Mediana D500 SVC Manual

SERVICE MANUAL
Defibrillator/Monitor D500
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
Local Distributor
Manufacturer
Mediana Co., Ltd.
132, Donghwagongdan-ro, Munmak-eup,
Wonju-si, Gangwon-do, Korea
Tel: (82) 2 542 3375 (82) 33 742 5400
Fax: (82) 2 542 7447 (82) 33 742 5483
D500 Service Manual

Part Number: A7225-4
Revised Date: 2016-09
Copyright © 2016 All rights reserved.

Directive
 Copyright law allows no part of this instruction manual to be reproduced without

permission.
 The content of this manual are subject to change without notice.
 The contents of this manual should be correct. If, for some reason, there are any
questionable points, please do not hesitate to contact our service center.
 The manual will be replaced if any pages are missing or collation is incorrect.
Warranty
 Please contact your local distributor about the warranty period.

 Device failure or damage related to the following situations during the guarantee period is
not covered by this warranty:
 Installation, transfer installation, maintenance and repairs by any person other than
an authorized employee or technician by Mediana.
 Damage sustained to the Mediana product(s) caused by product(s) from another
company excluding products delivered by Mediana.
 Damage – caused by mishandling and/or misuse – is the responsibility of the user.
 Maintenance and repairs utilizing maintenance components that are not specified
by Mediana.
 Device modifications or use of accessories not recommended by Mediana.
 Damage caused by accidents or natural disasters (earthquakes, flooding, etc.).
 Damage resulting from usage where caution statements and operating instructions
shown in this manual have not been followed.
 Damage due to neglect of specified maintenance checks.
 This warranty only covers the hardware of the D500. The warranty does not cover the
following selections:
 Whatever damage or loss results from the attachment of accessories or their
operation.
 In the event of a defect in the product, contact our sales outlet or EU representative
as noted on the back cover.
 The D500 conforms to the EMC standard IEC60601-1-2.
Note that mobile phones should not be used in the vicinity of the D500.
Note, however, any device not complying to the EMC standard that is used with the D500 renders
the D500 as non-compliable to the EMC standard.
Trademark
Product brand names shown in this manual are likely to be the trademark or registered
trademark of the company concerned.
This defibrillator/monitor is equipped with epoch-making ECG monitoring

function incorporating the cutting edge software for analysis of
electrocardiograms developed by the University of Glasgow in UK, which includes signal processing,
diagnostic interpretation of electrocardiograms from individuals of all ages and analysis of cardiac
rhythm.
Contents
Safety Information.................................................................................................................................. 1
General Safety Information .............................................................................................................. 1
Cautions ........................................................................................................................................... 4
Manual Overview ............................................................................................................................. 5
Related Documents .......................................................................................................................... 5
Intended Use for the D500 ............................................................................................................... 5
Indications for Use ........................................................................................................................... 6
Identifying the D500 Configurations ................................................................................................. 7
Defibrillator / Monitor Controls.......................................................................................................... 8
Front Panel Components ................................................................................................................. 8
Top Panel Components .................................................................................................................. 10
Rear Panel Components ................................................................................................................ 11
Left Panel Components .................................................................................................................. 12
Right Panel Components ............................................................................................................... 12
Routine Maintenance ........................................................................................................................... 15
Cleaning ......................................................................................................................................... 15
Periodic Safety and Functional Checks ......................................................................................... 15
Batteries ......................................................................................................................................... 16
Environmental Protection ............................................................................................................... 16
Performance Verification ..................................................................................................................... 17
General........................................................................................................................................... 17
Required Equipment ...................................................................................................................... 17
Performance Tests ......................................................................................................................... 18
Safety Tests .................................................................................................................................... 39
Service Menu and Parameter Default Settings ................................................................................. 47
General........................................................................................................................................... 47
Service Menu ................................................................................................................................. 47
Factory Default Settings ................................................................................................................. 74
Software Update ................................................................................................................................... 81
Troubleshooting ................................................................................................................................... 83
General........................................................................................................................................... 83
How to Use This Section ................................................................................................................ 83
Who Should Perform Repairs ........................................................................................................ 83
Replacement Level Supported ....................................................................................................... 83
Troubleshooting Guide ................................................................................................................... 84
Disassembly Guide .............................................................................................................................. 99
General........................................................................................................................................... 99
Prior to Disassembly .................................................................................................................... 100
Battery Replacement .................................................................................................................... 100
Side Option Case Disassembly (A) .............................................................................................. 101
Front Case Disassembly (B) ........................................................................................................ 104
Rear Case Disassembly (C)......................................................................................................... 110
Spare Parts.......................................................................................................................................... 117
General......................................................................................................................................... 117
Obtaining Replacement Parts ...................................................................................................... 117
Packing for Shipment ........................................................................................................................ 121
General Instructions ..................................................................................................................... 121
Returning the Defibrillator/Monitor ............................................................................................... 121
Repacking In Original Carton ....................................................................................................... 121
Repacking In a Different Carton ................................................................................................... 122
Specification ....................................................................................................................................... 123
Display.......................................................................................................................................... 123
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Controls ........................................................................................................................................ 123
Alarms .......................................................................................................................................... 123
Physical Characteristics and Printer ............................................................................................ 123
Electrical ....................................................................................................................................... 124
Environmental Conditions ............................................................................................................ 125
Tone Definition ............................................................................................................................. 126
Measurement Parameters............................................................................................................ 127
Event ............................................................................................................................................ 133
Defibrillator (Technical Specification) ........................................................................................... 134
Compliance .................................................................................................................................. 149
System Processing Description ....................................................................................................... 153
System Overview ......................................................................................................................... 153
System Block Diagram ................................................................................................................. 153
ECG Processing ........................................................................................................................... 159
NIBP Processing .......................................................................................................................... 159
SpO2 Processing .......................................................................................................................... 161
Respiration Processing ................................................................................................................ 163
Temperature Processing .............................................................................................................. 163
Invasive Blood Pressure Processing ........................................................................................... 164
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Figures
Figure 1. Front panel components .......................................................................................................... 8
Figure 2. Top panel components ........................................................................................................... 10
Figure 3. Rear panel components ......................................................................................................... 11
Figure 4. Left panel components ........................................................................................................... 12
Figure 5. Right panel components ........................................................................................................ 12
Figure 6. Manual Self-Test .................................................................................................................... 19
Figure 7. Parameter Default Setting ..................................................................................................... 25
Figure 8. Pressure Sensor Accuracy Test ............................................................................................. 32
Figure 9. Air Leakage Test .................................................................................................................... 33
Figure 10. Inflation Time Measurement ................................................................................................ 34
Figure 11. Deflation Rate Measurement ............................................................................................... 35
Figure 12. The access of Service menu via Setup menu ..................................................................... 47
Figure 13. Entering the pass code ........................................................................................................ 48
Figure 14. System Setting I ................................................................................................................... 49
Figure 15. System Setting II .................................................................................................................. 52
Figure 16. Printer Setting ...................................................................................................................... 55
Figure 17. Parameter Default Setting ................................................................................................... 56
Figure 18. ECG Setting ......................................................................................................................... 63
Figure 19. 12 Lead ECG Setting ........................................................................................................... 64
Figure 20. Shock Setting ....................................................................................................................... 66
Figure 21. AED Mode Setting ............................................................................................................... 68
Figure 22. Pacing Mode Setting ............................................................................................................ 70
Figure 23. 3G Network Setting .............................................................................................................. 71
Figure 24. Wi-Fi Network Setting .......................................................................................................... 72
Figure 25. Software update display....................................................................................................... 81
Figure 26. Disassembly Sequence Flow Chart ................................................................................... 100
Figure 27. Side option case disassembly (1) ...................................................................................... 101
Figure 28. Side option case disassembly (2) ...................................................................................... 102
Figure 29. Front case disassembly (1)................................................................................................ 104
Figure 33. Rear case disassembly (1) ................................................................................................ 110
Figure 34. Rear case disassembly (2) ................................................................................................ 111
Figure 35. Paddle mounting plate disassembly .................................................................................. 113
Figure 36. AC power supply (SMPS) disassembly ............................................................................. 115
Figure 37. D500 Exploded view .......................................................................................................... 116
Figure 38. Exploded View – Spare Parts ............................................................................................ 117
Figure 39. Biphasic Waveforms at 360 Joules and 360 Joules .......................................................... 138
Figure 40. Biphasic Waveforms at 200 Joules.................................................................................... 138
Figure 45. Biphasic Waveforms at 75 Joules...................................................................................... 141
Figure 51. Biphasic Waveforms at 9 Joules........................................................................................ 144
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Figure 60. System Block Diagram ...................................................................................................... 153
Figure 61. Power Unit Block Diagram ................................................................................................. 154
Figure 62. Main Process Unit Block Diagram ..................................................................................... 154
Figure 63. Display Unit Block Diagram ............................................................................................... 155
Figure 64. User-Control Unit Block Diagram....................................................................................... 155
Figure 65. Audio Unit Block Diagram .................................................................................................. 155
Figure 66. Communication Unit Block Diagram .................................................................................. 156
Figure 67. GUI Unit Block Diagram ..................................................................................................... 156
Figure 68. Thermal Printer Unit Block Diagram .................................................................................. 156
Figure 69. NIBP Unit Block Diagram ................................................................................................... 157
Figure 70. EtCO2 Unit Block Diagram ................................................................................................. 157
Figure 71. ECG Unit Block Diagram ................................................................................................... 157
Figure 72. SpO2 Unit Block Diagram................................................................................................... 158
Figure 73. Temperature Unit Block Diagram ....................................................................................... 158
Figure 74. IBP Unit Block Diagram ..................................................................................................... 158
Figure 75. Oxyhemoglobin Dissociation Curve ................................................................................... 162
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Tables
Table 1. The defibrillator/monitor controls on front panel ........................................................................ 9
Table 2. The defibrillator/monitor controls on paddle ............................................................................ 10
Table 3. Panel and Label Symbols........................................................................................................ 13
Table 4. Required Equipment................................................................................................................ 17
Table 5. Earth Leakage Current Values ................................................................................................ 39
Table 6. Enclosure Leakage Current Values......................................................................................... 40
Table 7. Patient Leakage Current Values ............................................................................................. 41
Table 8. Patient Leakage Current Values - Mains Voltage on Applied Part .......................................... 42
Table 9. Test Lead Combinations .......................................................................................................... 42
Table 10. Allowable Leakage Current ................................................................................................... 43
Table 11. System Setting I..................................................................................................................... 49
Table 12. System Setting II ................................................................................................................... 52
Table 13. Printer Setting ........................................................................................................................ 55
Table 14. Parameter Default Setting ..................................................................................................... 56
Table 15. ECG Setting........................................................................................................................... 63
Table 16. 12 Lead ECG Setting ............................................................................................................ 64
Table 17. Shock Setting ........................................................................................................................ 66
Table 18. AED Mode Setting ................................................................................................................. 68
Table 19. Pacing Mode Setting ............................................................................................................. 70
Table 20. 3G Network Setting ............................................................................................................... 71
Table 21. Wi-Fi Network Setting ............................................................................................................ 72
Table 22. Parameter ranges and factory defaults ................................................................................. 74
Table 23. Required Equipments for software update ............................................................................ 81
Table 24. Problem Categories ............................................................................................................... 84
Table 25. Technical error codes ............................................................................................................ 96
Table 26. Part descriptions – Side option case disassembly (1) ........................................................ 101
Table 27. Part descriptions – Side option case disassembly (2) ........................................................ 102
Table 28. Part descriptions – Front case (1) ....................................................................................... 104
Table 32. Part descriptions – Rear case (1) ........................................................................................ 110
Table 33. Part descriptions – Rear case (2) ........................................................................................ 111
Table 34. Part descriptions – Paddle mounting plate.......................................................................... 113
Table 35. Part descriptions – AC power supply (SMPS) ..................................................................... 115
Table 36. Part list................................................................................................................................. 118
Table 37. Delivered Energy at Every Defibrillator Settings into a Range of Loads ............................. 137
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vi
Safety Information
General Safety Information

This section contains important safety information related to general use of the
defibrillator/monitor. Other important safety information appears throughout the
manual. The defibrillator/monitor may be referred to as the defibrillator/monitor
throughout this manual.
Important! Before use, read carefully the manual, accessory directions for use,
all precautionary information and specifications.
Warnings
Warnings alert you to potential serious outcomes (death, injury, or adverse

events) to the patient or user.
Do not take into or use the defibrillator/monitor in locations where

highly combustible anesthetics or flammable gases are used or in high-
pressure oxygen rooms or inside oxygen tents, as this may cause a
flammable explosion. Turn off the gas source or move the source away
from patient during defibrillation.
When using the defibrillator/monitor with a commercial electric power
source, use the D500 with an electric power wall socket with a
grounding wire for medical use. Not doing so could cause electric
shock.
Do not connect grounding wire to gas pipes. This could cause fire.
Only doctors and officially certified personnel should use this D500. Do
not allow patients to touch this defibrillator/monitor. Allowing patients
to touch this defibrillator/monitor could cause accidents.
This defibrillator/monitor cannot be used when MRI is in progress. If
MRI is in use, keep patient attachments away from patients to prevent
accidents.
The defibrillator/monitor conforms to the requirements of the EMC
standard (IEC60601-1-2), and may therefore be used simultaneously
with pacemakers and other electrical simulators. It should, however, be
noted that the defibrillator/monitor may be affected by electrical
scalpels and microwave therapeutic apparatus. Please check operation
of the defibrillator/monitor during and after use of such equipment.
Do not take mobile phones or transceivers into a room where this
defibrillator/monitor is installed, as such devices may cause accidents.
In order to avoid accidents, do not use any unauthorized accessories or
options.
Thoroughly read the instruction manuals supplied with accessories and
options to ensure correct use. This instruction manual does not carry
the caution selections for such equipment.
Do not open cover or disassemble this defibrillator/monitor. Doing so
could cause electric shock or fire. It is prohibited by law to modify the
1
defibrillator/monitor without authorization.
Do not use power source other than the specified voltage, (100-
240V~50/60Hz) as this may cause fire or electric shock.
Pre-use inspection and preventive maintenance must be performed for
safe use.
The defibrillator/monitor may be used with electrical surgical
equipment.
Follow the instruction manuals for medical instruments – notably
electrosurgical and diathermy instruments – when used, as their high–
frequency energy units may cause burns to patients via attachments.
This defibrillator/monitor is protected against the discharge of a
defibrillator. However, do not touch the defibrillator/monitor when a
defibrillator is being discharged (electrified), as doing so may cause
electric shock.
The following cautions apply when connecting the defibrillator/monitor
with other equipment.
1. Ensure that the connected equipment is in accordance with the
IEC60601-1 or IEC safety standards, so that the system complies
with IEC60601-1.
2. Employ additional protective measures (e.g. additional protective
earthing) as necessary.
Do not connect devices that do not meet medical safety standards
(such as commercial PCs), as they may cause electric shock. This
defibrillator/monitor meets the restricted level of leakage current
required for medical devices. Therefore, this defibrillator/monitor
cannot be connected to a device that would give a combined total of
leakage current beyond the restricted level.
Avoid connecting the patient to several devices at once. Leakage
current limits may be exceeded. Do not use a second defibrillator on the
patient while pacing with the Mediana defibrillator/monitor.
Do not place anything on top of this defibrillator/monitor. If something
is spilled over the defibrillator/monitor or gets into it, such spillage may
cause fire or electric shock. If fluid spills on the defibrillator/monitor
accidentally, disconnect power cord, wipe dry immediately, and have
the defibrillator/monitor serviced to make sure that no hazard exists.
Do not place heavy objects on the power cord, as doing so may cause
fire or electric shock.
Before conducting maintenance work, turn the power Off and unplug
the power cord from the wall socket to prevent electric shock.
When the following occur, turn the power Off immediately and unplug
the power cord from the wall socket. Continued use in such situations
may cause fire or electric shock.
 There is smoke or a strange odor leaking out of the device.
 The device has been dropped or impacted by an object.
 Liquid or foreign matter gets inside the device.
 Device failure has occurred.
Also, when any of the above occurs, promptly do the following:
1. Check to see that the power cord has been unplugged from the
wall socket.
2. Place an “Out of Order” sign on the device and do not use it.
Do not connect more than one patient to the defibrillator/monitor. Do
2
not connect more than one defibrillator/monitor to a patient.
The defibrillator/monitor is a prescription device and is to be operated
by qualified personnel only.
As with any medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.
Never lift the defibrillator/monitor by the sensor cable, blood pressure
hose, power cord, or any other accessory. Such accessories could
detach, causing the defibrillator/monitor to fall on the patient.
Do not make any clinical judgments based on this
defibrillator/monitor’s measurement only.
Emergency defibrillation should be performed only by appropriately
trained, skilled and qualified personnel who are aware of the protocol
for handling a patient in medical emergency such as cardiac arrest and
have been certified in Advanced Cardiac Life Support (ACLS) or Basic
Life Support (BLS).
Synchronized electrical cardioversion should be performed only by
skilled personnel trained in Advanced Cardiac Life Support (ACLS) and
practiced in equipment operation. The precise cardiac arrhythmia must
be determined prior to performing defibrillation.
The defibrillator delivers up to 360 joules of electrical energy. Unless
properly used as described in this manual, this electrical energy may
cause serious injury or death. Do not attempt to operate this
defibrillator/monitor unless thoroughly familiar with this manual and the
function of all controls, indicators, connectors and accessories.
Do not discharge standard paddles on top of pads or ECG electrodes.
Do not allow standard paddles (or pads) to touch each other, ECG
electrodes, lead wires, dressings, transdermal patches, etc. Such
contact can cause electrical arcing and patient skin burns during
defibrillation and may divert defibrillating energy away from the heart
muscle.
Discharging the defibrillator with the standard paddle surfaces shorted
together can pit or damage the paddle electrode surface. Pitted or
damaged paddle surfaces may cause patient skin burns during
defibrillation. Discharge the defibrillator only as described in theses
operating instructions.
If a person is touching the patient, bed, or any conductive material in
contact with the patient during defibrillation, the delivered energy may
be partially discharged through that person. Clear every away from
contact with the patient, bed, and other conductive material before
discharging the defibrillator.
Do not discharge the defibrillator into the open air. To remove an
unwanted charge, change the energy selection, or change the mode, or
turn off the defibrillator.
Conductive gel on the paddle handles can allow the electrical energy to
discharge through the operator during defibrillation. Completely clean
the paddle electrode surfaces, handles, and storage area after
defibrillation.
A gel pathway on the skin between the standard paddles will cause
defibrillating energy to arc between paddles and delivery energy away
from the heart muscle. Do not allow conductive gel (wet or dry) to
become continuous between paddle sites.
During defibrillation checks, the discharged energy passes through the
3
cable connectors. Securely attach cable connectors to the simulator.
Do not touch the patient or any equipment connected to the patient
during defibrillation. Warn all persons around patient to STAY AWAY
prior to defibrillation.
The defibrillator/monitor should be out of contact with water (puddles
or water spray). It may cause electrical shocks and device failure.
Electrical safety of the device may not work properly when wet.
Defibrillation may cause implanted devices to malfunction. Place
standard paddles or pads away from implanted devices if possible.
Check implanted device function after defibrillation.
Implanted pacemakers may cause the heart rate meter to count the
pacemaker rate during incidents of cardiac arrest or other arrhythmias.
Pacemaker patients should be carefully observed. Check the patient’s
pulse; do not rely solely on heart rate meters. Dedicated pacemaker
detection circuitry may not detect all implanted pacemaker spikes.
Patient history and physical exam are important in determining the
presence of an implanted pacemaker.
Cautions
Caution statements identify conditions or practices that could result in damage
to the equipment or other property.
Always check that the defibrillator/monitor functions properly and is in

proper condition before use.
Federal law restricts this device to sale by or on the order of a
physician.
The defibrillator/monitor may not operate properly if it is operated or
stored at conditions outside the ranges stated in this manual, or
subjected to excessive shock or dropping.
When connecting the defibrillator/monitor to any instrument, verify
proper operation before clinical use. Both the defibrillator/monitor and
the instrument connected to it must be connected to a grounded outlet.
Accessory equipment connected to the defibrillator/monitor’s data
interface must be certified according to IEC60950 for data-processing
equipment or IEC60601-1 for electromedical equipment. All
combinations of equipment must be in compliance with IEC60601-1-1
system requirements. Anyone who connects additional equipment to
the signal input or signal output port configures a medical system and
is therefore responsible that the system complies with the requirements
of IEC 60601-1-1 and the electromagnetic compatibility system standard
IEC60601-1-2. If in doubt, consult Mediana Technical Support
Representative.
Where the integrity of the external protective conductor in the
installation or its arrangement is in doubt, equipment shall be operated
from its internal electrical power source.
Risk of explosion if battery is replaced by an incorrect type.
4
Manual Overview
This manual contains information for servicing the D500 defibrillator/monitor. The
D500 defibrillator/monitor will be referred to as the defibrillator/monitor throughout this
manual.
The defibrillator/monitor is subsequently referred to as the defibrillator/monitor

throughout this manual. Only qualified service personnel should service this product.
Before servicing the defibrillator/monitor, read the operator’s manual carefully for a
thorough understanding of safe operation.
Read and understand all safety warnings and service notes printed in this service
manual and the operator’s manual.
Related Documents
To perform tests and troubleshooting procedures, and to understand the principles of
operation and circuit analysis sections of this manual, you must know how to operate
the defibrillator/monitor. Refer to the defibrillator/monitor operator’s manual.
To understand the various paddle and pads, SpO2 sensors, ECG leads, blood
pressure cuffs, IBP transducer, capnography accessories and temperature probes
that work with the defibrillator/monitor, refer to the individual directions for use that
accompany these accessories.
Intended Use for the D500

The defibrillator/monitor is intended for use by trained medical technician, doctor,
nurse or medical specialist in outdoor and indoor emergency care settings including
air and ground ambulances within the environmental conditions specified. Manual and
Automated external defibrillation, External pacing, Diagnostic electrocardiography (12-
lead ECG) are intended for use on adult and pediatric patients.
The other monitoring functions (Electrocardiography (ECG, Heart Rate), Non-invasive

blood pressure (NIBP), functional arterial oxygen saturation(SpO2), respiration(RESP),
temperature(TEMP), invasive blood pressure(IBP) and end tidal CO2(EtCO2)) are
intended for use on adult, pediatric and neonatal patients.
5
Indications for Use
Indications Contraindications
Manual Manual defibrillation is Defibrillation is
Defibrillation indicated for the termination contraindicated in the
of certain potentially fatal treatment of Pulseless
arrhythmias, such as Electrical Activity (PEA),
ventricular fibrillation and such as idioventricular or
ventricular tachycardia. ventricular escape
Delivery of this energy in the rhythms, and in the
synchronized mode is a treatment if asystole.
method for treating atrial Defibrillation is not
fibrillation, atrial flutter. intended for patient who is
conscious and has a
palpable pulse and is
contraindicated for use on
neonates.
Automated External AED mode is to be used only AED is not intended for
Defibrillation on patients of at least 8 years patient who is conscious
of age in cardiopulmonary and has a palpable pulse
arrest. The patient must be and is contraindicated for
unconscious, pulseless, and use on neonates.
not breathing normally before
using the defibrillator to
analyze the patient’s ECG
rhythm.
External Pacing External pacing is indicated External pacing is
for symptomatic bradycardia contraindicated for the
in patients with a pulse. treatment of ventricular
Increased heart rates in fibrillation and asystole.
response to external pacing External pacing in the
often suppress ventricular presence of severe
ectopic activity and may hypothermia may be
prevent tachycardia. contraindicated and is
contraindicated for use on
neonates.
Electrocardiography The 12-lead No known
electrocardiogram is used to contraindications
identify, diagnose and treat
patients with cardiac
disorders and is useful in the
early detection.
Noninvasive Blood Noninvasive blood pressure Noninvasive Blood
Pressure monitoring is intended for Pressure is not intended
detection of hypertension or for use with severe
hypotension and monitoring arrhythmia. Noninvasive
BP trends in patient Blood Pressure is not
conditions such as, but not intended for patients who
limited to, shock, acute are experiencing
dysrhythmia, or major fluid convulsion or tremors.
imbalance.
Pulse Oximetry Pulse oximetry monitoring is Pulse Oximetry is not
intended to be used to intended for use with
monitor functional arterial severe peripheral vascular
6
Indications Contraindications
oxygen saturation and pulse disease and severe
rate. anemia (decreased
Hemoglobin).
Invasive Blood Invasive pressure monitor is No known
Pressure indicated for use in contraindications
measuring arterial, venous,
intracranial and other
physiological pressures using
and invasive catheter system
with a compatible transducer.
End-Tidal CO2 EtCO2 monitoring is indicated No known
for detection of trends in the contraindications
level of expired CO2. It is
used for monitoring breathing
efficacy and treatment
effectiveness in acute
cardiopulmonary care.
Temperature Temperature monitoring is No known
indicated for use in patients contraindications
who require continuous
monitoring of body
temperature.
Identifying the D500 Configurations

The following table identifies defibrillator/monitor configurations and how they are
indicated. The reference number and serial number are located on the back of the
product.
All information in this manual, including the illustrations, is based on a device
configured with the 12lead ECG, SpO2 module, Temperature(TEMP) module,
Capnography (EtCO2 and InCO2) (Mainstream or Sidestream) module, IBP module
and Printer module.
Product Code Description
D500M-0 Basic (Manual Defibrillation, Automated External Defibrillation,
Pacing, ECG (3 lead, 5 lead), Respiration, Printer)
D500M-S Basic + SpO2
D500M-L Basic + 12lead ECG
D500M-LS Basic + 12lead ECG + SpO2
D500M-LSNT Basic + 12lead ECG + SpO2 + NIBP/TEMP
D500M-LSNTB Basic + 12lead ECG + SpO2 + NIBP/TEMP + 2CH IBP
D500M-SNTEM Basic + SpO2 + NIBP/TEMP + Capnography (Mainstream)
D500M-SNTES Basic + SpO2 + NIBP/TEMP + Capnography (Sidestream)
D500M-LSNTEM Basic + 12lead ECG + SpO2 + NIBP/TEMP + Capnography
(Mainstream)
D500M-LSNTES Basic + 12lead ECG + SpO2 + NIBP/TEMP + Capnography
(Sidestream)
D500M-LSNTBEM Basic + 12lead ECG + SpO2 + NIBP/Temp +2CH IBP +
Capnography (Mainstream)
D500M-LSNTBES Basic + 12lead ECG + SpO2 + NIBP/Temp +2CH IBP +
Capnography (Sidestream)
7
Defibrillator / Monitor Controls
Front Panel Components 1
12
13 - 16
17
18
2
3 19 - 21
4 22
5
6 23
24 - 25
7
8 26 - 30
9
10
11
31 32
Figure 1. Front panel components

