OPERATOR’S MANUAL
Defibrillator/Monitor D100
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
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
D100 Operator’s Manual
Part Number: A7741-3
Revised Date: 2023-02
Copyright © 2023 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 D100. 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 D100 conforms to the EMC standard IEC60601-1-2.
Note that mobile phones should not be used in the vicinity of the D100.
Note, however, any device not complying to the EMC standard that is used with the D100
renders the D100 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.
CONTENTS
CONTENTS .................................................................................................................................................. iii
SAFETY INFORMATION .............................................................................................................................. 9
General Safety Information ................................................................................................................... 9
Warning ................................................................................................................................................. 9
Cautions .............................................................................................................................................. 14
INTRODUCTION ......................................................................................................................................... 15
Intended Use for the D100 .................................................................................................................. 15
Indications for Use ............................................................................................................................... 15
About This Manual ............................................................................................................................... 16
Identifying the D100 Configurations .................................................................................................... 17
DESCRIPTION OF THE DEFIBRILLATOR/MONITOR .............................................................................. 19
Front Panel Components..................................................................................................................... 19
Top Panel Components ....................................................................................................................... 21
Rear Panel Components ..................................................................................................................... 22
Left Panel Components ....................................................................................................................... 23
Right Panel Components..................................................................................................................... 24
SETTING UP THE DEFIBRILLATOR/MONITOR ....................................................................................... 27
Unpacking and Inspection ................................................................................................................... 27
List of Components .............................................................................................................................. 28
Power Cable Connections ................................................................................................................... 29
Battery Operation ................................................................................................................................ 32
USING THE DEFIBRILLATOR/MONITOR ................................................................................................. 37
Turning On and Off the Defibrillator/Monitor ....................................................................................... 38
Displays ............................................................................................................................................... 40
Operating the Defibrillator/Monitor ...................................................................................................... 42
Software Menu Area ............................................................................................................................ 42
Configure ............................................................................................................................................. 44
ALARMS AND LIMITS................................................................................................................................ 51
General ................................................................................................................................................ 51
Alarm Priority and Messages .............................................................................................................. 51
Visual Alarm Indication ........................................................................................................................ 53
Audible Alarm Indication ...................................................................................................................... 54
Changing Alarm Limits......................................................................................................................... 55
Alarm Audio Acknowledged (Silence) ..................................................................................................... 56
Audio Paused and OFF ....................................................................................................................... 57
AED(Automated External Defibrillator) MODE ....................................................................................... 59
AHA/ERC Guidelines (Rescue protocol) ............................................................................................. 61
Preparing for Defibrillation ................................................................................................................... 61
Performing CPR .................................................................................................................................. 62
Description of AED Mode Menu Functions ......................................................................................... 64
MANUAL MODE ......................................................................................................................................... 65
General ................................................................................................................................................ 65
Preparing for Defibrillation ................................................................................................................... 66
Operating the Manual Mode of Defibrillator/Monitor ........................................................................... 67
Defibrillating (Async mode) ................................................................................................................. 68
Synchronized Cardioversion (Sync mode) .......................................................................................... 69
Description of the Manual Mode Menu Functions ............................................................................... 70
MONITOR MODE ........................................................................................................................................ 71
General ................................................................................................................................................ 71
Description of Monitor Mode Menu Functions ..................................................................................... 71
Freeze ................................................................................................................................................. 72
PACING MODE ........................................................................................................................................... 73
General ................................................................................................................................................ 74
iii
Description of Pacing Mode Menu Functions ...................................................................................... 74
Demand Mode and Fixed Mode .......................................................................................................... 75
Preparing for Pacing ............................................................................................................................ 75
Operating the Pacing Mode of Defibrillator/Monitor ............................................................................ 75
ECG MONITORING .................................................................................................................................... 77
General ................................................................................................................................................ 78
Setup Connections .............................................................................................................................. 78
Description of ECG Waveform Menu Functions .................................................................................. 81
SpO2 MONITORING.................................................................................................................................... 83
General ................................................................................................................................................ 84
Setup Connections .............................................................................................................................. 85
Description of SpO2 Menu Functions .................................................................................................. 86
Description of SpO2 Waveform Menu Functions ................................................................................. 87
Theory of Operation............................................................................................................................. 88
Clinical Studies .................................................................................................................................... 90
RESPIRATION MONITORING .................................................................................................................... 93
General ................................................................................................................................................ 93
Setup Connections .............................................................................................................................. 93
Description of Respiration Menu Functions ........................................................................................ 94
Description of Respiration Waveform Menu Functions ....................................................................... 95
Theory of Operation............................................................................................................................. 96
SELF-TEST FUNCTION ............................................................................................................................. 97
General ................................................................................................................................................ 97
External Shock Test ............................................................................................................................. 98
Trouble Shooting ................................................................................................................................. 98
EVENT REPORT......................................................................................................................................... 99
General ................................................................................................................................................ 99
TRENDS .................................................................................................................................................... 101
General .............................................................................................................................................. 101
DATA MANAGEMENT .............................................................................................................................. 103
General .............................................................................................................................................. 103
Data Management Mode ................................................................................................................... 104
PRINTING ................................................................................................................................................. 107
General .............................................................................................................................................. 107
Type of Print-Out ............................................................................................................................... 109
Replace printer paper ........................................................................................................................ 112
EXTERNAL COMMUNICATIONS ............................................................................................................ 113
General .............................................................................................................................................. 113
SD Memory Card ............................................................................................................................... 113
Central System Communication ........................................................................................................ 113
MENU STRUCTURE ................................................................................................................................. 115
MAINTENANCE ........................................................................................................................................ 121
Recycling and Disposal ..................................................................................................................... 121
Returning the Defibrillator/Monitor and System Components ........................................................... 122
Service ............................................................................................................................................... 122
Periodic Safety Checks ..................................................................................................................... 122
Cleaning ............................................................................................................................................ 122
Battery Maintenance.......................................................................................................................... 123
TROUBLESHOOTING .............................................................................................................................. 125
General .............................................................................................................................................. 125
Obtaining Technical Assistance ......................................................................................................... 125
EMI (Electromagnetic Interference)................................................................................................... 126
FACTORY DEFAULTS .............................................................................................................................. 129
General .............................................................................................................................................. 129
Parameter Ranges and Default Settings ........................................................................................... 129
SPECIFICATION ....................................................................................................................................... 133
iv
Display ............................................................................................................................................... 133
Controls ............................................................................................................................................. 133
Alarms ............................................................................................................................................... 133
Physical Characteristics and Printer .................................................................................................. 133
Electrical ............................................................................................................................................ 134
Environmental Conditions.................................................................................................................. 135
Tone Definition ................................................................................................................................... 135
Measurement Parameters ................................................................................................................. 136
Event/Trend ....................................................................................................................................... 140
Defibrillator (Technical Specification)................................................................................................. 141
Compliance ........................................................................................................................................ 155
Manufacturer’s EMC Declaration ...................................................................................................... 157
v
Figures
Figure 1. Front panel components .............................................................................................................. 19
Figure 2. Top panel components ................................................................................................................. 21
Figure 3. Defibrillator/Patient monitor paddle controller .............................................................................. 21
Figure 4. Rear panel components ............................................................................................................... 22
Figure 5. Left panel components ................................................................................................................. 23
Figure 6. Right panel components .............................................................................................................. 24
Figure 7. Right panel components (Option) ................................................................................................ 25
Figure 8. AC power connection ................................................................................................................... 29
Figure 9. Cradle installation ......................................................................................................................... 30
Figure 10. Battery placement ...................................................................................................................... 33
Figure 11. Mode select knob ....................................................................................................................... 39
Figure 12. Displays (Manual mode) ............................................................................................................ 40
Figure 13. Software menu area (Manual mode) ......................................................................................... 42
Figure 14. Configure window....................................................................................................................... 44
Figure 15. 4mV waveform ........................................................................................................................... 47
Figure 16. AED mode menu ........................................................................................................................ 64
Figure 17. Manual mode screen.................................................................................................................. 70
Figure 18. Monitor mode menu – Full color mode ...................................................................................... 71
Figure 19. Monitor mode menu – Grayscale mode ..................................................................................... 72
Figure 20. Monitor mode menu – Freeze .................................................................................................... 72
Figure 21. Pacing mode menu .................................................................................................................... 74
Figure 22. Pacing display (Fixed mode) ...................................................................................................... 75
