Mediana D500 User manual

OPERATOR’S 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: [phone] (82) 33 742 5400
Fax: [phone] (82) 33 742 5483
Part Number: A7226-6
Revised Date: 2017-01
Copyright © 2017 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.

i
CONTENTS
CONTENTS....................................................................................................................................................i
SAFETY INFORMATION ..............................................................................................................................7
General Safety Information ...................................................................................................................7
Warning .................................................................................................................................................7
Cautions ..............................................................................................................................................12
INTRODUCTION.........................................................................................................................................13
Intended Use for the D500 ..................................................................................................................13
Indications for Use...............................................................................................................................13
About This Manual...............................................................................................................................15
Identifying the D500 Configurations ....................................................................................................15
DESCRIPTION OF THE DEFIBRILLATOR/MONITOR..............................................................................17
Front Panel Components.....................................................................................................................17
Top Panel Components.......................................................................................................................19
Rear Panel Components.....................................................................................................................20
Left Panel Components.......................................................................................................................21
Right Panel Components.....................................................................................................................21
Displays...............................................................................................................................................23
SETTING UP THE DEFIBRILLATOR/MONITOR.......................................................................................27
Unpacking and Inspection...................................................................................................................27
List of Components..............................................................................................................................28
Power Cable Connections...................................................................................................................30
Measurement Cable Connections.......................................................................................................31
BATTERY OPERATION..............................................................................................................................33
Operating the defibrillator/monitor on Battery Power ..........................................................................34
Battery Status Indication......................................................................................................................35
USING THE DEFIBRILLATOR/MONITOR.................................................................................................37
Turning On and Off the defibrillator/monitor........................................................................................38
Setting Date and Time.........................................................................................................................39
Continued use .....................................................................................................................................40
Setting the Main Screen......................................................................................................................40
ALARMS AND LIMITS................................................................................................................................43
General................................................................................................................................................43
Alarm Priority and Messages ..............................................................................................................44
Visual Alarm Indication........................................................................................................................49
Audible Alarm Indication......................................................................................................................49
Verifying Audible Alarm Indication .......................................................................................................49
Changing Alarm Limits.........................................................................................................................50
Audio Paused and OFF.......................................................................................................................52
ECG MONITORING ....................................................................................................................................55
General................................................................................................................................................56
Setup Connections..............................................................................................................................56
12-lead ECG........................................................................................................................................58
Preparing the 12 Lead.........................................................................................................................62
Calculation Feature .............................................................................................................................63
Description of HR/PR Menu Functions................................................................................................66
HR/PR Source.....................................................................................................................................67
AED(Automated External Defibrillator) MODE .......................................................................................69
2010 AHA Guidelines for CPR and ECC.............................................................................................72
Major changes in the 2010 AHAGuidelines for CPR and ECC ..........................................................72
CPR Guidelines 2010..........................................................................................................................73
AHA 2010 Configuration......................................................................................................................76
Note Performing CPR..........................................................................................................................76
Description of AED Mode Menu Functions .........................................................................................76