1 Paddle 17 MIC
2 NIBP connector 18 Mode select knob
3 LCD 19 ANALYZE button
4 Temperature1 connector 20 CHARGE button
5 Temperature2 connector 21 Energy Level button
6 IBP1 connector 22 SHOCK button
7 IBP2 connector 23 Multi function knob
8 Soft key 24 RATE button
9 EtCO2 Connector 25 mA button
10 SpO2 connector 26 NIBP button
11 Printer door 27 PRINT button
12 Handle 28 ALARM button
13 AC/DC in LED 29 LEAD button
14 Battery A charging status LED 30 SIZE button
15 Battery B charging status LED 31 ECG connector
16 Service LED 32 Paddle/Pads connector
8
Table 1. The defibrillator/monitor controls on front panel
Symbols Description
Mode select knob

selects five modes of operation. (Pacing, Manual, Monitor, OFF
and AED)
ANALYZE button
analyzes the patient’s ECG to determine whether or not to
deliver a shock.
CHARGE button
charges to the desired energy level automatically.
Energy Level button

selects the defibrillation energy level.
SHOCK button
delivers a shock.
Multi function knob

provides user interaction with the defibrillator/monitor to control
the functions.
RATE button
adjusts the rate of pacing waveform.
mA button
adjusts the current of pacing waveform.
NIBP button
toggles between starting and stopping NIBP measurements.
PRINT button
prints measured data.
Alarm button
pauses the audible alarm temporarily.
turns off the audible alarm by pressing over 2 seconds.
LEAD button
selects to display the desired ECG lead on the screen.
SIZE button
adjusts and selects the amplitude of an ECG waveform.
9
Top Panel Components 1 2 3 4 5
Figure 2. Top panel components
1 Paddle 4 SHOCK button

2 Energy level button 5 CHARGE button
3 REC button
Table 2. The defibrillator/monitor controls on paddle

Symbols Description
CHARGE button
charges to the desired energy level automatically.
Energy Level button

selects the defibrillation energy level.
REC button
Prints the measured data.
10
Rear Panel Components
3 4 5 6 7
Figure 3. Rear panel components

1 SMPS/battery push button 5 AC power supply (SMPS)
2 DC input connector 6 Speaker
3 AC power inlet 7 Li-ion battery
4 GND terminal
11
Left Panel Components
1 Side Option Case

Figure 4. Left panel components
Right Panel Components
1 Wireless(3G, Wi-Fi) module

2 USB/SD Card Slot
Figure 5. Right panel components
12
Table 3. Panel and Label Symbols
Symbols Description Symbols Description
AC indicator Dust and water resistance
Direct current CE mark
Battery charging status

Prescription only device
indicator
Service indicator Follow instructions for use
Type BF- Defibrillator Proof Separate Collection
Type CF- Defibrillator Proof EU representative
NIBP connector Manufacturer
Temperature 1 connector Date of manufacture
Temperature 2 connector Reference number
IBP 1 connector Serial number
Environmental shipping/storage
IBP 2 connector
altitude limitations
EtCO2 connector
humidity limitations
SpO2 connector
temperature limitations
ECG connector Fragile
AC power input rating Keep dry
Equipotential terminal This way up
Class II equipment Do not reuse
13
14
Routine Maintenance
Do not spray or pour any liquid on the defibrillator/monitor or its
accessories. Do not immerse the defibrillator/monitor or its accessories
in liquid or clean with caustic or abrasive cleaners.
Cleaning
The defibrillator/monitor may be surface-cleaned by using a soft cloth dampened with
either a commercial, nonabrasive cleaner or one of the solutions listed below. Lightly
wipe the top, bottom and front surfaces of the defibrillator/monitor lightly.
 Quatemary Ammonium
 Alcohol-70% Isopropyl
 10% Chlorine bleach solution
 PDI Sani-System
For cables, sensors, cuffs, and probes, follow cleaning instructions in the directions for
use shipped with those components.
Avoid spilling liquid on the defibrillator/monitor, especially in connector areas. If liquid

is accidentally spilled on the defibrillator/monitor, clean and dry thoroughly before
reuse. If in doubt about defibrillator/monitor safety, refer the defibrillator/monitor to
qualified service personnel for checking.
Periodic Safety and Functional Checks

The following performance verification tests may be used following repair or during
routine maintenance (if required by your local institution). The following checks should
be performed at least every year by qualified service personnel.
1. Inspect the exterior of the defibrillator/monitor for damage.

2. Inspect labels for legibility. If the labels are not legible, contact Mediana Technical
Service Department.
3. If the defibrillator/monitor has been visibly damaged or subjected to mechanical
shock (for example, if dropped), perform the performance tests as described in
Performance Verification section. If the defibrillator/monitor fails these
performance tests, refer to Troubleshooting section.
4. Perform the electrical safety tests detailed in Performance Verification section. If
the defibrillator/monitor fails these electrical safety tests, do not attempt to repair.
Contact Mediana Technical Service Department.
5. Inspect the fuses for proper value and rating.
qty 2, 6.3 A, 250 volts for AC mains
15
Batteries
If the defibrillator/monitor has not been used for a long period of time, more than 6
months, the battery will need charging. To charge the battery, connect the
defibrillator/monitor to an AC outlet as described in the Battery Charge paragraph in
this service manual or the Battery Operation section of the operator’s manual.
Note: Storing the defibrillator/monitor for a long period without charging the battery
may degrade the battery capacity. The battery may require a full
charge/discharge cycle to restore normal capacity. Mediana recommends that
the defibrillator/monitor’s sealed, Li-ion batteries be replaced at 2 years intervals
(shelf-life of Li-ion battery is 2 years). Refer to the Disassembly Guide section.
Note: Due to the physical dimensions of the battery compartment, only batteries
supplied by Mediana should be used. Using other types of replacement
batteries may result in damage to the defibrillator/monitor and void the limited
warranty.
If the defibrillator/monitor is to be stored for a period of 2 months or

longer, it is recommended to notify service personnel to remove the
battery from the defibrillator/monitor prior to storage. To replace or
remove the battery, refer to Disassembly Guide section. Recharging the
battery is strongly recommended when the battery has not been
recharged for 6 or more months.
If the battery shows any signs of damage, leakage, or cracking, it must
be replaced immediately.
Discarded battery may explode during incineration. Recycle used
batteries properly. Do not dispose of batteries in refuse containers.
Environmental Protection
Follow local governing ordinances and recycling plans regarding disposal or recycling
batteries and other defibrillator/monitor components.
Note: The defibrillator/monitor should be disposed of separately from the municipal

waste stream via designated collection facilities appointed by the government or
the local authorities.
Note: The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.
Note: For more detailed information about disposal of your old appliance, please
contact your city office, waste disposal service or the shop where you
purchased the defibrillator/monitor.
16
Performance Verification
General
This section discusses the tests used to verify performance following repairs or during
routine maintenance. All tests can be performed without removing the
defibrillator/monitor covers. All tests except the battery charge and battery discharge
tests must be performed as the last operation before the defibrillator/monitor is
returned to the user.
If the defibrillator/monitor fails to perform as specified in any test, repairs must be
made to correct the problem before the defibrillator/monitor is returned to the user.
Required Equipment
Table 4 lists the equipment required for performance verifications.
Table 4. Required Equipment

Equipment Description
Digital multimeter (DMM) Fluke Model 87 or equivalent
Defibrillation pads Defibrillation pads for adult
Pads extension cable Pads extension cable
External paddle External paddle pediatric
Paddle plate (option) Paddle plate for adult
ECG cable for 3 leads(option) Mediana ECG cable for 3 lead
NIBP hose(option) Omron cuff hose No.3
Dummy can(option) Dummy can-large
SpO2 extension cable(option) Nellcor DOC-10
SpO2 sensor (durable) (option) Nellcor DS-100A
Mainstream CO2 sensor (option) Capnostat 5 mainstream CO2 sensor
Mainstream CO2 monitoring airway TruLink adult reusable airway adapter
adapter (option)
Sidestream CO2 sensor (option) LoFlo sidestream CO2 sensor
Sidestream CO2 airway adapter and TruLink adult/pediatric airway adapter and
sampling line (option) sampling line
Temperature probe(option) BD YSI-400 series
Defibrillator analyzer Fluke Impulse 7000DP
SpO2 simulator Nellcor SRC-MAX simulator
ECG simulator METRON PS-420 or equivalent
NIBP simulator Bio-Tek BP Pump 2 or equivalent
Respiration simulator METRON PS-420 or equivalent
Temperature simulator Medsim 300 or equivalent
IBP simulator METRON PS-420 or equivalent
IBP test cable Mediana IBP test cable
Safety analyzer METRON QA-90 or equivalent
Stopwatch Manual or electronic
Note: The sphygmomanometer must be calibrated periodically. The correct value can
not be found if the sphygmomanometer has not been calibrated.
Note: Contact Mediana Technical Service Department for pricing and ordering
information.
17
Performance Tests
The battery charge and battery discharge test should be performed before
defibrillator/monitor repairs whenever the battery is suspected as being a source of
problems. All other tests may be used following repairs or during routine maintenance
(if required by your local institution). Before performing the battery discharge test,
ensure that the battery is fully charged. This section is written using factory defaults
as power-up. Please refer to the Service Menu and Parameter default settings
section to set the factory defaults. If your institution has preconfigured custom defaults,
those values will be displayed.
Power
1. Connect the defibrillator/monitor to AC power source or DC power source using
proper power cord.
2. Verify that AC/DC in LED and Battery A charging status LED are lit.
3. Rotate the Mode select knob to monitor mode to turn on the defibrillator/monitor.
4. Verify that the defibrillator/monitor is turned on.
5. After the defibrillator/monitor operates in normal mode, disconnect the power cord.
6. Verify that Battery status icon at top of the screen indicates the residual quantity
of battery capacity instead of AC and battery status icon. Verify that AC/DC in
LED and Battery A charging status LED are off.
7. Rotate the Mode select knob to OFF, and then verify that the defibrillator/monitor
is turned off.
Battery Charge
1. Connect the defibrillator/monitor to AC power source or DC power source using a
proper power cord.
2. Verify AC/DC in LED is lit with green color and Battery A charging status LED is
lit with orange color.
4. Verify that the Battery status icon appears at top of the screen. The bar in battery
status icon should be filled, indicating that the battery is charged.
5. To check for a full charge, perform the procedure in paragraph “Battery Discharge”.
Note: The battery may require a complete charge/discharge cycle to restore its normal
capacity, depending on its previous usage.
Battery Discharge
1. Disconnect the power cord from the defibrillator/monitor with fully charge battery.
3. Verify that the Battery status icon appears at top of the screen. The bar in battery
status icon should be filled and displays ‘100%’, indicates that the battery is fully
charged.
4. Connect ECG lead cable to appropriate terminals on the ECG simulator and make
no alarm condition.
5. The defibrillator/monitor must operate for 5 hours with one fully charged battery.
The monitor must operate for at least 15 minutes after the alarm message “Low
18
Battery” appears before the monitor powers down due to the low battery condition.
6. Verify that low priority audible alarm occurs and a alarm message “Low battery” is
displayed about 15 minutes before battery fully discharges.
7. Allow defibrillator/monitor to operate until it automatically powers down due to low
battery condition. Verify that high priority audible alarm occurs and a alarm
message “SYSTEM: Critically Low-Battery condition” is displayed about 5
minutes before defibrillator/monitor automatically shuts down.
If defibrillator/monitor passes this test, immediately recharge battery. (paragraph
“Battery Charge”)
Manual Self-Test
1. Connect the defibrillator/monitor to an AC power source.
3. Press Setup soft key.
4. Rotate Multi function knob and select Manual Self Test menu.
5. Manual Self-Test is started as Figure 6. After finish the test, the result is printed out
automatically.
Figure 6. Manual Self-Test
High-voltage module alive test

Test if high voltage module operates in normal.
Body impedance test
Test if the body impedance circuit operates in normal.
ECG circuit and algorithm test
Test if ECG circuit and algorithm operate in normal.
Internal shock test
Test if the shock energy is discharged accurately as set. The test shock energy can
be set in Service menu.
Internal pacing output test
Test if the pacing function operates in normal.
19
Pads/paddle connection test
Test if the defibrillator/monitor detects the condition of pads/paddle connection.
System ROM test
Test if the ROM reads data in normal.
System RAM test
Test if the RAM reads and writes data in normal.
Real time clock test
Test if the RTC chip for real time data operates in normal.
Installed module alive test
Test if the modules which are installed on defibrillator/monitor operate in normal.
Battery test
Test if the defibrillator/monitor detects the condition of battery installation and
charging.
General Operation Tests

Alarms and Audio OFF
3. Connect SpO2 simulator to sensor input cable and connect cable to
defibrillator/monitor.
4. Set SpO2 simulator as follows: SpO2 of 75% and pulse rate of 60bpm.
5. Verify following the defibrillator/monitor reaction:
a. Pulse amplitude indicator begins to track artificial pulse signal from SpO2
simulator.
b. After about 10 to 20 seconds, the defibrillator/monitor displays saturation
and pulse rate as specified by simulator. Verify values are within following
tolerances:
 Tolerance of Oxygen Saturation : ±2 %
 Tolerance of Pulse Rate : ±3bpm
c. Audible alarm sounds and “Low SpO2 limits violated” message will be
displayed and % SpO2 numerical area will flash, indicating the parameter
has violated default alarm limits.
6. Press ALARM button on the defibrillator/monitor front panel and hold it for at least 2
seconds. Audible alarm is off for the specified time interval.
7. Verify the following:
a. An audible alarm remains off.
b. Audio off icon appears in %SpO2 numerical area on display.
c. The %SpO2 display continues flashing.
d. The audible alarm returns in specified time.
20
Alarm Volume Control
5. Verify SpO2 and pulse rate values are correctly displayed.
6. Verify the audible alarm sounds.
7. Press Setup soft key and the setup menu will be displayed.
8. Rotate the Multi function knob to highlight Volume and then press the knob to
select Volume menu.
9. Rotate the Multi function knob to select Alarm menu, and if the Alarm menu is
highlighted, press Multi function knob.
10. Speaker icon is activated.
11. Rotate the Multi function knob to adjust the volume level from 1 to 8.
12. Press the Multi function knob to save the desired volume.
13. Press Return soft key. Verify the alarm sound is increased.
14. Set the alarm volume level from 8 to 1.
15. Verify the alarm sound is decreased.
Beep Volume Control

5. Verify SpO2 and pulse rate values are correctly displayed.
6. Verify the beep sounds.
7. Press Setup soft key and the setup menu will be displayed.
select Volume menu.
9. Press soft key to select Setup menu on the screen to display Setup menu.
10. Rotate the Multi function knob to select Beep menu, and if the Beep menu is
21
14. Press Return soft key. Verify the beep sound is increased.
15. Set the beep volume level from 7 to 0.
16. Verify the alarm sound is decreased.
Button Volume Control

3. Select the Setup menu by pressing the soft key and the setup menu will be
displayed.
select Volume menu.
5. Rotate the Multi function knob to select Button menu, and if the Button menu is
9. Press Return soft key. Verify the button sound is increased.
10. Set the button volume level from 7 to 0.
11. Verify the button sound is decreased.
Charging Alarm Volume Control

displayed.
select Volume menu.
5. Rotate the Multi function knob to select Charging alarm menu, and if the
Charging alarm menu is highlighted, press Multi function knob.
9. Press Return soft key. Verify the charging alarm sound is increased.
10. Set the charging alarm volume level from 8 to 1.
11. Verify the charging alarm sound is decreased.
22
Voice Prompt Volume Control
displayed.
select Volume menu.
5. Rotate the Multi function knob to select Voice prompt menu, and if the Voice
prompt menu is highlighted, press Multi function knob.
9. Press Return soft key. Verify the voice prompt sound is increased.
10. Set the voice prompt volume level from 8 to 1.
11. Verify the voice prompt sound is decreased.
CPR Metronome Volume Control

displayed.
select Volume menu.
5. Rotate the Multi function knob to select CPR Metronome menu, and if the
Button menu is highlighted, press Multi function knob.
9. Press Return soft key. Verify the CPR Metronome sound is increased.
10. Set the CPR Metronome volume level from 7 to 0.
11. Verify the CPR Metronome sound is decreased.
Pacing Alarm Volume Control

displayed.
23
select Volume menu.
5. Rotate the Multi function knob to select Pacing alarm menu, and if the Button
menu is highlighted, press Multi function knob.
9. Press Return soft key. Verify the Pacing alarm sound is increased.
10. Set the Pacing alarm volume level from 7 to 0.
11. Verify the Pacing alarm sound is decreased.
Sensor LED Excitation Test

This procedure uses normal system components to test circuit operation. An SpO2
sensor, DS-100A, used to examine LED intensity control. The red LED is used to
verify intensity modulation caused by the LED intensity control circuit.

3. Connect the SpO2 extension cable to the defibrillator/monitor.
4. Connect SpO2 sensor to the SpO2 extension cable.
5. Leave the sensor open with the LEDs and photo detector visible.
6. After defibrillator/monitor completes its normal power-up sequence, verify that the
sensor LED is brightly lit.
7. Slowly move sensor LED in proximity of photo detector element of the sensor (close
the sensor slowly). Verify as LED approaches the optical sensor, that the LED
intensity decreases.
8. Open the sensor and notice that the LED intensity increases.
9. Repeat step 7 and intensity will again decrease. This variation is an indication that
the microprocessor is in proper control of LED intensity.
10. Rotate the Mode select knob to OFF to turn off the defibrillator/monitor.
24
Restoring Power-On Default Settings
The following test procedures will verify that alarms are activated at the level of factory
default alarm limits and that any changed settings are saved and in effect when the
user changes alarm limit settings in Service menu.
Figure 7. Parameter Default Setting

3. Press Setup soft key then select Service menu using Multi function knob.
4. Press the Multi function knob to enter Pass code. Rotate the Multi function knob
until “0” appears, then press the Multi function knob.
5. Repeat step 3 to enter all the pass code “0” “0” “0”.
6. Press NEXT soft key until Parameter default setting menu is displayed as shown
in Figure 7.
7. Change various default settings including alarm limits. The factory default settings
are shown in Table 22. Parameter ranges and factory defaults.
8. Press SAVE soft key and select Yes when save settings confirmation window is
displayed.
9. Turn off the defibrillator/monitor then turn on the defibrillator/monitor again.
10. Verify the settings are changed.
Printer Test
The following test procedures will verify the printer performance.

3. Connect all necessary simulators to the defibrillator/monitor.
4. Access to the Service menu via Setup menu (for details to access Service menu,
refer to Service Menu and Parameter Default Settings section in this manual).
5. Press NEXT soft key until Printer Setting screen is displayed.
25
6. Set Print on alarm, Print on charge, Print on shock, Print on mark, Print on BP,
Print on self-test, 12 lead auto printing and Analyze auto printing to On.
7. Press SAVE soft key then select Yes to save the setting.
8. Turn off the defibrillator/monitor.
10. Press the Setup soft key. (Setup is displayed on the initial screen of each mode.)
11. Rotate the Multi function knob to highlight Printer setting via Setup Menu, and
then press the Multi function knob to select Printer setting.
12. Set 12 lead auto printing and Analyze auto printing to On.
13. Test #1: Print on alarm
a. Set SpO2 simulator as follows: SpO2 of 75% and pulse rate of 60bpm.
b. Verify that the audible alarm sounds.
c. Verify that the defibrillator/monitor automatically prints out information
before and after 10 seconds when a physiological alarm condition is
activated.
14. Test #2: Print on charge
a. Press the Energy Level button and rotate the Multi function knob to
choose energy level as 100J.
b. Press the CHARGE button to charge the energy.
c. Verify that the defibrillator/monitor automatically prints out information
before and after 10 seconds when shock energy is charged.
Note: Do not press the SHOCK button during the test. The charged energy will be
automatically discharged after 60 seconds.
15. Test #3: Print on mark
a. Press the Setup soft key.
b. Rotate the Multi function knob to highlight Clinical action list and then
press the Multi function knob to select Clinical action list.
c. Select the first clinical action.
d. Verify that the defibrillator/monitor automatically prints out the first clinical
action.
16. Test #4: Print on BP
a. Ensure the defibrillator/monitor is set up with dummy can-large.
b. Press NIBP button to start measuring NIBP value.
c. Verify that the defibrillator/monitor automatically prints out the result of
NIBP measurement.
17. Test #5: Print on self-test
a. Press the Setup soft key.
b. Rotate the Mode select knob to highlight Manual self-test and then press
the Multi function knob to start Manual self-test.
c. Verify that the defibrillator/monitor automatically prints out the result of
manual self-test.
26
18. Test #6: 12 lead auto printing
a. Connect ECG 12 lead cable to the defibrillator/monitor.
b. Connect the ECG 12 lead cable to appropriate terminals on the ECG
simulator.
c. Press 12 Lead soft key and then press Acquire soft key.
d. Verify that the defibrillator/monitor automatically prints out the analysis
result of acquired 12 lead ECG waveform data.
19. Test #7: Analyze auto printing
a. Ensure the ECG lead cable is set up with simulator and the waveform is
displayed in normal.
b. Press ANALYZE button.
c. Verify that the defibrillator/monitor automatically prints out the analyzing
data for 10 seconds after a rhythm analysis is done.
Real-time Printer Test

The following test procedures will verify the printer performance.

2. Rotate the Mode select knob to manual mode to turn on the defibrillator/monitor.
3. Access to the Patient Info menu via manual mode.
4. Press the NEXT soft key until Real-time data is highlighted.
5. Press the Print button.
6. Verify that the defibrillator/monitor automatically prints out the list of recording the
real-time data.
27
Defibrillator Operation Tests
Pacing mode
2. Turn on the analyzer and press pacer button.
3. Set the analyzer as follows:
 Brand: Default algorithm
 Load: 50Ω
4. Connect pads connector to defibrillator/monitor’s front panel.

5. Contact pads to the defibrillator analyzer’s adapter plates.
6. Rotate the Mode select knob to pacing mode to turn on the defibrillator/monitor.
7. Press the Pacing soft key to operate the Pacing mode.
8. Press RATE button and rotate Multi function knob to set pulse rate as 70 bpm.
9. Press mA button and rotate Multi function knob to set the output current value as
70 mA.
10. Verify that the analyzer displays pacing rate of 70bpm±1.5% and the output
current value of 70mA ±5% or ±5mA which ever greater.
Note: The accuracy of the defibrillator/monitor pacing rate is ±1.5% and output current
is ±5% or ±5mA, whichever greater. In the procedure, add the tolerance of the
simulator to the acceptable range of readings.
AED mode
2. Turn on the analyzer and press defibrillator button.
 Load: 50Ω
4. Press F1 button 3 times to enter to the waveform selection mode in the analyzer
and select VFib waveform.
5. Check the ECG waveform type is set as coarse in the analyzer then press F5
button to select Done.
6. Check the analyzer is set to ready.
7. Connect pads connector to defibrillator/monitor’s front panel.
8. Contact pads to the defibrillator analyzer’s adapter plates.
9. Rotate the Mode select knob to AED mode to turn on the defibrillator/monitor.
10. Defibrillator/monitor automatically starts the AED step with audio guidance and
STEP icon. When the audio guidance said “Press the SHOCK button now.”, press
SHOCK button on the defibrillator/monitor’s front panel. Delivered shock energy is
125J for the first shock.
11. Verify that the analyzer displays the delivered shock energy of 125J±15%.
Note: The accuracy of the defibrillator/monitor shock energy is ±15% when the load is
set to 50 Ω.
28
Manual mode
2. Turn on the analyzer and press defibrillator button.
 Load: 50Ω
4. Press F1 button 3 times to enter to the waveform selection mode in the analyzer
and select VFib waveform.
5. Check the ECG waveform type is set as coarse in the analyzer then press F5
button to select Done.
6. Check the analyzer is set to ready.
7. Connect paddles connector to defibrillator/monitor’s front panel.
8. Contact paddles to the defibrillator analyzer’s adapter plates.
9. Rotate the Mode select knob to Manual mode to turn on the defibrillator/monitor.
10. Press the Energy Level button to select the energy setting. Rotate the Multi
function knob to set energy level as 125J.
11. Press SHOCK button on the defibrillator/monitor’s front panel.
12. Verify that the analyzer displays the delivered shock energy of 125J±15%.
Note: The accuracy of the defibrillator/monitor shock energy is ±15% when the load is
set to 50 Ω.
External shock test