Figure 23. Standard 3 electrode placement ................................................................................................ 78
Figure 24. 5 electrode placement ................................................................................................................ 79
Figure 25. HR/PR display ............................................................................................................................ 80
Figure 26. ECG waveform display............................................................................................................... 81
Figure 27. SpO2 display............................................................................................................................... 86
Figure 28. SpO2 waveform display .............................................................................................................. 87
Figure 29. Oxyhemoglobin dissociation curve ............................................................................................ 89
Figure 30. Modified bland-altman plot ......................................................................................................... 92
Figure 31. Respiration display ..................................................................................................................... 94
Figure 32. Respiration waveform display .................................................................................................... 95
Figure 33. Event report ................................................................................................................................ 99
Figure 34. Event review ............................................................................................................................. 100
Figure 35. Trend – Tabular trend ............................................................................................................... 101
Figure 36. Data management .................................................................................................................... 104
Figure 37. Data management – Export ..................................................................................................... 105
Figure 38. Data management – Review .................................................................................................... 106
Figure 39. Measurement data printing ...................................................................................................... 109
Figure 40. Trend data printing ................................................................................................................... 109
Figure 41. Event data printing ................................................................................................................... 109
Figure 42. Event summary review data printing ........................................................................................ 110
Figure 43. Setting value printing................................................................................................................ 111
Figure 44. Self-test result printing ............................................................................................................. 111
Figure 45. Replace print paper .................................................................................................................. 112
Figure 46. Biphasic waveforms at 200 joules ............................................................................................ 145
Figure 47. Biphasic waveforms at 175 joules ............................................................................................ 145
Figure 48. Biphasic waveforms at 150 joules ............................................................................................ 146
Figure 49. Biphasic waveforms at 125 joules ............................................................................................ 146
Figure 50. Biphasic waveforms at 100 joules ............................................................................................ 147
Figure 51. Biphasic waveforms at 75 joules .............................................................................................. 147
Figure 52. Biphasic waveforms at 50 joules .............................................................................................. 148
Figure 53. Biphasic waveforms at 40 joules .............................................................................................. 148
Figure 54. Biphasic waveforms at 30 joules .............................................................................................. 149
Figure 55. Biphasic waveforms at 20 joules .............................................................................................. 149
vi
Figure 56. Biphasic waveforms at 10 joules .............................................................................................. 150
Figure 57. Biphasic waveforms at 9 joules ................................................................................................ 150
Figure 58. Biphasic waveforms at 8 joules ................................................................................................ 151
Figure 59. Biphasic waveforms at 7 joules ................................................................................................ 151
Figure 60. Biphasic waveforms at 6 joules ................................................................................................ 152
Figure 61. Biphasic waveforms at 5 joules ................................................................................................ 152
Figure 62. Biphasic waveforms at 4 joules ................................................................................................ 153
Figure 63. Biphasic waveforms at 3 joules ................................................................................................ 153
Figure 64. Biphasic waveforms at 2 joules ................................................................................................ 154
Figure 65. Biphasic waveforms at 1 joule ................................................................................................. 154
vii
Tables
Table 1. D100 controls ................................................................................................................................. 20
Table 2. Panel and label symbols ................................................................................................................ 26
Table 3. Standard accessories .................................................................................................................... 28
Table 4. Optional accessories ..................................................................................................................... 28
Table 5. Front panel indications for power source....................................................................................... 34
Table 6. The defibrillator/monitor battery status icon ................................................................................... 35
Table 7. Display Symbols ............................................................................................................................ 41
Table 8. Display menu ................................................................................................................................. 45
Table 9. Sound menu .................................................................................................................................. 45
Table 10. Waveform menu .......................................................................................................................... 46
Table 11. The number of ECG 4mV waveform (Full option)........................................................................ 46
Table 12. Parameter menu .......................................................................................................................... 47
Table 13. Alarm setup menu ........................................................................................................................ 48
Table 14. Patient menu................................................................................................................................ 48
Table 15. Printer menu ................................................................................................................................ 48
Table 16. Review menu ............................................................................................................................... 49
Table 17. Service setting menu ................................................................................................................... 49
Table 18. Others menu ................................................................................................................................ 49
Table 19. Alarm priority condition ................................................................................................................ 51
Table 20. Visual alarm characteristics ......................................................................................................... 53
Table 21. Audible alarm characteristics ....................................................................................................... 54
Table 22. Alarm setup menu ........................................................................................................................ 55
Table 23. Alarm limits ranges ...................................................................................................................... 56
Table 24. ECG lead colors........................................................................................................................... 79
Table 25. ECG lead pairs ............................................................................................................................ 79
Table 26. HR/PR menu................................................................................................................................ 80
Table 27. ECG waveform menu .................................................................................................................. 81
Table 28. SpO2 sensors ............................................................................................................................... 85
Table 29. SpO2 menu .................................................................................................................................. 86
Table 30. SpO2 waveform menu .................................................................................................................. 87
Table 31. Demographic data ....................................................................................................................... 90
Table 32. Demographic data ....................................................................................................................... 91
Table 33. SpO2 accuracy for Medtronic™ sensors ..................................................................................... 92
Table 34. Respiration menu......................................................................................................................... 94
Table 35. Respiration waveform menu ........................................................................................................ 95
Table 36. Printer Menu .............................................................................................................................. 107
Table 37. Printing waveform menu ............................................................................................................ 108
Table 38. Parameter ranges and factory defaults ..................................................................................... 129
Table 39. ECG analysis algorithm accuracy: Adult ................................................................................... 143
Table 40. ECG analysis algorithm accuracy: Pediatric ............................................................................. 143
Table 41. Delivered energy at every defibrillator settings into a range of loads ........................................ 144
Table 42. Electromagnetic emissions (IEC60601-1-2) .............................................................................. 157
Table 43. Electromagnetic immunity (IEC60601-1-2) ............................................................................... 157
Table 44. Electromagnetic immunity (IEC60601-1-2) ............................................................................... 159
Table 45. Electro-surgical unit interference (IEC60601-2-27) ................................................................... 160
Table 46. Recommended separation distances ........................................................................................ 160
Table 47. Immunity to proximity fields from RF wireless communications equipment (IEC60601-1-2) .... 161
Table 48. Cables (IEC60601-1-2) .............................................................................................................. 161
viii
SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the D100
defibrillator/monitor. Other important safety information appears throughout the manual.
The D100 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.
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 when 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
defibrillator/monitor without authorization.
Do not use power source other than the specified voltage, (100240V~50/60Hz) as this may cause fire or electric shock.
9
Pre-use inspection and preventive maintenance must be performed for
safe use.
The defibrillator/monitor
equipment.
may
be
used
with
electrical
surgical
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
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.
10
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, 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
defibrillator/monitor’s measurement only.
based
on
this
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 200 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
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
11
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)
60601-2-XX particular standards.
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.
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
12
move source away from patient during defibrillation.
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 200 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.
Do not position the defibrillator/monitor so it is difficult to operate the
disconnection device when a separable plug is used as isolation.
13
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.
Software alone does not encrypt data and should be used only in closed
hospital networks, and use a PC equipped with a security system such
as a firewall or vaccine that conforms to the hospital's policy.
In the event of an accident involving cybersecurity, contact qualified
service personnel or your local supplier for assistance and wait until the
administrator takes action.
14
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 D100
The defibrillator/monitor is intended for use by trained medical technician, doctor, nurse or
medical specialist in outdoor and indoor emergency care settings including ground
ambulances within the environmental conditions specified. Manual and Automated
external defibrillation, External pacing, Diagnostic electrocardiography are intended for
use on adult and pediatric patients.
The other monitoring functions (Electrocardiography (ECG, Heart Rate), Functional
arterial oxygen saturation (SpO2), Respiration (RESP)) are intended for use on adult,
pediatric and neonatal patients.
Indications for Use
Manual
Defibrillation
Automated External
Defibrillation
External Pacing
Indications
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.
AED mode is to be used only
on patients in cardiopulmonary
arrest. The patient who must
be unconscious, pulseless and
not breathing normally before
using the defibrillator to
analyze the patient’s ECG
rhythm.
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
prevent tachycardia.
Contraindications
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.
AED is not intended for patient
who is conscious and has a
palpable pulse and is
contraindicated for use on
neonates.
External pacing is
contraindicated for the
treatment of ventricular
fibrillation and asystole.
External pacing in the
presence of severe
hypothermia may be
contraindicated and is
contraindicated for use on
neonates.
15
Electrocardiography
Pulse Oximetry
Indications
The electrocardiogram is used
to identify, diagnose and treat
patients with cardiac disorders
and is useful in the early
detection.
Pulse oximetry monitoring is
intended to be used to monitor
functional arterial oxygen
saturation and pulse rate.
Contraindications
No known contraindications
Pulse Oximetry is not intended
for use with severe peripheral
vascular disease and severe
anemia (decreased
Hemoglobin).
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.
16
Identifying the D100 Configurations
The following table identifies D100 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 Battery, Pacing module, Mediana or Medtronic SpO2 module, Infoware X module
and Cradle/External adaptor.
Product Code
Basic
Top case
Pacing module
SpO2 module
Infoware X module
Cradle / External
adaptor
Description
0: Manual Defibrillation, Automated External Defibrillation,
ECG (3/5 lead), Respiration, Printer
H: with paddles
X: without paddles
P: Mediana Pacing module
X: Not installed
S: Medtronic SpO2 module
D: Mediana SpO2 module
X: Not installed
W: Mediana InfoX-W(Wi-Fi) module
E: Mediana InfoX-E(mobile) module
X: Not installed
A: Cradle / External AC Adaptor
C: Cradle / External DC Adaptor
X: Not installed
Note: ‘X’ in the product code is not indicated from the real product code.
17
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18
DESCRIPTION OF THE DEFIBRILLATOR/MONITOR
Front Panel Components
1
10
2
11
12 - 14
3
15
4
5
16
6
17
18
7
8
19
20
9
21
23
22
Figure 1. Front panel components
1
2
3
4
5
6
7
8
9
10
11
12
Paddle
Paddle energy level button (+,-)
Patient type button
ECG Lead button
ECG Size button
LCD
Print button
Soft key (1st from left)
Speaker
Paddle charge button
Handle
AC/DC in LED
13
14
15
16
17
18
19
20
21
22
23
Service LED
Battery charging status LED
Mode selection knob
Energy level button(+,-)
Charge button
Analyze button
Shock button
Sync button
Event button
Alarm button
Multi function knob
19
Table 1. D100 controls
Symbol
Function
Mode selection knob
selects five modes of operation. (AED, Manual, Monitor, OFF,
Pacing)
Energy level button(+,-)
selects the defibrillation energy level.
Analyze button
operates the advisory mode from the manual mode.
analyzes the patient’s ECG in the AED mode.
Sync button
selects sync or async mode.
Charge button
charges defibrillation energy.
Shock button
delivers a shock.
Patient type button
selects patient type. (Adult, Pediatric, Neonatal)
ECG Lead button
selects lead to display the first ECG waveform on the screen.
ECG Size button
selects to display the amplitude of an ECG waveform.
Print button
starts and stops the printing on operating.
Alarm button
pauses the audible alarm temporarily.
turns off the audible alarm.
Event button
selects and records event data.
Soft key x 4EA
operates the assigned function according to the operation mode.
Multi function knob
selects the function for change, search, select, enter, add, cancel,
etc..
20
Top Panel Components
1
2
3
Figure 2. Top panel components
1
2
3
Paddle
Shock Button
Paddle Cradle
1
2
3
4
5
Figure 3. Defibrillator/Patient monitor paddle controller
1
2
3
4
5
Shock Button
Energy Level Button(+)
Energy Level Button(-)
Shock Button
Charge Button
21
Rear Panel Components
1
2
5
3
4
4
6
Figure 4. Rear panel components
1
2
3
22
Cradle Hook
DC Power Connector
Battery
4 AC inlet cover
5 Battery Hook
6 Rubber Foot
Left Panel Components
1
3
4
2
Figure 5. Left panel components
1
2
3
4
Printer
Option Case
ECG Connector
SpO2 Connector
23
Right Panel Components
1
3
2
Figure 6. Right panel components
1 Side Cover
2 USB & SD Card Cover
3 Paddle/Pads Connector
24
1
4
2
3
Figure 7. Right panel components (Option)
1 Wireless Module
2 SD Card Insertion Hole
3 USB port
4 Paddle/Pads Connector
25
Table 2. Panel and label symbols
Symbols
Description
Description
AC indicator
Follow instructions for use
Direct current
Separate Collection
Battery
indicator
26
Symbols
charging
status
EU representative
Service indicator
Manufacturer
Type BF- Defibrillator Proof
Date of manufacture
Type CF- Defibrillator Proof
Reference number
ECG connector
Serial number
SpO2 connector
Environmental shipping/storage
altitude limitations
AC power input rating
Environmental shipping/storage
humidity limitations
Equipotential terminal
Environmental shipping/storage
temperature limitations
Prescription only device
Fragile
Dust and water resistance
(D100)
Keep dry
Dust and water resistance
(Cradle/External adapter)
This way up
CE mark
Single patient use only
SETTING UP THE DEFIBRILLATOR/MONITOR
To ensure accurate performance and prevent defibrillator/monitor
failure, do not expose the defibrillator/monitor to extreme moisture,
including direct exposure to rain. Such exposure may cause inaccurate
performance or device failure. Refer to Specification section.