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MANUAL MODE.........................................................................................................................................79
General................................................................................................................................................79
Preparing for Defibrillation...................................................................................................................80
Operating the Manual Mode of defibrillator/monitor............................................................................80
Defibrillating (async mode)..................................................................................................................81
Synchronized Cardioversion (sync mode) ..........................................................................................81
Description of Manual Mode Menu Functions.....................................................................................83
MONITOR MODE........................................................................................................................................89
General................................................................................................................................................89
Description of Pacing Mode Menu Functions......................................................................................89
PACING MODE...........................................................................................................................................95
General................................................................................................................................................95
Demand Mode and Fixed Mode..........................................................................................................96
Operating the Pacing Mode of defibrillator/monitor.............................................................................96
Demand mode Pacing.........................................................................................................................96
Fixed Mode Pacing..............................................................................................................................97
Description of Pacing Mode Menu Functions......................................................................................98
NIBP MONITORING..................................................................................................................................103
General..............................................................................................................................................104
Theory of Operation...........................................................................................................................104
Setup Connections............................................................................................................................107
Description of NIBP Menu Functions ................................................................................................108
SpO2MONITORING.................................................................................................................................. 111
General..............................................................................................................................................112
Theory of Operation...........................................................................................................................113
Clinical Studies..................................................................................................................................115
Setup Connections............................................................................................................................117
RESPIRATION MONITORING..................................................................................................................119
General..............................................................................................................................................119
Theory of Operation...........................................................................................................................120
Setup Connections............................................................................................................................120
Description of Respiration Menu Functions ......................................................................................121
CAPNOGRAPHY MONITORING..............................................................................................................123
General..............................................................................................................................................124
Theory of Operation...........................................................................................................................124
Setup Connections............................................................................................................................125
Calibrating the CO2Sensor...............................................................................................................125
Description of EtCO2Menu Functions...............................................................................................127
TEMPERATURE MONITORING...............................................................................................................129
General..............................................................................................................................................129
Theory of Operation...........................................................................................................................129
Setup Connections............................................................................................................................129
Description of Temperature Menu Functions.....................................................................................130
IBP MONITORING ....................................................................................................................................131
General..............................................................................................................................................132
Theory of Operation...........................................................................................................................132
Setup Connections............................................................................................................................132
Description of IBP 1 Menu Functions................................................................................................133
Description of IBP 2 Menu Functions................................................................................................134
SELF-TEST FUNCTION...........................................................................................................................137
General..............................................................................................................................................137
Functions to be tested in Self-test.....................................................................................................138
Self-test result transmission (if configured with Wireless module option).........................................138
Self-test result printing.......................................................................................................................138
External shock test............................................................................................................................139
Trouble shooting................................................................................................................................139

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EVENT.......................................................................................................................................................141
General..............................................................................................................................................141
Event Data List Display .....................................................................................................................141
Event Review Display........................................................................................................................142
12 Lead Record Display....................................................................................................................143
ID#.....................................................................................................................................................143
REAL-TIME DATA ....................................................................................................................................145
General..............................................................................................................................................145
Real-time data menu.........................................................................................................................145
Real-time data recording...................................................................................................................146
Header recording...............................................................................................................................146
Event messages recording................................................................................................................146
Waveform recording..........................................................................................................................147
Shock information recording..............................................................................................................147
Trend recording auto print.................................................................................................................147
Download...........................................................................................................................................147
Print Setting.......................................................................................................................................147
MENU STRUCTURE.................................................................................................................................149
PRINTING .................................................................................................................................................165
General..............................................................................................................................................165
Printer Settings..................................................................................................................................165
Print-Out ............................................................................................................................................166
EXTERNAL INTERFACE..........................................................................................................................169
General..............................................................................................................................................169
SD Memory Card...............................................................................................................................169
Central System Communication........................................................................................................170
MAINTENANCE........................................................................................................................................171
Recycling and Disposal.....................................................................................................................171
Returning the defibrillator/monitor and System Components............................................................172
Service...............................................................................................................................................172
Periodic Safety Checks.....................................................................................................................172
Cleaning ............................................................................................................................................172
Battery Maintenance..........................................................................................................................173
Loading Printer Paper .......................................................................................................................174
TROUBLESHOOTING..............................................................................................................................175
General..............................................................................................................................................175
Obtaining Technical Assistance.........................................................................................................175
EMI (Electromagnetic Interference)...................................................................................................176
FACTORY DEFAULTS..............................................................................................................................179
General..............................................................................................................................................179
Parameter Ranges and Default Settings...........................................................................................179
SPECIFICATION.......................................................................................................................................187
Display...............................................................................................................................................187
Controls .............................................................................................................................................187
Alarms ...............................................................................................................................................187
Physical Characteristics and Printer..................................................................................................187
Electrical............................................................................................................................................188
Environmental Conditions..................................................................................................................189
Tone Definition...................................................................................................................................190
Measurement Parameters.................................................................................................................191
Event .................................................................................................................................................197
Defibrillator (Technical Specification).................................................................................................198
Compliance........................................................................................................................................213
Manufacturer’s EMC Declaration ......................................................................................................217