User must verify the ability to deliver defibrillation energy once a week.
1. Make sure the paddles and the paddle tray are thoroughly clean and there is no
residue including the conductive material on electrode surface of the paddle and
paddle tray.
2. Connect paddles to the paddle connector.
3. Place the paddles on the paddle tray.
4. Turn on the defibrillator/monitor.
5. Select the defibrillation energy by pressing the Energy level button on paddle.
6. Charge the selected energy to pressing the Charge button on paddle.
7. Press the SHOCK button on paddle.
8. Confirm the energy level on the display.
29
Measurement Parameter Operation Tests
ECG Operation
3. Connect the ECG 3 lead cable to appropriate terminals on the ECG simulator.
4. Connect the ECG cable to ECG connector on the defibrillator/monitor’s front panel.
5. Set ECG simulator as follows:
 Heart rate: 30 bpm
 Amplitude: 1 mV
 Lead select: II
 Normal sinus rhythm
6. After normal power-up sequence, verify the following defibrillator/monitor reactions:

a. After about 15 seconds, the defibrillator/monitor displays a heart rate of 30
±5 bpm.
b. Verify that the audible alarm sounds and that “Low Heart Rate/Pulse Rate
limits violated” message displays on the message area.
c. Verify that the HR/PR numerical area flashes and that the heart rate is
below default low alarm limit (medium priority alarm).
7. Increase the heart rate setting on ECG simulator to 240 bpm.
a. After about 15 seconds, verify that the defibrillator/monitor displays heart
rate of 240 ±5 bpm.
b. Verify that audible alarm sounds and that “High Heart Rate/Pulse Rate
limits violated” message displays on the message area.
c. Verify that the HR/PR numerical area flashes and that the heart rate is
above default high alarm limit (medium priority alarm).
8. Decrease the heart rate setting on ECG simulator to 100 bpm.
a. After about 15 seconds, verify the defibrillator/monitor displays heart rate of
100 ±5 bpm.
9. Disconnect the LL lead from ECG simulator.
a. Verify that the “ECG Leads Off” message appears and low priority audible
alarm sounds.
b. Reconnect the LL lead to ECG simulator. Verify that “ECG Leads Off”
message no longer appears and that the audible alarm is stopped.
c. Repeat this test for the LA and the RA leads.
10. Connect all the leads to the defibrillator/monitor.
a. Press Setup soft key.
b. Rotate Multi function knob to select Waveform setting.
c. Set 2nd waveform to Lead I.
d. Verify that the selected lead waveform is displayed on the 2nd waveform
area.
e. Repeat this step for all the ECG Lead selections.
30
11. Set ECG Lead selection to Lead II.
12. Change ECG waveform size to all the selectable sizes and verify that an
appropriate size is displayed on the ECG waveform area.
13. Disconnect 3 ECG leads and connect 5 ECG leads.
14. Verify that Waveform Setting menu displays I, II, III, aVR, aVL, aVF, V.
15. Repeat step 9 to 12.
16. Disconnect 5 ECG leads and connect 12 ECG leads.
17. Verify that Waveform Setting menu displays I, II, III, aVR, aVL, aVF, V, V1, V2,
V3, V4, V5, V6.
18. Repeat step 9 to 12.
Note: The accuracy of the defibrillator/monitor ECG measurements is ±5 bpm. In the

procedure, add the tolerance of the simulator to the acceptable range of
readings.
NIBP Operation
A blood pressure cuff, connected to the defibrillator/monitor, should

never be applied to a human subject while the defibrillator/monitor is in
the pressure test mode, as injury could result.
These tests verify the functionality of the defibrillator/monitor pneumatic system. The
Bio-Tek simulator or any equivalent NIBP simulator is required to perform these tests.
Each of the tests must be performed to verify pneumatic system functionality.
Over-Pressure Test
1. Connect the cuff hose for adult to the NIBP connector on the defibrillator/monitor’s
front panel.
2. Connect the other end of the cuff hose to the NIBP simulator.
3. Set the NIBP simulator to Pressure Relief or Over-pressure Test mode.
4. Press the Start Test Button on the NIBP simulator. The simulator will pressurize the
system until the monitor’s over pressure relief system activates.
Verify that the peak point displayed on the NIBP simulator (point of protection
pressure) is within 330mmHg. Also, this point of protection pressure may be verified at
the moment of the monitor’s NIBP relief system activation.
These tests verify the functionality of the defibrillator/monitor’s pneumatic system. The
defibrillator/monitor must be placed in Service menu. For a detailed explanation to
access the service menu, refer to Service Menu and Parameter Default Settings
section.
1. Rotate the Multi function knob to select NIBP test mode in the service menu, and
then press the Multi function knob.
Note: Before accessing the NIBP test mode, ensure that current patient mode is
proper for the pneumatic system to be test. You can set patient mode:
Adult/Pediatric or Neonatal via the Setup menu.
31
Note: In the NIBP test mode, function buttons will have no effect except the Multi
function knob. All the tests will start to be performed by pressing or rotating the
Multi function knob. If you would like to stop the test during test progressing,
press the Multi function knob.
Note: Inflation time measurement and Deflation Rate Measurement are intended
for factory use only.
Pressure Sensor Accuracy Test
Figure 8. Pressure Sensor Accuracy Test
1. Connect the NIBP cuff hose to the NIBP connector on the defibrillator/monitor’s
front panel.
2. Connect the other end of the NIBP cuff hose to the NIBP simulator.
3. Rotate the Multi function knob to select NIBP test mode in the Service menu,
and then press the Multi function knob.
4. Rotate the Multi function knob to select Pressure Sensor Accuracy Test, and
then press the Multi function knob.
5. Press Select button on the simulator until simulator displays “Pressure Source
Set Test Pressure”. Adjust pressure on the simulator for 250, 150, 50 and 0
mmHg.
6. Press Start Pump button on simulator. The simulator will begin to pressurize.
Allow 15~20 seconds for pressure to stabilize.
7. Press Multi function knob on defibrillator/monitor to select Start.
The current pressure in mmHg will be displayed on both of the simulator and the
monitor displays. Ensure the monitor pressure sensor accuracy meets the
performance standard of ANSI/AAMI SP-10:2002+A1:2003 +A2:2006 (within the
specification by more than ±10 mmHg in Adult/Pediatric patient mode) to
successfully complete the test.
8. After finishing the test, press the Multi function knob to select Return. The
menu box will disappear. If Return is selected during the test progressing, the
test will stop and the menu box will disappear.
32
Air Leakage Test
The air leakage test verifies the integrity of the pneumatic system.
Figure 9. Air Leakage Test
1. Ensure the defibrillator/monitor is set up with dummy can-large.

2. Connect the cuff to the NIBP connector on the defibrillator/monitor’s front panel
via NIBP cuff hose.
3. Rotate the Multi function knob to select NIBP test mode in the service menu,
and then press the Multi function knob.
4. Rotate the Multi function knob to select Air leakage test, and then press the
Multi function knob.
5. Press Multi function knob to select Start.
6. The defibrillator/monitor displays the pressure of approximately 290 mmHg
automatically.
7. The test result displays at the test completion. The initial pressure value at 1
minute is displayed after the test start and the air leakage value at further 3
minutes after the 1 minute elapsed.
8. After finishing the test, press the Multi function knob to select Return. The
menu box will disappear. If Return is selected during the test progressing, the
test will stop and the menu box will disappear.
Note: The test will have been successfully completed if the pressure has dropped by
6 mmHg, or less, during the 1-minute period.
33
Inflation time measurement
Figure 10. Inflation Time Measurement
1. Ensure the defibrillator/monitor is set up with the dummy can-large.

2. Ensure NIBP Test screen is active on the defibrillator/monitor, then select Inflation
time measurement menu using Multi function knob.
automatically and measures the inflation time in seconds.
5. The test result displays at the test completion.
34
Deflation rate measurement
Figure 11. Deflation Rate Measurement
1. Ensure the defibrillator/monitor is set up with the dummy can-small.

2. Ensure NIBP Test screen is active on the defibrillator/monitor, then select
Deflation rate measurement menu using Multi function knob.
automatically, then measures the deflation rate during reducing the pressure.
5. The test result displays at the test completion.
Pulse Oximetry Operation

3. Connect the SpO2 extension cable to SpO2 connector on the defibrillator/monitor’s
front panel.
4. Connect the SpO2 simulator to the other end of the SpO2 extension cable.
5. Test #1: SpO2
a. Press % SpO2 selection button on the SpO2 simulator. The % SpO2 90
LED will light.
b. The defibrillator/monitor will display three dashes until the SpO2
simulator stabilizes at 90 % SpO2. The test pass criterion is 88 to 92 %
SpO2.
c. The defibrillator/monitor will display: - 90 % SpO2
- 60 bpm
- no alarm
6. Test #2: Pulse rate (bpm)
a. Press PULSE RATE selection button on the SpO2 simulator. The
PULSE RATE 200 LED will light:
b. The defibrillator/monitor will increase to 200 bpm. The test pass
35
criterion is 197 to 203 bpm.
c. The defibrillator/monitor will display:
- 90 % SpO2
- 200 bpm
- alarm: “High Heart Rate/Pulse Rate limits violated” message will
display and the HR/PR area will flash, indicating pulse rate is above
default high alarm limit (medium priority alarm).
d. Press PULSE RATE selection button on the SpO2 simulator. The
PULSE RATE 60 LED will light.
e. The defibrillator/monitor will decrease to 60 and stabilize at 60bpm.
The test pass criterion is 57 to 63 bpm.
f. The defibrillator/monitor will display:
- 90 % SpO2
- 60 bpm
- no alarm
- low level modulation
7. Test #3: Modulation Level
a. Press %MODULATION selection button on the SpO2 simulator.
The %MODULATION LED will light.
b. The defibrillator/monitor’s waveform area will spike and stabilizes at a
higher modulation level.
c. The defibrillator/monitor will display:
- 90 % SpO2
- 60 bpm
- no alarm
d. Disconnect all equipments and turn off the defibrillator/monitor.
Respiration Operation
3. Connect ECG lead cable to an appropriate terminal on the respiration simulator.
4. Connect the ECG cable to the ECG connector on the defibrillator/monitor’ front
panel.
5. Set the respiration simulator lead selection to lead I.
6. Set the respiration simulator to 120 breaths per minute.
7. After the normal power-up sequence, verify the following reactions:
a. The defibrillator/monitor displays respiration rate of 120 ±1 breaths per
minute.
b. Audible alarm will sound, “High Respiration Rate limits violated”
message will display and the Respiration numerical area will flash,
indicating a respiration rate is above default high alarm limits. (medium
priority alarm)
8. Decrease the respiration rate setting on Respiration simulator to 20 breaths per
minute.
a. Verify that the defibrillator/monitor displays the respiration rate of 20 ±1
36
breaths per minute.
Note: The accuracy of Respiration rate measurements is ±1 breaths per minute. In the
procedure above, add the tolerance of the simulator to the acceptable range of
readings.
Note: The respiration measure function does not operate if pads or paddles are
connected to the defibrillator/monitor. Verify the pads or the paddles are not
connected to the defibrillator/monitor before operates respiration measurement.
Temperature Operation
3. Connect the temperature probe (supplied with the temperature simulator) to an
appropriate terminal on the temperature simulator.
4. Connect the temperature probes to the temperature connector 1 and 2 on the
defibrillator/monitor’s front panel.
5. Set Temperature simulator as follows:
 Temperature: 37°C (98.0°F)
 Probe type: YSI-400 series Temperature Probes (Probe accuracy: ±0.1°C)
6. After the normal power-up sequence, verify that the temperature reads 37°C ±0.1°C
(98.6°F ±0.2°F if Fahrenheit is selected for the temperature units).
Note: The accuracy of temperature measurements is ±0.1°C (±0.2°F). In the

procedure above, add the tolerance of the simulator and the probe to the
acceptable range of readings.
IBP Operation
3. Connect the IBP test cable to the IBP simulator, then turn on the IBP simulator.
4. Press 6, zero button on the IBP simulator, then press Enter button on the IBP
simulator.
5. Connect the other end of IBP test cables to IBP channel 1 and 2 connectors on the
6. The defibrillator/monitor will display IBP waveform’s baseline on the screen.
7. Rotate the Multi function knob to select IBP numeric area, then press Zero
setting soft key and press Enter soft key to perform the zero calibration.
8. If zero calibration is successful, the defibrillator/monitor will display the value “0” on
the IBP numerical area.
9. Press the 5, wave button on the IBP simulator, and then press Enter button on the
IBP simulator.
10. The defibrillator/monitor will:
‐ display IBP waveform on the screen.
37
‐ display systolic, mean, diastolic measurement values on the IBP numerical area.
Note: Initial values of IBP simulator are systolic 120mmHg, diastolic 80mmHg at
channel 1, systolic 120mmHg, diastolic 0mmHg at channel 2.
Capnography Operation
Note: The recommended Capnostat5 CO2 sensor should be compared against
calibration gas every 6 months. Check the calibration status before the test.
Note: The airway adapter zero is required when changing to a different style of airway
adapter.

3. Test #1: Display Accuracy
 For Mainstream
a. Connect the mainstream CO2 sensor into the CO2 connector on the
b. Place a mainstream CO2 airway adapter into the transducer head.
c. Verify that the “CO2 – Sensor Warming-up” message displays and wait
until the message clears.
d. Breathe through the CO2 airway adapter for five slow breaths. Verify that
the waveform displayed rises and falls accordingly.
e. Connect a gas cylinder containing 10% CO2 to a flow meter and then to
the CO2 airway adapter.
f. Turn the gas ON and verify that the flow through the airway adapter is 200
to 300ml/min.
g. Allow the reading to stabilize for 15 seconds.
h. Verify that the defibrillator/monitor displays 76 ± 2 mmHg (10 ± 0.2%) in
CO2 numerical area.
 For Sidestream
a. Connect the sidestream sampling line to the inlet port located on the metal
container on the front of the CO2 module. You will hear a click when
properly inserted.
b. A “CO2 – Sensor Warming-up” message displays for up to 2 minutes,
depending on the temperature of the environment, the temperature of the
module, and the temperature of the sensor.
c. Breathe through the CO2 airway adapter for five slow breaths. Verify that
the displayed waveform rises and falls accordingly.
d. Connect a gas cylinder containing 10% CO2 to a flow meter and then to
the CO2 airway adapter.
e. Turn the gas On and verify that the flow through the airway adapter is 200
to 300 ml/min.
f. Allow the reading to stabilize for 15 seconds.
g. Verify that the defibrillator/monitor displays 76 ± 2 mmHg (10 ± 0.2%) in
CO2 numerical area.
38
4. Test #2: Flow Rate Accuracy
a. Connect the Sidestream CO2 module into the CO2 connector on the
defibrillator/monitor’ front panel.
b. Attach the sidestream sampling lime to the inlet port located on the metal
container on the front of the CO2 module. You will hear a click when
properly inserted.
c. Connect the calibrated flow meter to the exhaust port of the module after
the defibrillator/monitor is warmed up and all messages have cleared.
d. Verify that the flow rate is 50 ml/min ± 10ml. If the measured flow rate is
outside the specified limits, remove the CO2 module form use and contact
a Mediana Technical Service Department.
5. Test #3: Occlusion
a. Block the exhaust port while the sidestream CO2 sensor module is running.
b. Verify that the “CO2 – Occlusion or leak” message displays.
Safety Tests
The defibrillator/monitor safety tests meet the standards of, and are performed in
accordance with, IEC 60601-1, Clause 19 (Second Edition, 1988; Amendment 1,
1991-11, Amendment 2, 1995-03), EN60601-1 for instruments classified as Class I for
AC mains and Class II for DC mains and Type BF and Type CF of applied part.
Protective Earth Continuity
This test checks the integrity of the power cord ground wire from the AC plug to the
instrument chassis ground. The current used for this test is less than or equal to 4 Volt
RMS, 50 to 60 Hz, and 25 Amperes.
1. Connect the defibrillator/monitor AC mains plug to the analyzer recommended by

the analyzer operating instructions.
2. Connect the analyzer resistance input lead to the equipotential terminal (ground
lug) on the rear of the instrument. Verify that the analyzer indicates 100 mΩ or less.
Electrical Leakage
Earth Leakage Current

This test is in compliance with IEC60601-1 earth leakage current. The applied voltage
for IEC60601-1 the voltage is 264 Volts AC, 50 to 60 Hz. All measurements shall be
made with the power switch in both “On” and “Off” positions.
1. Connect the defibrillator/monitor AC plug to the electrical safety analyzer as

recommended by the analyzer operating instructions.
2. Perform the test as recommended by analyzer operating instructions.
Table 5. Earth Leakage Current Values

Test Condition Allowable Leakage Current (µA)
Normal Condition (NC) 500
SFC Open Supply (SFC OS) 1000
Normal Condition RM (NCRM) 500
SFC Open Supply RM (SFC OSRM) 1000
39
SFC: Single Fault Condition / RM: Reverse Mains/Lines Voltage
Note: Earth leakage current is measured under various conditions of the AC mains
and protective earth conductor. For each condition, the measured leakage
current must not exceed that indicated in Table 5.
Enclosure Leakage Current

This test is in compliance with IEC60601-1 enclosure leakage current. This test is for
ungrounded enclosure current, measured between enclosure parts and earth. The
applied voltage for IEC60601-1 the applied voltage is 264 Volts AC at 50 to 60 Hz.
1. Connect the defibrillator/monitor AC plug to the electrical safety analyzer as

2. Place a 200cm2 foil in contact with the instrument case making sure the foil is not in
contact with any metal parts of the enclosure that may be grounded.
3. Measure the leakage current between the foil and earth.
Note: The analyzer leakage current indication must not exceed the values listed in Table
6. Enclosure Leakage Current Values.
Table 6. Enclosure Leakage Current Values

Test Condition Allowable Leakage Current (µA)
Normal Condition (NC) 100
SFC Open Supply (OS) 500
SFC Open Earth (SFC OE) 500
Normal Condition RM (NCRM) 100
SFC Open Supply RM (SFC OSRM) 500
SFC Open Earth RM (SFC OERM) 500
Patient Leakage Current
This test measures patient leakage current in accordance with IEC60601-1, clause 19,
for Class I, type BF and type CF equipment. Patient leakage current in this test is
measured from any individual patient connection to earth (power ground).
1. Configure the electrical safety analyzer as recommended by the analyzer operating

instructions.
2. Connect the defibrillator/monitor’s AC mains power cord to the analyzer as
3. Connect the ECG test cable between the ECG connector on the defibrillator/monitor
and the appropriate input connector on the analyzer.
5. Perform the patient leakage current test as recommended by the analyzer operating
instructions.
6. Repeat the patient leakage current test for the SpO2, temperature, EtCO2, NIBP,
IBP patient connections and paddle, using the appropriate test cables.
Note: Patient leakage current is measured under various conditions of the AC mains
and protective earth conductor. For each condition, the measured leakage
current must not exceed that indicated in Table 7.
40
Note: This test requires a test cable for each patient connector. For example, the
ECG test cable consists of the ECG cable connector, with all conductors
shorted together, connected to a test lead from the electrical safety analyzer.
Test cables for SpO2 and temperature can be configured in a similar manner,
by wrapping each sensor end individually with aluminum foil filled with
conductive gel (only enough gel to ensure conductivity). Attach a wire to the foil
that is connected to a test lead from the electrical safety analyzer.
Table 7. Patient Leakage Current Values

Allowable Leakage Current (microamps)
Test Condition
Type BF Type CF
Normal Condition (NC) 100 10
SFC Open Supply (OS) 500 50
SFC Open Earth (SFC OE) 500 50
Normal Condition RM (NCRM) 100 10
SFC Open Supply RM (SFC OSRM) 500 50
SRC Open Earth RM (SFC OERM) 500 50
Patient Leakage Current - Mains Voltage on the Applied Part
AC mains voltage will be present on the applied part terminals during

this test. Exercise caution to avoid electrical shock hazard.
Do not touch the patient leads clips or the simulator parts connected to
patient leads during this test as an electrical shock will occur.
This test measures patient leakage current in accordance with IEC60601-1, clause 19,
for Class I, type BF and type CF equipment. In this test, 110% of mains voltage is
applied between each patient connection and earth (power ground). Patient leakage
current is then measured from any individual patient connection to earth.
Note: Keep the patient test cable length as short as possible during the leakage test.
Note: This test requires the same test cables for each patient connector as described
in paragraph “Patient Leakage Current”.
1. Configure electrical safety analyzer as recommended by analyzer operating

instructions.
2. Connect defibrillator/monitor’s AC mains power cord to analyzer as recommended
by analyzer operating instructions.
3. Connect ECG test cable between ECG connector on the defibrillator/monitor and
appropriate input connector on analyzer.
5. Perform the test as recommended by analyzer operating instructions.
6. Repeat the test for SpO2, temperature, EtCO2, NIBP, IBP patient connections and
paddle, using appropriate test cables.
Note: Patient leakage current is measured with normal and reverse mains polarity.
For each condition, the measured leakage current must not exceed that
indicated in Table 8.
41
Table 8. Patient Leakage Current Values - Mains Voltage on Applied Part
Test Condition
Type BF Type CF
Normal polarity (SFC) 5000 50
Reverse polarity (SFCRM) 5000 50
Patient Auxiliary Current
This test measures patient auxiliary current in accordance with IEC60601-1, clause 19,
for Class I, type BF and type CF equipment. The applied voltage for IEC60601-1 the
voltage is 264 volts, 50 to 60 Hz. Patient auxiliary current is measured between each
ECG test lead and between each sensor connection for all possible connections.
Note: Keep the patient test cable length as short as possible during the leakage test.
Note: This test requires the same test cables for each patient connector as described
in paragraph “Patient Leakage Current”.
1. Configure the electrical safety analyzer as recommended by the electrical

analyzer’s operating instructions.
2. Connect the defibrillator/monitor’s AC mains power cord to the electrical analyzer
as recommended by the electrical analyzer’s operating instructions.
3. Connect the patient test lead combination in Table 9 to the appropriate input
connector on the electrical analyzer.
5. Perform patient auxiliary current test per as Table 10 recommended by electrical
analyzer’s operating instructions.
6. Repeat the patient auxiliary current test for each test lead combination as listed in
Table 10 and measure each patient auxiliary current.
Table 9. Test Lead Combinations

First Test Lead Second Test Lead
SpO2, temperature, EtCO2, NIBP, IBP
ECG
and paddle
SpO2, ECG, EtCO2, NIBP, IBP and
Temperature
paddle
ECG, temperature, EtCO2, NIBP, IBP
SpO2
and paddle
SpO2, temperature, ECG, NIBP, IBP and
EtCo2
paddle
SpO2, temperature, EtCO2, NIBP, ECG
IBP
and paddle
SpO2, temperature, EtCO2, ECG, IBP
NIBP
and paddle
SpO2, temperature, EtCO2, NIBP, IBP
Paddle
and ECG
42
Table 10. Allowable Leakage Current
Test Condition
Type BF Type CF
Normal Condition (NC) 100 10
SFC Open Supply (OS) 500 50
SFC Open Earth (SFC OE) 500 50
Normal Condition RM (NCRM) 100 10
SFC Open Supply RM (SFC OSRM) 500 50
SRC Open Earth RM (SFC OERM) 500 50
43
Verification Check Sheet
Record the results of the performance verification on this sheet.

Model Serial Software
Date Tester
Name No. Version
ITEMS RESULTS REMARKS

PERFORMANCE TEST
Power Pass / Fail
Battery charge Pass / Fail
Battery discharge Pass / Fail
Manual self-test
-High-voltage module alive test Pass / Fail
-Body impedance test Pass / Fail
-ECG circuit and algorithm test Pass / Fail
-Internal shock test Pass / Fail
-Internal pacing output test Pass / Fail
-Pads/paddle connection test Pass / Fail
-System ROM test Pass / Fail
-System RAM test Pass / Fail
-Real time clock test Pass / Fail
-Installed module alive test Pass / Fail
-Battery test Pass / Fail
Alarms and audio off Pass / Fail
Alarm volume control Pass / Fail
Beep volume control Pass / Fail
Button volume control Pass / Fail
Charging alarm volume control Pass / Fail
Voice prompt volume control Pass / Fail
CPR metronome volume control Pass / Fail
Pacing alarm volume control Pass / Fail
Sensor LED excitation test Pass / Fail
Restoring power-on default settings Pass / Fail
Printer test Pass / Fail
Real-time printer test Pass / Fail
Pacing mode
-Pacing rate Pass / Fail Value: bpm
-Output current Pass / Fail Value: mA
AED mode Pass / Fail Value: J
Manual mode Pass / Fail Value: J
External shock test Pass / Fail Value: J
ECG operation
-30 ± 5bpm(High priority alarm condition) Pass / Fail Value: bpm
-240 ± 5bpm(High priority alarm condition) Pass / Fail Value: bpm
-100 ± 5bpm(Normal condition) Pass / Fail Value: bpm
-ECG leadoff(LL) for 3 leads Pass / Fail
-ECG leadoff(LA) for 3 leads Pass / Fail
-ECG leadoff(RA) for 3 leads Pass / Fail
-Lead selection for 3 leads Pass / Fail
-Change ECG waveform size Pass / Fail
NIBP operation
-Over pressure test(within 330mmHg) Pass / Fail Value: mmHg
-Pressure sensor accuracy test (250mmHg) Pass / Fail Value: mmHg
-Air leakage test Pass / Fail Value: mmHg
-Inflation time measurement Pass / Fail
44
ITEMS RESULTS REMARKS
PERFORMANCE TEST
-Deflation rate measurement Pass / Fail
Pulse Oximetry operation
- SpO2 90 ± 2% Pass / Fail Value: %
- Pulse rate 200 ± 3bpm (High priority alarm condition) Pass / Fail Value: bpm
- Pulse rate 60 ± 3bpm Pass / Fail Value: bpm
- Modulation level Pass / Fail
Respiration operation Pass / Fail
Temperature operation Pass / Fail
IBP operation Pass / Fail
CO2 operation
-Display accuracy 76 ± 2 mmHg (for Mainstream)
Pass / Fail Value: mmHg
-Display accuracy 76 ± 2 mmHg (for Sidestream)
-Flow rate Pass / Fail
-Occlusion Pass / Fail
SAFETY TEST
TEST CONDITIONS LIMIT(uA) RESULTS REMARKS
Earth leakage current (NC) 500 Pass / Fail Value: uA
Earth leakage current (SFC OS) 1000 Pass / Fail Value: uA
Earth leakage current (NCRM) 500 Pass / Fail Value: uA
Earth leakage current (SFC OSRM) 1000 Pass / Fail Value: uA
Enclosure leakage current (NC) 100 Pass / Fail Value: uA
Enclosure leakage current (OS) 500 Pass / Fail Value: uA
Enclosure leakage current (SFC OE) 500 Pass / Fail Value: uA
Enclosure leakage current (NCRM) 100 Pass / Fail Value: uA
Enclosure leakage current (SFC OSRM) 500 Pass / Fail Value: uA
Enclosure leakage current (SFC OERM) 500 Pass / Fail Value: uA
Patient leakage current (NC) 10 Pass / Fail Value: uA
Patient leakage current (OS) 50 Pass / Fail Value: uA
Patient leakage current (SFC OE) 50 Pass / Fail Value: uA
Patient leakage current (NCRM) 10 Pass / Fail Value: uA
Patient leakage current (SFC OSRM) 50 Pass / Fail Value: uA
Patient leakage current (SFC OERM) 50 Pass / Fail Value: uA
Mains voltage on applied part (SFC) 50 Pass / Fail Value: uA
Mains voltage on applied part (SFCRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG LL (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG LL (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG LL (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG LL (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG LL (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG LL (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG RA (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG RA (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG RA (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG RA (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG RA (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA–ECG RA (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL–ECG RA (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LL–ECG RA (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL–ECG RA (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL–ECG RA (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LL–ECG RA (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL–ECG RA (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA-TEMP (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA-TEMP (OS) 50 Pass / Fail Value: uA
45
SAFETY TEST
TEST CONDITIONS LIMIT(uA) RESULTS REMARKS
Patient auxiliary current ECG LA-TEMP (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA-TEMP (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA-TEMP (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA-TEMP (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-TEMP (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LL-TEMP (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-TEMP (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-TEMP (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LL-TEMP (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-TEMP(SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-TEMP (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG RA-TEMP (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-TEMP (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-TEMP (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG RA-TEMP (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-TEMP (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA-SpO2 (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA-SpO2 (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA-SpO2 (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA-SpO2 (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LA-SpO2 (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LA-SpO2 (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-SpO2 (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LL-SpO2 (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-SpO2 (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-SpO2 (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG LL-SpO2 (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG LL-SpO2 (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-SpO2 (NC) 10 Pass / Fail Value: uA
Patient auxiliary current ECG RA-SpO2 (OS) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-SpO2 (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-SpO2 (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current ECG RA-SpO2 (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current ECG RA-SpO2 (SFC OERM) 50 Pass / Fail Value: uA
Patient auxiliary current TEMP-SpO2 (NC) 10 Pass / Fail Value: uA
Patient auxiliary current TEMP-SpO2 (OS) 50 Pass / Fail Value: uA
Patient auxiliary current TEMP-SpO2 (SFC OE) 50 Pass / Fail Value: uA
Patient auxiliary current TEMP-SpO2 (NCRM) 10 Pass / Fail Value: uA
Patient auxiliary current TEMP-SpO2 (SFC OSRM) 50 Pass / Fail Value: uA
Patient auxiliary current TEMP-SpO2 (SFC OERM) 50 Pass / Fail Value: uA
Remarks
NC: Normal Condition
NCRM: Normal Condition Reverse
SFC: Single Fault Condition
OS: Single Fault Condition (Open Line/Neutral)
OSRM: Single Fault Condition (Open Line/Neutral) Reverse
OE: Single Fault Condition (Open Earth)
OERM: Single Fault Condition (Open Earth) Reverse
46
Service Menu and Parameter Default Settings
General
This section discusses use of the Service menu to configure system setting, printer
setting, parameter default setting, ECG setting, Shock setting, AED mode setting, 3G
network setting and Wi-Fi network setting. Also this section explains briefly the
Parameter Default Settings.
Service Menu
The purpose of the Service menu (Figure 14) is to allow the authorized user to create
a Power-on default for the settings in effect each time the defibrillator/monitor is
powered on. Once the Service menu is entered, physiological monitoring is
terminated. The screen layouts do not display any information associated with normal
monitoring operation. Use the following procedure to configure the Service menu for
the defibrillator/monitor (also see Using the defibrillator/monitor section, of the
operator’s manual):
Figure 12. The access of Service menu via Setup menu
1. Soft key menus are displayed on the lower of the normal screen.
2. Press Setup soft key to display Setup menu (see Figure 12).
3. Rotate the Multi function knob to highlight Service menu in Setup menu, and
then press the Multi function knob to access the Service menu.
4. Three digits are displayed in the Level 2 menu as shown in Figure 12.
47
Figure 13. Entering the pass code
Note: The pass code is 0, 0, 0. It is factory default setting.
5. Rotate the Multi function knob to highlight the top of the digits. Press the Multi
function knob to enter pass code.
6. Rotate the Multi function knob until “0” appears, then press the Multi function
knob.
7. Repeat step 5-6 to enter all the pass code “0” “0” “0”.
8. The Service menu will now be present (Figure 14). The available Service menu
items are explained in Figure 14 ~ Figure 24 and Table 11 ~ Table 21. Make
changes to these menu items as desired by rotating and pressing the Multi
function knob.
9. Select SAVE soft key and select Yes using Multi function knob. All changes made
to the power-up defaults will be in effect the next time the defibrillator/monitor is
turned on.
10. Turn off the defibrillator/monitor, and then turn on the defibrillator/monitor again.
Note: The defibrillator/monitor must be powered off upon selecting “Save” and “Yes” to
save any changes into the defibrillator/monitor, and then the changes made to
the Power on defaults will be in effect next time the defibrillator/monitor is
powered up.
48
System Setting I
Figure 14. System Setting I
Table 11. System Setting I