The defibrillator/monitor should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the
defibrillator/monitor should be observed to verify normal operation in
the configuration it is to be used.
Make sure that the defibrillator/monitor speaker is not obstructed.
Failure to do so could result in an inaudible alarm tone.
Recharging the battery is strongly recommended when the battery has
not been recharged for 6 or more months.
Follow local government ordinances and recycling instructions
regarding disposal or recycling of defibrillator/monitor components,
including batteries.
The use of accessories, cables, transducers and sensors sourced from
manufacturers, which Mediana has not recommended may cause
incorrect analysis.
Electrical installation of the room or the building in which the
defibrillator/monitor is to be used must comply with regulations
specified by the country in which the equipment is to be used.
Unpacking and Inspection
The defibrillator/monitor is shipped in one carton. Examine the carton carefully for
evidence of damage. Contact Mediana Technical Support Representative immediately if
any damage is discovered. Refer to the Maintenance section for instructions on
returning damaged items.
Note: Refer to the Performance Verification section in the service manual for detailed
information.
Set the defibrillator/monitor to the user’s intended position where the user can easily
recognize the visual and audible monitoring conditions. Normally it is recommended to
set at a distance of 1m from the user. Also the viewpoint is at any point within the base of
a cone by an angle of 30° to the center of the monitoring display.
27
List of Components
The following items are standard in the package.
Table 3. Standard accessories
Items
D100 defibrillator/monitor
Operator’s manual
AC Power cord
Print paper
Shock/Pacing Pads
Pads extension cable
ECG 3 leads Cable (SNAP)
For Mediana SpO2 Module
SpO2 reusable sensor YM-1
SpO2 extension cable MEX03
* Only when Mediana SpO2 option is installed
For Medtronic SpO2 Module
SpO2 reusable sensor DS-100A
SpO2 extension cable DOC-10
* Only when Medtronic SpO2 option is installed
Rechargeable Li-ion Battery Pack
Qty
Q
1
1
1
2
1
1
1
1
1
1
Table 4. Optional accessories
Items
External Paddle
Shock only pads
ECG 3 leads cable (SNAP)
ECG 3 leads cable (GRAB)
ECG 5 leads cable (SNAP)
ECG 5 leads cable (GRAB)
ECG 3 leads trunk cable
ECG 5 leads trunk cable
ECG 3 lead set (SNAP)
ECG 3 lead set (GRAB)
ECG 5 lead set (SNAP)
ECG 5 lead set (GRAB)
Service manual (English)
Cradle / External AC Adaptor
Cradle / External DC Adaptor
Mediana InfoX-W(Wi-Fi) module
Mediana InfoX-E(mobile) module
Carry bag
Pads test load
Qty
-
Optional items may be ordered if needed. Contact your local supplier for pricing and
ordering information.
28
Power Cable Connections
Do not connect to an electrical outlet controlled by a wall switch or
dimmer because the defibrillator/monitor may be accidentally turned off.
Do not turn off the Mediana defibrillator/monitor by using Mode
selection knob or disconnecting the power cord or battery. The data
stored will be damaged.
If the integrity of the AC power source is in doubt, the
defibrillator/monitor must be operated from its internal battery.
AC Power
Make sure that the AC outlet is properly grounded and supplies the specified voltage and
frequency (100-240V~ 50/60 Hz).
Figure 8. AC power connection
1. Connect the AC power cord to AC power connector on the rear of the
Defibrillator/Monitor.
2. Connector the power cord to a grounded AC socket.
3. Connect a grounding wire if needed. After connection a ground wire socket to the
equipotential grounding terminal on the rear, and then attach the clip end of the
grounding wire to the medical device grounding terminal on the outer wall.
4. After connection, check if the Battery charging status LED and AC/DC in LED on the
front of the Defibrillator/Monitor.
Note: Battery charging status LED indicates battery is installed and being charged by
the AC power.
Note: Even if the defibrillator/monitor is not turned on, the Battery charging status LED
is lit when the AC power cord is connected into a mains outlet.
Note: Do not place the defibrillator/monitor so that it is difficult to disconnect the AC power
cord.
29
Cradle / External adapter
The DC power source can be used, when the defibrillator/monitor is used for the
emergency condition in the moving car. Cradle uses AC or DC power.
AC/DC in LED
Figure 9. Cradle installation
30
1. Connect an AC or DC power to cradle and verify that the AC/DC Power Input LED is
lit.
2. Set the defibrillator/monitor as Figure 9.
3. Verify that the DC power input icon appears on the screen, Battery charging status
LED and AC/DC in LED on the defibrillator/monitor’s front panel is lit.
Note: Battery charging status LED turns on in orange and AC/DC in LED turns on in
green when battery is installed and being charged by the AC or DC power.
Note: Even if the defibrillator/monitor is not turned on, the Battery charging status LED
is lit when a Cradle/External DC adaptor is connected into AC or DC input
connector.
Note: If the Battery charging status LED is not lit, check:
⚫
⚫
⚫
⚫
⚫
the power cord
the AC or DC input connector
the Cradle/External DC adaptor
the power/ mains outlet
No Battery
Note: If the Battery charging status LED still is not lit although no problem is found,
contact qualified service personnel or your local supplier for assistance.
31
Battery Operation
Do not disassemble, puncture, crush, heat above 100°C (212°F), or
incinerate the battery. Be careful not to short the battery terminals
because this could result in a fire hazard.
Mediana has no information regarding the performance or effectiveness
of its Mediana defibrillator/monitors if other manufacturers’ batteries or
battery chargers are used. Using other manufacturers’ batteries or
battery chargers may cause the defibrillator/monitor to perform
improperly and invalidate the safety agency certifications. Use only
Mediana’s battery or battery charger.
Grounding reliability can only be achieved when the equipment is
connected to an equivalent receptacle marked ‘HOSPITAL ONLY’ or
‘HOSPITAL GRADE’. If the grounding integrity of the line cord or AC
receptacle is in doubt, operate on battery only.
Do not turn off the Mediana defibrillator/monitor by using Mode
selection knob or disconnecting the power cord or battery. The data
stored will be damaged.
Recharging the battery is strongly recommended when it has not been
fully recharged for 6 or more months.
Do not install the battery into the defibrillator/monitor when storage
may exceed 90 days. Battery damage may occur.
When the voltage of the battery is very low, it is a possibility of not
operating.
Check for the battery-in-use indication when the defibrillator/monitor is
operating on mains and apply corrective action.
Do not operate the defibrillator/monitor without a battery. Keep a fully
charged spare battery pack with the defibrillator/monitor at all times.
Partial charge of battery results in a shortened service life.
Storing at temperatures above 40°C (104°F) for extended periods of
time will significantly reduce a battery’s life-expectancy.
Using
an
improperly
maintained
battery
to
power
the
defibrillator/monitor may cause power failure without warning. Use the
appropriate battery charger to charge batteries.
Battery pins in the defibrillator/monitor may be damaged if batteries are
dropped or forced into battery wells. Inspect pins routinely for signs of
damage. Keep batteries installed at all times except when
defibrillator/monitor is removed from service for storage.
When storing the defibrillator/monitor for an extended period of time,
the battery should be removed from the defibrillator/monitor.
Stored batteries lose charge. Failure to charge a stored battery before
use may cause device power failure without warning. Always charge a
stored battery before placing it in active use.
Note: It is recommended that keep AC power source connected to the defibrillator/monitor
when not in use. This will ensure a fully charged battery whenever it is needed.
Note: As the battery is used and recharged over a period of time, the amount of time
between the onset of the low battery alarm and the defibrillator/monitor shut-off
may become shorter. It is recommended for service personnel to check periodically
or replace the battery if necessary.
32
Operating the defibrillator/monitor on Battery Power
The defibrillator/monitor has the rechargeable battery that can be used to power the
defibrillator/monitor when AC power source is not available. The battery status icon
appears on the screen when the defibrillator/monitor is on battery power.
Figure 10. Battery placement
1.
2.
3.
Turn off the defibrillator/monitor.
Push the Battery hook.
Insert the battery into the defibrillator/monitor carefully.
33
Table 5. Front panel indications for power source
Power Connections
AC source
DC source
Battery
Front Panel Indications
AC power input icon appears on the screen.
AC/DC in LED is lit.
DC power input icon appears on the screen.
AC/DC in LED is lit.
Battery status icon appears on the screen.
The defibrillator/monitor cannot operate with a completely discharged battery. Before
turning on the defibrillator/monitor with a battery that has been completely discharged,
plug the defibrillator/monitor into an AC outlet to charge the battery for a minimum of 3
minutes. The defibrillator/monitor may then be powered on.
A new, fully charged battery will provide 5 hours monitoring operation in Monitor mode or
at least 200 times of shock delivery in 200J selected energy in Manual mode or AED
mode or 2 hours monitoring operation in Pacing mode (pacing rate: 80 ppm, pacing
output: 60mA, load resistance: 50Ω) under the following conditions:
⚫
⚫
⚫
⚫
⚫
⚫
34
No audible alarm sound
No data Output, No communication (Communication system is installed)
No printing out (Printer module is installed)
All monitoring parameters are active
LCD Backlight: default
Ambient temperature at 25°C
Battery Status Indication
When operating on batteries, the battery status icon in the lower part of the display
indicates the battery charge condition. See Table 6.
Table 6. The defibrillator/monitor battery status icon
Battery Status Icons
Battery Status
Normal, Fully charged
More than 4/5 from fully charged
More than 3/5 from fully charged
More than 2/5 from fully charged
More than 1/5 from fully charged
Battery charging
Battery charging error
Low
Critical low
Note: The battery status icon is displayed in 5 levels depending on the amount of battery.
User can check the approximate amount of battery by the number of bars inside
the battery status icon.
A low priority alarm occurs when the remaining battery power is only enough for 15
minutes of operation. The ‘System: Low battery condition’ message is displayed on the
screen and visual alarm window is lit with yellow. Connect the AC power or replace the
battery with a fully charged battery immediately when alarm occurs.
This alarm audio cannot be paused while running on battery power. Connecting the
defibrillator/monitor to AC power will stop the alarm.
