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Instructions for use

Babyleo TN500

WARNING IncuWarmer
To properly use this medical device, Software 1.0n
read and comply with these
instructions for use.
This page has been left blank intentionally.

2 Instructions for use Babyleo TN500 SW 1.0n


Contents

Contents
1 Information about this document ........................................................... 6
1.1 Typographical conventions ............................................................. 6
1.2 Use of terms ................................................................................... 6
1.3 Illustrations...................................................................................... 6
1.4 Trademarks..................................................................................... 7

2 Safety-related information ...................................................................... 8


2.1 Intended use ................................................................................... 8
2.2 Indications....................................................................................... 8
2.3 Contraindications ............................................................................ 8
2.4 Environments of use ....................................................................... 8
2.5 Essential performance characteristics ............................................ 9
2.6 Target groups ................................................................................. 9
2.7 Information on safety instructions and precautionary statements... 10
2.8 Basic safety instructions ................................................................. 11
2.9 Electrical safety............................................................................... 13
2.10 Use of oxygen................................................................................. 14
2.11 Explosion protection ....................................................................... 15
2.12 Mechanical safety ........................................................................... 15
2.13 Thermal radiation and fire prevention ............................................. 18
2.14 Therapy and applications................................................................ 19
2.15 Safety during cleaning and service................................................. 22
2.16 Safety instructions for accessories ................................................. 23

3 Product description ................................................................................. 24


3.1 Structure and function..................................................................... 24
3.2 Screen views .................................................................................. 32
3.3 Range of functions.......................................................................... 41

4 Operating concept ................................................................................... 45


4.1 Display unit ..................................................................................... 45
4.2 Adjusting the device height............................................................. 48
4.3 Adjusting the mattress tray ............................................................. 49
4.4 Hood ............................................................................................... 51
4.5 Hand ports and access panels ....................................................... 52
4.6 Locking and unlocking functions..................................................... 55

5 Assembly and preparation ...................................................................... 56


5.1 Maximum load ................................................................................ 56
5.2 Nurse call........................................................................................ 57
5.3 Adjusting the gas cylinder holder and connecting the oxygen
cylinder 58
5.4 Establishing potential equalization.................................................. 62
5.5 MEDIBUS connection for data transfer........................................... 62

Instructions for use Babyleo TN500 SW 1.0n 3


Contents

6 Operation .................................................................................................. 63
6.1 Checking for operational readiness ................................................ 63
6.2 Switching on the device .................................................................. 64
6.3 Switching off the device .................................................................. 67
6.4 Operating modes ............................................................................ 68
6.5 Incubator operation......................................................................... 69
6.6 Radiant warmer operation .............................................................. 71
6.7 Transition ........................................................................................ 74
6.8 Skin temperature mode .................................................................. 77
6.9 Air temperature mode ..................................................................... 85
6.10 Manual mode .................................................................................. 91
6.11 Humidity.......................................................................................... 94
6.12 Oxygen (option) .............................................................................. 96
6.13 Heated mattress (option) ................................................................ 100
6.14 Kangaroo mode .............................................................................. 104
6.15 Tolerate cooling (option) ................................................................. 109
6.16 Warm-up (option)............................................................................ 111
6.17 Weaning (option) ............................................................................ 113
6.18 Scale (option).................................................................................. 116
6.19 Taking x-rays .................................................................................. 122
6.20 Developmental care (option)........................................................... 124

7 Alarms....................................................................................................... 127
7.1 Alarm priorities and alarm signals................................................... 127
7.2 Suppressing and delaying the alarm signal .................................... 127
7.3 Dismissing the alarm message....................................................... 130
7.4 Viewing the alarm history................................................................ 130

8 Configuration ........................................................................................... 131


8.1 Entering patient data....................................................................... 131
8.2 Transferring data to another device................................................ 134
8.3 Displaying trends and data ............................................................. 137
8.4 System setup .................................................................................. 142

9 Transfer..................................................................................................... 150
9.1 Intrahospital patient transfer with switched off warming therapy .... 150

10 Troubleshooting....................................................................................... 153
10.1 Alarm – Cause – Remedy............................................................... 153
10.2 Power failure alarm......................................................................... 161
10.3 Adjustment of device height not possible ....................................... 162
10.4 Adjustment of mattress tray not possible........................................ 162
10.5 Fault during weighing...................................................................... 162
10.6 Fault with the oxygen supply .......................................................... 163
10.7 Removing liquid from the heating plate .......................................... 164

11 Reprocessing ........................................................................................... 166


11.1 Automatic humidifier cleaning......................................................... 166
11.2 Dismantling ..................................................................................... 167
11.3 Information on reprocessing ........................................................... 171

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Contents

11.4 Classification for reprocessing........................................................ 172


11.5 Recommendations for reprocessing ............................................... 172
11.6 Surface disinfection with cleaning................................................... 174
11.7 Additional reprocessing measures.................................................. 176
11.8 After reprocessing........................................................................... 176

12 Service ...................................................................................................... 180


12.1 Overview......................................................................................... 180
12.2 Inspection ....................................................................................... 180
12.3 Maintenance ................................................................................... 184
12.4 Replacing the filter cloth for patient air in the sensor wall............... 185
12.5 Repair ............................................................................................. 185
12.6 Activating applications .................................................................... 185

13 Disposal .................................................................................................... 187


13.1 Disposing of the device................................................................... 187

14 Technical data .......................................................................................... 188


14.1 Ambient conditions ......................................................................... 188
14.2 Operating data ................................................................................ 188
14.3 Performance characteristics ........................................................... 189
14.4 Measured value display .................................................................. 190
14.5 Materials ......................................................................................... 192
14.6 Data exchange and interfaces ........................................................ 192
14.7 Device combinations....................................................................... 194
14.8 Connections to IT networks ............................................................ 194
14.9 EMC Declaration............................................................................. 196
14.10 Open-source software .................................................................... 199

15 Annex ........................................................................................................ 200


15.1 Description of skin temperature regulation ..................................... 200
15.2 Further information on heated mattress (option) ............................ 201
15.3 Automatic selftest ........................................................................... 202
15.4 Delay of the alarm condition ........................................................... 203
15.5 Schematic representation of alarm and information tones ............. 203
15.6 Interfaces ........................................................................................ 204
15.7 Abbreviations .................................................................................. 205
15.8 Symbols .......................................................................................... 206
15.9 Symbol in the software ................................................................... 209
15.10 Product labels ................................................................................. 210

16 Password .................................................................................................. 213


16.1 Configuration password for Babyleo TN500 Software 1.0n............ 213

Index.......................................................................................................... 215

Instructions for use Babyleo TN500 SW 1.0n 5


Information about this document

1 Information about this document


1.1 Typographical conventions
Text Texts printed in bold and italics indicate device labels and screen texts.
1 Numbers indicate the individual action steps of a sequence of actions. The
numbering restarts with 1 for each new sequence of actions.
(1) Numbers in parentheses refer to elements in illustrations.
Numbers in illustrations are shown within a circle and indicate elements to
1 which reference is made in the text.
► This triangle is used in safety instructions and precautionary statements to
indicate possible ways of avoiding the risk.
– Dashes indicate lists.
> The "greater than" symbol indicates the navigation path in a dialog window.
This symbol indicates information which makes it easier to use the product.
 This arrow indicates the result of a process step.
✓ This check mark indicates the result of a process sequence.

1.2 Use of terms


Dräger uses the term "accessory" not only for accessories in the sense of
IEC 60601-1, but also for consumable parts, removable parts and attached parts.

1.3 Illustrations
Depending on the configuration, the products and screen content shown in this
document may differ from the actual on-site products.

6 Instructions for use Babyleo TN500 SW 1.0n


Information about this document

1.4 Trademarks
Trademarks owned by Dräger
The trademarks are registered in the following countries:

Trademark Country
Germany, Australia, Switzerland, China, EU, Japan,
Babyleo® Korea, Mexico, New Zealand, Russia, Singapore, USA
Infinity® EU, USA, China, Brazil, Australia, India
IncuWarmer® EU
DrägerService® Germany, USA
MEDIBUS.X® EU, USA
® EU, USA
Oxycell
® EU, USA
KangarooMode
ThermoMonitoring® Germany, France, USA

Trademarks owned by third-party manufacturers

Trademark Trademark owner


® Ecolab
Actichlor
Incidin® Ecolab
BruTab6S® Brulin
® Schülke & Mayr
Buraton
® Schülke & Mayr
Mikrozid
Perform® Schülke & Mayr
acryl-des® Schülke & Mayr
Descogen® Antiseptica
® BODE Chemie
Dismozon
® Clorox
Dispatch
® Medentech
Klorsept
Oxycide® Ecolab USA
Virkon® DuPont
Neodisher® Chemische Fabrik Dr. Weigert
® ODU
ODU MEDI-SNAP

Instructions for use Babyleo TN500 SW 1.0n 7


Safety-related information

2 Safety-related information
2.1 Intended use
The IncuWarmer Babyleo TN500 is intended for use with premature babies and
neonates and can be used as both an incubator and a radiant warmer. When the
product is switched between incubator and radiant warmer operation, patients
continue to be kept warm during the transition. The device provides a thermally
regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a
height of up to 55 cm (22 in). The device can be operated as either a closed care
unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.
Neonates are kept warm in the patient compartment with humidifiable air, which can
be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant
warmer.

2.2 Indications
The IncuWarmer Babyleo TN500 provides controlled ambient conditions for
premature babies and neonates. The following parameters are regulated, according
to the intended use:
– Temperature
– Humidity
– Oxygen (option)

2.3 Contraindications
Do not use Babyleo TN500 outside the specified environments of use.

2.4 Environments of use


Babyleo TN500 provides controlled ambient conditions for premature babies and
neonates in a hospital. Babyleo TN500 is intended for use in the following
environments:
– Labor and delivery units
– Labor and delivery rooms
– Neonatal intensive care units
– Operating rooms
Babyleo TN500 is intended for use in the following environments where some of the
functions described under intended use are restricted (no active warming therapy,
humidification, and oxygen enrichment). For further information, see the following
chapter: ''Intrahospital patient transfer with switched off warming
therapy'' (page 150)
– During intrahospital patient transfer
Babyleo TN500 is not intended for use in the following environments:
– Home use
– Transport vehicles, e.g., ambulances, airplanes, or helicopters
– MRI environment

8 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

2.5 Essential performance characteristics


Provided that the essential performance characteristics are functioning correctly,
the product can be used for its intended purpose. The product has the following
essential performance characteristics:
– Skin temperature regulation in incubator operation
The measured central skin temperature is compared with the set value for the
skin temperature and adjusted accordingly, or an alarm is triggered.
– Air temperature regulation in incubator operation
The measured air temperature in the patient compartment is compared with the
set value for the air temperature and adjusted accordingly, or an alarm is
triggered.
– Skin temperature regulation in radiant warmer operation
The measured central skin temperature is compared with the set value for the
skin temperature and adjusted accordingly, or an alarm is triggered.

2.6 Target groups


2.6.1 Definition of target groups
The target groups may only carry out the following activities if they meet the
necessary requirements. For further information, see the following chapter: ''Basic
safety instructions'' (page 11)

2.6.1.1 Users
Users are clinical personnel such as doctors and nursing staff trained in
neonatology.
Activity Requirement
Use of the product in accordance with Specialist medical knowledge in neonatol-
the intended use ogy
Knowledge of currently known risks and
benefits of warming therapy

2.6.1.2 Reprocessing personnel

Activity Requirement
Reprocessing Specialist knowledge in the reprocessing of
medical devices

2.6.1.3 Service personnel


Service personnel are, e.g., hospital technicians trained in servicing the device.
Activity Requirement
Installation Specialist knowledge in electrical engineer-
Basic service work (inspection, main- ing and mechanics
tenance according to the "Mainte- Experience in the servicing of medical
nance" chapter) devices

Instructions for use Babyleo TN500 SW 1.0n 9


Safety-related information

2.6.1.4 Specialized service personnel

Activity Requirement
Installation Specialist knowledge in electrical engineer-
Basic and complex service work ing and mechanics
(inspection, maintenance, repair) Experience in the servicing of medical
devices
Experience in complex service work on this
product

Dräger recommends arranging a service contract with DrägerService.

2.6.1.5 Installation personnel


Installation personnel are, e.g., hospital technicians who have not received training
for this device.
Activity Requirement
Assembly and installation Specialist knowledge in electrical engineer-
ing and mechanics
Experience in the assembly and installation
of medical devices

2.7 Information on safety instructions and precautionary


statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.

2.7.1 Safety instructions


This document contains sections with safety instructions which warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.

2.7.2 Precautionary statements


Precautionary statements relate to action steps and warn of risks that may arise
when executing the action steps. Precautionary statements precede the action
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of non-compliance.

Warning sign Signal word Consequences of non-compliance


WARNING May result in death or serious injury.
CAUTION May result in moderate or minor injury.
NOTICE May result in property damage.

10 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

2.8 Basic safety instructions


2.8.1 Instructions for use
Failure to use the product in accordance with the information contained in these
instructions for use may result in personal injury and property damage.
► Follow these instructions for use and those for any products used in conjunction
with this product.
► Only use this product for the purpose specified in ''Intended use''.
► Keep these instructions for use close to hand.

The instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the product
– Potentially negative effects on patients with different underlying diseases

2.8.2 Symbols and product labels


Failure to observe symbols and product labels may result in personal injury and
property damage.
► Observe the symbols and product labels.

2.8.3 Monitoring the patient's condition


Monitoring of a patient's condition can range from direct observation to electronic
monitoring by means of medical devices. The patient may be put at risk if his or her
condition is not adequately monitored.
► Monitor the patient's condition by suitable means and at appropriate intervals.

2.8.4 Duties of the operating organization


The tasks described in this document specify the requirements which have to be
met by each respective target group. If the respective target group is not
appropriately qualified, personal injury and property damage may result.
The operating organization of this product must ensure the following:
► The target group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience)
► The target group has been trained to perform the task.
► The target group has read the sections of these instructions for use relating to
the activity concerned and noted the safety instructions and precautionary
statements they contain.

Instructions for use Babyleo TN500 SW 1.0n 11


Safety-related information

2.8.5 Operation of the device by persons outside the defined target


groups
The device is not intended for use by non-specialists (persons not defined as target
group). Responsibility for use of the device that is inconsistent with its intended use,
particularly by non-specialists, lies with the operating organization. If the operating
organization nevertheless allows non-specialists to interact with the device,
appropriate instruction and supervision must be provided.
If non-specialists (e.g., visitors) are given access to the device, the following
precautions must be taken:
► Non-specialists must be informed that unauthorized interactions may lead to
injury.
► Select the Family screen view or lock the user interface to prevent device
settings from being changed unintentionally.
► Lock the height adjustment and the bed-tilt mechanism to prevent them from
being activated unintentionally.

2.8.6 Modifications to the product


Modifications to the product may lead to malfunctions, which in turn may result in
personal injury and property damage.
► Do not modify this product.

2.8.7 Alarms
Failure to notice alarm signals may put the patient at risk.
► Check that 2 acoustic signals sound and the alarm light shows yellow and red
when the device is switched on.
► Set the alarm volume so that alarm signals can be heard.
► Be aware that only high- and medium-priority alarms trigger the nurse call.
► Take note of alarms directly on the device. Be aware that using the nurse call
does not unconditionally guarantee that alarms will be transmitted.
► Make sure that the alarm system has not been rendered ineffective by setting
the alarm limits to extreme values or deactivated by switching off the alarms.
► Adjust the basic alarm settings on devices to the needs of the patient.

2.8.8 Service port


Only use the service port on the device for servicing purposes. Any other use may
lead to malfunctions, which in turn may result in personal injury.
► Do not use the service port (RJ45) to connect the device to the IT network.

12 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

2.9 Electrical safety


2.9.1 Electric shock
Under the housing there are conducting components which may cause an electric
shock. To avoid the risk of personal injury and property damage, the following
preventive measures must be taken:
► The housing must only be opened by the target groups authorized to perform the
respective service measure.
► Disconnect the mains plug before opening the housing.
► Do not simultaneously touch the connectors of the interfaces and the patient.
► To prevent condensate formation and the resulting failure of electronic
components, do not switch on the device for 3 hours after sudden temperature
changes (e.g., after storage in unheated rooms).
► Only connect the device to grounded power sockets.
► Do not connect the device by means of a power socket strip.
► Only connect USB mass storage devices that are included in the list of approved
accessories to the USB port.
► Do not connect any accessory operating on mains voltage to the USB port.
► Only connect devices to the audio port, COM port, USB port and service port
that comply with the requirements set out in the standards and specifications
listed in the technical data. For further information, see the following chapter:
''Technical data'' (page 188).
► Do not place containers containing more than 1 liter of liquid in or on the device.
► Do not allow any liquids to penetrate into the device.

2.9.2 Electromagnetic compatibility (EMC)


Medical electrical equipment is subject to special precautionary measures
concerning electromagnetic compatibility. The EMC information must be observed
during installation and commissioning. For further information, see the following
section: ''EMC Declaration'' (page 196).
Portable and mobile radio frequency communication equipment can affect medical
electrical equipment.
To avoid the risk of malfunctions, the following measures must be taken and the
personnel concerned must be trained accordingly:
► Observe the ESD protective measures. Such protective measures may include
wearing antistatic clothing and shoes, touching a potential equalization pin
before and during connection of the pins, or using electrically insulating and
antistatic gloves.
► Comply with the requirements for an electromagnetic environment. For further
information, see the following chapter: ''Electromagnetic
environment'' (page 197).

Instructions for use Babyleo TN500 SW 1.0n 13


Safety-related information

Electromagnetic fields may disrupt the function of the device, putting the patient at
risk. Electromagnetic fields are generated by, for example:
– Cellular phones
– Radio-frequency surgical equipment
– Defibrillators
– Shortwave therapy equipment
► Observe the separation distances. For further information, see the following
chapter: ''Recommended safety clearances for portable and mobile high-
frequency communication equipment'' (page 199).

2.10 Use of oxygen


2.10.1 Oxygen cylinders
If oxygen cylinders or devices containing oxygen are installed in the vicinity of the
ventilation slot, oxygen may get into the device at the power supply unit. In the
event of sparking at the power supply unit there is an increased risk of fire, which
may lead to personal injury and property damage.
► Position oxygen cylinders and devices containing oxygen on that side of the
device without the ventilation slot.

2.10.2 Oxygen cylinder valves


The use of unauthorized or poorly maintained oxygen cylinder valves presents an
increased risk of fire, which may lead to personal injury and property damage.
► Do not use unauthorized oxygen cylinder valves.
► Make sure that oxygen connectors and oxygen seals are kept free from oil and
dust at all times. Always open oxygen cylinder valves slowly.

2.10.3 Oxygen supply


The health of patients can be endangered if they are provided with too much or not
enough oxygen. If O2 is supplied externally, there is also a risk of fire.
► If the device is switched off, do not supply any O2 from an external source. Do
not leave behind any oxygen-supplying accessories (e.g., O2 hood, nasal
prongs) in the patient compartment.
► Measure and monitor the oxygen concentration in the patient compartment.
► Make sure that the oxygen concentration in the patient compartment is always
below 65 %.
► Always monitor the oxygen concentration in the patient's blood, e.g., using blood
gas analysis and a pulse oxymeter.
► Make sure that the O2 settings are correct.
► Check the amount of O2 supplied via an external O2 hood.
► Always monitor the additional O2 supply via the central gas supply, an oxygen
cylinder or an O2 hood.
► Be aware that Babyleo TN500 displays no alarms in the case of an external
oxygen supply, e.g., via an O2 hood.
► In the patient compartment use only electrical devices that are approved for use
in an oxygen-enriched atmosphere.

14 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

2.10.4 Oxygen sensors


The air in the patient compartment can be enriched with oxygen (option). The
oxygen concentration in the patient compartment is measured by O2 sensors.
The user must adjust the O2 sensors regularly. If the O2 sensors are not adjusted,
the measurement uncertainty of the oxygen concentration may be increased. The
patient may then receive too much or too little oxygen. The health of the patient
may be endangered.
► Always monitor the oxygen concentration in the patient's blood, e.g., using blood
gas analysis and a pulse oxymeter.
► Adjust the O2 sensors at least every 2 weeks under Special procedures... >
Oxygen.
► Measure and monitor the oxygen concentration in the patient compartment.

2.11 Explosion protection


2.11.1 Flammable gases
In the presence of oxygen concentrations greater than 25 Vol%, combustible or
explosive gas mixtures, there is an increased risk of explosion and fire, which may
lead to personal injury and property damage.
► Do not operate the device in areas where oxygen concentrations greater than
25 Vol%, combustible or explosive gas mixtures are likely to occur.
► Do not operate the device in areas where combustible solvents or explosive
anesthetic agents are used.
► Do not use combustible solvents or explosive anesthetic agents in the device.
Even small residues of these agents may react with oxygen to cause a fire.

2.11.2 Unauthorized gases


The use of compressed gases that are not approved for medical purposes may
adversely affect the function of the device and put the patient's health at risk.
► Only use compressed gases that are approved for medical purposes.
► Only use compressed gases that are dry and free from dust and oil.

2.12 Mechanical safety


2.12.1 Tipping over of the device
Excessive weight loading or a change in the center of gravity may cause the device
to tip over, injuring the patient, users, and bystanders. The device and accessories
may also be damaged due to the tip over.
► Do not place the device on inclined surfaces and avoid lateral loading by
pushing, resting, or leaning against the side.
► Observe the maximum load for all shelves, drawers, and holding devices.
► Do not exceed the maximum load of the x-ray tray.
► During transfer make sure that the device does not tip over due to incorrect
alignment of accessories on the duct rail.

Instructions for use Babyleo TN500 SW 1.0n 15


Safety-related information

2.12.2 Trapping of body parts


The careless execution of functions or the accidental triggering of functions by
untrained persons may cause injury to the patient, users or third parties. Hands,
feet, and other body parts may become trapped and crushed. There is also a risk of
injury from incorrectly mounted accessories. The illustration below shows the
special hazard areas.

28227
1

3
10 4
5
9

7
8

Fig. 1 Special hazard areas during operation

No. Location where there is a risk of injury


1 Between the hood arm and the housing of the radiant warmer and between
the hood frame and the front of the radiant warmer (e.g., when opening and
closing the hood)
2 On the accessories of the side duct rails when closing the hood or lowering
the hood arm
3 Between the hood and the side panels (especially on the sensor wall)
4 On the sensor wall between the bed support and the inside of the device
(e.g., when lowering or tilting the mattress tray)
5 On the long side of the bed support between the mattress tray and the inside
of the device (e.g., when lowering or tilting the mattress tray)
6 Between the compressed gas cylinder and accessories fixed to the duct rail
(e.g., when lowering the device)
7 Between the trolley and the power cable connection (e.g., when lowering the
device)
8 Between the trolley and the drawer (e.g., when lowering the device)

16 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

No. Location where there is a risk of injury


9 On the front between the bed support and the inside of the device (e.g., when
lowering or tilting the mattress tray)
10 When closing the hand ports, when closing one of the two side access pan-
els or the front access panel.

Before moving device components, take the following precautions:


► Make sure that there is no-one else in the hazard area.
► Make sure that no body parts become trapped.

2.12.3 Risk of patient falling out


If the access panels or the hand ports are open or the mattress tray has been pulled
out, there is a risk of the patient falling out.
► Make sure that the side and front access panels are correctly locked.
► Monitor the patient at all times when the access panels or hand ports are open
or the mattress tray is pulled out.

2.12.4 Unintended movement of the trolley


If the locking brakes are not engaged, the trolley may move on inclined surfaces,
causing injury to the patient and bystanders.
► In stationary operation, engage all the locking brakes on the trolley and check
that they are working properly.

2.12.5 Falling objects


Objects placed on the hood may fall off, injuring the patient.
► Remove all objects before opening the hood.

2.12.6 Wear and material fatigue


Wear and material fatigue on the components may lead to device malfunctions and
other faults. There is a risk of injury.
► Check the device and reusable products for signs of wear (e.g., cracks,
deformation, discoloration, or detachment) and replace if necessary.
► Perform service measures at the specified intervals.
► Replace the fan impeller when damaged.
► Check that the side access panels, the front access panel, and the hand ports
lock securely, and repair if necessary.

Instructions for use Babyleo TN500 SW 1.0n 17


Safety-related information

2.13 Thermal radiation and fire prevention


2.13.1 Radiant warmer
Thermal radiation from the radiant warmer may cause increased water loss, skin
burns, and eye damage in the patient.
► Do not leave the patient unattended during radiant warmer operation.

2.13.2 Fire prevention


Objects placed on the housing of the radiant warmer or on the protective grid may
melt or fall off, injuring the patient. There is a risk of fire.
► Do not place objects (e.g., towels) or combustible materials over the housing of
the radiant warmer or hang them in front of the protective grid.
► Do not obstruct the ventilation slots on the radiant warmer and do not cover
them with combustible materials.
► In radiant warmer operation remove the hood cover and ensure a safety
clearance of 20 cm (8 in) between the top edge of the radiant warmer and the
ceiling.

30230
Fig. 2 Radiant warmer protective grid
The radiant warmer may heat up objects in the beam path close to the radiant
warmer to such an extent that touching the objects causes burns. In addition, the
objects may ignite and cause a fire.
► Do not permanently locate objects (e.g., examination lights) in the beam path of
the radiant warmer.
► Allow the objects to cool down before touching, to avoid burns.
► Before pivoting accessories (e.g., examination lights) out of the beam path of the
radiant warmer, take precautions to prevent burns.

2.13.3 Additional heat sources


The temperature in the patient compartment may rise to dangerous levels due to
direct sunlight or other external heat sources (e.g., phototherapy devices). The
patient may become overheated.
► When additional heat sources (e.g., solar radiation, examination lights, or
phototherapy lights) are active, make sure that the temperature in the patient
compartment remains non-critical.
► Check the patient's body core temperature at regular intervals.

18 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

2.13.4 Air flow in the warm air duct


If the warm air duct in the device becomes blocked or covered, thermoregulation is
disrupted. The hot air flow may reach the patient directly, causing burns.
► Do not block or cover the warm air duct (1) and do not deflect the hot air flow to
the patient using objects (e.g., blankets).

The warm air duct passes through the air ducts of the X-ray flap. The convective
heater directs the warm air through the air ducts of the X-ray flap into the patient
compartment.

30231
1

Fig. 3 Air ducts of the X-ray flap

2.14 Therapy and applications


2.14.1 Ambient conditions
If the permissible ambient conditions are not complied with, the values set for
humidity and temperature in the patient compartment may not be achieved. The
patient may be put at risk.
► Be aware of and comply with the permissible ambient conditions. For further
information, see the following chapter: ''Technical data'' (page 188)

2.14.2 Therapy settings


If the therapy settings are unsuitable for the patient, the patient may be put at risk.
► Before starting therapy, check the therapy settings carefully. Adjust the therapy
settings to the needs of the patient, e.g., after transferring patient data to a new
device, after transferring data via a USB port, after changing the operating
mode, when using the default settings.
► Measure the body core temperature at regular intervals using a separate
thermometer.

Instructions for use Babyleo TN500 SW 1.0n 19


Safety-related information

2.14.3 Increased CO2 concentration in the patient compartment


If the device does not have the "Tolerate cooling" option, it must be switched off to
cool down. When the device is switched off, an inadequate supply of fresh air may
result in an increase in CO2 in the patient compartment. This may put the patient at
risk.
► Ensure that the patient has an adequate supply of fresh air when the device is
switched off (e.g., by opening a hand port or a side panel).

2.14.4 Skin temperature sensors


Incorrect use of the skin temperature sensors may result in hypothermia or
hyperthermia. Reused skin temperature sensors may transmit pathogens or may be
defective and result in incorrect measurements. The patient is put at risk.
► Only use skin temperature sensors approved for the device.
► The skin temperature sensors are disposable products: Do not reuse,
reprocess, or sterilize.
► Incorrect interpretation of the values may result in hypothermia or hyperthermia.
► Do not use the skin temperature sensor as a clinical thermometer and do not
use it to measure rectal temperature.
► Use dry skin temperature sensors only.
► Use covers recommended by Dräger only, e.g., ThermoPad sensor covers or
similar covers with aluminum film.
► Check the position of the skin temperature sensors at regular intervals.
► Place the yellow skin temperature sensor in the liver or kidney region only.
► Place the white skin temperature sensor on the foot or hand only.
► Do not place the skin temperature sensors under the patient.
► The device cannot distinguish between an increase in body core temperature
when the skin is cold (e.g., with a fever) and a low body core temperature (e.g.,
with hypothermia). Do not use skin temperature mode in cases of fever or
shock.
► If skin temperature sensors are connected, do not use radio-frequency surgical
equipment, endocardial catheters, or defibrillators.

2.14.5 Air temperature in the device


The following situations may lead to hypothermia or hyperthermia in the patient:
– The hand ports or access panels are left open.
– The mattress tray or x-ray tray is left pulled out.
► Only open the hand ports or access panels temporarily and only for as long as is
necessary.
► Only pull out the mattress tray or x-ray tray temporarily and only for as long as is
necessary.

20 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

2.14.6 Heated mattress


If the heated mattress (option) is used as the only source of heat, the patient may
be put at risk.
► Provide the patient with the heated mattress and another source of heat,
especially if the patient is cold.
► Monitor the body core temperature of the patient with a thermometer.
► Do not leave the patient unattended.
► If the heated mattress is connected, do not use radio-frequency surgical
equipment, endocardial catheters, or defibrillators.

2.14.7 Transdermal plasters


If a plaster treated with an active agent (transdermal plaster) is applied to the
patient's skin during warming therapy, too much of the active agent may be
released. This may put the patient at risk.
► Do not apply transdermal plasters to the patient's skin during and prior to
warming therapy, or be aware of the possibility that the active agent may be
absorbed too rapidly.

2.14.8 Sensor unit


If the slots on the sensor unit become blocked, malfunction may be caused.
► Make sure that the slots on the sensor unit are kept clear at all times.

Instructions for use Babyleo TN500 SW 1.0n 21


Safety-related information

2.15 Safety during cleaning and service


2.15.1 Risk of infection
The device must be reprocessed, otherwise there is an increased risk of infection
and the function of the device may be impaired.
► Disinfect and clean the device thoroughly before using it for the first time, and
then once a week and every time the patient changes.
► Follow hospital hygiene regulations, including reprocessing intervals and
reprocessing procedures.
► Use validated reprocessing procedures.
► Reprocess reusable products after every use.
► Follow the manufacturer's instructions in respect of cleaning agents and
disinfectants.
► Reprocess the product as described in ''Reprocessing'' before carrying out
service work or returning it for repair.

2.15.2 Disinfectants and cleaning agents


Residues of disinfectants or cleaning agents left in the device after reprocessing
may put the patient at risk due to irritation to the skin or mucous membranes.
► Observe the instructions relating to disinfectants and cleaning agents.
► Make sure that the device is adequately ventilated after reprocessing.

2.15.3 Service
This product must be serviced at regular intervals and in the appropriate manner.
Failure to perform service measures correctly may result in personal injury and
property damage.
► Perform service work as described in ''Service''.
► Service work must only be performed by the target groups authorized to perform
the work in question.
► Only carry out service measures when there is no patient in the device.
► Perform calibration, adjustment, and verification of the scale (option) at the
specified intervals.

2.15.4 Undetected damage to the device


Reprocessing, wear and tear, and improper storage may damage the device. The
functional integrity of the device is no longer guaranteed. The patient is put at risk.
► Comply with the ambient conditions for operation and storage of the device.
► If a device is behaving suspiciously or is clearly malfunctioning, replace it with a
device in proper working order.

22 Instructions for use Babyleo TN500 SW 1.0n


Safety-related information

2.16 Safety instructions for accessories


2.16.1 Accessories
The approved accessories for this product are included in the list of accessories
and listed in declarations by Dräger (e.g., declaration of conformity). The use of
other accessories may adversely affect the functional integrity of the product and
lead to personal injury and property damage.
► Only use approved accessories.
► Only installation personnel are authorized to mount accessories.
► Observe the current list of accessories and the assembly instructions of the
device.
► Observe the instructions for use and assembly instructions for the accessories.
► Observe the weight limit for attached accessories.
► When attaching accessories, make sure that the device does not tip over.

2.16.2 Ventilation
The temperature measurement for breathing gas humidification may be distorted by
the radiant warmer or the incubator temperature. There is a risk of hypothermia if
the breathing gas is too cold and of suffocation due to condensate formation.
► Follow the instructions for use of the humidifier in conjunction with the
instructions for use of the breathing hose.

2.16.3 Hoses and cables


If the device or the trolley is moved in an uncontrolled manner, patient treatment
may be interrupted. The patient is put at risk.
► When using the height adjustment mechanism and the trolley, always make sure
that connected hoses and cables are not accidentally disconnected.
► Lock the double castors on the trolley with the locking brakes.
► Only use hoses and cables of sufficient length.
► Route hoses and cables into the patient compartment through the hose
grommets.
► Do not run hoses and cables over the hood arm.

2.16.4 Objects in the patient compartment


If objects are placed in the patient compartment, the patient may be infected by
pathogens. The patient may swallow parts and choke.
► Do not place any objects in the patient compartment.

2.16.5 Working light


Conducting a medical examination of the patient without the use of lighting with
neutral colors may cause e.g., misinterpretation of the skin color.
► Do not use the working light on the device when examining the patient.
► Always use an examination light in accordance with the standard IEC 60601-2-
41 when examining the patient.

Instructions for use Babyleo TN500 SW 1.0n 23


Product description

3 Product description
3.1 Structure and function
This chapter contains descriptions of the device components in table format.

Some components and functions are options. The actual device may differ in
appearance and functions from the descriptions below. For further information,
see the following chapter: ''Range of functions'' (page 41).

3.1.1 Overview of operating modes


The device can be operated as an incubator and as a radiant warmer. Opening or
closing the hood changes the operating mode.

30273

Fig. 4 Incubator operation (hood closed) and radiant warmer operation (hood
open)

The user's operating location can be on the right side, on the left side, or at the
front of the device.

24 Instructions for use Babyleo TN500 SW 1.0n


Product description

3.1.2 General view

28227
1 2

15
4
14

5
13

12

11
7

8
9
10

Fig. 5 General view of the device (incubator operation, hood closed)

No. Designation Description


1 Radiant warmer Warms the patient in radiant warmer operation
and during transition.
2 Working light Illuminates the patient compartment.
3 Display unit Provides access to the user interface via
touchscreen and rotary knob.
4 Main column Houses the display unit and the alarm light.
Accessories such as arms, etc., can be
mounted on the side duct rails.
5 Handles For pushing or pulling the device.
6 Hose grommets Located at the 4 corners, for routing cables
and hoses into the patient compartment.
7 Gas cylinder holder (option) For securing oxygen cylinders or compressed
air cylinders.
8 Lifting column For adjusting the height of the device.