iv
Figures
Figure 1. Front panel components ..............................................................................................................17
Figure 2. Top panel components.................................................................................................................19
Figure 3. Rear panel components...............................................................................................................20
Figure 4. Left panel components.................................................................................................................21
Figure 5. Right panel components ..............................................................................................................21
Figure 6. Displays........................................................................................................................................23
Figure 7. AC Power Connection..................................................................................................................30
Figure 8. DC Power Connection..................................................................................................................31
Figure 9. Battery Placement........................................................................................................................34
Figure 10. Mode Select Knob......................................................................................................................38
Figure 11. Select Date/Time Menu..............................................................................................................39
Figure 12. Setup: Display mode Menu........................................................................................................40
Figure 13. Normal Screen (4 waveform, Defibrillation mode, Full option) ..................................................41
Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option)..............................................41
Figure 15. Black-white Screen (4 waveform, Defibrillation mode, Full option) ...........................................42
Figure 16. Volume Menu Display ................................................................................................................44
Figure 17. Alarm Limit Menu .......................................................................................................................50
Figure 18. Standard 3 Electrode Placement ...............................................................................................56
Figure 19. 5 Electrode Placement...............................................................................................................57
Figure 20. Varying choice of baselines. ......................................................................................................60
Figure 21. Baseline at the level of QRS onset as used by the Glasgow program......................................60
Figure 22. Illustration of isoelectric segments I and K. ...............................................................................60
Figure 23. Definitions for QRS end / ST junction ........................................................................................61
Figure 24. 12 lead Placement .....................................................................................................................62
Figure 25. Measurement Reference............................................................................................................63
Figure 26. 12-Lead ECG Preview Screen...................................................................................................65
Figure 27. HR/PR Display ...........................................................................................................................66
Figure 28. ECG Waveform Display.............................................................................................................66
Figure 29. HR/PR Menu..............................................................................................................................66
Figure 30. AED Mode Menu........................................................................................................................76
Figure 31. Patient Info: ID Menu .................................................................................................................77
Figure 32. Manual Mode Screen.................................................................................................................80
Figure 33. Manual Mode Menu ...................................................................................................................83
Figure 34. Setup Menu................................................................................................................................85
Figure 35. Alarm Limit Menu.......................................................................................................................87
Figure 36. Patient Info: ID Menu .................................................................................................................87
Figure 37. Monitor Mode Menu ...................................................................................................................89
Figure 38. Setup Menu................................................................................................................................92
Figure 40. Patient Info: ID Menu .................................................................................................................93
Figure 41. Pacing mode screen ..................................................................................................................96
Figure 42. Pacing Mode Menu....................................................................................................................98
Figure 43. Setup Menu..............................................................................................................................100
Figure 44. Alarm Limit Menu.....................................................................................................................101
Figure 45. Patient Info: ID Menu ...............................................................................................................101
Figure 46. NIBP Display............................................................................................................................108
Figure 47. NIBP Menu Display..................................................................................................................108
Figure 48. Oxyhemoglobin Dissociation Curve.........................................................................................114
Figure 49. Modified Bland-Altman Plot......................................................................................................116
Figure 50. SpO2 Display ...........................................................................................................................118
Figure 51. SpO2Waveform Display ..........................................................................................................118
Figure 52. SpO2Menu Display..................................................................................................................118
Figure 53. Respiration Display ..................................................................................................................121
Figure 54. Respiration Waveform Display.................................................................................................121
Figure 55. Respiration Menu Display........................................................................................................121
Figure 56. Connection for mainstream......................................................................................................125