A high priority alarm occurs for about 5 minutes before the defibrillator/monitor shuts off.
The ‘System: Critically low battery condition’ message is displayed on the screen and
the visual alarm window is lit with red. After that, the monitor will automatically shut down.
Connect the defibrillator/monitor to an AC power source immediately to avoid any loss of
trend data or settings.
User cannot use printer while the device is in low battery and critically low battery
condition.
Note: The battery will not be charged for safety if the operating temperature exceeds 40°C.
Note: In critically low battery condition, the monitor is not turned on once the monitor is
turned off.
35
Measurement Cable Connections
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Mediana. Use accessories
according to the manufacturer’s directions for use and your facility’s
standards. Use only accessories that have passed the recommended
biocompatibility testing in compliance with ISO10993-1.
Connect the sensor, probe, cuff/hose or transducer firmly into socket
and do not use a damaged sensor, probe or cuff/hose.
To avoid damage to the cable, always hold by the connector rather than
the cable, when connecting or disconnecting either end.
The sensor connector should not be connected to anything other than a
sensor.
Note: Both frequent checks by the operator on a daily basis and more comprehensive
technical checks less frequently are covered by this requirement in order to detect
mechanical damage and damage to cables, etc.
ECG Cables and Leads
1. Connect an ECG cable to the ECG connector making sure that the connector arrow is
pointing panel (see Figure 5)
2. Connect an ECG leadwire cable to the ECG cable.
Defibrillator Paddle and Pads
1. Connect a paddle or pads to paddle / pads connector on the defibrillator/monitor’s right
panel. (see Figure 6)
2. Use ECG lead button to select pads. (If paddle is connected, the mode is
automatically changed to paddle.)
SpO2 Cables and Sensors (if configured with SpO2 option)
1. Select an appropriate sensor for the patient and desired application. (Refer to the SpO2
Monitoring section.)
2. Connect the extension cable to the SpO2 connector on the defibrillator/monitor’s front
panel. (see Figure 5)
3. Attach the sensor to the end of the cable.
Note: If lead wire cable, sensor and transducer are not connected firmly, the
defibrillator/monitor could lose signal from patient.
36
USING THE DEFIBRILLATOR/MONITOR
Each time the defibrillator/monitor is used, check alarm limits to make
sure that they are appropriate for the patient being monitored.
If different alarm presets are used for the same or similar equipment in
any single area, e.g. an intensive care unit or cardiac operating room, a
potential hazard can exist.
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and the defibrillator/monitor can cause inaccurate
measurement readings. Do not rely entirely on the defibrillator/monitor
readings for patient assessment.
Be aware of patient cables, including ECG monitoring equipment when
used with high frequency surgical equipment.
When inaccurate analysis is suspected because of motion artifact do
not analyze in a moving vehicle. Motion artifact may affect the ECG
signal resulting in an inappropriate SHOCK ADVISED or NO SHOCK
ADVISED message. Motion detection may delay analysis. Stop vehicle
and stand clear of patient during analysis.
To avoid risk of electrical shock, do not touch gelled area of the pads
while pacing or shock. When defibrillating with paddles use your
thumbs to operate the Shock button in order to avoid inadvertent
operator shock. No portion of the hand should be near the paddle
plates.
Pediatric defibrillation energy levels should be set based on sitespecific clinical protocols.
The metronome sounds do not indicate information regarding the
patient’s condition. Because patient status can change in a short time,
the patient should be assessed at all times. Do not perform CPR on a
patient who is responsive or is breathing normally.
Place the patient on a firm surface before performing CPR.
Ventricular fibrillation may be induced with improper synchronization.
Do not use the ECG from another monitor (slaving) to synchronize the
defibrillator/monitor’s discharge. Always monitor the patient’s ECG
directly through the defibrillator/monitor’s ECG cable or pad cable.
Pitted or damaged paddles may cause patient skin burns during
defibrillation.
The ECG rhythm analysis function does not warn the operator of patient
asystole, as it is not a shockable rhythm.
Determination of electrical capture should only be performed by viewing
the ECG on the screen with its ECG cable directly attached to the
patient.
Connect the device only to a three-wire, grounded, hospital grade
receptacle. The three-conductor plug must be inserted into a properly
wired three-wire receptacle; if a three-wire receptacle is not available, a
qualified electrician must install one in accordance with the governing
electrical code. Do not under any circumstances remove the grounding
connector from the power plug. Do not use extension cords or adapters
of any type. The power cord and plug must be intact and undamaged.
Only use thumbs to depress the paddle Shock button. Failure to do so
could result in the inadvertent depression of the energy select buttons,
causing the defibrillator/monitor to disarm itself.
37
Do not discharge the defibrillator/monitor except as indicated in the
instructions.
Do not permit gel to accumulate between the paddle electrodes on the
chest wall (gel bridge). This could cause burns and reduce the amount
of energy delivered to the heart.
Changing the selected energy while the defibrillator/monitor is charging
or charged will cause the defibrillator/monitor to disarm itself. Press the
Charge button again to charge the defibrillator/monitor.
If using defibrillation pads, make sure that the size of the pad is large
enough to cover the entire paddle electrode area.
Pads should be replaced after 8 hours of continuous pacing to ensure
maximum patient benefit.
Be sure to safely discharge external paddles.
Do not use high conductivity gel manufactured by other than
manufacturer recommended for defibrillation using paddle. It may cause
burns to the patients or device failure.
Note: Check if the defibrillator/monitor correctly operates according to the displays or
signal sounds during the measurement.
Note: If the power has some changes, the buzzer sound of the monitor will occur.
Note: To reduce the risks due to the software error, use the new software.
Note: If there is a software error, please contact qualified service personnel or your local
supplier.
Note: If the software or hardware is not restored after rebooting the device, the
defibrillator / monitor will beep. Forcibly shut down the equipment by disconnecting
the power and contact your local dealer or headquarter service.
Note: After the power turns on, check if the battery status indicator, display and other
indicators operate normally.
Turning On and Off the Defibrillator/Monitor
Before using the defibrillator/monitor, confirm that the defibrillator/monitor is working
properly and is safe to use as described below.
Look for display motion before accepting any displayed data as a
current measurement.
Note: If unusable sound like buzzer can be heard, do not use the defibrillator/monitor.
Instead, please contact qualified service personnel or your local supplier.
Turning On
The defibrillator/monitor can start to be used by rotating the Mode select knob of the
device that turned off.
1. Rotate Mode select knob to select one mode from AED, manual, monitor or pacing
mode.
2. While the defibrillator/monitor turns on, the LEDs of Alarm button and Shock button
are turned on.
3. The defibrillator/monitor automatically starts the Power On Self Test (POST) that
does the test for the function of the device.
4. When the Power On Self Test (POST) is completed successfully, the
defibrillator/monitor will display the selected mode screen.
Note: If internal problem is detected or the final self test result is failed during the Power
38
On Self Test (POST), the alarm of the defibrillator/monitor will occur and the error
code is displayed. When the error code is displayed, please contact qualified
service personnel or your local supplier.
Figure 11. Mode select knob
 Pacing mode - to enable pacing mode for Demand or Fixed mode pacing.
 Manual mode - to enable manual mode for asynchronous or synchronous defibrillation.
 Monitor mode - to enable monitor mode for 3- or 5-lead ECG monitoring and vital signs
trending, or monitoring of optional parameters.
 AED mode - to enable AED mode for semi-automated external defibrillation.
Turning Off
The defibrillator/monitor can start to be used by rotating the Mode select knob of the
device that turned off.
1.
To turn off the defibrillator/monitor, rotate Mode select knob to select Off mode.
After selecting Off mode, the settings will be stored and the defibrillator/monitor will
be turned off.
39
Displays
The screen below is a default screen in manual mode. The screen may be different
according to other modes. For screens in other modes, refer to the AED mode, manual
mode, monitor mode and pacing mode section.
A typical screen in Manual Mode is shown below.
13
12
11
10
9
8
7
1
6
2
6
5
3
4
5
Figure 12. Displays (Manual mode)
1
2
3
4
5
Patient type
Waveform area
Operating information
Soft key
Runtime
8
9
10
11
12
6
7
Numeric area
Power status
13
Alarm volume
Connection type
CMS status
Patient information
Physiological/Technical alarm
message
Date/Time display
Note: CMS (Central Monitoring System) bed number is not displayed on the screen if
there is no set bet number.
40
Table 7. Display Symbols
Symbols
Description
Symbols
Description
Patient type: Adult
Audio alarm paused
Patient type: Pediatric
Audio alarm off
Patient type: Neonatal
HR/PR icon
CMS status (Exchange)
HR/PR status icon (Pacer on)
CMS status (no connect)
HR/PR status icon (Pacer off)
CMS status (receive)
SpO2 SatSeconds status (Off)
CMS status (Send)
SpO2 SatSeconds status (fill,
1/8)
Network status icon (WiFi)
SpO2 SatSeconds status (fill,
2/8)
Volume indicator
SpO2 SatSeconds status (fill,
3/8)
Battery status indicator Ⅰ
SpO2 SatSeconds status (fill,
4/8)
Battery status indicator Ⅱ
SpO2 SatSeconds status (fill,
5/8)
AC input
SpO2 SatSeconds status (fill,
6/8)
DC input
SpO2 SatSeconds status (fill,
7/8)
Message list status icon
SpO2 SatSeconds status (fill,
8/8)
Alarm active
41
Operating the Defibrillator/Monitor
User can operate the cursor by rotating the Multi function knob
1. Move the cursor by rotating the Multi function knob.
2. Press the Multi function knob when the cursor is located on the desired position.
3. User can set Parameter menu by pressing the Multi function knob when the cursor is
located on each parameter of Numeric area.
Software Menu Area
Defibrillator/Monitor provides various functions via button of software menu area. Software
menu provides different function according to the mode.
1st
2nd
3rd
4th
Figure 13. Software menu area (Monitor mode)
Followings are software menus activated according to each mode.
Manual mode
1st
2nd
Manual mode, charging
Configure / Home
Alarm setup
Advisory mode, no charging
Configure / Home
Alarm setup
Disarm
Configure / Home
Alarm setup
3rd
4th
N/A
N/A
Pause for CPR /
Resume analyzing
Manual mode
N/A
Disarm
Note: Advisory mode is provided to help determine whether defibrillation is carried out in
manual mode. Advisory mode can be activated by pressing the ECG button.