Instructions for use Babyleo TN500 SW 1.0n 25


Product description

No. Designation Description


9 Trolley For moving the device. The 4 double castors
on the trolley are fitted with locking brakes. A
double castor can be locked as a swivel cas-
tor.
The locking brake on the castor is marked with
a product label and has 3 positions:
– Upper position (green arrow): The castor
can only be moved in the longitudinal direc-
tion. Serves to push the device in a straight
line.
– Middle position (green lock): The castor
can be moved in any direction.
– Lower position (red lock): The castor is
locked.
10 Foot pedals Move the device up or down.
11 Hand ports Provide access to the patient.
12 Handles Allow a second person to steer the device.
13 Patient compartment Provides the patient with warm air, which can
be humidified and enriched with oxygen.
14 Hood Closes the patient compartment. Can be man-
ually opened or closed.
15 Hood arm Attaches the hood to the main column. Con-
tains the mechanism for opening and closing
the hood.

26 Instructions for use Babyleo TN500 SW 1.0n


Product description

3.1.3 Detailed view of the patient compartment

27221
15 16 1
14 2

3
13

12
6

7
8
11
9
10

Fig. 6 Patient compartment

No. Designation Description


1 Sensor unit for temperature Measures the air temperature and humidity in
and humidity the device.
2 O2 sensors (option) Measure the oxygen concentration in the
device.
3 Noise and light sensors Measure the volume and the brightness in the
(option) patient compartment.
4 Night light Illuminates the darkened patient compartment.
5 Mattress tray control panel For adjusting the height and tilt of the mattress
tray (on both sides).
6 Warm air duct Directs warm air at the sides of the mattress
tray into the patient compartment.
7 X-ray flap Provides access to the x-ray tray on both
sides, with space for an x-ray cassette or for a
digital x-ray detector.
8 Potential equalization pin For potential equalization during surgical pro-
cedures.
9 Moodlight Illuminates the environment in a choice of col-
ors.
10 Drawer (option) Used as a storage compartment, contains an
insert, and can be locked.
11 Standard rail Used for fixing accessories to the device, e.g.,
Babylog VN500 bed coupling, suction unit.
12 Bed support Holds the x-ray tray and the scale (option).
13 Front access panel Provides access to the patient. Can be hinged
down.

Instructions for use Babyleo TN500 SW 1.0n 27


Product description

No. Designation Description


14 Side access panel Provides access to the patient from the side
(both sides). Can be hinged down.
15 Heated mattress (option) Warms the patient from below. Alternatively,
the SoftBed mattress can be placed on the
mattress tray.
16 Mini-walls Hold the mattress in place.

3.1.4 Detailed view of the main column

27220
1 2 3

5 4
6

7
11 8

10

Fig. 7 Rear of the main column

No. Designation Description


1 Main switch Switches the device off completely.
2 Serial port (COM) For connecting devices via the MEDIBUS.X
software protocol
3 Nurse call port Connects the device to the central hospital
alarm system.
4 USB port For connecting a USB mass storage device for
the import and export of configuration data and
patient data.
5 Service port (RJ45) Connects the device to the service PC for ser-
vicing purposes.

28 Instructions for use Babyleo TN500 SW 1.0n


Product description

No. Designation Description


6 Water bag holder Used to attach the water bag for the humidifier
and can be pulled out.
7 Opening For routing rigid hoses, e.g., a breathing hose.
8 Standard rail Used for fixing accessories to the device, e.g.,
Babylog VN500 bed coupling, suction unit.
9 Power cable connection Connects the device to the mains power sup-
ply.
10 Oxygen connector (option) For connecting the device to an oxygen cylin-
der or to a wall terminal unit for the supply of
oxygen from the central gas supply system.
11 Rating plate Shows device-specific information.

Instructions for use Babyleo TN500 SW 1.0n 29


Product description

3.1.4.1 Connectors on the rear sensor wall

27216
1

9
8
7

Fig. 8 Connectors on the rear sensor wall

No. Designation Description


1 Heated mattress connector For connecting the heated mattress (option) to
(orange) the device.
2 Scale connector (gray) For connecting the scale (option) to the
device.
3 Central skin temperature For connecting the skin temperature sensor for
sensor connector (yellow) measuring the central skin temperature to the
device.
4 Peripheral skin tempera- For connecting the skin temperature sensor for
ture sensor connector measuring the peripheral skin temperature to
(white) the device.
5 Ventilation slot (in front of Used to discharge air.
the power supply unit)
6 Luer Lock connector Connects the water bag hose to the humidifi-
cation system of the device.
7 Audio connector (option) For connecting an audio cable from an exter-
nal playback device.

30 Instructions for use Babyleo TN500 SW 1.0n


Product description

No. Designation Description


8 Filter cloth for patient air (in Filters the ambient air before it enters the
the sensor wall) patient compartment.
9 Sensor wall Contains the device's sensors and has con-
nections at the rear.

3.1.5 Display unit

27215
1

8 7 6 5 4

Fig. 9 Display unit

No. Designation Description


1 Alarm light Visual alarm indicator.
2 Touch screen Used for operating the graphical user inter-
face.
3 Rotary knob Used for setting and confirming set values.
4 Alarm suppression The "Audio paused" key suppresses the
acoustic alarm signal for all active alarms for a
certain period of time. For further information,
see the following chapter: ''Suppressing and
delaying the alarm signal'' (page 127)
5 Working light The key switches the working light on the
radiant warmer on and off. There is a choice of
3 light intensities.
6 Night light The key switches the night light in the
patient compartment on and off.
7 Power supply indicator Indicates the mains power supply status.
Mains power supply present: LED lights green.
8 Start/standby key The key switches the device on or off.

Instructions for use Babyleo TN500 SW 1.0n 31


Product description

3.2 Screen views


This chapter describes the structure of the main screen and the basic control
options.

The actual screen views may differ in appearance or configuration. The screen
views in these instructions for use show the maximum range of functions of the
device. The set values shown in the screen views are for illustration purposes
only. For further information, see the following chapter: ''Range of
functions'' (page 41)

3.2.1 Main screen


The main screen shows the most important warming therapy information.

28500
1
2

6 5

Fig. 10 Structure of the main screen

No. Designation Description


1 Header bar Shows active alarms, patient data, the stop-
watch, and the APGAR timer. In the header
bar, the symbol and the remaining alarm
silence time are displayed.
2 Alarm message field Shows up to 3 active alarms at the same time.
Alarm priority is indicated by different back-
ground colors.
3 All alarms Shows that there are more than 3 active
alarms. Touch the button to display all current
alarms.
Alarm reset Indicates that the current alarms can be reset.

32 Instructions for use Babyleo TN500 SW 1.0n


Product description

No. Designation Description


4 Main menu bar Contains buttons for opening dialog windows
and activating functions.
5 Therapy bar Provides access to therapy modes and ther-
apy settings.
6 Monitoring area Displays various parameters. If there is an
active alarm for a parameter, the background
of the corresponding parameter flashes.

3.2.2 Main menu bar


This chapter describes the main menu bar.

28477
1

Fig. 11 Main menu bar on the main screen

No. Designation Description


1 Alarms... Opens the dialog window for setting the alarm
limits and shows current alarms and the alarm
history.
2 Views... Switches the screen view between Main,
Thermomonitoring, Developmental care
and Family.
3 Lock... Activates the locking and unlocking of the
height adjustment, the bed-tilt mechanism,
and the touchscreen.
4 Trends/data... Opens the dialog window to display graphical
and tabular trends, measured values and set-
tings, and the logbook.

Instructions for use Babyleo TN500 SW 1.0n 33


Product description

No. Designation Description


5 Special procedures... Opens the dialog window for selecting special
procedures, e.g., warm-up or weaning (option)
or humidifier cleaning.
6 Scale... (option) Opens the dialog window for weighing the
patient.
7 Timer... Provides access to the APGAR timer and the
stopwatch. Touch the APGAR or Stopwatch
button to deselect it.
8 System setup... Opens the dialog window for configuring
device functions and entering patient data.

3.2.2.1 Timer
The APGAR timer or stopwatch can be activated using the Timer... button in the
main menu bar.

When the APGAR timer has been started, a signal tone is emitted after one
minute, after 5 minutes, and after 10 minutes. The stopwatch counts up to
99:59 minutes.

Procedure:
1 Touch the Timer... button in the main menu bar.
 The Timer dialog window is displayed.
2 Touch the APGAR or Stopwatch button.
 The selected timer is displayed in the header bar.
3 To use a timer, proceed as follows:
a Touch the button next to the timer.
b Select Start, Stop, or Reset.
c To deactivate the timer, touch the Timer... button in the main menu bar.
d In the Timer dialog window, touch the timer that should be deactivated.
✓ The button turns light green. The timer disappears from the header bar.

34 Instructions for use Babyleo TN500 SW 1.0n


Product description

3.2.3 Quick setup dialog window


There are two ways of setting the alarm limits:
– Via the main menu bar in the Alarms... dialog window
– Via the Quick setup dialog window

28482
Fig. 12 Quick setup dialog window for the air temperature (example)
The quick setup dialog window for the alarm limits can be opened by touching the
following parameter fields in the monitoring area:
– Skin temperature
– Air temperature
– Oxygen (option)
– Noise level (option)
– Light level (option)

Instructions for use Babyleo TN500 SW 1.0n 35


Product description

3.2.4 Standard view in incubator operation


The following screen view shows the setting options and display values in incubator
operation (hood closed).

27240
1

5
6
7
8

13 12 11 10 9

Fig. 13 Standard view in incubator operation with air temperature mode activated

No. Designation Description


1 Skin temp. Shows the current skin temperature measure-
ment.
2 Air temp. Shows the current air temperature measure-
ment in the patient compartment.
3 Mattress (option) Shows the current mattress core temperature
measurement.
4 Oxygen (option) Shows the current oxygen concentration mea-
surement in the patient compartment.
5 Humidity Shows the current humidity measurement in
the patient compartment.
6 Skin mode Selects skin temperature mode.
7 Air mode Selects air temperature mode.
8 Kangaroo mode Selects kangaroo mode.
9 ClearView on Reduces condensation on the inside of the
hood.
10 Mattress (option) Used for setting the mattress core tempera-
ture.
11 Oxygen (option) Used for setting the oxygen concentration in
the patient compartment.

36 Instructions for use Babyleo TN500 SW 1.0n


Product description

No. Designation Description


12 Humidity Used for setting the humidity in the patient
compartment.
13 Air temp. Used for setting the air temperature in the
patient compartment.

3.2.5 Standard view in radiant warmer operation


The following screen view shows the setting options and display values in radiant
warmer operation (hood open).

27253
1

4
5
6

8 7

Fig. 14 Standard view in radiant warmer operation with manual mode activated

No. Designation Description


1 Skin temp. Shows the current skin temperature measure-
ments.
2 Radiant warmer Shows the current power of the radiant
warmer as a percentage.
3 Mattress (option) Shows the current mattress core temperature
measurement.
4 Skin mode Selects skin temperature mode.
5 Manual mode Selects manual mode.
6 Kangaroo mode Selects kangaroo mode.
7 Mattress (option) Used for setting the mattress core tempera-
ture.
8 Warmer Used for setting the radiant warmer power.

Instructions for use Babyleo TN500 SW 1.0n 37


Product description

3.2.6 Thermomonitoring
Thermomonitoring is the continuous measurement and display of the central and
peripheral skin temperature, even when skin temperature mode is not active.

The Views... button is used to switch between the Main, Thermomonitoring,


Developmental care and Family screen views.

27264
1

Fig. 15 Thermomonitoring screen view

No. Designation Description


1 Central Shows the central skin temperature.
2 Peripheral Shows the peripheral skin temperature.
3 Difference Shows the difference between the central and
the peripheral skin temperature.
4 Skin temp. Shows the patient's skin temperature values
as a graphical trend.

38 Instructions for use Babyleo TN500 SW 1.0n


Product description

3.2.7 Developmental care


In the course of developmental care the noise level and the light level in the device
can be measured. The Developmental care screen view shows how the volume
and light vary over a period of time. This requires the "Developmental Care"
package to be installed.

27247
1

4 3

Fig. 16 Developmental care screen view

No. Designation Description


1 Noise level Shows the measured noise level in dB(A) as a
graphical trend.
2 Light level Shows the measured light level in lux or fc as
a graphical trend.
3 Light level Shows the current light level measurement in
lux or fc.
4 Noise level Shows the current noise level measurement in
dB(A).

Instructions for use Babyleo TN500 SW 1.0n 39


Product description

3.2.8 Family
If the patient's parents are present at the device, the Family screen view can be
selected. Only the most important therapy settings are displayed in this screen
view.

The therapy values and settings cannot be changed in this screen view. To
change the screen view, press the rotary knob.

27250
3 2 1

Fig. 17 Family screen view

No. Designation Description


1 Therapy settings Show the current therapy settings (green
background).
2 Therapy values Show the current therapy value measurements
in the patient compartment.
3 Patient data Show, e.g., the patient's name, age, and
weight.

40 Instructions for use Babyleo TN500 SW 1.0n


Product description

3.3 Range of functions


Some functions are options. The actual device may differ in appearance and
functions from the descriptions below.

3.3.1 Basic device


– Convection heater and radiant warmer
– Humidity regulation with condensation management
– Therapy modes
– Air temperature
– Skin temperature
– Kangaroo mode
– Transition between incubator operation and radiant warmer operation
– Height adjustment of the device
– Electronic bed-tilt mechanism
– Ergonomic access to patient compartment via hand ports, side access panels,
and hood
– Color touch screen
– X-ray tray
– Alarm management
– Light
– Working light
– Night light
– Moodlight
– Closed humidification system with automatic humidifier cleaning
– Data transfer via MEDIBUS.X
– Duct rails for fitting of accessories, e.g., monitors, syringe pumps, shelves

3.3.1.1 Options
– Scale (standard or NAWI/OIML certified)
– Heated, x-ray transparent mattress
– Drawer
– Oxygen regulation in the patient compartment
– Up to 2 gas cylinder holders
– AutoThermo package for advanced therapy applications
– Tolerate cooling
– Warm-up
– Weaning
– Developmental care package
– Audio stimulation
– Measurement of light level and noise level in the patient compartment
The device is intended for use with the accessories indicated in the list of
accessories.

Instructions for use Babyleo TN500 SW 1.0n 41


Product description

3.3.1.2 Monitoring
The device can monitor the following parameters and events (some are only
available if the corresponding option was selected):
– Thermomonitoring: skin temperature
– Air temperature
– Mattress core temperature (option)
– Relative humidity
– O2 concentration in the patient compartment (option)
– Noise level in the patient compartment (option)
– Light level in the patient compartment (option)
– Patient weight (option)
– Convection heater power
– Radiant warmer power
– Occurrence of Hood open and Access panel open events
– Kangaroo mode

3.3.1.3 Displays on the screen


The device has the following display types:
– Graphical trends
– Tabular trends
– Alarm history
– Logbook

3.3.1.4 Protocoling
The device can save the following data, among other things, in a logbook:
– Measured values
– Set values and changes to values
– Patient data
– Events (e.g., alarms, confirmed alarms)
– Test results

3.3.1.5 Gas supply variants

Gas Integrated Type Pressure reducer


O2 Yes The oxygen regulator is con- Dräger pressure reducer or
(option) nected to the central gas third-party pressure reducer
supply or to a compressed (using country-specific NIST
gas cylinder connection or DISS connection)
Air No A compressed gas cylinder Dräger pressure reducer or
is connected to an external third-party pressure reducer
ventilation unit

42 Instructions for use Babyleo TN500 SW 1.0n


Product description

3.3.1.6 Data exchange and ports


Serial port
A serial port (COM port) is provided for data communication with the Dräger
MEDIBUS.X data protocol.

USB port
The USB port enables the following actions to be carried out once a USB mass
storage device (e.g., USB flash drive from Dräger) has been connected:
– Saving and loading device configurations
– Saving and loading patient configurations

Service port
Specialized service personnel can connect the device to a DrägerService computer.
The following are used:
– Device status queries
– Support of software installation

3.3.2 Frequently used functions


Operation
Operating the hand ports and access panels Page 53
Opening and closing the hood Page 52
Adjusting the device height Page 48
Adjusting the mattress tray Page 49
Opening and closing the drawer Page 27

Alarms
Setting alarm limits for modes and therapy controls Page 63
Suppressing the acoustic alarm signal Page 127
Dismissing the alarm message Page 130

Switching between therapy modes


Incubator operation Air temperature mode Page 85
Skin temperature mode Page 77
Radiant warmer operation Manual mode Page 91
Skin temperature mode Page 77

Setting therapy parameters


Air temperature Page 87
Skin temperature Page 82
Radiant warmer power Page 92
Mattress core temperature Page 103
Humidity Page 95
Oxygen in the patient compartment Page 97

Monitoring therapy parameters


Air temperature Page 85

Instructions for use Babyleo TN500 SW 1.0n 43


Product description

Monitoring therapy parameters


Skin temperature Page 77
Radiant warmer power Page 91
Mattress core temperature Page 100
Humidity Page 94
Oxygen in the patient compartment Page 96

44 Instructions for use Babyleo TN500 SW 1.0n


Operating concept

4 Operating concept
4.1 Display unit
This chapter describes how to change the therapy settings using the display unit.
The chapter also explains how the device supports the user in operating the device
by means of visual and textual indicators (color signals, information texts, alarm
texts).

4.1.1 Selecting a therapy mode


1 Touch the tab (1) on the user interface (e.g., the Skin mode tab).
 The tab turns yellow.

30607
1

Fig. 18 Selecting a therapy mode


2 Press the rotary knob (2) to confirm.
 The selection is adopted.
✓ The tab turns dark green.

Instructions for use Babyleo TN500 SW 1.0n 45


Operating concept

4.1.2 Setting a parameter


1 Touch the therapy control (1) on the user interface (e.g., the Skin temp. tab).
 The therapy control turns yellow.

30608
1

2
3

Fig. 19 Setting a parameter


2 Turn the rotary knob (2) to the right or left to set a parameter (e.g., the skin
temperature value).
 The desired value is displayed in the therapy control.
3 Press the rotary knob (3) to confirm.
 The selected value is adopted.
✓ The therapy control turns dark green.

4.1.3 Colors of the control elements


Colors indicate the availability of functions and settings, e.g., for the following
control elements:
– Therapy controls and buttons
– Rotary knob
– Therapy bar
– Dialog windows
The following illustration shows the color scheme for the tabs:

46 Instructions for use Babyleo TN500 SW 1.0n


Operating concept

30607
4 3 2 1

Fig. 20 Meaning of the colors of control elements

No. Color Meaning


1 Gray Unavailable element
2 Light green Selectable element, function not activated
3 Dark green Selected element, function activated
4 Yellow Selected element, not yet confirmed

Backlighting of the rotary knob


When the device is ready for operation, the rotary knob is backlit in color. The
following table shows the meaning of the colors:
Color Meaning
Blue The most recently selected and confirmed therapy is running.
Yellow The selected function or setting has to be confirmed with the rotary
knob.

System support for unconfirmed selections


Using the example of the tabs and therapy controls, the following points show how
the device responds to an unconfirmed selection:
– If a selection has not been confirmed, a prompt indicates the unconfirmed
function or setting.
– If a selection remains unconfirmed for more than 10 seconds, the prompt
flashes blue. The backlighting of the rotary knob flashes yellow and an acoustic
signal sounds.
– If a selection remains unconfirmed for more than 15 seconds, the rotary knob
and prompt stop flashing. The device resets the selection. An alarm text warns
the user that the function or setting has not been adopted.

Instructions for use Babyleo TN500 SW 1.0n 47


Operating concept

4.2 Adjusting the device height


The height of the device can be adjusted with the lifting column. The lifting column
is controlled by means of 2 foot pedals on the trolley.
Prerequisites:
– The device is in operation.
– The device height adjustment mechanism is not locked.

WARNING
Risk of electric shock
If height adjustment is actuated and the power cable is trapped or wrapped around
a castor, the power cable may tear.
► When positioning the device, ensure that the power cable is not trapped.
► Be aware of the length of the power cable when operating the height
adjustment.
► During intrahospital transport, do not push the device over the power cable.

WARNING
Risk of injury by collision with compressed gas cylinders
When height adjustment is actuated, accessories on the duct rail may collide with
the gas cylinders.
► Actuate height adjustment with caution and stop it promptly.

WARNING
Risk to patient if hoses and cables are too short
Hoses and cables may be subjected to tensile loading when opening the hood,
moving the device, or actuating the device height adjustment. This risk applies
especially if the hoses and cables are routed into the patient compartment across
the hood.
► Choose hoses and cables that are long enough to perform the above
movements safely.
► Do not route hoses and cables across the hood; always pass them into the
patient compartment via the hose grommets.
► Pay attention to the hoses and cables when carrying out the above movements.

WARNING
Unintentional disconnection of hose and cable connections
Possible interruption to patient treatment due to uncontrolled movement of the
device via height adjustment or the trolley.
► When using the height adjustment mechanism and the trolley, always ensure
that no hoses and cables become disconnected.
► Lock the double castors on the trolley with the locking brakes.

48 Instructions for use Babyleo TN500 SW 1.0n


Operating concept

CAUTION
Risk of injury due to collision when using height adjustment
The radiant warmer or accessories may collide with obstacles when the device
height is raised. The patient may be injured by the jolting. The radiant warmer and
the accessories may be damaged.
► Make sure there is sufficient space above the radiant warmer and the installed
accessories.
► Stop the device promptly ahead of any possible obstacle.

Procedure:
1 Adjust the device height using the foot pedals:
– The right-hand foot pedal (1) moves the device up.
– The left-hand foot pedal (2) moves the device down.

28263
2 1

Fig. 21 Foot pedals


✓ The device height is set.

4.3 Adjusting the mattress tray


The height and tilt of the mattress tray can be adjusted by means of the buttons on
the mattress tray control panel.
Prerequisites:
– The device is in operation.
– The bed-tilt mechanism is not locked.

WARNING
Risk of injury when adjusting the mattress tray
If the mattress tray is adjusted without due care, parts of the body may become
trapped. If an external ventilator is being used, the patient may be accidentally
extubated.
► When lowering or tilting the mattress tray, make sure that no part of the patient's
body or user's body is within the hazard areas.
► The height adjustment and bed-tilt mechanism must only be operated by a
single user.
► If the mattress tray is pulled out, operate the device height adjustment with
caution and stop it promptly ahead of an obstacle.
► Ensure that hoses of a sufficient length are used when using an external
ventilator.

Instructions for use Babyleo TN500 SW 1.0n 49


Operating concept

CAUTION
Uneven heat distribution
If the mattress tray is tilted, heat may be unevenly distributed on the mattress tray.
► If the mattress tray is tilted, make sure that the patient is adequately warmed.

Procedure:
1 Adjust the mattress tray height with the upper buttons:
– The right-hand key (1) raises the mattress tray.
– The left-hand key (2) lowers the mattress tray.

28262
1
2

Fig. 22 Mattress tray control panel


– In incubator operation set the lowest position for the mattress tray so that
there is as much space as possible for the patient. This position also offers
good access to the patient.
 When the lowest position is reached, the LED in the button (2) goes out.
– In radiant warmer operation Dräger recommends setting the highest position
for the mattress tray. This position provides the most effective warming for
the patient. This position also offers good access to the patient.
 When the highest position is reached, the LED in the button (1) goes out.
2 Adjust the bed-tilt mechanism with the lower buttons:
– The two keys (3 and 4) tilt the mattress tray in the direction of the arrow.

28262

3
4

Fig. 23 Mattress tray control panel


When the mattress tray reaches the horizontal position, the mattress tray
stops automatically. The mattress tray can be tilted further by pressing the
corresponding button again.

 When the maximum mattress tray tilt is reached, the LED in the button (3 or
4) goes out.
✓ The height and tilt angle of the mattress tray are set.

50 Instructions for use Babyleo TN500 SW 1.0n


Operating concept

4.3.1 Mattress
The heated mattress or the SoftBed mattress can be placed on the mattress tray.
Procedure:
1 Place the mattress on the mattress tray.
2 Cover the mattress with a sheet.
For further information, see the following chapter: ''Connecting the heated
mattress'' (page 101)

4.4 Hood
This chapter describes how to open and close the hood.

4.4.1 Overview of the direction of movement


The hood is attached to the hood arm. The illustration below shows the direction of
movement when the hood is opened.

28260

Fig. 24 Direction of movement of the hood

Instructions for use Babyleo TN500 SW 1.0n 51


Operating concept

4.4.2 Opening and closing the hood


The hood can be opened and closed manually.

CAUTION
Risk of injury due to unexpected opening or closing of the hood
Opening or closing the hood unexpectedly may cause head or other injuries to
people nearby.
► Make sure that no-one else is using the device at the same time and that there is
no-one else in the vicinity of the hood.

CAUTION
Risk from falling objects
Objects placed on the hood may fall off, injuring the patient.
► Remove all objects before opening the hood.

Procedure:
1 To open the hood, take hold of the handle at the side of the hood and lift it
forwards and up.
 The hood moves up.
2 To close the hood, pull the handle at the side of the hood downwards.
 The device closes the hood automatically at the end.

4.5 Hand ports and access panels


This chapter describes how to operate the hand ports and access panels.

4.5.1 Overview of the access options


The patient can be cared for in the patient compartment via the following panels
and ports:
– On each side of the device there is a side access panel (1) with 2 hand ports (4).
– On the front of the device there is the front access panel (2) with one hand port
(3).

28257

1
2

Fig. 25 Access panels and hand ports

When the hand ports or access panels are open, a warm air curtain remains in
place, preventing the patient compartment from cooling down.

52 Instructions for use Babyleo TN500 SW 1.0n


Operating concept

4.5.2 Operating the hand ports and access panels


The locks on the hand ports are used for opening and closing. The locks can also
be operated with the elbow.

WARNING
Risk of falling out
If the access panels or the hand ports are open or the mattress tray has been pulled
out, there is a risk of the patient falling out of the device.
► Check that the access panels and hand ports are securely locked.
► Monitor the patient when the access panels or the hand ports are open or the
mattress tray is pulled out.

Procedure:
Operating the hand ports
1 To open the hand port, push down the ridged part of the lock (1) with the hand or
elbow.
 The hand port opens.
2 To close the hand port, allow the lock (1) to audibly engage.
 The hand port is closed.

28257
1

Fig. 26 Locks on the hand ports


Operating the access panels
1 To open an access panel, take hold of the recessed grip located in the middle
underneath the top edge of the access panel.
2 Gently raise the access panel and fold it down. In the case of the front access
panel, gently raise the hood. Raise the front access panel and fold it down.
 The access panel hangs vertically down towards the floor.
3 To close an access panel, fold it up and lower it slightly.
 The access panel is closed.

Instructions for use Babyleo TN500 SW 1.0n 53


Operating concept

4.5.3 Pulling out the bed support


The bed support can be pulled out of the device on both sides, e.g., to remove the
patient for kangarooing. If the mattress tray is tilted or raised, leave sufficient space
above the patient.
Procedure:
1 Lower the mattress tray and position it horizontally.
2 Open one of the two side access panels.
3 Open the X-ray flap.
4 Pull out the bed support on one side of the device using the recessed grips (1).

30843
1

Fig. 27 Bed support with recessed grips

54 Instructions for use Babyleo TN500 SW 1.0n


Operating concept

4.6 Locking and unlocking functions


This chapter describes how to lock and unlock functions. Locking a function can
prevent visitors from accidentally adjusting the device settings. The following
functions can be locked:
– Screen
– Device height adjustment
– Bed-tilt mechanism
Prerequisite:
– The device is in operation.
Procedure:
1 Touch the Lock... button (1) in the main menu bar.
 The Lock... dialog window is displayed.

30326
1

3 2

Fig. 28 Dialog windows Lock...


2 Use the following buttons to lock or unlock a function:
– The right-hand button (2) locks the function.
– The left-hand button (3) unlocks the function.
3 Confirm the selection using the rotary knob.
✓ The function is locked or unlocked.

Instructions for use Babyleo TN500 SW 1.0n 55


Assembly and preparation

5 Assembly and preparation


Follow the assembly instructions of the device.

5.1 Maximum load


The maximum total weight including all loads is 220 kg (485 lbs). The maximum
load must not exceed 80 kg (176.4 lbs). The following load limits apply to the
individual areas:

5
1 2

9
8 6

3
7
4

No Area Maximum load Examples


.
1 Duct rail on the side of 15 kg (33.1 lbs) (pivot Syringe pumps, monitors,
the hood arm; refer to arm and accessory) at a suction units, examination
additional information max. arm length of lights, trays
300 mm (11.81 in)
2 Duct rail on the side 12 kg (26.5 lbs) (pivot Syringe pumps, monitors,
without the hood arm; arm and load) at a max. suction units, examination
refer to additional infor- arm length of 300 mm lights, trays
mation (11.81 in)
3 Standard rail, front 2.5 kg (5.5 lbs) Baskets, Babylog VN500
bed coupling, suction unit
4 Drawer (option) 5 kg (11 lbs) Patient accessories
5 Hook for humidifier 3 kg (6.6 lbs) Water bag or water sack
6 Standard rail, rear 2.5 kg (5.5 lbs) Baskets, Babylog VN500
bed coupling, suction unit
7 Gas cylinder holder 10 kg (22 lbs) Oxygen cylinders or com-
(option) pressed air cylinders

56 Instructions for use Babyleo TN500 SW 1.0n


Assembly and preparation

No Area Maximum load Examples


.
8 X-ray tray 3 kg (6.6 lbs) X-ray cassette or X-ray
detector
9 Mattress 5 kg (11 lbs) Patient and patient acces-
sories

Additional information:
The following loading limits apply if only 1 pivot arm is fitted to the device:
Duct rail on the side of the hood arm:
Maximum load Arm length
15 kg (33.1 lbs) max. 300 mm (11.81 in)

Duct rail on the side without the hood arm:


Maximum load Arm length
20 kg (44.1 lbs) max. 300 mm (11.81 in)

Or:
Maximum load Arm length
25 kg (55.1 lbs) max. 250 mm (9.84 in)

The following loading limits apply if a total of 2 pivot arms are fitted to the device:
– Either 15 kg (33.1 lbs) or 12 kg (26.5 lbs) can be fitted to each duct rail.
– The user can decide which weight is fitted to which side of the device.

5.2 Nurse call


5.2.1 Information on the nurse call
The nurse call is used for transmitting high- and medium-priority alarms to a central
hospital alarm system.For further information, see the following chapter: ''Alarm –
Cause – Remedy'' (page 153)
If the acoustic alarm signal of the device fails or the power supply is interrupted, the
nurse call is still activated.
If the "Audio paused" key is pressed during an alarm, the acoustic alarm signal on
the device and the nurse call are suppressed.During this time, any new alarms that
occur do not trigger a nurse call.

Instructions for use Babyleo TN500 SW 1.0n 57


Assembly and preparation

5.2.2 Connecting the nurse call

WARNING
Risk of electric shock
If the interface connectors and the patient are touched at the same time, there is a
risk of an electric shock.
► Do not simultaneously touch the nurse call connector and the patient.

CAUTION
No alarm in event of a nurse call fault
The nurse call may fail in the event of an incorrect device configuration, operating
errors (e.g., nurse call connector incorrectly connected) or a fault in the connection
between the nurse call and the central hospital alarm system.Alarms are not
transmitted.
► Be aware that only high- and medium-priority alarms trigger the nurse call.
► Bear in mind that using the nurse call does not absolutely guarantee that alarms
will be transmitted.
► Take note of alarms directly on the device.

Procedure:
1 Push the nurse call connector into the nurse call socket so that it engages
audibly.

5.3 Adjusting the gas cylinder holder and connecting the


oxygen cylinder
This chapter describes how the gas cylinder holder is matched to the size of the
oxygen cylinder. It also describes how to connect the oxygen cylinder to the device.
Prerequisites:
– The gas cylinder holder is installed on the correct side of the device.
– A full oxygen cylinder is available.
– A pressure reducer has been screwed onto the oxygen cylinder valve.
– The following parts are available:
– Compressed gas hose
– 2 guard plates for the duct rails
– 3 mm hex key

58 Instructions for use Babyleo TN500 SW 1.0n


Assembly and preparation

30229
Fig. 29 Correct side of device for oxygen cylinders

WARNING
Risk of explosion and fire
If oxygen cylinders or devices containing oxygen are installed in the vicinity of the
ventilation slot, oxygen may get into the device at the power supply unit. In the
event of sparking at the power supply unit there is an increased risk of fire, which
may lead to personal injury and property damage.
► Position oxygen cylinders and devices containing oxygen on that side of the
device without the ventilation slot.

WARNING
Risk to patient if unauthorized gases are used
The use of compressed gases that are not approved for medical purposes may
adversely affect the function of the device and put the patient's health at risk.
► Only use compressed gases that are approved for medical use.
► Only use compressed gases that are dry and free from dust and oil.

WARNING
Increased risk of fire from unauthorized oxygen cylinder valves
The use of unauthorized or poorly maintained oxygen cylinder valves presents an
increased risk of fire, which may lead to personal injury and property damage.
► Do not use unauthorized oxygen cylinder valves.
► Make sure that oxygen connectors and oxygen seals are kept free from oil and
dust at all times.
► Always open oxygen cylinder valves slowly.

Instructions for use Babyleo TN500 SW 1.0n 59


Assembly and preparation

WARNING
Risk of crushing if accessories are mounted at too low a height
If compressed gas cylinders are present and accessories are mounted too low
down on the duct rail, hands or fingers may be crushed between the duct rail and
the compressed gas cylinders.
► If compressed gas cylinders are present, do not mount accessories too low
down.
► When lowering the height adjustment, do not touch the compressed gas
cylinders and the accessory arm.

5.3.1 Adjusting the gas cylinder holder

Before installation, set the lifting column to its lowest position. Mount
accessories with the lifting column in its lowest position. Do not mount
accessories too low down.

Procedure:
1 Adjust the bottom of the gas cylinder holder (3) to the height of the oxygen
cylinder. The height of the gas cylinder holder can be set to 2 levels.
2 Ensure that the pressure reducer is pointing towards the rear and protrudes over
the upper edge of the gas cylinder holder.
3 Adjust the height of the protection bar (2) to the size of the oxygen cylinder and
the position of the pressure reducer.

