature
Alarm the indicator shows
12 temperature “Alarm Temp. Display
deviation Deviation”, sound alarm temperature of
Baby High
start sensor 1 is Off <5s
mode priority
higher 1℃ than
set temperature

Display
temperature of
Baby High
sensor 1 is lower On <5s
mode priority
1℃ than set
temperature

Red alarm light flashes, Short-circuit,

the indicator shows open-circuit
Alarm error High
13 “Alarm O2 sensor 1 inside the All On <5s
O2 sensor 1 priority
Fault”, sound alarm oxygen sensor 1
start or own fault
Red alarm light flashes, Short-circuit,
the indicator shows open-circuit
Alarm error High
14 “Alarm O2 sensor 2 inside the All On <5s
O2 sensor 2 priority
Fault”, sound alarm oxygen sensor 2
start or own fault

Red alarm light flashes,

The difference
Alarm O2 the indicator shows
between oxygen High
15 Sensors are “ Alarm O2 sensors are All On <10s
1 and oxygen 2 priority
different different”, sound alarm
is 3%O2
start

Oxygen display
value is 5%O2 High
All On <5s
Red alarm light flashes, higher than set priority
Alarm O2 the indicator shows value
16
Deviation “Alarm O2 Deviation”, Oxygen display
sound alarm start value is 5%O2 High
All On <5s
lower than set priority
value

Yellow alarm light

Alarm Error flashes, the indicator
Fan inside the Medium
17 Fan in the shows “Alarm Fan 1 All On <5s
controller failure priority
Control Unit Fault”, sound alarm
start

I5 3-5
 MANUAL FOR INFANT INCUBATOR

ALARM INTRODUCTION（continued）

Alarm Alarm
Alarm Alarm Control Heater Alarm
Alarm character activation delay
no. information mode state level
conditions time

Yellow alarm light Short-circuit,

Alarm Error flashes, the indicator open-circuit
Medium
18 Humidity shows “Alarm Humidity inside the All On <30s
priority
Sensor Sensor Fault”, sound humidity sensor
or own fault
alarm start

Humidity display
value is higher Medium
Yellow alarm light All On <5s
15%RH than set priority
Alarm flashes, the indicator value
19 Humidity shows “Alarm Humidity
Deviation Deviation”, sound alarm Humidity display
value is lower Medium
start All On <5s
15%RH than set priority
value

Yellow alarm light is

Alarm Water continued on, the
Water reservoir Low
20 reservoir is indicator shows “Alarm All On <5s
is lack of water priority
empty Water Shortage”,
sound alarm start
Yellow alarm light is
continued on, the
Alarm Water
indicator shows “Alarm Bad connection
reservoir is Low
21 water Reservoir is between water All On <5min
placed priority
placed wrong”, 4 tank and base
incorrectly
minutes later, sound
alarm start

Alarm information Detail description

When including Alarm ROM of main MCU Fault, Alarm Internal System of main MCU
Fault, Alarm Communication A Fault, Alarm ROM of client MCU A Fault, Alarm Internal
System of client MCU A Fault, Alarm Communication B Fault, Alarm ROM of client
MCU B Fault, Alarm Internal System of client MCU B Fault, Alarm EEPROM Fault,
Alarm SRAM Fault, Alarm ADC 1 Fault, Alarm ADC 2 Fault, Alarm ADC 3 Fault, Alarm
Temperature Heater System Fault, Alarm Real Time Clock Fault, Alarm Humidity
System failure
Heater System Fault, Alarm Battery Fault, Alarm Keyboard Fault, Alarm LCD display
Fault, the alarm indicator light flash and cause sound alarm, the display shows system
alarm message at the same [Link] system fault alarm, the incubator can not
normal work, please stop using it and call authorized maintenance personnel to
repair. Service manual has detail description of alarm delay time and alarm activation
conditions.

3-6 I5
 MANUAL FOR INFANT INCUBATOR

NOTE: 1. When system failure appears, should stop using the incubator immediately, and maintain the
equipment by authorized qualified personnel.
2. All the above alarms except the deviation alarm and skin over temperature alarm in baby mode
are belong to physiological alarm status, the power failure alarm belongs to other alarm status; the
others are all technology alarm status.
3. Except for the power failure alarm, the other alarms are all can silence by pressing silence/reset
key, the time for silence is 4mins（the alarm about oxygen concentration silence time is about 115s）.
When the silence time is over, if the alarm condition is still not solved, the alarm will have to
activate. If occur multiple alarm at the same time, the device will give an alarm firstly for the higher
grade. Press the twice of silence /reset key can cancel the alarm state then the equipment back to
the set condition to monitor the alarm.
4. The power failure alarm lasts at least 10 mins, if the power supply recover before the alarm, the
device will back to the alarm setting before the outage.
5. Alarm system will save the all the alarm logs automatically. When the equipment is outage, the
saved log contents did not changed.

WARNING: When using the incubator in any independent place, if use different alarm
preset, there will be the potential risk.

I5 3-7
 MANUAL FOR INFANT INCUBATOR

SECTION 4
OPERATION

4.1 GENERAL
This section provides operating procedures for the infant incubator.

4.2 POWER SUPPLY CONNECTION AND SWITCH CONTROL

As figure 4.1 indicates, Controls, indicators and connectors for the controller are presented in
figure 4.1 and 4.2. As for the connection of oxygen input, please refer to the figure 4.3. The
connection for the sensor module, and the connection and control of the VHA stand are presented
respectively in figure4.4 and 4.5.

CONTROLLER POWER SWITCH

AC POWER CONNECTOR

RS232 PORT

SENSOR MODULE CONNECTOR

FIGURE 4.1

4-1
I5
 MANUAL FOR INFANT INCUBATOR

FIRST INDICATION INTERFACE

AIR, SKIN, OXYGEN AND HUMIDITY
2 1 3 18 4,15,19 5,16,20

8 7

10 6

9 11

1 Displays Air temperature 5 Self-definite function key. 7 Up and down function key
During alarm condition, the On first indication interface, Refer to individual
displayed temperature is press to select one of the parameter displays for
the real temperature where following parameter function.
locates the probe of air displays: Air temperature,
sensor. skin temperature, oxygen 8 Power alarm indicator
concentration, and When flashing, it illuminates
2 Displays skin temperature humidity. along with audible alarm to
on Probe No.1. “--.-” will be Press Air temperature, skin indicate a power failure.
displayed when Skin Probe temperature keys to enter
is disconnected. into the second indication 9 Alarm indicator
interface A, press humidity
3 Displays skin temperature to enter into the second When it lights, please stop
using it immediately and
on Probe No.2. “--.-” will be indication interface B, press
refer to the 3.4 chapter of
displayed when Skin Probe oxygen concentration to alarm and system prompt
is disconnected. enter into the second information related contents
indication interface C. in the specification.
4 self-definite function key Refer to other items for
When the incubator occurs
On first indication interface additional selections and
failure alarm, the lamp will
designating air, skin, other functions.
be on. Alarm messages
humidity, and oxygen 6 Silence /Reset Key substitute for Trend
concentration. Press the air displays.(Except for the
This key has two functions,
or skin key to enter into the power failure alarm)
second interface A, Press when alarm occurs , press
the humidity key to enter into this key once to stop 10 Battery status indicator
the second interface B, alarm, press this key twice To be yellow indicating
press the oxygen to reset the alarm status , that it is recharging. To be
concentration key to enter the incubator will be back to green indicating that it has
into the second interface C. the set state and monitor the been full.
As for the details, please alarm again. 11 Keypad lock indicator light
refer to the relevant
When the lamp lights, the
instruction.
system is settable and all
Rotating wheel indicates air
the function keys are in
or skin control mode is
commission. when the
active.
lamp goes out, the system
is not settable and all the
function keys are locked.

FIGURE 4.2 A
4-2 I5
 MANUAL FOR INFANT INCUBATOR

SECOND INDICATION INTERFACE A

TEMPERATURE SET
18 4,15,19 5,16,20

12

17 14 13

SECOND INDICATION INTERFACE B

HUMIDITY SET
18 4,15,19 5,16,20

12

17 14 13

SECOND INDICATION INTERFACE C

OXYGEN SELECTIVE FUNCTION SET
18 4,15,19 5,16,20

12

17 14 13

4-3
I5
 MANUAL FOR INFANT INCUBATOR

12 Lights to indicate 15 Self-definite function key 17 Displays one of the

temperature override On second indication following Trends: air temp,
mode >37℃ has been interface A, designating: Set skin temp 1, oxygen
selected. temperature, >37℃, Trend concentration, humidity,
Notice: Before setting and Home. On second weight. The curve trend can
temperature value indication interface B,
is set to 37℃, this designating: set, weight, indicate time intervals
key is invalid. trends, return. On second consult in 2hrs, 4hrs, 8hrs,
indication interface C, 12hrs, and [Link]
When in >37℃ designates: set, on/off, which, the weight curve
Mode, the Infant is in trends, return. Please refer intervals are 7days, 2weeks,
high temperature to the item 4 about the 3weeks, 4weeks, 5weeks,
condition, nominated function of first 6weeks and 7weeks In
Physicians and interface. Also refer to normal working condition, it
Nurses should pay individual parameter can indicate the chosen
more attention to displays for other trend.
the Infant. designations.
13 Humidity display- 16 Self-definite function key.
Display % RH within the On second indication
hood environment and interface A, designating:
humidity set point. Set temperature, >37℃,
During alarm condition it Trend and Home. On
displays real time second indication interface
humidity value on B, designating: press this
Humidity Probe. key can select the set value
14 When this model is ready or humidity or oxygen
for shipping, the Oxygen concentration, weight
concentration module is function set, humidity or
in the state of closure, oxygen concentration
and you need to start this curve, and return to the first
function to use the interface, press the trend 18 Temperature Set Point
Oxygen concentration key to enter into the third Display
module . Under the interface A, and press the The Set Point is under this
condition of starting the weight key to enter into the Working Mode.
Oxygen concentration third interface B. Please
module, the system can refer to the section 4.4.
indicate the Oxygen Please refer to the item 5
concentration inside of about the nominated
hood and the oxygen function of first interface.
concentration setting Also refer to individual
value. As for the details, parameter displays for
please refer to the other designations.
Oxygen concentration
monitoring /control
system in section 6.
FIGURE 4.2B
THIRD INDICATION INTERFACE A
INTERVAL OF THE TREND TIME SET
21 4,15,19 5,16,20

4-4 I5
 MANUAL FOR INFANT INCUBATOR

THIRD INDICATION INTERFACE B

WEIGHT SETTING

21 4,15,19 5,16,20

19 self-definite function key. on the third 20 self-definite function key. on the third
interface A, you can specify : the trend interface A, press this key to select the
intervals and the restore. on the third trend intervals, restore setting and the
interface B, you can specify : weight trend setting of returning to the first interface,
setting, calibration, be to zero. Refer to item on the third interface B, press this key to
4, item 15 for the functions on first weight trend setting, calibration, be to
indication interface and second indication zero and the setting of returning to the
interface. Also refer to individual parameter first interface.
for other designations. Refer to item 5, item 16 for selective
function of first indication interface and
21 time indication second indication interface. Also refer to
Please refer to the section 4.3.2 for current individual parameter for other
timer indication, and the user can reset designations.
according to the local time.

WARNING: To operate the Controller strictly as described in this Manual. Don’t press
any key optionally on the panel.

FIGURE 4.2C

Manual Oxygen Input Port Servo Control Oxygen Input Port

FIGURE 4.3

4-5
I5
 MANUAL FOR INFANT INCUBATOR

SKIN PROBE 1 CONNECTOR SKIN PROBE 2 CONNECTOR

SKIN TEMPERATURE PROBE CONNECTORS

FIGURE 4.4A

FAILURE ALARMING INDICATOR

HUMIDITY SENSOR

AIR TEMPERATURE

MONITORING SWITCH FOR SENSOR BOX POSITION OXYGEN SENSOR

DISTRIBUTION OF SENSORS
FIGURE 4.4B

4-6 I5
 MANUAL FOR INFANT INCUBATOR

MAIN POWER CONNECT SOCKET

MAIN POWER SWITCH

MAIN POWER SWITCH CONNECTOR (If applicable)

MAIN POWER CONNECT SOCKET MAIN POWER SWITCH

MAIN POWER SWITCH CONNECTOR

DOWN SWITCH

UP SWITCH
THE VHA STAND CONTROL
CAUTION: The VHA Stand is only for INTERMITTENT OPERATION with 30 seconds ON and
30 seconds OFF.

AC OUTPUT RECEPTACLES
FIGURE 4.5

WARNING: Connecting electrical equipment to the SOCKET-OUTLET effectively leads

to creating an ME SYSTEM and the result can be a reduced level of safety.
To complete the ME SYSTEM requires evaluation to the requirements of
IEC60601-1, clause 16.

4-7
I5
 MANUAL FOR INFANT INCUBATOR

4.3 OPERATIONAL CHECKOUT PROCEDURE

WARNING
1. Please stop using this device once some functions fail or the spare parts for fixing the
front panel are loose.
2. Set temperature must be 3℃ higher than ambient temperature. And then you can
proceed this checkout procedure.
3. Please do not damage the VHA stand during movement. And lower the cabinet to the
lowest position before moving so that the incubator is stable.
Incubator should be only operated by trained personnel who are familiar about the general
risk of operating the incubator and under the instructions of medical practitioner.
Please do the following checkout procedure each time before operation.
The operator should operate the equipment within 20cm in front of the device, and the specific
distance between the device and operator with the operation shall be kept in a comfort level.

4.3.1 CHECK THE INTEGRITY OF INCUBATOR

 Make sure that the device has been sterilized;
 Make sure that the hoods are locked firmly;
 Make sure that there is no crack or the sharp edge on the hood;
 Make sure that the I.V. Pole and shelf are locked firmly;
 Make sure that fasteners are installed firmly;
 Make sure that the tilt mechanism of bed can work properly ;
 Make sure that the needed accessories and other devices are available;
 Make sure that the power cord is connected and is safe.
 Make sure that the casters are installed well.
Check whether the caster can drop when lifting the incubator 2cm above the ground. In the
process of movement, when the loose caster dorp during the incubator crossed the cable,
threshold or elevator threshold, it would case dangerous. Please do not move incubator before
replace the loose caster.

4.4.2 CHECK CONTROLLER

WARNING
1. To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
2. Make sure that the power supply is compatible with the electrical specifications
lapelled on the incubator. The equipment can not use the extension power cord.

A. START-UP THE CONTROLLER

Open the power switch (If applicable) and the controller power switch when the power is
supplied, the device sounds like "di..." and company's label and the system edition will be
displayed. Then self-check being carried for RAM, SRAM, REAL TIME CLOCK, EEPROM and
communication system by the main body of the device. After through self-inspection can access
control interface, keyboard lock indicator light shine, or else, the screen indicates the reason for
not passing the self-check procedure and display the words of "Please repair it by professional
maintenance man".

4-8 I5
 MANUAL FOR INFANT INCUBATOR

B. CHECK THE POWER FAILURE ALARM

Disconnect the power supply of whole unit; the device should give a power failure alarm, the
power failure alarm light flashes, the device gives continuous alarm sound.
This operation is used for checking if the power failure is normal or not. Insert the power cord
again after finishing checking.
IMPORTANT: Make sure that the rechargeable battery is full before usage. If not full, it may
cause the power failure without the alarming indication. If full, and there is no
any indication after disconnecting the main power supply, please refer to the
qualified service personnel.

C. CHECK HEATER

Control the environment temperature at 21℃ ~ 26℃, and choose the Air Mode, and set the
temperature at 33.0℃, and all heat power indicators are on, and heater will output heat
completely.
NOTE: When the incubator works under the set state, and continue the following operation
procedure.

D. CHECK THE ACCURACY OF TEMPERATURE CONTROL

Select the Air Mode, and set the air temperature at 36℃, after the air temperature enters into
the STEADY TEMPERATURE CONDITION, put the calibrated temperature measuring device on
the position above 10cm from the center of mattress to measure the air temperature, compared
with the indicated air temperature to check whether the deviation between them is within 0.8℃.

E. CHECK BABY MODE

Insert two skin temperature sensors into the socket of skin sensor1 and skin sensor2
separately, the arrow sign on the plug should aim to the opening on the sensor socket so that the
sensor is inserted correctly.

Arrow Opening

Sensor plug
Skin temperature Sensor 1 Skin temperature Sensor 2
4-9
I5
 MANUAL FOR INFANT INCUBATOR

[Link] or pull out the skin sensor, you must hold the plug of skin sensor,
pulling the leads is forbidden.
[Link] do not bend the connection of sensor.

When the Air Mode works stably, change it into the Baby Mode, set temperature at 37℃.
Keep the temperature detected by skin temperature sensor is 2℃ lower than the set temperature
while making the displayed air temperature 4℃ lower than the set skin temperature. After a while
the incubator can give a high priority alarm sound, “Alarm Skin sensor 1 is placed wrong”
information will replace the curve indication on the screen, the alarm character should be
consistent with the description of section 3.4.
Disconnect the connection of skin temperature sensor and socket 1. The device should give a
high priority alarm sound, “Alarm Error Skin Sensor 1” information will replace the curve
indication on the screen, and the alarm character should be consistent with the description of
section 3.4.

F. CHECK PRECISION OF SKIN TEMPERATURE SENSOR

Put the skin temperature sensor with the mercury thermometer for the accuracy with ±0.1ºC
into the water cup with warm water. To make the probe of the skin temperature sensor and the
mercury ball as closely as possible, please stir enough and then read the value of mercury
thermometer. Compare the value of the skin temperature sensor and the mercury thermometer,
and the deviation must be within± 0.2℃.
NOTE: Please check again if the accuracy of the skin temperature sensor exceeds the
allowable deviation. Please let the professional personnel maintain machine if the
accuracy of the skin temperature sensor still exceeds the allowable deviation after
double check.

G. CHECK THE SENSOR BOX

Check the connection between the modular and its socket. Only when the interface of the
sensor box is correctly facing the interface of the sensor socket, they can be successfully
connected.

4-10 I5
 MANUAL FOR INFANT INCUBATOR

STATOR

Undraw the left stator of sensor box as the arrow indicates; under the condition of stator
undrawing, undraw the sensor box outwards, to check if the Sensor box slides in or out of the hood
smoothly. When the modular falls off from the hood, the controller can give a high priority alarm
sound and indicates “Alarm Sensor Box is placed wrong” information, and alarm character
should be consistent in the description of section 3.4. The sensor connection light is on. After the
modular being put into the correct location and being fixed by stator, the alarm cancels
automatically as well as the sensor connection indicating light off.

WARNING: 1. All gaps in the sensor module must not be blocked.

2. Please pull out and plug in the sensor module correctly.
3. Sensor Module is an important part which supply Temperature
Control to Incubator, and must operate carefully.

H. CHECK FAN MOTOR ALARM

Refer to paragraph 4.3.3 A, open the hood, and take out Infant Mattress, Mattress Tilt
Mechanism, Mattress Tray, and the heater cover. According to the operations sequence of section
5.2.1. As the follow figure, hold the Motor Fan on hand carefully, turn on the switch of the controller
power, the device should give a high priority alarm sound, “Alarm Motor Fault” information will
replace the curve indication on the screen, the alarm character should be consistent with the
description of section 3.4. Press the Silence/Reset key, alarm is over and the Controller return to
operation status.

NOTE: It must take at least 45 minutes after the incubator stopped working to perform this
operation.
4-11
I5
 MANUAL FOR INFANT INCUBATOR

I. CHECK OVER-TEMPERATURE ALARM

The device into the working state, press the air temperature self-definite function key and set
value increasing key in figure 4.2A, at this time, all heating indicators are on, If the set temperature
is no indication, it means that the controller has entered into the over-temp test state. After a long
time, the device should give a high priority alarm sound, “Alarm Over Temperature” information
will replace the curve on the screen, and the alarm character should be consistent with the
description of section 3.4. Press silence/reset key, alarm is over and the Controller return to
operation status.

J. CHECK DEVIATION ALARM

In Air Mode, close all door and panels, set the temperature at 32℃. Enter TEMPERATURE
ALARM CHECKOUT STATE（refer to descriptions of terms and symbols concerned）, fan into the
hot air inside the hood. When the air temperature indicates 35.1℃, the device can give a high
priority alarm sound, “Alarm Temp. Deviation” information will replace the curve indicator on the
screen, and the alarm character should be consistent with the description of section 3.4. Set the
temperature at 35℃, after the device enters into the temperature alarming checkout state, open
the front access panel, when the air temperature indicates 31.9℃, the device can give a high
priority alarm sound, “Alarm Temp. Deviation” information will replace the curve indicator on the
screen, and the alarm character should be consistent with the description of section 3.4..
NOTE: If the system can not enter into the TEMPERATURE ALARM CHECKOUT STATE or
the air Temperature does vary within ±3℃ than the setting temperature, the
deviation alarm can not occur.
In Baby Mode, set the temperature at 35℃. Enter TEMPERATURE ALARM CHECKOUT
STATE, put the skin sensor into the water cup at 37℃. When the skin temperature indicates
36.1℃, the device can give a high priority alarm sound, “Alarm Temp. Deviation” information will
replace the curve indicator on the screen, and the alarm character should be consistent with the
description of section 3.4; Set the temperature at 35℃, after the device enters into the
temperature alarming checkout state, put the skin sensor into the water cup at temperature 33℃,
when the skin temperature indicates to 33.9℃, the device can give a high priority alarm sound,
“Alarm Temp. Deviation” information will replace the curve indicator on the screen, and the alarm
character should be consistent with the description of section 3.4.
NOTE: If the system can not enter into TEMPERATURE ALARM CHECKOUT STATE or the
skin temperature does vary within ±1℃ than the setting temperature, the
deviation alarm can not occur.

4-12 I5
 MANUAL FOR INFANT INCUBATOR

K. CHECK THE WATER LACKING ALARM

When humidifying system is on working, pour out the water in the water tank. The device can
give a low priority alarm sound, “Alarm Water Shortage” information will replace the curve
indication on the screen, and the alarm character should be consistent with the description of
section 3.4.

L. CHECK THE WATER RESERVOIR POSITION WRONG ALARM

When the incubator is in the working state, pulling out the water tank, the device should give a
low priority alarm sound, the yellow alarm light continues to work, “Alarm water Reservoir is
placed wrong” information will replace the curve indication on the screen, and the alarm character
should be consistent with the description of section 3.4. 4 minutes later, the water tank is still not in
position, the alarm sound start immediately.

M. CHECK THE TIMER

When the controller is normally working, the message shall display the current real time. If the
displayed time is not correct, please reset the time. The setting method is as following:
When the controller is off, press the first button (From top side) and switch on the
controller. Controller will enter into the interface as shown below figure, then set time of
controller. The controller’s time display in turn order is year, month, day, week, hour, minute and
second, year is displayed by four digits, the first two on behalf of the century value and last two on
behalf of year.

Press set self-definite function key, the underlined century can indicate, and then press the
select self-definite function key, the underline can move with the time indication, press the
increasing key or the decreasing key can change the underlined information, after correction,
press the store key to change the time and record the time, press Exit key, the controller can enter
into the first interface.

4.3.3 MECHANICAL EXAMINATION

A. CHECK THE HOOD OPERATION

NOTE: Make sure all cables are disconnected from the all accessories before raising the
hood in order to avoid interfering with raising the Hood.
4-13
I5
 MANUAL FOR INFANT INCUBATOR

Disconnect the cord of sensor module.

THE KNOB LOCATED

Disconnect the cord of the Sensor Module. Slowly tilt the Hood back until the Hood locks in
place. Release the Hood by pulling on and holding the knob located on the right rear hinge while
closing the Hood.

B. CHECK THE ACCESS PANEL

The Pawl Latch

UNLOCK

The Latch Seat

LATCHED

Rotate the panel latches and keep them open. Then press the latch seat to open the access
panels to maximum state (rotate downward). If the front access panel has panel damping system,
you can release the panel after opening to a certain angle and the panel will descend to maximum
state slowly and [Link] front and back access panels. The seat latch fastens
automatically and then rotate both latches until they are fully locked. Both latches and the seat
latch muse be locked firmly to prevent unexpectedly opening of the front access panel.

4-14 I5
 MANUAL FOR INFANT INCUBATOR

C. CHECK IRIS ENTRY PORTS

Rotate the outer ring of each entry Port, the port should be open and close as rotation is
continued through 360 degree.

D. CHECK THE LATCH AND GASKET OF ACCESS DOOR

Press on-off of each access door to open it automatically and check the seal of gaskets.

E. CHECK INNER WALLS ARE PROPERLY LATCHED

INNER WALL UNLATCHED INNER WALL LOCKED

Open the Access Panels and check that the front and rear inner walls are properly latched.

4-15
I5
 MANUAL FOR INFANT INCUBATOR

F. CHECK MATTRESS TILT MECHANISM

Rotate the mattress tilt mechanism to adjust it.

G. CHECK BASSINET

Open the Access Panel and slide it out to the fully extended position indicated by the arrow.
The mattress of the bassinet is the applied part. Lean on Mattress Tray to make sure it is properly
supported to provide a firm infant platform. Return the mattress and close Access Panel.

H. CHECK THE AIR INTAKE FILTER

Loosen the two thumb screws of the Air Intake Filter Cover and remove the cover and inspect
the filter, if dirty, it should be cleaned. Put the filter cover back.

4-16 I5
 MANUAL FOR INFANT INCUBATOR

A dirty air filtering material will increase the concentration of carbon dioxide
inside the hood, according to the actual condition, must check the air filter
materials regularly. If the air filters materials look dirty or used more than 2
months, should replace it.

I. CHECK THE X-RAY TRAY

Open the Access Panel and withdraw The X-Ray Tray can be pull out easily Indicated
the X-Ray Tray. as the arrow.

J. CHECK THE HIGH ADJUSTMENT OF THE VHA STAND

Step the Up and Down button with your feet in figure 4.5 to adjust the height of whole unit.

4.4 GENERAL OPERATION PROCEDURE

WARNING
1. Please read this operator’s manual carefully before use.
2. You should not use the incubator without the checkout procedure, and please refer
to the qualified person.
3. For the incubator’s normal function, the setting temperature must 3℃ higher than
environment temperature.
4. The display module of the controller is susceptible to electromagnetic interference, so
can not use the controller under the high electromagnetic field. If a device which sends
or receive weak signal installed in the equipment nearby, it may be affected by the
electromagnetic wave sent by this equipment. Before using, please check if the device
has been affected.

4.4.1 PREPARATION
[Link] Connect the power supply cord, sensor modular and skin temperature sensor 1 correctly.
[Link] Pre-warm the incubator, put the patient on the bassinet after the air temperature reaches
the stable temperature to avoid the body temperature of the patient decreasing in the incubator
that does not have preheated. The specific pre-warm method is as follows:
See section [Link], set a proper control temperature, and make the device continue working
until the air temperature reaches the control value.

4-17
I5
 MANUAL FOR INFANT INCUBATOR

IMPORTANT: 1. The temperature of the warm air entering the Patient Compartment at the
front and rear of Incubator is higher than the typical air Incubator
temperature; therefore, keep the infant clear of the slots where the warm air
enters the Patient Compartment.
2. Please ask the physician to decide the set temperature.

4.4.2 OPERATION
[Link] AIR MODE
Air Mode means the controller will control the incubator temperature automatically to keep the
air temperature close to set temperature.
Incubator temperature is monitored the sensor probe and compared with the set air
temperature. The result of comparing is passed to the heater control circuit to control the heat for
keeping the set air temperature. The isolated temperature sensor as backup can control the
maximum incubator temperature. If the temperature is over high, and the heat protective device
will active, and the heater is cut off.

SELECT AIR TEMPERATURE CONTROL AND SET POINT

On first indication interface, the keypad lock indicator light is on (If not on, press the keypad
key); press the Air self-definite function key to enter into the second interface A (Temperature
setting interface). Refer to Figure 4.6, and set the Air Temperature to the prescribed temperature.
Once stabilized, the air temperature will be maintained within± 0.2℃ of the set temperature.
Air temperature is trended over periods of 2, 4, 8, 12 and 24 hours. Refer to Paragraph
[Link] to select Air-Trend Display.
In the air temperature control mode a sign of moving caster is running means the incubator is
operating by air temperature mode. Air temperature and set temperature are display in air
temperature and set position at same [Link] skin temperature sensor 1 and 2 respective connect
with socket 1 and 2, the skin temperature sensor probe temperature is display skin temperature 1
and 2 position, if not connected, the display is“--.-”。

FIGURE 4.6
4-18 I5
 MANUAL FOR INFANT INCUBATOR

NOTE: 1. All setting should be operating under the keypad lock indicator light is on.
2. If no keys are pressed within 15 seconds of selecting this Display, it will
automatically revert to first indication interface and store the last operation result.

1 Set

Press this key to enter the Air Temperature Setting, the Indicator “Set” flashes.

2 Set
32.0
Press Up Arrow to raise set temperature to 37℃. In Temperature Override Mode (Step 4), press to
raise set temperature from 37℃ to 39℃. Press one time to raise set temperature setting in 0.1℃
increments. If press this key continuously, the setting temperature can rise rapidly.

3 Set
32.0
Press Down Arrow to lower set temperature to 25℃. Press one time to lower set temperature
setting in 0.1℃ increments. If press this key continuously, the setting temperature can decrease
rapidly.

4 >37℃ >37 ℃
Press to place Air Set Temperature in Temperature Override Mode, >37℃ Indicator lights and the
actual air temperature on the probe is displayed. If press this key continuously, the setting
temperature can decrease rapidly.
NOTE: This key is inoperative until the air set temperature has been set to 37℃.

5 Trend

Press to enter the third indication interface A curve set Refer to Paragraph [Link] for details.

6 Home

Press to acknowledge Set Temperature setting and return to first indication interface.

7
Press this key, the keypad lock indicator light will shine and access controller set state. After
setting back to first interface, press keypad lock to control area, and keypad lock indicator light
goes out, or don’t press any key it will return to control state automatically and keypad lock
indicator light goes out after 15 seconds.

4-19
I5
 MANUAL FOR INFANT INCUBATOR

8 ALARM

Under the alarm condition, the alarm light will flash and sound alarm calls, the alarm
message instead of the curve display(expect outage alarm). Please refer to the specific
description of 3.4 chapter. Alarm mute/reset key has two functions, when occurs alarm, press
this key once to stop alarm, press this key twice to reset the alarm status , the incubator will back
to the set state and monitor the alarm again.

[Link] BABY MODE

Baby Mode is one temperature control method which means the controller will control the
incubator temperature automatically to keep the baby temperature close to set temperature. Skin
temperature sensor is the applied part.
Refer to the step B in section [Link], Connect the Skin sensor to the socket 1 on the sensor
box correctly. On first indication interface, press SKIN self-definite function key to select Baby
Mode, the controller can enter into the second indication interface A. Please refer to the figure 4.7
and the skin temperature setting part. Once stabilized, the infant probe temperature will be
automatically controlled within ±0.2℃ of the set temperature. When the wheel in the screen is
running beside the skin temperature control mode, and it means that the incubator is working in
the Baby Mode.
IMPORTANT: The controller of Infant incubator controls the temperature in the incubator
by sensor inserted in sensor socket 1. Therefore, the sensor must be
connected to sensor socket 1 when the controller controls the temperature
in the incubator by skin temperature. The sensor connect to sensor socket 2
couldn't control the temperature but only display detected temperature.
In Baby Mode, Skin Temperature 1, Air Temperature and Set Point Temperature are
displayed at the same display. If the Skin Probe is connected with Skin Connector 2, the
temperature from the Skin Probe 2 will also be displayed there.
In the baby mode,the skin temperature sensor 1 should be closed to baby [Link] incubator
internal controller compare the skin temperature sensor 1 detect temperature value with the set
skin temperature,and according to the comparison result output control signal control temperature
heater of heating rate, eventually make the skin temperature 1 sensor detects the temperature
stability near the set value.
Infant skin temperature is trended over periods of 2, 4, 8, 12 and 24 hours. Refer to paragraph
[Link] to select Skin Trend Display.
For setting the appropriate temperature and correctly control the baby temperature of the
infant, the incubator hold the following functions:
4-20 I5
 MANUAL FOR INFANT INCUBATOR

When the temperature detected by the skin temperature sensor 1 is always below the set
temperature for more than 2℃, the incubator will rise the air temperature in the incubator in the
speed of 1℃ per hour to enable the slowly rising of the infant’s temperature and avoids the
damage caused by the rapid rising of the temperature as well. If the baby temperature detected is
always 2℃ below the set temperature in 1 hour, “Alarm Skin sensor 1 is placed wrong” alarm
will be activated by system. At that time, the incubator still rise the air temperature in the hood
slowly until the air temperature reaches the STEADY TEMPERATURE CONDITION which its
temperature is equal to “ set skin temperature -4℃”. For example, in Baby Mode, if the set
temperature is 36.5℃, finally the air temperature in the incubator will reach the STEADY
TEMPERATURE CONDITION which its temperature is 32.5℃.
For avoiding the incubator unnecessarily decreases its temperature for the reason of infant
pyrexia or something else, the incubator holds the following functions:
If the baby skin temperature surpasses the set temperature for less than 0.5℃, the air
temperature in the incubator will not lower 5℃ than the baby skin temperature. If the baby skin
temperature surpasses the set temperature for over than 0.5℃, the air temperature in the
incubator will not below 25℃.
For example, in Baby Mode, if the set temperature is 36℃ while the baby temperature rising
to 36.3℃, the air temperature in the incubator will not lower than 31.3℃; while the baby
temperature rising to 36.7℃ which is higher 0.5℃ than the set temperature, the air temperature in
the incubator will not lower than 25℃.

CONNECT THE PROBE OF SKIN TEMPERATURE SENSOR TO THE PATIENT:

In Baby Mode, make sure that the probe of skin temperature sensor 1 is attached closely on
the skin of patient. Put the probe on the right position of skin, and clean the position of skin where
the skin sensor located and the metal surface of skin sensor probe with alcohol or the moderate
water to wipe off the grease and dirt. In order to fix the probe' position, medical tape or the like can
be used to fix it （Disposable skin temperature sensor can be fixed with its glue）. If the patient lies
on back, please stick the metal surface of skin sensor probe between the xiphoid of the belly and
the bellybutton, to avoid the liver; if the patient bends over, stick the metal surface of skin sensor
probe on the back of patient, the best place is on the kidney. If the patient lies on side, as for the
position of probe, please follow the instruction of doctor.
NOTE: 1. Skin temperature sensor must be cleaned and disinfected before use.
2. Please do not put the skin sensor under the patient.
3. Skin sensor probe can not be regarded as the rectum thermometer.

4-21
I5
 MANUAL FOR INFANT INCUBATOR

WARNING
1. Make sure that the probe of skin sensor 1 is attached closely on the skin of patient. If
the probe falls off the patient, the measured temperature from sensor is not the real
skin temperature, maybe the air temperature or the mattress temperature, and it may
cause the patient receive more heat or lose heat, even scald or death.
2. Please do not cover the blanket or diaper on the probe of skin sensor, because it will
affect the accuracy of temperature.
3. Skin sensor will measure the skin temperature of patient, not the real body
temperature, Therefore, measure the body temperature regularly, and check whether
the patient has a fever or not, whether the temperature of patient decreases.

SELECT BABY MODE AND SET POINT

Press the Skin Temperature Soft key to enter the interface as figure 4.7 when the keypad
lock indicator light is on.

FIGURE 4.7
NOTE: 1. All setting should be operating under the keypad lock indicator light is on.
2. If no keys are pressed within 15 seconds of selecting this Display, it will
automatically revert to first indication interface and restore the last operation
results.

1 Set
Press this key to enter the Skin Temperature Setting, the Indicator “Set” flashes.

2 Set
34.0
Press Up Arrow to raise set temperature to 37℃. In Temperature Override Mode (Step 4), press to
raise set temperature from 37℃ to 38℃. Press one time to raise set temperature setting in 0.1℃
increments. If press this key continuously, the setting temperature can rise rapidly.

4-22 I5
 MANUAL FOR INFANT INCUBATOR

3 Set
34.0
Press Down Arrow to lower set temperature to 34℃. Press one time to lower set temperature
setting in 0.1℃ increments. If press this key continuously, the setting temperature can decrease
rapidly.

4 >37℃ >37 ℃
Press this key, the device enters into the Temperature Override Mode, >37℃ Indicator lights and
the controller can working the >37℃ temperature setting.
NOTE: This key is inoperative until the skin set temperature has been set to 37℃.

5 Trend

Press to enter the third indication interface A curve trend setting. Refer to Paragraph 4.5 for
details.

6 Home

Press to acknowledge Set Temperature setting and return to first indication interface.

7
Press this key, the keypad lock indicator light will shine and access controller set state. After
setting back to first interface, press keypad lock to control area, and keypad lock indicator light
goes out, or don’t press any key it will return to control state automatically and keypad lock
indicator light goes out after 15 seconds.

8 ALARM

Under the alarm condition, the alarm light will flash and sound alarm calls, the alarm message
instead of the curve display(expect outage alarm). Please refer to the specific description
of 3.4 chapter. Alarm mute/reset key has two functions, When occurs alarm, press this key once
to stop alarm, press this key twice to reset the alarm status , the incubator will back to the set state
and monitor the alarm again.

[Link] TREND DISPLAYS

On second interface A, press the curve self-definite function key to select the menu of the
following curve indicates.

4-23
I5
 MANUAL FOR INFANT INCUBATOR

SELECT TREND ON SECOND INDICATION INTERFACE A

NOTE: 1. All setting should be operating under the keypad lock indicator light is on.
2. In the state of air temperature control, press the curve self-definite function key,
and then the choice is the air temperature curve indication, while in the state of skin
temperature control, press the curve self-definite function key, and then the choice
is the skin temperature curve indication.
3. If no keys are pressed within 15 seconds of selecting this Display, it will
automatically revert to first indication interface and restore the last operation
results. (Except the step2: like are you sure question, and return the last interface)
FIGURE 4.8

1 Times

Press this key continuously to select the time intervals of curve trend, curve indication area can
indicate 2 hrs, 4 hrs, 8 hrs, 12 hrs, and 24hrs.

2 Store
Press this key to restore from the current state, meanwhile, the following interface can be
indicated, and inquiry the operator YES or No.

Press Yes key to return to the last screen, the controller can restore the information while the
original storage data will be cleared, Press NO key to return to the the last screen, the controller
can restore the information on basis of the original information.
4-24 I5
 MANUAL FOR INFANT INCUBATOR

3 Home

press this key to return to the first interface, the curve indicator can display the control mode.

4
Press this key, the keypad lock indicator light will shine and access controller set state. After
setting back to first interface, press keypad lock to control area, and keypad lock indicator light
goes out, or don’t press any key it will return to control state automatically and keypad lock
indicator light goes out after 15 seconds.

4.4.3 OTHER OPERATION

A. Raise the head or foot of patient
Please raise the head or foot of patient according to the step F in section 4.3.3.
CAUTION: 1. Please do not add the over load on the mattress.
2. The mattress tilt will affect the temperature uniformity on the mattress, the
horizontal position of mattress is best state.

B. X-RAY PROCEDURES
1. Open the Access Panel and withdraw the X-ray Tray from under the mattress.
2. Place the X-ray Cassette in the center of the X-ray Tray.
3. Place the Infant at center Mattress. Close the Access Panel. When the X-Ray is complete
remove the X-ray cassette from the tray and return the tray.

C. Operation to the oxygen concentration control system.

Please refer to the section 6.

D. Operation to the humidity control system

Please refer to the section 7.

E. Operation to the weighting control system

Please refer to the section 8.

4.4.4 Shutdown
After finishing the operation, turn off the power switch of controller and main power switch,
and disconnect the wire of power.

4-25
I5
 MANUAL FOR INFANT INCUBATOR

SECTION 5
CLEANING AND MAINTENANCE
5.1 GENERAL
This section provides cleaning and maintenance instructions.

WARNING: Disconnect all the connections with oxygen feeding device before cleaning
and maintenance. Cleaning or maintenance in the environment full with
oxygen will cause fire or explosion.

5.2 CLEANING
This device must be cleaned and sterilized for the first time for initial use, or after usage for
one week.
5.2.1 DISASSEMBLY BEFORE CLEANING
1. Turn off the Power Switch on the VHA stand and remove the Power Cord. Refer to
Paragraph 4.3.3, Step A, and disconnect the cables from the Sensor Module and slowly raise the
Hood.
CAUTION: Before lifting Incubator Hood for cleaning, ensure that all mounted accessories
have been removed to prevent possible interference with the raised Hood.
2. Refer to Paragraph 4.3.3, Step I, and remove the X-ray Tray from the Mattress Tray.
3. Refer to Figure 5.1 and remove the Mattress Tray. (For the bed with the baby scale, please
see the figure 8.1, disconnect the weight sensor and take the baby scale out. Then lift the raise the
Hood.)