42
AED mode
1st
No charging
Configure / Home
Charging
Configure / Home
2nd
3rd
4th
Alarm setup
Grayscale /
Full color
Pause for CPR /
Resume analyzing
Alarm setup
Grayscale /
Full color
Disarm
2nd
Alarm setup
3rd
Pacing setup
4th
Resume / Pause pacing
2nd
Alarm setup
3rd
Freeze
4th
N/A
Pacing mode
1st
Configure / Home
Monitor mode
1st
Configure / Home
Configure
User may confirm and set the information of Display, Sound, Waveform, Parameter, Alarm
setup, Patient, Printer, Review, Service setting and Others via Configure button on the
Software Menu Area. Refer to the Configure section for details.
Home
User may exit the menu window via Home button on the Software Menu Area.
Alarm setup
User may confirm and set the alarm setting via Alarm Setup button on the Software
Menu Area. The other method is entering Alarm menu or Alarm Limits menu on
Configure menu. Refer to the Alarms and Limits section for details.
Pause for CPR
User may stop analyzing and performs CPR.
Resume analyzing
User may resume analyzing.
Manual mode
User may change the screen to the manual mode screen.
Disarm
User may disarm the charged energy to the internal resistance.
Grayscale/Full Color
User may change the color filter setting.
Pacing setup
User may set demand/fixed mode, pacing rate and pacing current. Refer to the Pacing
mode section for details.
Resume/Pause Pacing
User may resume or pause pacing output.
Freeze
User may change the screen to the Freeze screen.
43
Configure
User may confirm and set the information of Display, Sound, Waveform, Parameter, Alarm
setup, Patient, Printer, Review, Service setting and Others via Configure button on the
Software Menu Area.
When user opens Configure menu, Configure button on the Software Menu Area is
changed to Home button. Menu window is closed when the Home button is pressed.
The title of menu is shown as ‘Previous menu title / Current menu title’ on the top of
Configure Menu window when the sub menu is selected. User can navigate the menu with
Back Button.
Figure 14. Configure window
44
Display
In the Display menu, users may set the monitor display: Display patient information,
Brightness, Menu timeout, color filter and Parameter color.
Table 8. Display menu
Level 1 Menu
DISPLAY MENU
Display patient information
Brightness
Menu timeout
Color filter
Parameter color
Level 2 Menu or Response
ID, Name, None
1, 2, 3, 4, 5
Off, 10 sec, 20 sec, 30 sec
Full color/Grayscale
Color 1~17 for each parameter
Display patient information
Select the type of patient information to display on patient information area. Refer to
Patient section to create patient information.
Brightness
Adjust the brightness of display.
Menu timeout
If no user input during the set-time when the defibrillator/monitor displays Menu window,
Menu window is automatically closed. Whenever there is user input, count down stars
again.
Color filter
Change the color of display.
Parameter color
Select the color of ECG, SpO2, and RESP.
Sound
In the Sound menu, users may set the defibrillator/monitor sound: Alarm volume, HR/PR
tone volume, Key beep volume, Defibrillator sound volume, Voice prompt volume and
other sound volume.
Table 9. Sound menu
Level 1 Menu
SOUND MENU
Alarm volume
HR/PR tone volume
Key beep volume
Defibrillator sound volume
Voice prompt volume
Other sound volume
Level 2 Menu or Response
1, 2, 3, 4, 5
Off, 1, 2, 3, 4, 5
Off, 1, 2, 3, 4, 5
1, 2, 3, 4, 5
1, 2, 3, 4, 5
Off, 1, 2, 3, 4, 5
Alarm volume
Set the volume of alarm generated by the defibrillator/monitor.
HR/PR tone volume
Set the volume of HR/PR tone generated by the defibrillator/monitor.
45
Key beep volume
Set the volume of key beep generated by the defibrillator/monitor.
Defibrillator sound volume
Set the volume of Defibrillator generated by the defibrillator/monitor.
Voice prompt volume
Set the volume of Voice prompt generated by the defibrillator/monitor.
Other sound volume
Set the volume of other sound generated by the defibrillator/monitor.
Waveform
In the Waveform menu, users may set the waveform setting: ECG 4mV, Waveform 1~3,
ECG, Respiration and SpO2.
Table 10. Waveform menu
Level 1 Menu
WAVEFORM MENU
Waveform setting
ECG
Level 2 Menu or Response
ECG 4mV, Waveform 1~3
Grid, Sweep speed, Size, Pacer pulse detection, ST level
measurement position, Filter mode
Sweep speed, Size
Sweep speed
Respiration
SpO2
Waveform setting
Set ECG 4mV and select the waveforms to be displayed on the screen.
When ECG 4mV is selected, waveforms are displayed using the 2 waveform areas on the
screen, and the number of waveforms for each mode is shown below.
Table 11. The number of ECG 4mV waveform (Full option)
46
Mode
AED/Manual
4mV Off
4mV On
N/A
Monitor
3
2
Pacing
2
1
Figure 15. 4mV waveform
ECG
Set Grid, Sweep speed, Size, Pacer pulse detection, ST level measurement position,
Filter mode and Number of waveforms for ECG parameter.
Respiration
Set Sweep speed and Size for Respiration parameter.
SpO2
Set Sweep speed for SpO2 parameter.
Parameter
In the Parameter menu, users may set the defibrillator/monitor parameter: HR/PR,
Respiration and SpO2.
Table 12. Parameter menu
Level 1 Menu
PARAMETER MENU
HR/PR
RR
SpO2
Level 2 Menu or Response
HR/PR source, Asystole time, Alarm limits, Limit audio
alarm
Apnea time, Alarm limits, Limit audio alarm
SatSeconds, Alarm limits, Limit audio alarm
HR/PR
Set HR/PR source, Asystole time, Alarm limits and Limit audio alarm.
RR
Set Apnea time, Alarm limits and Limit audio alarm.
SpO2
Set SatSeconds, Alarm limits and Limit audio alarm.
Alarm Setup
Set the alarm limits for the each parameter or select whether alarm limits display is
enabled or not. Audio alarm pause/off function can be activated during the audio alarm
pause/off period. For more information about Alarm limits, refer to Alarms and Limits
section.
47
Table 13. Alarm setup menu
Level 1 Menu
ALARM SETUP MENU
Alarm limits
Alarm limit display
Audio alarm pause/off
Level 2 Menu or Response
Alarm limits for each parameter
On, Off
Start, Cancel
Note: The audio alarm pause/off period can be set to Disable, 1 min, 3 min, 5 min, 10 min,
20 min, 30 min, 60 min or Indefinite by authorized personnel via Service menu.
Audio alarm off menu is not displayed when Audio alarm pause/off period is set
Disable. For more information to set the Audio alarm pause/off period, refer to
Service manual.
Patient
For patient management, user can access the Patient Menu via Configure Menu. (It is
also accessible by pressing the Knob on the Patient information area)
In the Patient Menu, user can manage patient information, including admitting and
discharging a patient.
Table 14. Patient menu
Level 1 Menu
PATIENT MENU
Patient information area
Discharge patient
Modify
New patient
Level 2 Menu or Response
(Open the Discharge patient pop-up window)
Patient ID, Patient type, Pacer pulse detection, Name,
Gender, Birth date
(Open the New patient pop-up window)
Note: Name can be entered by using the keyboard.
Printer
In Printer menu, set Print on shock delivery, Print on shock decision, Print on pacing
output, Print on alarm, Print on mark event, Print on self-test and Printing waveform for
Printer. For more information about Printer, refer to Printing section.
Table 15. Printer menu
Level 1 Menu
PRINTER MENU
Print on shock delivery
Print on shock decision
Print on pacing output
Print on alarm
Print on mark event
Print on self-test
Printing waveform
48
Level 2 Menu or Response
On, Off
On, Off
On, Off
On, Off
On, Off
On, Off
Printing speed, Printing time
Review
In Review menu, user can open Event report, tabular trend and Data management.
Table 16. Review menu
Level 1 Menu
REVIEW MENU
Event report
Tabular trend
Data management
Clear event report
Clear trends
Clear data management
Level 2 Menu or Response
Display the Event report screen
Display the Tabular trend screen
(Open the Data management pop-up window)
(Open the Clear event report pop-up window)
(Open the Clear trends pop-up window)
(Open the Clear data management pop-up window)
Service setting
In Service setting, user can enter the Password using the keyboard to open the Service
menu. User can terminate the defibrillator/monitor and check the system information
applied to the defibrillator/monitor: Serial number, System software version and Font
license
Note: For more details about Pass code and Service menu, contact qualified service
personnel or your local supplier for assistance.
Table 17. Service setting menu
Level 1 Menu
SERVICE SETTING MENU
Password
System information
Level 2 Menu or Response
(Entered by numeric keyboard)
Serial number
System software version
Password
Activate the numeric keyboard to enter the password. User can enter the password to
open the Service menu. The defibrillator/monitor operates differently depending on each
password entered. For more details on Password, refer to the Service manual.
System information
Display general information applied to the defibrillator/monitor such as Serial number,
System software version and Font license.
Others
In others menu, user may set the date & time, and can open the User test menu.
Table 18. Others menu
Level 1 Menu
OTHERS MENU
Date & Time
User test
Level 2 Menu or Response
Year, Month, Date, Hour, Minute, Set
(Open the User test pop-up window)
Date & Time
Users may set the date and time displayed on the defibrillator/monitor display and printed
out a printer paper.
Note: The date format may be selected either ’YYYY/MM/DD’, ‘MM/DD/YYYY’
or ’DD/MM/YYYY’ via Service menu.
Note: According to the date format, the order of Year, Month and Date can be different.
49
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50
ALARMS AND LIMITS
Each time the defibrillator/monitor is used, check alarm limits to make
sure that they are appropriate for the patient being monitored.
If different alarm presets are used for the same or similar equipment in
any single area, e.g. an intensive care unit or cardiac operating room, a
potential hazard can exist.
Always respond immediately to a system alarm since the patient may
not be monitored during certain alarm conditions.
Alarm volume adjustment is related to safety to patient. If the volume of
alarm sound is not loud enough for clinician to hear the clinicians are
not able to recognize patient alarm. It causes patient risk.
Do not to cover the holes for the speaker which allows the alarm sound
to exit the defibrillator/monitor. Also do not disable audible alarms when
it is not appropriate to do so.
General
When the defibrillator/monitor detects certain conditions that require user attention, the
defibrillator/monitor enters an alarm state. The defibrillator/monitor response is indicated
by:
⚫ Visual alarm
⚫ Audible alarm
⚫ Physiological alarm including identification of out-of-limit vital signs
⚫ Technical alarm
Note: The audible and visual alarms on the defibrillator/monitor, used in conjunction with
clinical signs and symptoms, are the primary source for notifying medical personnel
that a patient alarm condition exists.
Changing Alarm Volume
User can select an alarm volume level of 1 to 5. Refer to Using the defibrillator/monitor
section.