30227
1

Fig. 30 Adjusting the height of the gas cylinder holder


4 Fit the spacers to the duct rails (1) to prevent the accessories colliding with the
oxygen cylinder when the device is lowered.
✓ The gas cylinder holder has been adjusted.

60 Instructions for use Babyleo TN500 SW 1.0n


Assembly and preparation

5.3.2 Connecting the oxygen cylinder


Procedure:
1 Place a full oxygen cylinder in the gas cylinder holder and fasten with the hook-
and-loop straps.
2 Check that the pressure reducer protrudes over the upper edge of the gas
cylinder holder and is secured by the protection bar (4).
3 Feed the compressed gas hose on the rear of the gas cylinder holder
downwards
and secure with the clamp (3).

30228
1

Fig. 31 Connecting the oxygen cylinder


4 Note the contents of the product label on the oxygen connection. Screw the
compressed gas hose to the oxygen connection (1) located closest to the
device.
5 Place the compressed gas hose in the strain relief of the device (2). Screw the
strain relief tight.
✓ The oxygen cylinder is attached.

The gas cylinder holder can also be used for compressed air cylinders.
Compressed air cylinders can be attached to both sides of the device. Further
information about gas cylinders can be found in the technical data.

Instructions for use Babyleo TN500 SW 1.0n 61


Assembly and preparation

5.4 Establishing potential equalization


Differences in electrical potential between devices can be reduced by potential
equalization.
Potential equalization does not replace the protective ground connection.

5.4.1 Connecting the potential equalization cable


1 Connect the potential equalization cable to the potential equalization pin on the
device.
2 Connect the potential equalization cable to the hospital's potential equalization
connection (e.g., wall, ceiling supply unit, operating table).

5.5 MEDIBUS connection for data transfer


This chapter describes the software protocol for data transfer between the device
and an external medical or non-medical device.
MEDIBUS.X is a software protocol for data transfer between the device and an
external medical or non-medical device (e.g., hemodynamic monitors, data
management systems, or computers) via a COM port.
Note the following software protocols before transmitting any data:
– MEDIBUS.X, Rules and Standards for Implementation (9052607)
– MEDIBUS.X, Profile Definition for Data Communication V1.n (9052608)
Prerequisite:
– The MEDIBUS cable is ready to use.

WARNING
Risk of electric shock
If the interface connectors and the patient are touched at the same time, there is a
risk of an electric shock.
► Do not simultaneously touch the COM port and the patient.

CAUTION
Risk to patient due to incorrect data transfer
All data transferred via the COM port are for information only and must not be used
as the sole basis for diagnostic or therapeutic decisions. This may put the patient at
risk.
► Do not use data transferred via the COM port as the sole source of information.

Procedure:
1 Connect an external device to the COM port.
2 Configure the COM port.

62 Instructions for use Babyleo TN500 SW 1.0n


Operation

6 Operation
6.1 Checking for operational readiness
This chapter describes how to check the device for operational readiness. For
further information, see the following chapter: ''Automatic selftest'' (page 202)
Prerequisites:
– The device has been acclimatized in the environment of use for 24 hours prior to
use.
– The device has been reprocessed and assembled ready for operation.
– The mains plug is plugged in.

WARNING
Risk to patient due to undetected damage to the device
Reprocessing, wear and tear, and improper storage may damage parts of the
device such that they no longer function correctly.
► Comply with the ambient conditions for operation and storage of the device.
► Before operating the device, always carry out the test steps listed in the
"Checking for operational readiness" chapter.
► Only operate the device when all test steps and the automatic selftest have been
completed successfully.

Position the device so that the mains plug is readily accessible at all times. The
device can only be safely disconnected from the mains power supply by
unplugging the mains plug.

Procedure:
Always perform the following test steps before operating the device:
1 Check that all parts of the device are free from cracks and sharp edges,
especially the hood, the access panels, and the mattress tray.
2 Check that all cables and hoses are free from damage and are routed correctly.
3 Check that the heated mattress (option) is free from damage.
4 Check that all access panels and hand ports are free from damage and close
securely.
5 Check that 2 acoustic signals sound and the alarm light shows yellow and red
when the device is switched on.
6 After switching the device on, check that the touch screen and rotary knob are
working correctly.
7 Check whether the O2 sensors need to be adjusted. For further information, see
the following chapter: ''Adjusting the O2 sensors'' (page 99)
✓ Only operate the device when all test steps and the automatic selftest have been
completed successfully.

Instructions for use Babyleo TN500 SW 1.0n 63


Operation

6.2 Switching on the device


This chapter describes how to switch on the device.
Prerequisites:
– There is no mains power supply to the device.
– The device has been reprocessed and assembled ready for operation.
– The user has checked that the device is complete and is free from defects.

The device carries out an automatic selftest when it is switched on. If the device
detects a fault, a corresponding message or an alarm is displayed. The
automatic self-test checks, e.g., the functional integrity of the primary and
secondary alarm systems and the power supply of the device. For further
information, see the following chapter: ''Automatic selftest'' (page 202)

Procedure:
1 Plug in the mains plug.
2 Switch on the device at the main switch on the rear of the main column (position
I).
 The start process commences and lasts about 7 seconds.
3 Switch on the device on the display unit using the Start/standby key (1).
 The device carries out an automatic selftest.
4 Check the following points shortly after switching on the device:
– An acoustic signal sounds (power failure alarm).
– The power supply indicator next to the Start/standby key lights up red.
– Another acoustic signal sounds (alarm system).
– The alarm light lights yellow and red alternately.

27215

Fig. 32 Start/standby key on the display unit


5 Check that the touch screen and rotary knob are working correctly.
✓ Once the automatic selftest has been completed, the main screen is displayed.

64 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.2.1 Start dialog


This chapter describes the start dialog and how to adjust the therapy settings.

6.2.1.1 Overview of the start dialog


If the device was switched off for more than 2 hours, all existing patient data are
deleted. The device starts up as follows, depending on the operating mode:
Incubator operation
If the hood is closed, the device starts up in air temperature mode with the user-
specific settings.

Radiant warmer operation


If the hood is open, the device starts automatically in pre-warm mode.

If the device was switched off for less than 2 hours, the following dialog window is
displayed:

28478
Fig. 33 New patient dialog window
– By touching the New patient New patient button, all existing patient data are
deleted.
– By touching the Current patient button, the device continues operation with all
existing patient data and the most recent settings.

Skin temperature mode is not suitable for warming up the device during
incubator and radiant warmer operation.

Instructions for use Babyleo TN500 SW 1.0n 65


Operation

6.2.1.2 Adjusting the therapy settings


Before a patient is placed in the device, the device must be warmed up.
Prerequisites:
– The device is in operation.
– The device has been warmed up.
– The device is in incubator operation or radiant warmer operation.

WARNING
Risk due to incorrect settings
Devices within an environment of use can be configured differently. User-specific
alarm limits or therapy settings may be set on the devices. If the settings are
unsuitable for the patient, the patient may be put at risk.
► Ensure that the set therapy values are suitable for the new patient.
► Make sure that the alarm system has not been rendered ineffective by setting
the alarm limits to extreme values or deactivated by switching off the alarms.
► Check the basic alarm settings and the patient-specific alarm settings when a
new therapy is started.

CAUTION
Risk of hypothermia
If the device has not been warmed up, the patient may become hypothermic.
► Wait for the warm-up time of the radiant warmer.
► In incubator operation, wait for a warm-up time of 30 minutes.

Procedure:
1 Select the desired mode in the therapy bar.
2 Set the desired temperature with the therapy control.
3 Set additional parameters (e.g., humidity).
✓ The therapy settings have been adjusted.

66 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.3 Switching off the device


This chapter describes how to switch off the device. Before switching off the device,
lower the lifting column to transfer height. This prevents the device from tipping over
or being damaged during a transfer. For further information, see the following
chapter: ''Intrahospital patient transfer with switched off warming
therapy'' (page 150).
Prerequisite:
– The device is in operation.
Procedure:
1 Adjust the height of the device using the foot pedals. The correct transfer height
is reached when the red hatched label on the lifting column is completely
covered.
2 Switch off the device on the display unit using the Start/standby key .
 The Shut down dialog window is displayed.
3 Touch the Shut down button and confirm.
 The device functions are shut down.
4 Switch off the device using the main switch on the rear of the main column
(position ).
Before disconnecting the mains plug, the device must be switched off at the
main switch. If the device is only switched off using the Start/standby key on
the display unit and the mains plug is then disconnected, an alarm signal will
sound after a few seconds.

5 Disconnect the mains plug.


6 Fasten the power cable to the device, e.g., by wrapping it around the standard
rail.

Instructions for use Babyleo TN500 SW 1.0n 67


Operation

6.4 Operating modes


The device can be operated as an incubator and as a radiant warmer. The diagram
shows the two operating modes with the corresponding settings and applications.

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Fig. 34 Overview of incubator operation and radiant warmer operation

68 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.5 Incubator operation


This chapter describes how to set which modes and settings in incubator operation.

6.5.1 Overview of incubator operation


When the hood is closed, the device is automatically operated as an incubator. The
device displays the user interface for incubator operation.

27240
1

3 2

Fig. 35 Standard view in incubator operation with air temperature mode activated

No. Designation Description


1 Air temp. Shows the current air temperature measure-
ment in the patient compartment.
2 ClearView on Reduces condensation on the inside of the
hood.
3 Therapy bar Shows the available modes in incubator oper-
ation. In this example, air temperature mode is
activated.

6.5.1.1 Condensation management


High humidity settings may cause the inside of the hood to fog up. To limit fogging,
the ClearView function can be activated. If the ClearView on button is activated in
the therapy bar, the radiant warmer operates at low power. This warms the hood,
reducing fogging.

Instructions for use Babyleo TN500 SW 1.0n 69


Operation

The Standard function or the Eco function can be selected for the transition
between incubator operation and radiant warmer operation. For further
information, see the following chapter: ''Configuring the transition'' (page 76).
The Standard function automatically activates the ClearView on setting. The
ClearView on setting can only be deactivated when the Eco function is
selected.

6.5.2 Modes in incubator operation


To regulate the temperature in the patient compartment, the following modes are
available in incubator operation:
– Skin temperature mode
– Air temperature mode
– Kangaroo mode

If the device is switched on with the hood closed, it is automatically operated in


air temperature mode.

For further information, see the following chapter: ''Skin temperature


mode'' (page 77)
For further information, see the following chapter: ''Air temperature
mode'' (page 85)
For further information, see the following chapter: ''Kangaroo mode'' (page 104)

6.5.3 Settings in incubator operation


The following settings can be made in incubator operation:
– Skin temperature (skin temperature mode), air temperature (air temperature
mode)
– Humidity
– Oxygen (option)
– Mattress core temperature (option)
– ClearView
For further information, see the following chapter: ''Humidity'' (page 94)
For further information, see the following chapter: ''Oxygen (option)'' (page 96)
For further information, see the following chapter: ''Heated mattress
(option)'' (page 100)
For further information, see the following chapter: ''Kangaroo mode'' (page 104)

In incubator operation set the lowest position for the mattress tray so that there
is as much space as possible for the patient. This position also offers good
access to the patient.

70 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.6 Radiant warmer operation


This chapter describes how to set which modes and settings in radiant warmer
operation.

6.6.1 Overview of radiant warmer operation


When the hood is open, the device is automatically operated as a radiant warmer.
The device displays the user interface for radiant warmer operation. The radiant
warmer power is indicated on the user interface by means of bars. In skin
temperature mode, the radiant warmer power is regulated by means of the set
value for the skin temperature. In manual mode the radiant warmer power can be
set manually. In both modes the radiant warmer power is reduced according to the
ambient temperature. The bars on the user interface show the maximum possible
radiant warmer power in each situation. If the mattress tray is tilted, the radiant
warmer power is adjusted to compensate for an uneven radiation distribution on the
mattress tray. If the side of the mattress tray against the sensor wall is raised, the
uneven radiation distribution on the mattress tray can only be compensated for up
to a radiant warmer power of 80 %. If a radiant warmer power of over 80 % is set,
the lower end of the mattress tray is warmed to a slightly lesser degree.

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1

Fig. 36 Standard view in radiant warmer operation with manual mode activated

No. Designation Description


1 Radiant warmer Shows the radiant warmer power numerically
and as bars.
2 Therapy bar Shows the available modes in radiant warmer
operation. In this example, manual mode is
activated.

Instructions for use Babyleo TN500 SW 1.0n 71


Operation

The patient's thermal equilibrium may be influenced by the ambient conditions, e.g.,
by drafts.

In radiant warmer operation Dräger recommends setting the highest position for
the mattress tray. This position provides the most effective warming for the
patient. This position also offers good access to the patient.

6.6.2 Modes in radiant warmer operation


To regulate the temperature, the following modes are available in radiant warmer
operation:
– Skin temperature mode
– Manual mode
– Kangaroo mode
As soon as the patient is placed in the device, switch to manual mode or skin
temperature mode.
Dräger recommends using skin temperature mode in radiant warmer operation as
the radiation intensity is adjusted automatically in this mode according to the
measured central skin temperature.

6.6.3 Settings in radiant warmer operation


The following settings can be made in radiant warmer operation:
– Skin temperature (skin temperature mode), radiant warmer power (manual
mode)
– Mattress core temperature
For further information, see the following chapter: ''Skin temperature
mode'' (page 77)
For further information, see the following chapter: ''Manual mode'' (page 91)
For further information, see the following chapter: ''Heated mattress
(option)'' (page 100)
For further information, see the following chapter: ''Kangaroo mode'' (page 104)

6.6.4 Pre-warm mode


If the following prerequisites are met, the device is automatically operated in pre-
warm mode:
– The device has been switched off for longer than 2 hours.
– The device is switched on with the hood open.
In pre-warm mode the radiant warmer power is set automatically and comprises the
following 3 phases:

No. Radiant warmer power Duration Display


1 100 % 3 minutes Pre
2 60 % 11 minutes and 30 seconds Pre
3 30 % Until the user sets a value. 30

72 Instructions for use Babyleo TN500 SW 1.0n


Operation

The radiant warmer starts up with 100 % power. Within a period of 14 minutes and
30 seconds the power is gradually reduced. In pre-warm mode the therapy control
displays either Pre or a value, depending on the radiant warmer power.

28481
1

Fig. 37 Pre-warm mode

No. Designation Description


1 Pre Shows that pre-warm mode is activated.

Instructions for use Babyleo TN500 SW 1.0n 73


Operation

6.7 Transition
This chapter describes the transition between incubator operation and radiant
warmer operation.

6.7.1 Overview of transition


Patients continue to be warmed during the transition between incubator operation
and radiant warmer operation. When the device is in the one operating mode, the
other mode is kept available. This shortens the warm-up time for the other heater,
ensuring optimum warming during and immediately after the transition.

To configure the transition, select System setup... > Therapy >


Thermoregulation. For further information, see the following
chapter: ''Configuring the transition'' (page 76)

During the transition the device operates the heaters as follows:

Incubator operation Radiant warmer operation


(hood closed) (hood open)

As soon as the hood is opened, the device switches automatically to radiant


warmer operation. The radiant warmer is already preheated before the hood is
opened.

Radiant warmer operation Incubator operation


(hood open) (hood closed)

As soon as the hood is closed, the device switches automatically to incubator


operation. The convection heater is already preheated before the hood is closed.

74 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.7.1.1 Temperature adjustment during transition


The table shows how the temperature is adjusted during the transition in air
temperature mode, in skin temperature mode, and in manual mode:
Mode Transition Temperature
Air temperature The radiant warmer power
mode corresponds to the air tem-
perature that was set with the
hood closed. The Check set-
tings alarm indicates that the
user must confirm or adjust
this setting.
Skin tempera- The device adopts the skin
ture mode temperature value that was
set with the hood closed.

The device adopts the skin


temperature value that was
set with the hood open.

Manual mode The air temperature corre-


sponds to the radiant warmer
power that was set with the
hood open. The Check set-
tings alarm indicates that the
user must confirm or adjust
this setting.

6.7.1.2 Interrupting incubator operation


If the hood was opened for less than 2 hours, the device continues operating with
the most recent air temperature settings for incubator operation once the hood is
closed. The settings for oxygen (option) and humidity are also retained.
Example: The hood is opened for a few minutes to check the position of the
ventilation mask.

Instructions for use Babyleo TN500 SW 1.0n 75


Operation

6.7.2 Configuring the transition


This chapter describes how to configure the transition.
Prerequisite:
– The device is in operation.

WARNING
Risk to patient due to incorrect temperature settings
When switching between incubator operation and radiant warmer operation, the
temperature setting may subsequently be too high or too low.
► After opening or closing the hood, always check the temperature settings.
► After the transition, adjust the temperature settings to the patient's needs.

Procedure:
1 Touch the System setup... button in the main menu bar.
2 Touch the Therapy tab.
3 Enter the password and confirm with OK.
4 Select a button in the Thermoregulation tab:

Button Meaning
Standard – In incubator operation the radiant warmer operates contin-
uously at low power.
– In radiant warmer operation the convection heater oper-
ates continuously at low power.
 This ensures optimum warming during and after the tran-
sition.
Eco – In incubator operation the radiant warmer is switched off.
– In radiant warmer operation the convection heater is
switched off.
 This saves energy.

✓ The transition is configured.

76 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.8 Skin temperature mode


This chapter describes skin temperature mode.

6.8.1 Overview of skin temperature mode


Skin temperature mode can be activated in incubator operation and in radiant
warmer operation. In skin temperature mode, the temperature of the device is
regulated by means of the set value for the skin temperature. This mode requires
the use of skin temperature sensors. When the skin temperature sensors are
connected, the user sets the desired skin temperature on the device. The
temperature can be set in steps of 0.1 °C (0.1 °F).
The following table shows the temperature ranges:
Setting range Extended range
34 to 37 °C (93.2 to 98.6 °F) 37.1 to 38 °C (98.7 to 100.4 °F)

To set the temperature in the extended range, first confirm the extended range
by pressing the rotary knob.

In incubator operation the air temperature in the device is regulated according to


the set skin temperature. In radiant warmer operation the radiant warmer power is
regulated according to the set skin temperature. If the current skin temperature
differs from the target value, an alarm is triggered. Additional alarm limits can be set
by means of the Advanced skin temperature monitoring function. If the central
skin temperature and the peripheral skin temperature are measured, changes in
skin temperature can be detected more quickly using the Thermomonitoring
function. For further information, see the following
section: ''Thermomonitoring'' (page 83)

To open the quick setup dialog window, touch a skin temperature value. The
buttons for the alarm limits are displayed.

Instructions for use Babyleo TN500 SW 1.0n 77


Operation

6.8.1.1 Main screen in incubator operation


The main screen of the user interface differs according to the operating mode in
which skin temperature mode is used.

27245
1 2 3 4 5 6

Fig. 38 Main screen in incubator operation

No. Designation Description


1 Skin mode Starts skin temperature mode.
2 Skin temp. Used for setting the skin temperature.
3 Humidity Used for setting the humidity in the patient
compartment.
4 Oxygen (option) Used for setting the oxygen concentration in
the patient compartment.
5 Mattress (option) Used for setting the mattress core tempera-
ture.
6 ClearView on Limits fogging of the hood.

78 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.8.1.2 Main screen in radiant warmer operation

30327
1 2 3

Fig. 39 Main screen in radiant warmer operation

No. Designation Description


1 Skin mode Starts skin temperature mode.
2 Skin temp. Used for setting the skin temperature.
3 Mattress (option) Used for setting the mattress core tempera-
ture.

6.8.2 Connecting the skin temperature sensors


This chapter describes how to connect the skin temperature sensors to the device.

Dräger recommends that the central temperature and peripheral skin


temperature are measured and monitored. If 2 skin temperature sensors are
used, changes in skin temperature can be detected more quickly using the
thermomonitoring function. Dräger recommends the use of original Dräger skin
temperature sensors.

Instructions for use Babyleo TN500 SW 1.0n 79


Operation

The following table shows the differences between the skin temperature sensors:
Symbols on Sensor color Temperature measure- Attachment position
the device ment
Yellow Central skin temperature In the liver or kidney
region
White Peripheral skin tempera- Foot or hand
ture

Prerequisites:
– The device is in operation.
– The patient is inside the device.
– The yellow and white skin temperature sensors and the corresponding covers
are ready to use.
– The area of skin where the sensor is to be placed is clean and dry.

WARNING
Risk of electric shock
If the contact pins are touched, the user and the patient will be exposed to the risk
of an electric shock.
► Do not touch the pins in the skin temperature sensor plugs.

Procedure:
1 Push the yellow skin temperature sensor into the yellow socket (1) on the rear
sensor wall.
 The Skin mode tab in the therapy bar is available.
2 Push the white skin temperature sensor into the white socket (2) on the rear
sensor wall.

26457
1

Fig. 40 Connecting the skin temperature sensors


To activate skin temperature mode, at least the yellow skin temperature
sensor for measuring the central skin temperature must be connected.

3 Pass the sensor cables into the device through a hose grommet.

80 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.8.3 Attaching the skin temperature sensors to the patient

WARNING
Risk of hypothermia or hyperthermia
If the attachment positions of the skin temperature sensors have been swapped
accidentally or the skin temperature sensors are not attached correctly to the
patient, the patient may become too hot or too cold.
► Place the yellow skin temperature sensor in the liver or kidney region only.
► Place the white skin temperature sensor on the foot or hand only.
► Do not place the skin temperature sensors under the patient.
► Check at regular intervals that the skin temperature sensors are correctly
attached.

WARNING
Risk of hypothermia or hyperthermia
If the skin temperature sensors are wet, the patient may become too hot or too cold.
► Use dry skin temperature sensors only.

WARNING
Risk to patient due to incorrect use of the skin temperature sensors
If the rectal temperature is measured with the skin temperature sensors, the device
will display incorrect values or will regulate the temperature on the basis of incorrect
values.
► Only use the yellow skin temperature sensor for measuring the central skin
temperature.
► Only use the white skin temperature sensor for measuring the peripheral skin
temperature.

Procedure:
1 Attach the yellow skin temperature sensor for measuring the central skin
temperature in one of the following positions on the patient:
– Supine position: using a sensor cover, attach the sensor to the abdomen in
the liver region.
– Prone position: using a sensor cover, attach the sensor to the back in the
kidney region.
2 Attach the white skin temperature sensor for measuring the peripheral skin
temperature to the patient's foot or hand using a sensor cover.

Instructions for use Babyleo TN500 SW 1.0n 81


Operation

6.8.4 Starting skin temperature mode

WARNING
Risk of hypothermia or hyperthermia
If skin temperature mode is used for patients with a fever or in a state of shock, the
patient may become too hot or too cold.
► Do not use skin temperature mode in cases of fever or shock.

Procedure:
1 Touch the Skin mode tab (1) in the therapy bar.
 The tab turns yellow.
2 Press the rotary knob to confirm.
 The tab turns dark green.

27245
1 2

Fig. 41 Starting skin temperature mode


3 Touch the Skin temp. therapy control (2).
 The therapy control turns yellow.
4 Set the target skin temperature using the rotary knob.
5 Press the rotary knob to confirm.
 The therapy control turns dark green and displays the target value.
 When the hood is closed, the measured central skin temperature determines
the air temperature in the patient compartment; when the hood is open, the
measured central skin temperature determines the radiant warmer power.
6 At regular intervals check that the skin temperature sensors are correctly
attached to the patient.
7 Check the skin temperature value at regular intervals and adjust it if necessary.
 The patient is warmed in accordance with his or her needs.
 The temperature is continuously monitored by skin temperature sensors.
8 Check the alarm limits for skin temperature and adjust them if necessary.

82 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.8.5 Thermomonitoring
If 2 skin temperature sensors are used, the Thermomonitoring view shows the
continuous measurement and display of a central and a peripheral temperature.

The Views... button is used to switch screen views.

Thermomonitoring can be used for the early detection of cold stress, heat stress, or
infection. Thermomonitoring means the continuous monitoring of the central skin
temperature and the peripheral skin temperature. The difference between the two
temperature values is displayed. The difference can indicate a change in the
temperature of the patient. The diagram below shows thermomonitoring in a patient
with cold stress: the peripheral skin temperature (2) drops before the central skin
temperature (1) and can be the first indication of cold stress.

30262
1

Fig. 42 Example of cold stress

No. Designation
1 Central skin temperature
2 Peripheral skin temperature

6.8.6 Setting the skin temperature alarm limits


This chapter describes how to set the alarm limits for the central skin temperature.
Prerequisites:
– At least the yellow skin temperature sensor is connected to the device and
attached to the patient.
– Skin temperature mode is activated.
Procedure:
1 Touch the Alarms... button in the main menu bar.
 The Alarm limits dialog page is displayed for skin temperature mode.
2 Set and confirm the alarm limits for the tolerated deviation for the central skin
temperature.
✓ The alarm limits for the central skin temperature are set.

Instructions for use Babyleo TN500 SW 1.0n 83


Operation

6.8.7 Setting the advanced skin temperature alarm limits


With the Advanced skin temperature monitoring function the alarm limits for the
difference between the central and the peripheral skin temperature can be defined
additionally.
Prerequisite:
– The 2 skin temperature sensors are connected to the device and attached to the
patient.
Procedure:
1 Touch the System setup... button in the main menu bar.
2 Open the Alarms screen.
3 Enter the password and confirm.
4 Touch the Skin mode tab.
5 Select Advanced skin temperature monitoring > On and confirm.
 The additional buttons for setting the skin temperature alarm limits are
displayed.

28483
Fig. 43 Additional skin temperature alarm limits
6 Set and confirm the alarm limits for the difference between the central and the
peripheral skin temperature.
✓ The advanced skin temperature alarm limits are set.
If one of the advanced skin temperature alarm limits is switched off, the following
symbol is displayed on the main screen:

The same symbol is displayed if skin temperature monitoring is deactivated.

84 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.8.8 Ending skin temperature mode


As soon as a different mode is selected in the therapy bar, skin temperature mode
is ended.
Procedure:
1 Touch a different tab in the therapy bar.
 The selected tab turns yellow.
2 Press the rotary knob to confirm.
 The selected tab turns dark green.
✓ Skin temperature mode is ended.

6.9 Air temperature mode


This chapter describes air temperature mode. Air temperature mode can be set in
incubator operation.

6.9.1 Overview of air temperature mode


In air temperature mode the user determines the appropriate temperature in the
patient compartment. The temperature is measured by a sensor in the patient
compartment and compared with the set target value. The air temperature can be
set in steps of 0.1 °C (0.1 °F). The following table shows the temperature ranges:
Extended range Setting range Extended range
20 to 27.9 °C 28 to 37 °C 37.1 to 39 °C
(68 to 82.3 °F) (82.4 to 98.6 °F) (98.7 to 102.2 °F)

To set the temperature in the extended range, first confirm the extended range
by pressing the rotary knob.

The target air temperature must be at least 3 °C (5.4 °F) above the ambient
temperature in order for the device to reach the desired temperature.

In air temperature mode the patient's skin temperature can be monitored with skin
temperature sensors.

Instructions for use Babyleo TN500 SW 1.0n 85


Operation

27240
1

2 3 4 5 6

Fig. 44 Main screen with air temperature mode activated

No. Designation Description


1 Air mode Selects air temperature mode.
2 Air temp. Used for setting the air temperature.
3 Humidity Used for setting the humidity in the patient
compartment.
4 Oxygen (option) Used for setting the oxygen concentration in
the patient compartment.
5 Mattress (option) Used for setting the mattress core tempera-
ture.
6 ClearView on Limits fogging of the hood.

86 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.9.2 Starting air temperature mode


This chapter describes how to start air temperature mode.
Prerequisites:
– The device is in operation.
– The hood is closed.

WARNING
Risk of hyperthermia due to external heat sources
The temperature in the patient compartment may rise to dangerous levels due to
direct sunlight or other external heat sources (e.g., phototherapy devices). The
patient may become overheated.
► When additional heat sources (e.g., solar radiation, examination lights, or
phototherapy lights) are active, make sure that the temperature in the patient
compartment remains non-critical.
► Check the patient's body core temperature at regular intervals.

WARNING
Risk to patient due to incorrect settings
If the air temperature and humidity settings are unsuitable for the patient, the patient
may be put at risk.
► Check the suggested air temperature and humidity settings carefully and adjust
them to the patient's needs if necessary.

Procedure:
1 Touch the Air mode tab (1) in the therapy bar.
 The tab turns yellow.
2 Press the rotary knob to confirm.
 The tab turns dark green.
 The mode is activated.

27240

2 1

Fig. 45 Starting air temperature mode

Instructions for use Babyleo TN500 SW 1.0n 87


Operation

3 Touch the Air temp. therapy control (2).


 The therapy control turns yellow.
4 Set the target air temperature using the rotary knob.
5 Press the rotary knob to confirm.
 The therapy control turns dark green and displays the target value.
6 Check the alarm limits for the air temperature and adjust them if necessary.

6.9.3 Setting the air temperature alarm limits


This chapter describes how to set the alarm limits for the air temperature in air
temperature mode.
Prerequisite:
– Air temperature mode is activated.
Procedure:
1 Touch the Alarms... button in the main menu bar.
 The Alarm limits dialog page is displayed.
2 Set and confirm the upper alarm limit for the air temperature deviation.
3 Set and confirm the lower alarm limit for the air temperature deviation.
✓ The alarm limits for air temperature monitoring are set.

6.9.4 Setting the advanced skin temperature alarm limits


If the skin temperature sensors are connected and advanced skin temperature
monitoring is activated, alarm limits can be set for the skin temperature. For further
information, see the following chapter: ''Setting the advanced skin temperature
alarm limits'' (page 84)
Prerequisites:
– The 2 skin temperature sensors are connected to the device and attached to the
patient.
– The Advanced skin temperature monitoring function is activated.

28473

Fig. 46 Skin temperature alarm limits

88 Instructions for use Babyleo TN500 SW 1.0n


Operation

Procedure:
1 Set and confirm the upper and lower alarm limit for the central skin temperature.
2 Set and confirm the upper and lower alarm limit for the peripheral skin
temperature.
3 Set and confirm the upper and lower alarm limit for the difference between the
central and the peripheral skin temperature.
✓ The alarm limits for skin temperature monitoring are set.

6.9.5 Automatic setting of the skin temperature alarm limits


The skin temperature alarm limits can be set automatically on the basis of the
current skin temperature measurement.
Prerequisites:
– The 2 skin temperature sensors are connected to the device and attached to the
patient.
– The Advanced skin temperature monitoring function is activated.
Procedure:
1 Touch the Autoset all limits button (1).

28473
2
1

Fig. 47 Current skin temperature measurement


2 Press the rotary knob to confirm.
 The following alarm limits are set automatically for the current skin
temperature measurement (2):

Current skin temperature measure- Automatic alarm limits


ment
Central skin temperature Upper alarm limit: + 1 °C (1.8 °F)
Lower alarm limit: -1 °C (1.8 °F)
Peripheral skin temperature Upper alarm limit: +1 °C (1.8 °F)
Lower alarm limit: -1 °C (1.8 °F)
Difference Upper alarm limit: +0.5 °C (0.9 °F)
Lower alarm limit: -0.5 °C (0.9 °F)

The automatic alarm limits relate in each case to the current skin temperature
measurement or to the current difference.

Instructions for use Babyleo TN500 SW 1.0n 89


Operation

6.9.6 Ending air temperature mode


As soon as a different mode is selected in the therapy bar, air temperature mode is
ended.
Procedure:
1 In the therapy bar touch either the Skin mode tab or the Kangaroo mode tab.
 The selected tab turns yellow.
2 Press the rotary knob to confirm.
 The selected tab turns dark green.
✓ Air temperature mode is ended.

90 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.10 Manual mode


This chapter describes manual mode.

6.10.1 Overview of manual mode


In this mode the radiant warmer power can be set manually. To protect the patient
from overheating, time limits are set for the supply of heat above a certain power. If
the user sets the radiant warmer power above 30 %, a timer starts and the following
alarms are displayed after predefined time intervals:
– After 14 minutes the Check patient's condition alarm is displayed.
– After 15 minutes, the radiant warmer is switched off and the Warmer off, check
patient's condition alarm is displayed.

27253
1

3 2

Fig. 48 Radiant warmer operation with manual mode activated

No. Designation Description


1 Timer Starts with radiant warmer power settings
above 30 %. Limits the supply of heat to
15 minutes.
2 Manual mode Selects manual mode.
3 Warmer Used for setting the radiant warmer power.

Instructions for use Babyleo TN500 SW 1.0n 91


Operation

6.10.2 Starting manual mode


This chapter describes how to start manual mode in radiant warmer operation.
Prerequisites:
– The device is in operation.
– The hood is open.

WARNING
Risk of hyperthermia in manual mode
If the radiant warmer power is set too high or additional heat sources are active
(e.g., phototherapy devices or sunlight), the patient may become overheated.
► In manual mode check the patient's body core temperature at regular intervals.
► Only supply the patient with as much thermal radiation as is necessary.
► Do not leave the patient unattended during radiant warmer operation.

WARNING
Risk of fire underneath the radiant warmer
Objects in the beam path of the radiant warmer may ignite, putting people and
property at risk.
► Do not place combustible materials under the radiant warmer.
► Do not place objects in the beam path of the radiant warmer.

CAUTION
Risk to patient due to increased water loss when exposed to thermal radiation
The thermal radiation may cause increased water loss in the patient.
► Only expose the patient to the necessary amount of thermal radiation and only in
a controlled manner.

92 Instructions for use Babyleo TN500 SW 1.0n


Operation

Procedure:
1 Touch the Manual mode tab (1).
 The tab turns yellow.
2 Press the rotary knob to confirm.
 The tab turns dark green.

27253
2 1

Fig. 49 Starting manual mode


3 Touch the Warmer therapy control (2).
 The therapy control turns yellow.
4 Set the radiant warmer power using the rotary knob.
5 Press the rotary knob to confirm.
 The therapy control turns dark green.
 The radiant warmer power is set.

If the radiant warmer power is set above 30 %, a timer starts. The device
switches the radiant warmer off after 15 minutes.

6.10.3 Setting the advanced skin temperature alarm limits


Provided the following prerequisites are met, alarms for the skin temperature can
be set in manual mode:
– The skin temperature sensors are connected.
– The Advanced skin temperature monitoring function is activated.
For further information, see the following chapter: ''Setting the advanced skin
temperature alarm limits'' (page 84)

Instructions for use Babyleo TN500 SW 1.0n 93


Operation

6.10.4 Ending manual mode


As soon as a different mode is selected in the therapy bar, manual mode is ended.
Manual mode can also be ended by closing the hood.
Procedure:
1 Touch a different tab in the therapy bar.
 The selected tab turns yellow.
2 Press the rotary knob to confirm.
 The selected tab turns dark green.
✓ Manual mode is ended.