System Setting I
Level1 Level2 Level3
Software information Return
Software update Main software Start, Return
Display software Start, Return
Analog software Start, Return
Voice prompt Start, Return
Return
Parameters color ECG Color table
NIBP Color table
SpO2 Color table
Respiration Color table
Temperature Color table
IBP 1 Color table
IBP 2 Color table
EtCO2 Color table
Return
Brightness Brightness 1~4
Volume Alarm volume 1~8
Beep volume OFF, 1 ~ 7
Button volume OFF, 1 ~ 7
Charging alarm 1~8
Voice prompt 1~8
CPR Metronome OFF, 1 ~ 7
Pacing alarm OFF, 1 ~ 7
Return
Audio pause time 30 sec
60 sec
49
System Setting I
Audio pause time 90 sec
120 sec
Return
Audio off time 3 min
5 min
10 min
Return
Alarm reminder tone OFF
3 min
10 min
Return
Alarm active at power up Enable
Disable
Service menu data Save service menu data Start
Return
Load service menu data Start
Return
Auto block erase Enable
Disable
Return
Software information
This menu displays software versions of Main software, Display software, Analog
software, Charger, H/V, ECG, SpO2, TEMP, NIBP Main, NIBP Sub, CO2, and IBP.
Software update
Main software update
The main software can be updated in this menu.
Display software update
The display software (screen display and alarm messages) can be updated in this
menu.
Analog software update
The analog software (for ECG analyzes CPU) can be updated in this menu.
Voice prompt
The voice prompt can be updated from SD card via this menu.
Parameter color
The color of each parameter’s waveform and measured value can be set in this menu.
Brightness
The brightness can be adjusted in this menu. The brightness can be set at level 1 to 4.
Volume
The volume of alarm, beep, button, charging tone, voice prompt, CPR metronome and
pacing alarm sound can be set in this menu.
50
Audio pause time
Pressing the ALARM button temporarily off alarms for the period selected in this menu.
The factory default of alarm off period is 30 seconds.
Audio off time

If pressing and holding the ALARM button for 2 seconds, alarm is not activated during
set time interval through this menu.
Alarm reminder tone

The defibrillator/monitor generates the alarm reminder tone at the preset interval to
remind the user that the audible alarm is inactivated. The interval can be set to 3
minutes, 10 minutes, Return of OFF via this menu. If OFF is selected, the reminder
tone will be disabled.
Alarm active at power up

If Alarm active at power up is set to Enable, audible alarm is activated when the
defibrillator/monitor is powered on. If Alarm active at power up is set to Disable, audible
alarm is not allowed to activate when the defibrillator/monitor is powered on.
Service menu data

Save configuration data
The current configuration data can be downloaded to SD card via this menu.
Load configuration data

The configuration data can be downloaded from SD card to defibrillator/monitor. The
downloaded configuration data can be set as default configuration of
Auto block erase

If Auto block erase is set to Enable, the past memory will be deleted when the
memory is full. If Auto block erase is set to Disable, the ‘Not enough memory’
message will be displayed when the memory is full.
51
System Setting II
Figure 15. System Setting II
Table 12. System Setting II

System Setting II
Auto self-test Self-test Time 0 ~ 23 ‘ clock
Self-test Interval Off
24 hours
48 hours
72 hours
Return
Internal Shock Energy 0~10J
Return
Clinical action list 1 ~ 10 None, CPR, EPI,
Atrop, DOPA, PHEN,
Bicarb, Aspirin,
Oxygen, IV,
Morphine, Valium, β-
block, LIDO, Mag
Sulf, Thrombo,
Sedation, Heparin,
Procain, Cordar,
Thiamine, Dilantin,
Intubate, Narcan,
Atrovent, Adenosin,
Fentanyl, Digoxin,
Vasopr, Dextrose,
Paralytic, Nitro,
Albuterol, Amrinon,
Benadryl, Demerol,
Oral Glu, Lasix,
Calcium
Return Return
Device installation ID Confirm
Return
52
System Setting II
Device ID Confirm
Return
12 lead institution name Confirm
Return
12 lead location code Confirm
Return
Communication phone numbers Confirm
Return
Manual mode protection Enable
Confirm
Password
Return
Manual mode locking passcode Pass number 1
Pass number 2
Pass number 3
Confirm
Return
Pacing mode protection Disable
Confirm
Password
Confirm
Return
Pacing mode locking passcode Pass number 1
Pass number 2
Pass number 3
Confirm
Return
Service menu passcode Pass number 1
Pass number 2
Pass number 3
Confirm
Return
Auto self-test
Auto self-test configuration can be set in this menu.
Self-test time
The time of self test operation can be set in this menu.
Self-test interval
The self test time interval can be set as Off, 24, 48 and 72 hours in this menu. If Self-
test interval is set to Off, the self-test is not performed.
Internal shock energy

The Internal shock energy for self-test can be set in this menu. The factory default of
internal shock energy is 10J.
Clinical action list

This menu indicates the information of drug administration.10 of frequently clinical
actions can be set in this menu.
53
Device installation ID
Device installation ID can be entered in this menu.
Device ID
Device ID can be entered in this menu.
12 lead institution name

12 lead institution name can be entered in this menu.
12 lead location code

12 lead location code can be entered in this menu.
Communication phone numbers

The phone number related to device service can be entered in this menu.
Manual mode protection

If Manual mode protection is set to Confirm, the confirmation window is displayed
with asking confirm manual mode or switch to AED when start the manual mode. If
Manual mode protection is set to Passcode, the passcode window is displayed when
start the manual mode. The factory default of passcode is 0,0,0. If Manual mode
protection is set to Disable, there is no confirmation process when start the manual
mode.
Manual mode locking passcode

The passcode for Manual mode protection can be set in this menu.
Pacing mode protection

If Pacing mode protection is set to Confirm, the confirmation window is displayed
with asking confirm pacing mode or switch to AED when start the Pacing Mode. If
Pacing mode protection is set to Passcode, the passcode window is displayed when
start the Pacing Mode. The factory default of passcode is 0,0,0. If Pacing mode
protection is set to Disable, there is no confirmation process when start the Pacing
Mode.
Pacing mode locking passcode

The passcode for Pacing mode protection can be set in this menu.
Service menu passcode

The passcode for Service mode can be set in this menu.
54
Printer Setting
Figure 16. Printer Setting
Table 13. Printer Setting

Printer Setting
Print on alarm On
Off
Print on charge On
Off
Print on shock On
Off
Print on mark On
Off
Print on BP On
Off
Print on self-test On
Off
12 lead auto printing On
Off
Analyze auto printing On
Off
Print on alarm
If Print on alarm is set to On, the defibrillator/monitor will automatically print out
information before and after 10 seconds when a physiological alarm condition is
activated.
Print on charge
If Print on charge is set to On, the defibrillator/monitor will automatically print out
information before and after 10 seconds when energy is charged for shock.
Print on shock
If Print on shock is set to On, the defibrillator/monitor will automatically print out
55
information before and after 10 seconds when a shock is generated.
Print on mark
If Print on mark is set to On, the defibrillator/monitor will automatically print out when
Clinical action list is selected in Setup menu.
Print on BP
If Print on BP is set to On, the defibrillator/monitor will automatically print out when the
NIBP value is measured.
Print on self-test
If Print on self-test is set to On, the defibrillator/monitor will automatically print out the
result of Self-Test when Self-Test is performed.
12 lead auto printing

If 12 lead auto printing is set to On, the defibrillator/monitor will automatically print out
after 12 lead ECG is acquired.
Analyze auto printing

If Analyze auto printing is set to On, the defibrillator/monitor will automatically print
out data for 10 seconds after starting the analyze.
Parameter Default Setting
Figure 17. Parameter Default Setting
Table 14. Parameter Default Setting

HR/PR alarm limit (high limit) : 25~300 (5 BPM steps)
(low limit) : 20~295 (5 BPM steps)
Return
RESP alarm limit Impedance (high limit) : 4~120
56
Airway (high limit) : 1~150
Impedance (low limit) : 3~119
Airway (low limit) : 0~149
Return
RESP ON/OFF On
Off
Power on waveform select 1st Waveform I, II, III, Pads
2nd Waveform I, II, III, Pads, SpO2,
RESP, IBP1, IBP2,
EtCO2, Return
3rd Waveform I, II, III, Pads, SpO2,
RESP, IBP1, IBP2,
EtCO2, Return
4th Waveform I, II, III, Pads, SpO2,
RESP, IBP1, IBP2,
EtCO2, Return
Return
SpO2 alarm Limit (high limit) : 21~100
(low limit) : 20~99
Return
NIBP alarm Limit – SYS Adult/Pedi (high limit):
35 to 270 mmHg
(4.6 to 36.0 kPa)
Neonatal (high limit)
45 to 130 mmHg
(6.0 to 17.3 kPa)
(5 mmHg, 0.6 or 0.7kPa steps)
Adult/pediatric
30 to 265 mmHg
(4.0 to 35.3 kPa)
Neonatal
40 to 125 mmHg
(5.3 to 16.6 kPa)
NIBP alarm Limit – MAP Adult/Pedi (high limit):
25 to 260 mmHg
(3.3 to 34.7 kPa)
Neonatal (high limit):
35 to 110 mmHg
(4.7 to 14.7 kPa)
Adult/Pedi (low limit):
20 to 255 mmHg
(2.7 to 34.0 kPa)
Neonatal (low limit):
30 to 105 mmHg
(4.0 to 14.0 kPa)
NIBP alarm Limit – DIA Adult/Pedi (high limit):
15 to 250 mmHg
(2.0 to 33.3 kPa)
Neonatal (high limit):
10 to 245 mmHg
57
(1.3 to 32.6 kPa)
Adult/Pedi (low limit):
10 to 245 (mmHg)
1.3 to 32.6 (kPa)
Neonatal (low limit):
25 to 85 mmHg
(3.3 to 12.0 kPa)
Return
NIBP inflate Pressure Adult/Pedi: 120 mmHg
Adult/Pedi: 140 mmHg
Neonatal: 80 mmHg
Neonatal: 100 mmHg
Neonatal: 120 mmHg
Neonatal: 140 mmHg
Return
NIBP patient mode Adult/Pedi
Neonatal
NIBP unit mmHg
kPa
NIBP test mode Pressure sensor accuracy test Start
Return
Air leakage test Start
Return
Inflation time measurement Start
Return
Deflation rate measurement Start
Return
Return
Temp alarm limit Temp 1(high limit):
0.1 to 50.0 °C
(32.2 to 122.0 °F)
(0.1°C, 0.1° or 0.2°F steps)
Temp 1(low limit):
0.0 to 49.9 °C
(32.0 to 121.8 °F)
(0.1°C, 0.1° or 0.2°F steps)
Temp 2(high limit):
0.1 to 50.0 °C
(32.2 to 122.0 °F)
(0.1°C, 0.1° or 0.2°F steps)
Temp 2(low limit):
58
0.0 to 49.9 °C
(32.0 to 121.8 °F)
(0.1°C, 0.1° or 0.2°F steps)
Return
Temp unit °C
°F
IBP alarm limit P1 SYS(high limit):
-45 to 300 mmHg
(-6 to 40 kPa)
P1 SYS(low limit):
-50 to 295mmHg
(-6.7 to 39.3 kPa)
P1 MEAN(high limit):
-45 to 300 mmHg
(-6 to 40 kPa)
P1 MEAN(low limit):
-50 to 295 mmHg
(-6.7 to 39.3 kPa)
P1 DIA(high limit):
-45 to 300 mmHg
(-6 to 40 kPa)
P1 DIA(low limit):
-50 to 295 mmHg
(-6.7 to 39.3 kPa)
P2 SYS(high limit):
-45 to 300 mmHg
(-6 to 40 kPa)
P2 SYS(low limit):
-50 to 295mmHg
(-6.7 to 39.3 kPa)
P2 MEAN(high limit):
-45 to 300 mmHg
(-6 to 40 kPa)
P2 MEAN(low limit):
-50 to 295mmHg
(-6.7 to 39.3 kPa)
P2 DIA(high limit):
-45 to 300 mmHg
(-6 to 40 kPa)
P2 DIA(low limit):
-50 to 295mmHg
59
(-6.7 to 39.3 kPa)
Return
IBP unit mmHg
kPa
IBP1 label P1
ABP
Return
IBP2 label P2
CVP
PAP
LAP
Return
EtCO2 alarm limit EtCO2(high limit):
1 to150 mmHg
(0.13 to 20.0 kPa), (0 to 20.0 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
EtCO2(low limit):
0 to 149 mmHg
(0 to 19.9 kPa), (0 to 19.9 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
InCO2(high limit):
1 to 20 mmHg
(0.13 to 2.7 kPa), (0.13 to 2.6 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
InCO2(low limit):
0 to 19 mmHg
(0 to 2.5 kPa), (0 to 2.5 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
Return
EtCO2 unit mmHg
kPa
%
Return
HR/PR alarm limit

The custom-default HR/PR alarm limit can be set in this menu.
RESP alarm limit

The custom-default respiration alarm limit can be set in this menu.
RESP On/Off
The custom-default respiration function can be set in this menu.
Power on waveform select

The custom-default waveforms for each waveform screen from 1st to 4th can be set in
this menu.
60
SpO2 alarm limit
The custom-default SpO2 alarm limit can be set in this menu.
NIBP alarm limit

The custom-default NIBP SYS, MAP, DIA alarm limit can be set in this menu.
NIBP inflate pressure

The custom-default NIBP inflate pressure can be selected as 120, 140, 160, 180, 200,
220, 240, 260 or 280 mmHg on adult mode or 80, 100, 120, 140 mmHg on neonatal mode in
this menu.
NIBP patient mode

The custom-default NIBP patient mode can be selected as Adult/Pedi or Neonatal.
NIBP unit
The custom-default NIBP unit can be selected as mmHg or kPa.
NIBP test mode

The performance of NIBP measurement can be tested in this menu.
Pressure sensor accuracy test

Pressure sensor accuracy can be tested in this menu. Refer to Performance
Verification section of this manual for more information.
Air Leakage Test

Air Leakage can be tested in this menu. Refer to Performance Verification section
of this manual for more information.
Inflation time measurement

Inflation time can be measured in this menu. Refer to Performance Verification
section of this manual for more information.
Deflation rate measurement

Deflation rate can be measured in this menu. Refer to Performance Verification
section of this manual for more information.
Temp alarm limit

The custom-default Temperature alarm limit can be set in this menu.
Temp unit
The custom-default Temperature unit can be selected as ℃ or ℉.
IBP alarm limit

The custom-default IBP P1/P2 SYS, MEAN, DIA alarm limit can be set in this menu.
IBP unit
The custom-default IBP unit can be selected as mmHg or kPa.
61
IBP1 label
The IBP1 label can be selected as P1 or ABP in this menu.
IBP2 label
The IBP2 label can be selected as P2, CVP, PAP or LAP in this menu.
EtCO2 alarm limit

The custom-default EtCO2 and InCO2 can be set in this menu.
EtCO2 unit
The custom-default EtCO2 unit can be selected as mmHg, kPa or %.
62
ECG Setting
Figure 18. ECG Setting
Table 15. ECG Setting

ECG Setting
AC line filter 50 Hz
60 Hz
Off
Pacer detection Enable
Disable
ECG size x 0.5
x1
x 1.5
x2
x3
Return
ECG filter 0.5 Hz - 21 Hz
0.05 Hz - 40 Hz
1 Hz - 21 Hz
Return
Message display Enable
Disable
AC line filter
The AC line filter can be set to 50Hz or 60Hz in this menu.
Pacer detection
If Pacer detection is set to Enable, defibrillator/monitor detects pacer pulses of ±2mV
to ±700mV with pulse widths of 0.1 to 2ms and rise times 10% of width not to exceed
100ms.
ECG size
The 1st waveform ECG gain is set to x0.5, x1, x1.5, x2 or x3.
63
ECG filter
The filter bandwidth frequency for ECG signal display can be set to 0.5Hz ~ 21Hz or
0.05Hz ~ 40Hz or 1Hz~21Hz.
Message display
If Message display is set to Enable, defibrillator/monitor sets ECG waveform message
to display.
12 Lead ECG Setting
Figure 19. 12 Lead ECG Setting
Table 16. 12 Lead ECG Setting

12 Lead ECG Setting
Auto transmit On
Off
Print on 12 lead measurements On
Off
Print on 12 lead interpretation On
Off
Setting print lead I, II, III, aVL, aVF,
1st Waveform aVR, V1, V2, V3, V4,
V5, V6, Return
I, II, III, aVL, aVF,
2nd Waveform aVR, V1, V2, V3, V4,
V5, V6, Return
I, II, III, aVL, aVF,
3nd Waveform aVR, V1, V2, V3, V4,
V5, V6, Return
Return
12 lead frequency response 0.05 Hz ~ 40 Hz
0.05 Hz ~ 150 Hz
Print 2 copies 12 lead On
Off
12 lead print second 2.5 sec
10 sec
64
12 Lead ECG Setting
12 lead print speed 25mm/s
50mm/s
Auto transmit
If the Auto transmit is set to On, the reading result of 12 lead ECG signal is sent by
3G or Wi-Fi.
Print on 12 lead measurement

If the Print on 12 lead measurement is set to On, the each results of 12 lead ECG
reading are printed.
Print on 12 lead interpreter

If the Print on 12 lead interpreter is set to On, the results of 12 lead ECG signal
analysis are printed with the reading result of 12 lead ECG signal.
Setting Print Lead

3 leads of ECG waveform can be selected for print out among 12leads of ECG
waveform in this menu.
12 lead frequency response

The filter bandwidth frequency for 12 lead ECG signal display can be set to 0.05Hz ~
40Hz or 0.05Hz ~ 150Hz.
Print 2 copies 12 lead

If Print 2 copies 12 lead is set to On, the results of 12 lead ECG reading are printed
twice.
12 lead print second

If select 2.5 seconds, the waveforms from leads I,II,III / AVR,AVL,AVF / V1,V2,V3 /
V4,V5,V6 are printed for 2.5 seconds data each. If select 10 seconds, the waveforms
are printed for 10 seconds data each.
12 lead print speed

The print speed of waveform of 12 lead ECG signals can be set to 25mm/s or 50mm/s.
65
Shock Setting
Figure 20. Shock Setting
Table 17. Shock Setting

Shock Setting
Elapsed time display Enable
Disable
CPR guide display Enable
Disable
Message display On
Off
Voice prompt Enable
Disable
Basic auto energy escalation Enable
Disable
Above 200J setting Enable
Disable
1st Energy: 1~200J (Adult)
Manual shock energy
1~100J (Pediatric)
2nd Energy: 1~200J (Adult)
1~100J (Pediatric)
3rd Energy: 1~200J (Adult)
1~100J (Pediatric)
Return
Analyze continuous mode Enable
Disable
Auto charge On
Off
Remain in sync mode after shock On
Off
Charging hold time 15 sec
60 sec
ECG display with paddle in openair On
Off
66
Elapsed time display
If Elapsed time display is set to Enable, the elapsed time of defibrillator/monitor
operation is displayed on the main screen each mode.
CPR guide display

If CPR guide display is set to Enable, the CPR Guide is displayed in the manual mode.
Message display
If Message display is set to On, the defibrillation guide line is displayed in the manual
mode.
Voice prompt
If Voice prompt is set to Enable, the voice prompt is played in the manual mode.
Basic auto energy escalation

If Basic auto energy escalation is set to Enable, the shock energy is changed
according to pre-defined manual shock energy level which can be set in Manual shock
energy menu.
Above 200J setting

If Above 200J setting is set to Enable, the shock energy level can be set up to 360J. If
Above 200J setting is set to Disable, the shock energy level can be set up to 200J.
Manual shock energy

If Basic auto energy escalation is set to Enable, the 1st, 2nd and 3rd shock energy
level can be defined in this menu.
Analyze continuous mode

If Analyze continuous mode is set to Enable, the defibrillator/monitor keeps the
analyze of ECG signal in manual mode when the ANALYZE button on the front panel is
pressed in the manual mode.
Auto change
If Auto change is set to On, the shock energy is auto changed when the shockable
rhythm is detected.
Remain in sync mode after shock

If Remain in sync mode after shock is set to On, the defibrillator/monitor is kept as
sync mode after a shock in manual mode.
Charging hold time

If Charging hold time is set to 15s or 60s, the shock energy is discharged in case the
‘SHOCK’ button is not pressed within the setting time.
ECG display with paddle in openair

If ECG display with paddle in openair is set to On, the ECG waveform is displayed
on the screen even though paddles are open.
67
AED Mode Setting
Figure 21. AED Mode Setting
Table 18. AED Mode Setting

AED Mode Setting
Setup menu Enable
Disable
Alarm limit menu Enable
Disable
12 lead menu Enable
Disable
AED display setting Waveform display Enable
Disable
Icon display Enable
Disable
Value display Enable
Disable
AED step 1 display Enable
Disable
AED step 2 display Enable
Disable
AED step 3 display (CPR) Enable
Disable
Return
AED shock energy Above 200J setting Enable
Disable
1st Energy: 1~200J (Adult)
1~100J (Pediatric)
1~100J (Pediatric)
1~100J (Pediatric)
Return
68
Setup menu
If Setup menu is set to Enable, Setup soft key menu is enabled in AED mode.
Alarm limit menu

If Alarm limit menu is set to Enable, Alarm limit soft key menu is enabled in AED
mode.
12 Lead menu
If 12 Lead menu is set to Enable, 12 Lead soft key menu is enabled in AED mode.
AED display setting

The configuration of AED display can be set in this menu.
Waveform display
If Waveform display is set to Enable, the waveforms from measurement parameters
are displayed in AED mode.
Icon display
If Icon display is set to Enable, the icons for AED guide line are displayed in AED
mode.
Value display
If Value Display is set to Enable, the measurement values are displayed in AED mode.
AED step 1 display

If AED step 1 display is set to Enable, the AED mode is started from AED Step 1
which display “Check Response / Call for help” message.
AED step 2 display

If AED step display is set to Enable, the AED mode is started from AED Step 2 which
display “Open airway / Check breathing” message.
AED step 3 display (CPR)

If AED step 3 display (CPR) is set to Enable, the AED mode is started from AED Step
3 which display metronome for CPR.
AED shock energy