Push the Mattress Tray to end following as the arrow 1, raising the Mattress Tray like the
arrow 2, then pull out it as the arrow 3.
FIGURE 5.1

5-1
I5
 MANUAL FOR INFANT INCUBATOR

4. Refer to Figure 5.2, pull out the mattress tilt bars left and right sides.

FIGURE 5.2
5. Refer to Figure 5.3 and take out the Main Deck by rotate the knob to the unlocked position.

FIGURE 5.3
6. Refer to Figure 5.4 and remove the Heater Cover.

FIGURE 5.4

The Heater can be sufficiently hot to cause burns. Avoid removing or touching
the Heater until the unit has been switched off for at least 45 minutes.

5-2
I5
 MANUAL FOR INFANT INCUBATOR

7. As the figure 5.5 shows, press down the latch on the access panel to unfold the inner wall.

Latch

Inner Wall

Access Panel

FIGURE 5.5

8. Refer to figure 5.6 and take out the water reservoir.

Handle

Reservoir

Rotate the spanner of the water tank to the horizontal position and pull the water tank out then.
(Please keep the water tank flat and straight and don't move it up towards when it been pulled out,
or else it will be hard to pulled out).
FIGURE 5.6

WARNING: 1. Because the temperature of the water tank is high after the power of the
device is on as well as the heating groups are tighten then, so please take
out the water tank after it is totally cooling down to avoid damage to the
heating group.
2. The humidifying system is in the bottom of the reservoir. Don’t put
hands into the reservoir to avoid being burned.

5-3
I5
 MANUAL FOR INFANT INCUBATOR

9. Refer to figure 5.7 and take out the fan.

Cover For Bolt

Hold the fan, and loose the cover for bolt indicated as the arrow, draw the fan upward
FIGURE 5.7
10. As the figure 5.8, take out the oxygen transfusion tube.

Clamp ring

Toward the arrow director to push the clamp ring, and take it out
FIGURE 5.8
11. Remove all Access Door Sleeves, Cuff and Gaskets from each side of the Hood by
pulling them freely.
12. Remove Tubing Access Ports from the Hood by pulling them freely.
13. Remove the Air Intake Micro filter Cover by loosening the two thumbscrews. Refer to
Paragraph 4.3.3 Step H.

5.2.2 CLEANING PROCEDURE

CAUTION: Some chemical cleaning agents may be conductive and/or leave a residue which
may permit a build-up of dust or dirt which may be conductive. Do not permit
cleaning agents to contact electrical components. Do not spray cleaning
solutions onto any of those surfaces.

5-4
I5
 MANUAL FOR INFANT INCUBATOR

A. Clean the skin temperature sensor

Use neutral disinfectant-detergent to thoroughly clean the skin temperature (including
detector), then disinfect it with neutral disinfectant or ultraviolet.
CAUTION: 1. Do not put the sensor into the disinfectant-detergent. The disposable skin
temperature sensor is only for the same patient’s use, after using it, please
discard.
2. Skin temperature sensor suggest to be changed every two years, to avoid the
damage of sensor surface and strong impact for long-time use and disinfection.
B. Clean the Soft tubing, Gaskets, Iris Port Sleeves
Soak and clean them in neutral disinfectant-detergent vessel, then clean with water and use
clean cloth to dry.
C. Clean the hood, inner wall and sensor box
Use neutral disinfectant-detergent to thoroughly clean all surfaces, including sensor box,
inner wall and all contacted doors and windows, ensure to clean all holes and sag places, then dry
with clean cloth and paper towel.
CAUTION: 1. Alcohol can cause crazing of the clear Acrylic panel. Do not use alcohol,
acetone, or any organic solvents for cleaning. Do not expose the panel
assembly to direct ultraviolet radiation.
2. Please avoid the liquid flowing into the sensor box.
D. Clean the controller
Use neutral disinfectant-detergent to clean the all surfaces thoroughly. Then dry it with clean
cloth.
E. Clean the heater radiator and fan impeller
Remove any lint build-up on the Heater Radiator and Fan Impeller.

WARNING: Not clean the heater and fan will result in accumulation of fibre dust,
baffle the air flow. That will influence the temperature control and result
in high CO2 concentration.

F. Clean the mattress, mattress tilt bars, main deck, shelf, storage compartment and heater
cover.
Use neutral disinfectant-detergent to thoroughly clean all surfaces, then dry with a clean cloth
or paper towel.
G. Clean the infant bed
Separate the upper bed and the lower bed, clean the dirt inside the bed, clean the surface of
bed and baby scale (accessory) with the cloth dipping into the national registered neutral
disinfectant-detergent, and dry it with clean cloth.
NOTE: There is weight sensor inside of bed, clean and place carefully, do not put it into the
detergent and sterilized liquid.

5-5
I5
 MANUAL FOR INFANT INCUBATOR

H. Clean air filter

Use neutral disinfectant-detergent to thoroughly clean all surfaces, including all holes,
indentations, Access Doors and Iris Ports then dry them with a clean cloth or paper towel. If the air
filter is dirt or is used for more than 2 months, please replace it.
I. Clean the water tank
Take the humidifying chamber out from the drawer group as figure 5.9 shows. Open the two
cover boards on the humidifying chamber and pull up the water input baffle. Use the national
registered neutral disinfectant-detergent to clean the all surfaces and cupped place thoroughly.
Clean it again with clear water and then dry it with clean cloth or paper.
Please pay special attention to cleaning the inner and outer surface of the probe with the
around the detect point can control the microorganism breed in the water tank and ensure the
accuracy of the water level detection.
When the scale appears visibly on the radiating cover inside the water tank, it is
recommended to soak it with table vinegar or the scale cleaning detergents which is used
exclusively for casting water dispenser. The soaking time is about 15min to 20 min. (The longer
the radiating cover be soaked, the better) .In the process of soaking, make sure that the cover is
immersed entirely. After soaking, scrub with bottle brush and rinse the cover till the scale is
cleaned completely.
Reek outlet Cover board Detecting probe
Radiating cover

Water proof

Gap of the water proof

Humidity chamber Drawer groups Water inlet hole on the bottom

CAUTION: 1. Please clean the water tank after the radiating cover inside the water tank
totally cooled down.
2. Make sure the water inlet hole on the bottom and the reek outlet hole of tank
clear unobstructed after cleaning. Two gaps on the water proof must placed
downwards.
3. If the water tank is uncleaned, especially if there are dusts near the probe,
there will be a possibility that water-lacking alarm failure.
4. Please use soft cloth to wipe the surface of the probe when it is covered by
noble metal. Do not use the hard material to scrape the probe so as not to
damage it.
5. When the scale appears on the radiating cover visibly, you must clean it in
time, or it will easily breed ground for bacterium and affect the humidification.
FIGURE 5.9

5-6
I5
 MANUAL FOR INFANT INCUBATOR

The water tank can use steam sterilization. The way of steam sterilization: before steam
sterilization, should clean and dry the water tank thoroughly. The duration of steam sterilization is:
132℃ for 3 to 5 minutes; 121℃ for 15 to 20 minutes. Repeating sterilization will lead to crack for
some parts, will damage the water tank and will eventually need to change the water tank.
J. Clean the oxygen infusion tube
Clean the surface of oxygen infusion tube with clean cloth. Replace it when it is damaged.
K. Clean surface of device
Use neutral disinfectant-detergent to thoroughly clean all surfaces, including all holes,
indentations, then dry them with a clean cloth or paper towel.

5.2.3 REASSEMBLY AFTER CLEANING

NOTE: Before reassembling parts into Incubator, check carefully if there is any crack or
damage.
A. Install the water tank back to tank in the reverse steps as they are moved out.
B. Install the Heater Cover.
C. Install the Main Deck.
CAUTION: Make sure the Hood is raised before attempting to install the Main Deck.
Installing the Main Deck when the Hood is down may result in damage to the
Main Deck and/or jamming of the Hood in place.
D. Install the Mattress Tilt Bars on the Main Deck.
E. Install the Mattress Tray and X-ray Tray.
F. Install the Mattress.
Visually and physically examine the mattress for any holes or cuts that will permit the entry of
fluids onto the inner foam. If the mattress is damaged, it should be replaced.
G. Lock the inner wall back and make sure that the inner wall in a locked condition.
H. Rotating the iris entry sleeves, see figure 5.10.

Install the smaller diameter elastic band of a new Fold back and slip elastic band over
Sleeve over the inner ring of the port housing. the outer ring of the port housing.

5-7
I5
 MANUAL FOR INFANT INCUBATOR

Rotate outer ring to close. If properly installed, the sleeve will open again if rotation is reversed.
FIGURE 5.10
I. See figure 5.11, install the Access door gasket, and then install the Access door cuff.

Installation of Access Door Gasket Installation of Access Door Cuff

FIGURE 5.11
NOTE: 1. If the Incubator is to be gas sterilized, wait until after sterilization to install new
cuffs.
2. If the Access Door Gasket is too hard and difficult installation, please place them
into warm water before installation.
J. Install Tubing Access Ports, as shown in Figure 5.12.
NOTE: the gap of the tubing access ports should be outward.

FIGURE 5.12

5-8
I5
 MANUAL FOR INFANT INCUBATOR

K. Install an Air Intake Micro filter. Refer to the Paragraph 4.3.3, Step H, place the Air Intake
Microfilter into the Cover and tighten the thumbscrews.

5.3 MAINTENANCE

WARNING: To ensure the safety of using the equipment is not affected, the
modification of incubator is forbidden.

5.3.1 Build-in rechargeable battery maintenance

Please check the condition of the build-in rechargeable battery before the first use of device
or in the alternation of device using.
A. Operate the unit for a period of 12 to 24 hours.
B. Trigger a power failure alarm by disconnecting the AC power cord.
C. The power failure alarm should activate and continue to alarm for at least 10 minutes.
D. Reconnect the unit to the AC line and recharge the battery.
If the power failure alarm cannot last more than 10 minutes, please replace the rechargeable
battery. For this battery, it should be replaced by authorized and qualified service personnel.
NOTE: The replaced rechargeable battery will affect the environment if discarded, so it
needs to be recovered according to the regulations.
5.3.2 Cleaning of the fan inside the controller and the fan inside the sensor box
It is recommended to clean the fan inside controller and the fan inside the sensor box every
six months. The fans should be cleaned by authorized qualified service personnel.

5.4 TROUBLE SHOOTING

Troubleshooting of the infant incubator is presented in the following table. If the fault cannot
be localized from the table, the unit should be removed from service and servicing should be
referred to our company or authorized and qualified service personnel.
TROUBLESHOOTING TABLE

SYMPTOM POSSIBLE CAUSE REMEDY

No power and Power Failure
Power Switch not on Depress Power Switch
Alarm is not activated

Switch off the temperature

controller, restart it after cool,
The color of screen is High temperature for
if the abnormal condition
abnormal controller
occurs again, Please refer to
qualified service personnel

5-9
I5
 MANUAL FOR INFANT INCUBATOR

TROUBLESHOOTING TABLE (Continued)

SYMPTOM POSSIBLE CAUSE REMEDY

No power supply Turn off the Power Switch
Power failure alarm light
flashes, power failure alarm Make sure the Power Cord is
Power Cord unplugged
fully inserted.
The “Alarm” light will flash,
and the screen indicator will The sensor box wrongly
The sensor box right placed
show “Alarm Sensor box is placed
placed wrong”
Connect the Skin
The “Alarm” light will flash, Skin temperature sensor 1
temperature sensor 1
and the screen indicator will unconnected or ill-connect
correctly.
show “Alarm error Skin
Skin temperature sensor 1 Replace the skin temperature
Sensor 1”
damaged sensor 1
The “Alarm” light will flash, Oxygen sensor 1 not Install the oxygen sensor 1
and the screen indicator will installed correctly
show “Alarm O2 Sensor 1
Fault” Oxygen sensor 1 damaged Replace the Oxygen sensor 1

The “Alarm” light will flash, Oxygen sensor 2 not Install the oxygen sensor 2
and the screen indicator will installed correctly
show “Alarm O2 Sensor 2
Fault” Oxygen sensor 2 damaged Replace the Oxygen sensor 2

Far away from the heat

The “Alarm” light will flash, Ambient temperature
source or decrease the
and the screen indicator will over-high
ambient temperature
show “Alarm Over
Decrease the humidity inside
Temperature” High humidity
hood
Door or panel of hood is Close the door or panel of
open hood
The “Alarm” light will flash, Ambient temperature Check the Ambient
and the screen indicator will changes a lot temperature
show “Alarm Temp. Far away from the heat
Deviation” Heat source nearby
source
Ambient temperature Check the Ambient
changes a lot temperature

Power cord disconnected Connect the power cord

VHA stand can’t work up and
down
Power switched off Switch on the power

5-10
I5
 M
MANUAL FO
OR INFANT INCUBATOR

SECTION
N6
OX
XYGEN CONCEN
C NTRATIO
ON MON
NITORIN
NG /
CONT
TROL SY
YSTEM
6.1 GE
ENERAL
Thiss Section prrovides operration checkkout procedu
ure and operration instruction for the
e Oxygen
Control System. Oxxygen conce
entration servve Control System
S is op
ptional function.

6.2 INS
STALLATION OF OX
XYGEN SE
ENSOR
Stator
Sensor
S Cov
ver

Stopp
per
Pull out the stattor on the le ndicates, and pull out the sensor
eft side of sensor box as the arrow in
box, unsscrew 2 Cro
oss groove countersunkk head bolts
s, and take out the sen
nsor cover, and
a then
unscrew
w the stoppe
er on it.

Oxy
ygen Senso
or
S
Sensor Cove
er

Screw 2 oxxygen senso

ors into the sensor
s cover clockwise.

Pull the conneccting wire off oxygen sen

nsor out and
d connect the sensor witth the doublle wire in
green and black (if the device is equipped
d with oxyge
en control system,
s plea
ase connectt another
h the other double
oxygen sensor with d wire in yellow and
a black). After
A correcttly connectin
ng them,
screw th
he sensor co
over board down
d with tw
wo M3×8 cro hen push the sensor
oss groove head bolt, th
box into the original place in the
e hood.
ON: 1. Do no
CAUTIO ot block any of the holes on the sensor
s box
x.
2. Please pull out and
a push in
n the sensor box in corrrect way.
3. Sens
sor box is the important part of controlling the te
emperature
e of the
incubato
or, please treat it careffully.
FIGURE 6.1
1

I5 6-1
 MANUAL FOR INFANT INCUBATOR

6.3 FUNCTIONAL DESCRIPTION

The incubator has function of monitoring and servo-controlling the oxygen concentration. But
“Alarm O2 sensor 1 Fault” is applied for both functions, “Alarm O2 sensor 2 Fault”, “Alarm of O2
Sensor Differential”, “Alarm of O2 concentration Deviation” are only applied for the function of
servo-controlling. Please see the table 3.1 to get details of alarm message. If the above alarms are
active, press the Silence /Reset key to stop alarming for about 115s. If the power of the heater is
not cut off, the oxygen servo-control system will cut off the oxygen supply automatically (Except for
low oxygen deviation alarm).
When the indicator displays “O2 Module Switched off”, there’s something wrong with
Oxygen concentration module, it hasn’t been installed or its function failure. If the indicator
displays “O2 Module Off”, the O2 Module is switched off by user selection in the software.

6.4 CONNECTION OF OXYGEN INPUT CONNECTOR

WARNING
1. Please read the operation manual carefully before operating.
2. Oxygen concentration control system must use oxygen analyzer to supply oxygen
through the oxygen input connector, the relative operation must be referred to the
operation manual of oxygen analyzer or other documents similarly.
3. Only given decompress valve or pressure adjusting valve can be used on the oxygen
cylinder.
4. According to the theory that the oxygen concentration breathed in by the patient can
not judge his artery PaO2. Accurately, so other acceptable clinical measures should
be taken to testify the patient’s artery PaO2.

6.4.1 CONNECTION OF MANUAL OXYGEN INPUT PORT

Connect the oxygen transfuse tube of monitoring device and the manual oxygen input port,
(refer to figure 4.3) to make sure the air-proof connecting port. This port can not control the oxygen,
while the oxygen flow can be adjusted by the user. The different oxygen flow can cause the
different oxygen concentration, please refer to the oxygen concentration table, which is located on
the back of incubator, the oxygen concentration needs a calibrated oxygen analyzer for long
period monitoring.

FIGURE 6.2

6-2 I5
 MANUAL FOR INFANT INCUBATOR

6.4.2 CONNECTION ABOUT THE INPUT INTERFACE OF SERVE CONTROL OXYGEN

Connect the oxygen input tube of serve control oxygen interface (see figure 4.3)and the
oxygen-offering system equipped with the oxygen monitoring device, and make sure the
connecting part is sealed.
Electromagnetic valve is in servo control oxygen input [Link] the oxygen sensor in
sensor box detects the oxygen is enough for user, it will cut off the oxygen supply,if not enough it
will continue to supply [Link] sensor box will alarm if put in wrong place and the
electromagnetic will cut off oxygen supply.
NOTE: 1. To make sure the safety, when offering the oxygen, there must be a calibrated
oxygen analyzer that can monitor the oxygen concentration inside of hood.
2. The oxygen input tube offered by our company can only connect with the serve
control oxygen input interface, using the manual oxygen input interface is
forbidden.

WARNING：Over high oxygen concentration can cause terrible hurt on the baby, so please
follow the advice of doctor when offering the oxygen, and use the relevant
oxygen monitoring device to help it reach the setting state set by physician.
Please read the indication values, the oxygen concentration table is just
regarded as a reference.

6.5 OXYGEN SYSTEM OPERATIONAL CHECKOUT PROCEDURE

Before the first usage of incubator and the reuse after maintenance, should perform the
oxygen concentration calibration system operating process.
The system support with two kinds of oxygen concentration calibration: 21% oxygen
concentration and 100% oxygen concentration. When the oxygen concentration of the
environment is below 21%, we suggest using 100% oxygen concentration calibration.

21% OXYGEN CALIBRATION

Keep the incubator in the environment which oxygen concentration is 21%.

a. Take out the sensor box under the condition of controller is turned off.
b. After press the second self-definite function key, turning the controller to enter the interface
of oxygen concentration calibration. Press “21% Cal.” Key, see the figure 6.3. The controller can
calibrate oxygen sensor automatically, and the screen indicates “O2 sensor calibration”. After
calibration, controller can enter into the first interface. If calibration work fails, the indicator displays
the failure hint, and then users can solve problems according to the hint. If these failures can not
be terminated, please ask the authorized and qualified personnel for repair.

I5 6-3
 MANUAL FOR INFANT INCUBATOR

FIGURE 6.3

100% OXYGEN CALIBRATION

a. Turn off the controller, pull the sensor box out as figure 6.4 shows, connect the oxygen
calibration device which is equipped with oxygen connecting pipe to the sensor box, supplying the
device with 100% oxygen for more than 2min.
b. After pressing the second self-definite function key, turning on the controller, the indicator
display the interface of oxygen concentration calibration. Press “100% Cal.” Key, see the figure 6.3.
The controller can calibrate oxygen sensor automatically, and the screen indicates “O2 sensor
calibration”. After calibration, controller can enter into the first interface. If calibration work fails,
the indicator displays the failure hint, and then users can solve problems according to the hint. If
these failures can not be terminated, please ask the authorized and qualified personnel for repair.

Sensor box

Oxygen concentration
calibration device

FIGURE 6.4

CHECK THE OXYGEN CONCENTRATION MONITOR FUNCTION

1. Place a calibrated oxygen concentration analyzer on the middle of the bassinet.

2. Input oxygen to the device, wait until the oxygen concentration displays steady, the value
deviation displayed between the value displays in the Oxygen Concentration indicator and the
oxygen concentration analyzer should in the range of ±3%.

6-4 I5
 MANUAL FOR INFANT INCUBATOR

CHECK FOR OXYGEN CONCENTRATION DEVIATION ALARMING FUNCTION

Connect the oxygen supply system and manual oxygen input interface, set the oxygen
concentration as 30%O2, when the oxygen concentration reaches the setting value, increase the
oxygen flow immediately, when the display value is different from the setting value +5%O2, the
device should give a high priority alarm sound, “Alarm O2 Deviation” information will replace the
curve indication on the screen, the alarm character should be consistent with the description of
section 3.4; set the oxygen concentration as 30%O2, when the oxygen concentration reaches the
setting value, decrease the oxygen flow immediately, when the display value is different from the
setting value -5%O2, the device should give a high priority alarm sound, “Alarm O2 Deviation”
information will replace the curve indication on the screen, the alarm character should be
consistent with the description of section 3.4. When alarm occurs, press silence/reset key once,
can cancel the alarm sound, but the alarm light still flashes until the display value is within ±5%O2
of setting value.
Connect the oxygen supply system and servo control oxygen input interface, set the oxygen
concentration as 30%O2, when the oxygen concentration reaches the setting value, increase the
oxygen flow immediately, when the display value is different from the setting value +5%O2, the
device should give a high priority alarm sound, “Alarm O2 Deviation” information will replace the
curve indication on the screen, the alarm character should be consistent with the description of
section 3.4; set the oxygen concentration as 30%O2, when the oxygen concentration reaches the
setting value, decrease the oxygen flow immediately, when the display value is different from the
setting value -5%O2, the device should give a high priority alarm sound, “Alarm O2 Deviation”
information will replace the curve indication on the screen, the alarm character should be
consistent with the description of section 3.4. When alarm occurs, press silence/reset key once,
can cancel the alarm sound, but the alarm light still flashes until the display value is within ±5%O2
of setting value.

6.6 USING OF OXYGEN SUPPLY SYSTEM

6.6.1 Preparation
Connecting the oxygen flowmeter and oxygen input valve with one PU-10×6.5 medical pipe.
6.6.2 Operation
[Link] According to the requirements of physician, on the first screen, press oxygen self-definite
function key, please refer to the figure 6.5 to set the oxygen concentration monitoring datum mark.
NOTE: During operation, if there is information like “O2 Module Switched off” displays on
the screen, there must be something wrong with the oxygen module: not been
installed or fails to work.

WARNING: 1. The oxygen input interface of oxygen –offering system and the one of serve
control can not be used together.
2. If the artery blood oxygen pressure of patient (PaO2) can not maintain 65%
O2 saturation; you need to change the other oxygen transfusion method.
3. Do not supply wet oxygen to the oxygen port, or else the oxygen inlet port
would be damaged.

I5 6-5
 M
MANUAL FO
OR INFANT INCUBATOR

SET OXYGEN MODULE

M WORKING
W M
MODE

When the
t keypad lock indica
ator light iss on, press
s O2 Soft key to ente
er into the oxygen

concenttration opera
ation interfacce.

Press On/Off
O key to
o open or close the oxyygen module. In the op
pen state, oxxygen concentration

indicatio
on window can
c indicate
e the actua
al oxygen co n inside of the incubattor. After
oncentration

entering
g into the norrmal conditio ped with the oxygen concentration sservo control system,
on, if equipp

and the oxygen con

ncentration indication window
w can indicate the arks on the top right
e circular ma

corner in
n the oxygen
n indicating area.

The start-up
s ma
ark of oxyg
gen inpput The clo
osed mark of oxygen iinpput valve e under
valve under the oxygen conncentration the oxy
ygen concen
ntration servvo control sy
ystem
servo control systtem

FIGURE 6.5
5

6-6 I5
 M
MANUAL FO
OR INFANT INCUBATOR

NOTE: 1.
1 Only whe en the keyp
pad lock ind
dicator lightt is on, valu
ue setting to
o the device
e can be
proceed.
y is presse
2. If no key ed within 15
5 seconds during the value settting proced dure, the
indicator will
w automattically reverrt to first ind
dication intterface and keep the la
atest set
value.

1 S
Set

Press to m mark set point, the In

o activate Setting Oxygen Concenttration datum ndicator “Se
et” in the
area of O2 flashes.

2 Se
et
20
Press Up
U Arrow to rise set poin
nt from the current
c value
e to 60%O2. Press one
e time to rais
se datum
mark in 1% O2 increments. Prress this ke
ey without sttopping to make
m the oxxygen concentration
setting increase rap
pidly.

3 S
Set
20
Press do
own Arrow to decrease set point fro
om current va
alue to 20%
% O2. Press o
one time to decrease
d
datum mark in 1%
% O2 incre
ements. Pre
ess this key
y without stopping
s to make the oxygen
concenttration settin
ng decrease rapidly.

4 On/Off
Press th
his key to close or open
n the oxygen
n module. Iff the followin
ng indication
n can appea
ar on the
screen, and it means that the system is in the state of opening,, and the oxxygen concentration
ed or the oxxygen senso
sensor is not installe or or oxygen system is fa
ailed.

5 Trrend

Press to
o enter third indication in
nterface A Refer
R to Para 2.2 for detail.
agraph 6.6.2

6 Ho
ome

Press to
o acknowledge Oxygen Control Settting and retu
urn to first in erface.
ndication inte
I5 6-7
 M
MANUAL FO
OR INFANT INCUBATOR

7
Press th
his key, the
e keypad locck indicator light will sh
hine and acccess contro
oller set sta
ate. After
setting back
b to firstt interface, press
p keypa
ad lock to co
ontrol area, and keypad
d lock indica
ator light
goes ou
ut, or don’t press any key it will return
r to co
ontrol state automaticallly and keypad lock
indicator light goes out after 15 seconds.

8 ALARM
Under the alarm co
ondition, the
e alarm lightt will flash and
a sound alarm
a calls, the alarm message
m
instead of the curv
ve display(expect outa
age alarm). Please re
efer to the s
specific des
scription
of 3.4 chapter.
c Alarrm mute/resset key has two
t function
ns, When ala
arm occurs, press this key
k once
to stop alarm,
a presss this key tw
wice to resett the alarm status
s , the incubator
i will be back to
o the set
state an
nd monitor th
he alarm aga
ain.

[Link] OXYGEN
O CONCENTRA
ATION TREND DISPLA
AY
Und ndition whicch as Figure 6.6 indicated, presss Soft keyy to select Oxygen
der the con
Concenttration Trend
d Display Menu.

6
FIGURE 6.6
NOTE: 1.
1 Only whe
en the keyp
pad lock ind
dicator lightt is on, valu
ue setting to
o the device
e can be
proceed.
y is presse
2. If no key ed within 15
5 seconds during the value settting proced
dure, the
indicator will
w automattically reverrt to first ind
dication intterface and keep the la
atest set
value. (Butt for the ste
ep 2 inquiry
y screen, the indicatorr displays th
he previous
s screen
instead).

1 Times
Press th
his key to select
s the time intervalss of curve trend
t and th
he indication area xan indicate
2,4,8,12
2 and 24 hou
urs Oxygen Concentration Trend Diisplay.

2 Store

Press th
his key to ma
ake the trend restore fro
om the curre
ent state, at the same tim
me, the operrator can
read the
e information
n about noticce as the folllowing screen.
6-8 I5
 M
MANUAL FO
OR INFANT INCUBATOR

If press YES, it can

n return the last scree
en, the controller can cancel the original stora
age data;
press NO, it can retturn the last screen, th
he controllerr can continu
ue to store the data on basis
b the
original one.

3 Ho
ome

Press th
his key to re
eturn to firstt indication interface,
i the curve indication wind
dow can indicate the
on curve.
oxygen concentratio

4
Press th
his key, the
e keypad locck indicator light will sh
hine and acccess contro
oller set sta
ate. After
setting back
b to firstt interface, press
p keypa
ad lock to co
ontrol area, and keypad
d lock indica
ator light
goes ou
ut, or don’t press any key it will return
r to co
ontrol state automaticallly and keypad lock
indicator light goes out after 15 seconds.

AINTENAN
6.7 MA NCE
A. Oxygen
O conccentration sensor
When the oxyg
gen concentrration lifetim
me is in due, replace it even
e it is wo
orkable to en
nsure the
veracity of the deteccting value. That is beca
ause:
e detecting accuracy
The a of oxygen concentration sensor
s is influenced by tthe electroly
yte inside
the senssor modularr, and the electrolyte wiill be consumed along with
w the working time. So
S using
the overr lifetime oxyygen concen
ntration senssor will result in wrong detected
d value.
B. Troubleshoo
T oting
Troubleshooting of the oxyygen concen
ntration sens
sor is presen
nted in the ffollowing tab
ble. If the
nnot be loca
fault can alized from the table, th
he unit shou
uld be remo
oved from se
ervice and servicing
s
should be
b referred to
t our compa
any or autho
orized and qualified
q servvice personn
nel.

I5 6-9
 MANUAL FOR INFANT INCUBATOR

SYMPTOM POSSIBLE CAUSE REMEDY

No indication of oxygen
Not install the oxygen sensor install the oxygen sensor
concentration value

Please calibrate the oxygen

sensor again
Displayed oxygen concentration
too high
Adjust the proper oxygen flow
The “Alarm” light will
flash, and the screen Please calibrate the oxygen
indicator will show sensor again
“Alarm O2 Deviation” Displayed oxygen concentration
too low
Adjust the proper oxygen flow

Open the access door Close the access door

6-10 I5
 MANUAL FOR INFANT INCUBATOR

SECTION 7
HUMIDITY CONTROL SYSTEM
7.1 GENERAL
This section provides operation and checkout procedures and operation manual about
humidity control system.

7.2 FUNCTION DESCRIPTION

The humidity display range of the incubator is from 0%RH to 99%RH, with a setting range of
0% to 90%RH (Note: If environmental humidity is relatively high，it may not be able to achieve
relatively low humidity control). The deviation alarm is pre-set to ± 15% RH, which means in
humidity steady condition,the humidity deviation alarm will occur if the humidity value is above or
below the selected humidity setting range ± 15% RH.
Vapour produced when the water in the humidity chamber flow by the heat pipe located on
the bottom of the chamber, enters into the hood by vapour outlet port. The humidity control system
enables the humidity increase inside the chamber. The evaporating speed is decided by the power
of the heater. There’s a humidity sensor inside the sensor modular of the hood which adjusts the
output power of the evaporator. Please see the alarm introduction of section 3.4. If the alarms
about humidity are active, press silence/reset key, terminate the alarm sound for 4mins, if the
power of the temperature heater is not cut off, the power of the humidity heater will automatic cut
off when the high humidity deviation alarm is activated.
When the indicator displays “Humidity Module Switched off”, there’s something wrong with
the humidity module.

7.3 OPERATION AND CALIBRATION PROCEDURES

Please calibrate the incubator when the incubator is used for the first time or reuse it after
cleaning and installation. Before calibrating the device, please refer to section 7.4 to see how to
set humidity of the incubator.
A. Fulfill the humidity chamber to the highest level with water, then place a calibrated humidity
analyzer in the middle of the bassinet.
B. Preheating the incubator to 36℃, set the humidity value in 50%RH.
C. After temperature and humidity reach stable state, the readings on both the hygrometer
and the humidity display indicator should display 50%RH±5%RH.
D. Check the humidity deviation alarm
On humidity set mode, set the value at 40%RH, when the humidity reaches the setting value,
increase the humidity display value, keep the display value higher than set value +15%RH, the
device should give a medium priority alarm, the “Alarm Humidity Deviation” information will
replace the curve indication on the screen, the alarm character should be consistent with
description of section 3.4. On humidity set mode, set the value at 40%RH, when the humidity
reaches the setting value, decrease the humidity display value, keep the display value lower than
set value -15%RH, the device should give a medium priority alarm, the “Alarm Humidity
Deviation” information will replace the curve indication on the screen, the alarm character should
be consistent with description of section 3.4. Press silence/reset key can terminate the alarm
sound, but the alarm light still flashes until the display value is within ±15%RH. If 4mins later, the
alarm condition is still not canceled, alarm sound will start again.

I5 7-1
 MANUAL FOR INFANT INCUBATOR

NOTE：If the displayed value won’t rise anymore or can’t decline to the set value in the
deviation rate more than ±15%, the alarm won’t occur. When checking the
low-deviation alarm, please make sure that the environmental humidity is
lower than the humidity in the hood so that the alarm can be activated.

7.4 USING THE HUMIDITY CONTROL SYSTEM

WARNING：In any temperature, the relatively high humidity in the incubator will decrease
the heat evaporating from the patient and result in increasing the patient’s
temperature. This is especially clear in the neonate. Therefore, temperature
control mode, temperature value and humidity value should be certified by
the chief doctor. Monitor the patient’s recta and armpit temperature
according to the doctor’s instruction.

7.4.1 Preparation
Pull the water tank out as following figure shows, adding proper distilled water into the tank.
But not over the high water level. Set the incubator in the Air control mode. It can pre-warm the air

in the hood according to the set temperature which set by the main doctor or chief nurse.
Water level display window Water Inlet

Handle Reservoir

NOTE: When the handle of the water tank is pulled to a vertical position, water level can be
observed. When the handle is pulled to the horizontal position, water tank can be
took out. (Please keep the water tank flat and straight and don't move it up towards
when it been pulled out, or else it will be hard to pulled out)

1. Do not start using the humidifying function in the condition that lack water, or
humidifying system will be damaged.
2. The water must be pushed in position when the incubator works in any time,
or will affect the normal temperature control.
3. In order to extend the service life of humidity device, the cleaned distilled
water is the only choice; the sterilized water can not take place of distilled water.
4. The water tank should be thoroughly cleaned every 24 hours and replace
cleaned distilled water, to prevent the microbial propagation and the pollution of
humidifying chamber. The water changing should be performed after the water
tank is cooling sufficient, so as not to scald. Do not exceed maximum water level.

7-2 I5
 MANUAL FOR INFANT INCUBATOR

IMPORTANT：1. Please clean the water tank every time before adding water in the tank. Dry
it with a clean cloth or paper towel for both inside and outside of the water
tank to ensure than water lacking alarm will normally working.
2. Please set the humidity value to 0%RH when you're not using the
"humidify" function.

Burns may occur under the condition of high temperature and high humidity
(temp. ≥37℃, humidity ≥85%RH). Therefore, please wait no less than 45minutes
when taking out the water tank or restart the humidifier.

7.4.2 Operation
[Link] According to the requirements of physician, on the first screen, press humidity self-definite
function key, please refer to the figure 7.1 to set the humidity value.
NOTE: The actual humidity achievable inside the system is depend on the Incubator Set
Temperature and room conditions.

SELECTING HUMIDITY CONTROL AND SET POINT

When the keypad lock indicator light is on, select and press Humidity Soft key to enter Figure
7.1 on first indication interface.

Humidity control system is in the state of adding humidity Humidity control system stops working
FIGURE 7.1
NOTE: 1. All setting should be operating under the keypad lock indicator light is on.
2. If no keys are pressed within 15 seconds of selecting this Mode or setting
Humidity, it will automatically revert to first indication interface.

I5 7-3
 MANUAL FOR INFANT INCUBATOR

1 Set

Press to activate Setting Humidity set point, the indicator “Set” in the area of Humidity flashes.

2 Set
20
Press Up Arrow to raise set point from 0%RH to 90%RH. Press one time to raise set point setting
in 1% RH increments.

3 Set
20
Press Down Arrow to lower set point from 90%RH to 0%RH. Press one time to lower set point
setting in 1% RH increments.

4 Weight

Press this key to enter into the weight function set.

5 Trend
Press to enter third indication interface A. Refer to Paragraph [Link] for detail.

6 Home

Press to acknowledge Humidity Control setting and return to first indication interface.

7
Press this key, the keypad lock indicator light will shine and access controller set state. Press
keypad lock to control area, and keypad lock indicator light goes out, or don’t press any key it will
return to control state automatically and keypad lock indicator light goes out after 15 seconds.

8 ALARM

Under the alarm condition, the alarm light will flash and sound alarm calls, the alarm
message instead of the curve display(expect outage alarm). Please refer to the specific
description of 3.4 chapter. Alarm mute/reset key has two functions, when alarm occurs, press
this key once to stop alarm, press this key twice to reset the alarm status, the incubator will be
back to the set state and monitor the alarm again.

7-4 I5
 MANUAL FOR INFANT INCUBATOR

[Link] Humidity trend display

Under the condition as indicated in Figure 7.1, press Soft key to select Humidity Trend
Display Menu.

FIGURE 7.2
NOTE: 1. All setting should be operating under the keypad lock indicator light is on.
2. If no keys are pressed within 15 seconds of selecting this Mode or setting
Humidity, it will automatically revert to first indication interface. (Return the last
step except for the step 2)

1 Times
Press to select 2,4,8,12 and 24 hours Humidity Trend Display.

2 Store
Press this key to make the trend restore from the current state, at the same time, the operator can

read the information about notice as the following screen.

Press YES, it can return the last screen, the controller can cancel the original storage data; press

NO, it can return the last screen, the controller can continue to store the data on basis the original

one.

I5 7-5
 MANUAL FOR INFANT INCUBATOR

3 Home

Press to acknowledge Humidity Control setting and return to first indication interface.

4
Press this key, the keypad lock indicator light will shine and access controller set state. After
setting back to first interface, press keypad lock to control area, and keypad lock indicator light
goes out, or don’t press any key it will return to control state automatically and keypad lock
indicator light goes out after 15 seconds.

7.5 MAINTENANCE
Troubleshooting of the humidity control system is presented in the following table. If the fault
cannot be localized from the table, the unit should be removed from service and servicing should
be referred to our company or authorized and qualified service personnel.

SYMPTOM POSSIBLE CAUSE REMEDY

Environmental humidity change Check the surrounding humidity

greatly condition
Humidity deviation alarm

No distilled water in the tank Add distilled water into the tank

Add distilled water into the tank

Indication symbol No distilled water in the tank
(Wash it when there's a need)

Push the water tank to the

Bad connection between water
Alarm Water Reservoir is correct position to fully
tank and the main body of the
placed incorrectly connecting with the main body of
device
the device.
Fill the water tank with
water after water lack
Humidifier over-heat protection
indication, "humidify" Waiting for about 10 minutes
not restored.
can't be started
immediately
Excessive microorganism breed Using the soft cloth with
Alarm not be activated
in the water tank or the water disinfectant to wipe around the
when the water tank is
tank haven't been cleaned for detect point to clean the water
lack of water
many days. tank thoroughly.
After it cool down, using the soft
Heating circuit failure Over-heat relay works because cloth with disinfectant to wipe
alarm the dusts near the probe. around the detect point to clean
the water tank thoroughly.

7-6 I5
 MANUAL FOR INFANT INCUBATOR

SECTION 8
WEIGHING SYSTEM
8.1 GENERAL
This section provides operation and checkout procedures and operation manual about
weighing system.
Weighing system is optional.

8.2 INSTALLATION
Install the weighing system in the incubator as figure 8.1 directs.

Please refer to the F of chapter 4.3.3, Adjust the bed to the lowest position, and open the front
door, place the bed with baby scale on the wavering mechanism, and it can be pulled out and push
in freely as the arrow 1 and 2 indicates.

Arrow Gap

Weight Sensor Make the weight sensor be inserted into

The gap of socket correctly

WARNING: 1. When plug in or out the power supply cord, the plug must be taken hold
and the wring should not be pulled.
2. Do not bend the connection of sensor.

Connect the plug of sensor on the baby scale with the socket on sensor box correctly.

FIGURE 8.1

I5 8-1
 MANUAL FOR INFANT INCUBATOR

8.3 FUNCTION DESCRIPTION

The weighing system has the operation of calibration and zeroing. Users can do this through
custom function keys on the control panel. The system weight display range is 100~8000g; the
display resolution is 1g; the display accuracy is ±1%; and the zero setting range is 0~2000g.

8.4 OPERATION AND CALIBRATION PROCEDURES

If the weight indication is required, the user should reset the controller and enter into the third
indication interface B. The body weight can be indicated only on the third indication screen or
weight curve indicate window.
NOTE：Apply the weight sensor calibration and operation procedure when first using the
incubator or reuse it after installation, cleaning, or maintaining.

CALIBRATION OF WEIGHT SENSOR

When the keypad lock indicator light is on, on the second interface B, press weight
self-definite function key to enter into the interface in figure 8.2 to calibrate the weight sensor.