6.11 Humidity
This chapter describes how to humidify the air in incubator operation. It also
describes how to attach an external water supply to the device.

6.11.1 Overview of the humidity settings


The warm air in the incubator contains less moisture than the cooler ambient air.
Dräger recommends humidifying the air in incubator operation. The relative
humidity can be set manually or automatically.
The water for the humidification system must be Aquadest/distilled water. An
external water supply (water bag or water bottle) is connected to the device via a
Luer Lock connector. The water is evaporated in the humidification system and
directed into the patient compartment. The desired relative humidity is set by means
of the Humidity therapy control. The humidity level can be set in increments of 1 %.
The following settings are possible:
– Off
– Auto
– 30 to 99 %
There are 2 ways of setting the relative humidity level in incubator operation:

Manual Automatic
The user sets the relative humidity level The device sets the relative humidity
manually according to the patient's automatically according to the air tem-
needs. perature.
Example: If the air temperature is
increased, the relative humidity is
increased correspondingly.

6.11.2 Using the humidification system


Prerequisites:
– Aquadest/distilled water for the humidification system is available in a water bag
or water bottle.
– The connection kit with a Luer Lock connector is ready to use.

94 Instructions for use Babyleo TN500 SW 1.0n


Operation

WARNING
Risk to patient due to germs in the humidification system
If the humidification system is filled with water, germs may form and contaminate
the breathing gas (e.g., with exogenous pyrogens).
► Only fill the water reservoir of the humidification system with Aquadest/distilled
water.

WARNING
Risk to patient due to unsuitable liquids in the humidification system
Undistilled water, water containing additives, and infusion solutions damage the
humidification system and may endanger the patient.
► Only fill the water reservoir of the humidification system with Aquadest/distilled
water.
► Do not introduce infusion solutions into the humidification system.

Procedure:
1 Disinfect your hands.
2 Attach the water bag or water bottle to the water bag holder on the rear of the
main column. The water bag or water bottle must be attached above the Luer
Lock connector. For further information, see the following chapter: ''Connectors
on the rear sensor wall'' (page 30)
3 Close the clamp on the connection hose.
4 Attach the connection hose to the water bag or water bottle.
5 Connect the connection hose to the Luer Lock connector on the device.
6 Open the clamp on the connection hose.
✓ The humidification system is ready for use.

6.11.3 Setting the humidity


The relative humidity can be set manually or automatically.
Prerequisite:
– The device is being operated as an incubator.

WARNING
Risk to patient due to incorrect settings
If the air temperature and humidity settings are unsuitable for the patient, the patient
may be put at risk.
► Check the suggested air temperature and humidity settings carefully and adjust
them to the patient's needs if necessary.

If a high humidity level is set and the ambient temperature is low, condensation
may form next to the device. This may cause the user or a third-party to slip
over.

Instructions for use Babyleo TN500 SW 1.0n 95


Operation

Procedure:
1 Touch the Humidity therapy control (1) in the therapy bar.
 The therapy control turns yellow.

27240
1

Fig. 50 Therapy control for humidity


2 Set the value for the humidity manually using the rotary knob.
or
3 Turn the rotary knob to the right as far as it will go and set the Auto function.
 The device sets the humidity automatically according to the air temperature.
4 Press the rotary knob to confirm.
 The therapy control turns dark green.
✓ The value for the humidity is set.

6.12 Oxygen (option)


This chapter describes how to enrich the air in the patient compartment with oxygen
(option).

6.12.1 Overview of the oxygen supply


The air in the patient compartment can be enriched with oxygen. The oxygen
concentration in the patient compartment is measured by O2 sensors.
The table below shows the setting ranges for the supply of oxygen:
Setting range Extended range
Off, 21 to 40 % 41 to 65 %

To set the oxygen supply in the extended range, first confirm the extended range
by pressing the rotary knob.

96 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.12.2 Setting the oxygen supply


Prerequisites:
– The device is in operation.
– The device is connected to an oxygen cylinder or to the central O2 supply.
– The device is equipped with O2 (option).

WARNING
Risk due to increased external O2 supply
If O2 is supplied from an external source (e.g., via the central supply unit, an oxygen
cylinder, or an O2 hood), the O2 concentration may exceed 65 %. The health of the
patient may be endangered and there is an increased risk of fire in the device.
► Measure and monitor the oxygen concentration in the patient compartment.
► Make sure that the oxygen concentration in the patient compartment is always
below 65 %.
► Always monitor the oxygen concentration in the patient's blood, e.g., using blood
gas analysis and a pulse oxymeter.
► Always monitor the external O2 supply.
► Be aware that Babyleo TN500 displays no alarms in the case of an external
oxygen supply, e.g., via an O2 hood.

WARNING
Risk of fire if unauthorized electrical devices are used
If the air in the patient compartment is enriched with oxygen, there is an increased
risk of fire if unauthorized electrical devices are used.
► In the patient compartment use only electrical devices that are approved for use
in an oxygen-enriched atmosphere.

CAUTION
Risk to patient due to background noise
The supply of oxygen may cause additional background noise.
► Protect the patient from background noise.

Instructions for use Babyleo TN500 SW 1.0n 97


Operation

Procedure:
1 Touch the Oxygen therapy control (1) in the therapy bar.
 The therapy control turns yellow.

27240
1

Fig. 51 Therapy control for oxygen


2 Set the required oxygen concentration using the rotary knob.
3 Press the rotary knob to confirm.
 The therapy control turns dark green.
✓ The oxygen concentration is set.

6.12.3 Adjusting the oxygen alarm limits


Prerequisite:
– The required oxygen concentration is set.
Procedure:
1 Touch the Alarms... button (1) in the main menu bar.
 The Alarm limits dialog page is displayed.
28480

Fig. 52 Alarm limits for oxygen

98 Instructions for use Babyleo TN500 SW 1.0n


Operation

2 Touch the Oxygen tab (2).


3 Set and confirm the alarm limit for the tolerated deviation of the oxygen
concentration.
✓ The alarm limit for oxygen is set.

6.12.4 Adjusting the O2 sensors


The oxygen concentration in the patient compartment is measured by O2 sensors.
To ensure measurement accuracy, the user must adjust the O2 sensors at least
every 2 weeks. Dräger recommends adjusting the O2 sensors before every change
of patient, while checking for operational readiness.
Prerequisites:
– The device has been operating for at least 30 minutes.
– The Oxygen therapy control is at Off.
– The external oxygen supply is turned off.
– If oxygen has been used, air the device thoroughly: Open the hood and the side
access panels for at least 3 minutes. Close them again after airing.
– There is no externally supplied oxygen in the device.
Procedure:
1 Touch the Special procedures... button (1) in the main menu bar.
 The Special procedures... dialog window is displayed.

32774
2
3

Fig. 53 Adjusting the O2 sensors


2 Open the Oxygen dialog window (2).
3 Wait for the warm-up time of the O2 sensors.
 The remaining warm-up time is displayed in the dialog window.
4 Make sure that no oxygen is led into the patient compartment from the central
supply, cylinders or external sources.

Instructions for use Babyleo TN500 SW 1.0n 99


Operation

5 If oxygen has been used, air the device thoroughly: Open the hood and the side
access panels for at least 3 minutes. Close them again after the airing.
 The Start button changes from gray to green when the following conditions
are met:
– The warm-up time has elapsed.
– The Oxygen therapy control is at Off.
– The device has been adequately aired.
If the Start button is displayed in gray, repeat steps 3 to 5.

6 Touch the Start button (3).


7 Press the rotary knob to confirm.
 The adjustment takes approximately 1 minute.
 A notification will be displayed if the adjustment was successful.
✓ The O2 sensors have been adjusted.

After the O2 sensors have been adjusted, the date of the next adjustment is
displayed in the Oxygen dialog window. An alarm message will be displayed if
the O2 sensors have not been adjusted by this date. Additionally, the oxygen
measurement on the main screen is shown in gray. A gray measurement
indicates that the measurement accuracy is no longer guaranteed.

6.13 Heated mattress (option)


This chapter describes how to connect the heated mattress (option) to the device
and how to set the mattress core temperature.

6.13.1 Heated mattress overview


The heated mattress can be placed on the mattress tray of the device as an
alternative to the SoftBed mattress. The heated mattress provides additional
warmth for the patient by means of thermal conduction. The temperature of the
heated mattress can be set manually or automatically.
The following table shows the setting options:
Setting Meaning
35 to 39 °C Setting range for the mattress core temperature
(95 to 102 °F) The mattress core temperature can be set in steps of 0.5 °C
(0.5 °F).
Auto – At a lower air temperature, a lower mattress core tem-
perature is selected automatically.
– At a higher air temperature, a higher mattress core tem-
perature is selected automatically.
Off The heated mattress is deactivated.

The main screen of the user interface displays the mattress core temperature. The
mattress core temperature is measured inside the mattress. The mattress core
temperature is the mean of 2 temperatures measured at the edges of the heating
element. The mattress core temperature can also be influenced by other heat
sources.

100 Instructions for use Babyleo TN500 SW 1.0n


Operation

The heated mattress is x-ray transparent. Therefore, x-rays can be taken while
using the heated mattress. In this case, the x-ray cassette is placed in the x-ray
tray.

6.13.2 Connecting the heated mattress


This chapter describes how to connect the heated mattress to the device.
Prerequisites:
– The device has a port for the heated mattress (option).
– The heated mattress is available.

WARNING
Risk of patient injury if the heated mattress is used as the only source of heat
The heated mattress is not sufficient for use as the only source of heat, especially in
the case of hypothermic patients.
► Provide the patient with the heated mattress and an additional heat source.
► Monitor the body core temperature of the patient with a thermometer.

WARNING
Risk of patient injury due to damaged heated mattress
If the cover of the heated mattress is damaged, fluid may penetrate into the
mattress. This may damage the electronic components in the heated mattress. The
temperature sensors of the heated mattress may be damaged.
► Check the heated mattress for damage before use.
► Replace any damaged heated mattresses.

WARNING
Risk of electric shock
If the heated mattress is connected when radio-frequency surgical equipment,
endocardial catheters, or defibrillators are used, this may endanger the patient.
► If the heated mattress is connected, do not use radio-frequency surgical
equipment, endocardial catheters, or defibrillators.

WARNING
Risk of electric shock
If the contact pins are touched, the user and the patient will be exposed to the risk
of an electric shock.
► Do not touch the pins in the plug of the heated mattress.

Instructions for use Babyleo TN500 SW 1.0n 101


Operation

Procedure:
1 Place the heated mattress on the mattress tray. Ensure the following:
– The heating side of the heated mattress points towards the patient. The
product label on the heated mattress shows the correct side.
– The heated mattress cable is facing the sensor wall.
2 Pull the cable through the hose grommet in the center of the sensor wall and
push it into the cable guide.
3 Make sure that the cable runs downward between the bed support and the
sensor wall and is not caught.
4 Connect the orange plug of the heated mattress to the orange socket (1) on the
rear of the sensor wall.

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1

Fig. 54 Connecting the heated mattress


 The therapy control for the heated mattress changes to dark green.
✓ The heated mattress is connected to the device.

102 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.13.3 Setting the mattress core temperature


The mattress core temperature can be set manually or automatically.
Prerequisite:
– The heated mattress is connected to the device.
Procedure:
1 Touch the Mattress therapy control (1) in the therapy bar.
 The therapy control turns yellow.

27240
1
Fig. 55 Therapy control for the heated mattress
2 Adjust the mattress core temperature manually using the rotary knob.
or
3 Turn the rotary knob to the right as far as it will go and set the Auto function.
 The device sets the mattress core temperature automatically according to the
air temperature.
4 Press the rotary knob to confirm.
 The therapy control turns dark green.
✓ The mattress core temperature is set.

Instructions for use Babyleo TN500 SW 1.0n 103


Operation

6.14 Kangaroo mode


This chapter describes kangaroo mode.

6.14.1 Overview of kangaroo mode


In kangaroo mode, the patient is warmed by the parent's body heat instead of the
device. To do so, the patient is placed on the parent's breast. Kangaroo mode can
be used during incubator operation and radiant warmer operation. The settings
cannot be changed.
Incubator operation
Once kangaroo mode has been activated, the device is operated in air temperature
mode. The following settings are adopted from the previously set mode:
– Air temperature
– Humidity
– Oxygen (option)
– Mattress core temperature (option)
Radiant warmer operation
Once kangaroo mode has been activated, the device is operated in manual mode
with 30 % of the radiant warmer power and with the set mattress core temperature.
During kangarooing, the patient's temperature must be monitored continuously,
e.g., via the skin temperature sensors. If the central skin temperature and the
peripheral skin temperature are monitored, signs of hypothermia or hyperthermia
can be detected promptly.
Depending on the patient, kangarooing may last for several minutes or hours. When
the patient is back in the device again and kangaroo mode has ended, the device
resumes the warming therapy using the settings that were activated prior to
kangaroo mode.

104 Instructions for use Babyleo TN500 SW 1.0n


Operation

27244
1 2 3

Fig. 56 Main screen with kangaroo mode activated

No. Designation Description


1 Kangaroo mode Starts kangaroo mode.
2 Kangaroo Shows the elapsed time since kanga-
roo mode began.
3 End kangaroo Ends kangaroo mode.

6.14.2 Starting kangaroo mode


This chapter describes how to start kangaroo mode.
Prerequisites:
– The device is in operation.
– The patient is inside the device.
– The mother or father lies in a comfortable position on a couch next to the device
or sits on a stool.
– The last settings in incubator operation have been checked:
– Air temperature
– Humidity
– Oxygen (option)
– Mattress core temperature (option)
These settings are adopted in kangaroo mode.

Instructions for use Babyleo TN500 SW 1.0n 105


Operation

Procedure:
1 Touch the Kangaroo mode tab (1).
 The tab turns yellow.
2 Press the rotary knob to confirm.
 The tab turns dark green.
 The duration of kangaroo mode is continuously displayed on the main
screen.

27244
1

Fig. 57 Starting Kangaroo mode


3 Open the hood or the side access panel and remove the patient from the device.
4 Place the patient on the mother's or the father's naked breast. Also cover the
patient with a blanket to prevent heat loss.
5 If skin temperature sensors are used: Check that the skin temperature sensors
are correctly connected to the device and attached to the patient.
In kangaroo mode, the yellow sensor monitors the central skin temperature.
However, the central skin temperature value does not affect the temperature
in the patient compartment.

6 Close the hood or the side access panel. Make sure that the hoses or cables do
not get caught.
7 Check the alarm limits for skin temperature and adjust them if necessary.

106 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.14.3 Setting skin temperature alarm limits for kangaroo mode


This chapter describes how to set the alarm limits for kangaroo mode. The alarm
limits in kangaroo mode can be set independently from the other alarm limits.
Prerequisites:
– The 2 skin temperature sensors are connected to the device and attached to the
patient.
– Kangaroo mode is activated.
Procedure:
1 Touch the Alarms... button (1) in the main menu bar.
 The Alarm limits dialog page is displayed for kangaroo mode.

28475
1

Fig. 58 Alarm limits for kangaroo mode


2 Set and confirm the lower alarm limit for the central skin temperature.
3 Set and confirm the lower alarm limit for the peripheral skin temperature.
4 Set the alarm limits for the difference between the central and peripheral skin
temperature:
– Set and confirm the upper alarm limit.
– Set and confirm the lower alarm limit.
When kangaroo mode starts, the following alarms are delayed for 4 minutes:
– Humidity low
– Skin temperature difference high
– Skin temperature difference low
– Air temperature low
– Peripheral skin temperature low
– Oxygen low
– Central skin temperature low

Instructions for use Babyleo TN500 SW 1.0n 107


Operation

6.14.4 Ending kangaroo mode


Kangaroo mode ends as soon as another mode is selected on the therapy bar.
Kangaroo mode can also be ended as follows:
Procedure:
1 Touch the End kangaroo button (1).
 The button turns yellow.

27244
1

Fig. 59 Ending Kangaroo mode


2 Press the rotary knob to confirm.
 The button turns light green. Kangaroo mode has ended. The device
continues warming therapy with the settings that were active prior to
kangaroo mode.
3 Open the hood or side access panel and place the patient in the device.
4 If skin temperature sensors are used: Check that the skin temperature sensors
are correctly connected to the device and attached to the patient.
5 Close the device.
6 Depending on the operating mode and the mode, check the following settings
and adjust them if necessary:
– Skin temperature
– Air temperature
– Radiant warmer power
– Oxygen (option)
– Humidity
– Mattress core temperature (option)

108 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.15 Tolerate cooling (option)


This chapter describes the "Tolerate cooling" option.

6.15.1 Overview of "Tolerate cooling"


When the "Tolerate cooling" function is activated, the warming therapy is interrupted
to support therapeutic hypothermia for the patient. The convection heater, radiant
warmer, and the heated mattress (option) are switched off to allow the air
temperature in the patient compartment to cool.
When the "Tolerate cooling" function is activated and the device is in incubator
operation, the device switches to air temperature mode. In radiant warmer
operation, the device switches to manual mode with switched off radiant warmer.
Although all heat sources are switched off, the skin temperature can still be
monitored continuously. Skin temperature sensors must be used for this. The air
humidity and oxygen concentration in the patient compartment can be set and
measured.
When "Tolerate cooling" is activated, the following symbol is displayed on the main
screen:

28476
6.15.2 Starting "Tolerate cooling"
The chapter describes how to start the "Tolerate cooling" function. If a cooling
device is used, interrupt the warming therapy with the "Tolerate cooling" function.
Prerequisites:
– The device is in operation.
– The patient is inside the device.
Procedure:
1 Touch the Special procedures... button (1) in the main menu bar.
 The Special procedures dialog window is displayed.

28486

3 2

Fig. 60 Starting Tolerate cooling

Instructions for use Babyleo TN500 SW 1.0n 109


Operation

2 Open the Tolerate cooling dialog window (3).


3 Touch the On button (2).
4 Press the rotary knob to confirm.
✓ The function is activated.

6.15.3 Setting skin temperature alarm limits for "Tolerate cooling"


This chapter describes how to set the alarm limits for the skin temperature.

6.15.3.1 Manual setting of alarm limits for "Tolerate cooling"


Prerequisite:
– The 2 skin temperature sensors are connected and attached to the patient. For
further information, see the following chapter: ''Connecting the skin temperature
sensors'' (page 79)
Procedure:
1 Touch the Alarms... button (1) in the main menu bar.
 The Alarm limits dialog page is displayed for Tolerate cooling. The buttons
for the alarm limits are displayed. The currently measured skin temperature
values are displayed.

28485
1

Fig. 61 Skin temperature alarm limits


2 Set the upper and lower alarm limit for the following values:
– Central skin temperature
– Peripheral skin temperature
✓ The alarm limits for the skin temperature are set.

6.15.3.2 Automatic setting of alarm limits for "Tolerate cooling"


In the Alarm limits dialog window, the currently measured skin temperature values
are also displayed. The alarm limits can be set automatically based on the current
values:

110 Instructions for use Babyleo TN500 SW 1.0n


Operation

Procedure:
1 Touch the Autoset all limits button.
2 Press the rotary knob to confirm.
✓ The following alarm limits are set automatically for the current skin temperature
value:

Current skin temperature value Automatic alarm limits


Central skin temperature Upper alarm limit: + 1 °C (1.8 °F)
Lower alarm limit: -1 °C (1.8 °F)
Peripheral skin temperature Upper alarm limit: + 1 °C (1.8 °F)
Lower alarm limit: -1 °C (1.8 °F)

6.15.4 Ending "Tolerate cooling"


There are 2 ways of ending the "Tolerate cooling" function:
– On the main screen on the therapy bar
– In the Tolerate cooling dialog window

6.15.4.1 Ending via the main screen


Procedure:
1 Touch the End cooling button on the therapy bar.
2 Press the rotary knob to confirm.
✓ Tolerate cooling has ended.

6.15.4.2 Ending via the dialog window


Procedure:
1 Touch the Special procedures... button in the main menu bar.
2 Open the Tolerate cooling dialog window.
3 Touch the Off button.
4 Press the rotary knob to confirm.
✓ Tolerate cooling has ended.

6.16 Warm-up (option)


This chapter describes the warm-up option.

6.16.1 Overview of warm-up


During warm-up, the patient can be warmed in small steps. Warm-up is possible in
incubator operation and in radiant warmer operation. When warm-up is activated,
the device switches to skin temperature mode. The device is operated with the skin
temperature settings from the previously set mode.
The following values can be set:
– Target value for central skin temperature
The patient's skin temperature at the end of the warm-up time.
– Temperature step
The increase in skin temperature per temperature step.

Instructions for use Babyleo TN500 SW 1.0n 111


Operation

– Interval for temperature steps


The duration in minutes until the next temperature step occurs.
When this option is activated, Warm-up is displayed on the main screen:

28490
6.16.2 Starting warm-up
This chapter describes how to start warm-up.
Prerequisites:
– The device is in operation.
– At least the yellow skin temperature sensor for measuring the central skin
temperature is connected. For further information, see the following chapter:
''Connecting the skin temperature sensors'' (page 79).
Procedure:
1 Touch the Special procedures... button (1) in the main menu bar.
 The Special procedures dialog window is displayed.

28489
1

Fig. 62 Starting warm-up


2 Open the Warm-up (2) dialog page.
3 Set and confirm the target value for the central skin temperature with the rotary
knob.
4 Set and confirm the temperature step with the rotary knob.
 The device automatically adjusts the current skin temperature value on the
main screen via the temperature step.
 The automatic change is displayed on the main screen by 2 arrows arranged
in a ring.
5 Set and confirm the interval for the temperature steps with the rotary knob.
 The value is adopted.
 The calculated warm-up time is displayed.
6 Touch the On button.

112 Instructions for use Babyleo TN500 SW 1.0n


Operation

7 Press the rotary knob to confirm.


 The On button and the previously set buttons change to dark green.
✓ The device switches to skin temperature mode.
Example: In skin temperature mode, 35 °C (95 °F) was set. 36.5 °C (97.7 °F) is set
as the warm-up target value for the central skin temperature. A temperature step of
0.5 °C (0.9 °F) is set. In this example, the therapy control displays the set skin
temperature values 35.5 °C (95.9 °F), 36 °C (96.8 °F), and 36.5 °C (97.7 °F)
according to the selected interval. The predicted warm-up time is displayed.

6.16.3 Ending warm-up


There are 2 ways to end the warm-up time prematurely:
– On the main screen on the therapy bar
– In the Warm-up dialog window

6.16.3.1 Ending via the main screen


Procedure:
1 Touch the End warm-up button on the therapy bar.
2 Press the rotary knob to confirm.
✓ Warm-up has ended.

6.16.3.2 Ending via the dialog window


Procedure:
1 Touch the Special procedures... button in the main menu bar.
2 Open the Warm-up screen.
3 Touch the Off button.
4 Press the rotary knob to confirm.
✓ Warm-up mode has ended.

When ending warm-up, the target value defined during warm-up is adopted as
set value for the skin temperature.

6.17 Weaning (option)


This chapter describes automatic weaning (option).

6.17.1 Overview of weaning


During weaning, the patient can be automatically weaned from the warm
environment in the incubator. To do so, the device gradually reduces the air
temperature. The skin temperature is measured to check if the patient can maintain
the required skin temperature on his or her own. If the patient is able to maintain the
required skin temperature, the air temperature is reduced to the next step after the
set time. If the patient is unable to maintain the required skin temperature, the
patient compartment is heated back up to the air temperature that was in effect
before the last temperature reduction. An alarm is triggered.

Instructions for use Babyleo TN500 SW 1.0n 113


Operation

The following values can be set for weaning:


– Target value for the air temperature at the end of weaning
– Temperature step
– Interval for the temperature steps
– Target value for the central skin temperature
– Tolerated deviation for the central skin temperature
When automatic weaning is activated, Weaning is displayed on the main screen:

28492
6.17.2 Starting weaning
This chapter describes how to start automatic weaning.
Prerequisites:
– The patient is inside the device.
– The device is in incubator operation.
– At least the yellow skin temperature sensor for measuring the central skin
temperature is connected. For further information, see the following chapter:
''Connecting the skin temperature sensors'' (page 79)

Automatic weaning can only be started when the start temperature is less than
38 °C (100.4 °F) and does not lie within the extended temperature range.

Procedure:
1 Touch the Special procedures... button (1) in the main menu bar.
 The Special procedures dialog window is displayed.

28491

Fig. 63 Starting weaning


2 Open the Weaning dialog window (2).
3 Set and confirm the target value for the air temperature with the rotary knob.
4 Set and confirm the temperature step with the rotary knob.

114 Instructions for use Babyleo TN500 SW 1.0n


Operation

5 Set and confirm the interval for the selected temperature step with the rotary
knob.
6 Set and confirm the target value for the central skin temperature with the rotary
knob.
7 Set and confirm the value for the tolerated deviation from the central skin
temperature with the rotary knob.
8 Touch the On button.
9 Press the rotary knob to confirm.
 The On button and the previously set buttons change to dark green.
✓ The device switches to air temperature mode. When the target value for the air
temperature is reached, a message appears.

6.17.3 Ending weaning


Weaning can be ended at any time. There are 2 ways of ending weaning:
– On the main screen on the therapy bar
– In the Weaning dialog window
Weaning ends when the set target value for the air temperature is reached. The
device continues to operate in air temperature mode with the set target value for
weaning.

6.17.3.1 Ending via the main screen


Procedure:
1 Touch the End weaning button on the therapy bar.
2 Press the rotary knob to confirm.
✓ Weaning has ended.

6.17.3.2 Ending via the dialog window


Procedure:
1 Touch the Special procedures... button in the main menu bar.
2 Open the Weaning dialog window.
3 Touch the Off button.
4 Press the rotary knob to confirm.
✓ Weaning has ended.

Instructions for use Babyleo TN500 SW 1.0n 115


Operation

6.18 Scale (option)


This chapter describes how to use the scale (option) in the device.

6.18.1 Overview of the scale


The scale is integrated in the bed support. When weighing the patient, the objects
resting on the mattress are also weighed. In order to precisely determine the
patient's weight, the scale must be tared. In order to tare the scale, the patient must
be lifted up so that the weight of the mattress tray and the objects resting on it can
be determined. This weight is deducted from the measured weight when the patient
is subsequently weighed so that only the patient's weight is displayed. An acoustic
signal sounds when the scale is tared and also when the weighing process is
complete. The patient can be weighed during incubator operation and radiant
warmer operation.

28493
1

4 3

Fig. 64 Scale dialog window

No. Designation Description


1 Last weight Shows the last measured weight.
2 Weigh patient Activates the weighing process.
3 Weight (NET) [g] Shows the weight after taring.
4 Adjusted weight The symbol indicates whether the measured
weight was adjusted by the user.

116 Instructions for use Babyleo TN500 SW 1.0n


Operation

Offers access to a table of the last weight measurement with the following
information: date and time, weight and manually adjusted weight. This button allows
to switch between the graphical view and the tabular view.

Only one weight measurement per day is saved in the graphical view and the
tabular view. Only the last measured value is saved.

6.18.2 Connecting the scale


Prerequisites:
– The device has a connection for the scale (option).
– A scale is integrated in the bed support.
– The "Scale" software option is included in the device.

WARNING
Risk of electric shock
If the contact pins are touched, the user and the patient will be exposed to the risk
of an electric shock.
► Do not touch the pins in the plug of the scale.

Procedure:
1 Make sure that the scale cable faces the sensor wall.
2 Place the bed support with the scale on the T-bars from above.
3 Pull the cable through the hose grommet in the center of the sensor wall and
push it into the cable guide.
4 Make sure that the cable runs downward between the bed support and the
sensor wall and is not caught.
5 Insert the gray plug for the scale into the gray socket on the rear of the sensor
wall.
✓ The scale is connected to the device.

6.18.3 Weighing
This chapter describes how to weigh the patient in the device.
Prerequisites:
– The device is in operation and the scale is connected.
– The bed support is resting securely on the T-bars and is not tilted to the side.
– The locking brakes are engaged.
– A mattress is placed on the mattress tray.
– The patient is lying in the center of the mattress.

Instructions for use Babyleo TN500 SW 1.0n 117


Operation

WARNING
Risk due to measuring error or measuring inaccuracy
If the mattress tray is not horizontal during weighing or if the weight is falsified by
hoses or cables, measuring errors or inaccuracies may occur.This may result in
incorrect therapy decisions.
► Always position the mattress tray horizontally before weighing.
► Before weighing, make sure that the air bubble in the spirit level is within the
black ring and is not touching the ring.
► Make sure that cables (such as the heated mattress cable) are correctly routed
and do not falsify the weighing result.
► If a weighing result seems implausible, cross check it with a known weight value.
► Double-check therapeutic decisions that are based on the patient's weight by
performing a reference measurement using an external scale.

WARNING
Measuring error due to incorrect taring weight
If a taring weight if not determined before weighing, measuring errors may occur.
► Tare the scale before each weighing process.

Procedure:
1 Touch the Scale button (1) in the main menu bar.
 The Scale dialog window is displayed.

28493
1

Fig. 65 Activating the Scale button


2 Place the mattress tray in a horizontal position using the mattress tray control
panel and the spirit level. The mattress tray stops automatically once it reaches
a horizontal position. For further information, see the following chapter:
''Adjusting the mattress tray'' (page 49)
 The air bubble in the spirit level is within the black ring and is not touching the
ring.

118 Instructions for use Babyleo TN500 SW 1.0n


Operation

30295
Fig. 66 Note the spirit level
3 Proceed as follows in order to tare the scale:
– Keep as many hoses and cables that lead to the patient as possible off the
mattress tray.
– Fasten the hoses and cables in the holders.
– Pull the hoses and cables tautly through the hose grommets.
 This prevents hoses and cables from jamming the mattress tray or falsifying
the weight measurement.
4 Touch the Weigh patient button (2).
5 To tare the scale, lift the patient up. At least 200 g (0.44 lbs) must be lifted off the
mattress tray for the scale to be tared. Wait until a signal sounds.
 The scale is tared.

27266

Fig. 67 Taring the scale


6 Place the patient on the mattress.
 The patient's weight is determined.
 Once weighing is complete, a signal sounds.
 The measuring result is displayed. The weight is also displayed as a trend.
7 To confirm the measuring result, touch the OK button.
8 To discard the measuring result, touch the Discard button.

Instructions for use Babyleo TN500 SW 1.0n 119


Operation

6.18.4 Reweighing
If the mattress tray is not adjusted or moved for 6 minutes after the previous
weighing, the patient can be reweighed without needing to tare the scale again. The
Scale dialog window must remain open.
Example: The patient's weight needs to be determined with a diaper and then
without a diaper.
Prerequisites:
– The patient was weighed earlier and the Scale dialog window remains open.
– The mattress tray has not been adjusted or moved for 6 minutes.

WARNING
Risk if taring is not performed
When changes are made between measurements, measuring errors may occur if
the device is not tared, e.g., if the mattress tray is moved or adjusted or additional
items are placed on the mattress tray.
► Before carrying out another weight measurement, lift the patient up and tare the
scale.

Procedure:
1 To weigh the patient again, touch the Reweigh (1) button.
 The measuring result is displayed.
 The weight is also displayed as a trend.

30328

Fig. 68 Buttons after a measurement has been made

120 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.18.5 Adjusting the measured patient weight


The measured patient weight can be adjusted manually after weighing.
Example: After weighing, the weight of the diaper needs to be subtracted.
Procedure:
1 Touch the System setup... button in the main menu bar.
2 Touch the Therapy tab.
3 Enter the password and confirm.
4 Touch the Scale tab.
5 Touch the On button.
 The weight can be adjusted manually in the Scale dialog window.
6 Switch to the Scale dialog window and weigh the patient. Observe the
information in the following chapter: ''Weighing'' (page 117)
7 Enter a value in the Adjust weight (1) input field and confirm with the rotary
knob.
8 Confirm the adjusted weight with OK.
✓ The measuring result is displayed in the dialog window. The adjusted weight
values are highlighted in the graphical view and the tabular view. Only the last
measured weight is displayed per day.

27254
1

Fig. 69 Adjusting the measured patient weight

Instructions for use Babyleo TN500 SW 1.0n 121


Operation

6.19 Taking x-rays


This chapter describes how to take x-rays in the device.

6.19.1 Overview of taking x-rays


X-rays can be taken in the device without needing to move the patient. The x-ray
cassette, the x-ray imaging plate, or the digital x-ray detector is placed in the x-ray
tray under the mattress tray. The following formats fit in the x-ray tray:
Media Format
X-ray cassette with film or 18 x 24 cm (7 x 9 in)
imaging plate 24 x 30 cm (9 x 12 in)
Digital x-ray detector Up to 34 x 38 cm and up to a thickness of 2.25 cm
(up to 13 x 15 in and up to a thickness of 1 in)

For digital x-ray detectors with larger formats, remove the x-ray tray and insert the
digital x-ray detector in the compartment.

6.19.2 X-ray
The chapter describes how to take an x-ray of the patient in the device.

Prior to taking the x-ray, remove all positioning aids from the imaging area. The
positioning aids may absorb x-rays and adversely affect the image quality.

Prerequisites:
– The device is in operation.
– The patient is inside the device.
– A mobile x-ray device and an image receiver (x-ray cassette or x-ray imaging
plate) are available.
– The regulations for taking x-rays in incubators are known.
– The weight limit for the x-ray cassette has been taken into account.
– Bring the mattress tray into the bottom position and ensure it is horizontal.

WARNING
Risk of tipping over if overloaded
If compartments, x-ray trays, drawers, and supports are overloaded, the device may
tip over. This may result in injury to the patient and user. The device and
accessories may also be damaged due to the tip over.
► Do not overload the open x-ray tray.
► Observe the maximum loading of all shelves, drawers and holding devices.

NOTICE
Risk of x-ray detector failure
If the ambient conditions (temperature and relative humidity) in the device are
unsuitable for a digital x-ray detector, the x-ray detector may provide incorrect
results.
► Observe the permitted temperature range for the digital x-ray detector.

122 Instructions for use Babyleo TN500 SW 1.0n


Operation

Procedure:
1 Open the flap for the x-ray tray on one side of the device. Pull the x-ray tray (1)
out.

30274
1

Fig. 70 Pulling the x-ray tray out


2 Position the x-ray cassette within the markings and push the x-ray tray into the
device.
3 Close the flap in front of the x-ray tray.