Alarm Priority and Messages
There are three possible priorities for visual and audible alarms: High, Medium, and Low.
The high, medium, low priority messages and informative messages are displayed in the
alarm/informative message area and the defibrillator messages are displayed in the
defibrillator message area. A message is displayed alternatively every 2 seconds when
the defibrillator/monitor is in multiple alarm conditions. Refer to the Troubleshooting
section for the recommended actions.
Table 19. Alarm priority condition
Alarm Priority
High Priority
Medium Priority
Messages
ECG: Asystole
ECG: V-FIB
SpO2: Loss of pulse
System: Critically low battery condition
Last self-test failed
HR: High limit is violated
HR: Low limit is violated
51
Alarm Priority
Low Priority
52
Messages
ECG: Signal Saturation
PR: High limit is violated
PR: Low limit is violated
PR: High limit is violated
PR: Low limit is violated
RR: Loss of respiration signal
RR: High limit is violated
RR: Low limit is violated
SpO2: High limit is violated
SpO2: Low limit is violated
ECG: Pads cable disconnected
ECG: Pads off
ECG: Cable/Sensor disconnected
ECG: Leads off
ECG: Chest lead off
ECG: Out of range
RR: Cable/Sensor disconnected
RR: Leads off
RR: Out of range
SpO2: Sensor off
SpO2: Cable/Sensor disconnected
SpO2: Out of range
SpO2: Module reset
SpO2: Reconnect / Replace SpO2 sensor
SpO2: Reposition / Replace SpO2 sensor
SpO2: Replace SpO2 Sensor
SpO2: EEE001
SpO2: EEE003
SpO2: EEE035
SpO2: EEE069
SpO2: EEE103
SpO2: EEE171
SpO2: EEE220
Printer: Out of paper
Low battery condition
Therapy module communication error
ECG/Respiration module communication error
SpO2 module communication error
Sub CPU communication error
Printer communication error
RT clock error
Speaker error
Connection to the CMS was disconnected
Module error / EEE901
Module error / EEE902
Module error / EEE903
Module error / EEE904
Module error / EEE905
Module error / EEE906
Module error / EEE907
Module error / EEE908
Module error / EEE909
Module error / EEE910
Alarm Priority
Informative
Messages
ECG: Motion artifact
SpO2: Weak pulse
SpO2: Weak signal
SpO2: Waveform interference*
SpO2: Excess infrared light*
SpO2: Electrical/Optical interference*
SpO2: High Pulse amplitude
SpO2: Try an alternate sensor placement site
SpO2: Optically cover sensor site
SpO2: Use an Ear or Forehead sensor
SpO2: Use a Nasal or Forehead sensor
SpO2: Use an OxiMax adhesive sensor
SpO2: Secure the sensor cable
SpO2: Use a headband with the forehead sensor
SpO2: Warm up sensor site
SpO2: Check the bandage assembly
SpO2: Remove any nail polish from nail beds
SpO2: Ensure sensor is not too tight
SpO2: Reposition sensor
SpO2: Eliminate external interference
SpO2: Clean sensor site
SpO2: Pulse search
SpO2: Motion interference
Abnormally shut down last time
Printer: Not available
Printer: Not available in Low battery condition
Audio alarm is off
Audio alarm is paused
Audio alarm is acknowledged (silenced)
Demo mode
Note: There may be other informative messages that are not listed above.
*When this informative message is displayed, the measurement may be inaccurate due to
the interference
Visual Alarm Indication
Table 20. Visual alarm characteristics
Alarm Priority
High priority
Medium priority
Low priority
Color
Red
Yellow
Yellow
Flashing Period
700ms (about 1.43Hz)
2000ms (about 0.5Hz)
N/A
Duty Cycle
ON: 400 ms / OFF: 300 ms
ON: 1000 ms / OFF: 1000 ms
Always ON
Note: Alarm button of the front panel respond with the flashing rates described in Table 20
when an alarm occurs.
When a high priority alarm is activated, a non-flashing alarm message is displayed. The
numerical area will flash red.
When a medium priority alarm is activated, a non-flashing alarm message is displayed.
The numerical area will flash yellow.
When a low priority alarm is activated, a non-flashing alarm message is displayed. The
numerical area will change to yellow.
53
Audible Alarm Indication
Do not turn off the audible alarm or decrease its volume if patient safety
could be compromised.
Make sure that the defibrillator/monitor speaker is not obstructed.
Failure to do so could result in an inaudible alarm tone.
Table 21. Audible alarm characteristics
Alarm Priority
High priority
Medium priority
Low priority
Audio Alarm Interval
9 sec
15 sec
30 sec
Tone Pitch
540 Hz
480 Hz
400 Hz
Beep Rate
10 beeps in 13.38 sec
3 beeps in 16.11 sec
1 beep in 30.27 sec
Note: Audible alarms may be decreased in volume as described in Table 9 or temporarily
paused.
Note: Audible alarm characteristics in Table 21 are default. Each alarm audio
characteristic depends on audio alarm interval setting. The detailed information is
described in the service manual.
Note: Audio alarm interval can only be changed by authorized personnel via the Service
Setting Menu.
Note: The maximum mean time of the alarm delay is less than 10 seconds unless
otherwise specified in this manual.
54
Changing Alarm Limits
Each time the defibrillator/monitor is used, check alarm limits to make
sure that they are appropriate for the patient being monitored.
If different alarm presets are used for the same or similar equipment in
any single area, e.g. an intensive care unit or cardiac operating room, a
potential hazard can exist.
Do not set the alarm limits to extreme values that can cause the alarm to
become useless.
If necessary, you can change alarm limits from default values for the following vital signs:
⚫
⚫
⚫
HR/PR upper and HR/PR lower alarm limits
Respiration upper and Respiration lower alarm limits
SpO2 upper and SpO2 lower alarm limits
Audio alarm off for each parameter may be set via interaction with the Alarm Setup Menu
on the Configure Menu that presents the limits. The other way, rotate the knob to highlight
the parameter of the screen, then press the knob.
Setting Alarm Limits via Alarm limits Menu
User may confirm and set the alarm limits via Alarm Setup Menu on the Software Menu
Area. The other method, press Alarm Setup Menu on Configure Menu or rotate the knob
to highlight the parameter of the screen, then press the knob. The defibrillator/monitor will
display all alarm limits that are currently in effect for all monitored parameters. Select the
alarm limits of relevant parameter to set.
Table 22. Alarm setup menu
Level 1 Menu
ALARM SETUP MENU
Alarm limits
Alarm limit display
Audio alarm pause/off
Level 2 Menu or Response
Alarm limits for each parameter
On, Off
Start, Cancel
Note: The audio alarm pause/off period can be set to Disable, 1 min, 3 min, 5 min, 10 min,
20 min, 30 min, 60 min or Indefinite by authorized personnel via Service menu.
Audio alarm off menu is not displayed when Audio alarm pause/off period is set
Disable. For more information to set the Audio alarm pause/off period, refer to
Service manual.
55
Alarm Limits Ranges
Table 23 describes the possible alarm limits. The defibrillator/monitor is shipped with
factory default settings.
Note: Authorized personnel can define the way to save the power default: user setting,
backup and factory default. The detailed information is described in the service
manual.
Table 23. Alarm limits ranges
Parameters
Upper Limit, Default
HR/PR (BPM)
Adult
25 ~ 300 BPM, 120 BPM
Pediatric
25 ~ 300 BPM, 160 BPM
Neonatal
25 ~ 300 BPM, 200 BPM
Respiration (/min)
Adult
4 ~ 150 /min, 30 /min
Pediatric
4 ~ 150 /min, 40 /min
Neonatal
4 ~ 150 /min, 65 /min
SpO2 (%)
Adult / Pediatric
21 ~ 100 %, 100 %
Neonatal
21 ~ 100 %, 100 %
Lower Limit, Default
Resolution
20 ~ 295 BPM, 50 BPM
20 ~ 295 BPM, 70 BPM
20 ~ 295 BPM, 100 BPM
5 BPM
5 BPM
5 BPM
3 ~ 149 /min, 5 /min
3 ~ 149 /min, 10 /min
3 ~ 149 /min, 25 /min
1 /min
1 /min
1 /min
20 ~ 99 %, 90 %
20 ~ 99 %, 85 %
1%
1%
Setting Alarm Limits
Alarm Limits determine the high and low points of patient data at which the
defibrillator/monitor will sound an alarm. User can change the alarm limits of the each
parameter. Alarm Setup menu can be accessed by pressing the area of each parameter
or via Configure.
Alarm Audio Acknowledged (Silence)
Do not pause the alarm audio or decrease its volume or turn off the
audible alarm if patient safety could be compromised.
When an alarm occurs, user can pause the alarm audio for the audio alarm acknowledged
(silenced) period (30, 60, 90 or 120 seconds) selected via the Service menu. However,
visual alarms continue during this time. The factory default for audio alarm acknowledged
(silenced) period is 60 seconds.
To pause the alarm audio:
1. Press the Audio Alarm Acknowledged Button to immediately pause the alarm tone. The
alarm resumes after the alarm audio period if the alarm condition has not been corrected.
2. Check the patient and provide appropriate care.
During the audio alarm acknowledged (silenced) period, you can press the Audio Alarm
Acknowledged button again to re-enable the alarm audio tones. Also, if another alarm
occurs during the alarm audio paused period, the alarm audio tones will be automatically
re-enabled.
Note: Invalid tone occurs when there is no alarm condition or the audio alarm pause/off is
activated already.
Note: Low battery alarm or critically low battery alarm cannot be stopped by the Audio
Alarm Acknowledged button or Audio Alarm Inactivation menu.
Note: The alarm audio is caused by some technical errors may be canceled by pressing
the Audio Alarm Acknowledged button. However, battery failure and physiological
alarms cannot be canceled until the alarm condition is corrected.
56
Audio Paused and OFF
Do not pause the audio or decrease its volume if patient safety could be
compromised.
If an alarm condition occurs while in the Audio Off state, the only alarm
indication on the defibrillator/monitor will be visual displays related to
the alarm condition.
Default startup setup is with Audio off on Power ON. If Audio Alarms are
required, make sure to activate audio alarm ON for the patient being
monitored.
Check the audible alarm silence duration before temporarily silencing
the audible alarms.
Do not pause the alarm audio or decrease its volume or turn off the
audible alarm if patient safety could be compromised.
To initiate an alarm audio pause or off:
1. To initiate an alarm audio pause or off, press the Configure button and press the
Alarm Setup button.
2. Press the Start button on Audio Alarm Off menu.
3. To cancel alarm audio pause or off condition, Press the Cancel button on Audio
Alarm Off menu.