FIGURE 8.2
NOTE: 1. All settings should be done when the keypad lock indicator light is on.
2. Whichever operation, If not proceeding the next step after pressing the key for
15s, and then the indication can come back to the first interface and restore the
operation result of last time.
A. Press the reset custom function key, and then remove all the items on the infant mattress,
to ensure the bed surface clean.
B. After 10S, the weight display window should show 0000g±5g. If exceeds ABOVE RANGE,
please press RESET key again.
C. Put the weight of 5000g on the baby scale, and then press Calibration self-definite function
key, the indication window can indicate the following figure 8.3, press No key or do not pressing
any key within 15s, the system can exit the calibration procedure automatically. Press Yes key, the
system can enter into the calibration state, the indication window can indicate the weight within
5000g±5g, when exceeding this range, repress Calibration self-definite function key until the
weight is in the right range. If failed, the baby scale should be repaired by qualified personnel.
8-2 I5
 MANUAL FOR INFANT INCUBATOR

FIGURE 8.3

CHECKING THE CONNECTING OF WEIGHT SENSOR

Disconnect the connection between the weight sensor and the sensor box, enter into the
interface in figure 8.2, weight indicator can hint the failure of weight sensor, the controller can
terminate the failure indication information automatically and indicate the weight of sensor.

OPERATION OF ALL KEYS OF WEIGHT INTERFACE

NOTE: All operation key should be done when the keypad lock indicator light is on.

1 Trend
Press this key to enter into the weight curve indication in figure 8.4.

2 Zero

Press this key to make the weight indication come back to zero, if exceeds 2000g, press this key,

the system can indicate zero error.

3 Calibration

This key is just used for calibrating the weight sensor; do not press this key in normal operation.

4 Home

Press this key to confirm the new setting value and come back the first indication interface.

INDICATION OF WEIGHT TREND

In indication interface of figure 8.2, press curve self-definite function key to select the menu
the weight trend indicates.
I5 8-3
 MANUAL FOR INFANT INCUBATOR

FIGURE 8.4

NOTE: 1. All setting should be done when the keypad lock indicator light is on.

2. Whichever operation,If not proceed the next step after pressing the key for 15s,

and then the indication can come back to the first interface and restore the

operation result of last time.(except for step 2: inquiry interface)

1 Times

Press this key without stopping can select the time intervals of curve trend, and indicate the trend
of one week, two weeks, three weeks, four weeks, five weeks, six weeks, and seven weeks.

2 Store
Press this key to restore the data from the current state, meanwhile, it can indicate the following
interface: inquiry the operator: are you sure?

Press Yes to confirm and return the last interface, the controller can restore the original information
continuously. press NO, it can return the last interface, the controller can continue to store the data
on basis the original one.

3 Home

Press this key to return to the first indication interface, the following trend can be indicated.

8-4 I5
 MANUAL FOR INFANT INCUBATOR

First: indicate the recorded weight of trend, last: indicate the current weight. The trend indicates
the deviation between the Last and First. If press store self-definite function key, and the result of
first can be replaced by the new storage weight.
NOTE: When there is failure on the connection of weight sensor, Last indication can be
replaced by Over.

8.5 OPERATION OF WEIGHING SYSTEM

After calibrating and reset the weighing system, lay the patient in, the Weight indicator will
display the patient’s weight by weight sensor.

8.6 MAINTENANCE
Troubleshooting of the humidity control system is presented in the following table. If the fault
cannot be localized from the table, the unit should be removed from service and servicing should
be referred to our company or authorized and qualified service personnel.

SYMPTOM POSSIBLE CAUSE REMEDY

No indication on Weight Turn on the power of the
No power supply
indicator controller
Take out every article on the
Weight indicator The reset range is over 0~2000g bassinet and keep the mattress
displays “Weight clean
Sensor Fault” The connection of weight sensor Connect the weight sensor
is failure correctly
The bassinet is not placed Adjust the bassinet into
horizontally horizontally
Infant is not placed in the centre Lay the infant in the centre of
of the mattress the mattress
Weighing inaccurate
Environmental temperature varies Check the environmental
greatly temperature
Weight sensor have been Please calibrate it again with a
incorrectly calibrated 5000g standard poise

I5 8-5
 MANUAL FOR INFANT INCUBATOR

SECTION 9 PARTS LIST

This section provides the lists of accessories and removable parts of the incubator. The users only
can use the materials provided by our company, or will reduce the safety of equipment.

No. Part Name Replacement Period/Conditions

1 Skin temperature sensor 2 years

2 Rechargeable battery 3 years

Apparently dirty or broken or used

3 Air filter material
over 2 months

4 Access door gasket

5 Plastic sleeve of access door

If damaged
6 Plastic sleeve of circular port for rotating

7 Power cable

Up to 10,000 hours at 100% oxygen

8 Oxygen sensor
concentration

I5 9-1
 SPECIAL STATEMENT: All of the content in the manual is checked carefully, if there is any
error or content of printing misunderstanding, our company retains
finally explanation of this card-usage.
NOTE: The product’s appearances maybe differ from the one in this manual, but it dose not
affect the capability of product. Please understand if it brings you troubles.

NINGBO DAVID MEDICAL DEVICE CO., LTD.

ADD: NO. 2, KEYUAN ROAD, SHIPU SCIENCE AND TECHNOLOGY PARK, XIANGSHAN, 315731
NINGBO, ZHEJIANG PROVINCE, PEOPLE’S REPUBLIC OF CHINA
FAX: +86-574-65962111
MARKETING CENTER: BLDG NO 5. NINGBO SMART PARK, #98 CHUANGYUAN ROAD, YINZHOU
DISTRICT, NINGBO, CHINA 315048
FAX: +86-574-87801111, 87803714
TEL: +86-574-87800008, 87800007
E-MAIL: sales@[Link]
WEBSITE: [Link]
EUROPEAN REPRESENTATIVE: SHANGHAI INTERNATIONAL HOLDING CORP. GMBH (EUROPE)
ADD: EIFFESTRASSE 80, 20537 HAMBURG, GERMANY
TEL: +49-40-2513175 FAX: +49-40-255726

EDITION/REVISION G/0

DATE OF ISSUE 2020/08

YP-2200B
INFANT INCUBATOR

Operator’s Manual
 Appendix A: EMC Information
This section is precaution for electromagnetic compatibility. The device shall be installed,
operated and used according to the electromagnetic compatibility information specified in this
section.

A.1Environmental Conditions of Electromagnetic Compatibility

1. The equipment intend to use in the professional healthcare facility environment.
2. Equipment cannot be operated or exposed in RFID, X-RAY, MRI environments.
3. Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
4. Equipment should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the equipment should be observed to verify normal
operation in the configuration in which it will be used.
5. If the essential performance is lost or degraded due to EM disturbances, the user might
need to take mitigation measures, such as relocating or re-orienting the equipment.

A.2 Classification of Electromagnetic Interference:

Group 1, Class A

A.3Cable List Provided by the Manufacturer

NAME CABLE LENGTH

Power Cable 3.0m

Signal cable for Monitoring cable(If applicable) 1.8m

Signal cable for External panel cable 1.8m

Signal cable for Skin temperature -1 1.5m

Signal cable for Skin temperature -2 1.5m

Signal cable for weight system 0.7m

Signal cable for Sensor box 0.7m

Power cable of checking lamp between parts of the ME （If applicable） 1.5m

Signal cable for Camera 1.1m

SpO2 Main cable for RC-12 4.0m

（If applicable） Main cable for RC-4 1.2m

Page 1 of 7
 NAME CABLE LENGTH

Main cable for ECG 5 lead，IEC 2.0m

Branch cable for ECG 3 lead，IEC 0.6m

Branch cable for ECG 5 lead，IEC 0.6m

ECG
（If applicable） Main cable for ECG 5 lead，AAMI 2.0m

Branch cable for ECG 3 lead，AAMI 0.6m

Branch cable for ECG 5 lead，AAMI 0.6m

CO2 Patch cord for CO2 0.3m

（If applicable）
mainstream module for IRMA CO2 2.5m

side-stream module for ISA CO2 0.6m

side-stream module for NomoLine ISA CO2 0.6m

Signal cable for Asphyxia awaken（If applicable） 2.0m

A.4 EMC Immunity Performance Test (essential performance)

1. With an INFANT INCUBATOR working in the BABY CONTROLLED INCUBATOR mode
with horizontal MATTRESS orientation ， the temperature as measured by the SKIN
TEMPERATURE SENSON shall not differ from the CONTROL TEMPERATURE by more than
0.7℃ in STEADY TEMPERATURE CONDITICN.
2. With an INFANT INCUBATOR or operating as an AIR CONTROLLED INCUBATOR, the
AVERAGE INCUBATOR TEMPERATURE shall not differ from the CONTROL INCUBATOR by
more than ±1.5℃.
3. After steady temperature conditions of an air controlled incubator have been achieved, any
sensed temperature deviation of the displayed air temperature exceeding ±3℃ compared with
the control temperature shall cause an auditory and visual alarm to operate
4. After STEADY TEMPERATURE CONDITIONS of a BABY CONTROLLED INCUBATOR
have been achieved, any deviation of the displayed SKIN TEMPERATURE exceeding ±1 °C
compared with the CONTROL TEMPERATURE shall cause an auditory and visual alarm to
operate. The ME EQUIPMENT heater shall switch off when the displayed SKIN TEMPERATURE
exceeds the CONTROL TEMPERATURE by more than 1 °C.
5. Within 5 s after exposure to the defibrillation voltage, the ME EQUIPMENT shall resume
normal operation in the previous operating mode, without loss of any OPERATOR settings or
stored data, and shall continue to perform its intended function.
6. Interrupted for 30 s or less, no change of OPERATOR settings shall occur, including the
mode of operation, and all stored PATIENT data shall remain available.

Page 2 of 7
 7. Provide a TECHNICAL ALARM CONDITION at least 5 min prior to the time that the ME
EQUIPMENT can no longer function in accordance with the MANUFACTURER’S specification
when powered from the INTERNAL ELECTRICAL POWER SOURCE.
8. The ALARM SIGNAL GENERATION DELAY for cardiac standstill (asystole) shall not
exceed 10 s.
9. Provide accuracy at a rate up to 125 mV/s, shall be reproduced on the output with an error
of ≤ ±5% of the nominal value of the output.
10. Nominal measurement range shall be ≤ ± 3mmHg or 2% of the reading.
11. Reproducibility of the blood pressure determination of the automated sphygmomanometer
shall be less than or equal to 3 mmHg.
12. ALARM PAUSED and AUDIO PAUSED interval shall be the same forall ALARM
SIGNALS of MULTIFUNCTION PATIENT MONITORING EQUIPMENT.
13. Medium priority is minimum alarm condition priority for CO2 inspired High priority is
minimum alarm condition priority for O2 inspired.
14. The SpO2 ACCURACY of PULSE OXIMETER EQUIPMENT shall be a root‐mean‐
square difference of less than or equal to ±3.0 % SpO2 overthe range of 70% to 100%,±3.0BPM
accuracy of pulse rate over the range of 60 to 100BPM.
15. The PULSE OXIMETER EQUIPMENT is equipped with an ALARM SYSTEM that detects
a PHYSIOLOGICAL ALARM CONDITION, the ALARM SYSTEM shall provide at least a
MEDIUMPRIORITY ALARM CONDITION for low SpO2 level

A.5 Warning
1. Pay attention to the electromagnetic environment at the scene, because the equipment
may be affected by the electromagnetic environment at the scene.
2. Use of cables other than those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.

Page 3 of 7
 Guidelines and Manufacturer's Declaration - Electromagnetic
Emission

Guidelines and Manufacturer's declaration - Electromagnetic Emission

The INFANT INCUBATOR is intended for use in the electromagnetic environment specified below. The
customer of the user of the INFANT INCUBATOR should assure that it is used in such and environment.

Emission Test Conformance

RF emission
Group 1
CISPR 11

RF emission
Class A
CISPR 11
Harmonic emission
Class A
IEC61000-3-2

Voltage fluctuation/scintillation emission

Conform
IEC61000-3-3

NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to radio-frequency communication services. The
user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Page 4 of 7
 Guidelines and Manufacturer's Declaration - Electromagnetic
Immunity

Guidelines and Manufacturer's declaration - Electromagnetic Immunity

The INFANT INCUBATOR is expected to be used in the following specified electromagnetic environment,
and the purchaser or user shall ensure that it is used in this electromagnetic environment:

Immunity Test IEC60601Test Electrical Level Compliance Level

Electrostatic discharge 8 kV contact 8 kV contact

IEC 61000-4-2 15 kV air 15 kV air
Electrical fast transient
2 kV for power supply lines 2 kV for power supply lines
burst
±1kV for signal input/output ±1kV for signal input/output
IEC 61000-4-4
Surge 1 kV differential mode
1 kV differential mode
IEC 61000-4-5 2 kV common mode
0 % UT; 0,5 cycle 0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315° and 315°
Voltage dips,
short interruptions
0 % UT; 1 cycle and 0 % UT; 1 cycle and
and voltage variations on
the power input line
70 % UT; 25 cycles 70 % UT; 25 cycles
IEC 61000-4-11
Single phase: at 0° Single phase: at 0°

0 % UT; 250cycle 0 % UT; 250 cycle

Power frequency
magnetic field
30A/m 30A/m
(50 Hz)
IEC 61000-4-8

NOTE UT is the a.c. mains voltage prior to application of the test level.

Page 5 of 7
 Guidance and manufacture’s declaration – electromagnetic
immunity – for EQUIPMENT and SYSTEMS that are
LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity

The INFANT INCUBATOR is intended for use in the electromagnetic environment specified below. The customer or
the user of INFANT INCUBATOR should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level

3Vrms
150 kHz to 80 MHz 3 Vrms
Conducted RF
IEC 61000-4-6
6 Vrms
150 kHz to 80 MHz
in ISM bands 6 Vrms

Radiated RF
3 V/m 3V/m
IEC 61000-4-3
80 MHz to 2.7 GHz

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to 6.795MHz; 13.553
MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range 80
MHz to 2.5GHz are intended to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is
used in calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the INFANT INCUBATOR is used
exceeds the applicable RF compliance level above, the INFANT INCUBATOR should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the INFANT INCUBATOR.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Page 6 of 7
 Guidance and manufacturer’s declaration – electromagnetic
immunity – for all EQUIPMENT and SYSTEMS
IMMUNITY to proximity fields from RF wireless communications
equipment
The ENCLOSURE PORT of ME EQUIPMENT and ME SYSTEMS shall be tested as specified
in Table 9 using the test methods specified in IEC 61000-4-3..
Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment

Test Maximum IMMUNITY

Band a) Distance
frequency Service a) Modulation b) Power TEST
(MHZ) (m)
(MHZ) (W) LEVEL (v/m)
Pulse
385 380-390 TETRA 400 modulation b) 1,8 0,3 27
18 Hz
c)
FM
GMRS 460,
450 430-470 ±5 kHz deviation 2 0,3 28
FRS 460
1 kHz sine
710 Pulse
LTE b)
745 704-787 modulation 0,2 0,3 9
Band13, 17
780 217 Hz
GSM
810
800/900,TETR
Pulse
870 A 800, iDEN
800-960 modulation b) 2 0,3 28
820, CDMA
18 Hz
850, LTE Band
930
5
GSM 1800;
1720
CDMA 1900;
Pulse
1700- GSM 1900;
1845 modulation b) 2 0,3 28
1990 DECT; LTE
217 Hz
Band 1, 3, 4,
1970
25; UMTS
Bluetooth,
WLAN, Pulse
2400-
2450 802.11 b/g/n, modulation b) 2 0,3 28
2570
RFID 2450, 217 Hz
LTE Band 7
5240 Pulse
5100- WLAN 802.11
5500 modulation b) 0,2 0,3 9
5800 a/n
5785 217 Hz
NOTE If necessary to achieve the IMMUNITY TEST LEVEL , the distance between the transmitting antenna and
the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC
61000-4-3.
a)
For some services, only the uplink frequencies are included.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case.

Page 7 of 7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

WARRANTY
The company warrants that products described in this manual enjoy free warranty for defects
in materials and workmanship for a period of one year from the date of shipment. The warranty,
however, does not cover the following conditions:
1. All consumable and disposable products are guaranteed to be free from defects upon
shipment only.
2. The scope of routine maintenance is not included in the one-year warranty.
Within the warranty period, except for the above listed conditions, any defective parts will be
replaced for free.
This warranty is disclaimed upon any of the following conditions and the company does not
assume any responsibility for personal injuries or property loss arising from such conditions:
1. Failure or damage due to incorrect operations.
2. Product failure or damage caused by user maintenance against the user manual.
3. Product failures or damages caused by use of parts not approved by the manufacturer
during product alteration or maintenance.
4. Product or maintenance service purchased from unauthorized dealers or service providers.
5. Refer to the Maintenance Guide for the relevant technical specifications.
This warranty is in lieu of all other warranties. In no event will the company be liable for
accidental and/or consequential damages, including the loss of use, property loss, or personal
injury resulting from breach of warranty.
Users must check the product performance and mechanical integrity before product
application and once every 12 months during usage. To follow this guideline, you are
recommended to attend training courses provided by us or our authorized dealers within the
warranty period.

SERVICES
To achieve optimal performance, product maintenance can only be carried out by qualified
maintenance personnel authorized by the company. To obtain relevant maintenance service
information, contact your local dealer or the After-Sales Department of the company.
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is
established

i
 OPERATOR'S MANUAL OF INFANT INCUBATOR

OPERATING PRECAUTIONS
1. INFANT INCUBATOR (incubator) belongs to high risk medical device which can endanger
infant's life. Therefore please use the device only in neonate nursing room, children nursing room,
pediatric intensive care unit or similar sickroom in hospital. Operators for the device should be
special trained and operate the device under the instruction of medical practitioner. The device is
intended for infants with body weight within 10 kg (8 kg for incubators with an electronic scale).
2. The INFANT INCUBATOR cannot differentiate between an increase in core temperature with a

cold skin (fever) and a low core and SKIN TEMPERATURE (hypothermia). Periodically monitor

and record the infant temperature and check for abnormal infant temperature.
3. Please stop using the device when failure or malfunction appears. Turn off the power and
transfer the patient out from the device, then inform our company or our authorized agency for
service. DO NOT ask for service from person who's not been authorized by our company.
4. Direct radiation from sunlight or other infrared source could cause overheating of the infant
without activating the Over Temperature Alarm. DO NOT leave the INCUBATOR in direct sunlight
or near other sources of radiant heat.
5. DO NOT leave the INCUBATOR in the presence of flammable an aesthetic gases or other

flammable materials, such as some types of cleaning fluids.

6. DO NOT leave the INCUBATOR in the presence of strong electromagnetic field. Portable and

mobile RF communication devices may have an impact on this device.

7. Devices which are easily interfered by magnetic field should not be used near the INCUBATOR

because they may interfered by the INCUBATOR.

8. The incubator does not equip the air cleaner, to make sure the good air quality inside hood, the

incubator should be used in the environment with clean air.

9. Please DO NOT use the INCUBATOR under working environment not stipulated in table 1.1, or

else, it may cause the failure or the INCUBATOR can not reach the requirements.

10. To prevent harm to the infant, the hood should not be raised while leads are connected to the

infant or if the mattress tilted.

11. There should be no need to raise the hood at any time while the infant is cared for in the

incubator. All necessary access to the infant can be achieved by means of the Access Panel and

Access Doors.

12. When the Front and Back Access Panels are open, the temperature from the air temperature

indicator maybe not the real temperature inside incubator. Therefore, do not leave the Access

Panels open in a long period.

ii
 OPERATOR'S MANUAL OF INFANT INCUBATOR

13. All access panel‘s latch should be firm plugged, in case accidental open.
14. For infant safety, DO NOT leave the infant unattended when the Front and Back Access
Panels are open.
15. Other accessories within the incubator which can alter the air flow pattern may affect
temperature uniformity and temperature variability. In addition, we suggest the incubator run on
skin temperature mode. Otherwise, according to the baby temperature measurement result, the
incubator temperature set value must be reduced.
16. When another device is used together with this device, use cables to connect the equipotential
ends of all devices to eliminate the potential difference between them to ensure safety.
17. Use the device for only one infant at a time.
18、Patient safety and incubator performance may be compromised if air flow passages are not
kept clear from obstructions (blankets, stuffed animals, etc.) during clinical usage.
19. Do not place surgical covers or blankets over the infant and warm air curtain or side vents
simultaneously. This may cause heat induced injury and burns.
20. The incubator should be moved by at least two personnel who have certain power, the handle
located on both side of the incubator can be used as hands handle when moving. Please pull out
all power cords before moving.
21. To prevent the harm on patient for accidental movement, please lock the casters during usage.
22. To prevent accidental disconnection, secure all patient leads, infusion lines and ventilator
tubing to the mattress with sufficient excess length to allow for the full range of mattress height
adjustment.
23. To avoid water over flow from water chamber, and keeping the most stable position of infant
incubator, before moving all of accessories should be fixed to the right position and let out all of the
water.
24. Do not switch on for longer time than essential, when the machine not connected to the power
supply, otherwise, power supply failure alarm will be activated and the internal battery current
waste.
25. When using X-Ray tray via incubator hood, the shadow of hood will reflect on the X-ray
negative. That maybe influence the doctor’s diagnose.
26. Do not place any article higher than incubator’s caster under its VHA stand which may affect
the stabilization of VHA stand.
27. When operating the VHA stand, support the incubator with one hand on to prevent it from
unbalance.

28. In nursing operation, the operator can not touch the other charged equipment at the same time,

may bring shock hazard to patients.

iii
 OPERATOR'S MANUAL OF INFANT INCUBATOR

29. Only the authorized and qualified maintenance personnel can replace the fuse according to

the specification. When replace the fuse, you should disconnect the power supply of the incubator

first, and can not touch the patients and metal parts at the same time.

30. The device must be fully cleaned and sterilized for the first time for initial use, after nursing for

one baby, after used it for one week or there's dirt in the incubator. Cleaning and sterilizing

methods please refer to Section 15.

31. Please use the registered neutral detergent/ disinfectant. Other disinfectant (like alcohol) will

destroy some parts of the incubator. Please follow the instruction for detergent usage.

32. After cleaning the incubator by combustible cleaning solvent should airing the incubator

completely. The residual a handful of the flammable solvent (such as ethyl ether, ethanol or similar
cleaning solvent) in the incubator can cause a fire.

33. Please only use skin temperature sensor, rechargeable battery, power cord, extension of the

pulse oximetry sensor or other accessories provided by our company. Otherwise, it may reduce the

safety of the equipment.

34. The lifetime of incubator internal rechargeable battery is usually 3 years. Before using it every

time, we should inspect the status of internal rechargeable battery according to the requirement in

section 15.3. If it isn't getting through the inspection or the battery has been used more than three

years, it must be replaced. The internal rechargeable battery should be replaced by authorized

qualified service personnel.

35. The device should not be close to or use with other device. If have to, please observed to

verify that in its use of configuration can run normally or not.

36. Damages will be easily caused if using the incubator after it reached its lifetime. Previous

capability guideline and requirement cannot be reached as well.

37. The life period of incubator is 10 years. The device, accessories and the packaging have to be

disposed of waste correctly at the end of the usage. Please follow Local Ordinances or

Regulations for disposal.

ELECTRICAL PRECAUTIONS
1. To avoid the risk of electric shock, this equipment must only be connected to a supply mains

with protective earth.

2. An electric shock hazard exists within the Controller and VHA stand assembly when the cover is

removed. Servicing should be performed only by qualified personnel with appropriate service

documentation.

iv
 OPERATOR'S MANUAL OF INFANT INCUBATOR

3. To prevent equipment damage or accidental power disconnection, Do NOT connect an

Incubator power cord directly to an ac wall socket. Always provide power to the Incubator using

the power cord coming directly form the VHA stand.

4. Make sure the building power source is compatible with the electrical specifications shown on

the rear center column of the VHA stand.

5. Power of incubator is supplied by the net power from VHA stand. Please unplug the power cable

when stop using or maintain incubators.

6. Improbably using of the assistant device will cause the decrease of our device’s safety. The

safety of auxiliary devices shall comply with the general requirements for safety according to

IEC60601-1, and have acquired the certificate by relative institution.

7. Equipment provided an integral multiple socket-outlet, If connecting the auxiliary equipment on

this interface, the maximum power of the auxiliary equipment shall not exceed the prescribed load

limit, The assembly of ME SYSTEMS and modifications during the actual service life require

evaluation to the requirements of IEC60601-1, clause 16. No matter who connect the auxiliary

equipment to the medical system of the medical electrical equipment must comply with the

requirements of medical system. They must focus on the local law, means the law takes

precedence over the above requirements. If there is any question, please contact with local agent

or technical service department.

8. When the incubator is installed with the VHA, for, the device will use the power plug and socket

as the way to insulate the device from the main power supply for safety. Please ensure that the

plug is easy to operate.

9. General Power switch used as isolation device from the mains supply. When the operator wants

to safely terminate operation of Me Equipment, please cut off the General Power switch.

Equipment should be placed where it is easy to operate.

10. Any parts are not serviced or maintained while in use with the patient.
11. When selecting the ancillary equipment must insure that the equipment had tested according
to the requirements in IEC60601-1 or other relevant standard, and acquire the safety certificate.
12. Mains plug or appliance coupler is intended to be used as isolation device from the supply
mains. Please always make mains plug easily to operate.

HUMIDITY PRECAUTIONS
1. The incubator is with the humidity controller, it can increase the Humidity of incubator according
to the clinical demands.

v
 OPERATOR'S MANUAL OF INFANT INCUBATOR

2. Higher relative humidity will, at any given time, decrease an infant’s evaporative water loss and
may cause an increase in infant temperature. Monitor the infant’s temperature as required.
3. Use only distilled water to fill or refill the Reservoir. Tap water may contain organisms that may
flourish in the heated water of the humidifier.
4. Make sure all hood access door gaskets and tubing ports are properly installed. Any open gaps
in the incubator hood will reduce the incubator’s internal relative humidity.
5. Fill the humidity chamber to the bottom of the MAXIUM LIMIT line. DO NOT OVERFILL. Or else
water spillage may result.
6. At high humidity levels within the incubator hood (typically more than 80%RH), condensation
may form on the inside walls of the hood.
7. When there is much more difference between the humidity setting value and the humidity of
environment, it is very difficult to reach the needed control value of the humidity inside of the
incubator.
8. Following the doctor’s advice when setting the relative humidity.

OXYGEN PRECAUTIONS
1. This incubator is with oxygen control system, please use medical oxygen when feeding oxygen.
2. Abusing of supplemental oxygen may result in serious aftereffects which include blindness,
brain damage, even death. Therefore, keeping to the main doctor's direction strictly and
monitoring the oxygen supplement condition for the patient in a regularly time.
3. If it is necessary to administer Oxygen in an emergency, notify the attending physician
immediately.
4. When supplementing the oxygen, calibrated oxygen analyzer must be turned on for monitoring
the oxygen concentration.
5. Oxygen feeding may increase the noise level inside the hood.
6. As Oxygen use increases the danger of fire. To ensure the device safety, make all flammable
material far away from incubator, and auxiliary equipment producing sparks should not be placed
near incubator.
7. When the oil, grease, other fat substance and the compressed oxygen meet, it will self-ignite
seriously, therefore, try to avoid the oxygen pressure reducing valve/adjustment valve, valve for
oxygen cylinder, pipe, connector containing these substance.
8. Do not use combustible material like aether, alcohol etc. because once even a little aether,
alcohol, or other combustible material mixed with oxygen in the incubator, it’ll cause fire.
9. When modulating the oxygen flux every time, please leave 30min. at least for the incubator
regaining the new oxygen concentration.

vi
 OPERATOR'S MANUAL OF INFANT INCUBATOR

10. There’s a pressurize device filling with potassium hydroxide electrolyte installed inside the

oxygen sensor. If the sensor leaks, please stop using and chuck it. If the leaking electrolyte

touches skin or clothes, please wash with clean water immediately. If the leaking electrolyte

touches eyes, please wash eyes with clean water for 15 min. and keep them open, notify the

doctor immediately.

11. Seasonal check the gas and the oxygen transporting parts to see if they are eroded or broken.

12. Seasonal check the battery of oxygen sensor to if they are leaking or aging. Replace them if it

is necessary.

13. To operate the auxiliary oxygen equipment together with incubator, please refer to the

corresponding instruction manual.

14. Under 100% oxygen concentration the oxygen sensor service life is up to 10000 hours.

WEIGHING PRECAUTIONS
1. The electrical scale installed in the bassinet must work after 30 minutes’ warm-up in the

incubator, that is to say the electrical scale can’t work until being put in the incubator which is set

the using temperature and begins working for at least 30min. Or else, the number read on the

scale will surpass the regulated value.

2. Please keep the patient horizontal and in the middle of the bassinet while weighing.

3. The maximum weighing weight of Infant scale is 8kg, please don’t over loading, or else the

scale will be damaged.

4. Lay the bassinet with infant scale gently when loading or unloading, don’t press surface of the

bassinet to avoid damage the weight sensor inside the bassinet.

5. The displayed weighing value is just for reference.

SpO2 PRECAUTIONS
1. Do not use the SpO2 monitoring system in a magnetic resonance imaging (MRI) environment.
2. Remove the sensor and check the detected site at least every four hours or less. If necessary,
move the sensor to another detection site based on the blood circulation or skin integrity.
3. Do not place accessories of the SpO2 monitoring system in any position from which the
accessories may fall onto the infant.
4. Arrange the extension cable of the SpO2 sensor carefully to avoid entangling the infant.
5. Do not wind the sensor extension cable into a tight coil or around the device; otherwise, the

sensor extension cable may be damaged.

vii
 OPERATOR'S MANUAL OF INFANT INCUBATOR

REGULAR SECURITY CHECK

1. Clean the area between power plug terminals at least once a year. Dust accumulated between
the power plug terminals may cause a fire.
2. The air sensor should be calibrated every half year, and only the authorized qualified service
personnel can do that.
3. The following safety checks should be performed at least every 12 months by a qualified person
who has adequate training, knowledge, and practical experience to perform these tests. The data
should be recorded in an equipment log.
①. Check the device mechanical structure and function integrity.
②. Check the clarity of the symbols and signs on the device according to this manual.
③. Check the fuse tube value for damages against the rated value.
④. Check the performance specifications of the device against Table 1.1.
⑤. Use the test method defined in IEC 60601-1:2005+A1:2012 to check that the protective
grounding impedance of the device is equal to or less than 0.1 Ω. (including Power line: Limit
0.2Ω).
⑥. Use the test method defined in IEC 60601-1:2005+A1:2012 to measure the earth
leakage current of the device. The value must not exceed 500 μA in normal conditions and not
exceed 1,000 μA in single failure conditions.
⑦. Use the test method defined in IEC 60601-1:2005+A1:2012 to measure the shell leakage
current of the device. The value must not exceed 100 μA in normal conditions and not exceed 500
μA in single failure conditions.
8 . Use the test method defined in IEC 60601-1:2005+A1:2012 to measure the patient
○
leakage current of the device. The value must not exceed 100 μA for AC and 10 μA for DC in
normal conditions.
9 . Use the test method defined in IEC 60601-1:2005+A1:2012 to measure the patient
○
leakage current of the device. The value must not exceed 500 μA for AC and 50 μA for DC in
single failure conditions.
10 . Use the test method defined in IEC 60601-1:2005+A1:2012 to measure the patient
○
leakage current of the device (with the application part added with the power grid voltage). The
value must not exceed 5,000 μA in single failure conditions.
11 . Use the test method defined in IEC 60601-1:2005+A1:2012 to measure the patient
○
auxiliary current of the device. The value must not exceed 100 μA for AC and 10 μA for DC in
normal conditions. The value must not exceed 500 μA for AC and 50 μA for DC in single failure
conditions.
4. The essential performance should be verified at least once a year by qualified service personnel
who gets trained and obtain written authorization of the company. The essential performance
verification method shall meet the requirements of clause [Link], [Link],
[Link].1ee) and [Link].1dd) of IEC60601-2-19:2016.

viii
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE OF DEFINITIONS AND SYMBOLS

TECHNICAL DEFINITIONS
Parent-child mode: If the parent-child mode is enabled in incubator temperature mode, the
device will continue to run according to the current setting of the incubator temperature. If the
parent-child mode is enabled in skin temperature mode, the device will run at the incubator
temperature of 32℃.
SKIN TEMPERATURE SENSOR: A sensing device including the link with the equipment intended
to measure the infant’s skin temperature.
INCUBATOR TEMPERATURE: Air temperature at a point 10cm above and centered over the
mattress surface.
CONTROL TEMPERATURE: The temperature set at the temperature control.
AVERAGE INCUBATOR TEMPERATURE: The average of the maximum and minimum Incubator
temperatures achieved during Temperature Condition.
STEADY TEMPERATURE CONDITION: A condition which is reached when the temperature does
not vary by more than 1℃ over a period of 1 hour.
TEMPERATURE ALARM CHECKOUT STATE: The difference between real temperature and
control temperature is within ±0.5℃. The equipment must stay in such state when check up the
alarm about temperature.
TEMPERATURE UNIFORMITY: The amount by which the average temperature at each of four
points 10cm above the mattress surface differs from the Average incubator Temperature at steady
Temperature Condition. The four points are the centers of four quadrants formed by lines that
divide the width and length of the mattress surface.
WARM-UP TIME: The time required for the Incubator Temperature to rise 11℃, when the Air
Control Temperature is at least 12℃ above ambient.
STEADY HUMIDITY CONDITION: A condition that the disparity between the indicated humidity
value and control value is less than ±5%RH, and maintains over 1 min.
LIFETIME OF PRODUCT: The period from sell-by date to the date of discarding as useless.

NOTE, IMPORTANT, CAUTION AND WARNING

NOTE: A note is inserted in text to point out procedures or conditions, which may otherwise be
misinterpreted or overlooked. A note may also be used to clarify apparently contradictory or
confusing situations.
IMPORTANT: Similar to a Note but be used where greater emphasis is required.
CAUTION: A caution is inserted in text to call attention of a procedure which, It not followed
exactly, can lead to damage or destruction of the equipment.
WARNING: A warning is inserted in text to call attention to dangerous or hazardous conditions
inherent to the operation, cleaning, and maintenance of the equipment which may result in
personal Injury or death of the operator or patient.
ix
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SYMBOLS AND SIGNS

Follow instructions for use No heavy load

Spray proof sign for the VHA

CLASS I Class I equipment IPX1
stand control

Main power on Main power off

On (only for a part of equipment) Off (only for a part of equipment)

SpO2 SpO2 socket RS-232 RS-232 Connector

Socket for skin temperature 1 Socket for skin temperature 2

High water level Low water level

Warning; Hot surface

LOW HIGH

Mattress tilt direction

The VHA stand rising key The VHA stand falling key

220-230V~ AC Power 220-230V,50/60Hz F 6.3AH/250V F Type Fuse 6.3AH/250V

50/60Hz

SN Serial Number Date of manufacture

ECG ECG socket NIBP NIBP socket

CO2 CO2 socket USB socket

WAKE WAKE socket ℃ Air temperature/humidity sensor

%RH
CF-type application part for
General warning sign
defibrillation

Manufacturer Baby scale socket

BF-type application part for

Gas exhaust
defibrillation
Authorized representative in the
Gas sample
European community

CE Marking

220-230V~, 50/60Hz MAX: 3A Auxiliary power output, permissible current:3A

x
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SYMBOLS AND SIGNS

This way up Handle with care

Keep way from moisture Do not roll

200kg max

2 Stacking layer limit Do not roll

93 %
+55 ℃

Temperature limit Humidity limit

-20 ℃
0 %

106 kPa

Atmospheric pressure limit

50 kPa

xi
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE OF CONTENTS
SECTION PAGE
1. OVERVIEW………………………………………………….…………………………………………1-1
1.1 PREFACE…………………………………..………………………………………………………1-1
1.2 INTENDED USE…………………………………………………………………………………1-2
1.3 CONTRAINDICATIONS…………………………….………………………………………………1-2
1.4 COMPOSITION……………………………………………………………………………………1-2
1.5 PARTS…………………………………………………………...……………………………………1-2
1.6 PRODUCT PERFORMANCE………………………………………………………………………1-4

2. INSTALLATION………………………………………………………………………………………2-1
2.1 OVERVIEW…………………………………………………………………………………………2-1
2.2 UNPACKING…………………………………………………………………………………………2-1
2.3 INSTALLATION…………………………………………………………………………………… 2-1

3. FUNCTION …………………………………………………………………………………………3-1
3.1 OVERALL……………………………………………………………………………………………3-1
3.2 TEMPERATURE CONTROL PRINCIPLE………………………………………………………3-1
3.3 DATA COMMUNICATION INTERFACE………………………………………………………3-2
3.4 ALARMING AND SYSTEM MESSAGE……………………………………………………………3-3

4 . O P E R AT I O N … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … 4 - 1
4 . 1 O V E RV I E W… …… … … … …… … … … …… … … … …… … … … …… … … … …… … … 4 - 1
4.2 POWER CONNECTION AND SWITCH CONTROL………………………………………4-1
4.3 THE CONTROLLER AND DISPLAY PANEL……………………………………………4-2
4 . 4 C A L I B R AT I O N …… … … … …… … … … …… … … … …… … … … …… … … … …… … 4 - 1 7
4 . 5 O P E R AT I O N S … … … … … … … … … … … … … … … … … … … … … … … … … … … … 4 - 2 7

5. TEMPERATURE OPERATIONS…………………………………………………………5-1
5.1 OVERVIEW……………………………………………………………………………5-1
5 . 2 O P E R AT I O N S … … … … … … … … … … … … … … … … … … … … … … … … … … … … 5 - 1

6. OXYGEN CONCENTRATION CONTROL SYSTEM………………………………………6-1

6.1 OVERVIEW…………………………………………………………………………………………6-1
6.2 REPLACING AN OXYGEN SENSOR…………………………………………………………6-1
6.3 FUNCTIONS…………………………………………………………………………………………6-2
6.4 CONNECTION OF SERVO-CONTROLLED OXYGEN INLET…………………………………6-2
6.5 CALIBRATION OF OXYGEN SUPPLY SYSTEM………………………………………………6-4

xii
 OPERATOR'S MANUAL OF INFANT INCUBATOR

6.6 USING OF THE OXYGEN SUPPLY SYSTEM……………………………………………………6-6

6.7 MAINTENANCE……………………………………………………………………………………6-7

7. HUMIDITY CONTROL SYSTEM……………………………………………………………………7-1

7.1 OVERVIEW…………………………………………………………………………………………7-1
7.2 FUNCTIONS…………………………………………………………………………………………7-1
7.3 CALIBRATION………………………………………………………………………………………7-1
7.4 OPERATIONS………………………………………………………………………………………7-2
7.5 MAINTENANCE……………………………………………………………………………………7-4

8. WEIGHT SYSTEM……………………………………………………………………………………8-1
8.1 OVERVIEW…………………………………………………………………………………………8-1
8.2 INSTALLATION……………………………………………………………………………………8-1
8.3 FUNCTIONS…………………………………………………………………………………………8-2
8.4 CALIBRATION………………………………………………………………………………………8-2
8.5 OPERATIONS………………………………………………………………………………………8-3
8.6 MAINTENANCE……………………………………………………………………………………8-4

9. ECG MONITORING SYSTEM………………………………………………………………………9-1

9.1 OVERVIEW………………….………………………………………………………………………9-1
9.2 CONNECTION OF ECG CABLES…………………………………………………………………9-1
9.3 FUNCTIONS…………………………………………………………………………………………9-2
9.4 OPERATIONS……………………………………………..…………………………………………9-2

10. NIBP MONITORING SYSTEM……………………………………………………………………10-1

10.1 OVERVIEW………………………………………………………………………………………10-1
10.2 CONNECTION OF THE NIBP GAS TUBE……………………………………………………10-1
10.3 FUNCTIONS………………………………………………………………………………………10-2
10.4 OPERATIONS………………………………………………………………….…………………10-2

11. SpO2 MONITORING SYSTEM…………………………………………………………………11-1

11.1 OVERVIEW………………………………………………………………………………………11-1
11.2 CONNECTION OF EXTENSION CABLE OF SpO2 SENSOR………………………………11-1
11.3 FUNCTIONS…………………………………………………………….…………………………11-2
11.4 CALIBRATION………………………………………….…………………………………………11-2
11.5 OPERATIONS……………………………………………………………………………………11-4
11.6 COMMON FAULTS………………………………….……………………………………………11-9

xiii
 OPERATOR'S MANUAL OF INFANT INCUBATOR

12. RESP MONITORING SYSTEM…………………………………………………………………12-1

12.1 OVERVIEW…………………………………………………..……………………………………12-1
12.2 FUNCTIONS………………………………………………………………………………………12-1
12.3 OPERATIONS……………………………………………………………………………………12-1

13. CO2 MONITORING SYSTEM……………………………………………………………………13-1

13.1 OVERVIEW………………………………………………………..………………………………13-1
13.2 CONNECTION OF THE CO2 SENSOR……………………………………………………….13-1
13.3 FUNCTIONS………………………………………………………………………………………13-1
13.4 OPERATIONS…………………………………………………….………………………………13-2
13.5 CO2 MODULE INDICATOR……………...………………………………………………………13-8
13.6 CO2 ZEROING………………………………………………………….…………………………13-8
13.7 MEASUREMENT INFLUENCE FACTORS……………………………………….……………13-9
13.8 EXHAUST EMISSION…………………………………………………………………………13-10
13.9 COMMON FAULTS……………………………………………………………………………13-10

14 WAKE MONITORING SYSTEM……………………………………………..……………………14-1

14.1 OVERVIEW…………………………………………………………..……………………………14-1
14.2 CONNECTION OF WAKE CABLES……………………………………………………………14-1
14.3 FUNCTIONS………………………………………………………………………………………14-1
14.4 OPERATIONS………………………………………………….…………………………………14-1

15. CLEANING AND MAINTENANCE……………………………………………………………15-1

15.1 OVERVIEW………………………………………………………………………………………15-1
15.2 CLEANING………………………………………………………………………………………15-1
15.3 MAINTENANCE…………………………………………………………………………………15-8
15.4 COMMON FAULTS…………….…………………………………………………………….…15-9

16. LIST OF COMPONENTS…………………………………………….……………………………16-1

NOTE: The product appearance may slightly differ from the corresponding description in
this Manual, which does not affect the product performance. We sincerely apologize
for the inconvenience arising therefrom.

xiv
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 1
OVERVIEW
1.1 PREFACE
This document describes the YP-2200B infant incubator (hereinafter referred to as incubator)
of the company in terms of their installation, commissioning, operation, cleaning, and
maintenance. Install, commission, operate, clean, and maintain the infant incubator according to
the instructions provided in this document and use approved parts only. If you fail to do so, the
company is not responsible for the incubator operation and performance.
Read this document carefully before using the incubator.
Attach this document to the incubator for the convenience of future reference when
necessary.
Product configuration table:

Model
YP-2200B
Configuration
Controller display mode LCD
Air Control mode Yes
Skin Control mode Yes
Parent-child mode * Yes
Humidity control Yes
Function for adjusting the machine height Yes
Oxygen concentration control Yes
Function for adjusting the tilt angle of the bassinet Yes
Weighing Optional
Ambient temperature/humidity monitoring Optional
Video recording Optional
SpO2 monitoring Optional
ECG monitoring Optional
Monitoring NIBP monitoring Optional
Hemoglobin monitoring Optional
CO2 monitoring Optional
Observation lamp Optional
Note: 1. If you do not select these parts or functions, skip the corresponding content in
this document.
2. *See explanations of terms and tags.