NOTICE
Risk of impact with x-ray tube assembly
If the clearance above the device is too small, the x-ray tube assembly may hit
the hood of the device.
► Before aligning the x-ray tube assembly, make sure that there is enough
room for maneuver above the device.

4 Position the x-ray tube assembly between the radiant warmer and the patient
compartment.
5 Use the light field of the x-ray device to set the aperture to determine the desired
image section.
6 X-ray the patient.
7 Take the image receiver out of the x-ray tray and read it.
✓ The patient's x-ray is available.

Instructions for use Babyleo TN500 SW 1.0n 123


Operation

6.20 Developmental care (option)


This chapter describes the "Developmental Care" package. It also describes the
hood cover and how to play audio files.

6.20.1 Overview of "Developmental care"


A quiet environment is important for a premature baby's development. In the patient
compartment, a low noise level and soft lighting are crucial. The device measures
the noise level and the light level in the patient compartment. It is also possible to
provide acoustic stimulation by playing audio files, e.g., the parents' voices or
music.
The sensors for measuring the noise level and the light level are located in the
sensor wall of the device. The currently measured value is displayed on the user
interface. The values can be measured in incubator operation and radiant warmer
operation.

The Views... button is used to switch screen views.

The Developmental care view graphically shows how the noise level and the light
level in the patient compartment change over time.

27247

Fig. 71 Developmental care view

If the monitoring limits for noise and light are exceeded, the color of the graph
changes in the Developmental care view and in the Trends/data dialog
window as follows:
– If the medium threshold is exceeded, the graph turns yellow.
– If the upper threshold is exceeded, the graph turns red.

124 Instructions for use Babyleo TN500 SW 1.0n


Operation

6.20.2 Setting the monitoring limits for noise and light


This chapter describes how to set the monitoring limits for the noise level and the
light level.
Prerequisite:
– The "Developmental Care" package has been installed.
Procedure:
1 Touch the Alarms... button (1) in the main menu bar.
 The Alarm limits dialog page is opened.

28479
1

Fig. 72 Monitoring limits for noise and light


2 Touch the Noise/light tab (2).
 The buttons for the monitoring limits are displayed.
3 Use the rotary knob to set and confirm the thresholds for the noise level and the
light level.
✓ The monitoring limits for noise and light are set.

The monitoring limits for noise and light are only indicated visually. There is no
acoustic signal.

Instructions for use Babyleo TN500 SW 1.0n 125


Operation

6.20.3 Playing audio files


Audio files from an external MP3 player or a cellular phone can be played in the
patient compartment, e.g., the parents' voices or music.
A loudspeaker which transmits the audio signals into the patient compartment is
located in the sensor wall. The volume in the patient compartment is limited to a
maximum of 55 dB(A), regardless of the volume set on the cellular phone or MP3
player.
Prerequisites:
– The "Developmental Care" package has been installed.
– The device is in operation.
– The Dräger audio cable is available.
– An external playback device is available along with an audio file.

WARNING
Risk of electric shock
If the interface connectors and the patient are touched at the same time, there is a
risk of an electric shock.
► Do not simultaneously touch the audio port and the patient.

Procedure:
1 Connect the audio cable to an MP3 player or a cellular phone.
2 Insert the audio cable into the audio port on the rear of the sensor wall. For
further information, see the following chapter: ''Connectors on the rear sensor
wall'' (page 30)
3 Start playback and adjust the volume on the playback device.
 The voices or music are played in the patient compartment.
4 Observe the patient while the audio file is played.
5 Stop the playback after an appropriate amount of time.
The selection and use of audio material is left to the discretion of the clinical
staff.

6.20.4 Hood cover


A hood cover can be used to protect the patient from strong incident light. The hood
cover also dampens ambient noise. The hood cover has a flap on the top which can
be folded down for phototherapy treatment. A phototherapy light can then be placed
above the device.
The hood cover can only be used during incubator operation.
Observe the separate instructions for use for the hood cover.

126 Instructions for use Babyleo TN500 SW 1.0n


Alarms

7 Alarms
7.1 Alarm priorities and alarm signals
This device indicates alarms visually and acoustically. Each alarm is assigned a
specific priority, which indicates the level of urgency. The alarm conditions are
monitored automatically. The alarm presettings for the factory settings, user-
specific settings and patient-specific settings are retained after a power supply
failure, no matter how long it lasts.

7.1.1 Alarm priorities


The following table shows the differences between the alarm priorities in regard to
visual indicator and need for action:
Alarm priority Indicator Meaning
High Red !!! Immediate action required
Medium Yellow !! Rapid action required
Low Cyan ! Attention or action required

If several alarms are triggered at the same time, the alarm message with the
highest priority is displayed first. High-priority alarm messages that are no longer
active are displayed in the background color of the alarm message field.

7.2 Suppressing and delaying the alarm signal


Manually suppressing the acoustic alarm signal
The acoustic alarm signal for certain alarms can be suppressed for 2 to 15 minutes.
The duration of the suppression is based on the urgency of the alarm.
If several alarms are displayed, all alarms are suppressed by pressing the "Audio
paused" key. The duration of the suppression is based on the urgency. The most
urgent alarm determines the duration of suppression. If a new alarm occurs during
this time, the alarm signal sounds and the suppression is canceled.

Proactively suppressing the acoustic alarm signal


If the user is planning to use the device and acoustic alarms are to be expected,
these alarms can be suppressed in advance for 4 minutes.
Example: The device will be operated in incubator mode with oxygen. The patient
compartment must be briefly opened for therapeutic reasons (hood or access
panel). In such cases, the oxygen concentration in the patient compartment will
probably fall.
If the "Audio paused" key is pressed before the hood or access panel is opened, the
device suppresses the alarm as follows: If the oxygen concentration falls, no
acoustic alarm is generated for 4 minutes. Only a visual alarm is displayed. If during
this time an alarm occurs which is unforeseeable, then the suppression is canceled
and the alarm signal sounds.

Instructions for use Babyleo TN500 SW 1.0n 127


Alarms

Automatic delaying of acoustic and optical alarm signals


If the user switches on the device or changes settings that will probably result in
alarms, the acoustic and optical alarm signal for some alarms will be automatically
delayed. Whenever the settings are changed, the device checks whether an alarm
condition exists. The device delays the output of the alarm signals for as long as it
takes for it to reach the new values set by the user.
Example: The device is switched on when the room temperature is 23 °C (73.4 °F).
An air temperature of 36.5 °C (97.7 °F) is set. For the period that the device was
switched off, the current air temperature in the incubator was the same as the
ambient temperature and lower than the set value. The device detects the warm-up
phase and automatically suppresses the Air temperature low alarm for a
maximum of 30 minutes.
When kangaroo mode is started, some alarms are delayed for 4 minutes, as these
alarms are to be expected when the device is opened. For further information, see
the following chapter: ''Setting skin temperature alarm limits for kangaroo
mode'' (page 107)
The following table shows the duration of the suppression and the classification as
a foreseeable alarm.
Alarm Duration of Duration of Duration of
manual alarm proactive automatic
suppression alarm sup- delay of
(min) pression alarm sig-
(min) nal (min)
Air temperature high 15 - max. 30
Air temperature low 15 4 max. 30
Air temperature too high 5 - max. 30
Ambient temperature sensor 2 - -
faulty
Centr. sensor missing, heating off 5 - -
Centr. temp. sensor faulty, heating 5 - -
off
Central skin temp. sensor missing 5 - -
Central skin temperature high 15 - -
Central skin temperature low 15 4 -
Central skin temperature too high 2 - -
Device failure, heating off 2 - -
Fan motor faulty, heating off 2 - -
Humidity low - 4 max. 60
Internal temperature high 2 - -
Mattress faulty 2 - -
Mattress temperature too high 2 - -
Oxygen high 4 - max. 30
Oxygen low 4 4 max. 10
Oxygen module faulty 2 - -
Oxygen sensor faulty 2 - -
Peripheral skin temp. sensor 5 - -
faulty

128 Instructions for use Babyleo TN500 SW 1.0n


Alarms

Alarm Duration of Duration of Duration of


manual alarm proactive automatic
suppression alarm sup- delay of
(min) pression alarm sig-
(min) nal (min)
Peripheral skin temp. sensor 5 - -
missing
Peripheral skin temperature high 15 - -
Peripheral skin temperature low 15 4 -
Peripheral skin temperature too 2 - -
high
Skin temp. sensor faulty, heating 2 - -
off
Skin temperature difference high 15 - -
Skin temperature difference low 15 4 -
Skin temperature high 5 - -
Skin temperature low 5 4 -
Temp. of convective heater high 2 - -
Temp. of humidifier heater high 2 - -
Temperature high in warm air duct 5 - -
Warmer off, check patient's condi- 2 - -
tion
Water level low - 4 -
Weaning failed 2 - -

If the fault triggering the alarm is not eliminated after the suppression time has
elapsed, the alarm signal sounds again.
1 Press the "Audio paused" key.
✓ In the header bar, the symbol and the remaining time for the suppressed alarm
signal are displayed.

7.2.1 Premature reactivation of the alarm signal


1 Press the "Audio paused" key.
✓ The symbol for the suppressed alarm signal is no longer displayed in the header
bar.

Instructions for use Babyleo TN500 SW 1.0n 129


Alarms

7.3 Dismissing the alarm message


Depending on what caused them, some alarms must be dismissed. The following
situations may arise:
– Once the fault triggering the alarm has been remedied, the alarm signal no
longer sounds and the user does not need to dismiss the alarm.
– Once the fault triggering the alarm has been remedied, the alarm signal no
longer sounds and the user needs to dismiss the alarm.
– An alarm is displayed, the user can dismiss the alarm and the device continues
operation with the specified values. The alarm signal no longer sounds.
– Once the fault triggering the alarm has been remedied, the alarm signal no
longer sounds. The alarm message remains in the alarm message field in the
header bar until the user dismisses it by pressing Alarm reset. This process
applies to the following alarms:

Alarm
Air temperature too high
Central skin temp. sensor missing
Check oxygen supply
Data loss
Fan motor faulty, heating off
Mattress faulty
Mattress temperature too high
Oxygen module faulty
Oxygen sensor faulty
Peripheral skin temp. sensor missing
Temperature high in warm air duct

Procedure:
1 Touch the Alarm reset button on the header bar on the main screen.
✓ The alarm message has been dismissed and is no longer displayed.

Safety-relevant alarms cannot be dismissed.

7.4 Viewing the alarm history


The alarm history records all alarm messages in chronological order.
1 Touch the Alarms... button in the main menu bar.
2 Touch the Alarm history tab.
3 Use the rotary knob or the arrow buttons to scroll the cursor up or down.
When the alarm history reaches its capacity, the oldest entries are overwritten.
When the device is shut down, the alarm history is deleted. There is no record kept
of how long the device and alarm system were shut down. The alarm history is also
deleted in the event of a power supply failure.

130 Instructions for use Babyleo TN500 SW 1.0n


Configuration

8 Configuration
8.1 Entering patient data
This chapter describes how to enter patient data. At the start of therapy, the device
suggests an air temperature range based on the patient data and weight entered.*
For further information, see the following section: ''Recommended air
temperature'' (page 133)
Prerequisite:
– The device is in operation.
Procedure:
1 Touch the System setup... button (1) in the main menu bar.
 The System setup dialog window and the Patient dialog page are
displayed.

28495
1

Fig. 73 Input fields for patient data


To enter data, touch the pen icon on the display. To confirm, press Enter on
the keyboard or press the rotary knob.

2 Touch the pen icon to the right of the relevant input field.
 The keyboard is displayed. 27252

Fig. 74 Keyboard

* Sauer PJ, Dane HJ, Visser HK. New standards for neutral thermal environment of healthy very
low birth weight infants in week one of life. 1984

Instructions for use Babyleo TN500 SW 1.0n 131


Configuration

Either the patient name or identification number can be displayed in the


header bar. If an identification number has been entered, the header bar
always displays the identification number. In the System setup dialog
window, it is possible to specify that neither the patient name nor the
identification number is displayed in the header bar: System setup... >
Screen layout > More settings

3 Enter and confirm the following data using the keyboard:


– First name
– Last name
– Identification number
 The name or identification number is displayed in the header bar.
4 For the following data, touch the button, turn the rotary knob to the right or left,
and confirm each input:
– Date of birth
– Gestational age [wk + d]
– Birth weight [g]
5 Touch a button for the gender.
 The gender is displayed in the header bar and in the Family screen view.
6 Select a symbol for the patient in the list field.
 The symbol is displayed in the header bar and in the Family screen view.

8.1.1 Deleting patient data


This chapter describes how to delete patient data.

Patient data can only be deleted by restarting the device.

1 Switch off the device on the display unit using the Start/standby key .
 The Shut down dialog window is displayed.
2 Touch the Shut down button.
 The device shuts down.
3 Switch on the device on the display unit using the Start/standby key .
 The start-up screen is displayed.
4 Touch the New patient button.
 The existing patient data is deleted.
 The therapy settings and the patient-specific alarm settings are reset to the
user-specific settings.
 The logbook is not deleted.
✓ Patient data can be entered anew.

132 Instructions for use Babyleo TN500 SW 1.0n


Configuration

8.1.2 Recommended air temperature


If patient data, such as date of birth, gestational age and weight, is entered, then
the device uses this data to determine an air temperature range for the patient.*
The suggested air temperature range is based on a naked patient and on the
following settings:
– ClearView on
– Humidity with the setting Auto
Procedure:
1 Enter the date of birth.
2 Enter the gestational age in weeks and days.
3 Select the actual weight range from the picklist.
Example: The current weight of the patient is 1057 g (2.33 lbs). The range
1000–1100 g (2.2–2.43 lbs) is selected from the pick list.
 The recommended air temperature range (1) for the patient is displayed.

28495
1

Fig. 75 Recommended air temperature range


4 Close the System setup dialog window.
5 Touch Air mode in the therapy bar and confirm with the rotary knob.
6 Touch the Air temp. therapy control.
7 Use the rotary knob to set the air temperature value according to the
recommended air temperature range.
8 Press the rotary knob to confirm.
✓ The air temperature is set.

* Sauer PJ, Dane HJ, Visser HK. New standards for neutral thermal environment of healthy very
low birth weight infants in week one of life.1984

Instructions for use Babyleo TN500 SW 1.0n 133


Configuration

Additional information:
– According to the data from this study, the recommended air temperature for a
patient aged 1 to 7 days does not depend on the patient's weight. Consequently,
the weight range cannot be selected for patients of this age.
– The last measured weight is used for determining the recommended air
temperature range. If there is no scale in the device, the weight range must be
selected manually.
– The range for the recommended air temperature in the System setup dialog
window is automatically adjusted in line with the age. The required air
temperature must be set on the main screen.
– If the ClearView on setting or the Auto setting of the Humidity therapy control
is changed or the patient is clothed or covered, this must be taken into account
in the air temperature settings.
– The recommended air temperature applies for patients up to an age of 36 days
and < 2500 g (5.5 lbs).
For further information, see the following chapter: ''Starting air temperature
mode'' (page 87)

8.2 Transferring data to another device


This chapter describes how configuration data and patient data are transferred from
one device to another.

8.2.1 Overview of data export


The data can be exported with a USB mass storage device.
Examples:
– To transfer the configured default settings to several devices
– To transfer the patient data to a new device when a device is changed
The following table shows which data can be exported.

Button Exported data


Configuration Settings in System setup... > Therapy, e.g., air temperature,
data skin temperature, air humidity, mattress core temperature
Settings in System setup... > Screen layout, e.g., screen
brightness, screen lock
Settings in System setup... > Alarms, e.g., alarm limits for the
skin temperature
Patient data Settings in System setup... > Patient, e.g., the configured
patient data, such as name, date of birth, birth weight
Current settings, which have been determined using the ther-
apy controls, e.g., with the therapy control for air temperature,
skin temperature, air humidity, mattress core temperature
Current settings in Alarms

The trend data and the logbook data cannot be exported.

134 Instructions for use Babyleo TN500 SW 1.0n


Configuration

8.2.2 Exporting data


This chapter describes how to transfer the data to a USB mass storage device.
Prerequisites:
– The device is switched on.
– A USB mass storage device (e.g., a USB mass storage device from Dräger) is
available.
– The USB port function is activated. (System setup... > System > Interfaces >
USB > USB port > On)

WARNING
Risk of patient injury due to incorrect patient data
Only one data record with configuration data and one data record with patient data
can be stored on the USB mass storage device. If a data record already exists on
the USB mass storage device, the new data record overwrites the existing data.
► Check the configuration data and the current settings on the new device after
the data import.

WARNING
Risk of electric shock on USB port
Connecting mains voltage carrying accessories to the USB port may trigger an
electric shock.
► Only connect USB mass storage devices that are included in the list of approved
accessories to the USB port.
► Do not connect any accessory operating on mains voltage to the USB port.
► Do not simultaneously touch the USB port and the patient.

Procedure:
1 Connect the USB mass storage device to the USB port on the rear of the main
column.
It may take a few seconds for the device to recognize the USB mass storage
device.

2 Touch the System setup... button (3) in the main menu bar.
30325

2
3

Fig. 76 Import/export dialog window of patient data

Instructions for use Babyleo TN500 SW 1.0n 135


Configuration

3 Open the Import/export tab (1).


 The Patient data dialog window is displayed.
 If there is already data on the USB mass storage device, the data record is
displayed with date and time.
4 To export the Patient data, touch the Export button (2) and confirm with the
rotary knob.
 The patient data is exported to the USB mass storage device.
 The exported data record is displayed in the dialog window with the date and
time.
5 Touch the Configuration data tab.
6 Enter the password and confirm.
7 To export the Configuration data, touch the Export button and confirm with the
rotary knob.
 The configuration data is exported to the USB mass storage device.
 The exported data record is displayed in the dialog window with the date and
time.
8 Remove the USB mass storage device from the USB port.
✓ The configuration data and the patient data can be transferred to another
device.

8.2.3 Importing data


This chapter describes how to transfer the exported data to another device.
Prerequisites:
– The USB mass storage device contains exported patient data and/or
configuration data.
– The USB port function is activated. (System setup... > System > Interfaces >
USB > USB port > On)
Procedure:
1 Connect the USB mass storage device to the USB port on the rear of the main
column.
2 Touch the System setup... button in the main menu bar.
3 Open the Import/export tab.
 The exported patient data are displayed with date and time in the Patient
data dialog window.
4 To import the patient data, touch the Import button and confirm with the rotary
knob.
 The patient data is imported.
 The imported data is displayed with date and time.
 Once the import is complete, the device restarts automatically.
5 Touch the Configuration data tab.
6 Enter the password and confirm.
 The exported data records are displayed with date and time in the
Configuration data dialog window.

136 Instructions for use Babyleo TN500 SW 1.0n


Configuration

7 To import the configuration data, touch the Import button and confirm with the
rotary knob.
 The configuration data is imported.
 The imported data is displayed with date and time.
 Once the import is complete, the device restarts automatically.
Once the import is complete, the patient data is automatically deleted from
the USB mass storage device. This prevents patient data from being
transferred accidentally. The configuration data is not deleted.

8 Once the device is ready for operation again, check the alarm limits and the
therapy values.
9 Remove the USB mass storage device from the USB port.
 The configuration data and the patient data have been transferred to the
other device.
✓ The configuration data can be transferred to another device.

8.3 Displaying trends and data


This chapter describes how to display trends, data, and logbook entries.
Parameters are displayed over time in the Trends/data dialog window. The
parameters can be displayed as a graphical or a tabular trend.

This chapter describes the maximum possible display of trends and data.
Depending on how the device is configured, the display on the actual device
may differ.

Prerequisite:
– The device is in operation.
Procedure:
1 Touch the Trends/data... button (1) in the main menu bar.

28487

Fig. 77 Trends/data dialog window


2 Touch the Graphical trends, Tabular trends, Values/settings, or Logbook
tab.

Instructions for use Babyleo TN500 SW 1.0n 137


Configuration

8.3.1 Graphical trends


A temporal resolution of the display from 2 hours to 7 days can be set in the
Graphical trends tab. Earlier time periods can be displayed using the arrow keys.
Different groups of parameters can be selected in the vertical tabs.

8.3.1.1 Vertical tab Thermoregulation


The following overviews and parameters can be displayed in the
Thermoregulation tab:
Overview Parameter Selected in factory
settings
Temperature Central skin temperature X
Peripheral skin temperature X
Air temperature X
Mattress core temperature (option) X
Patient compart- Humidity X
ment Oxygen (option) X
Heating Radiant warmer –
Convection heater –

A maximum of 2 overviews can be displayed at the same time. The following


combinations are possible:
– Temperature and patient compartment
– Temperature and heating
– Patient compartment and heating

28488
1

Fig. 78 Configuration menu of displayed thermoregulation parameters


To change the overviews, touch the pen icon (1).

138 Instructions for use Babyleo TN500 SW 1.0n


Configuration

The color of the buttons indicates the overviews in which parameters can still be
selected.
Color Meaning
Dark green The parameter is selected and displayed as a
graphical trend.
Light green The parameter can be selected.
Gray The parameter cannot be selected.

To select a gray parameter, a dark green parameter must be deselected first.


To select a different overview, all parameters for a selected overview must be
deselected first. Afterwards, a new overview and its associated parameters can be
selected.
Example: The "Temperature" and "Patient compartment" overviews are selected.
The "Patient compartment" overview needs to be replaced with the "Heating"
overview. First, the parameters from "Patient compartment" – "Relative humidity"
and "Oxygen" – must be deselected before the parameters from "Heating" –
"Radiant warmer" and "Convection heater" – can be selected.

8.3.1.2 Vertical tab Weight (option)


The measured patient weight is displayed in the Weight tab. Only one measured
value is saved per day. For further information, see the following chapter:
''Weighing'' (page 117)

8.3.1.3 Vertical tab Noise/light (option)


The noise level and light level in the patient compartment are displayed in the
Noise/light tab in temporal resolution.

8.3.1.4 Vertical tab Userdefined


Users can use the Userdefined tab to decide themselves which trends to display.
The following overviews and parameters can be displayed:

Overview Parameter Selected in factory


settings
Temperature Central skin temperature X
Peripheral skin temperature X
Air temperature X
Mattress core temperature –
Patient compart- Humidity –
ment Oxygen –
Heating Radiant warmer X
Convection heater X
Events Hood open X
Access panel open X
Air mode –
Manual mode –
Skin mode –
Kangaroo mode X

Instructions for use Babyleo TN500 SW 1.0n 139


Configuration

Overview Parameter Selected in factory


settings
Noise/light Noise level –
Light level –

A maximum of 3 overviews can be displayed at the same time. As per the


Thermoregulation tab, all parameters for a selected overview must be deselected
before a new overview can be selected.
A maximum of 3 parameters can be displayed simultaneously per overview. If
3 parameters are already selected in an overview, one of the parameters must be
deselected before a new parameter can be selected.
The colors of the buttons correspond to those of the indicators in the
Thermoregulation tab.

8.3.2 Tabular trends


Trends are displayed in tabular form in the Tabular trends tab. The temporal
resolution of the display can be set from 30 minutes to 24 hours. Earlier time
periods and other parameters can be displayed with the arrow keys.
As per the graphical trends, the overview can be changed with the pen icon. The
following parameters can be selected:
Vertical tab Heading Parameter Selected in fac-
tory settings
Thermoregulation Temperature Central skin temperature X
Peripheral skin tempera- X
ture
Skin temperature differ- X
ence
Air temperature X
Mattress core tempera- X
ture
Patient com- Humidity X
partment Oxygen –
Heating Radiant warmer –
Convection heater –
Weight
Noise/light Noise level
Light level

140 Instructions for use Babyleo TN500 SW 1.0n


Configuration

Vertical tab Heading Parameter Selected in fac-


tory settings
Userdefined Temperature Central skin temperature X
Peripheral skin tempera- X
ture
Skin temperature differ- X
ence
Air temperature X
Mattress core tempera- –
ture
Patient com- Humidity –
partment Oxygen –
Heating Radiant warmer X
Convection heater X
Noise/light Noise level –
Light level –

8.3.3 Measured values and settings


All current measured values and current settings for the thermoregulation are
displayed in the Values/settings tab.

8.3.4 Logbook
All events and alarms are displayed in chronological order in the Logbook tab. The
latest event/latest alarm is at the top. Earlier events and alarms can be displayed
using the arrow keys.
The entries in the logbook cannot be deleted and are preserved even after the
device is switched off and on or after a power supply failure. There is no record kept
of how long the device and alarm system were shut down. When the capacity of the
logbook is reached, the oldest entries are overwritten.
The following events and alarms are displayed:
– All alarms, their confirmation, and muting by the user
– Alarm limit changes
– Operating mode changes
– Therapy control changes
– Start and end of applications
– Events such as hood open, side access panel open
– Data import and export to USB mass storage device
– Device time changes

Instructions for use Babyleo TN500 SW 1.0n 141


Configuration

8.4 System setup


8.4.1 Specifying the device settings
The following tables show the settings options in the System setup dialog window.

The description assumes the maximum device configuration. The actual device
may differ in its functions from the descriptions below.

Various settings are possible for the device:

Factory settings
Dräger delivers the device with factory settings that are used when starting the
device for the first time. Users can reset the device to factory settings.

User-specific settings
The user can define specific settings for the device. The settings (e.g., therapy
values, alarm limits, or screen layout) can be made in the System setup dialog
window. User-specific settings are saved automatically once they are confirmed.
User-specific settings can be transferred to other devices via the Import/export
function. For further information, see the following chapter: ''Transferring data to
another device'' (page 134)
User-specific settings are automatically applied in the following situations:
– When the device is restarted after it has been switched off for more than 2
hours.
– If the New patient button was activated when the device was switched on.

Patient-specific settings
The user can adjust the factory settings or the user-specific settings to suit the
current patient. The values for the patient-specific settings are set on the main
screen via the therapy bar (modes and therapy controls). Patient-specific alarms
are set via the main screen in the Alarms dialog window. The patient-specific
settings also include the information in System setup > Patient dialog window.
Patient-specific settings can be transferred to other devices via the Import/export
function. For further information, see the following chapter: ''Transferring data to
another device'' (page 134)
Patient-specific settings are automatically set in the following situations:
– When the device is restarted after it has been switched off for less than 2 hours.
– If the Current patient button was activated when the device was switched on.
The configuration password must be entered for some settings. For further
information, see the following section: ''Configuration password for Babyleo
TN500 Software 1.0n'' (page 213).

8.4.1.1 Resetting to factory settings


Certain tabs in the System setup dialog window have a button for resetting the
user-specific settings to the factory settings.
1 Open the relevant tab, e.g., Screen layout, Alarms, Therapy, System.

142 Instructions for use Babyleo TN500 SW 1.0n


Configuration

2 Touch the Factory defaults button and confirm.


✓ The corresponding factory setting is restored.
The following tables show the factory setting values.

8.4.1.2 Horizontal tab Patient

Heading or parameter Description Additional information


First name Enter the first name. Either the name or identification
Last name Enter the last name. number can be displayed in the
Identification number Enter the identification number. header bar. If an identification num-
ber has been entered, the header
bar always displays the identifica-
tion number.
Date of birth Enter the date of birth.
Gestational age [wk + d] Enter the gestational age in weeks
and days.
Birth weight [g] Enter the birth weight.
Gender Select the gender.
Select a symbol for the patient. The symbol is also displayed in the
Family screen view.

8.4.1.3 Horizontal tab Screen layout

Vertical tab Heading or parame- Description Factory setting


ter
General settings Color scheme Select day mode or night mode Day
for the screen.
Screen brightness Set the screen brightness as a 50 %
[%] percentage.
More settings Display patient Switch the display of the On
name/ID patient name or identification
number on or off in the header
bar.
Display patient Switch the display of the On
weight patient weight on or off.
Display suggested Switch the display of the sug- On
air temp. range gested air temperature on or
off.
Colors Configure the colors for the All parameters are dis-
displayed parameters. played in dark blue.
Screen lock Enter and confirm the configu-
ration password.
Automatic lock Switch the automatic screen Off
lock on or off.
Lock after Select when the screen should 30 s
be automatically locked follow-
ing a period of inactivity: 30 s,
1 min, 5 min, 15 min, 30 min.

Instructions for use Babyleo TN500 SW 1.0n 143


Configuration

8.4.1.4 Horizontal tab Alarms

Vertical tab Heading or parame- Description Factory setting


ter
Air mode/Man. Enter and confirm the configu-
mode ration password.
Upper limit for air Specify the upper alarm limit + 1.5 °C (2.7 °F)
temp. deviation + for the air temperature devia-
tion.
Lower limit for air Specify the lower alarm limit for - 1.5 °C (2.7 °F)
temp. deviation - the air temperature deviation.
Advanced skin tem- In air temperature mode and Off
perature monitoring manual mode, the patient's
skin temperature can be moni-
tored. The skin temperature
sensors must be connected to
the device and attached to the
patient.
Skin temperature If the Advanced skin tem- 39 °C (102.2 °F)
perature monitoring function
is activated, the following
alarm limits can be defined:
– The upper alarm limits for
the central and the periph-
eral skin temperature
– The lower alarm limits for Off
the central and the periph-
eral skin temperature
– The upper alarm limit for 5 °C (9 °F)
the difference between the
central and peripheral skin
temperature
– The lower alarm limit for the Off
difference between the cen-
tral and peripheral skin tem-
perature

144 Instructions for use Babyleo TN500 SW 1.0n


Configuration

Vertical tab Heading or parame- Description Factory setting


ter
Skin mode Tolerated deviation The skin temperature sensors
for central skin must be connected to the
temp. ± device and attached to the
patient.
– Specify the upper and lower 0.6 °C (1.1 °F)
alarm limit for the tolerated
deviation of the central skin
temperature.
Advanced skin tem- When the Advanced skin Off
perature monitoring temperature monitoring func-
tion is activated, additional
alarm limits can be determined:
Skin temperature – Upper alarm limit for the dif- 5 °C (9 °F)
ference between the central
and peripheral skin tem-
perature
– Lower alarm limit for the dif- Off
ference between the central
and peripheral skin tem-
perature
Kangaroo mode Skin temperature The skin temperature sensors
must be connected to the
device and attached to the
patient. Specify the following
alarm limits:
– The lower alarm limits for 35 °C (95 °F)
the central and the periph-
eral skin temperature
– The upper alarm limit for 5 °C (9 °F)
the difference between the
central and peripheral skin
temperature
– The lower alarm limit for the Off
difference between the cen-
tral and peripheral skin tem-
perature
Tolerate cooling Skin temperature Specify the following alarm lim-
(option) its:
– The upper alarm limit for 35 °C (95 °F)
the central skin temperature
– The lower alarm limit for the 30 °C (86 °F)
central skin temperature
– The upper and lower alarm Off
limit for the peripheral skin
temperature

Instructions for use Babyleo TN500 SW 1.0n 145


Configuration

Vertical tab Heading or parame- Description Factory setting


ter
Oxygen (option) Tolerated deviation Specify the upper and lower 5%
for oxygen con- alarm limit for the tolerated
centr. ± deviation of oxygen concentra-
tion in the patient compart-
ment.
Noise/light (option) Noise level Specify the threshold for the
Threshold for medium and high noise level in Threshold for medium
medium exposure the patient compartment: noise level: 50 dB(A)
Threshold for high – Noise level in dB(A) Threshold for high noise
exposure level: 80 dB(A)
Light level Specify the threshold for the
Threshold for medium and high light level in Threshold for medium
medium exposure the patient compartment: light level: 500 lux, 46
– Light level in lux or fc fc
Threshold for high Threshold for high light
exposure level: 800 lux, 74 fc

8.4.1.5 Horizontal tab Therapy

Vertical tab Heading or parame- Description Factory setting


ter
Thermoregulation Enter and confirm the configu-
ration password. Define the fol-
lowing therapy values:
Skin temp. Skin temperature 36.5 °C (97.7 °F)
Air temp. Air temperature 30 °C (86 °F)
Humidity Humidity Off
Mattress temp. Mattress core temperature Off
(option)
Transition Standard Standard
– In incubator operation the
radiant warmer operates
continuously at low power.
– In radiant warmer opera-
tion the convection heater
operates continuously at
low power.
Eco
– In incubator operation the
radiant warmer is switched
off.
– In radiant warmer opera-
tion the convection heater is
switched off.
ClearView Switch on so that the radiant On
warmer operates at low power
and reduces the level of fog-
ging on the hood.

146 Instructions for use Babyleo TN500 SW 1.0n


Configuration

Vertical tab Heading or parame- Description Factory setting


ter
Scale (option) Weight adjustment Switch on so that the user can Off
by user manually adjust the measured
patient weight.

The Standard function or the Eco function can be selected for the transition
between incubator operation and radiant warmer operation. For further
information, see the following chapter: ''Configuring the transition'' (page 76).
The Standard function automatically activates the ClearView on setting. The
ClearView on setting can only be deactivated when the Eco function is
selected.

8.4.1.6 Horizontal tab Import/export

Heading or parameter Description


Configuration data Enter and confirm the configuration password. If a specific
device configuration is available, this is shown here.
USB mass storage device If a USB mass storage device is connected and a specific
device configuration is available, this is shown here.
Patient data If patient data is available on the device, this is shown here.
USB mass storage device If a USB mass storage device is connected and patient data is
available, this is shown here.

8.4.1.7 Horizontal tab System

Vertical tab Heading or parame- Description Factory setting


ter
Moodlight Brightness [%] Set the brightness for the 50 %
moodlight.
Color Select the color of the mood- Blue
light.
Moodlight The moodlight can be switched On
on or off. Alternatively, auto-
matic switch on/off can be acti-
vated.
Timer Specify the time period for
automatic switch on/off.
Country Enter and confirm the configu-
ration password.
Language Select a language.
Date/time Set the date and time and con-
firm with the rotary knob. Then
confirm with the Apply button.

Instructions for use Babyleo TN500 SW 1.0n 147


Configuration

Vertical tab Heading or parame- Description Factory setting


ter
Interfaces Enter and confirm the configu-
ration password.
COM
Set the following parameters:
Protocol – MEDIBUS.X MEDIBUS.X
– None
Baud rate – Baud rate 9600
USB
USB port Switch the USB port on or off. On
Units Enter and confirm the configu-
ration password.
Temperature Specify the unit ºC or ºF. ºC
Weight (option) Specify the unit g or lbs oz. g
Light (option) Specify the unit lux or fc. lux
Alarm volume Enter and confirm the configu-
ration password.
Start level for alarm Set the start level for the alarm 50 %
volume [%] volume as a percentage.
Maximum alarm Set the maximum alarm vol- 70 %
volume [%] ume as a percentage.