The shock energy level in AED mode can be set to 1st, 2nd and 3rd level in this menu.
69
Pacing Mode Setting
Figure 22. Pacing Mode Setting
Table 19. Pacing Mode Setting

Pacing Mode Setting
Fixed pacing On
Off
Pace pulse rate 30~180BPM
Return
Default pacing energy 0 mA
30 mA
70 mA
100 mA
140 mA
Return
Fixed pacing
If Fixed pacing is set to On, the defibrillator/monitor performs pacing in pacing mode.
Pace pulse rate

The initial Pace pulse rate bpm can be set in this menu.
Default pacing energy

The initial Default pacing energy can be set to 0mA, 30mA, 70mA, 100mA or 140mA
in this menu.
70
3G Network Setting
Figure 23. 3G Network Setting
Table 20. 3G Network Setting

Configuration Menu – 3G Network Setting
3G ON
OFF
Destination IP address
Destination port
USIM1 Enable
Disable
APN
Authentication protocol None
PAP
CHAP
Authentication ID
Authentication password
USIM2 Enable
Disable
APN
Authentication protocol None
PAP
CHAP
Authentication ID
3G
3G for 3G network connection can be set in this menu.
Destination IP address for 3G network connection can be set in this menu.
Destination port
Destination port for 3G network connection can be set in this menu.
71
USIM1, USIM2
USIM for 3G network connection can be set in this menu.
APN
SSID for 3G network connection can be set in this menu.
Authentication protocol
Authentication protocol for 3G network connection can be set in this menu.
Authentication ID
Authentication ID for 3G network connection can be set in this menu.
Authentication password for 3G network connection can be set in this menu.
Wi-Fi Network Setting
Figure 24. Wi-Fi Network Setting
Table 21. Wi-Fi Network Setting

Configuration Menu – Wi-Fi Network Setting
Wi-Fi On
Off
IP configuration IP address
Subnet
Gateway
Return
Destination IP address Destination IP address
Return
Destination port Confirm
Return
Wireless network name (SSID) Confirm
Return
Wireless channel Channel1 ~ Channel13, Auto
72
Configuration Menu – Wi-Fi Network Setting
Wireless security mode None
WEP
WPA
WPA2
EAP
Return
WEP key length 64bit (10 hex digits)
128 bit (26 hex digits)
Shared key Confirm
Return
Wi-Fi
Wi-Fi is set to On or Off on this menu.
IP configuration
IP address, Subnet mask and Gateway address for Wi-Fi network connection can be
set in this menu.
IP address for Wi-Fi network connection can be set in this menu.
Destination port
Port number for Wi-Fi network connection can be set in this menu.
Wireless network name (SSID)

SSID for Wi-Fi network connection can be set in this menu.
Wireless channel
Channel for Wi-Fi network connection can be set from channel 1 to channel13 in this
menu.
Wireless security mode

The security type of wireless network can be set in this menu. If select None, there is
no security on wireless network
.
WEP key length
WEP key length can be set in this menu.
Shared key
WPA share key for Wi-Fi network connection can be set in this menu.
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Factory Default Settings
Service Menu Factory Defaults
Parameter ranges and Parameter Default Settings in Service menu are divided into 2
groups, adult/pediatric and neonatal as described in Table 22. Parameter ranges and
factory defaults.
The patient mode is preset to “Adult/Pediatric” mode. Alarm limits settings will be
automatically changed to the default settings for each patient mode as the mode is
changed to Adult/Pediatric or Neonatal mode.
Table 22. Parameter ranges and factory defaults

Parameter Ranges / Selections (Adjust step) Factory Defaults
ECG MENU
HR/PR Source Auto, HR, PR Auto
AC line filter* 50Hz, 60Hz, Off 60 Hz
Pacer Detect Enable, Disable Disable
ECG size* x0.5, x1, x1.5, x2, x3 x1
Filter Select 0.5 to 21 Hz, 0.05 to 40 Hz, 1 to 21 Hz 1 to 21 Hz
HR/PR High Alarm Limits 25 to 300 BPM (5 BPM steps) 120 BPM
HR/PR Low Alarm Limits 20 to 295 BPM (5 BPM steps) 50 BPM
Auto transmit* On, Off On
Print on 12 lead On, Off On
measurement**
Print on 12 lead On, Off On
interpretation**
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6 I
- 1st waveform*
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6 II
- 2nd waveform*
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6 III
- 3rd waveform*
12 lead frequency response* 0.05 Hz ~ 40 Hz, 0.05 Hz ~ 150 Hz 0.05 Hz ~ 40 Hz
Print 2 copies 12 lead** On, Off Off
12 lead print second** 2.5 sec, 10 sec 2.5 sec
12 lead print speed** 25mm/s, 50mm/s 25mm/s
SpO2 MENU
% SpO2 High Alarm Limits 21 to 100 % (1 % steps) 100 %
% SpO2 Low Alarm Limits 20 to 99 % (1 % steps) 90 %
NIBP MENU
Inflate Pressure Adult mode: 80, 100, 120, 120, 140 160, 180, 200, 180 mmHg (Adult
220, 240, 260, 280 mmHg mode)
Neonatal mode: 80, 100, 120, 140 mmHg 120 mmHg (Neonatal
mode)
Auto Interval 1, 2.5, 3, 5, 10, 15, 30, 60, 90, Off Off
Patient type Adult/Pedi, Neonatal Adult/Pedi
NIBP Unit* mmHg, kPa mmHg
NIBP SYS High Alarm Limits adult/pediatric adult/pediatric
35 to 270 mmHg 160 mmHg
(4.7 to 36.0 kPa) (21.3 kPa)
neonatal neonatal
(6.0 to 17.3 kPa) (12.0 kPa)
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NIBP SYS Low Alarm Limits adult/pediatric adult/pediatric
(4.0 to 35.3 kPa) (12.0 kPa)
neonatal neonatal
(5.3 to 16.7 kPa) (5.3 kPa)
NIBP DIA High Alarm Limits adult/pediatric adult/pediatric
(2.0 to 33.3 kPa) (12.0 kPa)
neonatal neonatal
(3.3 to 12.0 kPa) (8.0 kPa)
NIBP DIA Low Alarm Limits adult/pediatric adult/pediatric
(1.3 to 32.7 kPa) (6.7 kPa)
neonatal neonatal
(2.7 to 11.3 kPa) (2.6 kPa)
NIBP MAP High Alarm Limits adult/pediatric adult/pediatric
(3.3 to 34.7 kPa) (14.7 kPa)
neonatal neonatal
(4.7 to 14.7 kPa) (9.3 kPa)
NIBP MAP Low Alarm Limits adult/pediatric adult/pediatric
(2.7 to 34.0 kPa) (8.0 kPa)
neonatal neonatal
(4.0 to 14.0 kPa) (4.0 kPa)
IBP1 MENU
IBP1: Scale Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, Auto
0~300mmHg
IBP1: Label P1, ABP P1
IBP 1 SYS High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 120 mmHg
(-6 to 40 kPa) (16.0 kPa)
IBP 1 SYS Low Alarm Limits adult/pediatric adult/pediatric
-50 to 295mmHg 70 mmHg
(-6.7 to 39.3 kPa) (9.3 kPa)
IBP 1 DIA High Alarm Limits adult/pediatric adult/pediatric
(-6 to 40 kPa) (9.3 kPa)
IBP 1 DIA Low Alarm Limits adult/pediatric adult/pediatric
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(-6.7 to 39.3 kPa) (5.3 kPa)
IBP 1 MEAN High Alarm Limits adult/pediatric adult/pediatric
(-6 to 40 kPa) (12.0 kPa)
IBP 1 MEAN Low Alarm Limits adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (6.7 kPa)
IBP2 MENU
IBP2: Scale Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, Auto
0~300mmHg
IBP2: Label P2, CVP, PAP,LAP P2
IBP 2 SYS High Alarm Limits adult/pediatric adult/pediatric
(-6 to 40 kPa) (16.0 kPa)
IBP 2 SYS Low Alarm Limits adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (9.3 kPa)
IBP 2 DIA High Alarm Limits adult/pediatric adult/pediatric
(-6 to 40 kPa) (9.3 kPa)
IBP 2 DIA Low Alarm Limits adult/pediatricl adult/pediatric
(-6.7 to 39.3 kPa) (5.3 kPa)
IBP 2 MEAN High Alarm Limits adult/pediatric adult/pediatric
(-6 to 40 kPa) (12.0 kPa)
IBP 2 MEAN Low Alarm Limits adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (6.7 kPa)
IBP unit* mmHg, kPa mmHg
EtCO2
EtCO2 On, Off ON
N2O Gas On, Off OFF
O2 Gas On, Off OFF
Scale 0~40 mmHg, 0~60 mmHg, 0~80 mmHg, Auto Auto
EtCO2 High Alarm Limits adult/pediatric adult/pediatric
(0.13 to 10.7 kPa), (0.13 to 10.5 %) (10.7 kPa), (10.5 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
EtCO2 Low Alarm Limits adult/pediatric adult/pediatric
0 to 79 mmHg 0 mmHg
(0 to 10.5 kPa), (0 to 10.4 %) (0 kPa), (0 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
InCO2 High Alarm Limits adult/pediatric adult/pediatric
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(0.13 to 2.7 kPa), (0.13 to 2.6 %) (2.7 kPa), (2.6 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
InCO2 Low Alarm Limits adult/pediatric adult/pediatric
0 to 19 mmHg 0 mmHg
(0 to 2.5 kPa), (0 to 2.5 %) (0 kPa), (0 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
EtCO2 unit* mmHg, kPa, % mmHg
Temperature MENU
TEMP1 High Alarm Limits 0.1 to 50.0 °C 39.0 °C
(32.2 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1° or 0.2°F steps)
TEMP1 Low Alarm Limits 0.0 to 49.9 °C 36.0 °C
(32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1° or 0.2°F steps)
TEMP2 High Alarm Limits 0.1 to 50.0 °C 39.0 °C
(32.2 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1° or 0.2°F steps)
TEMP2 Low Alarm Limits 0.0 to 49.9 °C 36.0 °C
(32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1° or 0.2°F steps)
TEMP Unit* °C, °F °C
Respiration MENU
Respiration ON ON
OFF
RR Source Auto Auto
Impedance
Airway
Size x0.5, x1, x1.5, x2 x1
Apnea time setting Off, 10 seconds, 20 seconds, 30 seconds 10 seconds
40 seconds, 50 seconds, 60 seconds
RR High Limits 4 to 120 BPM (1 BPM step) 30 BPM
RR Low Limits 3 to 119 BPM (1 BPM step) 8 BPM
Manual, AED, Pacing, Monitor Mode MENU
Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8 5
Beep Volume OFF, 1, 2, 3, 4, 5, 6, 7 4
Button Volume OFF, 1, 2, 3, 4, 5, 6, 7 4
Charging alarm Volume 1, 2, 3, 4, 5, 6, 7, 8 4
Voice prompt Volume 1, 2, 3, 4, 5, 6, 7, 8 4
CPR metronome Volume OFF, 1, 2, 3, 4, 5, 6, 7 4
Pacing alarm Volume OFF, 1, 2, 3, 4, 5, 6, 7 2
2nd Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG SpO2 Waveform
aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
3rd Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG IBP1 Waveform – P1
4th Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG EtCO2 Waveform
Print on alarm** On, Off Off
Print on charge** On, Off Off
Print on shock** On, Off Off
Print on mark** On, Off Off
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Print on BP** On, Off Off
Print on self-test** On, Off On
12lead auto printing** On, Off On
Analyze auto printing** On, Off Off
Elapsed time display* Enable, Disable Enable
CPR guide display* Enable, Disable Enable
Message display* Enable, Disable Enable
Voice prompt* Enable, Disable Enable
Basic auto energy escalation* Enable, Disable Enable
Above 200J setting* Enable, Disable Disable
Manual shock energy – 1st 1~200J (Adult) 125J (Adult)
energy* 1~100J (Pediatric) 50J (Pediatric)
Manual shock energy – 2nd 1~200J (Adult) 150J (Adult)
Manual shock energy – 3rd 1~200J (Adult) 200J (Adult)
Analyze continuous mode* On, Off Enable
Auto charge* On, Off On
Remain in sync mode after On, Off On
shock*
Charging hold time* 15 sec, 60 sec 60 sec
ECG display with paddle in On, Off On
openair*
Setup Menu* Enable, Disable Disable
Alarm Limit Menu* Enable, Disable Disable
12 Lead Menu* Enable, Disable Disable
AED display setting – Enable, Disable Enable
Waveform display*
Icon display*
Value display*
AED display setting – Enable, Disable Disable
AED step 1 display*
AED step 2 display*
AED step 3 display*
AED shock energy – Enable, Disable Disable
Above 200J setting*
AED shock energy – 1~200J (Adult) 125J (Adult)
1st energy* 1~100J (Pediatric) 50J (Pediatric)
2nd energy* 1~100J (Pediatric) 50J (Pediatric)
3rd energy* 1~100J (Pediatric) 50J (Pediatric)
Fixed Pacing* On, Off Off
Pace Pulse Rate* 30 ~ 180 bpm 70 bpm
Default Pacing Energy* 0, 30, 70, 100, 140 mA 0 mA
Others
Parameters Color - ECG* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 00FA00(Green)
6464FA(Light blue), FA96FA(Pink), FA0000(Red),
FAFA00(Yellow), 9696C8(Light purple), FA9600,
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0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - NIBP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FAFAFA(White)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - SpO2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 64FAFA(Cyan)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - RESP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 9696C8(Light blue)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - TEMP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FA96FA(Pink)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - IBP 1* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FA0000(Red)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - IBP 2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FAFA00(Yellow)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - EtCO2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 9696C8(Light purple)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Brightness 1, 2, 3, 4 4
Audio pause time* 30 sec, 60 sec, 90 sec, 120 sec 60 sec
Audio off time* 3 min, 5 min, 10 min, Indefinite Indefinite
Alarm reminder tone* 3 min, 10 min, Off Off
Alarm activate at power up* Enable, Disable Enable
Auto self-test : 0 ~ 23 o‘clock 0 o‘clock
Self-test time*
Auto self-test : 24 hours, 48 hours, 72 hours, Off Off
Self-test time interval*
Auto self-test : 1~10J 10 J
Internal shock energy*
Clinical action list* None, CPR, EPI, Atrop, DOPA, PHEN, Bicarb, Aspirin, None
Oxygen, IV, Morphine, Valium, β-block, LIDO, Mag
Sulf, Thrombo, Sedation, Heparin, Procain, Cordar,
Thiamine, Dilantin, Intubate, Narcan, Atrovent,
Adenosin, Fentanyl, Digoxin, Vasopr, Dextrose,
Paralytic, Nitro, Albuterol, Amrinon, Benadryl,
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Demerol, Oral Glu, Lasix, Calcium
Manual mode protection* Disable, Confirm, Passcode Disable
Manual mode locking 000~999 (Passcode)
passcode*
Pacing mode protection* Disable, Confirm, Passcode Disable
Pacing mode locking 000~999 (Passcode)
passcode*
Service menu passcode* 000~999 (Passcode)
Print on charge** On, Off Off
Print on mark** On, Off Off
Print on BP** On, Off Off
Print on self-test** On, Off Off
Power on waveform select – ECG I, ECG II, ECG III, Pads ECG I
1st waveform*
Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, SpO2
2nd waveform* IBP2, EtCO2
Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, IBP1
3rd waveform* IBP2, EtCO2
Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, EtCO2
4th waveform* IBP2, EtCO2
Wi-Fi* On, Off On
Wireless Channel* Channel 1 ~ 13, Auto Channel 1
Wireless security mode* None, WEP, WPA, WPA2, EAP None
WEP key length* 64 bit (10 hex digits), 128 bit (24 hex digits) 64 bit (10 hex digits)
Outer Authentication* EAP-FAST, EAP-TLS, EAP-TTLS, EAP-PEAP EAP-FAST
Inner Authentication* EAP-MSCHAP, EAP-GTC EAP-MSCHAP
3G* On, Off On
USIM1* Enable, Disable Enable
Authentication protocol* None, PAP, CHAP PAP
USIM2* Enable, Disable Enable
Note: An asterisk (*) by a parameter in the above table indicates that the parameter can only be changed by authorized
personnel as described in the service manual
Note: Asterisks (**) by a parameter in the above table indicate the settings only when an optional printer is installed in the
80
Software Update
General
This section is for the purpose for reloading software into the defibrillator/monitor
when the possibility of corrupted software exists, or updating software with a new
system revision (system/device version). Call Mediana Technical Service Department
for the latest version of software utility required.
Equipment Needed
Table 23 lists the equipment required for software update.
Table 23. Required Equipments for software update

Equipment Description
Software Download Tool SD memory card with software utility
How to Update
2. Connect a SD memory card containing the software to the SD card port on the right
panel of the defibrillator/monitor.
4. Press Setup soft key then select Service menu using Multi function knob.
5. Enter the pass code.
6. The defibrillator/monitor will display the software update screen as shown below
Figure 25.
Figure 25. Software update display
81
7. Choose Software update menu and then select Main software menu or Analog
software menu or Display software menu or Voice prompt menu. In Main
software menu, the main CPU software for various parameters can be updated. In
Display software menu, the software for screen display, alarm messages. In
Analog software menu, the software for ECG analysis can be updated. In Voice
prompt menu, the voice prompt can be updated.
Note: If software update process is failed, defibrillator displays “Fail” message or

stop updating. This problem can be resolved by calling Mediana Technical
Service Department
Note: When a new software update is completed, the defibrillator/monitor is set to

the factory default.
82
Troubleshooting
General
This section provides information that can be helpful in troubleshooting the
How to Use This Section

If the defibrillator/monitor is not functioning properly, please check on the following
items before calling for repair service. Use this section in conjunction with the
Performance Verification section and the Spare Parts section. To remove and
replace a part suspected to be trouble, follow the instructions in the Disassembly
Guide section.
Who Should Perform Repairs

Only qualified service personnel should open the defibrillator/monitor housing, remove
and replace components, or make adjustments in accordance with this service manual.
If your medical facility does not have qualified service personnel, contact Mediana
Technical Service Department.
Replacement Level Supported

The replacement level supported for this product is to the printed circuit board (PCB
assembly) and major subassembly level. Once you isolate a suspected PCB
assembly, follow the procedures in the Disassembly Guide section to replace the
PCB assembly with a known good PCB assembly. Check to see if the trouble
symptom disappears and that the defibrillator/monitor passes all performance tests.
If the trouble symptom persists, swap back the replacement PCB assembly with the
suspected malfunctioning PCB assembly (the original PCB assembly that was
installed when you started troubleshooting) and continue troubleshooting as directed
in this section.
Obtaining Replacement Parts

Mediana provides technical assistance information and replacement parts. To obtain
replacement parts, contact Mediana Technical Service Department. Refer to the part
names and part numbers listed in the Spare Parts section.
83
Troubleshooting Guide
Problems with the defibrillator/monitor are separated into categories for further
troubleshooting instructions.
Note: Taking the recommended actions discussed in this section will correct the
majority of problems you will encounter. However, problems not covered here
can be resolved by calling Mediana Technical Service Department.
Table 24. Problem Categories

Categories Symptoms
1.1: The report data and customer settings are not saved.
1.2: The date and time printed on the recording paper is incorrect.
1. General
1.3: The screen does not turns on or the screen stop working with
buzzer sound even the defibrillator/monitor turns on.
2.1: Defibrillator/monitor does not turn on though the Mode select
knob is rotated.
2.2: Battery is not charging.
2.3: Battery charging indicators inaccurate.
2.4: Battery charging LED is blinking.
2. Power 2.5: The defibrillator/monitor operates with battery power even
thought the AC power is connected.
2.6: The defibrillator/monitor is suddenly turned off even thought
the AC power is connected.
2.7: The defibrillator/monitor does not turn on though external DC
power is connected.
3.1: The screen is deemed.
3. Display 3.2: Display is deformed.
3.3: Some pixels or lines are gone.
4.1: Audio is too low or absent.
4. Sound
4.2: No alarm is generated.
5.1: Soft keys, Multi function knob and Menu keys control failure.
5. Controls
5.2: Mode select knob failure.
6. NIBP 6.1: The cuff does not inflate.
7.1: The SpO2 sensor does not light.
7. SpO2 7.2: No display on the numeric area or waveform area though
sensor is in normal operation.
8. Temperature 8.1: Temperature value does not display.
9. Respiration 9.1: Respiration value or waveform does not display.
10. Capnography 10.1: Flow rates fall and function is not working properly.
11.1: QRS beeper inaudible or beeps do not occur with each QRS
complex.
11. ECG
11.2: Poor ECG signal quality (noisy trace, wandering baseline,
etc.) from signal acquired through monitoring electrodes.
84

Categories Symptoms
11.3: Poor ECG signal quality (noisy trace, wandering baseline,
etc.) from signal acquired through paddles/pads.
11.4: Solid flat line - no waveform, no Lead Off in operation.
11.5: ECG value or waveform does not display.
11.6: Lead select button does not respond.
11.7: One or more controls do not respond (e.g., select lead or soft
keys).
12.1: No display on the numeric area or waveform though sensor
12. IBP
is in normal operation.
13.1: Pacing does not start.
13. Defibrillation 13.2: Pacing (energy output) failure.
and Pacing 13.3: HV capacitor charging does not start.
13.4: Defibrillation failure.
14.1: Paper won't move.
14.2: Paper moves then stops.
14. Printer
14.3: Paper moves but printing is faint or absent.
14.4: Loud buzzing or grinding noise.
85
1. General
Symptom 1.1: The report data and customer settings are not saved.
Checkpoint Action Remark
CPU board Replace CPU board.
Main board Replace main board.
Note: If the report data were deleted in setup menu, the deleted data cannot be
recovered.
Symptom 1.2: The date and time printed on the recording paper is incorrect.
Date and time setting Reset the date and time in the
Date and Time menu.
Coin cell battery 1. If the Coin cell battery is
disconnected, connect Coin cell
battery properly.
2. If the Coin cell battery is
rusted, replace the Coin cell.
Main board or CPU board Replace main board or CPU
board.
Symptom 1.3: The screen does not turns on or the screen stop working with
buzzer sound though the defibrillator/monitor turns on.
2. Power
Power problems are related to AC/DC and/or Battery as follows. If the action requires
replacement of the components, refer to the Disassembly Guide section.
Electrical shock hazard. Disconnect the power cord from the

defibrillator/monitor before attempting to open or disassemble the
Symptom 2.1: Defibrillator/monitor does not turn on though rotate the Mode
select knob.
AC/DC line power cord Check AC/DC line power cord is
connected properly.
Battery If battery is depleted or defective,
replace battery.
AC power supply (SMPS) or Replace AC power supply
charger board (SMPS) or charger board.
86

Symptom 2.2: Battery is not charging.

Battery 1. Connect AC power cord to
check the AC/DC in LED is
lighted.
2. If AC/DC in LED is lighted in
Step1, then replace battery.
Service menu 1. Access to the Service menu
via Setup menu.
2. Enter the pass code “2”,”3”,”1”.
3. Check the battery information.
4. Replace battery if needed.
Replace AC power supply
AC power supply (SMPS)
(SMPS).
Charging circuit Replace charger board.
Symptom 2.3: Battery charging indicators inaccurate.

Battery Check if battery is nearing its end
of life. Replace battery.
AC battery LED board or charger Replace AC battery LED board
board or charger board.
Symptom 2.4: The battery charging LED is blinking.

Battery temperature If the battery is too hot, bring the
defibrillator/monitor to a cool
place. After the battery
temperature decreases, resume
charging.
Symptom 2.5: The defibrillator/monitor operates with battery power even

thought the AC power is connected.
AC/DC line power cord 1. Turn off the device then turn
on again.
2. Connect AC power cord
properly.
3. Check AC/DC in LED is
lighted.
4. Check battery charging status
icon is displayed.
Symptom 2.6: The defibrillator/monitor is suddenly turned off even thought the
AC power is connected.
AC/DC line power cord Turn off the device then turn on
again to check the AC power is
supplied properly.
87
Symptom 2.7: The defibrillator/monitor does not turn on though external DC
power is connected.
External DC module Replace External DC module
1. If DC connector cable is
disconnected, connect the cable
DC connector cable properly.
2. If DC connector cable is cut,
replace the cable.
Charger board Replace charger board.
3. Display
Symptom 3.1: The screen is deemed.

LCD back light cable 1. If LCD back light cable is
properly.
2. If cable is cut, replace the
cable.
LCD Replace LCD.
Symptom 3.2: Display is deformed.

LCD cable 1. If LCD cable is disconnected,
connect the cable properly.
2. If LCD cable is cut, replace
the cable.
board.
LCD Replace LCD.
Symptom 3.3: Some pixels or lines are gone.

LCD cable 1. If LCD cable is disconnected,
2. If LCD cable is cut, replace
the cable.
board.
LCD Replace LCD.
88

4. Sound
Symptom 4.1: Audio is too low or absent.

Volume setting 1. Check volume setting.
2. Change to AED mode to check
voice prompt sounds.
Speaker cable 1. If the cables are disconnected,
connect the cables properly.
2. If the cables are cut, change
the cables.
Speaker or main board Replace speaker or main board.
Symptom 4.2: No alarm is generated.

Alarm OFF key If Alarm OFF key is pressed, no
alarm is generated. Press Alarm
OFF key again.
Audio off time setting If audio off time is set to
indefinite, no alarm is generated.
Cancel the indefinite audio off
time set in service menu.
Speaker Replace speaker.
5. Controls
Symptom 5.1: Soft keys, Multi function knob and menu keys control failure.
Soft key and Multi function knob 1. If the cable is disconnected,
connection cable connect the cable properly.
2. If the cable is cut, change the
cable.
Front board and main board 1. If the cable is disconnected,
cables.
Front board Replace front board.
Symptom 5.2: Mode select knob failure.

Mode select knob cable 1. If the cable is disconnected,
cable.
89
cable.
6. NIBP
Symptom 6.1: The cuff does not inflate.

Battery status If the batter status is “Low
battery” or “Critically low
battery”, replace it with fully
charged battery or connect
AC/DC power.
Cuff or Cuff hose If cuff or cuff hose is folded,
unfold the cuff or cuff hose.
NIBP tube inside of the Check the tube assembly
defibrillator/monitor between NIBP module and hose
fitting.
NIBP module Replace the NIBP module.
7. SpO2
Symptom 7.1: The SpO2 sensor LED does not light.