1-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

1.2 INTENDED USE

Infant Incubator is intended to provide a controlled thermal environment and isolation from
ambient air for premature and neonatal infants. The infant incubator is not intended for the
transport of infants. It monitors the newborn physiological parameters, including ECG, NIBP, SpO2,
pulse, respiration and CO2.

1.3 CONTRAINDICATIONS
N/A

1.4 COMPOSITION
The infant incubator consists of the following parts: main unit (consisting of infant
compartment, machine case, controller, I.V. pole, and tray), External display screen, sensor box,
skin temperature sensor, multi-parameter monitor, mobile cabinet, weighing device, Monitoring
shelf, camera and Observation Lamp.

1.5 PARTS
The following diagram shows the main parts of the Infant Incubator.

Tray I.V. Pole

Monitoring tray

External display screen Camera

Observation lamp
Storage basket
Baby compartment

Base Controller

Mobile Cabinet

1-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

DESCRIPTION OF PART EXPLANATION

A kind of bearing part, which is used for hanging the infusion

I.V. pole
bottle. Max. Load: 2Kg
A core part of the device. It runs in Air Control mode or Skin
Control mode. It also provides weighing, humidity control, and
oxygen concentration control and monitoring functions.
External display screen Temperature control is detailed in Chapter 5, oxygen
concentration in Chapter 6, humidity control in Chapter 7,
weighing in Chapter 8, Monitoring functions in Chapter 9 to
Chapter 14.
Displays air temperature, skin temperature 1, skin temperature 2,
Controller humidity and oxygen concentration (Only for display the
measured value, setting is not supported).

A kind of bearing part, which is used for putting some small

Tray
objects. Max. Load: 2Kg

A kind of bearing part, which is used for putting Infant monitor

Monitoring tray
system. Max. Load: 8Kg

It is used for placing the infant inside, including the Double-wall

Acrylic hood, bassinet, and so on. Slow down function is optional
for the front access panel. The bassinet can be tilted at the
Baby compartment
request of clinical needs. The baby scale is optional part, and the
Max. Load of bassinet is 10 Kg.
Max. Load of mattress with weighing system configuration: 8kg.

An important part of Infant Incubator, which is mainly composed

Base
of the oxygen device, humidity chamber, air filter, and so on.

A support on the device, intended for place accessories such as

Storage basket ECG conductors.
Its maximum load capacity is 1kg.
A part which can support the main body of Infant Incubator.
which include large and small storage compartment.
Mobile Cabinet Big storage compartment Max. load: 4 Kg.
Small storage compartment Max. load: 2 Kg.
Storage cover Max. load: 1 Kg.
It is intended to be used to capture or record imaging data of
Camera
patients.
A lighting component on the device, intended for providing light
Observation lamp
for clinical practice.

The max. Load of tray and the other accessories is the value in the list, not
overloaded, so as not to damage to the accessories.
NOTE: Size of Infant Incubator: L1500mmx W675mmx H1650mm~L1500mmx W675mmx H1800mm.
Distance from the bassinet to the floor: 980mm~1130mm.
Weight of Infant Incubator: 117kg.

1-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

1.6 PRODUCT PERFORMANCE

This product’s classification as follows:
By the electric shock protection type classification: Type I equipment.
By the degree of shock proof classification: CF-type application part for defibrillation:
ECG, BF-type application part for defibrillation: Skin Temperature, SpO2, NIBP, CO2 and Mattress
By the specified of IEC60529 for liquid protection degree classification: IPX0.
By the manufacturers recommended disinfection and sterilization method classification: Use
neutral disinfection solvents or solution to clean. The tank can use steam sterilization.
By the air mixer of flammable gas or with oxygen or nitrous oxide mixture of
flammable anaesthetic gas safety degree classification: It should not use in air mixer of
flammable gas or with oxygen or nitrous oxide mixture of flammable anaesthetic gas.
By operational mode classification: Continuous operation.
Specifications for the Infant Incubator are provided in table 1.1.

TABLE 1.1 PRODUCT PERFORMANCE

Power supply requirements…………………………………………………AC220-230V, 50/60Hz

I n p u t p o w e r … … … … … … … … … … … … … … … … … … … … … … … … … … … … … 1 3 0 0 VA
Auxiliary power output…………………AC220-230V, 50/60Hz, maximum current allowed: 3 A
Incubator temperature control mode………………………………………..…Air Control mode
Skin Control mode
Air Control mode range……………………………………………………………20.0℃~37.0℃
37.1℃~39.0℃（>37℃ mode）
Skin Control mode range…………………………………………………………34.0℃~37.0℃
37.1℃~38.0℃（>37℃ mode）
Displayed ranges of air and skin temperatures………………………………………5.0～65.0℃
Warm-up time* (with the ambient temperature at +22°C)...................No longer than 40 minutes
Difference between the air temperature at one point and the average air temperature
………………………………………………………………………………………No greater than 0.5℃
Difference between the average air temperature and the control temperature
………………………………………………………………………………………No greater than 1.0℃
Temperature overshoot in Air Control mode…………………………..……No greater than 1.0℃
Temperature uniformity* (mattress horizontally placed)…………….......No greater than 0.8℃
Temperature uniformity* (mattress titled)…………………………………..No greater than 1.0℃
Accuracy of the skin temperature sensor…………………………………………….………..±0.2℃
Humidity control accuracy………………………………………………………..…………±5%RH
Humidity display accuracy.…..…..…..…..…..…..…..…....…..…..….………………………±5%RH
Humidity display range………………………………………………………..……0%RH～100%RH
Humidity control range………………………………………………………………30%RH～95%RH
Oxygen concentration display range………………………………………………0%O2～100%O2
Oxygen concentration control range………………………………………………20%O2～65%O2
1-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.1 PRODUCT PERFORMANCE (CONTINUED)

Oxygen concentration display accuracy………………………………………………………±2%O2

(with the oxygen concentration set to 25% or lower)
±3%O2
(with the oxygen concentration set to a value higher than 25%)
Oxygen concentration control accuracy……………………………±4%O2 volume concentration
Weight display accuracy……………………………………………………………………………±10 g
Weight display range………………………………………………………………………200g~8000g
Maximum tilt Angle for crib with electric adjustment function………….……No less than 12°

Precision of tilt Angle display for crib equipped with electric adjustment function………±1°

Ambient temperature (we recommend that you do not use the incubator in an environment
beyond the specified operating range)

Temperature
Operating range……………………………………………………………………………...20℃～30℃
Transportation and storage………………………………………………………..………-20℃～+55℃
Humidity
Operating range…………………………………………………….……………………….….30%～75%
Transport and storage range……………………………………………………………….….…..≤93%

Atmospheric pressure
Transport and storage range………………………………………..………………500hPa～1060hPa
Operating range…………………………………………………………….…………700hPa～1060hPa

Air flow speed

Ambient air flow speed………………………………………………………………………….<0.3m/s

Other indicators
Environmental noise in the hood in incubator mode…………………Under stable temperature,
no greater than 45 dB(A)
[Ambient noise no greater than 35 dB(A)]
In other cases, no greater than 50 dB(A)
[Ambient noise no greater than 40 dB(A)]
CO2 concentration in the hood in incubator mode………………….Lower than 0.5% when the
CO2 mixture is pumped in at the speed of
750 mL/h at 10 cm above the center of the mattress
Air flow speed above the mattress in incubator mode.............................No greater than 0.1 m/s
Video storage duration…………………………………………………..……..No less than 24 hours
SpO2 INDICATORS
Compliant with the standards ISO80601-2-61
Confirmation of the measurement accuracy: The SpO2 accuracy has been confirmed in human
experiments by comparing with the reference value of arterial blood samples measured by the
CO-oxygen pressure meter. The measurement results of SpO2 accord with statistical distribution.
Compared with the measurement results of the oxygen pressure meter, only two-thirds of the
measurement results are expected to fall within the specified accuracy range.

1-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.1 PRODUCT PERFORMANCE (CONTINUED)

SpO2 display range……………………………………………………………………………0%~100%

SpO2 resolution……………..…………………………………………………….…………………….1%
SpO2 waveform scan speed…………………….…………6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s
SpO2 measurement accuracy....within the range 70%-100% and without body movement: ±3%※
SpO2 average time…………………………2s~4s, 4s~6s, 8s, 10s, 12s, 14s, 16s, Factory default 8s
SpO2 alarm upper limit…………………………………………………………......………51%~100%
SpO2 alarm lower limit……………………………………………..……………......………50%~99%
PI display range……………………………………………………………………….….0.02%~20.00%
PI display resolution……………………………………………..……………………………….0.01%
PR display range………………………………………………………………………25bpm~240bpm
PR display resolution………………………………….…………………………………………..1bpm
PR measurement accuracy……………………………………….without body movement: ±3 bpm※
PR alarm upper limit…………………………………….………….…………………26bpm~240bpm
PR alarm lower limit…………………………………………….………………………25bpm~239bpm
Hemoglobin parameters (applicable only to incubators with the Masimo Rainbow sensor)
Parameters that can be measured and displayed: SpOC, PVI, and SpMet.

ECG PERFORMANCE INDICATORS

Lead type………………………………………………………………………………3-lead: I, II, and III
5-lead: I, II, III, aVR, aVL, aVF, and V
Gain and error…………………………………….………….At least support 1.25 mm/mV (×0.125),
2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV(×1),
20 mm/mV (×2) and 40 mm/mV (×4). Accuracy error: no more than ±5%
Waveform scan speed and error………………………6.25mm/s, 12.5mm/s, 25.0mm/s, 50mm/s,
Error: no more than ±10%
Common mode rejection ratio (CMRR)………………………….….....…Diagnostic mode: >90dB
Monitor mode: >100dB
Surgery mode:>105dB
Power frequency notch……………………...……..Monitor and Surgery modes: 50 Hz and 60 Hz
Diagnostic mode: 50 Hz, 60 Hz, and Off
Power frequency interference suppression ability……………………………….…..…….≥20dB
Input impedance……………..When the input signal frequency is 10 Hz, input impedance > 5 MΩ
Input signal range………………………………………………………….±10mV (peak-peak value)
Input dynamic range (IDR)………………………….Meet the requirements of IEC 60601-2-27.
The DC bias voltage can reach ±300 mV
Lead-off detection current………………………………….……Measurement electrode: < 0.1 µA
Drive electrode: < 1 µA
Baseline recovery time…………………………………..Recovery time after defibrillation < 5s
Patient leakage current……………………………………………………………………..……<10µA
Calibration signal……………………………..1mV ± 0.01 mV (peak-peak value), accuracy: ±10%
System noise…………………………………………………………………………………≤30 µV p-p
High T wave suppression capability………………can suppress a maximum of 1.2 mV T waves,
meeting the requirements of IEC 60601-2-27

1-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.1 PRODUCT PERFORMANCE (CONTINUED)

Electric knife noise suppression……………With the test method in Article IEC 60601-2-27,
when the ECG leads meeting the standard are used
The peak-peak noise is less than or equal to
2 mV compared with the ECG baseline
Heart rate (HR) measurement range……………………………………………….15 bpm-350 bpm
HR display resolution…………………………………………………………………………….1 bpm
HR measurement accuracy………………………………….±1% or ±1 bpm (whichever is greater)
HR alarm upper limit………………………….……………………….(lower limit + 1 bpm)-350 bpm
HR alarm lower limit………………………………………..……………….15bpm-(upper limit -1 bpm)
Change response time……………When the HR changes from 80 bpm to 120 bpm: less than 10s
When the HR changes from 80 bpm to 40 bpm: less than 10s
The response time does not include the 1.0 second within the update interval.
HR average…………………The HR average must meet the requirements of IEC 60601-2-27
and be calculated as follows: If the last three consecutive RR intervals is
greater than 1,200 ms, the HR is calculated by the average of the last
four RR intervals. Otherwise, the HR is calculated by the average
of the last 12 RR intervals with the maximum and minimum values excluded.
Response to irregular heart rhythms……….…..Meet the requirements of IEC 60601-2-27, that is,
the HR displayed when the heart rhythm becomes stable 20s later:
Waveform 3a (ventricular bigeminy): 80±6 bpm
Waveform 3b (slow alternating ventricular bigeminy): 60±6 bpm
Waveform 3c (fast alternating ventricular bigeminy): 120±8 bpm
Waveform 3d (bidirectional contraction): 90±9 bpm
Tachycardia alarm time………………………………………………………………………………< 10s
Arrhythmia type……………………………………………………….Asystole, V-Fib/V-Tach, V-Tach,
Vent Brady, Extreme Tachy, Extreme Brady
Vent Rhythm, PVC, Couplet, Run PVCs,
Nonsus V-Tach, Bigeminy, Trigeminy
Multi-PVC, R on T, Tachy, Brady, Missed Beats,
Pause, Pacer Not Pacing, and Pacer Not Captured

PACE PULSE PERFORMANCE INDICATORS

Pulse sign…………………………………………………………Pulse amplitude: ±2 mV to ±700 mV
Pulse width: 0.1 ms-2.0 ms
Rise time: 10 µs-100 µs
Pulse suppression…………….Meet the requirements of Article [Link] in ANSI/AAMIEC13:2002
and IEC 60601-2-27 suppress pace pulses meeting
the following conditions: Pulse amplitude: ±2 mV to ±700 mV
Pulse width: 0.1 ms-2.0 ms
Rise time: 10 µs-100 µs
(This device is not suitable for dual-pulse pacing in IEC 60601-2-27)
Suppression of fast ECG signal.....0.4V/s±0.1V/s, test with the method in Article IEC 60601-2-27
HR alarm upper limit…………………………….(Lower limit + 1 bpm)-350 bpm, resolution: 1 rmp

1-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.1 PRODUCT PERFORMANCE (CONTINUED)

HR alarm lower limit……………………..…………15 bpm-(upper limit - 1 bpm), resolution: 1 rmp

HR alarm setting range……………………………………………………………….15 bpm-350 bpm

RESP PERFORMANCE INDICATORS

Respiration lead……………………………………………………………………………………….I lead
II lead
Auto
Respiratory excitation waveform…………………..Sine wave signal, 62.8 kHz (±10%), < 500 μA
Sweep…………………………………………………………………....…….At least support 6.25 mm/s
12.5 mm/s
25 mm/s
50 mm/s
Waveform amplitude………………….At least support ×0.125, ×0.25, ×0.5, ×1, ×2, ×3, ×4, and ×5
Waveform bandwidth……………………………………………………………..0.1 Hz-3.0 Hz (-3 dB)
Base impedance range………………………500-4,000 Ω (including the 1 k resistance of the lead)
RR measurement range………………………………………………………………….0 rpm-150 rpm
RR measurement accuracy……………..…10 rpm-150 rpm ± 2 rpm or ±2%, whichever is greater
0 rpm-9 rpm, not defined
RR measurement resolution………………………………………………………………………..1 rpm
Apnea alarm delay…………………………At least 20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, and 60s
Allowed delay error: ±3s
RR alarm range……………………………………………………………………………0 rpm-150 rpm
Alarm upper limit………………………….……….(lower limit + 1 rpm)-150 rpm, resolution: 1 rmp
Alarm lower limit……………………………………….0 rmp-(upper limit -1 rpm), resolution: 1 rmp

NIBP PERFORMANCE INDICATORS

Humidity Operating range...............................................................................…………..15%~85%

Measurement mode..................................................................…………..Manual measuring mode
Automatic measuring mode
Short-term automatic mode (STAT)
Auto Measurement Interval……………………………………………2.5min, 5min, 10min, 15min,
20min, 30min, 45min, 60min, 90min, 120min
Time of Short-term Auto Mode………………………………………………………………5min±10%
Maximum time of a single measurement……………………………………………..…………<90s
Measurement range…………………………………………………………Sys: 40 mmHg-130 mmHg
Dia: 20 mmHg-100 mmHg
Mean: 27 mmHg-110 mmHg
Accuracy……………………………………………………….……Maximum average error: ±5 mmHg
Maximum standard deviation: 8 mmHg
Pressure resolution………………………………………………………….……….…1mmHg（0.1kPa）
Static pressure measurement range……………………………………..……….0mmHg~140mmHg
Static pressure measurement accuracy……………………………………………..……….±3mmHg

1-8
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.1 PRODUCT PERFORMANCE (CONTINUED)

PR range……………………………………………………………………………..…….30bpm~220bpm
PR accuracy………………………………………………………………………………………….±3bpm
Initial cuff pressure range…………………………………………60mmHg, 70mmHg, 80mmHg,
90mmHg, 100mmHg, 110mmHg, 120mmHg,
130mmHg, 140mmHg, Factory default 90mmHg
Overpressure protection………………………..…………………………………<150mmHg±5mmHg
Start initialization………………………………………………………………………………….7s
SYS alarm upper limit………………………（lower limit+1mmHg）~130mmHg，resolution: 1mmHg
SYS alarm lower limit……………………….40mmHg~（upper limit -1mmHg），resolution: 1mmHg
DIA alarm upper limit……………………….（lower limit +1mmHg）~100mmHg，resolution: 1mmHg
DIA alarm lower limit………………………….20mmHg~（upper limit -1mmHg），resolution: 1mmHg
MAP alarm upper limit…………………….（lower limit +1mmHg）~110mmHg，resolution: 1mmHg
MAP alarm lower limit……………………….27mmHg~（upper limit -1mmHg），resolution: 1mmHg
SYS alarm upper limit………………………….…(lower limit +0.1kPa)~17.3kPa，resolution: 0.1kPa
SYS alarm lower limit…………………….…….…5.3kPa~( upper limit–0.1kPa)，resolution: 0.1kPa
DIA alarm upper limit………………………...…(lower limit +0.1kPa)~13.3kPa，resolution: 0.1kPa
DIA alarm lower limit………………………..….…2.7kPa~( upper limit–0.1kPa)，resolution: 0.1kPa
MAP alarm upper limit……………………………(lower limit +0.1kPa)~14.7kPa，resolution: 0.1kPa
MAP alarm lower limit………………………….…3.6kPa~( upper limit–0.1kPa)，resolution: 0.1kPa

CO2 PERFORMANCE INDICATORS

Total system response time……………………………...…………………Mainstream system＜3s
Sidestream system＜5s
10%-90% RISE TIME(@0.6l/min)……………………...……………………Sidestream system＜0.3s
Measurement mode………………………………………...………………………………Mainstream
Sidestream
Measurement parameters……………………………………………………………………….……CO2
AwRR
Measurement range………………………………………………………….…CO2：0Vol%~25Vol%
AwRR：0Vol%~150rpm
Resolution………………………………………….........………………………CO 2 ：0.1Vol%
AwRR：1rpm
Measurement accuracy…………………………………………………….Under standard conditions
(22°C±5°C and 1013 hPa±40 hPa, single gas):
When CO2 is within the range 0.0 Vol% to 15.0 Vol%,
measurement accuracy: ±(0.2 Vol% + 2% of the reading),
(The accuracy is not defined when the range is 15.1 Vol% to 25.0 Vol%)
AwRR measurement accuracy: ±1 rpm
Under all conditions:
When CO2 is within the range 0.0 Vol% to 15.0 Vol%,
measurement accuracy: ±(0.3 kpa + 4% of the reading),
(The accuracy is not defined when the range is 15.1 Vol% to 25.0 Vol%)
AwRR measurement accuracy: ±1 rpm
Measurement error drift………..It can meet the requirement of measurement error within 6 hours

1-9
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.1 PRODUCT PERFORMANCE (CONTINUED)

O2 compensation………………………………………………………..Compensation range: 0-100%

Resolution: 1%
Default: 21%
N2O compensation……………………………………………………….Compensation range: 0-100%
Resolution: 1%
Default: 0%
Flow rate control accuracy………..……±15% of the setting or ±15 mL/min, whichever is greater
The minimum sampling rate of by-pass CO2 module is 50ml / min ± 10ml / min
Pre-warm time……………………………...……………………………………Accuracy mode: ≤ 45s
Full Accuracy mode ≤ 10 min
APNEA AWAKENING PERFORMANCE INDICATORS
Trigger parameters…………………………………………………………………………..Respiration
CO2
SpO2
HR
Trigger condition…………When the heart rate, blood oxygen and any parameter of the newborn
are less than the set value, the wake-up device will start to vibrate intermittently,
When it is greater than the preset value, the wake-up device will
automatically stop intermittent vibration;
When the breathing rate of CO2 is less than or equal to 6 rpm,
the wake-up device will start to vibrate intermittently,
When the breathing rate of CO2 is greater than 6 rpm, the wake-up
device will stop intermittent vibration automatically
Stimulation mode…………………………………………………………………………Beater vibration
Vibration strength…………………………………………50, 60, 70, 80, 90, 100, Factory default 50
*See explanations of terms and signs.
Note: 1. Opening the baffle or operating window, or using the bassinet, supplies, or other
devices in incubator mode will affect the air flow mode in the hood and thereby affect
the temperature uniformity, temperature variability, and the correlation between the
displayed air temperature and the temperature of mattress center as well as the skin
temperature. Changes to the ambient air flow speed, bassinet inclining angle, and
heat-generating devices around the device in warmer mode may all affect the
mattress temperature uniformity and relationship between the displayed temperature
and the skin temperature. If the ambient air flow is greater than 0.3 m/s, heat balance
on the infant may be affected due to quick heat dissipation.
2. Measurement accuracy items marked by ※ for the pulse oximetry monitor are
applicable when the incubator is connected to the specified sensors.

1-10
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Table 1.2 lists default settings of the multi-parameter monitor.

TABLE 1.2 DEFAULT PARAMETER SETTINGS

ECG PARAMETER CONFIGURATION

HR/PR alarm switch……………………..…….………………………………………………………On
HR/PR alarm upper limit…………………...……………...…………………………………200bpm
HR/PR alarm lower limit……………………………………………………...………………100bpm
HR/PR alarm priority…………………….………………………..…………………………………High
HR/PR source………………………………………………………...………………………………ECG
Lead mode……………………………...……………………………..……………………………5-lead
ECG1…………………………………………………………………….…………………………………II
ECG2（3-lead and 5-lead）………………..………………………………………………………………I
ECG gain…………………………………………………………………………………………………x1
Sweep………………………………...……………………………………………………………25mm/s
Filter mode………………………………….……………………………………………………Monitor
QRS volume…………………………………..…………………………………………………………3
Notch filter……………………………………………………………………………………………50Hz
Pace mark…………………………………….…………………………………………………………On

RESP PARAMETER CONFIGURATION

BR/PR alarm switch…………………………….……………………………………………………..On
BR/PR alarm upper limit…………………………………..……………………………………...80rpm
BR/PR alarm lower limit………………………..……………………………………….………..12rpm
BR/PR alarm priority……………………………………………...…………………………………High
Apnea alarm switch…………………………………………………………………………...………On
Apnea alarm priority…………………………………………………………High (not configurable)
Apnea delay……………………..……………………………………………………………………..15s
RR source………………………………………………………………………………….………..Auto
Respiration lead………………………….……………………………………………………………...II
Gain……………………………………………………………………………………………….………x1
Sweep………………………...……………………………………………………………………25mm/s

NIBP PARAMETER CONFIGURATION

Alarm switch…………………………………………………………………………….………On
Sys alarm upper limit…………………….…………………………………………………..100mmHg
13.3kPa
Sys alarm lower limit……………………………………………………………….………….50mmHg
6.7kPa
Sys alarm priority………………………………………………………………………………….High

1-11
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.2 DEFAULT PARAMETER SETTINGS (CONTINUED)

Dia alarm upper limit………………………………………………………………………….70 mmHg

9.3 kPa
Dia alarm lower limit……………………………………………………………………………30 mmHg
4.0 kPa
Dia alarm priority………………………………………………………………………….…………..High
Mean alarm upper limit……………………………………………………………………….80 mmHg
10.7 kPa
Mean alarm lower limit………………………………………………………………………..35 mmHg
4.7 kPa
Mean alarm priority………………………………………………………………….………………..High
Initial inflation pressure………………………………………………………………………90 mmHg
Measurement unit…………………………………………………………………………………mmHg
Measurement mode……………………………………………………………………………….Manual
Auto measurement interval………………………………………………………….……………90 min
NIBP completed tone…………………………………………………………………….……………..Off
NIBP additional measurement…………………………………………………………………….….Off

SPO2 PARAMETER CONFIGURATION

Alarm switch……………………………………………………………………………………………..On
Alarm upper limit…………………………………………………………………………………….95%
Alarm lower limit……………………………………………………………..………………………..85%
Alarm priority…………………………………………………………………….…………………….High
Sensitivity………………………………………………………………………..………………….Normal
Sweep…………………………………………………………………………………………..12.5 mm/s
Average time……………………………………………………………………………………………8s
Fast SpO2……………………………………………………………………………………………….Off
Smart beat volume……………………………………………………………….……………………..Off
Beat volume………………………………………………………………………..………………………1
NIBP simultaneous……………………………………………………………………………………..Off

CO2 PARAMETER CONFIGURATION

Alarm switch………………………………………………………….………………………………….On
Waveform type…………………………………………………………………….…………………Curve
EtCO2 alarm upper limit…………………………………………………………………………….60%
EtCO2 alarm lower limit………………………………………………………………………………7%
EtCO2 alarm priority…………………………………………………………………………………..High
FiCO2 alarm switch……………………………………………………………………………………..Off
FiCO2 alarm upper limit…………………………………………………………………………….60%
FiCO2 alarm priority…………………………………………………………………………………..High
Apnea delay……………………………………………………………………………………………..20s
Sweep………………………………………………………………………………………………25 mm/s
Scale……………………………………………………………..……0.0-20.0%, minimum: 0-30 mmHg
FiCO2 display…………………………………………………………………………………………..Off

1-12
 OPERATOR'S MANUAL OF INFANT INCUBATOR

TABLE 1.2 DEFAULT PARAMETER SETTINGS (CONTINUED)

O2 compensation………………………………………………………….…………………………21%
N2O compensation…………………………………………………………………………………….0%

APNEA AWAKENING PARAMETER CONFIGURATION

Self-test………………………………………………………………………………………………….Off
Vibration strength……………………………………………………………………………………50
RESP……………………………………………………………………………………………………Off
CO2………………………………………………………………………………………………………Off
HR………………………………………………………………………………………………….100 bpm
SpO 2 ……………………………………………………………………………..……………85%

1-13
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 2
INSTALLATION
2.1 OVERVIEW
This section provides installing procedures about Infant Incubator.

2.2 UNPACKING
Generally, the incubator is packaged as a whole. When taking out the equipment from the
box, take care not to damage the spare parts of the Infant Incubator.
2.3 INSTALLATION
At least two professionals are required to do the installation of the Infant
Incubator with spanners and cross screwdriver.
To install the device, perform the following steps:
A. Fix the casters.

WHEEL UNLOCKED WHEEL LOCKED

NOTE: The Pedestal front locking casters must be facing down to be locked indicated by
arrow 1. The Pedestal front locking casters must be facing down to be unlocked
indicated by arrow 2.
FIGURE 2.1

WARNING: To prevent the incubator from sliding when fixed on an incline, the front
locking caster for the VHA stand must be facing down the incline and
locked.

B. Install the I.V. pole.

As shown in Figure 2.2, rotate the fastening bolt of the fixing block of the I.V. pole leftward to

loosen the rotatable block. Insert the clips of the fixing block into the Slot of dovetail groove

column in order. Adjust the height and then fasten the bolt to lock the rotatable block.

2-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Slot of dovetail groove column

Rotatable block

Fastening bolt

Fixing block of the I.V. pole Rotatable block unlocked Rotatable block locked

FIGURE 2.2

C. Install the tray

Fix the collapsible tray into the column slot according to the method for installing
the infusion stand, insert the tray into the tray support, and fasten the hexagon socket
screws, as shown in Figure 2.3.

Tray

Hexagon socket screw

Tray support

Figure 2.3

D. Install the monitoring tray.

As shown in Figure 2.4, insert the fixing plate of the monitoring tray into the
column from top to bottom, and then tighten the countersunk screws to secure the
monitoring tray.

Monitoring tray

Column
Countersunk screw M4×6
Figure 2.4
E. Connect the sensor
Connect the sensor connector with sensor socket which is on the side of the incubator’s

main body as figure 2.5 directed. Then tighten the bolt in the connector.

2-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

NOTE ： Connection between the sensor connector and socket should in the right

orientation for these two parts have their own direction.

Fixed bolt

Sensor connector
FIGURE 2.5
F. Install the observation lamp.
As shown in Figure 2.6, observation lamp Insert the clips of the fixing block into the Slot of
dovetail groove column in order. The observation lamp has a flexible handle and shaft. You can
use a hexagon wrench to rotate the bolt of the shaft to change the friction of the shaft.

Slot of dovetail groove column

Handle

Shaft
Bolt

Rotatable block

Fixing block of the observation lamp Fastening bolt

1. To prevent injuring the eyes of the infant, do not expose the infant to the lamp
light for a long time.
2. The observation lamp is hot. Keep a distance between the lamp and the infant and
pay close attention to the infant's condition.
3. When checking the observation lamp stand, ensure that the tip of the lamp is not
right over the infant.

FIGURE 2.6
G. Install the camera.
Fix the camera into the column slot according to the method for installing the infusion stand,
and connect the cable to the USB interface of the external display screen.

2-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

H. Install the storage basket.

As shown in Figure 2.7, put the fixing block of the storage basket into the column slot, slide it
to a suitable height, and then fasten the hexagon socket screws to secure the storage basket.

Column

Hexagon socket screw Storage basket

Fixing block

FIGURE 2.7
I. Install oxygen sensor
Refer to the section 6 to see the detail.
J. Install weighing system
Refer to the section 8 to see the detail.
K. Insert the power cord
Insert the power cord into the socket of general power supply.
Check the INCUBATOR according to the instruction in section 4.4.

NOTE：The main power switch of the incubator is located in the VHA stand, not to position

incubator to make it difficult to operate the power switch.

2-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 3
FUNCTION
3.1 OVERALL
When the device functions as an infant incubator, it provides a temperature control (Air
Control mode and Skin Control mode) system, humidity control system, oxygen concentration
control system, weighing system and Multi-parameter monitoring.
Heat output control in Air Mode: It will control the heater’s output automatically
according to the Air temperature sensor; see instruction in section 5;
Heat output control in Baby Mode: It will control the heater’s output automatically
according to the Skin temperature sensor, see instruction in section 5.
Oxygen input control：Auto control the valve according to the oxygen concentration in the
incubator which detected by the oxygen concentration sensor. Please refer the section 6 to see
the details.
Reservoir humidifying output control：Auto control the humidifier according to the
humidity in the incubator which detected by the humidity sensor. Please refer the section 7 to
see the details.
Weighing system control: The device displays the weight detected by the infant scale
sensor in the bassinet on the screen and allows you to perform operations such as calibration
and resetting. For operation details, see Chapter 8.
Multi-parameter monitoring control: The device displays the detected infant
physiological sign values such as ECG, RESP, SpO2, NIBP, CO2, and WAKE values on the
screen and allows you to set the alarm limit and measurement mode. For operation details,
see Chapter 9 to Chapter 14.

3.2 TEMPERATURE CONTROL PRINCIPLE

The control of temperature, humidity and oxygen concentration inside hood is achieved by
means of the forced air circulation system as shown in Figure 3.1.
When the oxygen control function is off, the outside air is filtered, it will flow through the
heater which can heat the air, and then the air enters into the hood through the inlet port under
the drive of fan motor, after then, it will be cycled back to the fan motor through the inlet port to
form the heat air cycle flow. And this heat air flow will come to the top of water tank and enter
into the hood with the vapor above the water.
When turning on the oxygen control function, oxygen flow through the oxygen input
connector, then passes the electromagnetism valve and enters into the air-oxygen separating
device through the oxygen input connector, after then, it enters into the heat air cycle flow
under the drive of the fan motor to supply the oxygen in the incubator.

3-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 3.1

3.3 DATA COMMUNICATION INTERFACE

The incubator is equipped with RS232 data communication connector and used for data
terminal output.

1. If connecting the auxiliary equipment on this interface, the assembly of ME

SYSTEMS and modifications during the actual service life require evaluation on the
requirements of IEC60601-1, clause 16.
2. Everyone should be responsible for the safety of the whole system requirements.
3. Only the equipment provided by our company can be connected with RS232 data
communication connector. When using, must ensure the reliable connection.
4. The service department should be responsible for the maintenance of data
communication connector, and inspect the data communication every year.
5. The connection and usage of the data communication must be performed by special
trained medical personnel, and the personnel should clear and definite the risk of data
communication.
6. Do not touch RS232 data communication connector and patient simultaneously.
7. If have any question, please contact with the agency or the service department of
our company.

3-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

3.4 ALARMING AND SYSTEM MESSAGE

STATE
1. Alarm information
High priority: The most urgent information, red alarm light flashing, alarm sounds more than
65dB; alarm in five tones order, ring twice, and every 2.5 seconds to repeat
again.
Note: The sound of power failure alarm whose sound source is a single buzzer which
is different from other high priority alarms.
Medium priority: Medium priority information, yellow alarm light flashing, alarm sounds more
than 65dB; alarm in three tones order , and every 7.5 seconds to repeat
again.
Low priority: Low priority information, the yellow alarm light is continuously on, alarm sounds
more than 65dB; alarm in two tones order , and every 20 seconds to repeat
again.
2. The alarm preference is arranged according to the alarm serial number, the bigger the serial
number is, the lower level it is. When various failures appear, the alarm prompts according
to the priority, the sound is different too.
3. At a place 1 meter in front of the device, the sound pressure level of high-priority alarms is
equal to or greater than that of the medium-priority alarms, which is in turn equal to or greater
than that of the low-priority alarms. The sound pressure level of the low-priority alarms is equal
to or greater than 65 dB.
Note: The minimum alarm sound pressure level is equal to or greater than 50 dB(A).
4. Air overtemperature, Skin overtemperature and Air flow overtemperature are the latching
alarm signal, the other alarms are the non- latching alarm signal.

3-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Other Alarms

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The power alarm
The switch is turned on
Power failure indicator blinks in red,
1 when no power supply is All Off High < 2s
alarm and the alarm sound
connected.
rings.

Technical Alarms

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
blinks in red,
Communication "Communication
error between error between The communication
1 the system system board and between the system board All Off High < 10s
board and the main board" is and the main board fails.
main board displayed on the
screen, and the
alarm sound rings.

The ALARM indicator

Control Unit blinks in red, the
screen displays " The sensor box is not
and Sensor High
2 Control Unit and properly installed or All Off < 5s
Box Comm. Sensor Box Comm. connected. priority
Fault Fault r", and the
alarm sound rings.

The alarm indicator

blinks in red,
Main-slave "Main-slave The communication
3 communication communication error" between the main MCU All Off High < 10s
error is displayed on the and the slave MCU A fails.
screen, and the
alarm sound rings.

The alarm indicator

blinks in red,
Slave-slave "Slave-slave The communication
4 communication communication error" between slave MCUs A All Off High < 10s
error is displayed on the and B fails.
screen, and the
alarm sound rings.

The alarm indicator

blinks in red,
The circuit of the heater in
Temperature "Temperature heating
the incubator temperature
5 heating system system fault" is All Off High < 27s
control system is
fault displayed on the
abnormal.
screen, and the
alarm sound rings.

Red alarm light

Alarm sensor flashes, the indicator
Sensor box is placed High
6 box is placed shows “Alarm Sensor All Off <5s
wrong priority
wrong box is placed wrong”,
sound alarm start
The alarm indicator
blinks in red, "Air
The air temperature sensor
Air temperature temperature sensor
7 is short-circuited, All Off High < 2s
sensor fault fault" is displayed on
open-circuited, or loose.
the screen, and the
alarm sound rings.

The alarm indicator

blinks in red,
Isolated "Isolated temperature The isolated temperature
8 temperature sensor fault" is sensor is short-circuited, All Off High < 2s
sensor fault displayed on the open-circuited, or loose.
screen, and the
alarm sound rings.

3-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator The difference between
blinks in red, "Air temperatures detected by
Air temperature temperature sensor the air temperature sensor
9 sensor difference fault" is and the isolated All Off High < 17s
difference fault displayed on the temperature sensor
screen, and the respectively is more than
alarm sound rings. 0.8°C.

The alarm indicator

blinks in red, "Air flow
Air flow The air flow temperature
temperature sensor
10 temperature sensor is short-circuited, All Off High < 3s
fault" is displayed on
sensor fault open-circuited, or loose.
the screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "Skin
Skin The skin temperature
temperature sensor 1 Skin
11 temperature sensor is short-circuited, Off High < 4s
fault" is displayed on Control
sensor 1 fault open-circuited, or loose.
the screen, and the
alarm sound rings.

The alarm indicator

blinks in red,
The isolated skin
Isolated skin "Isolated skin
temperature sensor is Skin
12 temperature temperature sensor Off High < 2s
short-circuited, Control
sensor fault fault" is displayed on
open-circuited, or loose.
the screen, and the
alarm sound rings.

The alarm indicator The difference between

blinks in red, "Skin temperatures detected by
Skin
temperature sensor the air temperature sensor
temperature
13 difference fault" is and the isolated All Off High < 17s
sensor
displayed on the temperature sensor
difference fault
screen, and the respectively is more than
alarm sound rings. 0.8°C.

The alarm indicator

The air temperature does
blinks in red, "Air
not exceed 38°C (preset
Air overtemperature" is
14 temperature: < 37°C) or All Off High < 6s
overtemperature displayed on the
39.5°C (preset
screen, and the
temperature: > 37°C).
alarm sound rings.

The alarm indicator

blinks in red, "Skin
The temperature measured
Skin overtemperature" is Skin
15 by the skin temperature Off High < 6s
overtemperature displayed on the Control
sensor exceeds 38.5°C.
screen, and the
alarm sound rings.

The alarm indicator The temperature measured

blinks in red, "Air flow by the air flow temperature
Air flow overtemperature" is sensor exceeds 57°C
16 All Off High < 15s
overtemperature displayed on the (preset temperature: <
screen, and the 37°C) or 60°C (preset
alarm sound rings. temperature: > 37°C).