148 Instructions for use Babyleo TN500 SW 1.0n


Configuration

Vertical tab Heading or parame- Description Factory setting


ter
Service The service dialog can be
opened by entering the config-
uration password or the service
password.
Access with the service pass-
word is reserved for special-
ized service personnel and
DrägerService. Depending on
the password, the service dia-
log provides access to different
functions.
Service menu (user, Enter and confirm the configu-
service personnel) ration password for the follow-
ing functions:
– Activating applications
– Adjusting the Oxycell O2
sensors
– Remote Service (Help
Ticket, Device Check)
Service menu (spe- Enter and confirm the service
cialized service per- password for the following
sonnel, function:
DrägerService) – Adjusting the scale (option)
For more information, contact
DrägerService.
Maintenance notifi- Switch the display of mainte- On
cation nance messages on or off.
Password Change the configuration
password.

Instructions for use Babyleo TN500 SW 1.0n 149


Transfer

9 Transfer
9.1 Intrahospital patient transfer with switched off warming
therapy
This chapter describes how to move the patient in the device into another room.

9.1.1 Overview of intrahospital patient transfer with switched off


warming therapy
The patient can be moved within the hospital in the device, e.g., from the labor and
delivery room to the neonatal intensive care unit. warming therapy is interrupted
during this time. The patient is not supplied with heat and humidified air.
The device must be set to a low height prior to moving the patient so that the red
hatched label on the lifting column is no longer visible. At this height, the device can
be moved without the radiant warmer hitting a door frame, for example.

28226
Fig. 79 Label on the lifting column

9.1.2 Transferring the patient


This chapter describes how to prepare the device for transfer and how to transfer
the patient together with the device.
Prerequisites:
– The device is in operation.
– The device height adjustment mechanism is not locked.

WARNING
Risk of patient injury due to interruption of warming therapy
When the patient is moved to another room in the device, the device is switched off
during the transfer.The warming therapy is interrupted and the skin temperature is
not measured.
► During the transfer, monitor the patient's body temperature with a separate
measuring device.
► Make sure that the patient is sufficiently warmed during the transfer.

150 Instructions for use Babyleo TN500 SW 1.0n


Transfer

WARNING
Risk of patient injury during transfer
Device parts may be damaged during transfer. The device may tip over. The patient
may be injured and device functions may be impaired. Before transfer, perform the
following measures:
► Set the device to transfer height and observe the information in the chapter
"Transferring the patient".
► Make sure that there is always sufficient clearance above the radiant warmer
and that the radiant warmer is not damaged.
► Make sure that accessories, e.g., pressure reducers and cylinder valves, do not
protrude beyond the trolley during the transfer.
► When transferring the patient, the device must always be moved by two people.
► Avoid shocks and vibrations as much as possible, e.g., when crossing door
thresholds and passing through door frames.

Check the functional integrity of the accessories during and after the
intrahospital transport. Observe the chapter "Adjusting the device height".

Procedure:
1 Adjust the height of the device using the foot pedals. The correct transfer height
is reached when the red hatched label on the lifting column is completely
covered.
 The correct device height for transfer is set.

26836

Fig. 80 Setting the transfer height


2 Carefully fold additional devices on the mounted support arms, e.g., patient
monitors or syringe pumps, against the device.
3 Secure loose objects on mounted support arms to prevent them from falling
down.
4 Close the hood.
5 Remove the x-ray cassette from the x-ray tray. Slide the x-ray tray into the
device.
6 Slide the bed support into the device.
7 Slide the drawer into the device and lock the drawer.

Instructions for use Babyleo TN500 SW 1.0n 151


Transfer

8 Check if the patient can be moved without warming therapy.


 If the patient's state of health is stable enough, the patient can be moved in
the device.
9 Switch off the device on the display unit using the Start/standby key .
 The Shut down dialog window is displayed.
10 Touch the Shut down button and confirm.
 The device functions are shut down.
11 Switch off the device using the main switch on the rear of the main column.
12 Remove all plugs and the mains plug. Fasten the power cable to the device.
✓ The device is ready for transfer.

Check for operational readiness after the transfer. For further information, see
the following chapter: ''Checking for operational readiness'' (page 63)

152 Instructions for use Babyleo TN500 SW 1.0n


Troubleshooting

10 Troubleshooting
10.1 Alarm – Cause – Remedy
The alarm messages are displayed in the message field of the header bar in
hierarchical order. For further information, see the following chapter: ''Alarm
priorities and alarm signals'' (page 127)
Different background colors indicate the priority levels of the alarms.
In the Current alarms and Alarm history tables, the priority of the alarm
messages is also indicated by exclamation marks.
Alarm priority Exclamation marks Color
High !!! Red
Medium !! Yellow
Low ! Cyan

In order to classify the alarms within an alarm priority, internal priority numbers are
specified in the table below. The most critical alarm is given the number 255. The
priority of the alarm decreases the lower the number is.
In the following table, the alarm messages are listed in alphabetical order. If an
alarm occurs, the table helps to identify causes and remedies. The different causes
and remedies should be worked through in the order listed until the alarm has been
resolved.
Some alarms appear in this table several times with different priorities because their
priority may change under certain conditions.

Alarm pri- Alarm Cause Remedy


ority
! 119 Adjustment of O2 sensor The adjustment interval of Set the therapy control for
required the oxygen sensor has been oxygen to "Off".
exceeded. Adjust the oxygen sensor.
!! 64 Air mode not confirmed The mode was selected, but Select air mode and press
it was not confirmed. the rotary knob to confirm.
!! 214 Air temperature high The current air temperature Check the set value.
is above the set value. Check the set alarm limit.
Remove external heat
sources.
!! 165 Air temperature low The current air temperature Close the hood, the side
is below the set value. access panels, or the hand
ports.
Check the set value.
Check the set alarm limit.
!! 59 Air temperature not con- The setting was changed, Adjust the setting for air tem-
firmed but the change was not con- perature and press the rotary
firmed. knob to confirm.
!! 217 Air temperature too high The maximum allowed air Remove external heat
temperature has been sources.
exceeded. Contact specialized service
personnel.

Instructions for use Babyleo TN500 SW 1.0n 153


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
!! 163 Ambient temperature sen- An internal fault occurred. Contact specialized service
sor faulty personnel.
! 212 Audio paused key faulty The audio paused key has Release the audio paused
been pressed for more than key.
10 seconds. Contact specialized service
personnel.
! 163 Bed tilt inaccurate An internal fault occurred. Contact specialized service
personnel.
! 162 Bed-tilt mechanism faulty An internal fault occurred. Contact specialized service
personnel.
!! 169 Centr. sensor missing, The central skin temperature Make sure that the sensor is
heating off sensor (yellow) is not con- correctly connected.
nected.
!! 168 Centr. temp. sensor faulty, The central skin temperature Replace the sensor.
heating off sensor (yellow) is faulty.
!! 120 Central skin temp. sensor The central skin temperature Replace the sensor.
faulty sensor (yellow) is faulty.
!! 50 Central skin temp. sensor The central skin temperature Make sure that the sensor is
missing sensor (yellow) is not con- correctly connected.
nected.
!! 211 Central skin temperature The current central skin tem- Check the settings.
high perature is above the set Check the patient's condition.
alarm limit. Make sure that the sensor is
correctly attached to the
patient.
Remove external heat
sources.
!! 210 Central skin temperature The current central skin tem- Check the settings.
low perature is below the set Check the patient's condition.
alarm limit.
The temperature sensor is Make sure that the sensor is
not correctly attached to the correctly attached to the
patient. patient.
!! 219 Central skin temperature The current central skin tem- Check the settings.
too high perature is above 39.5 °C Check the patient's condition.
(103.1 °F). Make sure that the sensor is
correctly attached to the
patient.
Remove external heat
sources.

154 Instructions for use Babyleo TN500 SW 1.0n


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
! 169 Check oxygen supply The oxygen hose is not con- Make sure that the oxygen
nected. hose is correctly connected.
The oxygen cylinder is Check the oxygen cylinder.
empty.
The valve of the oxygen cyl-Make sure that the valve of
inder is closed. the oxygen cylinder is open.
The oxygen supply pressure Check the oxygen supply, the
is too high. central supply, and the pres-
sure reducer.
An internal fault occurred. Contact specialized service
personnel.
! 219 Check patient's condition The radiant warmer has Check the set value.
been running at more than To continue with the last
30 % for 14 minutes. active settings for the radiant
warmer, press the "Alarm
reset" key.
!! 53 Check settings New settings are applied Check the patient's condition.
automatically. Check the settings and adjust
them if applicable.
!! 52 Check settings Settings were imported from Check the settings and adjust
a USB mass storage device. them if applicable.
!! 51 Check settings An internal fault occurred. Check the settings and adjust
them if applicable.
! 108 Data export failed Data export failed. Repeat the data export.
The USB mass storage Use another USB mass stor-
device is faulty. age device.
Contact specialized service
personnel.
! 112 Data import failed Data import failed. Repeat the data import.
Check the USB mass storage
device.
Contact specialized service
personnel.
! 157 Data loss An internal fault occurred Check the current settings
during data storage. and the default settings.
Contact specialized service
personnel.
!! 69 Device failure, heating off An internal fault occurred. Put the device out of opera-
tion.
Contact specialized service
personnel.
!! 68 Fan faulty The fan impeller is not Switch off the device and
installed. check the fan impeller.
The fan is faulty. Contact specialized service
personnel.

Instructions for use Babyleo TN500 SW 1.0n 155


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
!! 67 Fan motor faulty, heating The fan impeller is faulty. Switch off the device.
off Contact specialized service
personnel.
! 158 Foot pedal faulty The foot pedal has been Release the foot pedal.
pressed for more than one Contact specialized service
minute. personnel.
! 167 Hood not closed, warmer The position of the hood can- Close the hood properly.
off not be determined. Contact specialized service
personnel.
! 166 Hood position unclear, The position of the hood can- Close the hood. Only incuba-
warmer off not be determined. tor operation is available.
Contact specialized service
personnel.
! 216 Humidifier faulty An internal fault occurred. Set the therapy control for
humidity to "Off".
Contact specialized service
personnel.
! 218 Humidity low The hood, the side access Close the hood, the side
panels, or the hand ports are access panels, or the hand
open. ports.
The water level of the humid- Make sure that the water
ification system is low. supply is correctly con-
nected.
Refill the water supply.
The humidity sensor is faulty. Contact specialized service
personnel.
!! 58 Humidity not confirmed The setting was changed, Adjust the setting for humidity
but the change was not con- and press the rotary knob to
firmed. confirm.
!! 66 Internal temperature high An internal fault occurred. Switch off the device.
Contact specialized service
personnel.
!! 100 Kangaroo mode not con- The mode was selected, but Select kangaroo mode and
firmed it was not confirmed. press the rotary knob to con-
firm.
! 159 Lifting column faulty An internal fault occurred. Contact specialized service
personnel.
! 105 Light sensor faulty An internal fault occurred. Contact specialized service
personnel.
! 160 Loudspeaker faulty An internal fault of the pri- Contact specialized service
mary acoustic alarm system personnel.
occurred.
! 156 Maintenance due The set maintenance inter- Contact specialized service
val has been exceeded. personnel.
!! 61 Manual mode not con- The mode was selected, but Select manual mode and
firmed it was not confirmed. press the rotary knob to con-
firm.

156 Instructions for use Babyleo TN500 SW 1.0n


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
! 164 Mattress disconnected The mattress cable is not Make sure that the mattress
connected. cable is correctly connected.
Set the therapy control for
mattress to "Off".
!! 14 Mattress faulty The mattress is faulty. Disconnect the mattress
cable.
Replace the mattress.
An internal fault occurred. Contact specialized service
personnel.
!! 56 Mattress temperature not The setting was changed, Adjust the setting for mat-
confirmed but the change was not con- tress temperature and press
firmed. the rotary knob to confirm.
!! 16 Mattress temperature too The maximum allowed mat- Disconnect the mattress
high tress core temperature has cable.
been exceeded. Replace the mattress.
Contact specialized service
personnel.
! 161 Mattress tray control panel A key on the mattress tray Release all keys of the mat-
faulty control panel has been tress tray control panel.
pressed for more than 10 Contact specialized service
seconds. personnel.
! 103 MEDIBUS.X communica- A MEDIBUS.X communica- Switch off the MEDIBUS.X
tion error tion error occurred. protocol.
Contact specialized service
personnel.
The MEDIBUS cable is not Make sure that the MEDIBUS
connected. cable is correctly connected.
! 113 No license for scale The license for the scale is Contact specialized service
not available. personnel.
Activate the license for the
scale.
! 104 Noise sensor faulty An internal fault occurred. Contact specialized service
personnel.
! 210 Option not available An internal fault occurred. Contact specialized service
personnel.
! 214 Overload during move- The load on the device is too Remove the load.
ment of column high.
An internal fault occurred. Contact specialized service
personnel.
! 213 Overload during move- The load on the mattress is Remove the load.
ment of mattr. too high.
The bed-tilt mechanism is Remove the obstacle.
blocked by an obstacle.
An internal fault occurred. Contact specialized service
personnel.
!! 216 Oxygen high The current oxygen concen- Check the set value.
tration is above the set value.

Instructions for use Babyleo TN500 SW 1.0n 157


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
!! 215 Oxygen low The current oxygen concen- Make sure that the oxygen
tration is below the set value. supply is correctly con-
nected.
Check the set value.
Close the hood, the side
access panels, or the hand
ports.
!! 167 Oxygen module faulty An internal fault occurred. Set the therapy control for
oxygen to "Off".
Contact specialized service
personnel.
!! 57 Oxygen not confirmed The setting was changed, Adjust the setting for oxygen
but the change was not con- and press the rotary knob to
firmed. confirm.
!! 166 Oxygen sensor faulty The allowed measurement Set the therapy control for
uncertainty of the oxygen oxygen to "Off".
sensor has been exceeded. Adjust the oxygen sensor.
An internal fault occurred. Set the therapy control for
oxygen to "Off".
Contact specialized service
personnel.
!! 119 Peripheral skin temp. sen- The peripheral skin tempera- Replace the sensor.
sor faulty ture sensor (white) is faulty.
!! 118 Peripheral skin temp. sen- The peripheral skin tempera- Make sure that the sensor is
sor missing ture sensor (white) is not correctly connected.
connected.
!! 209 Peripheral skin tempera- The current peripheral skin Check the settings.
ture high temperature is above the set Check the patient's condition.
alarm limit. Make sure that the sensor is
correctly attached to the
patient.
Remove external heat
sources.
!! 208 Peripheral skin tempera- The current peripheral skin Check the settings.
ture low temperature is below the set Check the patient's condition.
alarm limit.
The temperature sensor is Make sure that the sensor is
not correctly attached to the correctly attached to the
patient. patient.
!! 218 Peripheral skin tempera- The current peripheral skin Check the settings.
ture too high temperature is above 39.5 °C Check the patient's condition.
(103.1 °F). Make sure that the sensor is
correctly attached to the
patient.
Remove external heat
sources.

158 Instructions for use Babyleo TN500 SW 1.0n


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
! 217 Prewarming in progress The device is warming up. Wait until prewarming is fin-
ished.
To deactivate prewarming,
switch to manual mode.
! 215 Rotary knob faulty The rotary knob has been Release the rotary knob.
pressed for more than 10 Contact specialized service
seconds. personnel.
! 117 Scale calibration required An internal fault occurred. Disconnect the scale cable.
Contact specialized service
personnel.
! 115 Scale communication error A scale communication error Make sure that the scale
occurred. cable is correctly connected.
An internal fault occurred. Disconnect the scale cable.
Contact specialized service
personnel.
! 116 Scale disconnected The scale cable is not con- Make sure that the scale
nected. cable is correctly connected.
! 114 Scale faulty An internal fault occurred. Disconnect the scale cable.
Contact specialized service
personnel.
! 211 Secondary speaker faulty An internal fault of the sec- Contact specialized service
ondary acoustic alarm sys- personnel.
tem occurred.
!! 100 Skin mode not confirmed The mode was selected, but Select skin mode and press
it was not confirmed. the rotary knob to confirm.
!! 117 Skin temp. sensor faulty, At least one of the skin tem- Replace the faulty skin tem-
heating off perature sensors is faulty. perature sensor.
Contact specialized service
personnel.
!! 19 Skin temperature differ- The current temperature dif- Check the settings.
ence high ference between central skin Check the patient's condition.
temperature (yellow) and Make sure that the sensor is
peripheral skin temperature correctly attached to the
(white) is above the set patient.
upper alarm limit.
!! 18 Skin temperature differ- The current temperature dif- Check the settings.
ence low ference between central skin Check the patient's condition.
temperature (yellow) and Make sure that the sensor is
peripheral skin temperature correctly attached to the
(white) is below the set lower patient.
alarm limit.
!! 213 Skin temperature high The tolerated deviation for Check the settings.
central skin temperature (yel- Check the patient's condition.
low) has been exceeded. Make sure that the sensor is
The current central skin tem- correctly attached to the
perature is too high. patient.

Instructions for use Babyleo TN500 SW 1.0n 159


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
!! 212 Skin temperature low The tolerated deviation for Check the settings.
central skin temperature (yel- Check the patient's condition.
low) has been exceeded. Make sure that the sensor is
The current central skin tem- correctly attached to the
perature is too low. patient.
Close the hood, the side
access panels, or the hand
ports.
!! 54 Skin temperature not con- The setting was changed, Adjust the setting for skin
firmed but the change was not con- temperature and press the
firmed. rotary knob to confirm.
! 118 Start/standby key faulty The start/standby key has Release the start/standby
been pressed for more than key.
10 seconds. Contact specialized service
personnel.
!!! 219 Temp. of convective heater An internal fault occurred. Switch off the device and let
high it cool down.
Contact specialized service
personnel.
!! 17 Temp. of humidifier heater An internal fault occurred. Switch off the device and let
high it cool down.
Contact specialized service
personnel.
!! 164 Temperature high in warm The warm air duct is cov- Make sure that the warm air
air duct ered. duct is not covered.
An internal fault occurred. Contact specialized service
personnel.
!! 207 Warmer off, check patient's The radiant warmer was run- Check the set value.
condition ning at more than 30 % for To continue with the last
15 minutes. The radiant active settings for the radiant
warmer is off. warmer, press the "Alarm
reset" key.
!! 55 Warmer power not con- The setting was changed, Adjust the setting for warmer
firmed but the change was not con- power and press the rotary
firmed. knob to confirm.
! 109 Warm-up completed The set target value for Check the settings and adjust
warm-up is reached. them if applicable.
! 165 Water level low The water level of the humid- Make sure that the water
ification system is low. supply is correctly con-
nected.
Refill the water supply.
! 110 Weaning completed The set target value for Check the settings and adjust
weaning is reached. them if applicable.
Remove the patient from the
device.

160 Instructions for use Babyleo TN500 SW 1.0n


Troubleshooting

Alarm pri- Alarm Cause Remedy


ority
!! 15 Weaning failed The next temperature step Check the settings and adjust
for weaning could not be them if applicable.
reached. Check the patient's condition.
! 111 Weaning temperature not The next weaning tempera- Check the settings and adjust
reached ture step could not be them if applicable.
reached. The previous set- Check the patient's condition.
ting for air temperature is
applied.

10.2 Power failure alarm


Condition Cause Remedy
A loud acoustic signal The mains plug has been Switch off the device at the
sounds. The failure is also disconnected without first main switch.
signaled on the display by switching off the device
a red indicator light for using the Start/standby
missing mains power sup- key on the display unit.
ply. The user interface is Before disconnecting the
blank. The height of the mains plug, switch off the
device cannot be adjusted device at the main switch.
using the foot pedals. The For further information,
mattress tray control panel see the following chapter:
cannot be operated. ''Switching off the
device'' (page 67)
The mains power supply Restore the mains power
has failed. supply.

When the mains power supply is restored, the device continues the warming
therapy with the settings that were activated before the power supply failure.

Instructions for use Babyleo TN500 SW 1.0n 161


Troubleshooting

10.3 Adjustment of device height not possible


Condition Cause Remedy
The device height cannot The height adjustment Wait a few minutes to
be adjusted using the foot mechanism has been allow the drive to cool
pedals. actuated for 2 minutes. down. If the height of the
device still cannot be
adjusted when the drive
has cooled down, contact
specialized service per-
sonnel.
Height adjustment is Touch the Lock... button in
locked. the main menu bar. Unlock
the height adjustment
function.
Fault in the height adjust- Restart the device. Do not
ment or bed-tilt mecha- actuate the bed-tilt mecha-
nism. nism. Set the device to
transfer height. Contact
specialized service per-
sonnel.

10.4 Adjustment of mattress tray not possible


Condition Cause Remedy
The mattress tray control The bed-tilt mechanism is Touch the Lock... button in
panel cannot be operated. locked. the main menu bar. Unlock
Adjustment of the height the mattress tray function.
and tilt of the mattress tray
is not possible.

10.5 Fault during weighing


The weight of the patient cannot be determined.

Condition Cause Remedy


The following text is dis- The taring weight or the Check the position of the
played while taring the weight of the patient can- mattress tray and the mat-
scale or weighing the not be determined. There tress on the scale. Check
patient: Weight value is a problem with the that the scale plug is cor-
invalid. Check scale. scale. rectly plugged in. Repeat
the weighing process. If
weighing is still not possi-
ble, contact specialized
service personnel.

162 Instructions for use Babyleo TN500 SW 1.0n


Troubleshooting

Weight is too high.

Condition Cause Remedy


The following text is dis- There is too much weight Check the scale. Check
played during the weighing on the scale. that the mattress tray and
process: Maximum mattress are correctly
weight exceeded. The positioned on the scale.
weight cannot be deter- Take all unnecessary
mined. items off the mattress tray.
Repeat the weighing pro-
cess. If weighing is still not
possible, contact special-
ized service personnel.

Other faults during weighing:

Text Cause Remedy


Taring failed. The tare weight cannot be Tare the scale again.
determined. The patient
has not been lifted. The
scale has not been tared.
The scale has not been
tared.
Taring load is too high. The maximum permissi- Tare the scale again and
ble tare weight has been only lift the patient.
exceeded.
Weighing canceled. The weight of the patient Repeat the weighing pro-
could not be determined. cess. If weighing is still not
possible, contact special-
ized service personnel.
Weighing failed. The weight of the patient Repeat the weighing pro-
could not be determined. cess. If weighing is still not
possible, contact special-
ized service personnel.

10.6 Fault with the oxygen supply


Condition Cause Remedy
The oxygen supply to the The supply pressure from Check the oxygen supply,
patient compartment is the oxygen cylinder or the central supply, and the
activated. The Check oxy- from the central O2 supply pressure reducer.
gen supply alarm is per- is too high. Restart the device. If the
manently displayed. fault persists, turn off the
oxygen supply to the
patient compartment.
Dräger recommends that
the device not be operated
with a permanent oxygen
overpressure.

Instructions for use Babyleo TN500 SW 1.0n 163


Troubleshooting

10.7 Removing liquid from the heating plate


If large quantities of liquids are spilled in the device, the liquid must be removed
immediately. The liquid must be removed before the device is disassembled and
moved. If necessary, specialized service personnel must check if the liquid has
penetrated into the device.

30800
Fig. 81 Heating plate

WARNING
Risk due to penetrating liquid
If too much liquid is on the heating plate, the liquid may penetrate into the device
and cause damage to the device. If the device fails, the patient is put at risk.
► Make sure that no liquid penetrates into the device.
► If the liquid level on the heating plate reaches the upper edge of the fan impeller
receptacle, stop using the device and contact the specialized service personnel.

Procedure:
1 Switch off the device on the display unit using the Start/standby key .
2 Switch off the device with the main switch on the rear of the main column.
3 Disconnect the mains plug.
4 Remove any liquid on the mattress and the mattress tray.
5 Remove the mattress and mattress tray.
6 Remove any liquid on the bed support.
7 Remove the bed support and the T-bars.
8 Remove any liquid from the warm air duct covers.
9 Remove the warm air duct covers.
10 Check if the fan impeller is in the liquid and remove the fan impeller.
11 Check if there is liquid on the heating plate. The heating plate may be hot.
12 If the liquid level reaches the upper edge of the fan impeller receptacle (1),
contact the specialized service personnel. The specialized service personnel
must check if liquid has penetrated into the device.

164 Instructions for use Babyleo TN500 SW 1.0n


Troubleshooting

30275
1

Fig. 82 Fan impeller receptacle


13 All liquid must be removed from the heating plate before the device is moved.

Instructions for use Babyleo TN500 SW 1.0n 165


Reprocessing

11 Reprocessing
11.1 Automatic humidifier cleaning
This chapter describes how to perform automatic humidifier cleaning.

11.1.1 Overview of humidifier cleaning


During cleaning, the residual water is automatically heated and boiled in the
humidifier. The duration of the cleaning depends on the amount of water in the
humidifier and may last up to 60 minutes. Dräger recommends to perform
automatic humidifier cleaning prior to any reprocessing of the device.

11.1.2 Starting the automatic humidifier cleaning


Automatic humidifier cleaning can be performed with the hood open or closed.
Dräger recommends opening the hood. An open hood allows humidity to escape
and prevents possible condensate formation.
Prerequisites:
– There is no patient in the device.
– The device is in operation.

WARNING
Risk of patient injury due to overheating
If the automatic humidifier cleaning is started when the patient is in the device, this
may result in the patient overheating of the patient.
► Only start automatic humidifier cleaning when there is no patient in the device.

Procedure:
1 Make sure there is no patient in the device.
2 Open the hood.
3 Touch the Special procedures... button (2) in the main menu bar.
 The Special procedures dialog window is displayed.

28494

Fig. 83 Starting humidifier cleaning


4 Open the Humidifier cleaning tab (1).

166 Instructions for use Babyleo TN500 SW 1.0n


Reprocessing

5 Touch the On button.


6 Press the rotary knob to confirm.
 The device starts the humidifier cleaning.

27243
Fig. 84 Starting humidifier cleaning
7 Wait until the humidifier cleaning has ended. Do not disassemble the device
during cleaning.

11.1.3 Canceling the automatic humidifier cleaning


The automatic humidifier cleaning can be canceled at any time. Once the automatic
humidifier cleaning has been canceled, repeat the function as soon as possible.
Procedure:
1 To cancel the humidifier cleaning, touch the Cancel button.
 The humidifier cleaning is canceled.
2 To close the dialog window, touch the Exit button or switch the device off.
✓ The humidifier cleaning has been canceled and must be repeated.

11.2 Dismantling
This chapter describes how to disassemble the device before reprocessing.

Only disassemble the device after the patient and all items have been removed
from the device. All additional devices and accessories must be removed before
reprocessing.

Instructions for use Babyleo TN500 SW 1.0n 167


Reprocessing

11.2.1 Dismantling overview

30733
1
2

12

10 11

7 5

Fig. 85 Dismantling

No. Designation
1 Heated mattress (option) or SoftBed mattress
2 Mini-walls
3 Hood sealings
4 Side access panels and front access panel
5 Drawer insert (option)
6 Hose grommets
7 Fan impeller
8 Small and large warm air duct cover
9 T-bars
10 Bed support with scale (option)
11 X-ray tray
12 Mattress tray

168 Instructions for use Babyleo TN500 SW 1.0n


Reprocessing

11.2.2 Disassembling the components


Prerequisites:
– Automatic humidifier cleaning has been performed.
– The device and all additional devices are switched off.
– The mains plug has been disconnected.

CAUTION
Risk of injury due to hot surfaces
If the device is dismantled directly after operation or after the automatic humidifier
cleaning, hot surfaces may cause injuries.
► Before dismantling, make sure that the device has cooled down.
► Do not touch the hot surfaces near to the radiant warmer, the convection heater,
and the humidifier.

Procedure:

1 Open the hood and remove the sealings on


both sides of the hood frame.

2 Gently raise the side access panels and the


front access panel and fold downward.

3 Remove the hose grommets at the following


positions:
– Sensor wall: 3 pieces, on each corner
and in the middle of the sensor wall
– Front access panel: 3 pieces, on each
corner and in the middle of the front
access panel

Instructions for use Babyleo TN500 SW 1.0n 169


Reprocessing

4 Before the mini-wall can be removed,


release the fastenings: from the inside, take
hold of the mini-wall exactly in the center
(1). Push the lower half of the mini-wall out-
wards (away from the mattress tray) and as
soon as the mini-wall is free at the center,
tilt it inwards with a rotational movement (2)
(towards the mattress tray). Remove the
mini-wall.

5 If the heated mattress and the scale are


available, remove both cables on the rear of
the sensor wall. Remove the heated mat-
tress or the SoftBed from the mattress tray.

6 Remove the mattress tray.

7 Open the X-ray flaps on both sides. Pull out


the x-ray tray as far as it will go, lift it slightly
and then pull it out completely.

8 Remove the bed support.

9 Remove the T-bars.

170 Instructions for use Babyleo TN500 SW 1.0n


Reprocessing

10 Remove the small cover for the warm air


duct.

11 Remove the large cover for the warm air


duct.

12 Raise and remove the fan impeller.

13 If available, remove the insert from the


drawer.

11.3 Information on reprocessing


Instructions for reprocessing are based on internationally accepted guidelines, e.g.,
the ISO 17664 standard. Reprocessing must be performed by reprocessing
personnel or by persons who are responsible for the reprocessing.

11.3.1 Information on disinfectants


Use disinfectants that are nationally approved and are suitable for the respective
reprocessing procedure.

Instructions for use Babyleo TN500 SW 1.0n 171


Reprocessing

11.4 Classification for reprocessing


11.4.1 Classification of medical devices
Medical devices and their components are classified according to the way they are
used and the resulting risk.
Classification Definition
Non-critical Components that come into contact with intact skin only
Semi-critical Components that carry breathing gas or come into con-
tact with mucous membranes or pathologically altered
skin
Critical Components that penetrate skin or mucous membranes
or come into contact with blood

11.4.2 Classification of device-specific components


The entire device must be reprocessed. Observe the following classification and the
instructions for use for the components.
Classification Device-specific components
Non-critical – The entire device and all components that can be dis-
mantled (e.g., the mattress tray, fan impeller, hood,
hose grommets)
– The heated mattress (option) and the SoftBed mat-
tress
Semi-critical -
Critical -

11.5 Recommendations for reprocessing


11.5.1 Validated reprocessing procedure
The effectiveness of the reprocessing procedures listed has been validated by
independent laboratories certified to ISO 17025.
At the time of validation, the following reprocessing procedures showed good
material compatibility and effectiveness:

Surface disinfection
Surface disinfection using the following surface disinfectant is suitable for the
device and all components (non-critical and semi-critical):
Class of active Product name ManufacturerContact Concentra-
ingredient time tion
Oxygen-releasing Dismozon plus BODE Chemie 15 min 1,6 %
agents

172 Instructions for use Babyleo TN500 SW 1.0n


Reprocessing

Machine cleaning and thermal disinfection


Machine reprocessing is only suitable for the fan impeller and the hose grommets:
Process step Product name Manufacturer Contact Temperature
time
Machine Neodisher Med- Chemische At least 40 to 60 °C (104
cleaning iClean forte Fabrik Dr. Wei- 5 minutes to 140 °F)
gert
Machine dis- - - At least 90 °C (194 °F)
infection (ther- 5 minutes
mal)

11.5.2 Surface disinfectant


Additional surface disinfectants can be used on the device and all components.
Surface disinfectants with good material compatibility:

Class of active ingredi- Surface disinfectant Manufacturer


ent
Oxygen-releasing agents Descogen Liquid Antiseptica
Descogen Liquid r.f.u.
Dismozon plus BODE Chemie
Dismozon pur
Incidin Active Ecolab
Aldehydes Buraton 10F Schülke & Mayr

Surface disinfectants with restricted material compatibility:

Class of active ingredi- Surface disinfectant Manufacturer


ent
Chlorine-releasing agents Actichlor plus Ecoloab
BruTab 6S Brulin
Clorox Professional Disinfect- Clorox
ing Bleach Cleaner
Dispatch Hospital Cleaner Dis-
infectant Towels with Bleach
Klorsept 17 Medentech
Oxygen-releasing agents Oxycide Ecolab USA
Perform Schülke & Mayr
Virkon DuPont
Quaternary ammonium Mikrozid sensitive liquid1) Schülke & Mayr
compounds
Mikrozid alcohol free liquid1)
Mikrozid sensitive wipes1)
Mikrozid alcohol free wipes1)
acryl-des1)
1) Virucidal against enveloped viruses

Instructions for use Babyleo TN500 SW 1.0n 173


Reprocessing

Dräger states that some oxygen-releasing agents and chlorine-releasing agents


may cause color change in some materials. Color change does not indicate that the
product is not functioning correctly.
The manufacturers of the surface disinfectants have verified at least the following
spectra of activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses
Other disinfectants are used at own risk. Observe the specifications of the surface
disinfectant manufacturers. Use surface disinfectants that are nationally authorized.

11.6 Surface disinfection with cleaning


This chapter describes surface disinfection with cleaning for the entire device and
for all components.

WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electrical shock when switching on the device
– Device malfunctions
► Make sure that no liquid penetrates into the device.

WARNING
Risk of O2 sensor malfunction
Disinfectants or cleaning agents which contain formaldehyde or ammonia may
damage the O2 sensors. The O2 sensors may provide incorrect measured values.
This may put the patient at risk.
► Only use disinfectants or cleaning agents which do not contain formaldehyde or
ammonia.

1 Remove soiling immediately. Use a cloth dampened with disinfectant to remove


the soilings.
2 Perform surface disinfection.
3 After the contact time has elapsed, remove residual disinfectant.
4 Check the product for visible soiling. Repeat steps 1 to 4 if necessary.
5 Check the product for visible damage and replace it if necessary.

11.6.1 Information regarding cleaning and surface disinfection of


individual parts
The cleaning and surface disinfection of individual parts demands particular care.
All sides of every part must be thoroughly cleaned and disinfected. Examples:
– Hood and hood seal
– Side panels and hand ports
– Air ducts of the X-ray flap

174 Instructions for use Babyleo TN500 SW 1.0n


Reprocessing

If no specific instructions for use are available for the approved device accessory,
then the accessory can be reprocessed by means of surface disinfection using the
listed surface disinfectants.
Procedure:
1 Wipe the inside and outside of the hood.
2 When treating the hood seal, ensure that the disinfectant also comes into
contact with the inner part of the hood seal.
3 Wipe the inside and outside of the side panels. Pay particular attention to the
locking mechanism of the hand ports.
4 Carefully wipe the grip on the X-ray flap.
5 To clean the air ducts of the X-ray flap (1), pull a piece of cloth soaked in
disinfectant through each duct.