v
Figure 57. Connection for sidestream.......................................................................................................126
Figure 58. EtCO2Display ..........................................................................................................................127
Figure 59. EtCO2Waveform Display.........................................................................................................127
Figure 60. EtCO2Menu Display ................................................................................................................127
Figure 61. Temperature Display................................................................................................................130
Figure 62. Temperature Menu Display......................................................................................................130
Figure 63. IBP connections .......................................................................................................................132
Figure 64. IBP 1 Display............................................................................................................................133
Figure 65. IBP 1 Waveform Display ..........................................................................................................133
Figure 66. IBP 1 Menu Display..................................................................................................................133
Figure 67. IBP 2 Display............................................................................................................................134
Figure 68. IBP 2 Waveform Display ..........................................................................................................134
Figure 69. IBP 2 Menu Display..................................................................................................................134
Figure 70. Auto Self-test display ...............................................................................................................138
Figure 71. External shock test...................................................................................................................139
Figure 72. Event Data List Display............................................................................................................141
Figure 73. Event Review Display ..............................................................................................................142
Figure 74. 12 Lead Record Display...........................................................................................................143
Figure 75. Patient Info Menu.....................................................................................................................143
Figure 76. Real-time data Menu................................................................................................................145
Figure 77. Real-time print (Header and Event messages)........................................................................146
Figure 78. Real-time print (Waveform, Shock info and Trend)..................................................................147
Figure 79. Printer setting Menu.................................................................................................................165
Figure 80. Print-out....................................................................................................................................166
Figure 81. Print-out on shock....................................................................................................................166
Figure 82. Print-out on 12 lead ECG data.................................................................................................167
Figure 83. Print-out on self-test result.......................................................................................................167
Figure 84. Print-out on setting information................................................................................................168
Figure 85. Printer Paper Replacement......................................................................................................174
Figure 86. Biphasic Waveforms at 300 Joules and 360 Joules ................................................................202
Figure 87. Biphasic Waveforms at 200 Joules..........................................................................................202
Figure 88. Biphasic Waveforms at 175 Joules..........................................................................................203
Figure 89. Biphasic Waveforms at 150 Joules..........................................................................................203
Figure 90. Biphasic Waveforms at 125 Joules..........................................................................................204
Figure 91. Biphasic Waveforms at 100 Joules..........................................................................................204
Figure 92. Biphasic Waveforms at 75 Joules............................................................................................205
Figure 93. Biphasic Waveforms at 50 Joules............................................................................................205
Figure 94: Biphasic Waveforms at 40 Joules............................................................................................206
Figure 95. Biphasic Waveforms at 30 Joules............................................................................................206
Figure 96. Biphasic Waveforms at 20 Joules............................................................................................207
Figure 97. Biphasic Waveforms at 10 Joules............................................................................................207
Figure 98. Biphasic Waveforms at 9 Joules..............................................................................................208
Figure 99. Biphasic Waveforms at 8 Joules..............................................................................................208
Figure 100. Biphasic Waveforms at 7 Joules............................................................................................209
Figure 101. Biphasic Waveforms at 6 Joules............................................................................................209
Figure 102. Biphasic Waveforms at 5 Joules............................................................................................210
Figure 103. Biphasic Waveforms at 4 Joules............................................................................................210
Figure 104. Biphasic Waveforms at 3 Joules............................................................................................211
Figure 105. Biphasic Waveforms at 2 Joules............................................................................................211
Figure 106. Biphasic Waveforms at 1 Joules............................................................................................212