The temperature measured

by the skin temperature
The alarm indicator
sensor 1 is always at least
blinks in red, "Skin
Skin 2°C lower than the preset
temperature sensor
temperature temperature. The Skin
17 position error" is On High < 110s
sensor position temperature measured by Control
displayed on the
error the air temperature sensor
screen, and the
is 3.5°C to 4.5°C lower
alarm sound rings.
than the preset skin
temperature.

The alarm indicator

blinks in red, "Fan The motor stops rotating or
18 Fan fault fault" is displayed on rotates at a speed of less All Off High < 11s
the screen, and the than 800 rpm.
alarm sound rings.

3-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time

The alarm indicator

blinks in red, "Control
Controller fan fan fault" is displayed The controller fan fails or is
19 All Off High < 6s
fault on the screen, and not connected.
the alarm sound
rings.

The alarm indicator

blinks in red, "O2
The oxygen concentration
O2 sensor 1 sensor 1 fault" is
20 sensor 1 is short-circuited, All On High < 4s
fault displayed on the
open-circuited, or faulty.
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "O2
The oxygen concentration
O2 sensor 2 sensor 2 fault" is
21 sensor 2 is short-circuited, All On High < 4s
fault displayed on the
open-circuited, or faulty.
screen, and the
alarm sound rings.

The alarm indicator

The difference between
blinks in red, "O2
oxygen concentration
O2 sensor sensor difference" is
22 measured by oxygen All On High < 2s
difference displayed on the
concentration sensors 1
screen, and the
and 2 is 3%.
alarm sound rings.

The alarm indicator

blinks in red,
Communicatio "Communication with
n with the the SpO2 module The connection to the
23 All On High < 1 min
SpO2 module interrupted" is SpO2 module is abnormal.
interrupted displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, " SpO2
SpO2 system y system fault" is The SpO2 system has an
24 All On High < 10s
fault displayed on the internal error.
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, " SpO2
SpO2 system fault" is The SpO2 system has an
25 All On High < 10s
diagnostic fault displayed on the internal error.
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "SpO2
SpO2
conductive wire not
conductive The SpO2 conductive wire
26 connected" is All On High < 10s
wire not is not connected properly.
displayed on the
connected
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "SpO2
SpO2 conductive wire
The SpO2 conductive wire
27 conductive expired" is displayed All On High < 10s
has expired.
wire expired on the screen, and
the alarm sound
rings.

The alarm indicator

blinks in red, "SpO2
SpO2 conductive wire not
The SpO2 conductive wire
28 conductive match" is displayed All On High < 10s
does not match.
wire not match on the screen, and
the alarm sound
rings.

3-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
blinks in red, "Failed
Failed to
to identify SpO2
identify SpO2 The SpO2 conductive wire
29 conductive wire" is All On High < 10s
conductive cannot be identified.
displayed on the
wire
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "SpO2
SpO2
conductive wire fault" The SpO2 conductive wire
30 conductive All On High < 10s
is displayed on the fails.
wire fault
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "SpO2
SpO2 sensor
sensor connection The SpO2 sensor is not
31 connection All On High < 10s
error" is displayed on connected correctly.
error
the screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "SpO2
SpO2 sensor sensor expired" is The SpO2 sensor has
32 All On High < 10s
expired displayed on the expired.
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "SpO2
The SpO2 sensor is
SpO2 sensor sensor fault" is
33 short-circuited, All On High < 10s
fault displayed on the
open-circuited, or loose.
screen, and the
alarm sound rings.

The alarm indicator

blinks in red, "Failed
Failed to to identify SpO2
The SpO2 sensor cannot
34 identify SpO2 sensor" is displayed All On High < 10s
be identified.
sensor on the screen, and
the alarm sound
rings.

The alarm indicator

blinks in red, "Check
Check SpO2 SpO2 conducting
The SpO2 conducting wire
35 conducting wire or sensor" is All On High < 5s
or sensor is abnormal.
wire or sensor displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in red,
"Adhesive SpO2
Adhesive
sensor not The adhesive sensor is not
36 SpO2 sensor All On High < 5s
connected" is connected.
not connected
displayed on the
screen, and the
alarm sound rings.
The alarm indicator
blinks in red,
Adhesive "Adhesive SpO2
The adhesive SpO2 sensor
37 SpO2 sensor sensor expired" is All On High < 5s
has expired.
expired displayed on the
screen, and the
alarm sound rings.
The alarm indicator
blinks in red,
Adhesive "Adhesive SpO2
The adhesive SpO2 sensor
38 SpO2 sensor sensor not match" is All On High < 5s
does not match.
not match displayed on the
screen, and the
alarm sound rings.

3-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
blinks in red, "Failed
Failed to
to identify adhesive
identify The adhesive SpO2 sensor
39 SpO2 sensor" is All On High < 5s
adhesive SpO2 cannot be identified.
displayed on the
sensor
screen, and the
alarm sound rings.
The alarm indicator
blinks in red,
"Adhesive SpO2
Adhesive SpO2 The adhesive SpO2 sensor
40 sensor fault" is All On High < 5s
sensor fault has an internal error.
displayed on the
screen, and the
alarm sound rings.
The alarm indicator
blinks in red, "SpO2
sensor off" is The SpO2 sensor is
41 SpO2 sensor off All On High < 5s
displayed on the disconnected.
screen, and the
alarm sound rings.
The alarm indicator
blinks in red, "Check
Check SpO2 SpO2 sensor
The SpO2 sensor
42 sensor connection" is All On High < 5s
connection is abnormal.
connection displayed on the
screen, and the
alarm sound rings.
The alarm indicator
blinks in red, "ECG
ECG communication The communication
43 communication interrupted" is between the system board All On High < 6s
interrupted displayed on the and the ECG board fails.
screen, and the
alarm sound rings.
The alarm indicator
blinks in red, "RESP
RESP communication
Failed to receive the RESP
44 communication interrupted" is All On High < 6s
data.
interrupted displayed on the
screen, and the
alarm sound rings.
The alarm indicator
blinks in red, "NIBP
NIBP
module disabled" is The NIBP module is
45 module All On High < 6s
displayed on the disabled.
disabled
screen, and the
alarm sound rings.
The alarm indicator
blinks in red, "NIBP
NIBP communication The communication
46 communication interrupted" is between the system board All On High < 6s
interrupted displayed on the and the NIBP board fails.
screen, and the
alarm sound rings.
The alarm indicator
blinks in red, "NIBP
NIBP self-test failed" is
47 The NIBP self-test failed. All On High < 6s
self-test failed displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in red,
Humidity "Humidity heating The circuit of the heater in
48 heating system system fault" is the humidity control system All Off Medium < 30s
fault displayed on the is faulty.
screen, and the
alarm sound rings.

3-8
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
blinks in red,
The humidity sensor is
Humidity "Humidity sensor
49 short-circuited, All On Medium < 30s
sensor fault fault" is displayed on
open-circuited, or faulty.
the screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
The rechargeable battery
"Ni-MH battery
Ni-MH battery in the controller is not
50 alarm" is displayed All Off Medium < 30s
fault connected, open-circuited,
on the screen, and
or short-circuited.
the alarm sound
rings.

The alarm indicator

blinks in yellow,
"ECG lead off" is The ECG lead is
51 ECG lead off All On Medium < 6s
displayed on the disconnected.
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
ECG "ECG V lead off" is The V lead is
52 All On Medium < 6s
V lead off displayed on the disconnected.
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
ECG "ECG overload" is
53 ECG overload occurs. All On Medium < 6s
overload displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP cuff error" is
54 The NIBP cuff is incorrect. All On Medium < 6s
cuff error displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP cuff weak" is The NIBP cuff is weakly
55 All On Medium < 6s
cuff weak displayed on the connected.
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP measurement
The measured NIBP is out
56 measurement overrange" is All On Medium < 6s
of the range.
overrange displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP cuff
The cuff pressure is out of
57 cuff overpressure" is All On Medium < 6s
the range.
overpressure displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP measurement
The NIBP measurement
58 measurement timeout" is displayed All On Medium < 6s
times out.
timeout on the screen, and
the alarm sound
rings.

3-9
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
blinks in yellow,
"NIBP signal
NIBP The NIBP signal is
59 saturated" is All On Medium < 6s
signal saturated saturated.
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP measurement
The NIBP measurement is
60 measurement interrupted" is All On Medium < 6s
interrupted.
interrupted displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP cuff type error"
61 The cuff type is incorrect. All On Medium < 6s
cuff type error is displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP cuff leakage"
62 The cuff leaks. All On Medium < 6s
cuff leakage is displayed on the
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP pressure The NIBP pressure is
63 All On Medium < 6s
pressure error error" is displayed on incorrect.
the screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP excessive The infant has too much
64 excessive movement" is movement during NIBP All On Medium < 6s
movement displayed on the measurement.
screen, and the
alarm sound rings.

The alarm indicator

blinks in yellow,
NIBP "NIBP hardware The NIBP hardware has an
65 All On Medium < 6s
hardware error error" is displayed on error.
the screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 "CO2 hardware error" The CO2 module has a
66 All On Low < 6s
hardware error is displayed on the hardware error.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 software "CO2 software error" The CO2 module has a
67 All On Low < 6s
error is displayed on the software error.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 "CO2 motor rotation The motor rotation of the
68 motor rotation overrange" is CO2 module exceeds the All On Low < 6s
overrange displayed on the limit.
screen, and the
alarm sound rings.

3-10
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
is steady yellow,
CO2 "CO2 not calibrated
The CO2 module is not
69 not calibrated upon delivery" is All On Low < 6s
calibrated upon delivery.
upon delivery displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 "CO2 sampling line
The sampling line of the
70 sampling line occluded" is All On Low < 6s
CO2 module is occluded.
occluded displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow, "No
CO2
CO2 sampling line" is The CO2 module has no
71 no sampling All On Low < 6s
displayed on the sampling line.
line
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2
"CO2 not out of
out of The accuracy of the CO2
72 accuracy range" is All On Low < 6s
accuracy module is out of the range.
displayed on the
range
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 "CO2 temperature The temperature of the
73 temperature overrange" is CO2 module is out of the All On Low < 6s
overrange displayed on the range.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2
"CO2 atmospheric The atmospheric pressure
atmospheric
74 pressure overrange" of the CO2 module is out of All On Low < 6s
pressure
is displayed on the the range.
overrange
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 zero "CO2 zero required" The CO2 module needs to
75 All On Low < 6s
required is displayed on the be zeroed.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 zero and "CO2 zero and
The CO2 zero and
76 calibration calibration error" is All On Low < 6s
calibration are incorrect.
error displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"CO2 zeroing" is The CO2 module is being
77 CO2 zeroing All On Low < 6s
displayed on the zeroed.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
CO2 "CO2 calibration
Failed to calibrate the CO2
78 calibration failed" is displayed All On Low < 6s
module.
failed on the screen, and
the alarm sound
rings.

3-11
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
is steady yellow,
"CO2 calibrating" is The CO2 module is being
79 CO2 calibrating All On Low < 6s
displayed on the calibrated.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Tank position error The water tank is not
Tank position
80 alarm" is displayed properly connected to the All On Low < 6s
error
on the screen, and incubator case.
the alarm sound
rings 4 minutes later.

The alarm indicator

is steady yellow,
"Water shortage
Water shortage
81 alarm" is displayed The tank lacks water. All On Low < 14s
alarm
on the screen, and
the alarm sound
rings.

The alarm indicator

is steady yellow,
"Poor SpO2 signal
Poor SpO2 The SpO2 signal quality is
82 quality" is displayed All On Low < 10s
signal quality poor.
on the screen, and
the alarm sound
rings.

The alarm indicator

is steady yellow,
"Invalid SpO2" is
83 Invalid SpO2 The SpO2 data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
Low confidence "Low confidence PR" The confidence of the PR
84 All On Low < 5s
PR is displayed on the data is low.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Invalid PR" is
85 Invalid PR The PR data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
Low confidence "Low confidence PI" The confidence of the PI
86 All On Low < 5s
PI is displayed on the data is low.
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Invalid PI" is
87 Invalid PI The PI data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
Invalid smooth "Invalid smooth PI" is The PI data is invalid and
88 All On Low < 5s
PI displayed on the smooth.
screen, and the
alarm sound rings.

3-12
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
is steady yellow,
Low "Low confidence
The confidence of the
89 confidence SpCO" is displayed All On Low < 5s
SpCO data is low.
SpCO on the screen, and
the alarm sound
rings.

The alarm indicator

is steady yellow,
SpCO with low "SpCO with low
The SpCO blood perfusion
90 blood blood perfusion" is All On Low < 5s
is low.
perfusion displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Invalid SpCO" is
91 Invalid SpCO The SpCO data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
Low "Low confidence
The SpMet confidence is
92 confidence SpMet" is displayed All On Low < 5s
low.
SpMet on the screen, and
the alarm sound
rings.

The alarm indicator

is steady yellow,
SpMet with low "SpMet with low
The SpMet blood perfusion
93 blood blood perfusion" is All On Low < 5s
is low.
perfusion displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Invalid SpMet" is
94 Invalid SpMet The SpMet data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
Low "Low confidence
The SpHb confidence is
95 confidence SpHb" is displayed All On Low < 5s
low.
SpHb on the screen, and
the alarm sound
rings.

The alarm indicator

is steady yellow,
SpHb with low "SpHb with low blood
The SpHb blood perfusion
96 blood perfusion" is All On Low < 5s
is low.
perfusion displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Invalid SpHb" is
97 Invalid SpHb The SpHb data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
Low "Low confidence
The SpOC confidence is
98 confidence SpOC" is displayed All On Low < 5s
low.
SpOC on the screen, and
the alarm sound
rings.

3-13
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Technical Alarms (continued)

Alarm
Alarm Alarm Alarm Control Heater Alarm
Alarm Cause Delay
No. Message Characteristics Mode State Priority
Time
The alarm indicator
is steady yellow,
SpOC with low "SpOC with low
The SpOC blood perfusion
99 blood blood perfusion" is All On Low < 5s
is low.
perfusion displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Invalid SpOC" is
100 Invalid SpOC The SpOC data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
Low
"Low confidence The confidence of the PVI
101 confidence All On Low < 5s
PVI" is displayed on data is low.
PVI
the screen, and the
alarm sound rings.

The alarm indicator

is steady yellow,
"Invalid PVI" is
102 Invalid PVI The PVI data is invalid. All On Low < 5s
displayed on the
screen, and the
alarm sound rings.

System Messages

Control Message
System Heater
No. Message Characteristics Message Cause Delay
Message Mode State
Time

Weight
"Weight sensor not connected" The weight scale is not
1 sensor not All On < 5s
is displayed on the screen. connected properly.
connected

Low blood "Low blood perfusion" is

2 The blood perfusion is low. All On < 5s
perfusion displayed on the screen.

SpO2 sensor "SpO2 sensor initializing" is The SpO2 sensor is

3 All On < 5s
initializing displayed on the screen. initialized.

Search for "Search for pulse" is displayed The device is searching for
4 All On < 5s
pulse on the screen. pulse.

SpO2
"SpO2 interference detected"
5 interference Interference is detected. All On < 5s
is displayed on the screen.
detected
Adhesive
"Adhesive SpO2 sensor near
SpO2 sensor The adhesive SpO2 sensor
6 expiration" is displayed on the All On < 5s
near will expire soon
screen.
expiration
SpO2
"SpO2conductive wire near
conductive The SpO2 conductive wire
7 expiration" is displayed on the All On < 5s
wire near will expire soon.
screen.
expiration

SpO2 sensor "SpO2 sensor not match" is The SpO2 sensor does not
8 All On < 5s
not match displayed on the screen. match.

SpO2 sensor
"SpO2 sensor near expiration" The SpO2sensor will expire
9 near All On < 5s
is displayed on the screen. soon.
expiration

3-14
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Physiological Alarms

Alarm Alarm Control Heater Alarm Alarm

Alarm Characteristics Alarm Cause
No. Message Mode State Priority Delay Time

The displayed
The alarm indicator temperature is 3°C higher Air
1 Off High < 2s
blinks in red, than the preset Control
Temperature temperature.
"Temperature upper
upper
deviation" is displayed
deviation
on the screen, and the The displayed skin
alarm sound rings. Skin
2 temperature is 1°C higher Off High < 2s
Control
than the set temperature.

The displayed
temperature is 3°C lower Air
3 The alarm indicator On High < 2s
than the preset Control
blinks in red,
Temperature temperature.
"Temperature lower
lower
deviation" is displayed The displayed skin
deviation
on the screen, and the temperature is 1°C lower Skin
4 alarm sound rings. On High < 2s
than the preset Control
temperature.

The alarm indicator

The displayed oxygen
blinks in red, "O2 upper
O2 upper concentration is 5%
5 deviation" is displayed All On High < 2s
deviation higher than the preset
on the screen, and the
value.
alarm sound rings.

The alarm indicator

blinks in red, "O2 lower The displayed oxygen
O2 lower
6 deviation" is displayed concentration is 5% lower All On High < 2s
deviation
on the screen, and the than the preset value.
alarm sound rings.

The alarm indicator

blinks in red, "Asystole"
7 Asystole is displayed on the ECG detects Asystole. All On High < 5s
screen, and the alarm
sound rings.

The alarm indicator

blinks in red,
"V-Fib/V-Tach" is ECG detects
8 V-Fib/V-Tach All On High < 5s
displayed on the screen, V-Fib/V-Tach.
and the alarm sound
rings.

The alarm indicator

blinks in red, "Apnea" is
9 Apnea displayed on the screen, ECG detects Apnea. All On High < 5s
and the alarm sound
rings.

The alarm indicator

blinks in yellow, "SpO2 The displayed SpO2 value
10 SpO2 High High" is displayed on the is higher than the preset All On Medium < 5s
screen, and the alarm alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "SpO2 The displayed SpO2 value
11 SpO2 Low Low" is displayed on the is lower than the preset All On Medium < 5s
screen, and the alarm alarm lower limit.
sound rings.

3-15
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Physiological Alarms

Alarm Alarm Control Heater Alarm Alarm

Alarm Characteristics Alarm Cause
No. Message Mode State Priority Delay Time

The alarm indicator

blinks in yellow, "PR The displayed PR value is
12 PR High High" is displayed on the higher than the preset All On Medium < 5s
screen, and the alarm alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "PR The displayed PR value is
13 PR Low Low" is displayed on the lower than the preset All On Medium < 5s
screen, and the alarm alarm lower limit.
sound rings.

The alarm indicator

blinks in yellow, "SpOC The displayed SpOC
14 SpOC High High" is displayed on the value is higher than the All On Medium < 5s
screen, and the alarm preset alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "SpOC The displayed SpOC
15 SpOC Low Low" is displayed on the value is lower than the All On Medium < 5s
screen, and the alarm preset alarm lower limit.
sound rings.

The alarm indicator

blinks in yellow, "SpMET The displayed SpMET
16 SpMET High High" is displayed on the value is higher than the All On Medium < 5s
screen, and the alarm preset alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "SpMET The displayed SpMET
17 SpMET Low Low" is displayed on the value is lower than the All On Medium < 5s
screen, and the alarm preset alarm lower limit.
sound rings.

The alarm indicator

blinks in yellow, "PI The displayed PI value is
18 PI High High" is displayed on the higher than the preset All On Medium < 5s
screen, and the alarm alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "PI Low" The displayed PI value is
19 PI Low is displayed on the lower than the preset All On Medium < 5s
screen, and the alarm alarm lower limit.
sound rings.

The alarm indicator

blinks in yellow, "PVI The displayed PVI value
20 PVI High High" is displayed on the is higher than the preset All On Medium < 5s
screen, and the alarm alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "PVI The displayed PVI value
21 PVI Low Low" is displayed on the is lower than the preset All On Medium < 5s
screen, and the alarm alarm lower limit.
sound rings.

The alarm indicator

blinks in yellow, "HR The displayed HR value is
22 HR High High" is displayed on the higher than the preset All On Medium < 5s
screen, and the alarm alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "HR The displayed HR value is
23 HR Low Low" is displayed on the lower than the preset All On Medium < 5s
screen, and the alarm lower alarm limit.
sound rings.

The alarm indicator

blinks in yellow, "RR The displayed RR value is
24 RR High High" is displayed on the higher than the preset All On Medium < 5s
screen, and the alarm alarm upper limit.
sound rings.

3-16
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Physiological Alarms

Alarm Alarm Control Heater Alarm Alarm

Alarm Characteristics Alarm Cause
No. Message Mode State Priority Delay Time

The alarm indicator

blinks in yellow, "RR The displayed RR value is
25 RR Low Low" is displayed on the lower than the preset All On Medium < 5s
screen, and the alarm lower alarm limit.
sound rings.

The alarm indicator

blinks in yellow, "NIBP The displayed NIBP Sys
NIBP
26 Sys High" is displayed value is higher than the All On Medium < 5s
Sys High
on the screen, and the preset alarm upper limit.
alarm sound rings.

The alarm indicator

blinks in yellow, "NIBP The displayed NIBP Sys
NIBP
27 Sys Low" is displayed value is lower than the All On Medium < 5s
Sys Low
on the screen, and the preset alarm lower limit.
alarm sound rings.

The alarm indicator

blinks in yellow, "NIBP The displayed NIBP Dia
NIBP
28 Dia High" is displayed value is higher than the All On Medium < 5s
Dia High
on the screen, and the preset alarm upper limit.
alarm sound rings.

The alarm indicator

blinks in yellow, "NIBP The displayed NIBP Dia
NIBP
29 Dia Low" is displayed on value is lower than the All On Medium < 5s
Dia Low
the screen, and the preset alarm lower limit.
alarm sound rings.

The alarm indicator

blinks in yellow, "NIBP The displayed NIBP Mean
NIBP
30 Mean High" is displayed value is higher than the All On Medium < 5s
Mean High
on the screen, and the preset alarm upper limit.
alarm sound rings.

The alarm indicator

blinks in yellow, "NIBP The displayed NIBP Mean
NIBP
31 Mean Low" is displayed value is lower than the All On Medium < 5s
Mean Low
on the screen, and the preset alarm lower limit.
alarm sound rings.

The alarm indicator

blinks in yellow, "EtCO2 The displayed EtCO2
32 EtCO2 High High" is displayed on the value is higher than the All On Medium < 5s
screen, and the alarm preset alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "EtCO2 The displayed EtCO2
33 EtCO2 Low Low" is displayed on the value is lower than the All On Medium < 5s
screen, and the alarm preset alarm lower limit.
sound rings.

The alarm indicator

blinks in yellow, "FiCO2 The displayed FiCO2
34 FiCO2 High High" is displayed on the value is higher than the All On Medium < 5s
screen, and the alarm preset alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "FiCO2 The displayed FiCO2
35 FiCO2 Low Low" is displayed on the value is lower than the All On Medium < 5s
screen, and the alarm preset alarm lower limit.
sound rings.

The alarm indicator

blinks in yellow, "BR The displayed BR value is
36 BR High High" is displayed on the higher than the preset All On Medium < 5s
screen, and the alarm alarm upper limit.
sound rings.

The alarm indicator

blinks in yellow, "BR The displayed BR value is
37 BR Low Low" is displayed on the lower than the preset All On Medium < 5s
screen, and the alarm alarm lower limit.
sound rings.

3-17
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Physiological Alarms

Alarm Alarm Control Heater Alarm Alarm

Alarm Characteristics Alarm Cause
No. Message Mode State Priority Delay Time

The alarm indicator

blinks in yellow, "SpO2
SpO2 The SpO2 is less than
38 below 85%" is displayed All On Medium < 5s
below 85% 85%.
on the screen, and the
alarm sound rings.

The alarm indicator is

steady yellow, "Humidity
The displayed humidity is
Humidity upper upper deviation" is
39 15%RH higher than the Incubator On Low < 2s
deviation displayed on the screen,
preset value.
and the alarm sound
rings.

The alarm indicator is

steady yellow, "Humidity
The displayed humidity is
Humidity lower lower deviation" is
40 15%RH lower than the Incubator On Low < 2s
deviation displayed on the screen,
preset value.
and the alarm sound
rings.

Note: 1. When a system fault alarm occurs, stop using the device immediately and ask
authorized and qualified maintenance personnel for repair.
2. Except for the power failure alarm, all other alarms can be muted for 4 minutes
(115s for oxygen concentration alarms and 120s for Multi-parameter monitoring
alarms) by pressing the Mute/Reset button on the panel. When the muting time ends,
the alarm is triggered again if the fault persists. If multiple alarms are triggered at
the same time, the total number of alarms are displayed in the alarm message area.
For example, "Air temperature sensor fault alarms (2)" indicates that two alarms are
not processed yet. The device prompts those with higher priorities. Click Alarm
Message in the general information area to view all alarms triggered. When there
are multiple alarms, the sound pause time is the current highest priority alarm
pause time.
3. The power failure alarm lasts for at least 10 minutes. If the power supply
recovers before the alarm message, the device automatically recovers to the
alarm setting before power failure. After the SUPPLY MAINS has been interrupted
when the “on-off” switch remains in the “on” position and is restored after 30
s，you can use the device as normal as before.
4. The alarm system saves alarm logs automatically. The saved alarm logs remain
unchanged after power failure.
5. When a function is enabled, its alarm function is also enabled.
6. Messages of alarms with the same priority are listed by their No. in the alarm
list.
7. In the state of sound pause, the alarm sound of the equipment shall be sounded
again after any alarm is triggered.
8. The alarm volume can be adjusted. If the operator changes the alarm volume
when an alarm is triggered, the alarm volume changes accordingly.
9. The ALARM SYSTEM discards the oldest date when the log becomes full.

Warning: 1. When you use the incubator in any independent area, potential hazards
may occur if different alarm presets are used.
2. If the presets exceed the alarm upper or lower limit, the alarm system
fails.
3-18
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 4
OPERATION
4.1 OVERVIEW
This section provides operating procedures for the infant incubator.

4.2 POWER CONNECTION AND SWITCH CONTROL

As shown in Figure 4.1, the main power supply socket and main power switch of the
incubator are located at the back of the lifting frame. Figure 4.2 shows the connections of the
controller, sensor box, external screen, and monitoring device.

Main power supply socket Main power switch

Equal potential terminal

FIGURE 4.1
Power switch of controller and
External display screen

Controller power connection

RS-232 port Monitoring module power socket

USB port External display screen power socket

Sensor Module Connector

FIGURE 4.2
Note: When the infant incubator and other devices are to be used together, their
Equipotential potential terminal should be connected to the Equipotential potential
terminal of the hospital, in order to eliminate the potential difference between them.
4-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

4.3 THE CONTROLLER AND DISPLAY PANEL

4.3.1 External screen display

The controller supports two display formats, as shown in Figure 4.3. You can switch the

formats. This manual describes the device in Display Format A. For details about how to switch

the display format, see [Link].

Format A

Format B

FIGURE 4.3

4-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Home screen

1 2 3 4

5
6
7
8
10
9 11
12

13 14
15

16
17

Figure 4.4A
1. Power indicator
When the green indicator is steady on, the device works normally. When the indicator blinks in
red, the device is powered off.
Note: When the green indicator is on but the display is not on, stop using the device
immediately and ask authorized and qualified maintenance personnel for
maintenance.

2. >37℃ indicator
When the incubator runs in >37℃ mode, this indicator lights.

In >37℃ mode, the infant is under a high temperature. The nursing personnel
should pay close attention to the infant.

3. Alarm indicator
It is on when the incubator generates an alarm.

When this indicator is on, immediately stop using the incubator and refer to alarms
and system messages in section 3.4.

4-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

4. Operating mode area

①

②
①. Preset temperature value
The control value set by the operator for the air or skin temperature sensor 1 is displayed here. In
Air Control mode, the preset air temperature is displayed here. In Skin Control mode, the preset
value of the skin temperature sensor 1 is displayed here.
②. Operating mode area
It indicates whether the device runs in Air Control or Skin Control mode.

5. General information area

① ② ③ ④ ⑤
①. Infant information area
The infant name and No. are displayed here.
②. Battery capacity area
The residual capacity of the internal rechargeable battery is displayed here. The device
automatically checks the battery status and charges it during running.
③. Physiological alarms and ambient temperature/humidity area
When the incubator triggers a physiological alarm, the alarm message is displayed here. You can
click in the area to view all alarms triggered.
When the incubator has no alarm, the ambient temperature/humidity measured by the sensor is
displayed here.
④. Technical alarm message area
When the incubator triggers a technical alarm, the alarm message is displayed here. You can
click in the area to view all alarms triggered.
⑤. Time area
The current system time is displayed here.

6. Skin temperature 1 information area

①
②

①. Parent-child mode icon

If the icon is displayed, the device enters the parent-child mode.
4-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

②. Displayed value of skin temperature 1

The temperature measured by the probe of skin temperature sensor 1 is displayed here. If skin
temperature sensor 1 is disconnected from the device, "--.-" is displayed here.

7. Air temperature information area

The temperature measured by the air temperature sensor is displayed here.

8. Shaker angle area

①. Bassinet tilting direction

When the icon is displayed on the screen, the bed close to the controller is lifted. When
the icon is displayed, the bed close to the controller is lowered.
②. Bassinet tilting angle
The bassinet tilting angle is displayed here.

9. Skin temperature 2 information area

The temperature detected by the probe of the skin temperature sensor 2 is displayed here. If the
sensor 2 is disconnected from the device, it displays "--.-".

10. PR/ HR information area

① ③

② ④
①. Preset PR alarm upper/lower limit
The PR alarm upper/lower limit set by the operator is displayed here.
②. Displayed PR value
The PR value measured by the sensor is displayed here.

4-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

③. Preset HR alarm upper/lower limit

The HR alarm upper/lower limit set by the operator is displayed here.
④. Displayed HR value
The HR value measured by the sensor is displayed here.

11. Humidity information area

② ①

①. Running status of the humidity control system

When is displayed, the humidity control system is working. When is displayed, the
humidity control system stops working.
②. Preset humidity value
The humidity control value set by the operator is displayed here.
③. Displayed humidity value
The value measured by the humidity sensor is displayed here.
Note: When the humidity function is disabled, no value is displayed here.

12. O2 information area

② ①
③

①. Running status of the oxygen concentration control system

When is displayed, the oxygen concentration control system is working. When is
displayed, the oxygen concentration control system stops working.
②. Preset oxygen concentration value
The oxygen concentration control value set by the operator is displayed here.
③. Displayed oxygen concentration value
The oxygen concentration measured by the O2 sensor inside the hood is displayed here.
Note: When the oxygen concentration function is disabled, no value is displayed here.

4-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

13. SpO2 information area

① ② ③ ④

⑤ ⑥ ⑦ ⑧ ⑨ ⑩
①. Displayed SpO2 value

The SpO2 value measured by the sensor is displayed here.

②. Preset SpO2 alarm upper/lower limit

The SpO2 alarm upper/lower limit set by the operator is displayed here.

③. Displayed PI value

The PI value measured by the sensor is displayed here.

④. Preset PI alarm upper/lower limit

The PI alarm upper/lower limit set by the operator is displayed here.

⑤. Displayed SpOC value

The SpOC value measured by the sensor is displayed here.

⑥. Preset SpOC alarm upper/lower limit

The SpOC alarm upper/lower limit set by the operator is displayed here.

⑦. Displayed SpMet value

The SpMet value measured by the sensor is displayed here.

⑧. Preset SpMet alarm upper/lower limit

The SpMet alarm upper/lower limit set by the operator is displayed here.

⑨. Displayed PVI value

The PVI value measured by the sensor is displayed here.

⑩. Preset PVI alarm upper/lower limit

The PVI alarm upper/lower limit set by the operator is displayed here.

4-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

14. CO2 / RESP information area

② ① ⑦

③ ④ ⑤ ⑥ ⑧
①. Preset EtCO2 alarm upper/lower limit
The EtCO2 alarm upper/lower limit set by the operator is displayed here.
②. Displayed EtCO2 value
The measured EtCO2 value is displayed here.
③. Displayed AwRR value
The measured AwRR value is displayed here.
④. Preset AwRR alarm upper/lower limit
The AwRR alarm upper/lower limit set by the operator is displayed here.
⑤. Displayed Fi value
The measured Fi value is displayed here.
⑥. Preset Fi alarm upper/lower limit
The Fi alarm upper/lower limit set by the operator is displayed here.
⑦. Preset RESP alarm upper/lower limit
The RESP alarm upper/lower limit set by the operator is displayed here.
⑧. Displayed RESP value
The measured RESP value is displayed here.

15. NIBP information area

①
② ③

④ ⑤

①. Preset NIBP alarm upper/lower limit

The NIBP alarm upper/lower limit set by the operator is displayed here.
②. Displayed Sys value
The measured Sys value is displayed here.
③. Displayed Dia value
The measured Dia value is displayed here.

4-8
 OPERATOR'S MANUAL OF INFANT INCUBATOR

④. Measurement time and mode

The time and mode of the last measurement are displayed here.
Note: If the measurement fails, the word "fail" will be displayed here.
⑤. Displayed Mean value
The Mean value is displayed here.

16. Screen switchover area

① ② ③

④ ⑤ ⑥

⑦
①. NIBP measurement button
You can click this button to start the NIBP measurement and click it again to stop the
measurement.
②. Screen selection button
You can click this button to select the standard screen, simple screen, temperature curve, weight
curve, physiological waveform, 7-lead screen, Rainbow screen, and video.
③. Waveform freezing button
You can click this button to freeze the waveform and click it again to unfreeze the waveform.
④. Graphic trends button
You can click this button to enter the trend setup display page.
⑤. Video surveillance button
You can click this button to open the video surveillance page.
⑥. Printing setup button
You can click this button to set the required waveform source for printing and the print speed.
⑦. Alarm setup button
You can click this button to set the upper/lower limit of ECG, SpO2, CO2, RESP, and NIBP alarms.

17. Function button area

① ② ③ ④ ⑤
4-9
 OPERATOR'S MANUAL OF INFANT INCUBATOR

①. Keyboard lock indicator

The unlocked icon (the icon is displayed) indicates that the system can be set and all
functions are activated. The locked icon (the icon is displayed) indicates that the system
cannot be set and all functions are deactivated.
②. Home button
You can click this button to return to the home screen.
③. Menu button
You can click this button to set and view the comfort range, sensor calibration, function setup,
user setup, infant addition, and incubator system.
④. Audio pause button
When an alarm is triggered, you can click this button to mute the alarm sound for four minutes.
（115s for oxygen concentration alarms and 120s for Multi-parameter monitoring alarms）
⑤. Alarm reset button
When an overtemperature alarm is triggered, you can click this button to reset the alarm status.
Note: When an overtemperature alarm is triggered, this button can be used for resetting
only when the temperature decreases to a value below the overtemperature
threshold.

Second UI (A) Temperature setup

4-10
OPERATOR'S MANUAL OF INFANT INCUBATOR

Second UI (B) Humidity setup

Second UI (C) O2 setup

Second UI (D) ECG setup

4-11
OPERATOR'S MANUAL OF INFANT INCUBATOR

Second UI (E) SpO2 setup

Second UI (F) NIBP setup

Second UI (G) RESP setup

4-12
OPERATOR'S MANUAL OF INFANT INCUBATOR

Second UI (H) CO2 setup

Second UI (I) Wake setup

Second UI (J) Screen selection

4-13
OPERATOR'S MANUAL OF INFANT INCUBATOR

Second UI (K) Graphic trends

Second UI (L) Alarm setup

Second UI (M) Print setup

4-14
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Second UI (N) Menu setup

FIGURE 4.4B

Warning: Follow the instructions in this manual strictly to operate the controller. Do
not press buttons on the panel before you understand their functions.

4.3.2 Controller display

Display screen displays the measured value of air temperature, skin temperature 1, skin
temperature 2, humidity and oxygen concentration (setting is not supported).

FIGURE 4.4C

Manual Oxygen Input Port Servo Control Oxygen Input Port

Oxygen Input Port

FIGURE 4.5

4-15
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Skin temperature sensor socket 1 weight sensor socket

Skin temperature sensor socket 2

Socket for skin temperature sensor and weight sensor

FIGURE 4.6A

Monitoring Switch For Sensor Box Position

Air Temperature

Humidity Sensor

Oxygen Sensor
Distribution of sensors
FIGURE 4.6B

SpO2 socket

WAKE socket

Printer ECG socket CO2 socket NIBP socket

Monitoring module device

FIGURE 4.7

4-16
 OPERATOR'S MANUAL OF INFANT INCUBATOR

UP SWITCH DOWN SWITCH

The VHA stand control

CAUTION: The VHA Stand is only for INTERMITTENT OPERATION with 30 seconds ON and
30 seconds OFF.
FIGURE 4.8

4.4 CALIBRATION

WARNING
1. Please stop using this device once some functions fail or the spare parts for fixing
the front panel are loose.
2. Set temperature must be 3℃ higher than ambient temperature. And then you can
proceed this checkout procedure.
3. Please do not damage the VHA stand during movement. And lower the cabinet to the
lowest position before moving so that the incubator is stable.
Incubator should be only operated by trained personnel who are familiar about the general
risk of operating the incubator and under the instructions of medical practitioner.
Please do the following checkout procedure each time before operation.
The operator should operate the equipment within 20cm in front of the device, and the
specific distance between the device and operator with the operation shall be kept in a comfort
level.

4.4.1 Check The Integrity Of Incubator

 Make sure that the device has been sterilized;
 Make sure that the hoods are locked firmly;
 Make sure that there is no crack or the sharp edge on the hood;
 Make sure that the I.V. Pole and shelf are locked firmly;
 Make sure that fasteners are installed firmly;
 Make sure that the tilt mechanism of bed can work properly ;
 Make sure that the needed accessories and other devices are available;
 Make sure that the power cord is connected and is safe.
 Make sure that the casters are installed well.
Check whether the caster can drop when lifting the incubator 2cm above the ground. In the
process of movement, when the loose caster dorp during the incubator crossed the cable,
threshold or elevator threshold, it would case dangerous. Please do not move incubator before
replace the loose caster.

4-17
 OPERATOR'S MANUAL OF INFANT INCUBATOR

4.4.2 Check Controller

WARNING
1. To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
2. Make sure that the power supply is compatible with the electrical specifications
lapelled on the incubator. The equipment can not use the extension power cord.

A. START THE CONTROLLER AND EXTERNAL DISPLAY SCREEN

After connecting the incubator to a power supply, turn on the main power switch and
controller power switch. The controller beeps once (the volume cannot be adjusted), displays the
startup UI, and performs self-test. After passing the self-test, the controller displays the operation
UI. If the self-test fails, repair the controller.

B. CHECK THE POWER FAILURE ALARM

Disconnect the power supply of whole unit; the device should give a power failure alarm, the
power failure alarm light flashes, the device gives continuous alarm sound.
This operation is used for checking if the power failure is normal or not. Insert the power cord
again after finishing checking.
IMPORTANT: Make sure that the rechargeable battery is full before usage. If not full, it may
cause the power failure without the alarming indication. If full, and there is
no any indication after disconnecting the main power supply, please refer to
the qualified service personnel.

C. CHECK HEATER

Control the environment temperature at 21℃ ~ 26℃, and choose the Air Mode, and set the
temperature at 33.0 ℃ , and all heat power indicators are on, and heater will output heat
completely.
NOTE: When the incubator works under the set state, and continue the following operation
procedure.

D. CHECK THE ACCURACY OF TEMPERATURE CONTROL

Select the Air Mode, and set the air temperature at 36℃, after the air temperature enters

into the STEADY TEMPERATURE CONDITION, put the calibrated temperature measuring

device on the position above 10cm from the center of mattress to measure the air temperature,

compared with the indicated air temperature to check whether the deviation between them is

within 0.8℃.

4-18
 OPERATOR'S MANUAL OF INFANT INCUBATOR

E. CHECK BABY MODE

Insert two skin temperature sensors into the socket of skin sensor1 and skin sensor2

separately, the arrow sign on the plug should aim to the opening on the sensor socket so that the

sensor is inserted correctly.

Arrow Opening

Skin temperature Sensor 1 Skin temperature Sensor 2

[Link] or pull out the skin sensor, you must hold the plug of skin sensor,
pulling the leads is forbidden.
[Link] do not bend the connection of sensor.

When the incubator runs stably in Air Control mode, switch the mode to Skin Control, set the
temperature to 37°C, and keep the temperature of the skin temperature sensor to be at least 2°C
less than the control temperature. When the displayed air temperature is 4°C less than the preset
skin temperature, the incubator generates a high-priority alarm, "Skin temperature sensor position
fault" is displayed in the general information area, and alarm characteristics conform to Section
3.4.
When the skin temperature sensor 1 is disconnected, the device generates a high-priority
alarm tone, "Skin temperature sensor 1 fault" is displayed in the general information area, and
alarm characteristics conform to Section 3.4.