SpO2 sensor and extension cable If the connection between SpO2
connection sensor and extension cable is
loose, reconnect sensor and
extension cable.
SpO2 sensor If SpO2 sensor is broken, replace
the SpO2 sensor.
SpO2 PI cable If SpO2 PI cable is broken,
replace the SpO2 PI cable.
SpO2 module Replace the SpO2 module.
Symptom 7.2: No display on the numeric area or waveform though sensor is in

normal operation.
SpO2 PI cable If SpO 2 PI cable is broken,
replace the SpO2 PI cable.
SpO2 module Replace the SpO2 module.
90

8. Temperature
Symptom 8.1: Temperature value does not display.

Sensor connection Check the connection of
temperature sensor to the skin.
Temperature module Replace the temperature
module.
9. Respiration
Symptom 9.1: Respiration value or waveform does not display.

Electrodes If electrodes are not attached
tightly, attach the electrodes
properly to skin.
ECG connector cable 1. If the cable is disconnected,
cable.
ECG board Replace ECG board.
10. Capnography
Symptom 10.1: Flow rates fall and function is not working properly.
Pump If pump is not working properly,
check CO2 module.
EtCO2 isolation board Replace EtCO2 isolation board.
11. ECG
Symptom 11.1: QRS beeper inaudible or beeps do not occur with each QRS
complex.
Beep volume setting If the QRS volume is configured
to OFF or the setting is too low,
configure the beep volume.
Lead If the amplitude of the QRS
complex is too small to detect,
select a different lead.
91
Symptom 11.2: Poor ECG signal quality (noisy trace, wandering baseline, etc.)
from signal acquired through monitoring electrodes.
Electrodes connection with patient 1. Check that the monitoring
electrodes are properly applied.
If necessary, prepare the
patient's skin and apply new
electrodes.
2. Check the date code on the
electrodes. Do not open the
electrode package until
immediately prior to use.
Power noise Check the connecting condition
between ground and product.
ECG cable Run the Operational check with
the ECG cable. If the test fails,
run it without the ECG cable. If
the test passes, replace the
cable. If not, remove the device
from use and call for service.
Symptom 11.3: Poor ECG signal quality (noisy trace, wandering baseline, etc.)
from signal acquired through paddles/pads.
Paddles/pads connection with Ensure proper skin preparation
patient. and correction application. If
necessary, apply new pads.
Pads condition If the pads are dried-out, check
the date code on the pads. Do
not open the pads package until
immediately prior to use.
Power noise Check the connecting condition
between ground and product.
Paddles/pads cable 1. If the cable is disconnected,
cable.
Symptom 11.4: Solid flat line - no waveform, no Lead Off in operation.

Patient cable or leads 1. If the cable or leads are
properly.
2. If the cable or leads are cut,
change the cable.
ECG connector cable 1. If the cable is disconnected,
cable.
H/V board Replace H/V board.
92

Symptom 11.5: ECG value or waveform does not display.

Paddles/pads or Leads 1. Check the pads, paddles or
ECG cables are connected.
2. Check the pads, paddles, or
monitoring electrodes are
properly applied.
3. Check the desired lead is
selected.
Symptom 11.6: Lead select button does not respond.

Mode selection Lead select button does not
respond in AED mode. Exit AED
mode if appropriate condition.
Symptom 11.7: One or more controls do not respond (e.g., select lead or soft
keys).
Front membrane cable 1. If the cable is disconnected,
cable.
cable.
12. IBP
Symptom 12.1: No display on the numeric area or waveform though sensor is in
normal operation.
IBP connector cable 1. If cable is disconnected,
2. If cable is cut, change the
cable.
IBP module Replace IBP module.
93
13. Defibrillation and Pacing
Symptom 13.1: Pacing does not start.

Pacing energy If pacing energy is set to 0mA,
set the appropriate pacing
energy.
Pause key If pause key is pressed, press
pause key again to cancel.
Pacing rate in demand mode Set the pacing rate appropriately
for the patient heart rate. If the
patient heart rate is slower than
the selected pacing rate, pacing
function is operated
automatically.
ECG lead Connect lead properly.
Symptom 13.2: Pacing(energy output) failure.

Pads or paddle 1. Check the pads or paddles
are connected.
properly applied.
selected.
HV connector cable 1. If the cable is disconnected,
2. If the cable is cut, replace the
cable.
HV board Replace H/V board.
Symptom 13.3: HV capacitor charging does not start.

HV main cable 1. If the cable is disconnected,
cable.
HV capacitor cable 1. If the cable is disconnected,
cable.
Symptom 13.4: Defibrillation failure.

Pads or paddle 1. Check the pads or paddles
94


are connected.
properly applied.
selected.
HV connector cable 1. If the cable is disconnected,
cable.
14. Printer
Symptom 14.1: Paper won't move.

Battery status If the batter status is “Low
battery” or “Critically low
battery”, replace it with fully
charged battery or connect
AC/DC power.
Paper Reload paper or clear jam, If
paper is wet, replace with fresh,
dry paper.
Printer cable 1. If cable is disconnected,
2. If cable is cut, change the
cable.
Printer module or mecha Replace printer module or
mecha.
Symptom 14.2: Paper moves then stops.

Printer cover improperly latched. Latch printer cover properly.
Paper Reload paper or clear jam.
Symptom 14.3: Paper moves but printing is faint or absent.

Paper 1. Check that the paper is
installed correctly.
2. Use only recommended paper
type.
Printerhead temperature 1. If printerhead temperature is
approached maximum
recommended operating
temperature, wait until the
printer cools down and restart
95
printing.
2. If dirt on printerhead, clean
the printerhead.
Printer mecha or control board Replace printer mecha or control
board.
Symptom 14.4: Loud buzzing or grinding noise.

Printer cover Latch printer cover properly.
Printer Replace printer (include roller).
15. Technical Alarm Condition

When the defibrillator/monitor detects an error condition, the defibrillator/monitor will
attempt to show an error code on the display screen.
If such an error occurs during operation, the defibrillator/monitor will sound a low-
priority alarm. Audible alarm can be terminated by pressing ALARM button, but it
depends on error codes and conditions.
Table 25. Technical error codes provides a complete list of error codes and problem
identification.
If an error code occurs, take the following actions:

1. Turn defibrillator/monitor off, and then turn on again.
Note: If error code still appears, take defibrillator/monitor out of service and contact
Mediana Technical Service Department or your local representative for advice
on remedial action.
Table 25. Technical error codes

Error codes Conditions
EEE001 SpO2 module RAM error
EEE002 SpO2 module ROM/code integrity error
EEE003 SpO2 module bad CRC in communications
EEE004 SpO2 module bad communication message
EEE005 SpO2 module communication error, incorrect value
EEE006 SpO2 module calibration (offset) failure
EEE009 SpO2 module syntax communication error
EEE010 SpO2 module sensor error
EEE012 SpO2 module other hardware problem
EEE017 SpO2 module indicator that sensor appears defective
EEE050 SpO2 module intermittent error
EEE051 SpO2 module DigiCAL communication error
EEE255 SpO2 module invalid jumper selection
EEE256 SpO2 module beginning of packet missing
EEE257 SpO2 module packet start (SID) missing
EEE258 SpO2 module packet length error
EEE259 SpO2 module message length error
EEE260 SpO2 module packet contains unsupported key
96


EEE261 SpO2 module packet CRC error
EEE262 SpO2 module end of packet missing
EEE263 SpO2 module packet contains undefined key
EEE264 SpO2 module corrupted variable
EEE265 SpO2 module memory overflow
EEE266 SpO2 module bad pointer
EEE267 SpO2 module parameter value out-of-range
EEE268 SpO2 module reset detected
EEE269 SpO2 module unexpected value
EEE270 SpO2 module time out
EEE271 SpO2 module not ready/not initialized
EEE272 SpO2 module double fault
EEE273 SpO2 module data out of range error
EEE274 SpO2 module incompatible digiCAL sensor
EEE275 SpO2 module incorrect registration number
EEE276 SpO2 module sensor read failure
EEE277 SpO2 module sensor signature verification fails
EEE281 SpO2 module overflow/underflow
EEE282 SpO2 module sensor activation failure
EEE283 SpO2 module sensor write failure
EEE284 SpO2 module both HW and SW ECG triggers received
EEE285 SpO2 module host attempted read or close of sensor trend before
successful open
EEE286 SpO2 module host attempted redundant open of sensor trend
EEE287 SpO2 module sensor trend data unavailable for reading by host
EEE288 SpO2 module no more sensor trend data available for reading by
host
EEE289 SpO2 module sensor private label/host sensor key incompatible
EEE401 CO2 module RAM error
EEE402 CO2 module FLASH error
EEE403 CO2 module CRC error
EEE404 CO2 module pulse error
EEE405 CO2 module voltage error
EEE406 CO2 module current error
EEE407 CO2 module software error
EEE499 CO2 module error
EEE700 NIBP : NIBP module RAM error
EEE701 NIBP : NIBP module ROM error
EEE702 NIBP : Pressure sensor error
EEE703 NIBP : Offset error
EEE704 NIBP : A communication timeout with substitute CPU
EEE705 NIBP : NIBP internal error
EEE706 NIBP : NIBP module communication error
EEE801 Analog system ECG & respiration module error*
EEE802 Analog system temperature module error*
EEE803 Analog system error*
EEE804 Analog system SpO2 module communication error*
EEE901 Analog CPU communication error
EEE902 H/V charging error
EEE903 NAND flash error
EEE904 Battery communication error
EEE905 Printer communication error*
EEE906 Battery status checking error*
97
EEE907 RTC error*
EEE908 Printer Vp voltage or head temperature error
EEE910 Speaker error
Note: An asterisk (*) by an error code explanation in the above table indicates that an audible alarm
occurred by the error code cannot be silenced by pressing ALARM button.
98
Disassembly Guide
Performance Verification. Do not place the defibrillator/monitor into
operation after repair or maintenance has been performed, until all
Performance Tests and Safety Tests listed in Performance Verification
section of this service manual have been performed. Failure to perform
all tests could result in erroneous defibrillator/monitor readings.
Before attempting to open or disassemble the Ornage1
defibrillator/monitor, disconnect the power cord from the
Observe ESD (electrostatic discharge) precautions when working within
the unit.
General
This section describes disassembly procedures with detailed disassembly instructions
and illustrations. Disassembly Sequence Flow Chart that is used to access
replaceable parts of the defibrillator/monitor is illustrated in Figure 26. The boxes on
the flow chart represent the various components or sub-assemblies. A complete listing
of the available spare parts and part numbers is in Spare Parts section. Follow the
reverse sequence of the disassembly procedures for reassembly.
The defibrillator/monitor can be disassembled down to all major component parts,

including:
 PCB assemblies
 acquisition modules, the power supply assembly & the LCD assembly
 battery
 cables &wires
 cases
 printer
The following tools are required:

 small, Phillips-head (+) screwdriver
 medium, Phillips-head (+) screwdriver
 needle-nose pliers
99
D 500
Figure 26. Disassembly Sequence Flow Chart
Replacement Level Supported

The replacement level supported for this product is to the printed circuit board (PCB)
and major subassembly level. Once you isolate a suspected PCB, follow the
procedures in Disassembly Guide, to replace the PCB with a known good PCB. Check
to see if the trouble symptom persists, swap back the replacement PCB with the
suspected malfunctioning PCB (the original PCB that was installed when you started
trouble shooting) and continue troubleshooting as detected in this section.
Prior to Disassembly
1. Turn off the defibrillator/monitor by rotating Mode select knob.
2. Disconnect the defibrillator/monitor from the AC or DC power source.
Battery Replacement
1. Turn off the defibrillator/monitor and remove AC or DC power code/
2. Press the SMPS/battery push button on the rear panel of defibrillator/monitor.
3. Separate battery from defibrillator/monitor.
4. Replace new battery.
100

Side Option Case Disassembly (A)

This section describes the items that may be removed on the side option case
assembly.
Figure 27. Side option case disassembly (1)
Table 26. Part descriptions – Side option case disassembly (1)

Part Codes Descriptions
P1239 Parameter PCB
P1249 Parameter link PCB
S8007 Screw 3 x 6
S8093 Screw 3 x 25
T0598 Front case
T0599 Rear case
T0630 Side option case
W0496 Parameter data cable (25pin, ref: P1239-AUJ4, P1249-J1)
A1. Side option case disassembly

1. Remove 4 screws (3 × 25, S8093) on the side option case (T0630).
2. Remove 9 screws (3 × 6, S8007) on the rear case (T0599).
3. Separate rear case (T0599) from front case (T0598).
4. Disconnect parameter base data cable2 (W0496) from Parameter PCB (P1239).
5. Separate side option case (T0630) from side option cover (T0620).
101
Figure 28. Side option case disassembly (2)
Table 27. Part descriptions – Side option case disassembly (2)

A0366 NIBP hose
E4114 NIBP cuff connector (EU/AP/JP)
E4232 NIBP cuff connector (US)
P1072 IBP PCB
P1239 Parameter PCB
P1240 Temp PCB
P1241 EtCO2 PCB
P1242 Temp connector PCB
S8007 Screw 3 × 6
S8020 Screw 3 × 8 (tapping)
S8072 Screw 3 × 4
T0618 Side option connector
T0620 Side option cover
T0630 Side option case
W0153 IBP connector cable 1 (4pin)
W0154 IBP connector cable 2 (5pin)
W0450 EtCO2 cable (8pin, ref:P1241-J1)
W0495 Temp connector (7pin, ref:P1240-TJ3, P1242-TCJ1)
A2. Parameter PCB disassembly

1. Remove 1 screw (3 × 8, S8020) on the side option cover (T0620).
2. Separate parameter PCB (P1239) from the side option cover (T0620).
102

A3. Temp PCB disassembly

1. Remove 3 screws (3 × 4, S8072) on the parameter PCB (P1239).
2. Disconnect temp connector cable (W0495) from parameter PCB (P1239).
3. Remove temp connector cable (W0495) from side option connector (T0618).
4. Separate temp PCB (P1240) from parameter PCB (P1239).
A3. IBP PCB disassembly

2. Remove 4 screws (3 × 8, S8020) from IBP connector cable1 (W0153) and IBP
connector cable2 (W0154) on the side option connector (T0618).
3. Disconnect IBP connector cable1 (W0153) and IBP connector cable2 (W0154) from
parameter PCB (P1239).
4. Separate IBP PCB (P1072) from parameter PCB (P1239).
A4. EtCO2 PCB disassembly

2. Disconnect EtCO2 cable (W0450) from EtCO2 PCB (P1239).
3. Remove EtCO2 cable (W0450) from side option connector (T0618).
4. Separate EtCO2 PCB (P1241) from parameter PCB (P1239).
103
Front Case Disassembly (B)
This section describes the items that may be removed on the front case disassembly.
Figure 29. Front case disassembly (1)
Table 28. Part descriptions – Front case (1)

E9030 Speaker
P1233 Main PCB
P1236 HV PCB
T0598 Front case
T0599 Rear case
W0461 HV data cable (12pin, ref:P1233-CJ3, P1236-HJ2)
W0490 Charger power cable
W0491 HV connector cable
W0492 Charger data cable
104

B1. Front Case disassembly

1. Disconnect HV power cable (W0491) from HV PCB (P1236).
2. Disconnect charger power cable (W0490) from main PCB (P1233).
3. Disconnect HV data cable (W0461) from main PCB (P1233).
4. Disconnect charger data cable (W0492) and speaker cable (E9030) from main PCB
(P1233).
5. Remove 4 screw (3 x 8, S8020) from HV connector cable (W0491) and separate
from front case (T0598). Disconnect HV connector cable (W0491) from main PCB
(P1233).
6. Separate front case (T0598) from rear case (T0599).
105

M0007 SpO2 module
M0015 NIBP module
P1176 CPU PCB
P1233 Main PCB
P1245 ECG PCB
S8007 Screw 3 × 6
S8072 Screw 3 × 4
S8099 Screw 2.5 × 5
T0598 Front case
T4313 NIBP bracket
W0125 NIBP cable (16pin, ref: P1233-NJ2)
W0354 ECG connector cable (13pin, ref: P1245-MJ2, MJ3, MJ5)
W0456 LCD backlight cable (6pin, ref: P1233-LJ1)
W0468 Mode knob cable (9pin)
106


W0469 Printer cable 1 (4pin, ref: P1233-RJ1, M4065-CN1)
W0486 SpO2 PI cable
W0488 Front cable 1 (15pin, ref: P1233-UJ3, P1234-J3)
W0489 Front cable 2 (25pin, ref: P1233-UJ2, P1234-J4)
W0497 3G / Wi-Fi cable (20pin, ref : P1233-J5)
W0498 LCD cable (20pin, ref: P1233-LJ2)
B2. ECG PCB disassembly

1. Remove 3 screws (3 × 4, S8072) fastening main PCB (P1233) and ECG PCB
(P1245).
2. Disconnect ECG connector cable (W0354) from ECG PCB (P1245).
3. Remove 4 screws (3 × 8, S8020) fastening ECG connector cable (W0354) and front
case (T0598).
4. Separate ECG PCB (P1245).
B3. SpO2 module disassembly

1. Remove 2 screws (3 × 4, S8072) fastening main PCB (P1233) and SpO2 module
(M0007).
2. Remove 2 screws (2.5 x 5, S8099) fastening SpO2 PI cable (W0486) and front
case (T0598).
3. Separate SpO2 module (M0007).
B4. NIBP module disassembly

1. Remove 4 machine screws (3 × 4, S8072) fastening main PCB (P1233) and NIBP
bracket (T4313).
2. Disconnect NIBP cable (W0125) from main PCB (P1233).
3. Separate NIBP bracket (T4313) from main PCB (P1233).
4. Remove 3 screws (3 × 4, S8072) fastening NIBP bracket (T4313) and NIBP module
(M0015).
5. Separate NIBP module (M0015).
B5. CPU PCB disassembly

1. Remove 3 screws (3 × 4, S8072) fastening CPU PCB (P1176) and main PCB
(P1233).
2. Separate CPU PCB (P1176) from main PCB (P1233).
B6. Main PCB disassembly

1. Remove 4 screws (3 × 8, S8020) from main PCB (P1233).
2. Disconnect front cable 1 (W0488), front cable 2 (W0489), LCD cable (W0498), LCD
backlight cable (W0456), mode knob cable (W0468), 3G / Wi-Fi cable (W0497),
printer cable 1 (W4069) and printer cable 2 (W4070) from main PCB (P1233).
3. Separate main PCB (P1233) from front case (T0598).
107

P1234 Front PCB
P1243 Knob PCB
T0536 LCD window
T0598 Front case
B7. Front PCB disassembly

1. Remove 4 screws (3 × 8, S8020) fastening front PCB (P1234) and front case
(T0598).
2. Separate front PCB (P1234) from front case (T0598).
B8. Knob PCB disassembly

1. Remove 4 tapping screws (3 × 8, S8020) fastening knob PCB (P1243) front case
(T0598).
2. Separate knob PCB (P1243) from front case (T0598)
B9. LCD disassembly

1. Remove 5 screws (3 × 8, S8020) from the front case (T0598).
2. Separate LCD window (T0536) from front case (T0598).
108


M4065 Thermal printer module
M4066 Printer mecha
S8013 Screw 2 × 6
T0598 Front case
T0601 Printer case
B10. Thermal printer module disassembly

1. Remove 3 screws (2 × 6, S8013) from the printer case (T0601).
2. Disconnect printer cable1 (W0469) and printer cable2 (W0470) from thermal printer
module (M4065).
3. Separate thermal printer module (M4065) from front case (T0598).
B11. Printer case disassembly

1. Remove 4 screws (3 × 8, S8020) fastening printer case (T0601) and front case
(T0598).
2. Separate printer case (T0601) from front case (T0598).
B11. Printer mecha disassembly

3. Remove 2 tapping screws (2 × 6, S8013) from the printer case (T0601).
4. Separate printer mecha (M4066) from the printer case (T0601).
109
Rear Case Disassembly (C)
This section describes the items that may be removed on the rear case disassembly.
Figure 33. Rear case disassembly (1)
Table 32. Part descriptions – Rear case (1)

M0039 Wi-Fi module
M0057 3G module
M4074 3G antenna
M4075 Wi-Fi antenna
P1246 3G interface PCB
P1247 Wi-Fi interface PCB
S8070 Screw 3 × 8 (flat head)
T0625 Wireless cover
T0631 Wireless case
T0632 Wireless inner case
W0447 External DC connector (ref: P1237-J6)
C1. 3G or Wi-Fi interface PCB disassembly

1. Remove 2 screws (3 × 8, S8070) on wireless case (T0631).
2. Remove 4 flat head screws (3 × 6, S8075) on wireless inner case (T0632).
3. Disconnect external DC connector cable (W0447) from rear case (T0599).
4. Remove 2 screws (3 × 8, S8020) fastening wireless cover (T0625) and 3G or Wi-Fi
interface PCB (P1246 or P1247).
5. Separate 3G or Wi-Fi interface PCB (P1246 or P1247) from wireless inner case
(T0632).
110

Figure 34. Rear case disassembly (2)
Table 33. Part descriptions – Rear case (2)

E9030 Speaker
M2027 HV capacitor
P1236 HV PCB
P1237 Charger PCB
P1244 Battery connector PCB
S8007 Screw 3 × 6
T0599 Rear case
T0600 Inner case
T4395 Capacitor bracket
W0375 HV connector cable (15pin)
W0447 External DC connector
W0491 HV power cable (4pin, ref: P1237-J7, P1236-HJ1)
W0493 Battery connector cable (7pin, ref: P1237-J3,J4)
111
C2. HV capacitor disassembly
1. Remove 2 machine screws (3 × 6, S8007) fastening capacitor bracket (T4395) and
inner case (T0600).
2. Disconnect HV connector cable (W0375) from HV board (P1236).
3. Separate HV capacitor (M2027) from inner case (T0600).
C3. HV PCB disassembly

1. Remove 6 tapping screws (3 × 8, S8020) fastening HV PCB (P1236) and inner
case (T0600).
2. Disconnect HV power cable (W0491) from charger board (P1237).
3. Separate HV PCB (P1236) from inner case (T0600).
C4. Battery connector PCB disassembly

1. Remove 3 tapping screws (3 × 6, S8007) fastening battery connector PCB (P1244)
and inner case (T0600).
2. Disconnect battery connector cable (W0493) from charger PCB (P1237).
3. Separate battery connector PCB (P1244) from back side of inner case (T0600).
C5. Charger PCB disassembly

1. Remove 3 tapping screws (3 × 8, S8020) fastening charger PCB (P1237) and inner
case (T0600).
2. Separate charger PCB (P1237) from inner case (T0600).
C6. Speaker disassembly

1. Remove 2 tapping screws (3 × 8, S8020) on the rear case (T0599).
2. Separate speaker (E9030) from rear case (T0599).
C7. External DC connector disassembly

1. Release nut on the rear case (T0599).
2. Separate external DC connector (W0447) from rear case (T0599).
112

Figure 35. Paddle mounting plate disassembly
Table 34. Part descriptions – Paddle mounting plate

A0418 Paddle
A0419 D500 Paddle adult ass’y (Left and Right)
M4078 Paddle mounting resistor
S8007 Screw 3 x 6
T0599 Rear case
T0607 Paddle mounting plate
T1068 Paddle mounting locker x 8ea
T1069 Paddle mounting holder
113
T4397 Paddle ground
W0514 Paddle mounting cable
C8. Paddle mounting plate disassembly
1. Remove 4 flat head screws (3 × 6, S8075) on the rear case (T0599).
2. Separate paddle mounting plate (T0607) from rear case (T0599).
3. Remove 2 screws (3 × 6, S8007) from paddle mounting holder (T1069).
4. Separate paddle mounting holder (T1069) from paddle mounting plate (T0607).
5. Remove paddle mounting cable (W0514) from paddle mounting holder (T1069) and
paddle mounting resistor (M4078).
6. Remove 1 screw (3 × 6, S8007) from paddle mounting locker (T1068). Repeat 8
times to remove each mounting locker (T1068).
114

Figure 36. AC power supply (SMPS) disassembly
Table 35. Part descriptions – AC power supply (SMPS)

M0055 D500 AC power supply (SMPS) module
T0599 Rear case
T0605 AC power supply (SMPS) case top
T0606 AC power supply (SMPS) case bottom
W0398 AC power connector
W0487 Ground cable
C9. AC power supply (SMPS) disassembly

1. Remove 4 tapping screw (3 × 8, S8020) from AC power supply (SMPS) case top
(T0605).
2. Disconnect ground cable (W0487) from AC power supply (SMPS) module (M0055).
3. Push AC power connector (W0398) and separate from AC power supply (SMPS)
bottom case (T0606).
115
Figure 37. D500 Exploded view
116
Spare Parts
Follow local government ordinances and recycle instructions regarding
disposal or recycling of device components, including batteries.
General
Spare parts, along with part numbers, are shown in Table 36. Part list.
Obtaining Replacement Parts

Mediana Technical Service Department provides technical assistance information and
replacement parts. To obtain replacement parts, contact Mediana. Refer to parts by
the part names and part numbers Figure 38.
Figure 38. Exploded View – Spare Parts
117
Table 36. Part list
Item Part Code Description
1 T0645 Rubber stopper
NIBP cuff connector (EU/AP/JP) /
2 E4114/E4232
NIBP cuff connector (US)
3 T0618 Side option connector
4 W0153 IBP connector cable 1 (4pin)
5 W0154 IBP connector cable 2 (5pin)
6 W0450 EtCO2 cable (8pin)
7 T0620 Side option cover
8 P1239 Parameter connector PCB
9 P1241 EtCO2 PCB
10 P1072 IBP PCB
11 P1240 Temp PCB
12 P1242 Temp connector PCB
13 T0630 Side option case
14 T4397 Paddle ground
15 T0607 Paddle mounting plate
16 T0599 Rear case
17 E9030 Speaker
18 T0622 Battery lock button L
19 T4410 Spring lock Φ3.8
20 T0617 Battery lock case L
21 T0600 Inner case
22 P1236 HV PCB
23 T4395 Capacitor bracket
24 M2027 HV capacitor
25 T0623 Battery lock hook
26 T4409 Spring lock Φ4.2
27 T0616 Battery lock case R
28 T0621 Battery lock button R
29 P1237 Charger PCB
30 P1244 Battery connector PCB
31 P1248 Wireless connector PCB
32 T0632 Wireless inner case
33 T0644 USB cover
34 T0631 Wireless case
35 M0057/M0039 3G module / Wi-Fi module
36 P1246/P1247 3G interface PCB / Wi-Fi interface PCB
37 M4074/M4075 3G antenna / Wi-Fi antenna
38 T0625 Wireless cover
39 W0447 External DC connector
40 W0398 AC power wire
41 T4126 Ground pin
42 T0605 AC power supply (SMPS) case top
43 M0055 AC power supply (SMPS)
44 T0606 AC power supply (SMPS) case bottom
45 M0058 Li-ion battery
46 M0015 NIBP module
47 T4313 NIBP bracket (CPU cover)
48 T4394 LCD bracket
49 M4076 8.4" LCD
50 T0536 LCD window
51 M4065 Thermal printer module
52 T0624 Print door lock
118
Item Part Code Description
53 T0601 Printer case
54 M4066 Thermal printer mecha
55 T0602 Printer door
56 T0627 Mode knob
57 P1243 Mode knob PCB
58 P1234 Front PCB
59 T0642 Shock button
60 T0634 LED membrane
61 T0597 Front case deco
62 T0638 Front membrane (5key)
65 T0633 Multi function knob
66 T0598 Front case
67 W0354 ECG connector cable (13pin)
68 W0375 HV connector cable
69 W0486 SpO2 PI cable
70 P1233 Main PCB
71 M0007 SpO2 module
72 P1176 CPU PCB
73 P1245 ECG PCB
- A0343 Printer paper (80mm)
- A7225 D500 service manual
- A7226 D500 operator’s manual
Note: Please refer to the operator's manual for accessories.
119
120
Packing for Shipment
General Instructions
To ship the defibrillator/monitor for any reason, follow the instructions in this section.
Pack the defibrillator/monitor carefully. Failure to follow the instructions in this section
may result in loss or damage not covered by the Mediana warranty.
Prior to shipping the defibrillator/monitor, contact your supplier or the Mediana office
(Technical Service Department) for a returned goods authorization (RGA) number.
Mark the shipping carton and any shipping documents with the returned goods
authorization number.
Pack to shipping the defibrillator/monitor, contact your supplier or the Mediana office
(Technical Service Department) for a returned goods authorization number. Mark the
shipping carton and any shipping documents with the returned goods authorization
(RGA) number. Return the defibrillator/monitor by any method that provides proof of
delivery.
Returning the Defibrillator/Monitor

Contact Mediana Technical Service Department for shipping instructions, including a
Returned Goods Authorization (RGA) number. Unless otherwise instructed by
Mediana Technical Service Department, it is not necessary to return the sensor or
other accessory items with the defibrillator/monitor. Pack the defibrillator/monitor in its
original shipping carton. If the original carton is not available, use a suitable carton
with appropriate packing material to protect it during shipping.
Repacking In Original Carton

If available, use the original carton and packing materials. Pack the
defibrillator/monitor as follows:
1. Place the defibrillator/monitor and, if necessary, accessory items in original

packaging.
2. Place in shipping carton and seal carton with packaging tape.
3. Label carton with shipping address, return address and RGA number, if
applicable.
121
Repacking In a Different Carton
If the original carton is not available, use the following procedure to pack the
defibrillator/monitor:
1. Place the defibrillator/monitor in a plastic bag.