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Tables
Table 1. The defibrillator/monitor controls ...................................................................................................18
Table 2. The defibrillator/monitor controls on paddle ..................................................................................19
Table 3. Panel and Label Symbols..............................................................................................................22
Table 4. Display Symbols............................................................................................................................24
Table 5. Display Colors Factory Defaults ....................................................................................................25
Table 6. Standard Accessories....................................................................................................................28
Table 7. Optional Accessories.....................................................................................................................29
Table 8. Front Panel Indications for Power Source.....................................................................................34
Table 9. The defibrillator/monitor Battery Status Icon .................................................................................35
Table 10. Date/Time Menu..........................................................................................................................39
Table 11. High Priority Alarm.......................................................................................................................44
Table 12. Medium Priority Alarm .................................................................................................................45
Table 13. Low Priority Alarm........................................................................................................................46
Table 14. Informative Messages .................................................................................................................47
Table 15. Defibrillator Messages.................................................................................................................47
Table 16. Visual Alarm Characteristics........................................................................................................49
Table 17. Audible Alarm Characteristics......................................................................................................49
Table 18. Alarm Limits Ranges....................................................................................................................51
Table 19. Bell Icon.......................................................................................................................................52
Table 20. ECG Lead Colors.........................................................................................................................57
Table 21. ECG Lead Pairs...........................................................................................................................57
Table 22. Measurement Matrix....................................................................................................................64
Table 23. HR/PR Menu................................................................................................................................66
Table 24. AED Mode Menu .........................................................................................................................77
Table 25. Manual Mode Menu.....................................................................................................................83
Table 26. Monitor Mode Menu.....................................................................................................................89
Table 27. Pacing Mode Menu......................................................................................................................98
Table 28. Cuff Size ....................................................................................................................................108
Table 29. NIBP Menu.................................................................................................................................108
Table 30. Demographic Data.....................................................................................................................115
Table 31. SpO2 Accuracy for Nellcor™ Sensors ......................................................................................115
Table 32. SpO2 Sensors ...........................................................................................................................117
Table 33. SpO2 Menu................................................................................................................................118
Table 34. Respiration Menu.......................................................................................................................121
Table 35. EtCO2 Menu..............................................................................................................................127
Table 36. Temperature Sensors ................................................................................................................129
Table 37. Temperature Menu.....................................................................................................................130
Table 38. IBP 1 Menu................................................................................................................................133
Table 39. IBP 2 Menu................................................................................................................................135
Table 40. Self-test functions......................................................................................................................138
Table 41. Trouble shooting of Self-test......................................................................................................139
Table 42. Wireless Status Icon and Bed Number Icon..............................................................................169
Table 43. Parameter Ranges and Factory Defaults..................................................................................179
Table 44. Delivered Energy at Every Defibrillator Settings into a Range of Loads...................................201
Table 45. Electromagnetic Emissions (IEC60601-1-2) .............................................................................217
Table 46. Electromagnetic Immunity (IEC60601-1-2)...............................................................................217
Table 47. Electromagnetic Immunity (IEC60601-2-4)...............................................................................218
Table 48. Electro-surgical Unit Interference (IEC60601-2-27, IEC-60601-2-30) ......................................219
Table 49. Recommended Separation Distances.......................................................................................219
Table 50. Cables (IEC60601-1-2)..............................................................................................................220

7
SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the D500
defibrillator/monitor. Other important safety information appears throughout the manual.
The D500 defibrillator/monitor will 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.
Warning
Warnings alert you to potential serious outcomes (death, injury, or adverse events)
to the patient or user.
Do not take 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 anesthetics, nitrous oxide or
high concentrations of oxygen, connect the gas outlet to a scavenger
system.
When using the defibrillator/monitor with a commercial electric power
source, use the defibrillator/monitor 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
defibrillator/monitor. Do not allow patients to touch the
defibrillator/monitor. Allowing patients to touch the defibrillator/monitor
could cause accidents.
The 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.

8
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
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 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
defibrillator/monitor.
The defibrillator/monitor has been dropped or impacted by an
object.
Liquid or foreign matter gets inside the defibrillator/monitor.
Defibrillator/monitor 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

9
wall socket.
2. Place an “Out of Order” sign on the defibrillator/monitor and do
not use it.
3. Have the defibrillator/monitor serviced to make sure that no hazard
exists.
Do not connect more than one patient to the defibrillator/monitor. Do
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/monitor 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 everything away from
contact with the patient, bed, and other conductive material before
discharging the defibrillator/monitor.
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/monitor.
Conductive gel on the paddle handles can allow the electrical energy to
be discharged through the operator during defibrillation. Completely