F. CHECK PRECISION OF SKIN TEMPERATURE SENSOR

Place the skin temperature sensor 1 and a mercury glass thermometer with an accuracy of
±0.1°C into a cup filled with warm water. Keep the sensor probe as close as possible to the
mercury ball of the thermometer. Stir the water thoroughly, read the reading on the thermometer,
and compare it with the value displayed on the skin temperature display window. Check whether
the difference is within ±0.2°C.
NOTE: Please check again if the accuracy of the skin temperature sensor exceeds the
allowable deviation. Please let the professional personnel maintain machine if the
accuracy of the skin temperature sensor still exceeds the allowable deviation after
double check.

4-19
 OPERATOR'S MANUAL OF INFANT INCUBATOR

G. CHECK THE SENSOR BOX

Check the connection between the modular and its socket. Only when the interface of the
sensor box is correctly facing the interface of the sensor socket, they can be successfully
connected.

STATOR

Undraw the left stator of sensor box as the arrow indicates; under the condition of stator
undrawing, undraw the sensor box outwards, to check if the Sensor box slides in or out of the
hood smoothly. When the modular falls off from the hood, the controller can give a high priority
alarm sound and indicates “Alarm Sensor Box is placed wrong” information, and alarm
character should be consistent in the description of section 3.4. The sensor connection light is on.
After the modular being put into the correct location and being fixed by stator, the alarm cancels
automatically as well as the sensor connection indicating light off.

WARNING: 1. All gaps in the sensor module must not be blocked.

2. Please pull out and plug in the sensor module correctly.
3. Sensor Module is an important part which supply Temperature
Control to Incubator, and must operate carefully.

H. CHECK FAN MOTOR ALARM

Refer to paragraph 4.4.3 A, open the hood, and take out Infant Mattress, Mattress Tilt
Mechanism, Mattress Tray, and the heater cover. According to the operations sequence of section
15.2.1. Carefully hold the fan and power on the controller, As the follow figure, The incubator
generates a high-priority alarm tone, "Fan fault" is displayed in the general information area, and
alarm characteristics conform to Section 3.4. Release your hand. Check that the alarm is cleared
and that the incubator recovers.

4-20
 OPERATOR'S MANUAL OF INFANT INCUBATOR

NOTE: It must take at least 45 minutes after the incubator stopped working to perform this
operation.

I. CHECK OVER-TEMPERATURE ALARM

When the keyboard is unlocked, click on the home screen to enter the menu page of
the controller. Click and enter the password "36663". Click to enter the user
setup page and then select then select or . The
temperature area is not displayed and the heat power progress bar is displayed as 100%. The
controller enters the overtemperature test state. After a period of time, the incubator generates a
high-priority alarm tone, "Air overtemperature alarm" is displayed in the general information area,
and alarm characteristics conform to Section 3.4.
When the incubator is running, put the skin temperature sensor in water above 38.5°C. The
incubator generates a high-priority alarm tone, "Skin overtemperature alarm" is displayed in the
general information area, and alarm characteristics conform to Section 3.4.

J. CHECK DEVIATION ALARM

In Air Mode, close all door and panels, set the temperature at 32℃. Enter TEMPERATURE

ALARM CHECKOUT STATE（refer to descriptions of terms and symbols concerned）, fan into the

hot air inside the hood. When the air temperature indicates 35.1℃, the device can give a high

priority alarm sound, “Alarm Temp. Deviation” message is displayed, and the alarm character

should be consistent with the description of section 3.4. Set the temperature at 35℃, after the

device enters into the temperature alarming checkout state, open the front access panel, when

the air temperature indicates 31.9℃, the device can give a high priority alarm sound, “Alarm

Temp. Deviation” message is displayed, and the alarm character should be consistent with the

description of section 3.4..

NOTE: If the system can not enter into the TEMPERATURE ALARM CHECKOUT STATE or
the air Temperature does vary within ±3℃ than the setting temperature, the
deviation alarm can not occur.
4-21
 OPERATOR'S MANUAL OF INFANT INCUBATOR

In Baby Mode, set the temperature at 35℃. Enter TEMPERATURE ALARM CHECKOUT

STATE, put the skin sensor into the water cup at 37℃. When the skin temperature indicates

36.1℃, the device can give a high priority alarm sound, “Alarm Temp. Deviation” message is

displayed, and the alarm character should be consistent with the description of section 3.4; Set

the temperature at 35℃, after the device enters into the temperature alarming checkout state, put

the skin sensor into the water cup at temperature 33℃, when the skin temperature indicates to

33.9℃, the device can give a high priority alarm sound, “Alarm Temp. Deviation” message is

displayed, and the alarm character should be consistent with the description of section 3.4.
NOTE: If the system can not enter into TEMPERATURE ALARM CHECKOUT STATE or the
skin temperature does vary within ±1℃ than the setting temperature, the
deviation alarm can not occur.

K. CHECK THE WATER LACKING ALARM

When humidifying system is on working, pour out the water in the water tank. The device can

give a low priority alarm sound, “Alarm Water Shortage” message is displayed, and the alarm

character should be consistent with the description of section 3.4.

L. CHECK THE WATER RESERVOIR POSITION WRONG ALARM

When the incubator is in the working state, pulling out the water tank, the device should give
a low priority alarm sound, the yellow alarm light continues to work, “Alarm water Reservoir is
placed wrong” message is displayed, and the alarm character should be consistent with the
description of section 3.4. 4 minutes later, the water tank is still not in position, the alarm sound
start immediately.

M. CHECK THE TIMER

When the controller is normally working, the message shall display the current real time. If

the displayed time is not correct, please reset the time. The setting method is as following:

When the keyboard is unlocked, click on the home screen to enter the menu page.

Select , enter the password "36663", click to enter the user setup page, and then

select . Then, you can set the recording time of the controller.

4-22
 OPERATOR'S MANUAL OF INFANT INCUBATOR

After you select , you can click the numeric values to adjust the value. After

modification, click to save the modification and start timing. When you click in the

lower right corner, you cancel the modification. After you click , the controller returns to

the previous page. When you click in the upper right corner, the controller returns to

the home screen.

M. Check the multi-parameter monitor device and alarm

Check whether the multi-parameter is installed correctly or not. Turn on the controller, then
the monitoring device will start self-check automatically. The screen display the startup interface,
the alarm indicator flashes while the device sounds like “dingdong”, the alarm will be stopped,
then the equipment has been passed the self-check. That means visible and audible alarm is
starting on normal work. If only measure the alarm condition of the parameter further, it is
suggested using a simulator to do measurement, and adjust the alarm limit setting to check
whether the device can trigger correct alarm response. After starting the controller, you need to
check whether the waveform related to monitoring function is displayed normally or not.
Note: It is necessary to check the performance of the monitoring device.

4-23
 OPERATOR'S MANUAL OF INFANT INCUBATOR

4.4.3 Mechanical Examination

A. CHECK THE HOOD OPERATION

NOTE: Make sure all cables are disconnected from the all accessories before raising the
hood in order to avoid interfering with raising the Hood.

Disconnect the cord of sensor module.

THE KNOB LOCATED

Disconnect the cord of the Sensor Module. Slowly tilt the Hood back until the Hood locks in
place. Release the Hood by pulling on and holding the knob located on the right rear hinge
while closing the Hood.

B. CHECK THE ACCESS PANEL

The Pawl Latch

UNLOCK

The Latch Seat

LATCHED

4-24
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Rotate the panel latches and keep them open. Then press the latch seat to open the access
panels to maximum state (rotate downward). If the front access panel has slow down function,
you can release it after opening to a certain angle and the panel will descend to maximum state
slowly and automatically. Close front and back access panels. The seat latch fastens
automatically and then rotate both latches until they are fully locked. Both latches and the seat
latch muse be locked firmly to prevent unexpectedly opening of the front access panel.

C. CHECK IRIS ENTRY PORTS

Rotate the outer ring of each entry Port, the port should be open and close as rotation is
continued through 360 degree.

D. CHECK THE LATCH AND GASKET OF ACCESS DOOR

Press on-off of each access door to open it automatically and check the seal of gaskets.

E. CHECK INNER WALLS ARE PROPERLY LATCHED

INNER WALL UNLATCHED INNER WALL LOCKED

Open the Access Panels and check that the front and rear inner walls are properly latched.

4-25
 OPERATOR'S MANUAL OF INFANT INCUBATOR

F. CHECK MATTRESS TILT MECHANISM

Turn the tilt mechanism as shown in figure 4.17 the tilting angle of the bassinet is adjusted.

G. CHECK BASSINET

Open the Access Panel and slide it out to the fully extended position indicated by the arrow.
The mattress of the bassinet is the applied part. Lean on Mattress Tray to make sure it is properly
supported to provide a firm infant platform. Return the mattress and close Access Panel.

H. CHECK THE AIR INTAKE FILTER

Loosen the two thumb screws of the Air Intake Filter Cover and remove the cover and
inspect the filter, if dirty, it should be cleaned. Put the filter cover back.

A dirty air filtering material will increase the concentration of carbon dioxide
inside the hood, according to the actual condition, must check the air filter
materials regularly. If the air filters materials look dirty or used more than 2
months, should replace it.

I. CHECK THE X-RAY TRAY

Open the Access Panel and withdraw The X-Ray Tray can be pull out easily Indicated
the X-Ray Tray. as the arrow.

4-26
 OPERATOR'S MANUAL OF INFANT INCUBATOR

J. CHECK THE HIGH ADJUSTMENT OF THE VHA STAND

Step the Up and Down button with your feet in figure 4.8 to adjust the height of whole unit.

K. Check the observation lamp.

Press the observation lamp button. Verify that the lamp can be turned on or off.

L. Check the I.V. pole and tray.

Check whether the I.V. pole and tray are firmly installed.

4.5 OPERATIONS

WARNING
1. Please read this operator’s manual carefully before use.
2. You should not use the incubator without the checkout procedure, and please refer
to the qualified person.
3. For the incubator’s normal function, the setting temperature must 3℃ higher than
environment temperature.
4. The display module of the controller is susceptible to electromagnetic interference, so
can not use the controller under the high electromagnetic field. If a device which
sends or receive weak signal installed in the equipment nearby, it may be affected by
the electromagnetic wave sent by this equipment. Before using, please check if the
device has been affected.

4.5.1 Operations
Connect the power cables correctly and turn on the main power switch and controller power
switch.
[Link] Screen Selection
When the keyboard is unlocked, click the screen selection button in the screen switching
area to enter the second UI (J) Screen Selection, as shown in Figure 4.9. You can switch the
screen as needed.

FIGURE 4.9

4-27
 OPERATOR'S MANUAL OF INFANT INCUBATOR

[Link] Graphic Trend Display

When the keyboard is unlocked, click the graphic trend button in the screen switching area to
enter the second UI (K) Trend, as shown in Figure 4.10.

FIGURE 4.10
[Link] Setting Alarm Upper/Lower Limit
When the keyboard is unlocked, click the alarm setup button in the screen switching area to
enter the second UI (L) Alarm Setup, as shown in Figure 4.11. Select the alarm type and item you
want to modify, click the corresponding numeric value, select the appropriate value, and then click
to return to the home screen.

FIGURE 4.11

[Link] Operations of the Comfort Range

When the keyboard is unlocked, click in the function button area and then
select . The Conform Range page is displayed, as shown in Figure 4.12. You can set the
infant's age, gestational age, and weight. Then, the suggested temperature value is displayed on
the screen, and you can set the temperature accordingly.

4-28
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 4.12

[Link] Operations of Function

When the keyboard is unlocked, click in the function button area and then
select . The Function Setup page is displayed, as shown in Figure 4.13. You can set the
format switching, screen brightness, button volume, beat volume, APGAR volume, and alarm
volume.

FIGURE 4.13
[Link] Adding Infant Information
When the keyboard is unlocked, click in the function button area and
select . The Add Infant Information page is displayed, as shown in Figure 4.14. You
can edit or add infant information.
When the keyboard is unlocked, click in the function button area and select .
Enter the password "36663" and click to enter the User Setup page.
Select . Then, you can view the list of all infants.

4-29
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 4.14
[Link] Enabling/Disabling a Module
When the keyboard is unlocked, click in the function button area and
select . Enter the password "36663" and click to enter the User Setup page.
Select to enter the Module Setup page.
Select the or custom function key in the column of the target module

to enable or disable the module, as shown in Figure 4.15. When the module is disabled, all

module-related functions are disabled, including the module-related alarm functions, displayed

value and preset value.

FIGURE 4.15

[Link] Setting the Unit

When the keyboard is unlocked, click, click in the function button area and

select . Enter the password "36663" and select to enter the User Setup page.

Select . Then, you can set the unit for NIBP and CO2, as shown in Figure 4.16.

4-30
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 4.16

[Link] Video Monitoring Operations

When the keyboard is unlocked in the screen switching area to enter the Image
Recording page. Click to edit the image, click to record video, and click to
stop video recording.

4.5.2 Other Operations

A. Bassinet Tilting Angle

Tilt mechanism

Turn the tilt mechanism to adjust the bassinet tilting angle.（For details about the bassinet
tilting direction and angle, see Section 4.3.）
FIGURE 4.17
CAUTION: 1. Please do not add the over load on the mattress.
2. The mattress tilt will affect the temperature uniformity on the mattress, the
horizontal position of mattress is best state.

B. X-ray procedures
1. Open the Access Panel and withdraw the X-ray Tray from under the mattress.
2. Place the X-ray Cassette in the center of the X-ray Tray.
3. Place the Infant at center Mattress. Close the Access Panel. When the X-Ray is complete
remove the X-ray cassette from the tray and return the tray.

4-31
 OPERATOR'S MANUAL OF INFANT INCUBATOR

C. Observation Lamp
Connect the power cable of the observation lamp to the power outlet of the device, and press
the observation lamp button. Verify that the lamp can be turned on and off.

4.5.3 Shutdown
After finishing the operation, turn off the power switch of controller and main power switch,
and disconnect the wire of power.

4-32
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 5
TEMPERATURE OPERATIONS
5.1 OVERVIEW
This chapter describes how to set the incubator temperature.

5.2 OPERATIONS
5.2.1 Preparations
Connect the device to the power supply, sensor box and the skin temperature sensors 1 and
2 properly.
Before putting an infant in the incubator, pre-warm the device to make the air temperature in
the incubator reach the expectation. If an infant is put in the incubator when the device is cool, the
body temperature may drop quickly. The following describes how to pre-warm the incubator.
Select the Air Control mode, set an appropriate control temperature value, and make the
incubator work continuously until the displayed value reaches the preset value.
Important: 1. The air outlets of the device are located on the two sides of the bassinet.
Avoid the hot air from the outlets when putting an infant into the hood from a
side door.
2. For the preset temperature, consult the attending doctor.
A. Air Control mode
The air mode is used to control an infant's body temperature by controlling the air
temperature in the incubator. In this mode, the incubator automatically keeps the air temperature
at the preset value.
In Air Control mode, the incubator controller compares the temperature measured by the air
temperature sensor in the sensor box with the preset value, and transmits control signals to
control the heating ratio of the heater based on the comparison result so that the air temperature
remains the same as the preset value.

Select the Air Control mode, and set parameters.

If you want to increase or decrease the preset temperature when the incubation is running,
click to unlock the keyboard. Click in the air temperature area on the home screen. The
controller enters the second UI (A) Temperature Setup, as shown in Figure 5.1. Select the Air
Control mode, click the numerical value in the Setup field, and then click or to set
the temperature to the expected value. To select the >37°C mode, set the air temperature to 37°C,
and click in the >37°°C mode field. If the >37°C indicator is on, the device enters
the >37°C mode. Then, you can click in the setup field to set the control temperature to be
a value above 37°C. Set an appropriate value, click the set value to confirm the new value, and

5-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

then click to return the home screen. If you do not click any button in 30s, the controller
automatically returns to the home screen. Once the temperature becomes stable, the difference
between the displayed air temperature and the preset temperature will not exceed ±0.2°C. In the
air temperature area, the temperature measured by the air temperature sensor is displayed at the
left, and the preset air temperature is displayed in the operating mode area. The temperature
measured by the skin temperature sensor is displayed in the skin temperature area.

FIGURE 5.1

Note: 1. All settings must be configured when the keyboard is unlocked.

2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked.

1
Click this button. The incubator enters the temperature control mode selection page. You can set
the preset value.

Click this button to select the Air Control mode.

3
Click this button and then select or to change the preset value.

Press this button and then select . The device enters the >37°C mode, the >37°C
indicator is on, and the controller allows you to set a temperature value above 37°C.

5-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Tap this button, and the device will enter the parent-child mode.

B. Skin Control mode

The skin temperature of an infant is directly controlled in Skin Control mode. In this mode,
the incubator limits the infant's skin temperature measured by the skin temperature sensor 1 to
the value preset by the operator.
Two skin temperature sensors are available: skin temperature sensor 1 and skin temperature
sensor 2. The skin temperature sensor 1 serves as a control temperature sensor; that is, the
temperature controller controls the infant skin temperature based on the value measured by the
skin temperature sensor 1. The skin temperature sensor 2 is clinically used to observe the infant
skin temperature (the method of checking values displayed on the skin temperature sensor 2 is
described in Section 4.3). In Skin Control mode, the skin temperature sensor 1 must closely
contact the infant's skin. The controller inside the incubator compares the temperature measured
by the skin temperature sensor 1 with the preset value, and transmits control signals to control
the heating ratio of the heater based on the comparison result to make the measured skin
temperature close to the preset temperature. In Skin Control mode, the isolated temperature
sensor in the incubator still controls the maximum air temperature in the incubator as a backup. In
case of overtemperature, the heat protection device functions and the heater is disabled.
To ensure an appropriate temperature for infant skin temperature control, the incubator
implements the following protection function: When the temperature measured by a skin
temperature sensor is always at least 2°C lower than the preset temperature, the incubator
increases the air temperature by 1°C per hour, so as to slowly increase the infant's skin
temperature. This prevents injuries caused by rapid temperature increase. If the measured skin
temperature stays at least 2°C lower than the preset temperature for one hour, the device
generates a "Skin temperature sensor 1 position error" alarm. In this case, the incubator slowly
increases the air temperature until the skin temperature stays 4°C lower than the preset
temperature. For example, if the preset temperature is 36.5°C in Skin Control mode, the
temperature in the incubator remains at 32.5°C.
To prevent unexpected air temperature decreases due to infant fever or other reasons, the
incubator implements the following function: If the infant's skin temperature exceeds the preset
value by less than 0.5°C, the air temperature will not decrease to more than 5°C lower than the
skin temperature. If the skin temperature exceeds the preset value by more than 0.5°C, the air
temperature will not decrease to less than 25°C. For example, if the preset skin temperature is
36°C and the skin temperature increases to 36.3°C, the air temperature will not decrease to
below 31.3°C. If the skin temperature increases to 36.7°C, which is over 0.5°C higher than the
preset value, the air temperature will not decrease to less than 25°C.
5-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Connection between the skin temperature sensor probe and infant's skin:
In Skin Control mode, ensure reliable contact between the skin temperature sensor probe

and the infant's skin. You can use medical adhesive plaster or similar objects to fasten the probe

firmly. Before placing the skin temperature sensor probe on the infant's skin, use ethanol or warm

water to remove grease and dirt from the skin and dry the skin. If the infant lies facing upward,

place the probe between the cartilago xiphoidea and navel and avoid the liver. If the infant lies

facing downward, place the probe on the back of the infant, and if possible, on the kidney. If the

infant lies sideward, follow the attending doctor's advice.

Note: 1. The skin temperature sensor must be cleaned and sterilized before use.
2. Do not place the skin temperature sensor probe beneath the infant.
3. Do not use the skin temperature sensor probe as a rectal thermometer.

Warning
1. Keep reliable contact between the probe of the skin temperature sensor 1 and the
infant. If the probe is disconnected from the infant, the temperature measured by the
sensor is not the infant's skin temperature but the air temperature or mattress
temperature. This may cause excessive heating or cooling, or even burns or death to
the infant.
2. Do not cover the probe of a skin temperature sensor with an object like blanket or
diaper. Otherwise, the accuracy of temperature measurement may be affected.
3. The temperature measured by the skin temperature sensor is the skin temperature of
the infant rather than the actual body temperature. Therefore, regularly measure the
infant's body temperature to check whether the infant has a fever or hypothermia.

Select the Skin Control mode and set the related value.

As described in step E in Section 4.4.2, connect the skin temperature sensor 1 to the
socket for the sensor. If you want to increase or decrease the preset temperature, click to
unlock the keyboard. Click in the skin temperature area on the home screen. The controller
enters the second UI (A) Temperature Setup, as shown in Figure 5.2. Select the Skin Control
mode, and then click or to set the temperature to the expected value. To select
the >37°C mode, set the skin temperature to 37°C, and click in the >37°C field. If
the >37°C indicator is on, the device enters the >37°C mode. Then, click in the Setup
field to set the control temperature to a value above 37°C. Set an appropriate value, click the set
value to confirm the new value, and then click to return the home screen. If you do not
click any button in 30s, the controller automatically returns to the home screen. Once the skin
temperature becomes stable, the skin temperature measured by the skin temperature sensor is
controlled at the preset value with a tolerance of ±0.2°C. The temperature measured by the skin
5-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

temperature sensor is displayed in the skin temperature area. When the skin temperature sensor
is disconnected from the incubator, "--.-" is displayed here and the preset skin temperature is
displayed in the operating mode area. The temperature measured by the air temperature sensor
is displayed in the air temperature area.

FIGURE 5.2
Note: 1. All settings must be configured when the keyboard is unlocked.
2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked.

1
Click this button. The incubator enters the temperature control mode selection page. You can set
the preset value.

Click this button to select the Skin Control mode.

3
Click this button and then select or to change the preset value.

Press this button and then select . The device enters the >37°C mode, the >37°C
indicator is on, and the controller allows you to set a temperature value above 37°C.

Tap this button, and the device will enter the parent-child mode.
5-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 6
OXYGEN CONCENTRATION CONTROL SYSTEM
6.1 OVERVIEW
This Section provides operation checkout procedure and operation instruction for the Oxygen
Control System. Oxygen concentration serve Control System is optional function.

6.2 REPLACING AN OXYGEN SENSOR

Stator

Pull out the stator on the left side of sensor box as the arrow indicates, and pull out the

sensor box,

Sensor Cover

Stopper

Unscrew 2 Cross groove countersunk head bolts, and take out the sensor cover, and then
unscrew the stopper on it.

Oxygen Sensor

Sensor Cover

Screw 2 oxygen sensors into the sensor cover clockwise.

6-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Pull the connecting wire of oxygen sensor out and connect the sensor with the double wire in
green and black (if the device is equipped with oxygen control system, please connect another
oxygen sensor with the other double wire in yellow and black). After correctly connecting them,
screw the sensor cover board down with two M3×8 cross groove head bolt, then push the sensor
box into the original place in the hood.
CAUTION: 1. Do not block any of the holes on the sensor box.
2. Please pull out and push in the sensor box in correct way.
3. Sensor box is the important part of controlling the temperature of the
incubator, please treat it carefully.
FIGURE 6.1

6.3 FUNCTIONS
The incubator provides two functions: oxygen concentration monitoring and oxygen
concentration servo control. The oxygen concentration sensor 1 fault alarm is applicable to the
two functions. The oxygen concentration sensor 2 fault alarm, the oxygen concentration sensor
difference alarm, and the oxygen concentration deviation alarm are applicable only to the oxygen
concentration servo control function. For details about alarms, see Section 3.3. When an alarm is
generated, press the Mute button to mute the alarm sound for 115 seconds. The incubator
automatically cuts oxygen supply if the heater power supply is connected (except for the "O2
lower deviation" alarm). Press the Reset button to directly clear the alarm.
If the oxygen information area is gray on the screen, the oxygen concentration module is
disabled.

6.4 CONNECTION OF SERVO-CONTROLLED OXYGEN INLET

WARNING
1. Please read the operation manual carefully before operating.
2. Oxygen concentration control system must use oxygen analyzer to supply oxygen
through the oxygen input connector, the relative operation must be referred to the
operation manual of oxygen analyzer or other documents similarly.
3. Only given decompress valve or pressure adjusting valve can be used on the
oxygen cylinder.
4. According to the theory that the oxygen concentration breathed in by the patient can
not judge his artery PaO2. Accurately, so other acceptable clinical measures should
be taken to testify the patient’s artery PaO2.
6-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

6.4.1 CONNECTION OF MANUAL OXYGEN INPUT PORT

Connect the oxygen transfuse tube of monitoring device and the manual oxygen input port,
(refer to figure 4.5) to make sure the air-proof connecting port. This port can not control the
oxygen, while the oxygen flow can be adjusted by the user. The different oxygen flow can cause
the different oxygen concentration, please refer to the oxygen concentration table, which is
located on the back of incubator, the oxygen concentration needs a calibrated oxygen analyzer
for long period monitoring.

FIGURE 6.2

6.4.2 CONNECTION ABOUT THE INPUT INTERFACE OF SERVE CONTROL OXYGEN

Connect the oxygen input tube of serve control oxygen interface (see figure 4.5)and the
oxygen-offering system equipped with the oxygen monitoring device, and make sure the
connecting part is sealed.
Electromagnetic valve is in servo control oxygen input interface. When the oxygen sensor in
sensor box detects the oxygen is enough for user, it will cut off the oxygen supply, if not enough it
will continue to supply oxygen. The sensor box will alarm if put in wrong place and the
electromagnetic will cut off oxygen supply.
NOTE: 1. To make sure the safety, when offering the oxygen, there must be a calibrated
oxygen analyzer that can monitor the oxygen concentration inside of hood.
2. The oxygen input tube offered by our company can only connect with the serve
control oxygen input interface, using the manual oxygen input interface is
forbidden.

WARNING：Over high oxygen concentration can cause terrible hurt on the baby, so please
follow the advice of doctor when offering the oxygen, and use the relevant
oxygen monitoring device to help it reach the setting state set by physician.
Please read the indication values, the oxygen concentration table is just
regarded as a reference.

6-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

6.5 CALIBRATION OF OXYGEN SUPPLY SYSTEM

Before the first usage of incubator and the reuse after maintenance, should perform the
oxygen concentration calibration system operating process.
The system support with two kinds of oxygen concentration calibration: 21% oxygen
concentration and 100% oxygen concentration. When the oxygen concentration of the
environment is below 21%, we suggest using 100% oxygen concentration calibration.

Calibration in 21% oxygen concentration mode

Keep the incubator in the environment which oxygen concentration is 21%.

Start the controller, click and then select to enter the sensor calibration page.
Click as shown in Figure 6.3. The controller asks the operator whether to
calibrate the device in 21% oxygen concentration mode.
Click . The system enters the calibration procedure in 21% oxygen
concentration mode. After calibration is complete, the calibrated oxygen concentration value is
displayed.
Click . The system returns to the sensor calibration page.

FIGURE 6.3

100% OXYGEN CALIBRATION

a. Turn off the controller, pull the sensor box out as figure 6.4 shows, connect the oxygen
calibration device which is equipped with oxygen connecting pipe to the sensor box, supplying the
device with 100% oxygen for more than 2min.

b. Start the controller, click and then select to enter the sensor calibration

page. Click as shown in Figure 6.3. The controller asks the operator whether to

calibrate the device in 100% oxygen concentration mode.

6-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Click . The system enters the calibration procedure in 100% oxygen

concentration mode. After calibration is complete, the calibrated oxygen concentration value is

displayed.

Click . The system returns to the sensor calibration page.

Sensor box

Oxygen concentration
calibration device
FIGURE 6.4

CHECK THE OXYGEN CONCENTRATION MONITOR FUNCTION

1. Place a calibrated oxygen concentration analyzer on the middle of the bassinet.

2. Input oxygen to the device, wait until the oxygen concentration displays steady, the value
deviation displayed between the value displays in the Oxygen Concentration indicator and the
oxygen concentration analyzer should in the range of ±3%.

CHECK THE OXYGEN CONCENTRATION DEVIATION ALARM FUNCTION

Connect the oxygen supply system and manual oxygen input interface, set the oxygen
concentration as 30%O2, when the oxygen concentration reaches the setting value, increase the
oxygen flow immediately, when the display value is different from the setting value +5%O2, the
device should give a high priority alarm sound, “Alarm O2 Deviation” information will replace the
curve indication on the screen, the alarm character should be consistent with the description of
section 3.4; set the oxygen concentration as 30%O2, when the oxygen concentration reaches the
setting value, decrease the oxygen flow immediately, when the display value is different from the
setting value -5%O2, the device should give a high priority alarm sound, “Alarm O2 Deviation”
information will replace the curve indication on the screen, the alarm character should be
consistent with the description of section 3.4. When alarm occurs, press silence key once, can
cancel the alarm sound, but the alarm light still flashes until the display value is within ±5%O2 of
setting value.
Connect the oxygen supply system and servo control oxygen input interface, set the oxygen
concentration as 30%O2, when the oxygen concentration reaches the setting value, increase the
oxygen flow immediately, when the display value is different from the setting value +5%O2, the
device should give a high priority alarm sound, “Alarm O2 Deviation” information will replace the
curve indication on the screen, the alarm character should be consistent with the description of
section 3.4; set the oxygen concentration as 30%O2, when the oxygen concentration reaches the
6-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

setting value, decrease the oxygen flow immediately, when the display value is different from the
setting value -5%O2, the device should give a high priority alarm sound, “Alarm O2 Deviation”
information will replace the curve indication on the screen, the alarm character should be
consistent with the description of section 3.4. When alarm occurs, press silence key once, can
cancel the alarm sound, but the alarm light still flashes until the display value is within ±5%O2 of
setting value.

6.6 USING OF OXYGEN SUPPLY SYSTEM

6.6.1 Preparation
Connecting the oxygen flowmeter and oxygen input valve with one PU-10×6.5 medical pipe.
6.6.2 Operation

[Link] Select the oxygen concentration value specified by the attending doctor. On the home

screen, click in the oxygen concentration area and set the oxygen concentration, as shown in

Figure 6.5.
Note: If no information is displayed in the oxygen concentration area during operation, the
functions of the O2 module are unavailable.

WARNING: 1. The oxygen input interface of oxygen –offering system and the one of
serve control can not be used together.
2. If the artery blood oxygen pressure of patient (PaO2) can not maintain
65% O2 saturation; you need to change the other oxygen transfusion
method.
3. Do not supply wet oxygen to the oxygen port, or else the oxygen inlet
port would be damaged.

SET OXYGEN MODULE WORKING MODE

When the keyboard is unlocked, click in the oxygen concentration area on the home screen.
The controller enters the second UI (C) Oxygen Concentration Setup, as shown in Figure 6.5.
Click the numeric value, and then click or to adjust the preset oxygen concentration
value. After setting a value, click the value to confirm the new value and then click to
return to the home screen. If you press no button in 30s, the controller automatically returns to the
home screen.

6-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 6.5

Note: 1. All settings must be configured when the keyboard is unlocked.

2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked.

1
Click this button to increase the value. Each time you click this button, the value is increased by
1%.

2
Click this button to decrease the value. Each time you click this button, the value is decreased by
1%.

6.7 MAINTENANCE
A. Oxygen concentration sensor
When the oxygen concentration lifetime is in due, replace it even it is workable to ensure the
veracity of the detecting value. That is because:
The detecting accuracy of oxygen concentration sensor is influenced by the electrolyte inside
the sensor modular, and the electrolyte will be consumed along with the working time. So using
the over lifetime oxygen concentration sensor will result in wrong detected value.
B. Troubleshooting
Troubleshooting of the oxygen concentration sensor is presented in the following table. If the
fault cannot be localized from the table, the unit should be removed from service and servicing
should be referred to our company or authorized and qualified service personnel.

6-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SYMPTOM POSSIBLE CAUSE REMEDY

No indication of oxygen
Not install the oxygen sensor install the oxygen sensor
concentration value
Please calibrate the oxygen
Displayed oxygen concentration sensor again
too high
The “Alarm” light will Adjust the proper oxygen flow
flash, and the screen Please calibrate the oxygen
indicator will show Displayed oxygen concentration sensor again
“Alarm O2 Deviation” too low
Adjust the proper oxygen flow
Open the access door Close the access door

6-8
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 7
HUMIDITY CONTROL SYSTEM
7.1 OVERVIEW
This section provides operation and checkout procedures and operation manual about
humidity control system.

7.2 FUNCTIONS
The humidity display range of the incubator is from 0%RH to 100%RH，with a setting range of
30% to 95%RH(Note: If environmental humidity is relatively high，it may not be able to achieve
relatively low humidity control). The deviation alarm is pre-set to ± 15% RH, which means in
humidity steady condition, the humidity deviation alarm will occur if the humidity value is above or
below the selected humidity setting range ± 15% RH.
Vapour produced when the water in the humidity chamber flow by the heat pipe located on
the bottom of the chamber, enters into the hood by vapour outlet port. The humidity control
system enables the humidity increase inside the chamber. The evaporating speed is decided by
the power of the heater. There’s a humidity sensor inside the sensor modular of the hood which
adjusts the output power of the evaporator. Please see the alarm introduction of section 3.4. If the
alarms about humidity are active, press silence key, terminate the alarm sound for 4mins, if the
power of the temperature heater is not cut off, the power of the humidity heater will automatic cut
off when the high humidity deviation alarm is activated.

7.3 CALIBRATION
Please calibrate the incubator when the incubator is used for the first time or reuse it after
cleaning and installation. Before calibrating the device, please refer to section 7.4 to see how to
set humidity of the incubator.
A. Fulfill the humidity chamber to the highest level with water, then place a calibrated
humidity analyzer in the middle of the bassinet.
B. Preheating the incubator to 36℃, set the humidity value in 50%RH.
C. After temperature and humidity reach stable state, the readings on both the hygrometer
and the humidity display indicator should display 50%RH±5%RH.
D. Check the humidity deviation alarm
On humidity set mode, set the value at 40%RH, when the humidity reaches the setting value,
increase the humidity display value, keep the display value higher than set value +15%RH, the
device should give a medium priority alarm, the “Alarm Humidity Deviation” information will
replace the curve indication on the screen, the alarm character should be consistent with
description of section 3.4. On humidity set mode, set the value at 40%RH, when the humidity

7-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

reaches the setting value, decrease the humidity display value, keep the display value lower than
set value -15%RH, the device should give a medium priority alarm, the “Alarm Humidity
Deviation” information will replace the curve indication on the screen, the alarm character should
be consistent with description of section 3.4. Press silence key can terminate the alarm sound,
but the alarm light still flashes until the display value is within ±15%RH. If 4mins later, the alarm
condition is still not canceled, alarm sound will start again.
NOTE：If the displayed value won’t rise anymore or can’t decline to the set value in the
deviation rate more than ±15%, the alarm won’t occur. When checking the
low-deviation alarm, please make sure that the environmental humidity is lower
than the humidity in the hood so that the alarm can be activated.

7.4 OPERATIONS

WARNING：In any temperature, the relatively high humidity in the incubator will
decrease the heat evaporating from the patient and result in increasing
the patient’s temperature. This is especially clear in the neonate.
Therefore, temperature control mode, temperature value and humidity
value should be certified by the chief doctor. Monitor the patient’s recta
and armpit temperature according to the doctor’s instruction.

7.4.1 Preparation
Pull the water tank out as following figure shows, adding proper distilled water into the tank.
But not over the high water level. Set the incubator in the Air control mode. It can pre-warm the air

in the hood according to the set temperature which set by the main doctor or chief nurse.

Water level display window Water Inlet

Handle Reservoir

NOTE: When the handle of the water tank is pulled to a vertical position, water level can be
observed. When the handle is pulled to the horizontal position, water tank can be
took out. (Please keep the water tank flat and straight and don't move it up towards
when it been pulled out, or else it will be hard to pulled out)

7-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

1. Do not start using the humidifying function in the condition that lack water, or
humidifying system will be damaged.
2. The water must be pushed in position when the incubator works in any time, or
will affect the normal temperature control.
3. In order to extend the service life of humidity device, the cleaned distilled water
is the only choice; the sterilized water can not take place of distilled water.
4. The water tank should be thoroughly cleaned every 24 hours and replace
cleaned distilled water, to prevent the microbial propagation and the pollution of
humidifying chamber. The water changing should be performed after the water
tank is cooling sufficient, so as not to scald. Do not exceed maximum water level.
IMPORTANT：1. Please clean the water tank every time before adding water in the tank. Dry
it with a clean cloth or paper towel for both inside and outside of the water
tank to ensure than water lacking alarm will normally working.
2. Please set the humidity value to 0%RH when you're not using the
"humidify" function.

Burns may occur under the condition of high temperature and high humidity
(temp. ≥37 ℃ , humidity ≥85%RH). Therefore, please wait no less than
45minutes when taking out the water tank or restart the humidifier.

7.4.2 Operation
[Link] According to the requirements of physician, on the first screen, press humidity self-definite
function key, please refer to the figure 7.1 to set the humidity value.
NOTE: The actual humidity achievable inside the system is depend on the Incubator Set
Temperature and room conditions.

SELECTING HUMIDITY CONTROL AND SET POINT

When the keyboard is unlocked, click in the humidity area on the home screen. The
controller enters the second UI (B) Humidity Setup, as shown in Figure 7.1. Click the numeric
value, and then select or to adjust the preset humidity value. Set an appropriate
value, click the value to confirm the new value, and then click to return to the home
screen. If you press no key in 30s, the controller automatically returns to the home screen.

7-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 7.1
Note: 1. All settings must be configured when the keyboard is unlocked.
2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked.

1
Click this button to increase the value. Each time you click this button, the value is increased by
1%RH.

2
Click this button to decrease the value. Each time you click this button, the value is decreased by
1%RH.

7.5 MAINTENANCE
Troubleshooting of the humidity control system is presented in the following table. If the fault
cannot be localized from the table, the unit should be removed from service and servicing should
be referred to our company or authorized and qualified service personnel.

7-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Symptom Possible Cause Solution

Environmental humidity change Check the surrounding humidity
Humidity deviation alarm greatly condition
No distilled water in the tank Add distilled water into the tank
Add distilled water into the tank
Water shortage alarm No distilled water in the tank
(Wash it when there's a need)
Push the water tank to the
Bad connection between water
Alarm Water Reservoir is correct position to fully
tank and the main body of the
placed incorrectly connecting with the main body
device
of the device.
Fill the water tank with
water after water lack
Humidifier over-heat protection
indication, "humidify" Waiting for about 10 minutes
not restored.
can't be started
immediately
Excessive microorganism breed Using the soft cloth with
Alarm not be activated
in the water tank or the water disinfectant to wipe around the
when the water tank is
tank haven't been cleaned for detect point to clean the water
lack of water many days. tank thoroughly.
After it cool down, using the soft
Heating circuit failure Over-heat relay works because cloth with disinfectant to wipe
alarm the dusts near the probe. around the detect point to clean
the water tank thoroughly.

7-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 8
WEIGHING SYSTEM
8.1 OVERVIEW
This section provides operation and checkout procedures and operation manual about
weighing system.

8.2 INSTALLATION
Install the weighing system in the incubator as figure 8.1 directs.

Please refer to the A of chapter 4.5.2, Adjust the bed to the lowest position, and open the front
door, place the bed with baby scale on the wavering mechanism, and it can be pulled out and push
in freely as the arrow 1 and 2 indicates.

Arrow Gap

Weight Sensor Make the weight sensor be inserted into

The gap of socket correctly

WARNING: 1. When plug in or out the power supply cord, the plug must be taken hold
and the wring should not be pulled.
2. Do not bend the connection of sensor.

Connect the plug of sensor on the baby scale with the socket on sensor box correctly.

FIGURE 8.1

8-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

8.3 FUNCTIONS
The weighing system can be calibrated. The display range of the weighing system is 200g to

8,000g with a resolution of 1g.

8.4 CALIBRATION
NOTE：Apply the weight sensor calibration and operation procedure when first using the
incubator or reuse it after installation, cleaning, or maintaining.

CALIBRATION OF WEIGHT SENSOR

Start the controller, click then select to enter the sensor calibration page, as

shown in Figure 8.2.

FIGURE 8.2

A. Remove all objects from the bassinet and keep the bassinet surface clean.

Click . The controller asks the operator whether to calibrate the weight sensor in

0 g mode.

Click . The system enters the calibration procedure in 0 g mode. "Calibration

completed" is displayed on the screen. To avoid calibration failure, ensure that the difference

between the actual weight and the calibration value is no more than 1,000 g.

Click . The system returns to the sensor calibration page.

B. Put a 5,000 g standard weight on the electronic scale, and then click . The

controller asks the operator whether to calibrate the weight sensor in 5,000 g mode.

Click . The system enters the calibration procedure in 5,000 g mode.