30231
1

Fig. 86 Air ducts of the X-ray flap


6 Carefully wipe all the handles on the device.

11.6.2 Surface disinfection of the heated mattress (option)


1 Remove soiling immediately. Use a cloth dampened with disinfectant to remove
the soilings.
2 Perform surface disinfection, observing the recommended contact time specified
by the disinfectant manufacturer.
3 After the contact time has elapsed, remove residual disinfectant.
4 Check the product for visible soiling. Repeat steps 1 to 4 if necessary.
5 Check the product for visible damage and replace it if necessary.

Instructions for use Babyleo TN500 SW 1.0n 175


Reprocessing

11.7 Additional reprocessing measures


The fan impeller and the hose grommets can be cleaned with a machine.

11.7.1 Machine cleaning with thermal disinfection


Use a washer-disinfector which meets the requirements of ISO 15883. Dräger
recommends the use of a cart for anesthesia accessories and ventilation
accessories. Observe instructions for use for the washer-disinfector.
1 Securely position the product in the basket. Ensure the following:
– All surfaces and interior spaces can be completely flushed.
– The water can drain off freely.
2 Use a suitable cleaning agent.
3 Select a suitable cycle.
4 Use demineralized water for the final rinsing.
5 After the cycle has ended, check the product for visible soiling. If required,
repeat the cycle or carry out a surface disinfection with cleaning.
6 Check the product for visible damage and replace it if necessary.
7 Allow the product to dry completely.

11.8 After reprocessing


11.8.1 Assembling the components
This chapter describes how to assemble the device after reprocessing.
Prerequisites:
– The device has been reprocessed.
– Automatic humidifier cleaning has been performed.

WARNING
Risk of wear and material fatigue
Cleaning and disinfecting can cause components to wear, resulting in device
malfunctions. There is a risk of injury.
► Check the device and reusable products for signs of wear (e.g., cracks,
deformation, discoloration, or detachment) and replace if necessary.

176 Instructions for use Babyleo TN500 SW 1.0n


Reprocessing

Procedure:

1 Insert the fan impeller and press it down


until it engages.

2 Insert the large cover for the warm air duct.

3 Insert the small cover for the warm air duct.

4 Attach the T-bars.

5 Place the bed support on the T-bars from


above.

6 Slide in the x-ray tray and close the x-ray


flaps.

Instructions for use Babyleo TN500 SW 1.0n 177


Reprocessing

7 Fit the mattress tray.

8 Place the heated mattress or the SoftBed


mattress on the mattress tray. If the heated
mattress and the scale are available, pull
the cables through the hose grommets in
the center of the sensor wall. Push the
cables into the cable guides and plug in the
plug on the rear of the sensor wall.

9 Insert the 2 mini-walls at both ends of the


mattress tray.

10 Insert the hose grommets in the following


positions:
– Sensor wall: 3 pieces, on each corner
and in the middle of the sensor wall
– Front access panel: 3 pieces, on each
corner and in the middle of the front
access panel
Check that the hose grommets are correctly
seated.
11 Fold the side access panels and the front
access panel upward. Make sure that all
access panels latch securely in place.

178 Instructions for use Babyleo TN500 SW 1.0n


Reprocessing

12 Fasten the seals on the edges of the hood.


Close the hood and check that the seals are
correctly positioned.

13 If available, place the insert in the drawer.

11.8.2 Preparations prior to re-use


1 Assemble and prepare the device so it is ready for operation. For further
information, see the following chapter: ''Assembly and preparation'' (page 56).
2 Check for operational readiness. For further information, see the following
chapter: ''Checking for operational readiness'' (page 63).

Instructions for use Babyleo TN500 SW 1.0n 179


Service

12 Service
12.1 Overview
This chapter describes the service measures required to maintain the proper
functioning of the product. Technical documentation is available on request.

12.1.1 Definitions of service terminology


Concept Definition
Service All measures (inspection, maintenance, repair) intended to
maintain and restore the functional integrity of a product
Inspection Measures intended to determine and assess the actual state of
a product
Maintenance Regular specified measures intended to maintain the functional
integrity of a product
Repair Measures intended to restore the functional integrity of a prod-
uct after a failure

12.2 Inspection
Measure Interval Target group
Inspection and safety check 1) Every 12 months Service personnel
Metrological check of the skin Every 24 months Service personnel
temperature measurement
system
Visual check of the internal 6 years after commis- Service personnel
compressed gas hose sioning. If replacement
is not required, check
every 24 months.
Calibrating the scale Every 12 months Service personnel
Verifying the scale According to regulatory Officially authorized spe-
requirements for scales cialist personnel
which must be verified
1) Designation applies to the Federal Republic of Germany; corresponds to the “Recurring safety
inspection” in the Federal Republic of Austria

12.2.1 Remote Service


The device supports the following Remote Service functions:
– Help Ticket
– Device Check
For more information about the Remote Service function, contact DrägerService.

180 Instructions for use Babyleo TN500 SW 1.0n


Service

12.2.2 Verification of the NAWI scale (option)


Details regarding the conformity assessment carried out by the manufacturer and
the calibration made prior to installation at the operating location can be found on a
product label. In the stated area the scale can be operated with the specified
measurement uncertainty. For further information, see the following chapter:
''Technical data'' (page 188)
The verification is no longer valid once the verification deadline has passed. The
verification is also invalid in the following situations:
– After modifications of the basic scale settings
– Illegible or damaged main stamp or security stamp
– After changes in the service dialog due to pressing the Adjust (Adjust) button
– Exceeding the service error limits
In these situations, a new official verification in accordance with national regulations
is required. Verification of the scale may only be carried out by a local measuring
body and the relevant verification authority. To check that the scale is accurate and
is working correctly, specialized service personnel can carry out an appropriate
examination of the scale. For more information, contact DrägerService.
If the scale was installed by Dräger, the conformity assessment has already been
carried out. Before the verification deadline expires, the scale must be verified in
accordance with national regulations.

12.2.3 Safety checks


Safety checks are no substitute for maintenance including preventive replacement
of wearing parts as specified by the manufacturer.

12.2.3.1 Performing the safety checks

WARNING
Risk due to missing service measures
If the device is not maintained at the prescribed intervals, the function and the
safety of the device cannot be ensured.This may put the health of patients and
users at risk.
► Perform service measures on the device at the prescribed intervals.
► Service measures must only be performed by suitably qualified persons.

WARNING
Risk of patient injury due to service measures performed during therapy
Performing service measures during therapy may endanger the patient.
► Only perform service measures when there is no patient in the device.

Instructions for use Babyleo TN500 SW 1.0n 181


Service

1 Check that the respective instructions for use are present.


2 Perform a functional test of the following functions according to the instructions
for use:
– Complete lifting range of the lifting column from the highest position to the
lowest
– Closure of the side access panels, the front access panel, and the hand ports
(closing force 20 N in accordance with the IEC 60601-2-19 and IEC 60601-2-
21 standards)
– Change between incubator operation and radiant warmer operation in
dependence of the hood position
– Double castor with steering function and double castors with locking brakes
3 Check that the product is in good condition:
– All labels are complete and legible.
– The hood is securely attached to the hood arm.
– The hood arm functions safely.
– The following components do not exhibit any visible damage:
– Trolley and housing parts
– Display unit
– Sensor unit
– Gas inlets
– Heated mattress (option) or SoftBed mattress and mattress tray
– Hood
– X-ray tray
– Main column including alarm display
– Hoses and cables
– Strain relief for the compressed gas hoses and cables
– Holding arms (option)
– All pressure reducers (option)
– The gas cylinder holder (option)
– Hose grommets
– Sealings on the hood frame
– Fan impeller
4 Replace damaged components.
5 Using the instructions for use, check that all components and accessories
needed to use the product are present.
6 Check the electrical safety in accordance with the IEC 62353 standard.
7 Check the safety equipment:
– Check of the incubator temperature according to standard IEC 60601-2-19,
sentence 201.12.1.105
– Functional integrity of the acoustic alarm generator
– Functional integrity of the mains supply failure alarm
– Display of the optical alarm signals

182 Instructions for use Babyleo TN500 SW 1.0n


Service

8 Check the accuracy of the air temperature regulation:

Set value 36.0 °C (96.8 °F)


Accuracy ±0.8 °C (±1.44 °F)

9 Check the accuracy of the skin temperature regulation:

Set value 36.0 °C (96.8 °F)


Accuracy ± 0.1 °C (± 0.18 °F)

10 Check the accuracy of the O2 regulation:

Set value 50 Vol%


Accuracy ±3 Vol%

11 Check the accuracy of the humidity regulation and humidity measurement:

Set value 70 %
Accuracy ±10 %

12 Check the operating parameters for the lifting column under Service menu >
Operating Data > Lifting Column. The lifting column must be replaced if one of
the two operating parameters exceeds the maximum value. Contact
DrägerService.

Operating parameter Maximum value


Operating parameter 1 7680
Operating parameter 2 576

12.2.4 Metrological checks


If required by applicable regulations, the following measurement functions must be
checked in the specified intervals:

12.2.4.1 Skin temperature measurement


Prerequisites:
– The display range for the skin temperature sensors is active.
– Simulation resistors are connected instead of the skin temperature sensors. The
simulation resistors must maintain the following values:

Resistance Temperature
1586 Ω 33.2 °C (91.8 °F)
1412 Ω 36.0 °C (96.8 °F)
1312 Ω 37.8 °C (100.0 °F)

Instructions for use Babyleo TN500 SW 1.0n 183


Service

Procedure:
1 Set and connect the 3 simulation resistors.
2 Compare the displayed measured temperature values with the temperature
values in the table.
 The displayed measured temperature value must not deviate from the
temperature value simulated by the relevant resistance by more than 0.1 °C
(0.18 °F).

12.3 Maintenance
Component Interval Measure Target group
Skin temperature sen- Weekly, at the lat- Replace Users
sors est when the
patient changes
Sensor covers Weekly, at the lat- Replace Users
est when the
patient changes
Hose grommets As required, when Replace Users
the material is
brittle or when the
ribs are torn out.
Heated mattress (option), As required, when Replace Users
SoftBed mattress the heated mat-
tress or the Soft-
Bed mattress are
damaged.
Filter cloth (in the sensor Every 6 months Replace, see Users
wall) page 185
Oxycell O2 sensors Every 2 weeks Adjustment Users
Every 24 months Replace Service personnel

184 Instructions for use Babyleo TN500 SW 1.0n


Service

12.4 Replacing the filter cloth for patient air in the sensor
wall
The filter cloth for patient air is located in the rear of the sensor wall.

WARNING
Risk due to soiled or expired filter cloth
If the filter cloth is soiled or the life span has elapsed, the patient may be put at risk.
► Replace a soiled or worn out filter cloth.

Procedure:
1 Press the flap lock (1) down.

30704
1

Fig. 87 Filter cloth for patient air in the sensor wall


2 Remove and dispose of the filter cloth.
3 Insert a new filter cloth.
4 Close the flap and check that it is securely locked.

12.5 Repair
Dräger recommends that all repairs are performed by DrägerService and that only
authentic Dräger spare parts are used.

12.6 Activating applications


An activation code is linked with the serial number of the respective device and
cannot be transferred. The activation codes can either be loaded from a USB mass
storage device or entered manually.
1 Touch the System setup... button in the main menu bar.
2 In the System setup dialog window, open the System>Service dialog page.
3 Enter the password and confirm.
4 Touch the Service menu button and confirm.
✓ The Service dialog window is displayed.

Instructions for use Babyleo TN500 SW 1.0n 185


Service

12.6.1 Loading the activation code from a USB mass storage device
Prerequisites:
– A USB mass storage device with valid activation codes for this device is
connected to the USB interface.
– The Service dialog window is opened.
1 Open the Applications (Applications) dialog page.
2 Touch the Load from USB (Load from USB) button.
 The activation codes found on the storage medium are uploaded and
displayed in the list.

12.6.2 Manual entry of the activation code


1 Touch the Enter code (Enter code) button.
2 Use the keyboard to enter the activation code and confirm.
 The license is unlocked and displayed in the list.

12.6.3 Activating the licensed application


The licensed applications must be activated before they become available.
1 Select the corresponding license from the list.
2 Touch the Activate (Activate) button.
3 After activating all desired licenses, restart the device.

186 Instructions for use Babyleo TN500 SW 1.0n


Disposal

13 Disposal
13.1 Disposing of the device
The disposal of electrical and electronic devices is subject to special guidelines.
This device must be disposed of in accordance with national regulations. In
countries of the European Union, Dräger will organize the return of the device.
Additional information is available at www.draeger.com (search term: WEEE).

Instructions for use Babyleo TN500 SW 1.0n 187


Technical data

14 Technical data
14.1 Ambient conditions
During operation
Temperature 20 to 35 °C (68 to 95 °F)
Ambient pressure 620 to 1100 hPa (9.0 to 16.0 psi)
Relative humidity 20 to 95 %, non-condensing
Air flow in air-conditioned rooms Max. 0.3 m/s (11.8 in/s)
During storage and transportation
Temperature - 20 to 60 °C (- 4 to 140 °F)
Ambient pressure 500 to 1100 hPa (7.3 to 16.0 psi)
Relative humidity 10 to 95 %, non-condensing

14.2 Operating data


Power supply
Mains power connection 100 V to 240 V
50/60 Hz
Maximum current consumption/ 10 A/1000 W
power consumption

Gas supply (option)


O2 operating pressure 2.7 to 6.0 bar (or 270 to 600 kPa or 39 to
87 psi)
O2 peak input flow 45 L/min (at ambient pressure)
O2 connector Depending on configuration:
NIST,
DISS (internal thread, CGAV-5/N),
DISS (external thread, CGAV-5/B),
NF (Norme Française - French standard) or
AS (Australian)

Oil concentration <0.1 mg/m3


Particle size Dust-free air (filtered with pore size <1 μm)
Gas cylinders (option)
Diameter 100 to 140 mm (3.91 to 5.51 in)
Length 330 to 760 mm (12.99 to 29.92 in)
Dimensions
Device (width x depth) 1154 mm x 690 mm (45.43 in x 27.17 in)
Height (with hood closed) 1850 to 2250 mm (72.83 to 88.58 in)
Height of the mattress surface 700 to 1100 mm (27.56 to 43.31 in)
Mattress area 450 mm x 690 mm (17.72 in x 27.17 in)

188 Instructions for use Babyleo TN500 SW 1.0n


Technical data

14.2 Operating data (continued)


Side wall height >115 mm (mattress tray in top position),
>205 mm (mattress tray in bottom position)
Weight <140 kg (308.6 lbs) (without options and acces-
sories)
Height adjustment of the device
Height adjustment range 400 mm (15.75 in)
Operating time 2 minute continuous operation with subse-
quent interruption for 18 minutes to cool the
drive
Inclination of the mattress tray
Bed-tilt mechanism Continuous up to 13° inclination on both sides
Electrical protection class
Device Class I
Skin temperature sensor Type BF
Scale (option) Type BF
Heated mattress (option) Type BF
Classification in compliance with Directive Class IIb
93/42/EEC, Annex IX
UMDNS code 15-610
Universal Medical Device Nomenclature
System - nomenclature for medical devices
Electromagnetic compatibility (EMC) Tested in compliance with IEC 60601-1-2
Standards
Applicable standards IEC 60601-1
IEC 60601-2-19, for incubators
IEC 60601-2-21, for radiant warmers
OIML-R76-1 and
EN 45501, for scales

14.3 Performance characteristics


Operating noise
Operating volume in patient compartment Typically 40 dB(A)
Measured without oxygen application
Alarm volume
Setting range for high- and medium-priority 50 dB(A) to 70 dB(A)
alarms Measured in accordance with IEC 60601-2-19
and IEC 60601-2-21
Power failure alarm
Alarm volume 65 dB(A)
Duration 10 minutes

Instructions for use Babyleo TN500 SW 1.0n 189


Technical data

14.3 Performance characteristics (continued)


Radiant warmer operation
Radiant flux per area in highest horizontal mat-
tress tray position
At 30% radiant warmer power 10 mW/cm2
At 60% radiant warmer power 18 mW/cm2
At 100% radiant warmer power 32 mW/cm2
Minimum ceiling clearance To ensure safe operation of the radiant warmer,
maintain a distance of at least 20 cm (8 in)
between the upper edge of the radiant warmer
and the ceiling
Incubator operation
Warm-up time 15 to 20 minutes
Humidification Boiling of Aquadest/distilled water
Flow velocity over mattress surface 10 cm/s (3.94 in/s) (with a horizontal mattress
tray and an air temperature of 36 °C (96.8 °F))
Maximum CO2 concentration in the incubator <0.5 Vol%
measured in accordance with IEC 60601-2-19
Fresh air filter The fresh air filter is located in the rear of the
sensor wall.

14.4 Measured value display


Radiant warmer
Setting range Off, 10 % to 100 %
Pre-warm mode 100 % for 3 minutes
60 % for 11.5 minutes
30 % until setting is changed
Air temperature regulation
Measurement principle NTC, 2 x
Measurement range 13 to 45 °C (55.4 to 113 °F)
Measurement uncertainty ±0.8 °C (1.44 °F)
Setting range 20 to 39 °C (68 to 102.2 °F)
<28 °C (82.4 °F), after confirmation
>37 °C (98.6 °F), after confirmation
Skin temperature regulation
Measurement principle NTC
Measurement range 13 to 43 °C (55.4 to 109.4 °F)
Sensor Only use original Dräger skin temperature sen-
sors.
Measurement uncertainty (sensors) ± 0.1 °C (0.18 °F)
Measurement uncertainty (entire system) ±0.3 °C (0.54 °F)

190 Instructions for use Babyleo TN500 SW 1.0n


Technical data

14.4 Measured value display (continued)


Setting range 34 to 38 °C (93.2 to 100.4 °F)
>37 °C (98.6 °F), after confirmation
Heated mattress (option)
Temperature measurement (mattress core) NTC, 4 x
Setting range Off, 35 to 39 °C (95 to 102 °F), AUTO
Oxygen regulation
Measurement principle Electrochemical, with automatic barometric
pressure compensation
Measurement range Normal range: 18 to 65 Vol%
Extended range: 66 to 99 Vol%
Measurement uncertainty in normal range ± (2.5 Vol% + 2.5 % of measured value)
Influencing factors Relative ambient humidity <1.5 %
Setting range Off, 21 to 65 Vol%
>40 Vol%, after confirmation

O2 rise time from 21 to 65 Vol% <10 minutes


Humidifier regulation
Measurement principle Capacitive
Measurement range Normal range: 30 to 99 % R H
Extended range: 10 to 29 % R H
Measurement uncertainty in normal range ±10 %
Setting range Off, 30 to 99 % r. H. in steps of 1 %, AUTO
Noise measurement in patient compartment
Measurement range 40 to 90 dB(A)
Light measurement in patient compartment
Measurement range 3 to 999 Lux (1 to 93 fc)
Scale
The measuring accuracy depends on the local
geographic conditions. The geographical loca-
tion where the device is operated is stored in
the device ex works. The set parameters are
listed in the service dialog and on a product
label on the rear of the device.
Measuring range (incl. tare) 200 to 10000 g (0.44 lb to 22 lb)
Display range 0 to 10045 g (0 to 22 lb 2 oz)
Measurement uncertainty 0 to 2500 g (0 to 5.5 lb): 2.5 g (0.0055 lb)
for loads over 2500 g (5.5 to 22 lb): 5 g
(0.011 lb)
Resolution (OIML version) 5 g (0.011 lb)
Resolution (standard version) 1 g (1 oz)

Instructions for use Babyleo TN500 SW 1.0n 191


Technical data

14.5 Materials
Bisphenol A (BPA) The patient compartment of the device (without
accessories) is free from bisphenol A
Latex The device (without accessories) contains no
latex-containing components

14.6 Data exchange and interfaces


Port for central alarm Output for the connection to intercommunica-
tion system (nurse call)
Only connect devices that fulfill the require-
ments of the standard IEC 60950-1 on
unearthed SELV circuits or the requirements of
the standard IEC 60601-1 on accessible sec-
ondary circuits with max. 60 V DC nominal volt-
age.
Type ODU MEDI-SNAP 3-pole with 205° coding (J)
Operating voltage 30 V max.
Current 250 mA max.
Power 7.5 W max.
Floating changeover contact

1 - Common port
2 - Alarm
3 - No alarm
4 - Nurse call
COM port Only connect devices that fulfill the require-
ments of the standard IEC 60950-1 on
unearthed SELV circuits or the requirements of
the standard IEC 60601-1 on accessible sec-
ondary circuits with max. 60 V DC nominal volt-
age.
Type 9-pole D-sub, electrically isolated:
1.5 kV against internal electronics
1.0 kV against housing
Protocol MEDIBUS.X
Alarm delay Typically < 2 s
Baud rate 1200, 2400, 4800, 9600, 19200, 38400 baud

192 Instructions for use Babyleo TN500 SW 1.0n


Technical data

14.6 Data exchange and interfaces (continued)


Data bits 8
Parity Even
Stop bits 1
Pin assignment
Pin 1 n/c
Pin 2 RXD
Pin 3 TXD
Pin 4 Pins 4 and 6 are connected internally
Pin 5 SHLD-GND
Pin 7, 8 Pins 7 and 8 are connected internally
Pin 9 n/c
Housing SHLD-GND
USB port Only connect passive storage media, i.e.
devices that do not have a separate power sup-
ply.
Type USB type A socket; USB 1.1
Supported devices USB mass storage device from list of accesso-
ries formatted with FAT16 or FAT32
Service port Only for DrägerService
Only connect devices that fulfill the require-
ments of the standard IEC 60950-1 on
unearthed SELV circuits or the requirements of
the standard IEC 60601-1 on accessible sec-
ondary circuits with max. 60 V DC nominal volt-
age.
Type RJ45 connector
Transfer speed 10Base-T, IEEE 802.3 Clause 14.
Requires at least a CAT3 cable.
Audio port Only connect devices that fulfill the require-
ments of the standard IEC 60950-1 on
unearthed SELV circuits or the requirements of
the standard IEC 60601-1 on accessible sec-
ondary circuits with max. 60 V DC nominal volt-
age.
Type 3.5 mm (0.14 in) jack plug

Instructions for use Babyleo TN500 SW 1.0n 193


Technical data

14.7 Device combinations


This device can be operated in combination with other Dräger devices or with
devices from other manufacturers. Observe the accompanying documents of the
individual devices.
If a device combination is not approved by Dräger, the safety and the functional
integrity of the individual devices can be compromised. The operating organization
must make sure that the device combination complies with the applicable editions
of the relevant standards for medical devices.
Device combinations approved by Dräger meet the requirements of the following
standards:
– IEC 60601-1 (general requirements for safety)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-8 (alarm systems)

14.8 Connections to IT networks


In an IT network, data can be exchanged by means of wired or wireless
technologies. An IT network can be any data interface (e.g., RS232, LAN, USB,
printer interface) that is described in standards and conventions.
During operation, this device can exchange information with other devices by
means of IT networks and supports the following functions:
– Display of parameter data
– Signaling of alarms
– Transfer of device settings and patient data
– Service mode, access to logbooks
Connecting this device to a network that incorporates other devices or making
subsequent changes to that network can lead to new risks for patients, users, and
third parties. Before the device is connected to the network or the network is
changed, these risks must be identified, analyzed, and evaluated, and appropriate
measures taken.
Examples of subsequent changes to the network:
– Changing the network configuration
– Removing devices from the network
– Adding new devices to the network
– Performing upgrades or updates on devices that are connected to the network

194 Instructions for use Babyleo TN500 SW 1.0n


Technical data

14.8.1 Information about connecting to an IT network


Prerequisites
This device must only be connected to the network by service personnel. The IT
representative of the hospital must be consulted in advance.
The following documents must be observed:
– Accompanying documents of this device
– Descriptions of the network
– Description of the network-based alarm systems
Dräger recommends complying with IEC 80001-1 (risk management for IT
networks with medical devices).

14.8.1.1 LAN networks


– LAN networks are usually configured in a star topology. Individual devices can
be combined into groups by means of layer-n-switches. Other data traffic is
decoupled by means of separate VLAN networks. Configure the network
settings of the device in accordance with these instructions for use and the
network specifications.
– Specifications for LAN connections are described in the following standards:
– Wired networks: IEEE 802.3
– Wireless networks: IEEE 802.11 (b, g, n)
– If the device is used with a layer 2 switch or a layer 3 switch, the port settings
must be configured on the network switch. Before the device is shipped, Dräger
can configure the network settings of the device so that they are compatible with
the specifications of the operating organization.

14.8.1.2 Serial interfaces


The following interfaces are supported:
– RS232 interfaces conforming to EIA RS-232 (CCITT V.24/V.28) for the following
applications:
– MEDIBUS.X
– Connections to medical devices from other manufacturers
– Interfaces based on USB 1.1 or USB 2.0 (USB flash drive)

14.8.1.3 Consequences of using an unsuitable network


If the network does not meet the requirements, hazardous situations can result. The
following situations can occur with this device:
– Due to unsafe distributed alarm system:
– Alarms are not transmitted.
– Alarms or data are delayed.
– False alarms are indicated.
– During an interruption of the network connection:
– Alarms are not transmitted.
– Suppressed alarms or alarm tones are not reactivated, but remain
suppressed.

Instructions for use Babyleo TN500 SW 1.0n 195


Technical data

– Without firewall and antivirus software:


– Data are not protected.
– Device settings are changed.
– The device generates false alarms or no alarms.
– Data are sent incomplete, sent to the wrong device, or not sent at all.
– Patient data are intercepted, falsified, or damaged.
– Data have incorrect time stamps.
– An overload of the device due to very high network loads (e.g., caused by
denial-of-service attacks) can lead to deactivation of the interface. The interface
will only be available again after the device has been restarted. In very rare
cases, a warm boot may take place and may occur repeatedly.

14.8.1.4 Requirements for the electrical characteristics of connected devices and


networks
The LAN interfaces and the serial interfaces are only suitable for the connection of
devices or networks that have a rated voltage of at most 24 V DC on the network
side and that meet the requirements of one of the following standards:
– IEC 60950-1: Ungrounded SELV circuits
– IEC 60601-1 (as of 2nd edition): Touchable secondary circuits

14.9 EMC Declaration


14.9.1 General information
The EMC compliance of the product has been evaluated with the external cables,
transducers, and accessories specified in the list of accessories. Other accessories
which do not affect EMC compliance may be used if no other reasons forbid their
use (see other sections of the instructions for use). The use of noncompliant
accessories can result in increased emissions or decreased immunity of the
medical device.
The medical device may only be used adjacent to or stacked with other devices
when the configuration is approved by Dräger. When use adjacent to or stacked
with other devices is absolutely necessary without the configuration being approved
by Dräger, the correct operation of the device in this configuration must be tested
before the product is used. In any case, strictly observe the instructions for use of
the other devices.

14.9.2 Electromagnetic emissions


When using wireless networking, be aware that the system operates at 2.4 GHz
range. Other equipment, even if compliant with CISPR emission requirements, can
interfere with reception of wireless data. When selecting wireless systems (wireless
communication media, pager systems, etc.) for use in installations where wireless
networking is used, care must always be used to make sure that operating
frequencies are compatible. For example, selecting wireless communication media
that operate at 2.4 GHz will likely cause difficulty with the networking components.
Low-level signals such as ECG signals are particularly susceptible to interference
from electromagnetic energy. Even if the equipment meets the test requirements

196 Instructions for use Babyleo TN500 SW 1.0n


Technical data

described below, smooth operation cannot be guaranteed – the 'quieter' the


electrical environment the better. In general, increasing the distance between
electrical devices decreases the likelihood of interference.

14.9.2.1 Detailed radio frequency characteristics


Communication devices in accordance with IEEE 802.11b:
– 2412 to 2472 MHz
– DSSS (direct-sequence spread spectrum) limited to 100 mW
– Applicable to access points and client adapters
Communication devices in accordance with IEEE 802.15.1:
– 2400 to 2485 MHz
– FHSS (frequency-hopping spread spectrum) limited to 2.5 mW
See the instructions for use of the wireless devices for further details.

14.9.3 Electromagnetic environment


The medical device is intended for use in an electromagnetic environment as
specified below. The user must make sure that the medical device is used in such
an environment.

Emissions Compliance Electromagnetic environment


according to
Radio frequency Group 1 The medical device uses radio fre-
emissions quency energy only for its internal
(CISPR 11) function. Therefore, its radio fre-
quency emissions are very low and
are not likely to cause any interfer-
ence in nearby electronic equipment.
Class A The medical device is suitable for
use in all establishments other than
domestic establishments and those
directly connected to the public low-
voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions Not applicable
(IEC 61000-3-2)
Voltage fluctua- Not applicable
tions/flicker emis-
sions (IEC 61000-3-
3)

14.9.4 Electromagnetic immunity


The medical device is intended for use in an electromagnetic environment as
specified below. The user must make sure that the medical device is used in such
an environment.

Instructions for use Babyleo TN500 SW 1.0n 197


Technical data

Immunity against IEC 60601-1-2 test Compliance level Electromagnetic environment


level (medical device)
Electrostatic dis- Contact discharge: ± 6 kV Floors should be wood, concrete,
charge (ESD) ±6 kV or ceramic tiles. If floors are cov-
(IEC 61000-4-2) Air discharge: ±8 kV ±8 kV ered with synthetic material, the
relative humidity should be at
least 30 %.
Electrical fast tran- Power cables: ±2 kV ± 2 kV Mains voltage quality should be
sients/bursts Longer input cables / ± 1 kV that of a typical commercial or
(IEC 61000-4-4) output cables: ±1 kV hospital environment.
Impulse voltages / Common mode volt- ± 2 kV Mains voltage quality should be
surges age: ±2 kV that of a typical commercial or
(IEC 61000-4-5) Differential voltage: ± 1 kV hospital environment.
±1 kV
Magnetic field at sup- 3 A/m 3 A/m Power frequency magnetic fields
ply frequency should be at levels characteristic
(50/60 Hz) of a typical commercial or hospi-
(IEC 61000-4-8) tal environment.
Voltage dips and short Dip >95 %, >95 %, Mains voltage quality should be
interruptions of the 0.5 periods 0.5 periods that of a typical commercial or
supply voltage Dip 60 %, 60 %, hospital environment. If the user
(IEC 61000-4-11) 5 periods 5 periods of the medical device requires
Dip 30 % 30 % continued operation during mains
25 periods 25 periods power supply interruptions, it is
recommended that the medical
Dip >95 %, >95 %,
device is powered from an unin-
5 seconds 5 seconds
terruptible power supply or a bat-
tery.
Radiated radio fre- 80 MHz to 2.5 GHz: 10 V/m Recommended minimum dis-
quency 10 V/m tance of portable and mobile
(IEC 61000-4-3) radio frequency transmitters with
transmission power PEIRP from
the medical device including its
lines:1)
Pၮ3(,53>ZDWWV@
IWၮ3(,53>ZDWWV@ 
Conducted radio fre- 150 kHz to 80 MHz: 10 V Recommended minimum dis-
quency 10 V within the ISM tance to portable and mobile
(IEC 61000-4-6) bands2) radio frequency transmitters with
150 kHz to 80 MHz: 3V transmission power PEIRP to the
3 V outside the ISM medical device including its lines:
1)
bands2)
Pၮ3(,53>ZDWWV@
IWၮ3(,53>ZDWWV@ 
1) For PEIRP, insert the maximum effective isotropic radiated power of the adjacent radio device in watts. Even in the
vicinity of equipment marked with the symbol interference can occur. Field strengths from stationary, portable, or
mobile high-frequency transmitters at the location of the medical device should be less than 3 V/m within the fre-
quency range 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz.
2) ISM bands in this frequency range are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to
27.283 MHz; 40.66 MHz to 40.70 MHz.

198 Instructions for use Babyleo TN500 SW 1.0n


Technical data

14.9.5 Recommended safety clearances for portable and mobile high-


frequency communication equipment
The safety clearances listed in the following comply with IEC 60601-1-2.

Max. PEIRP 150 kHz to All other fre- Examples


(W) 2.5 GHz quencies
0.03 0.32 m (1.1 ft) 0.96 m (3.2 ft) WLAN 5250 / 5775 (Europe)
0.10 0.58 m (1.9 ft) 1.8 m (5.9 ft) WLAN 2440 (Europe)
0.17 0.76 m (2.5 ft) 2.3 m (7.6 ft) Bluetooth, RFID 2.5 GHz
0.20 0.82 m (2.7 ft) 2.5 m (8.2 ft) WLAN 5250 (not in Europe)
0.25 0.92 m (3.0 ft) 2.8 m (9.2 ft) UMTS cellular phones
0.41 1.2 m (3.9 ft) 3.5 m (12 ft) Cordless DECT phones
0.82 1.7 m (5.6 ft) 5.0 m (16 ft) RFID 13.56 MHz
1.00 1.8 m (5.9 ft) 5.5 m (18 ft) WLAN 5600 (not in Europe)
1.64 2.4 m (7.9 ft) 7.1 m (23 ft) GSM 1800/GSM 1900
3.3 3.3 m (11 ft) 10 m (33 ft) GSM 900 cellular phones,
RFID 868 MHz

14.9.6 Reduced safety clearance for portable and mobile high-


frequency communication equipment
The following separation distances are based on additional tests performed by
Dräger to determine the minimum separation distances absolutely necessary.
These reduced separation distances are valid only for mobile radio frequency
communication devices using the standards listed. The following safety clearances
to the sensor wall must be maintained:

Mobile radio frequency communication device using Separation distance


...
GSM 850, GSM 900, RFID 868 MHz (limited to 2 W 0.3 m (1.1 ft)
ERP)
GSM 1800, GSM 1900 (limited to 1 W ERP) 0.2 m (0.6 ft)
UMTS, DECT (limited to 0.25 W ERP) 0.1 m (0.3 ft)
Bluetooth, WLAN 2450, RFID 2450 (limited to 0.1 W 0.03 m (0.1 ft)
ERP)

14.10 Open-source software


Dräger devices that use software may use open-source software, depending on
their setup. Open-source software may be subject to different terms of license.
Additional information regarding the open-source software used in this device is
available at the following web page:
www.draeger.com/opensource

Instructions for use Babyleo TN500 SW 1.0n 199


Annex

15 Annex
15.1 Description of skin temperature regulation
This chapter describes skin temperature regulation in incubator operation and in
radiant warmer operation.