Note: The names of menu items are displayed differently depending on the user defined
time period.
If the Start button is pressed:
The audio alarm is stopped when the audio off condition, and the audio alarm paused
when the audio alarm pause condition. If an alarm condition that can be cleared occurs,
the audio alarm is cleared. Audio alarm off condition is started in the audio alarm off.
If the Cancel button is pressed:
The audio alarm condition is changed from the Pause condition or off condition to the
normal condition.
This action disables alarm audios for a user-defined Alarm Audio Pause (when Audio
alarm pause/off period is 1, 3, 5, 10, 20, 30, 60 minutes) or Alarm Audio Off (When Audio
alarm pause/off period is Indefinite) selected via the Service Setting menu. The factory
default for alarm audio pause/off is indefinite.
Note: The periods can only be changed by authorized personnel via the Service Setting
Menu.
57
Alarm Audio Pause/Off Period
If alarm audio pause/off period is set to 1, 3, 5, 10, 20, 30 or 60 minutes, the alarm audio
is not activated for the specified time interval and the message, ‘Audio alarm is paused’,
is displayed.
If alarm audio pause/off period is set to Disable is selected, the audio alarm off function is
disabled and alarm is not off.
If alarm audio pause/off period is set to Indefinite is selected, the audio alarm is off and
the message, ‘Audio alarm is off’, is displayed.
In the alarm audio off state, an Alarm Reminder Tone will sound at the preset interval to
remind the user that the alarm audio is off. The preset interval for an Alarm Reminder
Tone can be set to OFF, 3 or 10 minutes via Service Menu. If OFF is selected, the Alarm
Reminder Tone will be disabled.
Note: Low battery alarm or critically low battery alarm cannot be stopped by the audio
alarm acknowledged (silenced) button or Audio alarm pause/off button.
Note: Users may disable limit violation alarm audios of each vital sign via alarm limits
menu.
58
AED(Automated External Defibrillator) MODE
The defibrillator/monitor will only administer a shock if it is needed. A
voice prompt will tell you when to press the Shock button to administer
defibrillation therapy.
The defibrillator/monitor should not be used on someone who is
responsive when shaken or breathing normally.
Do not use pads if the adhesive gel is dried or damaged. Pads that are
dried out or damaged may cause electrical arcing and patient skin burns
during defibrillation. Do not use pads that have been removed from foil
package for more than 24 hours. Do not use electrodes beyond
expiration date. Check that pads adhesive is intact and undamaged. Do
not reuse disposable pads that are labeled for single patient use.
Do not use paddles for AED mode. AED mode is enabled only with pads.
Disconnect non-defibrillation proof electronic devices or equipment
from patient before defibrillation.
Do not administer a shock using the electrode monitoring cable.
Do not place pads in the anterior-posterior position when operating this
defibrillator/monitor in AED mode. A shock or no shock advised
decision may be inappropriately advised. The shock advisory algorithm
requires the electrodes to be placed in the anterior-lateral (Lead II)
position.
Be sure that the electrodes do not come in contact with other
conductive materials, especially when connecting or disconnecting the
electrodes to or from the patient.
Heart rate alarms are temporarily paused in AED Mode. Heart rate
alarms are also paused while the defibrillator/monitor is charging for
defibrillation and delivering a shock.
Do not use pediatric electrodes on adults or larger children. Delivery of
defibrillation energies equal to or greater than 100 joules (typically used
on adults) through these smaller electrodes increases the possibility of
skin burns.
The AED Mode of defibrillator/monitor is designed for the treatment of sudden cardiac
arrest (SCA). It should only be used to treat someone who may be a victim of a SCA and
is:
⚫ unresponsive to stimulus,
⚫ not breathing,
⚫ exhibiting no signs of life.
If the person is unresponsive but you are unsure that they have suffered from a SCA
begin CPR. When it is appropriate to treat, apply the defibrillator/monitor and follow the
audible instructions.
59
General
Defibrillation therapy is the definitive method for termination of a variety of potentially
fatal arrhythmias. The defibrillator/monitor’s Automated External Defibrillation (AED)
Mode is designed to guide you through standard treatment algorithms for cardiac arrest.
The defibrillator/monitor provides therapy through the application of a brief biphasic
pulse of electricity to the cardiac muscle. This electrical energy is transferred through
disposable multifunction pads applied to the patient’s bare chest.
Configuration choices allow you to customize AED Mode to better meet the unique
needs of your organization or resuscitation team. This chapter describes how to use
AED Mode. It explains the prompts that guide you through the defibrillation process and
describes how prompts vary depending upon the condition of the patient and the
configuration of your device.
Sudden Cardiac Arrest (SCA)
Sudden cardiac arrest is a condition in which the heart suddenly stops pumping
effectively due to a malfunction of the heart‘s electrical system. Often victims of SCA have
no prior warning signs or symptoms. SCA can also occur in people with previously
diagnosed heart conditions. Survival for an SCA victim depends on immediate cardiopulmonary resuscitation (CPR). The use of an external defibrillator within the first few
minutes of collapse can greatly improve the patients’ chances of survival. Heart attack
and SCA are not the same, though sometimes a heart attack can lead to a SCA. If you
are experiencing symptoms of a heart attack (pain, pressure, shortness of breath,
squeezing feeling in chest or elsewhere in the body) seek emergency medical attention
immediately.
Heart Rhythm
The normal electrical rhythm by which the heart muscle contracts to create blood flow
around the body is known as Normal Sinus Rhythm (NSR). Ventricular Fibrillation (VF)
caused by chaotic electrical signals in the heart is often the cause of SCA, but a shock
can be administered to re-establish normal sinus rhythm. This treatment is called
defibrillation. The AED Mode is designed to automatically detect ventricular fibrillation
(VF) and perform defibrillation on victims of sudden cardiac arrest.
Detecting Fibrillation
The electrical rhythm by which the heart muscle contracts can be detected and used for
medical diagnosis and the resulting reading is called an Electrocardiogram (ECG). The
AED Mode is designed to analyze a patient’s ECG in order to detect ventricular fibrillation
(VF) in the heart. If ventricular fibrillation (VF) is detected, the defibrillator/monitor will
deliver a carefully engineered electrical shock designed to stop the chaotic electrical
activity experienced within the heart muscle during SCA. This may allow the victim‘s
heart to return to a normal sinus rhythm.
Rhythm Recognition Performance
The ECG database for validation of rhythm recognition performance includes ventricular
fibrillation (VF) rhythms of varying amplitudes, ventricular tachycardia (VT) rhythms of
varying rates and QRS width, various sinus rhythms including supraventricular
tachycardias, atrial fibrillation and atrial flutter, sinus rhythms with PVC (premature
ventricular contraction), asystole, and pacemaker rhythms.
60
AHA/ERC Guidelines (Rescue protocol)
The AED rescue protocol is consistent with the guidelines recommended by the
AHA/ERC 2015 Guidelines for Resuscitation and Emergency Cardiac Care. The AED
rescue protocol is subject to be upgradeable in order to be consistent with and optimized
for the guidelines recommended by the latest version of AHA/ERC Guidelines for
Resuscitation and Emergency Cardiac Care. Please contact your Mediana service
representative for more information.
Note: AHA is the abbreviation for ‘American Heart Association’ and ERC is the
abbreviation for ‘European Resuscitation Council’.
Note: This section is described in accordance with ERC Guidelines. Differences for ERC
Guidelines and AHA Guidelines are described with Note format.
Preparing for Defibrillation
The AED algorithm is not designed to handle erratic spiking problems
caused by a properly or improperly functioning pacemaker. In patients
with cardiac pacemakers, the defibrillator/monitor may have reduced
sensitivity and not detect all shockable rhythms.
1. Confirm that the patient is:
⚫ unresponsive to stimulus,
⚫ not breathing,
⚫ exhibiting no signs of life.
2. Remove clothing to expose the patient’s chest. Wipe moisture from the patient’s chest
and if the patient has an excessively hairy chest, shave the area where the electrodes
are about to be applied.
3. Make sure the pads packaging is intact and within the expiration date shown.
4. Apply pads to the patient as directed on the pads package. Use the anterior-anterior
(anterior-lateral) pads placement.
5. If not pre-connected, insert the pads cable into paddle/pads connector located on the
left panel of the device. Push until you hear it click into place.
Note: Successful resuscitation is dependent on many variables specific to the patient’s
physiological state and the circumstances surrounding the patient incident. Failure
to have a successful patient outcome is not a reliable indicator of
defibrillator/monitor performance. The presence or absence of a muscular
response to the transfer of energy during electrical therapy is not a reliable
indicator of energy delivery or device performance.
61
Operating the AED Mode of defibrillator/monitor
Do not let the multifunction pads touch each other or other monitoring
electrodes, lead wires, dressings, transdermal patches, etc. Such
contact can cause electrical arcing and patient skin burns during
defibrillation and may divert defibrillation current away from the heart.
During defibrillation, air pockets between the skin and multifunction
pads can cause patient skin burns. To help prevent air pockets, make
sure defibrillation pads completely adhere to the skin. Do not use driedout multifunction pads.
Aggressive handling of multifunction pads in storage or prior to use can
damage the pads. Discard the pads if they become damaged.
1. Rotate the Multi function knob of the defibrillator/monitor and start the AED Mode
2. Check whether the AED Mode is normally enable and follow the voice prompt and the
action icons.
Note: Impedance is the resistance between the defibrillator’s pads or paddles that the
defibrillator must overcome to deliver an effective discharge of energy. The degree
of impedance differs from patient to patient and is affected by several factors
including the presence of chest hair, moisture, and lotions or powders on the skin.
Note: The low-energy biphasic waveform is an impedance-compensating waveform that is
designed to be effective across a wide range of patients. However, if you receive a
‘Poor Pads Contact’ message, check that the patient’s skin has been washed and
dried and that any chest hair has been clipped. If the message persists, change the
pads and/or the pads cable.
Note: The AED mode constantly detects ECG signals from after the ECG analysis to
before delivering the shock. If the ECG rhythm changed to a non-shockable rhythm,
the shock energy that is accumulated on the high-voltage capacitor will be
disarmed through internal resistance.
Performing CPR
After the electric shock is delivered, the following voice prompt would be emitted.
⚫ It is safe to touch the patient.
⚫ Begin CPR.
Follow the voice prompts to properly perform the CPR.
When performing CPR, use the metronome sound from the defibrillator/monitor in AED
mode for compression rate – the defibrillator/monitor emits a tone at a rate of 100 beats
per minute. Also, action icon of the defibrillator/monitor will be flashing at a same rate of
metronome sound.