2. Locate a corrugated cardboard shipping carton with at least 200 pounds per square
inch (psi) bursting strength.
3. Fill the bottom of the carton with at least 2 inches of packing material.
4. Place the bagged defibrillator/monitor on the layer of packing material and fill the
box completely with packing material.
5. Seal the carton with packing tape.
6. Label the carton with the shipping address, return address, and RGA number, if
applicable.
122
Specification
Display
Screen Size 8.4” measured diagonally across the TFT-LCD screen
Screen Type Liquid Crystal Display (LCD) Color
Size 170 x 128 mm
Number of Traces 4 waveforms
Controls
Multi function knob; Mode select knob (Off, AED, Manual,
Pacing and Monitor); 11 buttons (Shock, Energy Level,
Standard
Charge, Analyze, NIBP, LEAD, Alarm, Size, Print, Rate,
mA); 5 soft key
Alarms
Categories Patient Status and System Status
Priorities Low, Medium and High Priorities
Notification Audible and Visual
Setting Default and Individual
Alarm Volume Level 45 to 85 dB
Distributed Alarm Less than 3 sec.
System Delay
Physical Characteristics and Printer

Instrument
Dimensions 340 × 305 × 210 (mm) (W×H×D) including battery and
excluding paddles, options and accessories
Weight Approx. 6.16 (kg) including battery and excluding paddles,
options and accessories.
Degree of Protection ECG: Type CF with defibrillator protection
against Electric SpO2: Type CF with defibrillator protection
Shock Temperature: Type CF with defibrillator protection
EtCO2: Type CF with defibrillator protection
NIBP: Type CF with defibrillator protection
IBP: Type CF with defibrillator protection
Paddle: Type BF with defibrillator protection
Pads: Type BF with defibrillator protection
Mode of Operation Continuous
Classification Class IIb (MDD Annex IX Rule9:MEDDEV 2.4/1 Rev.9)
Printer
Type Thermal
Weight 190 g
Number of Channels 1 to 3 channels
Paper Type Thermal
Paper Width 80 mm
Printer Speed 25 mm/sec, 50 mm/sec
123
Electrical
Instrument
Power Requirements AC Mains
100 to 240 V, 50/60 Hz, 120 - 130VA
DC Mains
18Vdc, 7.0A with DC/DC adapter, Model:MDD150-1218
(MDD150-1218: Input: 12-16Vdc, 160 - 160VA,
Output: 18Vdc, 7.0A)
Note: For 120 Volt applications, use only UL Listed detachable power cord with
NEMA configuration 5-15P type (parallel blades) plug cap. For 240 Volt
applications use only UL Listed Detachable power supply cord with NEMA
configuration 6-15P type (tandem blades) plug cap.
Battery (option)
Type Li-ion battery
Dimension 150 × 90 × 20 (mm) (W×H×D)
Voltage/Capacity 4S2P 14.4V/5200mAh
Discharge A minimum of 200 shocks at 200 Joules (per battery)
Operating time 5 hours (per battery), 10 hours (with two batteries)
At the following condition:
no printing
no external communication
no audible alarm sound
room temperature : 25°C
Recharge Over 8 hours with defibrillator/monitor turned on/off
(It would take about 8 hours to fully charge the battery from
the moment that low battery alarm is activated.)
6 months, new battery fully-charged
(- The battery life cycle may vary with the number of
recharging, operating temperature, and storage condition.
Typically, about 80% capacity of battery may remain after
300 cycles of recharge. If one cycle of recharging would be
Life Cycle about 2 or 3 days, the battery may have 80% capacity after
about 24 months.
- The battery is designed not to be charged for safety
reason when it reaches 40°C.)
After 2 months storage the defibrillator/monitor would run
for 50% of stated battery life.
124
Environmental Conditions
Operation
Temperature 0 to 50°C (32 to 122°F)
Humidity 15 to 95% RH, non-condensing
Altitude -170 to 4,877m (-557 to 16,000 ft)
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
Note: The battery will not be charged for safety if the operating temperature
exceeds 40°C.
Shipping and Storage (in shipping container)
Temperature −20°C to 70°C (−4°F to 158°F)
Humidity 15 to 95% RH, non-condensing
Altitude -304 to 6,096m (-1,000 to 20,000ft)
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
125
Tone Definition
High Priority Alarm Tone
Volume level Adjustable (level 1~8)
Pitch (± 48.8Hz) 976 Hz
Pulse width (± 10ms) 210 ms
Number of pulses 10 pulses per 4 sec, 10 sec inter burst
Repetitions Continually
Medium Priority Alarm Tone
Pitch (± 34.85Hz) 697 Hz
Pulse width (± 10ms) 210 msec
Number of pulses 3 pulses per 1 sec, 15 sec inter burst
Low Priority Alarm Tone
Pitch (± 9.4Hz) 488 Hz
Number of pulses 1 pulse per 0.25 sec, 30 sec inter burst
Alarm Reminder Tone
Volume level Not changeable
Pitch (± 40Hz) 800 Hz
Number of pulses 1 pulse per 1 sec, 3 min, 10 min inter burst
HR/PR Tone
Volume level Not changeable
650 Hz (ECG)
Pitch (± 32.5Hz)
(162 + 5*SpO2) Hz
Number of pulses N/A
Repetitions No repeat
Key Beep
Volume level Adjustable (Off, level 1~7)
Pitch 440 (± 22) Hz (valid)
168 (± 8.4)Hz (invalid)
Number of pulses N/A
Repetitions No repeat
126
Measurement Parameters
Pacing Mode
Pacing Mode
Pacing rate Variable from 30 bpm(ppm) to 180 bpm(ppm) ± 1.5%
(increments or decrements by a value of 2
bpm(ppm))
Resolution 2 bpm(ppm)
Accuracy ± 1.5 %
Output current 0 mA to 140 mA
Resolution 2 mA
Accuracy ± 5% or 5 mA, whichever is greater.
Pulse Type 40 msec constant current pulse
Pulse Amplitude Variable 0 mA to 140 mA ± 5% or 5 mA, whichever is
greater. Digitally displayed on the defibrillator/monitor
(increments or decrements by a value of 2 mA)
Defibrillator
AED mode
Lead Lead ll
Patient Impedance 25 to 175 Ω
Heart Rate 20 to 300 BPM
Accuracy 1 per min
Detection V/F ≤ 200 µV
V/T ≤ 160 per min
Shock Analysis Time < 10 seconds typical
Charging Time to 200J* Within 6 seconds with rated main voltage/DC main
voltage
Within 7 seconds with fully charged battery
*Charging time for other cases, refer to defibrillator (technical specification)
Manual Mode
Shock Energy Level External paddles:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100,
125, 150, 175, 200, 300, 360 J
Automatic Discharge Time 60 seconds
Charging Time to 200J* Within 6 seconds with rated main voltage/DC main
voltage
Charging time to 360J Within 8 seconds with rated main voltage/DC main
voltage
*Charging time for other cases, refer to defibrillator (technical specification)
127
ECG
Heart Rate
Measurement Range 0, 20 to 300 BPM
Resolution 1 BPM
Accuracy ± 10% or ±5 bpm, whichever is greater
Average Response Time 5 seconds (from 80 to120 BPM)
9 seconds (from 80 to 40 BPM)
Tall T-wave Rejection maximum T-wave amplitude 1.8 mV
ECG (Electrocardiograph)
Leads 3 / 5 / 12 Lead
Lead I, II, III, aVR, aVL, aVF, V, V1, V2, V3, V4, V5,
V6, Paddle, Pads
Lead Off Detection Detected and displayed
Pacer Detection Detect pacer pulses of ±2mV to ±700mV with pulse
widths of 0.1 to 2msec and rise times 10% of width
not to exceed 100msec
Input
Input Impedance 5 Mohm or more
Input Dynamic Range ±5 mV AC, ±300 mV DC
Voltage Range ±0.5 mV ~ ±5 mV
Signal Width 40 to 120 ms (Q to S)
Output
Filter mode 0.5 to 21 Hz
0.05 to 40 Hz
1 to 21 Hz
ECG Size Auto, 5.0, 10.0, 15.0, 20.0, 30.0 mm/mV
Display Sweep Speeds 25.0 mm/sec
Wave Size x0.5, x1, x1.5, x2, x3
Display Sensitivity 10 mm/mV (×1)
Pacing Pulse Detection On, Off
Electrode Disconnect Alarm Display and/or sound
CMRR 90 dB or more
Defibrillator Discharge <5 sec per IEC60601-2-27
Recovery
Defibrillator Protection Protected
ECG (Arrhythmia Supplemental Information as required by AAMI EC13)
Respiration, leads-off amp 0.03 µA
sensing, and active noise common 0.25 µA
suppression
Tall T-wave rejection Maximum T-Wave amplitude 1.8 mV
capability
Accuracy of input signal Displacement: 0.1 mV
reproduction Slope: 0.1 mV/s
Heart rate meter accuracy Provides correct heart rates, as follows:
and response to irregular Ventricular bigeminy: 79 to 83 bpm
rhythm Slow alternating ventricular bigeminy: 51 to 63 bpm
Rapid alternating ventricular bigeminy: 119 to
121bpm
Bidirectional systoles: 82 to 94 bpm
Response time of heart rate HR change from 80 to 120 bpm: 3.16 sec
meter to change in heart HR change from 80 to 40 bpm: 3.05 sec
rate
128
Time to alarm for Vent Tachycardia 1 mVpp, 206 bpm:
tachycardia Amplitude 0.5mV, Alarm activated time 6.79 sec
Amplitude 1mV, Alarm activated time 9.80 sec
Amplitude 2mV, Alarm activated time 8.19
Vent Tachycardia 2 mVpp, 195 bpm:

Time to alarm for cardiac Average: 3.28 sec
standstill
Time to alarm for heart rate Low heart rate: average:5.48 sec
High heart rate: average: 5.30 sec
Time base selection and 10 successive peaks: 10 mm
accuracy 20 successive peaks: 20 mm
40 successive peaks: 40 mm
Pacemaker pulse rejection Rejection of pacemaker pulses with amplitudes from
capability ±2mV to ±700mV with pulse widths of 0.1 to 2msec
Overshoot time constant 4 ms, Test method B (with
overshoot)
Pacer pulse detector Slew rate: 595mV/s
rejection of fast ECG signals
Respiration
IM Respiration
Technique Impedance Pneumography
Range 0, 3 to 120 breaths/min
Resolution ±3 breaths/min
Leads RA to LA
Base impedance 500 to 2000 Ω
Delta impedance 0.5 to 3 Ω
Lead Off Condition Detected and displayed
Display Sweep Speeds 25 mm/s
Wave Size x0.5, x1, x1.5, x2
AW Respiration
Technique Nondispresive Infrared Spectroscopy
Range 0 to 150 breaths/min
Accuracy ±1 breaths/min
129
NIBP
Pulse Rate
Pulse Rate Range Adult/Pediatric 40 to 200 BPM
Neonatal 40 to 240 BPM
Resolution 5 BPM
Pulse Rate Accuracy ±2 BPM or ±2%, whichever is greater
NIBP (Non-Invasive Blood Pressure)
Technique Oscillometric Measurement
Measurement Modes Off, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 minutes
Measurement Range Adult/Pediatric
SYS 60 to 250 mmHg
MAP 45 to 235 mmHg
DIA 40 to 200 mmHg
Neonatal
SYS 40 to 120 mmHg
MAP 30 to 100 mmHg
DIA 20 to 90 mmHg
NIBP Accuracy Mean error and standard deviation per ANSI/AAMI
SP10:2002+A1:2003+A2:2006, IEC 60601-2-30:2009,
EN 1060-4:2004
Pressure Display Range Adult/Pediatric 0 to 300 mmHg
Neonatal 0 to 150 mmHg
Pressure Display Within ±3 mmHg or 2%
Accuracy
Initial Cuff Inflate Adult/Pediatric
Pressure 120, 140, 160, 180, 200, 220, 240, 260, 280 mmHg
(16.0, 18.7, 21.3, 24.0, 26.7, 29.3, 32.0, 34.7, 37.3 kPa)
Neonatal
80, 90, 100, 110, 120, 130, 140 mmHg
(10.7, 12.0, 13.3, 14.7, 16.0, 17.3, 18.7 kPa)
Automatic Cuff Deflation Measurement time exceeding 180s in adult/pediatric
(90s in neonatal) or maximum pressure value
exceeding 300 mmHg in adult (150 mmHg in neonatal).
Overpressure Protector Adult/Pediatric: 300 mmHg
Neonatal: 150 mmHg
Measurement Speed About 20 seconds
At the following condition:
Adult
Cuff size 12 cm
SYS 120 mmHg
MAP 90 mmHg
DIA 80 mmHg/ PR 80 BPM
Manual Measurements (180 mmHg)
130
IBP
Pulse Rate
Pulse Rate Range 20 to 250 BPM
Accuracy ± 1 % or ± 1 bpm
Pulse Rate Resolution 1 BPM
IBP (Invasive Blood Pressure)
Parameter Displayed P1, ABP
P2, CVP, PAP, LAP
Measurement Range -50 mmHg to 300 mmHg
20 bpm to 250 bpm
Resolution 1 mmHg
Accuracy ± 3 mmHg
Input sensitivity 5µV/V/mmHg
Transducer Volume 0.1mm3/100mmHg
Displacement
Zero calibration range ± 100mmHg
Frequency response DC - 10 Hz ± 1 Hz, -3db
Wave Size 0 to 50, 0 to 100, 0 to 200, 0 to 300, Auto Size
Display Sweep Speeds 25.0 mm/s
SpO2
Measurement Ranges
SpO2 saturation range 1% to 100%
Pulse rate range 20 to 300 beats per minute (bpm)
Perfusion range 0.03% to 20%
Display sweep speed 25.0 mm/s
Measurement Accuracy
Pulse rate accuracy 20 to 250 beats per minute (bpm) ±3 digits
SpO2 saturation accuracy 70% to 100% ±2 digits, neonates: ±3 digits
Note: SpO2 saturation accuracy - Monitoring system measurements are statistically
distributed; about two-thirds of monitoring system measurements can be
expected to fall in this accuracy (ARMS) range. Reference the Clinical Studies
section for test results. For a complete listing of SpO2 accuracy across the full
line of available Nellcor™ sensors, contact Covidien, a local Covidien
representative, or locate it online at www.covidien.com.
Operating Range and Dissipation
Red Light Wavelength Approximately 660 nm
Infrared Light Wavelength Approximately 900 nm
Optical Output Power Less than 15 mW
Power Dissipation 52.5 mW
131
Capnography
Capnography
Parameter Displayed EtCO2, InCO2
Range 0 mmHg ~ 150 mmHg (0kPa ~ 20kPa, 0% ~ 20%)
Accuracy 0-40mmHg ±2mmHg of reading
41-70mmHg ±5% of reading
(No degradation due to respiration rate or
Inspiration/Expiration ratio (I/E ratio))
Display Accuracy ±2mmHg
Response Time Mainstream: Less than 60msec
Sidestream: Less than 3sec
Baromatric Pressure -152.4 to 4572 meters
Correction (-500 to 15,000 feet),
775 to 429 mmHg, Automatic
Gas Compensation User selective at O2 >60% and N2O >50%
Stability and drift Short term drift: Less than 0.8 mmHg over 4 hours.
Long term drift: Accuracy specification will be
maintained over a 120 hour period.
Accuracy Change for 0-40 mmHg ±1 mmHg additional error
interfering Gases and 41-70 mmHg ±2.5% additional error
Vapors Anesthetic and 71-100 mmHg ±4% additional error
interfering agents 101-150 mmHg ±5% additional error
Additional worst case error when compensation for O2

and N2O is correctly selected for actual fractional gas
constituents present.
Warm Up Time 2 minutes maximum
Sweep Speeds 25.0 mm/s
Sampling rate 100Hz
Sound Noise Level Less than 41dB when ambient sound pressure level is
22dB
Note: Respiration rate accuracy was verified by using a solenoid test setup to
deliver a square wave of known CO2 concentration to the device. 5% and
10% CO2 concentrations were used and respiration rate was varied over the
range of the device. Pass/Fail criteria was comparison of the respiratory rate
output from the sensor to the frequency of the square wave. EtCO2
measurements at those rates were compared to the CO2 readings under
static flow conditions.
132
Temperature
Thermistor Temp
Probe Type YSI 400 series and YSI 700 series Probes
Measurement Method Thermistor
Operating Mode Direct
Range 0 to 50°C (32.0 to 122°F)
Display Accuracy ±0.1
Probe Accuracy YSI 400 series and YSI 700 series Probes:
±0.1°C from 25 to 45°C,
±0.2°C from 0 to 25°C and from 45 to 50°C
Transient Response Time About 17 sec
Event
Type 12 lead, Event
Data storage Internal memory, SD card
Memory 12 lead
saves total 100 data
saves ECG waveform
saves ECG analysis result data
saves ECG analysis date and time
saves HR/PR, NIBP, SpO2, Respiration,
Temperature, IBP 1, IBP 2, EtCO2 numeric data
saves alarm condition
Event
saves total 250 data
saves defibrillation shock information (number of
shock, energy level, actual passed energy,
impedance)
saves pacing information (pace rate, pace current,
fixed mode)
saves clinical action list
saves 1 channel ECG waveform
saves Event date and time
saves HR/PR, NIBP, SpO2, Respiration,
Temperature, IBP 1, IBP 2, EtCO2 numeric data
saves alarm condition
133
Defibrillator (Technical Specification)
AED Mode
AED Mode
Charging Time - 200J Charging condition Time (sec)
With Rated Mains Voltage 5.8
With DC Mains Voltage 5.9
With fully charged battery 6.4
Charging Time - 200J Charging condition Time (sec)
(including time from the With Rated Mains Voltage 18.1
initiation of rhythm With DC Mains Voltage 18.4
analysis with a clear ECG With fully charged battery 19.3
signal to readiness for With Mains Voltage of 90% of the Rated
discharge.) 18.1
value
With DC Mains Voltage of 90% of the
18.8
Rated value
After 15 maximum energy discharges
19.6
taken from a new fully charged battery
With Mains Voltage of 90% of the Rated
value, but measured from initially
26.4
switching power on to ready for
discharge at maximum energy
Rated value, but measured from initially
26.3
switching power on to ready for
taken from a new fully charged battery,
but measured from initially switching 26.7
power on to ready for discharge at
maximum energy
Note: A used battery normally takes more time than the
charging time specified in above.
Waveform parameters The defibrillator/monitor delivers shocks to load
impedances from 25 to 175 ohms. The duration of each
pulse of the waveform is dynamically adjusted based on
delivered charge, in order to compensate for patient
impedance variations, as shown below:
(When 200J is selected)
Load resistance (Ω) Delivered energy(J)
25 195
50 200
75 196
100 199
125 199
150 200
175 200
134
Manual Mode
Manual Mode
Charging Time – 200J Charging condition Time (sec)
With Mains Voltage of 90% of the
5.8
Rated value
6.4
Rated value
6.6
Rated value, but measured from
11.7
initially switching power on to ready for
11.9
maximum energy
Charging Time – 360J Charging condition Time (sec)
7.4
Rated value
8.0
Rated value
8.5
13.0
14.0
maximum energy
Number of discharges The number of maximum energy discharges which are
available from a new and fully charged battery at 20°C
135
ambient temperature is above 200 times for 360J and
250 times for 200J
ECG Analysis Performance
Rhythm class AHA-DB MIT-DB CU-DB VF-DB Total number of

sample size
VF-shockable: TP 1013 22 280 915 2230
VF-shockable: FN 47 0 11 70 128
VF-shockable: 95.57 100.00 96.22 92.89 94.57
sensitivity(%)
VT-shockable: TP - - - 716 716
VT-shockable: FN - - - 73 73
VT-shockable: - - - 90.75 90.75
sensitivity(%)
Non-shockable: TN 32471 17513 1268 6946 58198
Non-shockable: FP 0 2 5 33 40
Specificity(%) 100.00 99.99 99.61 99.53 99.93
Positive Predictive 100.00 91.67 98.25 98.02 98.66
Value
Database for ECG Analysis
 From AHA (American Heart Association) official database

 From MIT (Massachusetts institute Technology) official database
(CU-DB: The Creighton University Sustained Ventricular Arrhythmia Database,
VF-DB: MIT-BIH Malignant Ventricular Arrhythmia Database)
ECG rhythm to determine if a shock is appropriate
 Ventricular Fibrillation at a amplitude greater than or equal to 0.2mV