"Calibration completed" is displayed on the screen. To avoid calibration failure, ensure that the

difference between the actual weight and the calibration value is no more than 1,000 g.

Click . The system returns to the sensor calibration page.

8-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

8.5 OPERATIONS
After the weighing system is calibrated, place the infant into the device, and click the screen
selection button on the home screen. The controller enters the second UI (I) Screen Selection.
Click the weight curve button, as shown in Figure 8.3. The infant weight measured by the weight
sensor is displayed in the upper right corner of the screen.
Click on the page as shown in Figure 8.3. Remove all objects from the bassinet;
otherwise, the weight measured by the weight sensor is not the net weight of the infant.
Click . The operator does not need to remove all objects from the bassinet. As shown in
Figures 8.4 and 8.5, the operator just needs to pick the infant up and then place the infant down to
weigh the infant.

FIGURE 8.3

FIGURE 8.4

8-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 8.5

8.6 MAINTENANCE
Troubleshooting of the humidity control system is presented in the following table. If the fault
cannot be localized from the table, the unit should be removed from service and servicing should
be referred to our company or authorized and qualified service personnel.

SYMPTOM POSSIBLE CAUSE REMEDY

No indication on Weight Turn on the power of the
No power supply
indicator controller
The bassinet is not placed Adjust the bassinet into
horizontally horizontally
Infant is not placed in the centre Lay the infant in the centre of
of the mattress the mattress
Weighing inaccurate
Environmental temperature varies Check the environmental
greatly temperature
Weight sensor have been Please calibrate it again with a
incorrectly calibrated 5000g standard poise

8-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 9
ECG MONITORING SYSTEM
9.1 OVERVIEW
This chapter describes how to calibrate and operate the ECG monitoring system.
9.2 CONNECTION OF ECG CABLES
As shown in Figure 9.1, insert the ECG cable plug into the ECG cable connector on the
multi-parameter monitor.

ECG cable connector ECG cable plug

FIGURE 9.1
Warning: 1. When you insert or remove the sensor cable, hold its plug instead of the
conductive wire.
2. Do not contact this device directly with the heart.
3. Use only the ECG electrodes and cables specified by our company. Otherwise,
our company is not responsible for any problems caused by using other
electrodes and accessories.
4. Use anti-defibrillation ECG cables during defibrillation.
5. Do not touch the infant and the device during defibrillation to avoid electric
shock.
6. Check the skin where the electrodes are placed regularly. In case of allergy,
replace the electrodes or change the electrode placement position.
7. Ensure that all ECG electrodes, including neutral electrodes, are attached to
the infant to prevent them from touching conductive parts or the ground.
8. Check the ECG cables before ECG monitoring. After the ECG cables are
disconnected, check whether the device generates an alarm tone and displays
the alarm message "Probe off".
9. The beat rate of implanted pacemakers may be affected in case of cardiac
arrest or other arrhythmia. Carefully observe infants with implantable
pacemakers and their pulses, instead of relying solely on the heart rate
displayed on the device.
10. Pacemaker fault: When the ventral conduction is completely blocked or the
pacemaker cannot be removed, the P wave (greater than 1/5 of the average
height of R wave) may be recorded incorrectly by the device, resulting in failure
to monitor the cardiac arrest.
9-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

11. Devices such as defibrillators and telemetry units produce filtered ECG
signals. When this signal is used as the input signal of the bedside device, the
signal will be filtered again, which damages the monitoring performance of
infants with pacemakers.
12. Distortion of waveforms may occur due to interference of ungrounded
devices and interference of ESU near infants.
13. When the device is connected with high-frequency surgical devices, to
prevent electric leakage from burning infants, prevent the sensors and cables of
the device from contacting with the high-frequency surgical devices.
14. Transient effect of grid power isolation devices similar to real ECG waveform
may inhibit alarm of the heart rate.
15. For infants with pacemakers, the heart rate meter can count pacemaker
pulses in case of cardiac arrest or arrhythmia. Do not rely solely on the heart
rate meter alarm. Closely monitor infants with pacemakers. Refer to this manual
for the ability of this device to suppress pacing pulses.

Note: 1. Excessive hair or wet skin may hinder the attachment of electrodes. Remove
excessive hair and dry the skin before attaching electrodes.
2. After defibrillation, if the correct electrode is used according to the
manufacturer's instructions, the screen display will be restored within 5 seconds.
3. If the ECC electrode is correctly placed but the ECG waveform is still inaccurate,
replace the leads.
4. Some electrodes may have large potential shift due to polarization.
5. This device can only suppress pacing pulses without overshoot.

9.3 FUNCTIONS
The device displays the waveform and its value on the screen by measuring, monitoring,
and calculating the bioelectric signals of the heart. It can perform ECG monitoring for infants
through 3-lead and 5-lead ECG sensor cables.

9.4 OPERATIONS
9.4.1 Preparations
Proper attachment of electrodes is necessary for high-quality ECG monitoring. Good contact
between electrodes and skin can minimize motion artifacts and signal interference. Therefore,
before attaching the electrodes, prepare the infant's skin as follows:
1. Remove excessive hair at the electrode attachment position.
2. Clean the skin with an alcohol-immersed cotton piece and gently dry the skin at the
attachment position.
3. Connect the electrode lead to the infant cable.
4. Insert the infant cable into the ECG interface of the monitor.
Note: Pay attention to impedance difference when using the same type of electrode pads
on the same infant.
9-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

9.4.2 Lead Connection

For 3-lead and 5-lead ECG electrodes, the electrode attachment positions during ECG
monitoring are explained below.
Note: Do not place electrodes at tendons and major muscle groups.
A. Placement of 3-lead electrodes
3-lead ECG electrodes have the following leads: RA, LA, and LL (or R, L, and F). The
following table lists the marks and color codes of different lead groups:

AAMI Color Code IEC Color Code Electrode Placement Position

Near the midline of the right clavicle, just

RA/white electrode R/red electrode
below the clavicle
Near the midline of the left clavicle, just below
LA/black electrode L/yellow electrode
the clavicle
Between the sixth and seventh ribs of the
LL/red electrode F/green electrode
infant's left clavicle midline

Placement position of the 3-lead electrode

B. Placement of 5-lead electrodes

5-lead ECG electrodes have the following leads: RA, LA, RL, LL, and V (or R, L, F, N, and C),
depending on local applications. The following table lists the marks and color codes of different
lead groups:

9-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

AAMI Color Code IEC Color Code Electrode Placement Position

Near the midline of the right clavicle, just below

RA/white electrode R/red electrode
the clavicle
Near the midline of the left clavicle, just below
LA/black electrode L/yellow electrode
the clavicle
Between the sixth and seventh ribs of the
LL/red electrode F/green electrode
infant's left clavicle midline
Between the sixth and seventh ribs of the
RL/green electrode N/black electrode
infant's right clavicle midline
Movable chest single electrode. Place the
electrode in one of V1-V6 positions, as shown
in the following figure:
V1 (C1): the fourth intercostal space on the
right edge of sternum
V2 (C2): the fourth intercostal space on the left
edge of sternum
V/brown electrode C/white electrode
V3 (C3): the midpoint of V2 and V4 connection
V4 (C4): the fifth intercostal part of the left
clavicle midline
V5 (C5): the left armpit axillary line at the same
level of V4
V6 (C6): the left armpit midline at the same
level of V4

Placement position of the 5-lead electrode

Electrodes must be placed for operational convenience. For example, in thoracotomy, the
chest electrode can be placed on the side or back of the chest. When an electrotome device is
used, to reduce the influence of artifacts on ECG waveforms, electrodes can be placed on the left
and right shoulders, close to the left and right sides of abdomen, while chest leads can be placed
on the left side in the middle of chest. Do not place electrodes on the upper arm of infants;
otherwise, ECG waveforms are very small.
Warming: 1. When electrosurgical units (ESUs) are used, place negative plates of ESUs
correctly to avoid burn infants. Do not entangle ESU cables with ECG cables.
2. When ESUs are used, never place electrode near negative plates of ESUs;
otherwise, the ECG signal is greatly interfered.
9-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

9.4.3 ECG Setup

When the keyboard is unlocked, click in the PR/ HR area on the home screen and then
select ECG. The controller enters the second UI (D) ECG Setup, as shown in Figure 9.2.

FIGURE 9.2
Note: 1. All settings must be configured when the keyboard is unlocked.
2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked and the system returns to the home screen.

Click this button to select the HR/PR source. Options are ECG, SpO2, and Auto.

Click this button to select the lead type. Options are 3-lead and 5-lead.

Click this button to select ECG calculation lead. When the lead type is 3-lead, options are I, II,
and III. When the lead type is 5-lead, options are I, II, III, aVR, aVL, aVF, and V.

4
Click this button to select the ECG waveform sweep. Options are 6.25 mm/s, 12.5 mm/s, 25.0
mm/s and 50.0 mm/s.

5
Click this button to adjust the waveform gain. Options are x0.125, x0.25, x0.5, x1, x2, x4, and
Auto.

9-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

6
Click this button to select the ECG filter mode. Options are Surgery, Monitor, and Diagnostic.

7
Click this button to select the notch filter. When the filter mode is Monitor or Surgery, options are
50 Hz, 60 Hz, and 50&60 Hz. When the filter mode is Diagnostic, options are 50 Hz, 60 Hz, and
Off.

8
Click this button to select whether to enable the pace detection function.

9
Click this button. The controller enters the Alarm Setup page.
Note: The ECG filter mode determines the waveform smooth processing result. The
following filter modes are supported:
1. Monitor: used during normal monitoring measurement.
2. Diagnostic: used when diagnosis quality is required. In this mode, non-filtered
ECG waveforms are displayed, that is, you can view changes to the waveforms.
3. Surgery: used when the signal is interfered by high frequency or low frequency.
High-frequency interference usually causes sharp pulses with high amplitude, which
leads to irregular ECG signals. Low-frequency interference usually leads to baseline
drift or coarsening. In the operating room, artifacts and interference from ESUs are
reduced in Surgery mode. Under the condition of normal measurement, this mode
may suppress QRS complex and interfere ECG analysis.
Note: When the interference is small, we recommend that you select the Surgery mode as
far as possible for monitoring.

9.4.4 COMMON FAULTS

The following table lists some common faults that may occur when the ECG monitoring
system is used before expiration. If you cannot find the cause of a fault, ask authorized
maintenance personnel to repair the incubator.

9-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Symptom Possible Cause Solution

HR High The displayed HR value is Check the physical well-being of

the patient, confirm whether the
The displayed HR value is
type and the alarm limit setting of
HR Low lower than the preset lower
the patient is applicable to this
alarm limit.
patient or not.

Asystole ECG detects Asystole. The patient developed an

arrhythmia, check the patient
V-Fib/V-Tach ECG detects V-Fib/V-Tach.
condition, lead, cable.

ECG lead off The ECG lead is

Check the connection of the lead
ECG V lead off The V lead is disconnected.
and cable.
ECG overload ECG overload occurs.

9-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 10
NIBP MONITORING SYSTEM
10.1 OVERVIEW
This chapter describes how to calibrate and operate the NIBP monitoring system.
10.2 CONNECTION OF THE NIBP GAS TUBE
As shown in Figure 10.1, insert the NIBP gas tube plug into the gas tube connector on the
multi-parameter monitor.

NIBP gas tube connector NIBP gas tube plug

FIGURE 10.1
Warning: 1. When you insert or remove the gas tube, hold its plug instead of the gas tube
itself.
2. Do not install the cuff on limbs with intravenous infusion or catheter insertion
Inflating the cuff will slow down or block infusion, which may cause damage to
surrounding tissues.
3. Do not perform any NIBP measurement on infants with sickle cell diseases or
any skin damage or expected damage.
4. For infants with severe coagulation disorder, check the necessity of automatic
blood pressure measurement according to clinical evaluation, because
hematoma may occur at the friction between limbs and the cuff.
5. Do not place the cuff on the wound, which may cause further injury.
6. Too frequent measurement hurts infants because of blood interference.
7. Do not on the application of the CUFF and its pressurization on the arm on the
side of a mastectomy or lymph node clearance.
8. Do not place the blood pressure cuff on limbs for intravenous infusion,
treatment or arteriovenous short circuit; otherwise, short-term interference of
blood flow may occur, causing harm to infants.
9. The pressurization of cuff may cause the function of monitoring devices
connected to the same limb to temporarily fail.
10. The gas tube connecting the cuff and the monitor must be free of occlusion
and not tangled Otherwise, it may cause harm to the infant.
11. Do not inflate the airbag for a long time; otherwise, it may cause discoloration
or even ischemia at the distal end of the limb.
12. If liquid splashes on the device or its accessories, especially when liquid
enters pipes or the device, contact the maintenance department of the hospital.

10-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

13. Calibrate the NIBP module once every two years (or according to the
maintenance regulations of your hospital). Check the module performance.
14. This device is applicable to scenarios where ESUs are used.
15. The device must be used under specified environmental conditions;
otherwise, it may not meet the technical parameters and specifications claimed
in this manual, and may lead to unpredictable consequences.

Note: 1. The measurement site, infant's location, movement, and state all affect the blood
pressure reading. If you doubt the accuracy of the measurement results, check the
infant's vital signs in other ways, and then check whether the device functions and
accessories are intact.
2. Check the patient category before measurement.
3. During measurement, check the infant limbs used for measurement to avoid
long-term damage to the infant's blood circulation caused by the operation of the
device.
4. Automatic measurement value is affected by the extreme value of temperature,
humidity, and altitude.

10.3 FUNCTIONS
This device uses oscillation method to measure the non-invasive blood oxygen. This
measurement method is applicable for newborns, and the vibration amplitude of cuff pressure is
measured by the oscillation method. The cuff pressure is the average pressure when the
amplitude is the maximum. After the average pressure is measured, the systolic pressure and
diastolic pressure can be calculated based on the algorithm.
According to IEC 80601-2-30, NIBP measurement can be applied during electrosurgery and
defibrillator discharge.
When NIBP measurement is performed, certain pressure is exerted on the measuring part of
the infant by inflating the cuff. Doctors must judge whether the infant is suitable for NIBP
measurement based on the infant's situation.
The blood pressure measured by this device is equivalent to that measured by auscultation,
and its error meets the requirements of IEC 80601-2-30.

10.4 OPERATIONS
10.4.1 Preparations
1. Open the device and connect the blood pressure cuff correctly.
2. Choose a cuff of the right size and ensure that the airbag is not folded or distorted.
Note: Select an appropriate cuff according to the infant's arm circumference. Inappropriate
cuff selection or distorted airbag leads to inaccurate measurement results. The cuff
width must be 50% of the limb circumference of newborns.

10-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

3. Wrap the cuff around the infant's limb at a position at the same level of the infant's heart.
4. Place the Φ mark of the cuff at the artery position. Do not wind the cuff too tightly;
otherwise, it may cause limb discoloration or even ischemia. The edge of the cuff must be within
the mark; otherwise, replace the cuff.
5. Connect the cuff to the gas tube, avoid squeezing the gas tube, and ensure that the gas
tube is smooth and free from entanglement.
6. PATIENT position in NORMAL USE:legs uncrossed, back and arm supported,and middle
of the CUFF at level of the right artium of the heart.

10.4.2 Measurement Limits

In the oscillation method, the regular pulse wave generated by arterial pressure is measured.
When this method is not applicable for the infant or the waveform cannot be detected, the
measured value is unreliable and the pressure measuring time also increases. NIBP
measurement is not applicable for the following circumstances:
 Ultimate heart rate: blood pressure cannot be measured when the heart rate is lower than 40
bpm and higher than 240 bpm.
 Heart-lung machine: If the infant is using a heart-lung machine, the measurement cannot be
performed.
 Infant movement: if the infant has excessive or continuous movement, tremor or spasm, the
measurement cannot be performed, the measurement result is unreliable, and the
measurement time is prolonged.
 Infants with arrhythmia.
 Infants in severe shock or hypothermia.
 Infants with rapid changes in blood pressure.
 Infants whose arterial oscillation waves cannot be detected due to obese or edema.

10.4.3 NIBP Setup

When the keyboard is unlocked, click in the NIBP area on the home screen. The controller
enters the second UI (F) NIBP Setup, as shown in Figure 10.2.

FIGURE 10.2
10-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Note: 1. All settings must be configured when the keyboard is unlocked.

2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked and the system returns to the home screen.
3. If the measured value exceeds the alarm limit to trigger the alarm, the overshoot
value will turn red.
4. If the measurement fails or the measured value is out of range, it is displayed as
"--".
5. If the measurement is stopped manually during the measurement, the last
measured value is displayed.

Click this button to select the measurement mode. Options are Auto and Manual.

Click this button to set the auto measurement interval. Options are 2.5 min, 5 min, 10 min, 15 min,
20 min, 30 min, 45 min, 60 min, 90 min, or 120 min.

Click this button to set the initial inflation pressure. Options are 60 mmHg, 70 mmHg, 80 mmHg,
90 mmHg, 100 mmHg, 110 mmHg, 120 mmHg, and 130 mmHg.

Click this button to turn on or off continuous measurement.

Click this button. The controller enters the Alarm Setup page.

10.4.4 Alarm Setup

NIBP alarm limit setup includes Sys upper/lower limit, Dia upper/lower limit, and Mean
upper/lower limit, as well as their priorities. The following table lists the setting range of each
parameter for your reference:

10-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Table 1:

Default Patient
Item Default Limit Limit Range
State Category

Lower: 50 mmHg Lower: 40-134 mmHg

Sys On Newborn
Upper: 100 mmHg Upper: 41-135 mmHg

Lower: 30 mmHg Lower: 10-109 mmHg

Dia On Newborn
Upper: 70 mmHg Upper: 11-110 mmHg

Lower: 35 mmHg Lower: 20-119 mmHg

MAP On Newborn
Upper: 80 mmHg Upper: 21-120 mmHg

Table 2:

Alarm Default Patient

Default Limit Limit Range
Source State Category

Lower: 6.7 kPa Lower: 5.3-17.9 kPa

Sys On Newborn
Upper: 13.3 kPa Upper: 5.4-18.0 kPa

Lower: 4.0 kPa Lower: 1.3-14.5 kPa

Dia On Newborn
Upper: 9.3 kPa Upper: 1.4-14.6 kPa

Lower: 4.7 kPa Lower: 2.7-15.9 kPa

MAP On Newborn
Upper: 10.7 kPa Upper: 2.8-16.0 kPa

10.4.5 COMMON FAULTS

The following table lists some common faults that may occur when the NIBP monitoring
system is used before expiration. If you cannot find the cause of a fault, ask authorized
maintenance personnel to repair the incubator.

Symptom Possible Cause Solution

When the displayed NIBP Sys
The displayed NIBP Sys value is
NIBP value is lower than the preset
higher than the preset alarm
Sys High alarm upper limit, the alarm is
upper limit.
automatically reset.
When the displayed NIBP Sys
The displayed NIBP Sys value is
NIBP value is higher than the preset
lower than the preset alarm
Sys Low alarm lower limit, the alarm is
lower limit.
automatically reset.
When the displayed NIBP Dia
The displayed NIBP Dia value is
NIBP value is lower than the preset
higher than the preset alarm
Dia High alarm upper limit, the alarm is
upper limit.
automatically reset.
When the displayed NIBP Dia
The displayed NIBP Dia value is
NIBP value is higher than the preset
lower than the preset alarm
Dia Low alarm lower limit, the alarm is
lower limit.
automatically reset.

10-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Symptom Possible Cause Solution

When the displayed NIBP Mean

The displayed NIBP Mean value
NIBP value is lower than the preset
is higher than the preset alarm
Mean High alarm upper limit, the alarm is
upper limit.
automatically reset.
When the displayed NIBP Mean
The displayed NIBP Mean value
NIBP value is higher than the preset
is lower than the preset alarm
Mean Low alarm lower limit, the alarm is
lower limit.
automatically reset.

Air leakage of the sleeve strap

NIBP measurement
Replace the sleeve strap
failure
Sleeve strap type is not correct

10-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 11
SpO2 MONITORING SYSTEM
11.1 OVERVIEW
This chapter describes how to calibrate and operate the SpO2 monitoring system.

11.2 CONNECTION OF EXTENSION CABLE OF SpO2 SENSOR

As shown in Figure 11.1, insert the extension cable plug of the SpO2 sensor into the SpO2
sensor connector below the device controller. Different sensors are placed on the infant differently.
For sensor installation, see the operator's manual attached with the sensor.

SpO2 sensor connector Extension cable plug

FIGURE 11.1
Warning: 1. When you insert or remove the extension cable, hold its plug instead of the
conductive wire.
2. Do not bend the sensor cable or extension cable at the connection point.
3. The compression at the placement site may lead to necrosis of the infant's
tissue and the surface adhesive of the SpO2 sensor may lead to injury or burn of
the infant. Therefore, do install the SpO2 sensor correctly.

11.2.1 SpO2 Probe of the Device

The following pulse oximeters are recommended. The IP classification of the accompanying
pulse oximeter should meet the requirements of IPX2. IPX2 means this pulse oximeter is
protected against harmful effects of dripping water when titled at 15° according to IEC 60529.

Sensor Model Type Infant Weight

R25-L For single patient Newborn: < 3 kg, adult: > 30 kg
R1 25L For single patient Newborn: < 3 kg, adult: > 30 kg
M-LNCS YI For multiple infants Adult, child, infant, and newborn >1kg

Note: 1. This device is provided with an SpO2 sensor of Masimo by default. Based on the
infant weight and pathology, its model and specifications include R25-L, R1 25L, and
M-LNCS YI.
2 Contact our company and our designated agents for information about the
designated SpO2 sensor and its extension cable. In case of any fault or
measurement inaccuracy caused by use of any SpO2 sensor not designated or
recommended by our company, the incubator cannot be used or causes clinical
risks.
11-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

3. Use the SpO2 sensor according to its attached operator's manual.

4. As for the usage of the ribbon, refer to the operator's manual attached with the
SpO2 sensor.
5. Do not reuse the disposable SpO2 sensor; otherwise, cross infection may occur.
Recycle and handle the used SpO2 sensor according to local regulations on medical
waste disposal.

11.3 FUNCTIONS
The calibrated SpO2 monitoring system can display the SpO2 value. The incubator's SpO2
sensor has a wavelength range of 660 nm to 905 nm and a maximum optical output power of less
than 15 mW. The SpO2 update interval is ＜15s, the response time is equal to or less than 20s,
the delay is equal to or less than 10s, the cardiac arrest detection time is equal to or less than 8s,
and the PI calibration range is 0.10% to 20.00%. The temperature at the contact of the SpO2
probe and the tissue is 0°C to 40°C.
The Masimo module and sensor can be used to measure the SpO2 measurement accuracy
in case of low perfusion and body movement. For specification details, see the operator's manual
of Masimo accessories: When the calibration range is 70% to 100% (other ranges not defined).
The SpO2 accuracy in lower perfusion and body movement is ±3%. When the calibration range is
30 bpm to 240 bpm, the SpO2 accuracy is ±3 bpm in low perfusion state (the detected PI range is
0.1% to 0.7%) and the SpO2 accuracy in body movement state is ±5 bpm. The accuracy has
been proven in the clinical report of the Masimo SpO2 module.
The device supports the following alarms: SpO2 upper limit alarm, SpO2 lower limit alarm,
PR upper limit alarm, PR lower limit alarm, SpOC upper limit alarm, SpOC lower limit alarm,
SpMet upper limit alarm, SpMet lower limit alarm, PI upper limit alarm, PI lower limit alarm, PVI
upper limit alarm, and PVI lower limit alarm. For alarm details, see Section 3.4. When any of the
above alarms occurs, you can click the Mute button to mute the alarm for two minutes.

11.4 CALIBRATION
To ensure normal use of the SpO2 monitoring module, perform the following steps to check

the module every time before you use it:

1. Insert the extension cable plug to the SpO2 sensor connector.

2. Adhere the sensor to the infant's finger and then connect the finger to the sensor

extension cable.

3. Wait until a reading is displayed in the SpO2 area and check whether the display is

normal.

11-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

4. Enter the SpO2 display page and curve display page, and check whether the PPG
waveform and SpO2 and PR curves are displayed normally.
5. Check the PR upper and lower limit alarms: Increase the PR upper/lower limit to be
higher/lower than the displayed value (for operations, see Section 11.5). The device generates an
alarm, "PR high/low" is displayed in the general information area, and alarm characteristics
conform to Section 3.4.
6. Check the SpO2 upper and lower limit alarms: Increase the SpO2 upper/lower limit to be
higher/lower than the displayed value (for operations, see Section 11.5). The device generates an
alarm, "SpO2 high/low" is displayed in the general information area, and alarm characteristics
conform to Section 3.4.
7. Check the SpOC upper and lower limit alarms: Increase the SpOC upper/lower limit to be
higher/lower than the displayed value (for operations, see Section 11.5). The device generates an
alarm, "SpOC high/low" is displayed in the general information area, and alarm characteristics
conform to Section 3.4.
8. Check the SpMet upper and lower limit alarms: Increase the SpMet upper/lower limit to be
higher/lower than the displayed value (for operations, see Section 11.5). The device generates an
alarm, "SpMet high/low" is displayed in the general information area, and alarm characteristics
conform to Section 3.4.
9. Check the PI upper and lower limit alarms: Increase the PI upper/lower limit to be
higher/lower than the displayed value (for operations, see Section 11.5). The device generates an
alarm, "PI high/low" is displayed in the general information area, and alarm characteristics
conform to Section 3.4.
10. Check the PVI upper and lower limit alarms: Increase the PVI upper/lower limit to be
higher/lower than the displayed value (for operations, see Section 11.5). The device generates an
alarm, "PVI high/low" is displayed in the general information area, and alarm characteristics
conform to Section 3.4.
11. Check the SpO2 sensor disconnection alarm: Remove the sensor from the finger. The
device generates an alarm, "SpO2 sensor off" alarm is displayed in the general information area,
and the alarm characteristics conform to those described in section 3.4.
12. Check the SpO2 sensor connection error alarm: Disconnect the extension cable plug
from the SpO2 sensor connector. The device generates an alarm, "SpO2 sensor connection error"
is displayed in the general information area, and alarm characteristics conform to Section 3.4.

11-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

11.5 OPERATIONS
If the SpO2 monitoring system is not used correctly, the measurement is inaccurate. The
compression at the placement site may lead to necrosis of the infant's tissue and the surface
adhesive of the SpO2 sensor may lead to injury or burn of the infant. Therefore, do install the
SpO2 sensor correctly.
Warning: 1. Each time you use the SpO2 monitoring system, calibrate and set the system.
2. The SpO2 sensor and its extension cable must be used only for the SpO2
monitoring system. Before use, the medical staff must check compatibility
among the SpO2 monitoring device, SpO2 sensor, and the sensor extension cable;
otherwise, the device may not be used, delaying therapy. The operator's manual
of the SpO2 sensor provides information about compatibility between the SpO2
sensor and SpO2 monitoring system and specific additional information,
including product performances in case of infant movement or low perfusion
during monitoring.
3. Do not use information displayed by the SpO2 monitoring system as the only
basis for clinical diagnosis. The information displayed by the SpO2 monitoring
system must be used as auxiliary information and must be used together with
clinical conditions and symptoms as well as diagnosis conclusions of doctors.
4. Long-time use of the SpO2 sensor results in measurement inaccuracy. The
compression at the placement site may lead to necrosis of the infant's tissue and
the surface adhesive of the SpO2 sensor may lead to injury or burn of the infant.
Change the placement site at least every four hours.
5. Arrange the infant extension cable and sensor to avoid winding the infant.
6. Do not place accessories of the SpO2 monitoring system in any position from
which the accessories may fall onto the infant.
7. Do not use the SpO2 monitoring system unless it has been calibrated and set
properly.
8. Do not use the SpO2 monitoring system in an MRI environment.
9. Use the SpO2 monitoring system in a quiet and comfortable environment for
higher SpO2 and PR measurement accuracy.
10. In case of damage or suspected fault, do not use the SpO2 monitoring
system.
11. Follow the instructions below to avoid electric shock:
 Do not place the system near a surface with liquid leakage.
 Do not immerse or place the SpO2 monitoring system in a liquid directly.
 Do not sterilize the SpO2 monitoring system.
 Clean the SpO2 monitoring system according to methods in this manual.
 Do not clean the SpO2 monitoring system when the vital signs of the
infant are monitored.
11-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

12. When multiple devices are applied to the same infant, leakage current may
cause danger due to superposition. Before multiple devices are connected, ask
qualified professionals to test the leakage current to ensure that the leakage
current is within the allowance range and causes no harm to the infant, operator,
and ambient environment. If you still have any doubt, consult the manufacturer
for the correct methods.
13. If you have any doubt about the measured value, monitor the vital signs of
the infant in other ways and then check whether the SpO2 monitoring system is
normal.
14. Causes for SpO2 reading inaccuracy include:
 COHb and MetHb are high.
When the COHb value exceeds the allowance range, the SpO2 value is high.
The SpO2 increase depends on the COHb content.
Note: When the SpO2 value is normal, the COHb value may still be high. In
case of suspecting higher COHb, collect the infant blood for lab analysis
(using the carbon oxygen oximeter).
When the MetHb value is high, the SpO2 value may decrease by about 10% to
15% based on the MetHb value. When the MetHb value is high, the SpO2
reading tends to be within the low to medium 80s range. In case of
suspecting higher MetHb, collect the infant blood for lab analysis (using the
carbon oxygen oximeter).
 Intravascular stain (such as indocyanine green or methylene blue)
 Pigments and substances for external use (such as nail polish, nail
protection oil, and glitter)
 Bilirubin increase
 Severe anemia
 Low arterial perfusion
 Motion artifact
15. Interfering substances: Dyes that can change blood pigmentation or any
substances containing dyes may cause incorrect readings.
16. The SpO2 value is calibrated by COHb and MetHb values in normal and
healthy adult volunteers.
17. Do not alter or dismantle the SpO2 monitoring system and its accessories;
otherwise, the operator is injured or the device is damaged. Return the device for
factory repair when necessary.
18. Misapplication of a PULSE OXIMETER PROBE with excessive pressure for
prolonged periods can induce pressure injury.

Note: 1. Do not put the device at a place where the system control mode may be changed
by the infant.
2. Before cleaning the device, turn off the device and cut off the power; otherwise,
electric shock or fire may be caused.
11-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

3. Do not place medical appliances and devices that may interfere with the test of
the SpO2 monitoring system around the incubator; otherwise, the system may fail.
4. If the SpO2 monitoring system shows that the infant has hypoxemia, the medical
staff must collect the infant blood for confirmation.
5. In case of frequent low perfusion prompt, change to a site with better perfusion
for monitoring. During this period, check and evaluate the infant conditions and
check the oxygenation status in other ways.
6. If the SpO2 monitoring system is used during phototherapy, the radiation source
may interfere with the SpO2 sensor, so it can only be used for a short time under
clinical supervision.
7. Check whether the monitoring alarm limit settings are suitable for the infant. Set
the alarm limits every time you use the SpO2 monitoring system.
8. Data change during measurement may be affected by the sampling technology or
infant physiological conditions. Any inconsistency with the infant clinical status
must be tested again and/or verified through other tests. The medical staff must
fully understand the infant conditions before sending the blood samples for
laboratory test and making decisions accordingly.
9. Do not immerse the SpO2 monitoring system into any cleaning solvent or sterilize
the system through high pressure, radiation, steam, gas, ethylene oxide, or other
methods; otherwise, the system is severely damaged.
10. Dispose the SpO2 monitoring system and its accessories according to local
laws.
11. To reduce electromagnetic interference, keep RF electrical devices away from
the SpO2 monitoring system.
12. Do not use the function tester to test the accuracy of the SpO2 monitoring
system.
13. Do not enable the sensor to contact with high intensity light sources (for
example, fluorescent lamps and infrared rays); otherwise, the SpO2 monitoring
system cannot read the vital signs of the infant.
14. The monitoring performance of the SpO2 sensor is affected in maximum
sensitivity mode. In this mode, the SpO2 sensor is affected by the ambient noise (for
example, ambient light, vibration, and too high air flow speed) and the readings of
the infant vital signs are incorrect.
15. Do not arrange the infant cable into a close coil or wind it around the incubator;
otherwise, the infant cable is damaged.
16. The operator's manual of the Masimo SpO2 sensor provides information about
compatibility between the SpO2 sensor and SpO2 monitoring system and specific
additional information, including product performances in case of infant movement
or low perfusion during monitoring.

11-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

17. If the SpO2 monitoring system is used during whole body radiotherapy, keep the
SpO2 sensor away from radiation sources. If the sensor is exposed to a radiation
source, the measured value is inaccurate or no measured value is displayed.
18. The displayed SpO2 waveform has been normalized.
19. The Masimo SpO2 module has passed the non-motion accuracy test with human
blood samples of 70% to 100% SpO2 in healthy adult volunteers and by comparing
the result with those of the laboratory combined photoelectric oximeter and
monitoring devices. This difference is equivalent to adding or subtracting a
standard deviation. Adding or subtracting a standard deviation contains 68% of the
samples.
20. The Masimo SpO2 module has passed the motion accuracy test with human
blood samples with low SpO2 induced by friction or minor movement in healthy
adult volunteers at a frequency of 2-4 Hz. No repetitive movement is made with 1-2
cm amplitude and 1-5 Hz. The result is compared with those of the laboratory
combined photoelectric oximeter and monitoring devices when the low SpO2 is
induced at 2-3 cm amplitude (SpO2 range: 70% to 100%). One difference is
equivalent to adding or subtracting a standard deviation. Adding or subtracting a
standard deviation contains 68% of the samples.

Select SpO2 monitoring and set the related value.

When the keyboard is unlocked, click in the SpO2 area on the home screen. The controller
enters the second UI (E) SpO2 Setup, as shown in Figure 11.2.

FIGURE 11.2

Note: 1. All settings must be configured when the keyboard is unlocked.

2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked.

11-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Click this button to select the SpO2 sensitivity mode. Options are Normal, APOD, and Max.
Note: 1. Select Normal for general infants. The APOD mode is applicable for measurement
on infants with many actions. The sensor disconnection detection efficiency is
higher. The Max mode is applicable for improving low perfusion, but the detection
result of sensor disconnection may be inaccurate.
2. Select the mode based on clinical decisions.

2
Click this button to select the averaging time. Options are 2s-4s, 4s-6s, 8s, 10s, 12s, 14s, and
16s. The default value is 8s.

3
Click this button to enable or disable the FastSAT mode. When FastSAT is enabled, the rapid
SpO2 changes can be captured. FastSAT is disabled by default.

4
Click this button to switch the Line Frequency between 50 and 60.

5
Click this button to enable or disable Beat Volume. When Beat Volume is enabled, the beat
volume is consistent with the QRS volume.

6
Click this button to set the SpO2 waveform sweep. Higher sweep results in faster scanning and
broader waveform. Sweep options are 6.25 mm/s, 12.5 mm/s, and 25.0 mm/s.

Click this button to set the SpO2 waveform gain. Larger gain results in larger waveform amplitude.
Waveform gain options are x0.5, x1, x2, and x4.

Click this button to switch the PVI average mode between Normal and Fast.

Click this button. The controller enters the Alarm Setup page.

11-8
 OPERATOR'S MANUAL OF INFANT INCUBATOR

11.6 COMMON FAULTS

The following table lists some common faults that may occur when the SpO2 monitoring
system is used before expiration. If you cannot find the cause of a fault, ask authorized
maintenance personnel to repair the incubator.

Symptom Possible Cause Solution

When the displayed SpO2 value

The displayed SpO2 value is
is lower than the preset alarm
SpO2 upper limit alarm higher than the preset alarm
upper limit, the alarm is
upper limit.
automatically reset.

The displayed SpO2 value is When the displayed SpO2 value

lower than the preset alarm is higher than the preset alarm
SpO2 lower limit alarm
lower limit, the alarm is
lower limit. automatically reset.
When the displayed PR value is
The displayed PR value is
lower than the preset alarm
PR upper limit alarm higher than the preset alarm
upper limit, the alarm is
upper limit.
automatically reset.
When the displayed PR value is
The displayed PR value is lower
higher than the preset alarm
PR lower limit alarm than the preset alarm lower
lower limit, the alarm is
limit.
automatically reset.
When the displayed SpOC value
The displayed SpOC value is
is lower than the preset alarm
SpOC upper limit alarm higher than the preset alarm
upper limit, the alarm is
upper limit.
automatically reset.
When the displayed SpOC value
The displayed SpOC value is
is higher than the preset alarm
SpOC lower limit alarm lower than the preset alarm
lower limit, the alarm is
lower limit.
automatically reset.
When the displayed SpMet
The displayed SpMet value is
value is lower than the preset
SpMet upper limit alarm higher than the preset alarm
alarm upper limit, the alarm is
upper limit.
automatically reset.
When the displayed SpMet
The displayed SpMet value is
value is higher than the preset
SpMet lower limit alarm lower than the preset alarm
alarm lower limit, the alarm is
lower limit.
automatically reset.
When the displayed PI value is
The displayed PI value is higher
lower than the preset alarm
PI upper limit alarm than the preset alarm upper
upper limit, the alarm is
limit.
automatically reset.
When the displayed PI value is
The displayed PI value is lower
higher than the preset alarm
PI lower limit alarm than the preset alarm lower
lower limit, the alarm is
limit.
automatically reset.
When the displayed PVI value is
The displayed PVI value is
lower than the preset alarm
PVI upper limit alarm higher than the preset alarm
upper limit, the alarm is
upper limit.
automatically reset.

11-9
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Continue:

Symptom Possible Cause Solution

When the displayed PVI value is
The displayed PVI value is
higher than the preset alarm
PVI lower limit alarm lower than the preset alarm
lower limit, the alarm is
lower limit.
automatically reset.
Press the Mute/Reset button
SpO2 sensor connection The SpO2 sensor is not
and connect the SpO2 sensor
error connected correctly.
correctly.

SpO2 sensor fault The SpO2 sensor fails. Replace the SpO2 sensor.

The SpO2 sensor is Connect the SpO2 sensor

SpO2 sensor off
disconnected. correctly.

Failed to identify SpO2 The SpO2 sensor cannot be Connect the SpO2 sensor
sensor identified. correctly or replace the sensor.
Click the Mute/Reset button and
Conductive wire not The conductive wire is not
connect the conductive wire
connected connected.
correctly.
Click the Mute/Reset button and
Adhesive probe not
Adhesive probe not connected connect the adhesive probe
connected
correctly.
 Use and place the SpO2
sensor correctly. Select a better
monitoring site when necessary.
 Warm the infant. The infant
body temperature may be too
Low blood perfusion The blood perfusion is low.
low.
 Check whether the SpO2
sensor is screwed too tightly.
 Check whether the SpO2
sensor model is appropriate.
The device is searching for
Search for pulse Wait until pulse is displayed.
pulse.

11-10
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 12
RESP MONITORING SYSTEM
12.1 OVERVIEW
This chapter describes how to calibrate and operate the RESP monitoring system.

12.2 FUNCTIONS
This device uses the thoracic electrical bioimpedance (TEB) method for measurement.
When the infant breathes, the thoracic activity causes changes to the thoracic impedance
between two ECG electrodes. By measuring the impedance change, a respiratory wave is
displayed on the display screen, and the respiratory rate (RR) is calculated according to the
waveform period.

12.3 OPERATIONS
Warning: 1. When the infant's respiration is monitored, do not use ESU-type ECG cables.
2. If the RR detection level is set incorrectly in manual calculation mode, the
device may not be able to detect the apnea state. If the detection level is too low,
the device easily detects the cardiac activity and mistakes cardiac activity for
respiration activity when respiration is suspended.
3. Respiration measurement cannot identify the cause of apnea, and the device
can only generate an alarm within a preset time after the last respiration, if the
next respiration is not detected. Therefore, the device can't be used for clinical
diagnosis.
4. When the device works in accordance with the IEC60601-1-2 standard
(radiation resistance: 3 V/m), the field strength exceeding 1 V/m may lead to
incorrect measurement results in various frequency ranges. Therefore, we
recommend that you do not use devices with any electrical radiation device near
the respiration detection device.
12.3.1 Preparations
1. Remove excessive hair at the electrode attachment position.
2. Clean the skin with an alcohol-immersed cotton piece and gently dry the skin at the
attachment position.
3. Connect the electrode lead to the infant cable.
4. Insert the infant cable into the ECG interface according to the sections about ECG.
Respiration measurement is performed based on the standard ECG cable and electrode
placement method, and respiration signal is measured by two ECG electrodes. If the ECG
electrodes are placed at the standard sites, the electrodes RA and LA of the lead I or the
electrodes RA and LL of the lead II collect the respiration.
Note: To obtain the optimal respiration wave, place the electrodes RA and LA horizontally
when using the lead I to measure the respiration. Place the electrodes RA and LL
diagonally when using the lead II to measure the respiration.