10
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
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 DO NOT
TOUCH THE PATIENT prior to defibrillation.
The defibrillator/monitor should be out of contact with water (puddles
or water spray). It may cause electrical shocks and defibrillator/monitor
failure. Electrical safety of the defibrillator/monitor 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.
To ensure patient electrical isolation, connect only to other equipment
with circuits that are electrically isolated.
To avoid risk of electric shock, the defibrillator/monitor must only be
connected to a supply mains with protective earth.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include: Use of the accessory in the PATIENT VICINITY. Evidence that
the safety certification of the ACCESSORY has been performed in
accordance with the appropriate IEC (EN) 60601-1 and/or IEC (EN)
60601-1-1 harmonized national standards.
The defibrillator/monitor is equipped with RF telemetry module which
transmits with 50dBm power in the 2.5GHz. The module has been tested
and certified to be equipped safely.
Check leakage levels prior to use. Leakage current may be excessive if
more than one defibrillator/monitor or other piece of equipment is
connected to the patient.
Do not place or use the defibrillator/monitor when flammable gas
presents in atmospheres or other flammable material exist near/around.
Eg. Oxygenrich area, flammable anesthetic gases, gasoline and any
flammable material or gas. Do not use the defibrillator/monitor near the
place of a gasoline or other volatile substances spill may cause an
explosion.
Do not disassemble the defibrillator. It contains no operator serviceable
components and dangerous high voltages may be present. Contact
authorized service personnel for repair.

11
Do not immerse any portion of this defibrillator in water or other fluids.
Avoid spilling any fluids on defibrillator or accessories. Spilled liquids
may cause the defibrillator and accessories to perform inaccurately or
fail. Do not clean with ketones or other flammable agents. Do not
autoclave or sterilize this defibrillator or accessories unless otherwise
specified.
Use care when operating this device close to oxygen sources (such as
bag-valve-mask devices or ventilator tubing). Turn off gas source or
move source away from patient during defibrillation.
Check leakage levels prior to use. Leakage current may be excessive if
more than one defibrillator/monitor or other piece of equipment is
connected to the patient.
If you are monitoring a patient and using the system connector, all
equipment connected to the system connector must be battery powered
or electrically isolated from AC power according to EN 60601-1. If in
doubt, disconnect the patient from the defibrillator before using the
system connector. Only use Mediana recommended data transmission
cables. For more information, contact Mediana Technical Support.
The defibrillator/monitor delivers up to 360 joules of electrical energy.
When discharging the defibrillator, do not touch the paddle electrode
surfaces or disposable paddle/pads electrodes. Do not attempt to
perform this test unless you are qualified by training and experience
and are thoroughly familiar with these operating instructions.
Electric shock hazards exist internally. Do not remove assembly
screws. Refer servicing to qualified personnel.
Monitors, defibrillators, and their accessories (including electrodes and
cables) contain ferromagnetic materials. As with all ferromagnetic
equipment, these products must not be used in the presence of the
high magnetic field created by a Magnetic Resonance Imaging (MRI)
device. The high magnetic field created by an MRI device will attract the
equipment with a force sufficient to cause death or serious personal
injury to persons between the equipment and the MRI device. This
magnetic attraction may also damage the equipment. Skin burns will
also occur due to heating of electrically conductive materials, such as
patient leads and pulse oximeter sensors. Consult the MRI
manufacturer for more information.
Medical electrical equipment which does not incorporate defibrillator
protection should be disconnected during defibrillation.
Operating the defibrillator/monitor or its accessories in conditions
outside the environmental specifications can result in device or
accessory malfunction. The defibrillator/monitor should be allowed to
stabilize within the operating temperature range prior to operation.

12
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.