Skin temperature mode


Skin temperature mode can be used in incubator operation and radiant warmer
operation. Two skin temperature sensors can be connected. The yellow skin
temperature sensor measures the central skin temperature. The optional white skin
temperature sensor measures the peripheral skin temperature. In skin temperature
mode, only the measured value from the yellow skin temperature sensor is used for
the regulation of the radiant warmer (radiant warmer operation) and the convection
heater (incubator operation). Only the yellow skin temperature sensor is used for
skin temperature regulation.

Skin temperature regulation in incubator operation


The measured central skin temperature is compared with the defined set value for
the skin temperature and regulated accordingly. The set value for the skin
temperature can be set to between 34 and 38 °C (93.2 and 100.4 °F). The
difference between the defined set value and the measured actual value for the skin
temperature regulates the air temperature in the device.
If the defined set value is greater than the measured value (skin too cold), the
convection heater receives a signal to increase the heat. The air temperature inside
the device increases.
If the defined set value is lower than the measured value (skin too warm), the
convection heater receives a signal to decrease the heat. The air temperature
inside the device decreases.

Skin temperature regulation in radiant warmer operation


The heating level is regulated based on the difference between the defined set
value for the skin temperature and the measured central skin temperature. For a set
value range between 34 and 38 °C (93.2 and 100.4 °F), the device regulates the
output power of the radiant warmer in such a way that the difference between the
set value and measured value is minimized.
If the defined set value is greater than the measured value (skin too cold), the
radiant warmer receives a signal to increase the heat. The radiant warmer power
increases and the patient receives more heat.
If the defined set value is lower than the measured value (skin too warm), the
radiant warmer receives a signal to decrease the heat.

200 Instructions for use Babyleo TN500 SW 1.0n


Annex

15.1.1 Safety mode in incubator operation and radiant warmer


operation
If a skin temperature regulation fault occurs in skin temperature mode, the device
generates an alarm and switches into a safety mode (fall-back). If one of the
following alarm messages is displayed, the device deactivates the heat supply:

Alarm Cause Effect


Air temperature too Air temperature > 40 °C The convective heater is
high (> 104 °F) switched off.
Centr. sensor miss- The central skin tem- The convective heater or the
ing, heating off perature sensor (yellow) radiant warmer is switched
is not connected. off.
Centr. temp. sensor The central skin tem- The convective heater or the
faulty, heating off perature sensor (yellow) radiant warmer is switched
is faulty. off.
Skin temperature high The tolerated deviation The convective heater or the
for central skin tem- radiant warmer is switched
perature (yellow) has off.
been exceeded. The
current central skin
temperature is too high.

15.2 Further information on heated mattress (option)


This chapter describes the special features of the heated mattress (option) when
used in incubator operation and radiant warmer operation.

15.2.1 Incubator operation and radiant warmer operation


The heated mattress can be used in incubator operation and in radiant warmer
operation:
Incubator operation
In incubator operation, the displayed mattress core temperature may be higher than
the temperature in the patient compartment.

Radiant warmer operation


In radiant warmer operation, the surface temperature of the mattress tray may be
higher than the displayed mattress core temperature due to the influence of the
radiant warmer.

Instructions for use Babyleo TN500 SW 1.0n 201


Annex

15.3 Automatic selftest


The operational readiness of the device is checked by means of a selftest. The
following table shows which device functions are automatically tested.

Test After Continu- Other


switching ously
on
Power supply to the device X X
Consumer (radiant warmer, X X
convective heater, humidi-
fier heater)
– Safety shut-down X Every 24 hours
Electronic components,
in areas flushed with
oxygen:
– Safety shut-down X
– Safety test X
Alarm loudspeaker: 2 acoustic signals sound;
– Acoustic and optical X the alarm light lights yel-
tests by the user low and red
– Electrical test When alarms of high and
medium priority are initi-
ated
Sensor box X
Water valve For the 1st use
Fan impeller:
– Installed X
– Rotational speed X
Safety function of heated
X X
mattress
All sensors X X
Scale Automatic
Device height adjustment When used
Bed-tilt mechanism When used

202 Instructions for use Babyleo TN500 SW 1.0n


Annex

15.4 Delay of the alarm condition


Some alarms are not indicated immediately after an alarm condition occurs, but
after a delay time. The following table shows the duration of the delay.

Alarm Duration of alarm delay


Audio paused key faulty 10 s
Centr. sensor missing, heating off 8s
Central skin temp. sensor missing 8s
Fan motor faulty, heating off 40 s
Foot pedal faulty 60 s
Hood not closed, warmer off 30 s
Mattress tray control panel faulty 60 s
Oxygen high 30 s
Oxygen low 30 s
Oxygen sensor faulty 30 s
Peripheral skin temp. sensor missing 8s
Rotary knob faulty 10 s
Start/standby key faulty 10 s
Water level low 10 s
Weaning temperature not reached 5 min

15.5 Schematic representation of alarm and information


tones
The table describes the tone sequences for the various alarm priorities.

Alarm priority Standard (in accordance with with IEC 60601-1- Repeated
8)
Yes

High Depending on the overall alarm situation, the timing


of individual alarms may cause this tone sequence
to be output as a 5-tone sequence only.
Yes
Medium

No
Low

The acoustic alarm signals described here will be output by a reserve loudspeaker
if the main loudspeaker should fail. The reserve loudspeaker plays the tone
sequences of the Warning and Caution alarm priorities at the same tone frequency
and volume level.

Instructions for use Babyleo TN500 SW 1.0n 203


Annex

Tone signals during operation

When Signal
Time-out following non-confirmation of
selection

15.6 Interfaces
The following devices can be connected to the interfaces on the device:

Interfaces on the main column

Interface Description Devices


Serial port (COM) For connecting devices via E.g., monitors, data man-
the MEDIBUS.X software agement systems
protocol
Nurse call port Connects the device to the Central hospital alarm sys-
central hospital alarm sys- tem
tem
USB port For connecting a USB USB mass storage device
mass storage device for
the import and export of
configuration data and
patient data
Service port (RJ45) Connects the device to the DrägerService PC
service PC for servicing
purposes

Audio interface

Interface Description Devices


Audio connector (option) For connecting an audio E.g., MP3 player, CD
cable for an external play- player, cassette recorder,
back device cellular phone

204 Instructions for use Babyleo TN500 SW 1.0n


Annex

15.7 Abbreviations
Abbreviation Explanation
% Radiant warmer power
%, Vol % Percentage gas ratio, related to total volume
A Ampere
Air Medical compressed air
CISPR Comité International Spécial des Perturbations Radioélec-
triques, International Special Committee on Radio Interference
CO2 Carbon dioxide
COM Serial port
CSA Canadian Standards Agency
dB(A) Sound pressure level, A-weighted
EMC Electromagnetic compatibility
ESD Electrostatic Discharge, electrostatic discharge
fc Foot candle
HF High-frequency
hPa Hectopascal
ID Identification
kg Kilogram
L Liter
LAN Local network
lbs Pound; unit of mass
LED Light emitting diode
mbar Millibar
MEDIBUS.X Dräger communications protocol for medical devices with uni-
form data definition for all devices
min Minute
mL Milliliter
MRI Magnetic resonance imaging
oz Ounce
ppm Parts per million
RFID Radio Frequency Identification, radio frequency identification
RI Revision index
SNMP Simple Network Management Protocol
UMDNS Universal Medical Device Nomenclature System, nomenclature
for medical devices
USB Universal Serial Bus, computer interface

Instructions for use Babyleo TN500 SW 1.0n 205


Annex

15.8 Symbols
Symbol Explanation

Manufacturer

Date of manufacture

WEEE marking

Follow the instructions for use

Warning! Strictly follow these instructions for use

Caution Follow the accompanying documentation (Symbol)

Main switch Off/On

Start/standby

Audio paused

Mains voltage

Oxygen cylinders on this side of the device only

No oxygen cylinders on this side of the device

Potential equalization connector

Do not cover the ventilation slots of the radiant warmer.

Warning: Hot surfaces

Warning: Risk of crushing of feet

Serial number

Revision index
Part number

LOT Lot number

206 Instructions for use Babyleo TN500 SW 1.0n


Annex

Symbol Explanation

Use by

Keep away from sunlight

Storage temperature

Relative humidity

Atmospheric pressure

Do not use if package damaged

Do not reuse

Spare part

Nurse call

USB port

Do not connect any accessory operating on mains voltage.

Applied part of type BF (body floating)

2
High-density polyethylene, class 2
PE-HD

PVC-free (polyvinyl chloride), DEHP-free

LATEX Not made with natural rubber latex

Lay the patient on this side of the heated mattress

Do not lay the patient on this side of the heated mattress

Do not fold the heated mattress

Do not place any sharp objects on the heated mattress

Keep sources of oxygen away from the ventilation slot

Working light

Instructions for use Babyleo TN500 SW 1.0n 207


Annex

Symbol Explanation

Night light

Move the device downwards

Move the device upwards

208 Instructions for use Babyleo TN500 SW 1.0n


Annex

15.9 Symbol in the software


Symbol Explanation

Central skin temperature

Peripheral skin temperature

Air temperature

Radiant warmer

Convection heater

Mattress core temperature

Humidity

Acoustic alarm signal temporarily suppressed.

Alarm inactive

Upper alarm limit

Lower alarm limit

Locked

Unlocked

Closes the dialog window

In lists: One line up

In lists: One line down

In lists: One page up

In lists: One page down

Enter key

Instructions for use Babyleo TN500 SW 1.0n 209


Annex

15.10 Product labels


Skin temperature sensors Explanation
Sockets for skin temperature sensors:
central skin temperature (yellow),
peripheral skin temperature (white)

Scale Explanation
Socket for the scale

Seal for the scale

Audio port Explanation


Socket for the audio port

Oxygen connector Explanation


Connectors for oxygen (oxygen cylinder
or wall terminal unit)

Intrahospital patient transfer Explanation


Maximum permissible transfer height
exceeded

210 Instructions for use Babyleo TN500 SW 1.0n


Annex

Mattress tray Explanation


Adjusting the mattress tray

Maximum load Explanation


Maximum load
x
Maximum load of duct rails; risk of tip-
ping over: do not push or pull the device
to either side of the main column

Weight of device and maximum total


weight of the device

Heated mattress Explanation


Socket for the heated mattress

Humidification system Explanation


Socket for the humidification system
(use Aquadest/distilled water)

Castor Explanation
Green arrow: castor is movable in longi-
tudinal direction (direction lock)
Green lock: castor is not locked (no
direction lock)
Red lock: castor is locked

Instructions for use Babyleo TN500 SW 1.0n 211


This page has been left blank intentionally.

212 Instructions for use Babyleo TN500 SW 1.0n


Password

16 Password
16.1 Configuration password for Babyleo
TN500 Software 1.0n
Cut out from the instructions for use Babyleo TN500 Software 1.0n
To prevent unauthorized alteration, the device settings for Babyleo TN500 are
protected by the following configuration password:

0000

16.1.1 Information for the configuration password


To prevent unauthorized alteration, the device settings for Babyleo TN500 are
protected by a password with 0 to 8 digits. For further information, see the following
chapter: ''Specifying the device settings'' (page 142).
The configuration password appears on this page of the instructions for use. Cut
out the area with the password and keep in a place which is safe from access by
unauthorized persons.
If it is necessary to reset the configuration password, contact service personnel.

Instructions for use Babyleo TN500 SW 1.0n 213


This page has been left blank intentionally.

214 Instructions for use Babyleo TN500 SW 1.0n


Index

Index
A Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Causes . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . 205
Colors. . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Access panel . . . . . . . . . . . . . . . . . . . . . . . . . 52
Device settings. . . . . . . . . . . . . . . . . . . . 144
Closing . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . 141
Opening . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Manual mode . . . . . . . . . . . . . . . . . . . . . . 91
Accessories
Remedy . . . . . . . . . . . . . . . . . . . . . . . . . 153
Safety instruction . . . . . . . . . . . . . . . . . . . 23
Safety instruction . . . . . . . . . . . . . . . . . . . 12
Activating
APGAR
Applications . . . . . . . . . . . . . . . . . . . . . . 185
Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Licensed application . . . . . . . . . . . . . . . . 186
Applications
Activation code
Activating . . . . . . . . . . . . . . . . . . . . . . . . 185
Loading from USB mass storage device 186
Assembling
Manual entry . . . . . . . . . . . . . . . . . . . . . . 186
Device . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Adjusting
Assembly and preparation. . . . . . . . . . . . . . . 56
Device height . . . . . . . . . . . . . . . . . . . . . . 48
Attaching
Mattress tray . . . . . . . . . . . . . . . . . . . . . . . 49
Skin temperature sensor . . . . . . . . . . 79, 81
O2 sensors . . . . . . . . . . . . . . . . . . . . . 15, 99
Audio file
Patient weight . . . . . . . . . . . . . . . . . . . . . 121
Playing . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Advanced skin temperature alarm limit
Auto
Setting . . . . . . . . . . . . . . . . . . . . . . . . 84, 88
Heated mattress. . . . . . . . . . . . . . . . . . . 103
Air temperature alarm limit
Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Air temperature mode . . . . . . . . . . . . . . . . . . 85
Ending . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 B
Extended temperature range . . . . . . . . . . 85 Bed-tilt mechanism
Main screen . . . . . . . . . . . . . . . . . . . . . . . 86 Activating . . . . . . . . . . . . . . . . . . . . . . . . . 49
Starting . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Temperature range . . . . . . . . . . . . . . . . . . 85 C
Alarm condition
Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . 203 Canceling
Alarm limit Humidifier cleaning. . . . . . . . . . . . . . . . . 167
Advanced . . . . . . . . . . . . . . . . . . . . . . 84, 88 Castor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Air temperature . . . . . . . . . . . . . . . . . . . . . 88 Locking brake. . . . . . . . . . . . . . . . . . . . . . 26
Automatic . . . . . . . . . . . . . . . . . . . . . 89, 110 Checks
Kangaroo mode . . . . . . . . . . . . . . . . . . . 107 Metrological . . . . . . . . . . . . . . . . . . . . . . 183
Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Skin temperature . . . . . . . . . . . . . . . 83, 110 Closing
Tolerate cooling . . . . . . . . . . . . . . . . . . . 110 Access panel . . . . . . . . . . . . . . . . . . . . . . 53
Alarm message . . . . . . . . . . . . . . . . . . . . . . 153 Hand port . . . . . . . . . . . . . . . . . . . . . . . . . 53
Dismissing . . . . . . . . . . . . . . . . . . . . . . . 130 Hood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Alarm priorities. . . . . . . . . . . . . . . 127, 127, 153 Color
Alarm signal . . . . . . . . . . . . . . . . . . . . . . . . . 127 Control element . . . . . . . . . . . . . . . . . . . . 46
Delaying . . . . . . . . . . . . . . . . . . . . . . . . . 127 Skin temperature sensor . . . . . . . . . . . . . 79
Suppressing . . . . . . . . . . . . . . . . . . 127, 130 Components
Alarm tones Disassembling . . . . . . . . . . . . . . . . . . . . 169
Schematic representation . . . . . . . . . . . . 203 Condensation management . . . . . . . . . . . . . 69
Configuration . . . . . . . . . . . . . . . . . . . . . . . . 131

Instructions for use Babyleo TN500 SW 1.0n 215


Index

Configuration data Disinfectant


Exporting . . . . . . . . . . . . . . . . . . . . . . . . 135 Surface disinfection . . . . . . . . . . . . . . . . 173
Importing. . . . . . . . . . . . . . . . . . . . . . . . . 136 Disinfectants, information . . . . . . . . . . . . . . 171
Transferring . . . . . . . . . . . . . . . . . . . . . . 134 Dismantling
Configuring Device . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Transition . . . . . . . . . . . . . . . . . . . . . . . . . 76 Display unit . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Connecting Detailed view . . . . . . . . . . . . . . . . . . . . . . 31
Heated mattress . . . . . . . . . . . . . . . . . . . 101 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Nurse call . . . . . . . . . . . . . . . . . . . . . . . . . 58 Double castor . . . . . . . . . . . . . . . . . . . . . . . . 26
Scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Locking brake. . . . . . . . . . . . . . . . . . . . . . 26
Skin temperature sensor . . . . . . . . . . 79, 81
Connections E
Rear sensor wall . . . . . . . . . . . . . . . . . . . . 30
Control element Electromagnetic compatibility
Color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Safety instruction . . . . . . . . . . . . . . . . . . . 13
EMC Declaration . . . . . . . . . . . . . . . . . . . . . 196
Ending
D Air temperature mode . . . . . . . . . . . . . . . 90
Delay Kangaroo mode . . . . . . . . . . . . . . . . . . . 108
Alarm condition . . . . . . . . . . . . . . . . . . . . 203 Manual mode . . . . . . . . . . . . . . . . . . . . . . 94
Deleting Skin temperature mode . . . . . . . . . . . . . . 85
Patient data . . . . . . . . . . . . . . . . . . . . . . 132 Tolerate cooling . . . . . . . . . . . . . . . . . . . 111
Developmental care. . . . . . . . . . . . . . . . . . . 124 Warm-up. . . . . . . . . . . . . . . . . . . . . . . . . 113
Audio file. . . . . . . . . . . . . . . . . . . . . . . . . 126 Weaning . . . . . . . . . . . . . . . . . . . . . . . . . 115
Hood cover . . . . . . . . . . . . . . . . . . . . . . . 126 Exporting
Monitoring limits for noise and light . . . . 125 Configuration data . . . . . . . . . . . . . . . . . 135
Device Patient data . . . . . . . . . . . . . . . . . . . . . . 135
Assembling . . . . . . . . . . . . . . . . . . . . . . . 176 Extended temperature range
Configuring . . . . . . . . . . . . . . . . . . . . . . . 131 Skin temperature mode . . . . . . . . . . . . . . 77
Disassembling . . . . . . . . . . . . . . . . . . . . 167
Height adjustment. . . . . . . . . . . . . . . . . . . 48 F
Switching off . . . . . . . . . . . . . . . . . . . . . . . 67
Switching on . . . . . . . . . . . . . . . . . . . . . . . 64 Factory settings
Device combinations . . . . . . . . . . . . . . . . . . 194 Resetting . . . . . . . . . . . . . . . . . . . . . . . . 142
Device height Family view . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Adjusting . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Filter cloth for patient air
Device settings . . . . . . . . . . . . . . . . . . . . . . 142 Replacing . . . . . . . . . . . . . . . . . . . . . . . . 185
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Factory settings . . . . . . . . . . . . . . . . . . . 142 H
Import/export . . . . . . . . . . . . . . . . . . . . . 147 Hand port . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Patient . . . . . . . . . . . . . . . . . . . . . . . . . . 143 Closing . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Patient-specific . . . . . . . . . . . . . . . . . . . . 142 Opening . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Screen layout . . . . . . . . . . . . . . . . . . . . . 143 Heated mattress . . . . . . . . . . . . . . . . . 100, 201
Specifying . . . . . . . . . . . . . . . . . . . . . . . . 142 Auto . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
System . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Connecting . . . . . . . . . . . . . . . . . . . . . . . 101
Therapy . . . . . . . . . . . . . . . . . . . . . . . . . 146 Mattress core temperature . . . . . . . 100, 201
User-specific . . . . . . . . . . . . . . . . . . . . . . 142 Setting range . . . . . . . . . . . . . . . . . 100, 201
Dialog window Height adjustment
Quick setup. . . . . . . . . . . . . . . . . . . . . . . . 35 Activating . . . . . . . . . . . . . . . . . . . . . . . . . 48
Disassembling
Components . . . . . . . . . . . . . . . . . . . . . . 169
Device. . . . . . . . . . . . . . . . . . . . . . . . . . . 167

216 Instructions for use Babyleo TN500 SW 1.0n


Index

Hood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 L
Closing . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Licensed application
Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Activating . . . . . . . . . . . . . . . . . . . . . . . . 186
Direction of movement . . . . . . . . . . . . . . . 51
Lifting column
Opening . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Safety check. . . . . . . . . . . . . . . . . . . . . . 181
Hood cover . . . . . . . . . . . . . . . . . . . . . . . . . 126
Liquid on heating plate
Humidification system
Removing . . . . . . . . . . . . . . . . . . . . . . . . 164
Using . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Load
Humidifier cleaning . . . . . . . . . . . . . . . . . . . 166
Maximum . . . . . . . . . . . . . . . . . . . . . . . . . 56
Canceling . . . . . . . . . . . . . . . . . . . . . . . . 167
Loading from USB mass storage device
Starting . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Activation code. . . . . . . . . . . . . . . . . . . . 186
Humidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Lock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Auto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Bed-tilt mechanism. . . . . . . . . . . . . . . . . . 55
Automatic . . . . . . . . . . . . . . . . . . . . . . . . . 94
Device height adjustment. . . . . . . . . . . . . 55
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Locking brake
Setting range . . . . . . . . . . . . . . . . . . . . . . 94
Castor. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Double castor . . . . . . . . . . . . . . . . . . . . . . 26
I Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Importing
Configuration data . . . . . . . . . . . . . . . . . 136 M
Patient data . . . . . . . . . . . . . . . . . . . . . . 136
Main column
Incubator operation . . . . . . . . . . . . . . . . . . . . 69
Detailed view . . . . . . . . . . . . . . . . . . . . . . 28
Interrupting . . . . . . . . . . . . . . . . . . . . . . . . 75
Main menu bar . . . . . . . . . . . . . . . . . . . . . . . 33
Main screen . . . . . . . . . . . . . . . . . . . . . . . 78
Main screen
Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Air temperature mode . . . . . . . . . . . . . . . 86
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Incubator operation . . . . . . . . . . . . . . . . . 78
Transition . . . . . . . . . . . . . . . . . . . . . . . . . 74
Kangaroo mode . . . . . . . . . . . . . . . . . . . 104
Information tones
Manual mode . . . . . . . . . . . . . . . . . . . . . . 91
Schematic representation . . . . . . . . . . . . 203
Radiant warmer operation . . . . . . . . . . . . 79
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 184
Metrological checks . . . . . . . . . . . . . . . . 183
Manual entry
Safety checks . . . . . . . . . . . . . . . . . . . . . 181
Activation code. . . . . . . . . . . . . . . . . . . . 186
Instructions for use
Manual mode . . . . . . . . . . . . . . . . . . . . . . . . 91
Safety instruction . . . . . . . . . . . . . . . . . . . 11
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Ending . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Interrupting
Main screen . . . . . . . . . . . . . . . . . . . . . . . 91
Incubator operation. . . . . . . . . . . . . . . . . . 75
Starting . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Intrahospital patient transfer . . . . . . . . . . . . 150
Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
IT networks . . . . . . . . . . . . . . . . . . . . . . . . . 194
Heated mattress. . . . . . . . . . . . . . . . . . . . 51
SoftBed . . . . . . . . . . . . . . . . . . . . . . . . . . 51
K Mattress core temperature
Kangaroo mode . . . . . . . . . . . . . . . . . . . . . . 104 Setting . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Alarm limit . . . . . . . . . . . . . . . . . . . . . . . . 107 Mattress tray
Duration . . . . . . . . . . . . . . . . . . . . . . . . . 104 Adjusting . . . . . . . . . . . . . . . . . . . . . . . . . 49
Ending . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Maximum load . . . . . . . . . . . . . . . . . . . . . . . . 56
Main screen . . . . . . . . . . . . . . . . . . . . . . 104 Modifications
Starting . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Safety instruction . . . . . . . . . . . . . . . . . . . 12

Instructions for use Babyleo TN500 SW 1.0n 217


Index

Monitoring Power failure alarm . . . . . . . . . . . . . . . . . . . 161


Safety instruction . . . . . . . . . . . . . . . . . . . 11 Precautionary statements . . . . . . . . . . . . . . . 10
Monitoring limits Pre-warm mode. . . . . . . . . . . . . . . . . . . . . . . 72
Developmental care . . . . . . . . . . . . . . . . 125 Product description . . . . . . . . . . . . . . . . . . . . 24
Noise and light . . . . . . . . . . . . . . . . . . . . 125 Product labels
Safety instruction . . . . . . . . . . . . . . . . . . . 11
N
Nurse call. . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
R
Connecting . . . . . . . . . . . . . . . . . . . . . . . . 58 Radiant warmer operation . . . . . . . . . . . . . . . 71
Main screen . . . . . . . . . . . . . . . . . . . . . . . 79
O Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 72
O2 sensors Transition . . . . . . . . . . . . . . . . . . . . . . . . . 74
Adjusting . . . . . . . . . . . . . . . . . . . . . . . 15, 99 Range of functions . . . . . . . . . . . . . . . . . . . . 41
Opening Rear sensor wall
Access panel . . . . . . . . . . . . . . . . . . . . . . 53 Connections . . . . . . . . . . . . . . . . . . . . . . . 30
Hand port . . . . . . . . . . . . . . . . . . . . . . . . . 53 Recommended air temperature . . . . . . . . . 133
Hood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Removing
Open-source software . . . . . . . . . . . . . . . . . 199 Liquid on heating plate . . . . . . . . . . . . . . 164
Operating concept . . . . . . . . . . . . . . . . . . . . . 45 Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Operating mode . . . . . . . . . . . . . . . . . . . . . . . 68 Replacing
Incubator operation. . . . . . . . . . . . . . . . . . 69 Filter cloth for patient air. . . . . . . . . . . . . 185
Radiant warmer operation . . . . . . . . . . . . 71 Reprocessing . . . . . . . . . . . . . . . . . . . . . . . 166
Switching . . . . . . . . . . . . . . . . . . . . . . . . . 74 Classifications . . . . . . . . . . . . . . . . . . . . 172
Transition . . . . . . . . . . . . . . . . . . . . . . . . . 74 Humidifier cleaning. . . . . . . . . . . . . . . . . 166
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Information . . . . . . . . . . . . . . . . . . . . . . . 171
Operational readiness Procedures. . . . . . . . . . . . . . . . . . . . . . . 172
Automatic selftest . . . . . . . . . . . . . . . . . . 202 Special reprocessing measures . . . . . . . 176
Checking. . . . . . . . . . . . . . . . . . . . . . . . . . 63 Surface disinfection . . . . . . . . . . . . . . . . 174
Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Validated reprocessing procedures . . . . 172
Extended setting range. . . . . . . . . . . . . . . 96 Reprocessing personnel . . . . . . . . . . . . . . . . . 9
Sensors . . . . . . . . . . . . . . . . . . . . . . . 15, 99 Resetting
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Factory settings . . . . . . . . . . . . . . . . . . . 142
Setting range . . . . . . . . . . . . . . . . . . . . . . 96 Reweighing
Oxygen alarm limit Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
S
P
Safety check
Password . . . . . . . . . . . . . . . . . . . . . . . . . . . 213 Lifting column . . . . . . . . . . . . . . . . . . . . . 181
Patient Safety instructions . . . . . . . . . . . . . . . . . . . . . 10
Transferring . . . . . . . . . . . . . . . . . . . . . . 150 Accessories . . . . . . . . . . . . . . . . . . . . . . . 23
Patient compartment Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Detailed view . . . . . . . . . . . . . . . . . . . . . . 27 Cleaning and service . . . . . . . . . . . . . . . . 22
Patient data Electrical safety . . . . . . . . . . . . . . . . . . . . 13
Deleting . . . . . . . . . . . . . . . . . . . . . . . . . 132 Operation . . . . . . . . . . . . . . . . . . . . . . . . . 15
Entering . . . . . . . . . . . . . . . . . . . . . . . . . 131 Risk of fire . . . . . . . . . . . . . . . . . . . . . 15, 18
Exporting . . . . . . . . . . . . . . . . . . . . . . . . 135 Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Importing. . . . . . . . . . . . . . . . . . . . . . . . . 136 Use of oxygen . . . . . . . . . . . . . . . . . . . . . 14
Transferring . . . . . . . . . . . . . . . . . . . . . . 134 Safety mode
Patient weight Skin temperature mode . . . . . . . . . . . . . 201
Adjusting . . . . . . . . . . . . . . . . . . . . . . . . . 121 Safety-related information . . . . . . . . . . . . . . . . 8
Performance characteristics . . . . . . . . . . . . . . 9

218 Instructions for use Babyleo TN500 SW 1.0n


Index

Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116 Skin temperature sensor


Adjusting patient weight . . . . . . . . . . . . . 121 Attaching . . . . . . . . . . . . . . . . . . . . . . . . . 81
Connecting . . . . . . . . . . . . . . . . . . . . . . . 117 Attachment position . . . . . . . . . . . . . . 79, 81
Reweighing. . . . . . . . . . . . . . . . . . . . . . . 120 Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Taring . . . . . . . . . . . . . . . . . . . . . . . . . . . 116 Connecting . . . . . . . . . . . . . . . . . . . . . . . . 79
Verification . . . . . . . . . . . . . . . . . . . . . . . 181 Specialized service personnel . . . . . . . . . . . . 10
Weighing. . . . . . . . . . . . . . . . . . . . . . . . . 117 Start dialog . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Screen view Starting
Developmental care . . . . . . . . . . . . . . . . . 39 Air temperature mode . . . . . . . . . . . . . . . 87
Family . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Humidifier cleaning. . . . . . . . . . . . . . . . . 166
Incubator operation. . . . . . . . . . . . . . . . . . 36 Kangaroo mode . . . . . . . . . . . . . . . . . . . 105
Main screen . . . . . . . . . . . . . . . . . . . . . . . 32 Manual mode . . . . . . . . . . . . . . . . . . . . . . 92
Radiant warmer operation . . . . . . . . . . . . 37 Skin temperature mode . . . . . . . . . . . . . . 82
Thermomonitoring . . . . . . . . . . . . . . . . . . 38 Tolerate cooling . . . . . . . . . . . . . . . . . . . 109
Selftest Warm-up. . . . . . . . . . . . . . . . . . . . . . . . . 112
Automatic . . . . . . . . . . . . . . . . . . . . . . . . 202 Weaning . . . . . . . . . . . . . . . . . . . . . . . . . 114
Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 Stopwatch
Filter cloth for patient air . . . . . . . . . . . . . 185 Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Inspection . . . . . . . . . . . . . . . . . . . . . . . . 180 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . 22, 63
Maintenance . . . . . . . . . . . . . . . . . . . . . . 184 Structure and function . . . . . . . . . . . . . . . . . . 24
Remote Service . . . . . . . . . . . . . . . . . . . 180 Switching off
Safety instruction . . . . . . . . . . . . . . . . . . . 22 Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Service dialog . . . . . . . . . . . . . . . . . . . . . 149 Switching on
Service password . . . . . . . . . . . . . . . . . . 149 Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Service personnel . . . . . . . . . . . . . . . . . . . . . . 9 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Specialized . . . . . . . . . . . . . . . . . . . . . . . . 10 Safety instruction . . . . . . . . . . . . . . . . . . . 11
Service port . . . . . . . . . . . . . . . . . . . . . . . 12, 12 System setup . . . . . . . . . . . . . . . . . . . . . . . 142
Setting
Alarm limit . . . . . . . . . . . 83, 88, 98, 107, 110 T
Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Mattress core temperature . . . . . . . . . . . 103 Taking x-rays . . . . . . . . . . . . . . . . . . . . . . . . 122
Monitoring limits for noise and light . . . . 125 Formats . . . . . . . . . . . . . . . . . . . . . . . . . 122
Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Media . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Setting range Target groups . . . . . . . . . . . . . . . . . . . . . . . . . 9
Heated mattress . . . . . . . . . . . . . . . 100, 201 Taring
Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Technical data . . . . . . . . . . . . . . . . . . . . . . . 188
Skin temperature alarm limit Temperature range
Advanced . . . . . . . . . . . . . . . . . . . . . . 84, 88 Air temperature mode . . . . . . . . . . . . . . . 85
Automatic . . . . . . . . . . . . . . . . . . . . . 89, 110 Extended . . . . . . . . . . . . . . . . . . . . . . 77, 85
Setting . . . . . . . . . . . . . . . . . . . . . . . 83, 110 Skin temperature mode . . . . . . . . . . . . . . 77
Skin temperature mode . . . . . . . . . . . . . . . . . 77 Thermomonitoring . . . . . . . . . . . . . . . . . . . . . 83
Ending . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Timer
Extended temperature range . . . . . . . . . . 77 APGAR. . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Safety mode . . . . . . . . . . . . . . . . . . . . . . 201 Stopwatch. . . . . . . . . . . . . . . . . . . . . . . . . 34
Setting advanced alarm limits. . . . . . . . . . 84 Tolerate cooling . . . . . . . . . . . . . . . . . . . . . . 109
Setting alarm limits . . . . . . . . . . . . . . . . . . 83 Ending . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Starting . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Starting . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Temperature range . . . . . . . . . . . . . . . . . . 77 Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Skin temperature regulation Transferring
Description . . . . . . . . . . . . . . . . . . . . . . . 200 Configuration data . . . . . . . . . . . . . . . . . 134
Patient data . . . . . . . . . . . . . . . . . . . . . . 134

Instructions for use Babyleo TN500 SW 1.0n 219


Index

Transition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Configuring . . . . . . . . . . . . . . . . . . . . . . . . 76
Temperature adjustment. . . . . . . . . . . . . . 75
Trends
Displaying . . . . . . . . . . . . . . . . . . . . . . . . 137
Graphical . . . . . . . . . . . . . . . . . . . . . . . . 138
Tabular . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 153
Adjusting the height of the device. . . . . . 162
Adjusting the mattress tray . . . . . . . . . . . 162
Fault with the oxygen supply . . . . . . . . . 163
Liquid on heating plate . . . . . . . . . . . . . . 164
Power failure alarm. . . . . . . . . . . . . . . . . 161
Weighing. . . . . . . . . . . . . . . . . . . . . . . . . 162

U
Unlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Bed-tilt mechanism . . . . . . . . . . . . . . . . . . 55
Device height adjustment . . . . . . . . . . . . . 55
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

V
Verification
NAWI scale . . . . . . . . . . . . . . . . . . . . . . . 181

W
Warm-up . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Ending . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Starting . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Weaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Ending . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Starting . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Weighing . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

X
X-ray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
X-rays
Taking . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

220 Instructions for use Babyleo TN500 SW 1.0n


This page has been left blank intentionally.

Instructions for use Babyleo TN500 SW 1.0n 221


These instructions for use are provided for
customer information only and are only
updated or exchanged upon customer request.

Directive 93/42/EEC concerning medical


devices

Manufacturer

Drägerwerk AG & Co. KGaA


Moislinger Allee 53 – 55
D-23542 Lübeck
Germany
+49 451 8 82-0
FAX +49 451 8 82-2080
http://www.draeger.com

Á9054863gÈ
9054863 – GA 6016.170 en
© Drägerwerk AG & Co. KGaA
Edition: 2 – 2017-01
(Edition: 1 – 2016-09)
Dräger reserves the right to make modifications
to the device without prior notice.

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