12-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

The following figure shows how to place the electrodes for respiration measurement:

Lead I Lead II

12.3.2 Simultaneous Measurement of ECG and Respiration

To measure ECG and respiration simultaneously, you need to adjust the sites of two
electrodes for respiration measurement. Change to ECG electrode position may result in change
to ECG waveforms or even affect the arrhythmia analysis.
12.3.3 Cardiac Activity Overlapping
The influence of cardiac activity on respiration waveform is called cardiac activity overlapping.
Overlapping happens when respiration electrodes collect impedance changes caused by
rhythmic blood flow. Proper placement of respiration electrodes can reduce this effect. It is
necessary to avoid placing the liver region and ventricle on the connecting line of respiration
electrodes, so as to avoid the artifacts caused by the cardiac or pulsating blood flow, which is
especially important for newborns.
12.3.4 Abdominal Respiration
Some infants breathe through the abdomen due to limited chest movement. In this case,
place the left leg electrode at the position where the left abdomen expands most, so as to obtain
the optimal respiration waveform.
12.3.5 Thoracic Expansion
In clinical practice, some infants (especially newborns) have lateral thoracic expansion,
causing negative internal thoracic pressure. In this case, it is best to place two respiration
electrodes the right axillary midline and the left thoracic region with the strongest respiration
movement, so as to obtain the optimal respiration waveform.
Note: Do not use this device for infants with excessive movement; otherwise, an alarm
may be generated by mistake.
12.3.6 RESP Setup
When the keyboard is unlocked, click in the CO2 / RESP area on the home screen and then
select RESP. The controller enters the second UI (G) RESP Setup, as shown in Figure 12.1.

12-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 12.1
Note: 1. All settings must be configured when the keyboard is unlocked.
2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked and the system returns to the home screen.

Click this button to select the RR source. Options are Auto, ECG or CO2.

Click this button to select the electrode for respiration measurement. Options are I, II, and Auto.

3
Click this button to set the RESP waveform sweep. Higher sweep results in faster scanning and
broader waveform. Options are 6.25 mm/s, 12.5 mm/s, 25 mm/s and 50 mm/s.

Click this button to set the RESP waveform gain. Larger gain results in larger waveform amplitude.
Options are x0.125, x0.25, x0.5, x1, x2, x3, x4, and x5.

Click this button. The controller enters the Alarm Setup page.
Note: 1. If the infant has apnea for a period exceeding the preset time, the device triggers
an alarm. The apnea delay settings of the RESP and CO2 modules are linked. The
apnea alarm priority is fixed to the highest.
2. When the respiration lead type is set to Auto, leads with better signal are selected
as the respiration leads. If any of the leads I and II is disconnected, the device
automatically selects another lead. If both leads I and II are disconnected, the device
automatically selects the lead II.
12-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

12.3.7 COMMON FAULTS

The following table lists some common faults that may occur when the RESP monitoring
system is used before expiration. If you cannot find the cause of a fault, ask authorized
maintenance personnel to repair the incubator.

Symptom Possible Cause Solution

When the displayed RR value is

The displayed RR value is
lower than the preset alarm
RR High higher than the preset alarm
upper limit, the alarm is
upper limit.
automatically reset.
When the displayed RR value is
The displayed RR value is lower
higher than the preset alarm
RR Low than the preset lower alarm
lower limit, the alarm is
limit.
automatically reset.

12-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 13
CO2 MONITORING SYSTEM
13.1 OVERVIEW
This chapter describes how to calibrate and operate the CO2 monitoring system.

13.2 CONNECTION OF THE CO2 SENSOR

As shown in Figure 13.1, insert the CO2 sensor into the CO2 socket on the multi-parameter
monitor.

CO2 socket

FIGURE 13.1
Warning: 1. Do not use this device in an environment with flammable anesthetic gas.
2. This device can be used only by well-trained professionals who are familiar
with the operation and precautions of this device.
3. Check the airway connector before use. Replace the connector in case of any
damage.
Note:EtCO2 Change： EtCO2 will typically decrease below nominal value (EtCO2nom) when
reapiration rate (RR) exceeds the RR threshold (RRth) according to the formulas:
EtCO2 = EtCO2nom * (125/RR) for RRth > 125. (Measured at I/E ratio 1:1 using breath
simulator according to EN ISO 80601-2-55)

13.3 FUNCTIONS
This device uses the infrared analysis method to measure CO2 concentration in infant's
respiration airway in the principle is that CO2 molecule can absorb infrared ray energy with
specific wavelength (4.2 μm), and the absorbed energy is related to the CO2 concentration. When
the infrared ray emitted by an infrared light source penetrates gas sample containing CO2, some
energy is absorbed by CO2 in the gas. A photodetector is used on the other side of the infrared
light source to measure the remaining infrared ray energy. The measurement of CO2 is to
determine the CO2 concentration at this time according to the absorbed light intensity, and
calculate the respiration rate, inhaled and exhaled CO2 concentration according to the detected
CO2 waveform.

13-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Both mainstream and sidestream CO2 modules of Masimo can be used. Measured
parameters include:
1. EtCO2: the CO2 value of the expiration tip.
2. FiCO2: the minimum CO2 value during respiration.
3. AWRR: the number of respirations calculated based on the CO2 waveform.

13.4 OPERATIONS
Mainstream measurement method: Directly place the CO2 sensor in the infant's
respiration airway catheter, covert the CO2 concentration in the respiration gas, and then send the
electrical signal to the monitor for analysis and processing to obtain the CO2 value.
Sidestream measurement method: configure an air pump, use a sampling tube to pump
out the infant's exhaled air, and then use the CO2 sensor and module built in the device to
analyze and measure the air.
13.4.1 Connection of the Mainstream CO2 Module (IRMA)
The IRMA mainstream module provides multiple-gas probes that can be connected to the
device to display the real-time and deduced CO2 monitoring data.
When the IRMA module is connected to the infant's respiration circuit, it can monitor
inhaled/exhaled gases during anesthesia, rehabilitation, and respiration care. It is applicable for
infant monitoring in operating rooms, intensive care units (ICUs), wards, and emergency medical
institutions.
It is not the only method for infant monitoring. It must always be used together with other
devices and assist in professionals' judgment for infant's situation. The IRMA probe can be used
only by trained and authorized medical professionals.
Warning: 1. Do not reuse the disposable IRMA airway adapter; otherwise, cross infection
may occur. Recycle and handle the used IRMA airway adapter according to local
regulations on medical waste disposal.
2. Do not use IRMA airway adapters for adults/children on infants; otherwise, a
dead space of 6 mL is formed in the infant's respiration circuit. Do not use IRMA
airway adapters for infants on adults; otherwise, the flow resistance is too large.
3. Mobile and RF communication devices affect the measurement accuracy. Use
the IRMA probe in the electromagnetic environments specified in this manual.
4. Do not place the IRMA airway adapter between the endotracheal tube and
elbow; otherwise, the infant's secretion may block the adapter window and cause
operation error.

13-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

5. To prevent secretions and moisture from accumulating in the window, always

place the IRMA probe vertically with the LED facing upwards.
6. Do not use the IRMA airway adapter with any quantitative spray; otherwise, the
light transmission in the window of the airway adapter is affected.
7. Use the IRMA probe for infant evaluation assistance only. The probe must be
used together with other devices that evaluate vital signs and symptoms.
8. Incorrect probe zeroing results in incorrect gas reading.
9. Replace the airway adapter in case of condensed water droplets.
10. Do not directly contact the IRMA probe with the infant. Use the airway adapter
accessories specified in this manual.

Note: 1. Do not sterilize the IRMA probe or immerse it into any liquid. The IRMA airway
adapter is not a sterile device. Do not autoclave it; otherwise, the device may be
damaged.
2. Do not pull the probe cable.

A. Installation of the IRMA Mainstream Module

1. Insert the IRMA connector into the CO2 connector of the monitor.
2. As shown in the figure below, fix the IRMA probe to the airway adapter and insert the
probe in place.

3. You can use the probe when the green LED indicator is on.

LED indicator
4. Connect the 15-mm male connector of the IRMA airway adapter to the Y-shaped
connector of the respiration circuit.
5. Connect the 15-mm female connector of the IRMA airway adapter to the infant's
endotracheal tube.

13-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

You can also connect a heat and moisture exchanger (HME) between the infant's
endotracheal tube and the IRMA probe. Placing HME before the IRMA probe can protect the
airway adapter from water vapor and secretions without replacing the adapter. Besides, with HME,
you can place the IRMA probe at any position.

6. Always keep the LED lamp upward when placing the IRMA probe unless the probe is
protected by HME.

B. Place the IRMA Probe Correctly

Do not directly contact the IRMA probe with the infant body when connecting the probe to
the infant respiration circuit. Use an insulation material between the IRMA probe and the infant
body when it is necessary to directly contact the probe with the infant body for any reason.
Warning: The IRMA probe is designed not to contact with the infant.

C. Check Before Use

1. Before connecting the IRMA airway adapter to the respiration circuit, check whether the
O2 reading on the monitor is correct (21%) and whether the O2 calibration has been verified.
2. Before connecting the airway adapter to the respiration circuit, always check the gas
reading and waveforms on the monitor.
3. After connecting the IRMA probe to the airway adapter, check the air tightness of the
infant's respiration circuit.
4. The Nasal oxygen catheter for Newborns is connected to the patient.
13.4.2 Connection of the Sidestream CO2 Module (ISA or NomoLine)
The ISA module can be used for monitoring infants with intubation and spontaneous
respiration.
The process of ISA gas analysis is to continuously measure the airflow passing through the
infrared spectrometer and the infrared absorptivity. The core component of the ISA gas analyzer
is the SIGMA spectrometer, which uses a proprietary wide-band infrared light source to transmit
light in gas samples. Before the light reaches the gas sample, the light path is cut off by a narrow
band filter, which only allows the light corresponding to the selected wavelength peak of the
measured gas to pass through. At the other end of the light path, the sensor detects the
unabsorbed light of the gas.
13-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Warning: 1. Tide the sampling tubes to prevent the risk of winding or strangulating the
infant.
2. Do not reuse the disposable sampling tube. Recycle and handle the used
sampling tube according to local regulations on medical waste disposal.
3. Do not lift ISA by grabbing the sampling tube; otherwise, ISA is disconnected
from the devices and falls onto the infant.
4. Do not use sampling tubes for adults/children on infants; otherwise, the dead
space in the infant's respiration circuit increases. Do not use sampling tubes for
infants on adults; otherwise, the flow resistance is too large.
5. Do not use the ISA sidestream gas analysis module with a quantitative spray
or other spray; otherwise, the bacterial filter may be blocked.
6. Check whether the flow rate of the sample gas is too high for the current
patient category.
7. Do not sterilize the ISA sidestream gas analysis module or immerse it into any
liquid. NomoLine sampling tube and its connector are not sterile devices. Do not
autoclave them; otherwise, they may be damaged.
8. Mobile and RF communication devices affect the measurement accuracy. Use
the ISA sidestream gas analysis module in the electromagnetic environments
specified in this manual.
9. Use the ISA sidestream gas analysis module for infant evaluation assistance
only. The module must be used together with other devices that evaluate vital
signs and symptoms.
10. If the indicator blinks in red at the sampling tube inlet or "NomoLine
occluded" is displayed on the main unit, replace the sampling tube immediately.
11. Do not modify the device without the permission of the manufacturer. If any
modification is made to the device, perform necessary check and test to ensure
its safe running.
12. The ISA sidestream gas analysis module is not designed for MRI
environments. Move the device out of the MRI room during MRI scanning.
13. Do not use the ISA module or device near high-frequency ESUs; otherwise,
interference or measurement inaccuracy may occur.
14. Do not external heat dissipation function of the ISA device.
15. Do not apply any negative pressure, such as by using a syringe, to
NomoLine to remove the condensed water. Too large positive or negative
pressure inside the infant's respiration circuit may affect the sample flow rate.
16. Too large discharge suction pressure may affect the sample flow rate. The
exhausted gas must be re-discharged into the infant's respiration circuit or into
the exhaust system.
17. If the collected gas sample is to supply air for respiration, always use a
bacterial filter on the exhaust side.
18. Do not place the device at any place where the device may fall onto the
infant.
13-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

19. Check the airway connector before use. Replace the airway connector in
case of any damage to the appearance.
20. This module supports auto pressure compensation.
Note: 1. Install the ISA sidestream gas analysis module firmly to avoid damage.
2. Do not pull the cable of the SA sidestream gas analysis device.
3. Do not run the SA sidestream gas analysis device under an ambient temperature
out of the specified range.

A. Install the ISA Sidestream Module

1. Connect the connector cable of the ISA analyzer to the device.

2. Connect the NomoLine sampling tube to the inlet of the ISA analyzer.
3. Connect the gas sample to the exhaust system or resupply the gas to the infant's
respiration circuit.
4. Start the device.
5. You can use the ISA analyzer when the green LED indicator is on.
6. You can start check before use.

B. Preparations

1. Connect the sampling tube to the ISA gas inlet (LEGI).

2. Check whether the green LEGI indicator is on (indicating that the system is normal).
3. Exhale towards the sampling tube, and check whether valid carbon dioxide waveform and
value are displayed on the screen;
4. Block the sampling tube with finger for 10s.
5. Check whether the occlusion alarm is triggered and whether the LEGI indicator blinks in
red.
6. Check the air tightness of the infant's respiration circuit connected to the sampling tube
when appropriate.
7. The Nasal oxygen catheter for Newborns is connected to the patient.
13.4.3 CO2 Setup
When the keyboard is unlocked, click in the CO2 / RESP area on the home screen and then
select CO2. The controller enters the second UI (H) CO2 Setup, as shown in Figure 13.2.
13-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

FIGURE 13.2

Note: 1. All settings must be configured when the keyboard is unlocked.

2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked and the system returns to the home screen.

1
Click this button to adjust the scale position on the waveform. The waveform amplitude changes
accordingly. The scale upper/lower limit options are 0.0-4.0%, 0.0-8.0%, 0.0-12.0%, and 0.0-20%.

2
Click this button to select the measurement/standby CO2 measurement function.

3
Click this button to select the O2 compensation value. The range is 0-100%.

4
Click this button to select the N2O compensation value. The range is 0-100%.
5

Click this button to make zero calibration for the CO2 module.

6
Click this button. The controller enters the Alarm Setup page.
Note: 1. If the infant's respiration is paused for a period exceeding the preset range, the
device triggers an alarm. The apnea delay settings of the RESP and CO2 modules
are consistent.
2. Gas compensation is not required in the mainstream measurement method.
3. In case of that there is a by-pass flow measurement and no CO2 sensor inserting,
CO2 zero calibration key is displayed as grey, CO2 is disabled to be made the zero
calibration.
13-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Warning: 1. The apnea cause cannot be detected by respiration measurement. An alarm is

triggered only when the period since the time when the last respiration is
detected to the time when no respiration is detected has exceeded the preset
value. Therefore, respiration measurement cannot be used for diagnosis.
2. Make compensation appropriately. Inappropriate compensation results in
measurement inaccuracy or even misdiagnosis.
3. This device supports manual gas compensation, but this function may be used
by medical professionals.

13.5 CO2 MODULE INDICATOR

The LED indicator on the CO2 module probe can indicate different states of the CO2 module.

The indicator is steady green The system is normal

The indicator blinks in green Zeroing is in progress

The indicator is steady red The sensor fails

The indicator blinks in red Check the sampling tube

13.6 CO2 ZEROING

1. Mainstream Module Zeroing

Warning: Incorrect probe zeroing results in incorrect gas reading.

To ensure probe measurement accuracy, zero the probe as follows:

a. During zeroing, install a new IRMA airway adapter to the probe instead of the infant's

respiration circuit. Then, send a zeroing command from a main unit to the IRMA probe.

b. Before or during zeroing, avoid respiration near the airway adapter accessories. Existence

of ambient air (21% O2 and 0% CO2) in the IRMA airway adapter is very importance of zeroing

success.
c. Insert the sensor into the CO2 socket, click the CO2 zero calibration key on the CO2 setting
UI, “CO2 is proceeding zero calibration”is displayed in general information area, when information
“CO2 is proceeding zero calibration” is disappeared, it means the zero calibration process is
successful( if failed, information “CO2 zero calibration and calibration failure”)
d. After the probe is zeroed, start the check before use.
IRMA CO2 Probe Zeroing:
a. Zeroing is required only when gas value deviation or inaccurate accuracy is observed.
b. After the CO2 probe is started and the airway adapter is replaced, wait for 10s until the
probe is pre-warmed and then perform zeroing. During zeroing, the probe LED indicator blinks in
green for about 5s.
13-8
 OPERATOR'S MANUAL OF INFANT INCUBATOR

2. Sidestream Module Zeroing

The infrared gas analyzer needs to determine the zero reference level of CO2 measurement,
which is called zeroing here.
The ISA sidestream gas analyzer switches the gas sample from the respiration circuit to the
ambient air to automatically perform zeroing. Auto zeroing is performed once every 24 hours. The
ISA CO2 analyzer can complete zeroing in 3s.
The NomoLine ISA CO2 module and ISA Capno module perform zeroing as follows: After
detecting the necessity of zeroing, the module automatically performs zeroing once when the
sampling tube is removed.
Warning: 1. For successful zeroing, the gas analyzer must have ambient air (21% O2 and
0% CO2). Therefore, place the ISA module in a well-ventilated place. Before and
after zeroing, avoid respiration near the ISA sidestream gas analyzer.
2. The automatic calibration/zeroing of an RGM will be suppressed during and for
at least 5min after any of the following situations:
a) if the apnoea alarm is activated;
b) if no breathing activity of the PATIENT is detcted for more than 30s after
breathing phases have been detected.
3. Any suppression of an automatic calibration/zeroing will be limited to no more
than 20 min.

13.7 MEASUREMENT INFLUENCE FACTORS

1. Leakage or internal exhaust of the sampling gas.
2. Mechanical vibration.
3. Circulation press as high as 10 kPa (100 cm H2O).
4. Other interference(e.g. environmental factors).
Interfering gas vapor effect：
Gas or vapor Gas level CO2
N2O 60vol% ---
HAL 4vol% ---
ENF, ISO, SEV 5vol% +8%
DES 15vol% +12%
Xe 80vol% -10%
He 50vol% -6%
Metered dose inhaler propellant Not for use with metered dose inhaler propellants
C2H5OH 0.3vol% ---
C3H7OH 0.5vol% ---
CH3COCH3 1vol% ---
CH4 3vol% ---
CO 1vol% ---
NO 0.02vol% ---
O2 100vol% ---
13-9
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Note：1. Negligible interference with N2O/O2 concentrations correctly set.

2. Interference at indicated gas level. For example, 50vol% helium typically
decreases the CO2 readings by 6%. this means that if measuring on a mixture
containing 5.0vol%CO2 and 50vol% helium，the actual measured CO2 concentration
will typically be （1-0.06）*5.0vol%=4.7vol%CO2.

13.8 EXHAUST EMISSION

Warning: When the module is used to measure infants who are using narcotic drugs or

infants who have recently used narcotic drugs, the exhaust outlet on the module

must be connected with the exhaust treatment system to prevent the medical

staff from inhaling narcotic drugs.

The module exhaust outlet must have an exhaust emission tube to emit the sample gas to
the exhaust treatment system.

13.9 COMMON FAULTS

The following table lists some common faults that may occur when the CO2 monitoring
system is used before expiration. If you cannot find the cause of a fault, ask authorized
maintenance personnel to repair the incubator.

Symptom Possible Cause Solution

Check and clean the CO2
CO2 sampling tube is blocked
CO2 observed value is sampling tube.
not displayed Connect the CO2 sampling tube
CO2 has no sampling tube
properly.
When the displayed EtCO2
The displayed EtCO2 value is
value is lower than the preset
EtCO2 High higher than the preset alarm
alarm upper limit, the alarm is
upper limit.
automatically reset.
When the displayed EtCO2
The displayed EtCO2 value is
value is higher than the preset
EtCO2 Low lower than the preset alarm
alarm lower limit, the alarm is
lower limit.
automatically reset.
When the displayed FiCO2 value
The displayed FiCO2 value is
is lower than the preset alarm
FiCO2 High higher than the preset alarm
upper limit, the alarm is
upper limit.
automatically reset.
When the displayed FiCO2 value
The displayed FiCO2 value is
is higher than the preset alarm
FiCO2 Low lower than the preset alarm
lower limit, the alarm is
lower limit.
automatically reset.
13-10
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Symptom Possible Cause Solution

When the displayed BR value is
The displayed BR value is
lower than the preset alarm
BR High higher than the preset alarm
upper limit, the alarm is
upper limit.
automatically reset.
When the displayed BR value is
The displayed BR value is lower
higher than the preset alarm
BR Low than the preset alarm lower
lower limit, the alarm is
limit.
automatically reset.

13-11
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 14
WAKE MONITORING SYSTEM
14.1 OVERVIEW
This chapter describes how to calibrate and operate the WAKE monitoring system.

14.2 CONNECTION OF WAKE CABLES

As shown in Figure 14.1, insert the WAKE cable into the WAKE socket on the
multi-parameter monitor.

WAKE socket WAKE cable plug

FIGURE 14.1
Warning: 1. Do not immerse the WAKE module in any liquid.
2. Do not plug the O2 sensor cable.
3. Do not run the WAKE module under an ambient temperature out of the
specified range.
4. Do not use the WAKE module on legs with wound.
14.3 FUNCTIONS
When the device accurately judges from the respiration rate (RR) that the newborn has slow
respiration (RR is less than or equal to 6bpm and the situation has lasted for a period exceeding
the preset apnea alarm time), the device triggers an alarm in time, automatically activates the
automatic wake-up function, and starts vibration, which produces an effect similar to that of
beating the soles of the feet for the newborn by medical staff, and wakes up the newborn. When
the newborn gets out of the apnea predicament (RR is greater than 6 bpm), the device
automatically stops the wake-up operation.
14.4 OPERATIONS
14.4.1 Preparations
1. Insert the cable plug of the WAKE module to the WAKE socket.
2. Place the WAKE module at the infant's foot sole and tight it with a bandage. Do not tight
the bandage too tight or too loose; otherwise, the use effect is affected (too loose) or the infant
blood circulation is affected (too tight).
3. Install the ECG leads.

14-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

4. Connect the SpO2 sensor.

5. When the newborn's RR is less than or equal to 6bpm and the situation has lasted for a
period exceeding the preset apnea alarm time, the WAKE module starts to vibrate.
14.4.2 WAKE Setup
When the keyboard is unlocked, Click the menu button in the first display interface, then
select function Settings, and then click choke wake Settings. The controller enters the second UI
(I) WAKE Setup, as shown in Figure 14.2.

FIGURE 14.2

Note: 1. All settings must be configured when the keyboard is unlocked.

2. If you do not perform any operation within 30s after pressing a button, the
keyboard is automatically locked and the system returns to the home screen.

1
Click this button to enable or disable the self-test function. The self-test function checks whether
the apnea WAKE probe works normally. When this function is enabled, the probe keeps vibrating,
which means the probe works normally.

2
Click this button to set the vibration strength. The range is 50, 60, 70, 80, 90, 100, Factory default
50.

3
Click this button to enable or disable the RESP function.

4
Click this button to enable or disable the CO2 function.

14-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

5
Click this button to set to trigger the WAKE function when the HR reaches a certain value. The
range is 90 to 110. Factory default 100.

6
Click this button to set to trigger the WAKE function when the SpO2 reaches a certain value. The
range is 80% to 90%. Factory default 85%.

14-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

CHAPTER 15
CLEANING AND MAINTENANCE
15.1 OVERVIEW
This section describes how to clean and maintain the incubator.

Warning: Before cleaning or maintaining the incubator, disconnect it from the oxygen supply.
Cleaning or maintaining the incubator in an oxygen-rich environment may lead to a
fire or explosion.

15.2 CLEANING
Clean and sterilize the incubator thoroughly before using it for the first time, after using it to
incubate a patient, or after using it for a week.
Applied parts: skin temperature sensor, mattress, Apnea WAKE module, Infant blood pressure cuff,
ECG electrodes, Nasal oxygen catheter for newborns and SpO2 sensor.
Any parts are not serviced or maintained while in use with the patient
For the incubator manufacturing date, see its nameplate.
15.2.1 Disassembling Before Cleaning
1. Turn off the main power switch on the VHA stand, and disconnect the power cable. Disconnect
the sensor box by referring to step A in section 4.3.3, and open the hood gently.
Caution: Before opening the hood, disconnect all auxiliary devices to avoid interference.
2. Remove the X-ray tray from the bassinet by referring to step I in section 4.3.3.
3. Remove the bassinet, as shown in Figure 15.1. (If the bassinet contains a weighing device,
disconnect the weight sensor first, as shown in Figure 8.1.)

2
1
Push the bassinet to the end in the direction of arrow 1, lift it in the direction of arrow 2, and remove
it in the direction of arrow 3.
Figure 15.1
4. Remove the shaker mechanisms on left and right sides of the bassinet, as shown in Figure 15.2.

Figure 15.2
15-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

5. Loosen the knob for fixing the shelf, and remove the shelf, as shown in Figure 15.3.

Figure 15.3
6. Remove the heater cover, as shown in Figure 15.4.

Figure 15.4

The heater may cause burns in the case of overheating. Therefore, remove the heater
cover or touch the heater at least 45 minutes after the heater is stopped.
7. Press the latch on the baffle to open the inner wall, as shown in Figure 15.5.
Latch

Inner wall

Baffle

Figure 15.5

15-2
 OPERATOR'S MANUAL OF INFANT INCUBATOR

8. Remove the water tank, as shown in Figure 15.6.

Water tank wrench

Water tank

Turn the water tank wrench downwards to be horizontal, and pull out the water tank. (When you
pull out the tank, keep it horizontal, without exerting an upward force. Otherwise, you will feel heavy
when you pull out the tank.)
Figure 15.6
Warning: 1. After the water tank is powered on, the tank and the water in it are very hot and the
heating components are “tight”. Therefore, remove the tank after it fully cools down;
otherwise, you may get scalded, or the heating components may be damaged.
2. The humidification system is located inside the tank. After removing the tank, do
not put your hand into the tank. Otherwise, you may be scalded by the heating tube.
9. Remove the fan, as shown in Figure 15.7.

Clamp screw cap

Hold the fan, loose the clamp screw cap in the arrow direction, and remove the fan upwards.
Figure 15.7

10. Remove the oxygen catheter, as shown in Figure 15.8.

Clamping ring

Push the clamping ring in the arrow direction, and remove the oxygen catheter.
Figure 15.8

15-3
 OPERATOR'S MANUAL OF INFANT INCUBATOR

11. Remove washers and plastic window sleeves of all operating windows from the hood.
12. Remove the I.V. cushion from the hood.
13. Remove two screws from the air filter cover, and remove the air filter by following step H in
section 4.3.3.
15.2.2 Cleaning Procedure
Caution: Some chemical cleaning/disinfection solvents may be conductive or have residues,
resulting in accumulation of conductive dusts or dirt. Prevent the solvents from
contacting any electric parts when cleaning the incubator. Do not spray chemical
cleaning/disinfection solvent onto the parts.

A. Clean the skin temperature sensor.

Use neutral detergents or sanitizers to thoroughly clean the skin temperature sensor (including the
probe) and then dry it with a clean cotton cloth or tissues.

Caution: 1. Do not dip the sensor into cleaning/disinfecting solvents. Discard the skin
temperature sensor once it has been used for an infant.
2. Replace the skin temperature sensor every two years because long-time use and
disinfection may damage the sensor surface and firmness.
B. Clean the I.V. cushion, washer, and plastic window sleeve
Immerse them in a neutral cleaning/disinfecting solvent or solution, rinse them, and dry them with a
clean cloth or tissues.
C. Clean the hood, inner container, and sensor box.
Use a neutral cleaning/disinfecting solution or solvent to thoroughly clean all the surfaces, including
the sensor box, inner wall, doors, and windows. Ensure that you clean all holes and recesses. Then, dry
them with a clean cloth or tissues.

Caution: 1. To prevent the hood and inner wall from cracking, do not use ethanol, acetone, or
other organic solvents, and do not expose them directly to ultra-violet rays.
2. Keep liquid out of the sensor box.
D. Clean the controller.
Clean all surfaces with a clean cloth dampened with a neutral cleaning/disinfecting solution, and
dry the surface with a clean cloth.
E. Clean the heater and fan.
Remove any accumulated scraps from the heater and fan. Clean all surfaces with a clean cloth
dampened with a neutral cleaning/disinfecting solution, and dry the surface with a clean cloth.

Warning: If you do not clean the heater or fan blades, fiber scraps will be accumulate on the
surface, which will affect air flows and thereby affect temperature control and lead to
excessive carbon dioxide concentration.

15-4
 OPERATOR'S MANUAL OF INFANT INCUBATOR

F. Clean the mattress, shaker mechanism, bassinet shelf, tray, storage box, and heater cover.

Use neutral cleaning/disinfection solvents or solutions to thoroughly clean all surfaces, and then dry

them with a clean cloth or tissues.

G. Clean the mattress.

Separate the upper shelf from the lower shelf, remove the dirt from the upper shelf, clean the inner

surface of the shelf and the sensor surface with a soft cloth dampened in detergent, and wipe them dry

with a clean cloth or tissues.

Note: The shelf contains a high-precision weight sensor. Handle it gently when cleaning it. Do
not dip it into a cleaning/disinfecting solution or solvent.
H Clean the air filter.

Use a neutral cleaning/disinfecting solvent or solution to thoroughly clean all surfaces, including all

holes and recesses, and then dry them with a clean cloth or tissues. Replace the air filter if it looks dirty

or has been used for over two months.

I. Clean the water tank.

As shown in Figure 15.9, remove the humidification chamber from the drawer assembly, open the

two covers of the humidification chamber, and lift the inlet baffle. Use a neutral cleaning/disinfecting

solvent or solution to thoroughly clean all surfaces and recesses in the tank, rinse them, and dry them

with a clean cloth or tissues.

Gently wipe the inner and outer surfaces of the probe with a soft cloth dampened with a

disinfectant every week to prevent microbial growth and to detect water shortage correctly.

If there is limescale in the heat dissipater, immerse the heat dissipater in table vinegar or water

dispenser disincrustant for 15 to 20 minutes (the longer, the better). Ensure that the whole heat

dissipater is immersed. Then brush it with a small bottle brush, and rinse it until limescale is removed.
Probe
Steam outlet Cover
Heat dissipater

Inlet baffle

Inlet baffle gap

Bottom inlet hole

Humidification chamber Drawer assembly

15-5
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Note: 1. Clean the heat dissipater after it completely cools down.

2. After cleaning the water tank, ensure that the bottom inlet hole and steam outlet are
unobstructed and that the two gaps of the inlet baffle are placed downwards.
3. The water shortage alarm may not be generated if the water tank is dirty, especially
when there is dirt near the probe.
4. As the probe is coated with precious metal, wipe it with a soft cloth. Do not scrub the
probe with a hard object.
5. Clean the heat dissipater when it has obvious limescale. Otherwise, the heat dissipater
will breed bacteria and affect the humidification effect.
Figure 15.9
The tank can be sterilized with steam. Method: Clean and air-dry the tank thoroughly before steam

sterilization. Duration: 3 to 5 minutes (temperature: < 132°C); 15 to 20 minutes (temperature: < 121°C).

Repeated sterilization may result in hairline-sized cracks in some areas, which may damage the water

tank and eventually require you to replace the tank.

J. Oxygen catheter

Clean the surface of the oxygen catheter by using a clean cloth.

K. Clean the outer surface of the incubator.

Use a neutral cleaning/disinfection solvent or solution to thoroughly clean all surfaces of the

incubator, including all corners and recesses, and then dry them with a clean cloth or tissues.

L. Clean and sterilize the SpO2, ECG, NIBP, CO2 modules and other accessories by referring to

their operator's manuals.

15.2.3 Installation after Cleaning

Note: Check that all components are intact before installing them in the incubator. If any
component is damaged, replace it immediately.
A. Install the water tank.

B. Install the heater cover.

C. Install the bassinet shelf.

Caution: Open the hood before installing the bassinet shelf. Otherwise, the bassinet shelf may
be damaged, and the hood is scratched.
D. Install the shaker mechanism on the bassinet shelf.
E. Install the bassinet and X-ray tray.
F. Install the bassinet mattress. By observing with your eyes and touching with hands, check the
mattress for holes or cuts, which will bring liquid into the sponge inside.
G. Lock the inner wall securely.
H. Install the plastic sleeve of the rotary round window, as shown in Figure 15.10.
15-6
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Wind a spring band of the plastic sleeve Wind the other spring band
around the inner ring of the rotary round window. around the outer ring.

Rotate the outer ring to close the plastic sleeve. If installed correctly, the plastic sleeve opens when

you rotate the outer ring in the opposite direction.

Figure 15.10
I. Install the gasket and plastic sleeve of the operating window, as shown in Figure 15.11.

Install the gasket on the operating window Install the plastic sleeve of the operating window

Figure 15.11
J. Install the I.V. cushion, as shown in Figure 15.12.
Note: The I.V. cushion gap must face outwards.

15-7
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Figure 15.12
K. Install the air filter. Install the air purification material in the air filter cover, and tighten the
fastening screws by following step H in section 4.3.3.

15.3 MAINTENANCE

Warning: To ensure safety, do not alter the incubator.

Before using the incubator for the first time or when the incubator is idle, check the rechargeable
battery inside the incubator.
A. Keep the incubator running continuously for 12 to 24 hours.
B. Disconnect the power cable to trigger the power failure alarm.
C. Ensure that the power failure alarm lasts for at least 10 minutes.
D. Connect the power cable to charge the battery.
Replace the battery if the power failure alarm lasts for less than 10 minutes. The battery can be
replaced only by authorized and qualified maintenance personnel.
Note: Recycle the replaced battery in accordance with regulations to prevent pollution.
When the monitoring module is continuously used for 6~12 months, maintained or updated, which
should be checked throughout by qualified service personnel authorized by our company to ensure the
monitoring module run and work normally. The checking items is including following:
 Whether the environment and power supply conform to requirements or not.
 Whether the monitoring module and accessory is damaged or not.
 Whether the power cord and cables are worn or not.
 Whether the accessory is an assigned part or not.
 Whether the alarm system function is normal or not.
 Whether the recorder is working normally or not.
 Whether every monitoring module runs normally or not.
 Whether earthed impedance and leakage current conform to requirements or not.
15-8
 OPERATOR'S MANUAL OF INFANT INCUBATOR

If any damage or abnormality are discovered, please do not use this equipment, and please
contact to local agent or service department from company.
Our company will provide the circuit diagram to the user with demand so as to help the user to
have appropriate , qualified technical personnel to maintain those parts that our company classifies as
available for maintenance by user.

15.4 COMMON FAULTS

The following table lists common faults of the temperature control system during use of the
incubator. If a fault persists or if an unknown fault occurs, ask authorized and qualified maintenance
personnel to repair the incubator or contact an authorized dealer or after-sales service.

Common faults and solutions

Symptom Possible Cause Solution

The incubator does not
The power switch is turned off. Turn on the power switch.
display or generate an alarm.
The controller temperature is Shut down the controller, and
The screen color is abnormal.
high. restart it after it cools down.
The power failure alarm Power failure occurs. Turn off the power switch.
indicator blinks, and the
power failure alarm is The power cable is
Connect the power cable.
generated. disconnected.

The ALARM indicator blinks,

and the screen displays The sensor box is not installed
Install the sensor box properly.
"Sensor Box Connection properly.
Error".
Skin temperature sensor 1 is not
Connect skin temperature
The ALARM indicator blinks, connected or not properly
sensor 1 properly.
and the screen displays "Skin connected.
Sensor 1 Fault". Skin temperature sensor 1 is Replace skin temperature sensor
damaged. 1.
Oxygen concentration sensor 1 Install oxygen concentration
The ALARM indicator blinks, is not installed. sensor 1 properly.
and the screen displays "O2
Sensor 1 Fault". Oxygen concentration sensor 1 Replace oxygen concentration
is damaged. sensor 1.
Oxygen concentration sensor 2 Install oxygen concentration
The ALARM indicator blinks, is not installed. sensor 2 properly.
and the screen displays "O2
Sensor 2 Fault". Oxygen concentration sensor 2 Replace oxygen concentration
is damaged. sensor 2.

15-9
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Symptom Possible Cause Solution

Move the device away from the
The ALARM indicator blinks, The ambient temperature is high. heat source or reduce the
and the screen displays "Air ambient temperature.
Overheat Alarm". The humidity in the incubator is
Reduce the humidity.
high.
The hood door or window is
Close the hood door or window.
open.
The ALARM indicator blinks, The ambient temperature
and the screen displays Check the ambient temperature.
changes greatly.
"Temp. Upper Deviation
Alarm”or "Temp. Lower A heat source is near the Keep the incubator away from
Deviation Alarm". incubator. the heat source.
The ambient temperature
Check the ambient temperature.
changes dramatically.
The power cable is not
The VHA stand cannot Connect the power cable.
connected.
rise or drop.
The power switch is turned off. Turn on the power switch.

15-10
 OPERATOR'S MANUAL OF INFANT INCUBATOR

SECTION 16
LIST OF COMPONENTS
This chapter lists the components and accessories to be used with the device, including the

skin temperature sensor and other replaceable components. Use only the materials delivered

with the device; otherwise, the device security performance may be degraded.

Replacement
No. Component Name
Period/Conditions

1 Skin temperature sensor 2 years

2 Rechargeable battery
3 years
3 Button battery

Apparently dirty or
4 Air filter broken or used over
2 months

5 Access door gasket

6 Plastic sleeve of access door

If damaged
7 Plastic sleeve of circular port for rotating

8 Power cable

Up to 10,000 hours
9 Oxygen sensor at 100% oxygen
concentration
Main Power cable conforming to EU
10 standards

3-core Bucket-type split cable conforming to

11 EU standards

5-core Bucket-type split cable conforming to

12 EU standards
ECG
Is damaged
accessories Main Power cable conforming to USA
13 standards

3-core Bucket-type split cable conforming to

14 USA standards

5-core Bucket-type split cable conforming to

15 USA standards

16-1
 OPERATOR'S MANUAL OF INFANT INCUBATOR

Continued:

Replacement
No. Component Name
Period/Conditions

16 Rainbow RC-4 main cable

SpO2
17 Rainbow RC-12 main cable Is damaged
accessories

18 Y type probe M-LNCS YI

2.6 m NIBP cuff connection tube, with one

19 female terminal and a male terminal
NIBP
Is damaged
accessories
20 Infant cuff（8~13cm）

21 CO2 connector adapter

22 Mainstream module IRMA CO2

Mainstream airway adapter for newborns

23
IRMA Airway Adapter Infant

24 CO2 Sidestream module (old model) ISA CO2

Is damaged
accessories
Sidestream module (new model) NomoLine
25
ISA CO2

Nasal oxygen catheter for newborns, without

26 oxygen catheter
Nomoline Nasal/Oral CO2 Cannula Infant

Sidestream T-pipe for newborns

27 Nomoline Airway Adapter Set Infant

Apnea
28 WAKE Apnea WAKE module Is damaged
accessories

16-2
 SPECIAL STATEMENT: All of the content in the manual is checked carefully, if there is any
error or content of printing misunderstanding, our company retains
finally explanation of this card-usage.
NOTE: The product’s appearances maybe differ from the one in this manual, but it dose not
affect the capability of product. Please understand if it brings you troubles.

NINGBO DAVID MEDICAL DEVICE CO., LTD.

ADD: NO. 2, KEYUAN ROAD, SHIPU SCIENCE AND TECHNOLOGY PARK, XIANGSHAN, 315731
NINGBO, ZHEJIANG PROVINCE, PEOPLE’S REPUBLIC OF CHINA
FAX: +86-574-65962111
MARKETING CENTER: BLDG NO 5. NINGBO SMART PARK, #98 CHUANGYUAN ROAD, YINZHOU
DISTRICT, NINGBO, CHINA 315048
FAX: +86-574-87801111, 87803714
TEL: +86-574-87800008, 87800007
E-MAIL: sales@[Link]
WEBSITE: [Link]
EUROPEAN REPRESENTATIVE: SHANGHAI INTERNATIONAL HOLDING CORP. GMBH (EUROPE)
ADD: EIFFESTRASSE 80, 20537 HAMBURG, GERMANY
TEL: +49-40-2513175 FAX: +49-40-255726
EDITION/REVISION A/0

DATE OF ISSUE 2021/07