 Ventricular Tachycardia at a heart rate greater than or equal to 160 bpm
136
Biphasic Waveform Characteristics
The efficiency of Mediana’s Biphasic waveform has been clinically verified during a
ventricular fibrillation (VF) and ventricular tachycardia (VT) defibrillation study. This
study (which was conducted using D500 defibrillator/monitors) and the findings are
described below.
Table 37. Delivered Energy at Every Defibrillator Settings into a Range of Loads
Selected Load
Accuracy
Energy 25 50 75 100 125 150 175
1J 1.0 1.0 1.0 1.0 1.0 1.0 1.0 15%
2J 2.0 2.0 2.0 2.0 2.0 2.0 2.0 15%
3J 3.0 3.0 3.0 3.0 3.0 3.0 3.0 15%
4J 4.0 4.0 4.0 4.0 4.0 4.0 4.0 15%
5J 5.0 5.0 5.0 5.0 5.0 5.0 5.0 15%
6J 6.0 6.0 6.0 6.0 6.0 6.0 6.0 15%
7J 7.0 7.0 7.0 7.0 7.0 7.0 7.0 15%
8J 8.0 8.0 8.0 8.0 8.0 8.0 8.0 15%
9J 9.0 9.0 9.0 9.0 9.0 9.0 9.0 15%
10J 11.0 10.0 10.0 10.0 10.0 10.0 10.0 15%
15J 16.0 15.0 15.0 15.0 15.0 15.0 15.0 15%
20J 21.0 20.0 20.0 20.0 20.0 20.0 20.0 15%
30J 31.0 30.0 30.0 30.0 30.0 30.0 30.0 15%
40J 41.0 40.0 40.0 40.0 39.0 39.0 39.0 15%
50J 51.0 50.0 50.0 50.0 49.0 49.0 49.0 15%
75J 77.0 76.0 75.0 75.0 74.0 74.0 74.0 15%
100J 102 101 101 100 99.0 99.0 99.0 15%
125J 127 126 126 124 124 122 123 15%
150J 152 151 150 150 148 147 148 15%
175J 177 174 173 173 173 172 172 15%
200J 203 198 200 199 198 197 197 15%
300J 304 302 300 298 296 297 296 15%
360J 370 371 365 363 363 356 356 15%
137
Figure through show the biphasic waveforms that are produced when the
defibrillator/monitor is discharged into loads of 25, 50, 75, 100, 125, 150 and 175
ohms at each energy setting (360, 300, 200, 175, 150, 125, 100, 75, 50, 40, 30, 20,
15, 10, 9, 8, 7, 6, 5, 4, 3,2 and 1 joule[s]).
The vertical axis shows the voltage in volts (V); the horizontal axis shows the duration
in milliseconds (ms).
Figure 39. Biphasic Waveforms at 360 Joules and 360 Joules
Figure 40. Biphasic Waveforms at 200 Joules
138
139
140
141
142
143
144
145
146
147
148
Compliance
Item Standard Description
Classification IEC60601-1:1988 Class I (on AC power)
+A1:1991+A2:1995, Internally powered (on battery power)
EN60601-1:1990+A1:1993
/AC:1994
Type of protection IEC60601-1:1988 Type BF and Type CF – Applied part
+A1:1991+A2:1995,
EN60601-1:1990+A1:1993
/AC:1994
Mode of operation IEC60601-1:1988 Continuous
+A1:1991+A2:1995,
EN60601-1:1990+A1:1993
/AC:1994
Degree of IEC60529:1989+A1:1999+A2 IP34 (provided by enclosures)
protection :2013,
EN60529:1991+A1:2000
+A2:2013
General 93/42/EEC as amended by Directives for medical devices
2007/47/EC
21CFR820 Code of federal regulations
2012/19/EU Waste electrical and electronic equipment
directive (WEEE)
2011/65/EU Restriction of the use of Hazardous
Substances in electrical and electronic
equipment II
93/86/EEC Battery disposal directive
2006/66/EC as amended by Battery directive
2008/103/EC
ISO13485:2003/Cor1:2009 Quality systems - Medical Devices -
EN ISO13485:2012 Requirements for regulating purposes
/AC:2012
ISO14971:2007, Risk analysis managements – medical
EN ISO14971:2012 devices
IEC60601-1:1988 General requirements for safety of medical
+A1:1991+A2:1995, electrical equipment
EN60601-1:1990+A1:1993
/AC:1994
IEC60529:1989+A1:1999+A2 Degree of protection provided by
:2013, enclosures (IP34)
EN60529:1991+A1:2000
+A2:2013
ISO14155:2011/Cor1:2011E Clinical investigation of medical devices for
N ISO14155:2011 human subjects – part 1: General
requirements
IEC60601-1-1:2000, Collateral standard for medical electrical
EN60601-1-1:2001 systems
IEC60601-1-6:2010, Collateral standard for usability
EN60601-1-6:2010
149
ISO 10993-1:2009/ Biological evaluation of medical devices –
Cor1:2010, Part 1: Evaluation and testing
EN ISO109931:2009
/AC:2010
ISO10993-5:2009, Biological evaluation of medical devices –
EN ISO10993-5:2009 Part 5: Tests for in vitro cytotoxicity
ISO10993-10:2010, Biological evaluation of medical devices –
EN ISO10993-10:2010 Part 10: Tests for irritation and delayed-
type hypersensitivity
IEC60601-2-49:2001, Particular requirements for multifunction
EN60601-2-49:2001 patient monitoring equipment
IEC62366:2007 Medical devices – Application of usability
EN62366:2008 engineering to medical devices
IEC62304:2006 Medical device software – Software life-
EN62304:2006/AC:2008 cycle processes
Ambulance EN1789:2007+A1:2010 Medical vehicles and their equipment –
road ambulance
EN13718-1:2008 Medical vehicles and their equipment – Air
ambulances – Part1:Requirements for
medical devices used in air ambulances.
RTCA/ DO-160 section 20, Environmental Conditions and Test
21 Procedures for Airborne Equipment
Alarms IEC60601-1-8:2006, Alarm systems requirements, tests and
EN60601-1-8:2007/AC:2010 guidance in medical electrical equipments
systems
Electrocardiograph IEC60601-2-27:2005, Particular requirements for the safety of
EN60601-2-27:2006 Electrocardiographic monitoring equipment
/AC:2006
IEC60601-2-25:1993 Particular requirements for the basic safety
+A1:1999 and essential performance of
EN60601-2-25:1995 electrocardiographs
+A1:1999
AAMI EC13:2002/(R)2007 Cardiac monitors, heart rate meters and
alarms
AAMI EC53:1995/®2008 ECG cable and leads
AAMI EC57:2012 Testing and reporting performance results
of cardiac rhythm and ST-segment
measurement algorithms
Non-invasive blood AAMI SP10:2002 Electronic or automated
pressure +A1:2003+A2:2006 sphygmomanometers
EN1060-3:1997 Supplementary requirements for electrical-
+A2:2009 mechanical blood pressure measuring
systems
EN1060-4:2004 Non-invasive sphygmomanometers - Test
procedures to determine the overall system
accuracy of automated non-invasive
150
sphygmomanometers
IEC60601-2-30:1999, Particular requirements for the safety,
EN60601-2-30:2000 including essential performance, of
automatic cycling indirect blood pressure
monitoring equipment
Oxygen saturation ISO9919:2005, Basic safety & essential performance of
EN ISO 9919:2009 pulse oximeter for medical use
Temperature EN12470-4:2000 +A1:2009 Performance of electrical thermometers for
monitoring continuous Measurement
Invasive blood IEC60601-2-34:2000 Particular requirements for the safety,
pressure EN 60601-2-34:2000 including essential performance, of invasive
blood pressure monitoring equipment
Capnography ISO21647:2004, Particular requirements for the basic safety
EN ISO 21647:2009 and essential performance of respiratory
gas monitors
Defibrillator IEC 60601-2-4:2002 Safety of cardiac defibrillators
EN 60601-2-4:2003
AAMI DF80:2003 Safety of cardiac defibrillators (including
automated external defibrillators)
Electromagnetic IEC60601-1, sub clause 36, Electromagnetic compatibility-requirements
compatibility and & test
IEC60601-1-2:2001
EN60601-1-2:2007
/AC:2010
IEC61000-3-2:2014 Harmonic emission Ed 3.2
EN61000-3-2:2014
IEC61000-3-3:2013, Voltage fluctuations/Flicker emission Ed 2.0
EN61000-3-3:2013
IEC61000-4-2:2008, Electrostatic discharge Ed 2.0
EN61000-4-2:2009
IEC61000-4- Radiated RF electromagnetic field Ed 3.1
3:2006+A1:2007+A2:2010
EN61000-4-3:2006
+A1:2008+A2:2010
IEC61000-4-4:2012 Electrical fast transient/burst Ed 2.1
EN61000-4-4:2012
IEC61000-4-5:2014, Surge current Ed 2.0
EN61000-4-5:2014
IEC61000-4-6:2013, Conducted disturbances, induced by RF
EN61000-4-6:2014 field Ed 3.0
IEC61000-4-8:2009, Power frequency (50/60Hz) magnetic field
EN61000-4-8:2010 Ed 2.0
IEC61000-4-11:2004, Voltage dips, short interruption and voltage
EN61000-4-11:2004 variation on power supply input lines Ed 2.0
CISPR11:2009 +A1:2010 Limits and methods of measurement of
EN55011: 2009 +A1:2010 radio disturbance characteristics of
industrial scientific and medical (ISM) radio-
151
frequency
equipment RF Emissions Group 1, Class B
CISPR22:2008 Information technology equipment - Radio
EN55022:2010/AC:2011 disturbance characteristics - Limits and
methods of measurement
Package ISTA (Procedure 1A, 2001) Pre-Shipment test procedures (Package)
IEC60068-1:2013 Environmental testing, Part1: General
EN 60068-1:2014 guidelines
IEC60068-2-1:2007 Environmental testing - Part 2-1: Tests -
EN60068-2-1:2007 Test A: Cold
EN60068-2-2:2007 Test B: Dry heat
EN60068-2-30:2005 Test Db: Damp heat, cyclic (12 h + 12 h
cycle)
Reliability IEC60068-2-27:2008, Environmental testing – Shock
EN60068-2-27:2009
IEC60068-2-6:2007, Environmental testing – Vibration
EN60068-2-6:2008
IEC60068-2-31:2008 Environmental testing: Rough handling
EN60068-2-31:2008 shocks, primarily for equipment-type
specimens
IEC60068-2-64:2008, Environmental testing: vibration, broad-
EN60068-2-64:2008 band random (digital control) and guidance
Labeling EN1041:2008 Information supplied by the manufacturer
with medical devices
Marking IEC /TR60878:2003 Graphical symbols for electrical equipment
in medical practice
ISO15223-1:2012 Symbols to be used with medical device
ENISO 15223-1:2012 labels, labelling and information to be
supplied -- Part 1: General requirements
ISO15223-2:2010 Symbols to be used with medical device
labels, labelling, and information to be
supplied -- Part 2: Symbol development,
selection and validation
ISO7000:2014 Graphical symbols for use on equipment-
index and synopsis
EN980:2008 Graphical symbols for use in the labeling of
medical devices
EN50419:2006 Marking of electrical and electronic
equipment in accordance with article II (2)
of directive 2002/96/EC (WEEE)
152
System Processing Description
System Overview
The D500 is a defibrillator and multi-function monitor. Manual and Automated external
defibrillation, External pacing and the other monitoring functions (Electrocardiography
(ECG), functional arterial oxygen saturation(SpO2), respiration(RESP),
temperature(TEMP), invasive blood pressure(IBP) and end tidal CO2(EtCO2)) are
intended for use on adult and pediatric patients. Non-invasive blood pressure is
intended for use on adult, pediatric and neonatal patients.
In addition to monitoring and displaying the status of these physiological parameters,
the instrument performs various microprocessor-programmed analytical functions;
 Creating both visual and audible alarm signals when settable limits are violated;
 Creating and displaying warning/error messages when conditions are detected that
would degrade or prevent valid measurements;
 Creating and displaying graphical or tabular trend data;
 Providing input to an optional recorder for printout of current or tabular trend data.
The defibrillator/monitor is essentially a battery-powered instrument. An internal

charging unit is designed to accept only an AC line voltage.
System Block Diagram
Figure 60. System Block Diagram
153
Unit Description
 Power unit: consists of power entry module, power supply, battery charger, battery,
external DC input and DC/DC unit.
Figure 61. Power Unit Block Diagram
 Main process unit: consists of Samsung S3C2440A ARM9 CPU, SDRAM and
Flash.
Figure 62. Main Process Unit Block Diagram
154
 Display unit: consists of Samsung S3C2440 CPU, SDRAM and Flash.
Figure 63. Display Unit Block Diagram
 User-control unit: consists of Multi function knob, 16 functional button, AC/DC

indicator LED and battery charging status indicator LED.
Figure 64. User-Control Unit Block Diagram
 Audio unit: 3-channel amplifiers and speaker.
Figure 65. Audio Unit Block Diagram
155
 Communication unit : 8-channel UART
Figure 66. Communication Unit Block Diagram
 GUI (graphic user interface) unit: consists of TFT LCD, inverter for backlit and
internal video controller.
Figure 67. GUI Unit Block Diagram
 Thermal Printer unit: prints data records.
Figure 68. Thermal Printer Unit Block Diagram
156
 NIBP unit: measures non-invasive blood pressure data.
Figure 69. NIBP Unit Block Diagram
 EtCO2 unit: measures EtCO2 data.
Figure 70. EtCO2 Unit Block Diagram
 ECG, Respiration and Defibrillation unit: measures electrocardiographic

waveform data.
Figure 71. ECG Unit Block Diagram
157
 SpO2 unit: measures oxygen saturation data
Figure 72. SpO2 Unit Block Diagram
 Temperature unit: measures temperature data.
Figure 73. Temperature Unit Block Diagram
 IBP unit: measures Invasive blood pressure waveform data.
Figure 74. IBP Unit Block Diagram
External Interface
 SD card : SD type for firmware and voice prompt update and real time data
download
 Wireless Communication : Wi-Fi, 3G Module
158
ECG Processing
The measurement of the skin surfaces electrocardiogram is based on the electrical
signals on the skin surface, produced as the heart muscle contracts and relaxes. The
signals are detected by electrodes placed on the patient body. The information on
heart activity carried by these signals varies with the placing of the electrodes.
The technique used in ECG senses the varying potential difference between two
points at the skin surface which respond to the chemical actions of the muscular
activity of the heart.
Three electrodes are attached to the patient’s right arm (RA), left arm (LA) and left leg
(LL). The varying potentials at these locations are cable-connected to the ECG circuit
inputs where they are conditioned, and the difference of potential between two
selected leads is digitized before transmitting through opto-isolators to the processor.
The processor-installed algorithms operate on the signals to develop drivers for the
graphic display and to compute the heart rate in beats per minute (bpm).
In addition to the acquisition of the QRS waveform complex, the ECG input and
subsequent signal processing computing circuitry perform a number of other
functions:
 They detect a lead-off condition if one of the electrode connections is disrupted.

 They detect the presence of pacemaker signals within the QRS waveform
complex of the ECG.
NIBP Processing
Overview
The oscillometric technique does not use Korotkoff sounds to determine blood
pressure. The oscillometric technique monitors the changes in cuff pressure caused
by the flow of blood through the artery. The defibrillator/monitor inflates the cuff to a
pressure that occludes the artery. Even when the artery is occluded, the pumping of
the heart against the artery can cause small pressure pulses in the cuff baseline
pressure. The defibrillator/monitor lowers cuff pressure at a controlled rate. As the cuff
pressure goes down, blood starts to flow through the artery. The increasing blood flow
causes the amplitude of the pressure pulses in the cuff to increase. These pressure
pulses continue to increase in amplitude with decreasing cuff pressure until they reach
a maximum amplitude at which point they begin to decrease with decreasing cuff
pressure. The cuff pressure at which the pulse amplitude is the greatest is known as
Mean Arterial Pressure (MAP). The manner in which the pulse amplitudes vary is
often referred to as the pulse envelope. The envelope is an imaginary line that
connects the peak of each pressure pulse and forms an outline. The shape of the
envelope is observed by the defibrillator/monitor using a variety of techniques to
determine the diastolic and systolic blood pressure.
159
MAP
● Oscillometric Response
Distole (Pressure Pulses)
Systole
TIME
Systole
Distole
Systole MAP
MAP ● Cuff Pressure
Distole
TIME
Overall Accuracy Discussion

Overall system accuracy shall be determined by considering various influences of the
pressure sensor accuracy, motion artifacts, other artifact created by pressure valve,
technical errors of electrical components, and the origin error of oscillometric method.
The origin error of oscillometric comes from the basic theory of that the MAP is
determined by the pulse. Therefore, there might be an error of the time between two
pulses. In another words, the greatest amplitude point of pulses could not represent
the MAP point exactly.
On clinical trial perspective, overall system accuracy is not easy to be determined.

The clinical trial test protocols have been tried and have been described in many
treatises, and international standards. So, there are many methods to determine the
overall system accuracy of Automated Sphygmomanometer using the oscillometric
method. But, there are no absolute test protocols to determine the overall system
accuracy of the Automated Sphygmomanometer using oscillometric method. Normally,
the Gold standards of Blood pressure for the reference are the intra-arterial pressure
and the auscultatory method.
The popular standard for the overall system accuracy is AAMI, SP-10 2002+A1;2003
(Electronic or automated sphygmomanometers).
The main test conditions are as follow:
A. Data comparing the Intra-arterial or the auscultatory by the clinical experts with
the automated sphygmomanometer.
B. For data collection and the data analysis, Bland-Altman Plot is used.
C. On the systolic, diastolic, and MAP, the Deltas of all measurements shall be met
under +/- 5mmHg of mean difference (MD), and +/- 8mmHg of standard deviation
(SD).
(Delta = Intra-arterial or Auscultatory – Automated sphygmomanometer)
160
SpO2 Processing
Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The
sensor contains a dual light source and photodetector. Bone, tissue, pigmentation,
and venous vessels normally absorb a constant amount of light over time. The
arteriolar bed normally pulsates and absorbs variable amounts of light during systole
and diastole, as blood volume increases and decreases. The ratio of light absorbed at
systole and diastole is translated into an oxygen saturation measurement (SpO2).
Because a measurement of SpO2 is dependent upon light from the sensor, excessive
ambient light can interfere with this measurement.
Pulse oximetry is based on two principles: that oxyhemoglobin and deoxyhemoglobin

differ in their absorption of red and infrared light (spectrophotometry), and that the
volume of arterial blood in tissue (and hence, light absorption by that blood) changes
during the pulse (plethysmography). The defibrillator/monitor determines SpO2 by
passing red and infrared light into an arteriolar bed and measuring changes in light
absorption during the pulsatile cycle. Red and infrared low-voltage light-emitting
diodes (LED) in the oximetry SpO2 sensor serve as light sources; a photo diode
serves as the photo detector. Because oxyhemoglobin and deoxyhemoglobin differ in
light absorption, the amount of red and infrared light absorbed by blood is related to
hemoglobin oxygen saturation. To identify the oxygen saturation of arterial
hemoglobin, the defibrillator/monitor uses the pulsatile nature of arterial flow. During
systole, a new pulse of arterial blood enters the vascular bed, and blood volume and
light absorption increase. During diastole, blood volume and light absorption reach
their lowest point. The defibrillator/monitor bases its SpO2 measurements on the
difference between maximum and minimum absorption (measurements at systole and
diastole). By doing so, it focuses on light absorption by pulsatile arterial blood,
eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous
blood.
161
Automatic Calibration
Because light absorption by hemoglobin is wavelength dependent and because the
mean wavelength of LEDs varies, an oximeter must know the mean wavelength of the
SpO2 sensor’s red LED to accurately measure SpO2. During monitoring, the
instrument’s software selects coefficients that are appropriate for the wavelength of
that individual sensor’s red LED; these coefficients are then used to determine SpO2.
Additionally, to compensate for differences in tissue thickness, the light intensity of the
sensor’s LEDs is adjusted automatically.
Measured versus Calculated Saturation

The measured SpO2 value from an oximeter may differ from the saturation value that
is calculated from a blood gas partial pressure of oxygen (PO2). This usually occurs
because the calculated saturation was not appropriately corrected for the effects of
variables that shift the relationship between PO2 and saturation: pH, temperature,
partial pressure of carbon dioxide (PCO2), 2, 3-DPG, and fetal hemoglobin.
pH
100
Temperature
PCO2
2,3-DPG
Fetal Hb
Saturation (%)
pH
50 Temperature
PCO2
2,3-DPG
0
50 100
PO2 (mmHg)
Figure 75. Oxyhemoglobin Dissociation Curve
Functional versus Fractional Saturation

The defibrillator/monitor measures functional saturation — oxygenated hemoglobin
expressed as a percentage of the hemoglobin that can transport oxygen. It does not
detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin
or methemoglobin. In contrast, hemoximeters such as the IL482 report fractional
saturation — oxygenated hemoglobin expressed as a percentage of all measured
hemoglobin, including measured dysfunctional hemoglobin. To compare functional
saturation measurements to those from an instrument that measures fractional
saturation, fractional measurements must be converted as follows:
functional saturation = fractional saturation × 100

100 – (%carboxyhemoglobin + %methemoglobin)
SpO2 Accuracy
The saturation (SpO2) accuracy specification and/or pulse rate (PR) performance
were analyzed by comparative oximetry performance (COPS) tests between
defibrillator/monitor SpO2 module and MP100 module with the same version of the
oximetry algorithm from Nellcor. This was to demonstrate that the performance of
defibrillator/monitor SpO2 module was equivalent to that of MP100, which had been
validated during both standard motion, combined motion and cold-induced peripheral
vasoconstriction (low perfusion) conditions by direct comparison to measurements of
arterial oxygen saturation (SpO2) obtained from arterial blood samples analyzed with
Instrumentation Laboratory (IL) CO-Oximeters under Nellcor’s clinical protocol,
Invasive Controlled Hypoxia Studies.
162
Respiration Processing
The respiration monitoring is designed to use the variation of this thoracic impedance.
The chest contains various materials, ranging from bone to air. Each of these
materials has different electrical properties and is located in a different portion of the
chest. The materials of the chest vary in electrical resistivity (the amount of electrical
resistance between opposite faces of a cube of that material), which is an important
determinant of electrical impedance in the body.
Two of the major components of the chest, blood and air, are at opposite ends of the
scale. Furthermore, the volume of each of these materials varies with time over the
cardiac and breathing cycles. The variation of the thoracic impedance is caused by
the difference between air and blood in the thoracic impedance. Blood has relatively
low resistivity, which varies over the cardiac cycle owing to changing blood volumes in
the heart and in the vascular compartment. Air, on the other hand, has high electrical
resistivity and hence impedance, and it undergoes wide volume changes in the lungs
during normal breathing. i.e. the impedance of blood is 150 Ω/cm and the one of air is
5000 Ω/cm.
The patient’s respiration is detected by using two of the three leads of the ECG
electrodes (RA and LA, or RA and LL) and cable. The electrical impedance between a
pair of electrodes is determined by dividing the voltage difference between the two
electrodes by the current that passes between them. When the electrodes are placed
on the actual structure, respective structures change.
A low-level excitation signal is applied to these leads, and the variation of the thoracic
impedance caused by the breathing is sensed and processed for display and
measurement. This variation is processed to the voltage value for the measurement.
In order to transfer the thoracic impedance by a transformer, it is used a minimum
constant current of the sine wave carrier signal. The transferred thoracic impedance is
changed to the voltage signal by using bridge circuit and differential amplifier. Then,
ECG signal is removed by filter, and carrier frequency is removed by full wave rectifier
and filter in order to extract only thoracic impedance in amplifying at the definite level
of signal. This extracted thoracic impedance signal is used to measure the respiration
by digital signal processing.
Temperature Processing
Measurement of patient temperature is accomplished by processing the signal from a
probe containing a resistor whose resistance is temperature dependent. The class of
such components is called thermistor.
Temperature measurement used by the defibrillator/monitor based on a thermistor

whose resistance is inversely proportional to its temperature. By measuring the
thermistor’s resistance, its temperature can be calculated. The resistance of the
thermistor is measured by passing a current through it and measuring the voltage
developed across it.
The defibrillator/monitor is designed to accept the signals from electrically isolated a
range of temperature probes from YSI-400 and YSI-700 series. The probes may be
used for skin or rectal temperature measurement. Probes are furnished with a
standard 10-feet lead; extension leads are available. The signal from the probe is
conditioned by the defibrillator/monitor input circuitry, processed, and used to drive the
numeric display.
163
Invasive Blood Pressure Processing
The pressure transducer is connected to a pressure line which, by means of a
catheter is invasively connected to the patient blood stream. The force of movement of
the blood in the patient vessels in transported by the fluid column in the pressure line
to the transducer. This movement cause an electrical signal to be generated which is
then amplified to display the pressure wave and the numeric for the systolic, diastolic
and mean pressure values.
The blood pressure is influenced by the respiratory system. This occurs in

spontaneous breathing patients, but is more apparent in positive pressure ventilated
patients. To reduce this respiration artifact the module uses a variable weight filter
technique in the processing of the pressure values.
Capnography Processing
The defibrillator/monitor CO2 sensor measures CO2 by using the infrared technique.
The principle is based on the fact that CO2 molecules absorb infrared (IR) light energy
of specific wavelengths, with the amount of energy absorbed being directly related to
the CO2 concentration. When an IR beam is passed through a gas sample containing
CO2, the electronic signal from the photodetector (which measures the remaining light
energy) is measured. This signal is then compared to the energy of the IR source and
adjusted to accurately reflect CO2 concentration in the sample. The
defibrillator/monitor CO2 sensor’s response to a known concentration of CO2 is stored
at the factory in the sensor’s memory. A reference channel accounts for optical
changes in the sensor, allowing the system to remain in calibration without user
intervention.
Defibrillation Processing
The defibrillator is energy-based, meaning that the defibrillator charges a capacitor to
an appropriate level of voltage (either by an operator or automatically) and upon
initiation of the shock (automatically or upon the press of a button) current is delivered
directly to the heart to interrupt the arrhythmia and restore normal conduction. The
defibrillator delivers energy in a biphasic waveform by paddle or pads. With a biphasic
waveform, current is delivered to the heart in two vectors. Because of the two-vector
approach, the peak current required to convert the arrhythmia is reduced, and the
efficacy of the shock is greatly enhanced. It is generally accepted that biphasic
defibrillation results in less myocardial damage from the shock itself.
164

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SERVICE MANUAL

D500 Service Manual

Copyright © 2016 All rights reserved.

 Copyright law allows no part of this instruction manual to be reproduced without

 Please contact your local distributor about the warranty period.

This defibrillator/monitor is equipped with epoch-making ECG monitoring

General Safety Information

Warnings alert you to potential serious outcomes (death, injury, or adverse

Do not take into or use the defibrillator/monitor in locations where

Always check that the defibrillator/monitor functions properly and is in

The defibrillator/monitor is subsequently referred to as the defibrillator/monitor

Intended Use for the D500

The other monitoring functions (Electrocardiography (ECG, Heart Rate), Non-invasive

Identifying the D500 Configurations

Front Panel Components 1

Figure 1. Front panel components

Mode select knob

Energy Level button

Multi function knob

Figure 2. Top panel components

1 Paddle 4 SHOCK button

Table 2. The defibrillator/monitor controls on paddle

Energy Level button

Figure 3. Rear panel components

1 Side Option Case

Right Panel Components

1 Wireless(3G, Wi-Fi) module

AC indicator Dust and water resistance

Direct current CE mark

Battery charging status

Service indicator Follow instructions for use

Type BF- Defibrillator Proof Separate Collection

Type CF- Defibrillator Proof EU representative

NIBP connector Manufacturer

Temperature 1 connector Date of manufacture

Temperature 2 connector Reference number

IBP 1 connector Serial number

ECG connector Fragile

AC power input rating Keep dry

Equipotential terminal This way up

Class II equipment Do not reuse

Avoid spilling liquid on the defibrillator/monitor, especially in connector areas. If liquid

Periodic Safety and Functional Checks

1. Inspect the exterior of the defibrillator/monitor for damage.

If the defibrillator/monitor is to be stored for a period of 2 months or

Note: The defibrillator/monitor should be disposed of separately from the municipal

Table 4. Required Equipment

Figure 6. Manual Self-Test

High-voltage module alive test

General Operation Tests

Beep Volume Control

Button Volume Control

Charging Alarm Volume Control

CPR Metronome Volume Control

Pacing Alarm Volume Control

Sensor LED Excitation Test

1. Connect the defibrillator/monitor to an AC power source.

Figure 7. Parameter Default Setting

1. Connect the defibrillator/monitor to an AC power source.

1. Connect the defibrillator/monitor to an AC power source.

Real-time Printer Test

1. Connect the defibrillator/monitor to an AC power source.

4. Connect pads connector to defibrillator/monitor’s front panel.