13
INTRODUCTION
Patient conditions may result in erroneous readings. If the
measurements are suspect, verify the reading using another clinically
accepted measurement method.
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) and invasive blood pressure(IBP)) are intended for use on adult,
pediatric and neonatal patients. End tidal CO2(EtCO2) are intended for use on adult,
pediatric and infant patients.
Indications for Use
Indications
Contraindications
Manual
Defibrillation
Manual defibrillation is
indicated for the termination of
certain potentially fatal
arrhythmias, such as
ventricular fibrillation and
ventricular tachycardia.
Delivery of this energy in the
synchronized mode is a
method for treating atrial
fibrillation, atrial flutter.
Defibrillation is contraindicated
in the treatment of Pulseless
Electrical Activity (PEA), such
as idioventricular or ventricular
escape rhythms, and in the
treatment if asystole.
Defibrillation is not intended for
patient who is conscious and
has a palpable pulse and is
contraindicated for use on
neonates.
Automated External
Defibrillation
AED mode is to be used only
on patients of at least 8 years
of age in cardiopulmonary
arrest. The patient must be
unconscious, pulseless, and
not breathing normally before
using the defibrillator to
analyze the patient’s ECG
rhythm.
AED is not intended for patient
who is conscious and has a
palpable pulse and is
contraindicated for use on
neonates.
External Pacing
External pacing is indicated for
symptomatic bradycardia in
patients with a pulse.
Increased heart rates in
response to external pacing
often suppress ventricular
ectopic activity and may
External pacing is
contraindicated for the
treatment of ventricular
fibrillation and asystole.
External pacing in the
presence of severe
hypothermia may be

14
Indications
Contraindications
prevent tachycardia.
contraindicated and is
contraindicated for use on
neonates.
Electrocardiography
The 12-lead electrocardiogram
is used to identify, diagnose
and treat patients with cardiac
disorders and is useful in the
early detection.
No known contraindications
Noninvasive Blood
Pressure
Noninvasive blood pressure
monitoring is intended for
detection of hypertension or
hypotension and monitoring
BP trends in patient conditions
such as, but not limited to,
shock, acute dysrhythmia, or
major fluid imbalance.
Noninvasive Blood Pressure is
not intended for use with
severe arrhythmia.
Noninvasive Blood Pressure is
not intended for patients who
are experiencing convulsion or
tremors.
Pulse Oximetry
Pulse oximetry monitoring is
intended to be used to monitor
functional arterial oxygen
saturation and pulse rate.
Pulse Oximetry is not intended
for use with severe peripheral
vascular disease and severe
anemia (decreased
Hemoglobin).
Invasive Blood
Pressure
Invasive pressure monitor is
indicated for use in measuring
arterial, venous, intracranial
and other physiological
pressures using and invasive
catheter system with a
compatible transducer.
No known contraindications
End-Tidal CO2
EtCO2monitoring is indicated
for detection of trends in the
level of expired CO2. It is used
for monitoring breathing
efficacy and treatment
effectiveness in acute
cardiopulmonary care.
No known contraindications
Temperature
Temperature monitoring is
indicated for use in patients
who require continuous
monitoring of body
temperature.
No known contraindications

15
About This Manual
This manual explains how to set up and use the defibrillator/monitor.
Read the entire manual including the Safety Information section, before you operate the
defibrillator/monitor.
Identifying the D500 Configurations
The following table identifies D500 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 12 lead 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 + 12 lead ECG
D500M-LS
Basic + 12 lead ECG + SpO2
D500M-LSNT
Basic + 12 lead ECG + SpO2+ NIBP/TEMP
D500M-LSNTB
Basic + 12 lead 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 + 12 lead ECG + SpO2+ NIBP/TEMP + Capnography
(Mainstream)
D500M-LSNTES
Basic + 12 lead ECG + SpO2+ NIBP/TEMP + Capnography
(Sidestream)
D500M-LSNTBEM
Basic + 12 lead ECG + SpO2+ NIBP/TEMP + 2CH IBP +
Capnography (Mainstream)
D500M-LSNTBES
Basic + 12 lead ECG + SpO2+ NIBP/TEMP + 2CH IBP +
Capnography (Sidestream)

16
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17
DESCRIPTION OF THE DEFIBRILLATOR/MONITOR
Front Panel Components
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
EtCO2Connector
25
mA button
10
SpO2connector
26
NIBP button
11
Printer
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
2
3
4
5
6
7
8
9
10
11
12
13 - 16
17
18
19 - 21
22
23
24 - 25
26 - 30
1
31 32

18
Table 1. The defibrillator/monitor controls
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.