Rescuer performs 5 cycles of CPR, each cycle include 30 times of chest compression
and 2 times of rescue breaths. Or perform the chest compression without rescue breath,
if untrained or unable to do rescue breaths. The defibrillator/monitor will remain in CPR
mode for 5 cycles (approximately 2 minutes). After CPR mode you will hear the following
voice prompt:
⚫ Stop CPR.
The defibrillator/monitor in AED mode will then return to analyzing procedure. Continue to
follow this instruction until emergency physician arrives and the hand over patient to
emergency physician.
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Note: In accordance with AHA/ERC 2015 Guidelines,
-
the recommended compression rate is 100 ~ 120 beats per minute,
the recommended compression depth is at least 2 inches (5 cm), but not more
than 2.4 inches (6 cm),
the recommended compression ventilation ratio is 30:2,
the recommended duration is 5 cycles (30:2 x 5 cycles).
Note: Your Mediana dealer will have trained you in the particular SCA treatment protocol
you have chosen. In all cases follow the voice prompts and visual instructions
given by the defibrillator/monitor in AED mode.
63
Description of AED Mode Menu Functions
1
6
5
2
4
3
1 Operating mode
2 Instruction message
3 Contact indicator
4 Number of shock
5 Energy level
6 Energy escalation
Figure 16. AED mode menu
Contact indicator
When the Contact indicator is set to On, the indicator bar and impedance measured from
pads are displayed. Contact indicator can be set between On, Off via Service Setting
menu. Refer to the Service manual for detail.
Energy escalation
When the Energy escalation is set to On, energy escalation is displayed. When shock is
delivered twice, three times, selected energy level is gradually escalated. Energy
escalation can be set between On, Off via Service Setting menu. Energy escalation
energy cab be set via Service Setting menu. Refer to the Service manual for detail.
Note: For displayed content except for informative message, refer to the Using the
Defibrillator/Monitor section.
64
MANUAL MODE
Make sure that the ECG signal quality is good and that sync marks are
correctly displayed above each QRS complex prior to performing
synchronized defibrillation (cardioversion).
Artifact introduced by paddle movement may resemble an R-wave and
trigger a defibrillation shock when performing synchronized
defibrillation (cardioversion).
Disconnect non-defibrillation-proof electronic devices or equipment
from patient before defibrillation.
The defibrillator/monitor has a mechanism to inhibit its output when the
impedance of human body which can be measured by paddle is out of
range.
Whenever possible, Mediana recommended that user performs
synchronized defibrillation (cardioversion) procedures while directly
monitoring the patient through the defibrillator’s electrodes or lead
inputs.
This section explains how to prepare for and perform asynchronous defibrillation and
synchronous defibrillation (cardioversion) using multifunction electrode pads, external
paddles.
General
Defibrillation therapy is the definitive method for termination of a variety of potentially fatal
arrhythmias. The defibrillator/monitor provides this therapy through the application of a
brief biphasic waveform of electricity to the cardiac muscle. This electrical energy is
transferred through attached paddles or disposable multifunction pads applied to the
patient’s bare chest.
In manual mode, you must assess the ECG, decide if defibrillation or cardioversion is
indicated, select the appropriate energy setting, charge the defibrillator/monitor, and
deliver the shock. The entire defibrillation process is under your control. Voice prompts
are not present. However, text messages on the display provide relevant information
throughout the process. It is important to be attentive to these messages when displayed.
Note: Defibrillation is always performed through paddles or pads. However, during
defibrillation you may choose to monitor the ECG using an alternate ECG source
(3- or 5-lead monitoring electrodes).
Note: Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart
and completely eliminate any chance of recovery. Asystole should not be routinely
shocked.
Note: Successful resuscitation is dependent on many variables specific to the patient’s
physiological state and the circumstances surrounding the patient event. Failure to
have a successful patient outcome is not a reliable indicator of defibrillator/monitor
performance. The presence or absence or a muscular response to the transfer of
energy during electrical therapy is not a reliable indicator of energy delivery or
device performance.
65
Preparing for Defibrillation
Using adult external paddles
1. External paddles are placed on the device.
2. Remove the paddles from the paddle tray by pulling the paddles straight up and out
of the paddle tray.
3. Apply conductive matter to the paddle electrodes. Do not distribute conductive
matter by rubbing the paddle electrodes together.
4. Apply paddles to the patient’s bare chest.
Using pediatric external paddles
1. The defibrillator/monitor external paddles come with pediatric paddles included.
2. Depress the latch at the front of the external paddles while pulling forward on the
adult paddle plate.
3. Apply paddle to the patient’s bare chest.
Note: The paddle is an assembled product which is intended to use for adult patient.
Remove the plate of paddle for adult, and there is the paddle for pediatric patient.
66
Operating the Manual Mode of Defibrillator/Monitor
1. Select manual mode of defibrillator/monitor by rotating the Mode select knob.
2. Select the defibrillation energy by pressing the Energy level button.
3. Charge the selected energy to pressing the Charge button.
4. Check the defibrillation mode and set the mode between sync mode and async mode
by using Sync button.
5. Press the Shock button when charge complete message is displayed.
Note: Press the Analyze button and follow instruction on the screen to use advisory mode.
Note: In the manual mode, Advisory mode can help you judge whether the defibrillation is
needed is provided.
Note: When using the external paddle, Shock button on the front panel does not work;
only the Shock button on the paddle works. The Shock button on the external
paddle works only when the Shock buttons of APEX and STERNUM are pressed
together.
Note: Defibrillation currents can be passed to you or others around you to cause injury.
Do not touch the patient or any equipment connected to the patient during
defibrillation.
Note: Defibrillation should always be done with a paddle or pad. During defibrillation,
however, other ECG sources (3- or 5-lead monitoring electrodes) can be used to
monitor the ECG.
Note: Implementing defibrillation in patients with asystole may interfere with the natural
recovery of the heart‘s inherent pacemaker or may not permanently recover the
heart‘s inherent pacemaker. Therefore, defibrillation therapy should not be used in
the absence of a pulse.
Note: For defibrillation in sync mode, you must hold the Shock button (or the Shock button
on the paddle) until shock is delivered. The defibrillator/monitor will deliver shock
based on the next detected R-wave.
Note: If Continuous mode is off, advisory mode will exit after completion of advisory mode
to CPR. To use advisory mode continuously, turn on the continuous mode. See the
Advisory Mode section of the service manual for details.
67
Defibrillating (Async mode)
If the device and paddles are prepared for defibrillation, perform the following steps;
1.
To select the energy setting, press the Select Energy Level button and rotate the
Multi function knob to the desired energy level. Energy choices range from 1 to
200J.
Note: If Select Energy Level button is not pressed, defibrillator/monitor has default energy
level setting. To change default setting, enter the Service Setting menu.
Note: Clinicians must select an appropriate energy level for defibrillation of pediatric
patients.
2.
To charge the energy, press the Charge button. If using external paddles, the
Charge buttons on the paddle or on the front panel can be used. When completing
the charge, the charge indicator of the paddle turns on in red. Before 3 steps, check
the charge indicator.
Note: You may increase or decrease the selected energy at any time during charging or
after charging is complete.
3.
⚫
⚫
68
There are two ways to shock the energy.
Press the Shock button which is placed on the front side of defibrillaotr/monitor
Press the Shock button located on the external paddles.
Synchronized Cardioversion (Sync mode)
Synchronized Cardioversion allows you to synchronize delivery of the shock with the Rwave of the ECG being monitored in Wave Sector 1. You may choose to perform
synchronized cardioversion through either multifunction pads, or external paddles.
When using paddles, you should defibrillator/monitor the ECG through monitoring
electrodes connected to a 3- or 5-lead ECG cable or a defibrillator/monitor. You may
choose to defibrillator/monitor through an alternate source when using pads, as well.
During cardioversion, energy shock is still delivered through either pads or paddles.
If the defibrillator/monitor and paddles are prepared for defibrillation, perform the following
steps;
1. To activate Sync mode, press the Sync Soft key located lower right corner of the
screen.
2. Confirm that the Sync marker appears with each R-wave.
3. To select the energy setting, rotate the Multi function knob to the desired Energy
Level button and press it. Energy choices range from 1 to 200J.
Note: Clinicians must select an appropriate energy level for defibrillation of pediatric
patients.
4.
To charge the energy, press the Charge button. If using external paddles, the
Charge button on the paddles may be used instead. When completing the charge,
the charge indicator of the paddle turns on in red. Before 5 steps, check the charge
indicator.
Note: You may increase or decrease the selected energy at any time during charging or
after charging is complete.
5.
⚫
⚫
There are two ways to shock the energy.
Press the Shock button which is placed on the front side of defibrillator/ monitor.
Press the Shock button located on the external paddles. The shock will be
delivered when the next R-wave is detected.
Note: Defibrillation current can cause operator or bystander injury. Do not touch the
patient, or equipment connected to the patient, during defibrillation.
If additional synchronized shocks are indicated, perform the following steps;
1. Make sure the Sync function is still enabled, as indicated by the presence of the
Sync message in the upper right corner of the Wave Sector 1.
2. Repeat Steps 4-5 under ‘Delivering a Synchronized Shock’.
To turn off the Sync function of the defibrillator/monitor, Press the Sync Soft key.
Note: The maximum time delay between synchronization pulse and delivery of energy is
not exceeded 60ms.
69
Description of the Manual Mode Menu Functions
6
1
2
5
4
3
1 Operating mode
2 Instruction message
3 Contact indicator
4 Number of shock
5 Energy level
6 Synchronous mode
Figure 17. Manual mode screen
Contact indicator
When the Contact indicator is set to On, the indicator bar and impedance measured from
pads are displayed. Contact indicator can be set between On, Off via Service Setting
menu. Refer to the Service manual for detail.
Number of shock
Number of delivered shock is displayed. When the number exceeds 999, the number
initializes to 1. In the advisory mode, the number of shock is added up, in the AED mode,
the number of shock is not added up.
Synchronous mode
Synchronous or asynchronous mode state is displayed. Sync is displayed in the
synchronous mode and message is not displayed in the asynchronous mode.
Note: For displayed content except for informative message, refer to the Using the
Defibrillator/Monitor section.
70
MONITOR MODE
General
In monitor mode, you can monitor Electrocardiography (ECG) acquired a 3-, or 5-lead
ECG electrodes. Optional monitoring of functional arterial oxygen saturation (SpO 2) and
respiration (RESP) are also available. Measurements from these parameters are
presented on the display and alarms are available to alert you to changes in the patient’s
condition. Monitor mode also provides display format of large numeric screen. However,
monitor mode cannot provide the defibrillator function including select the delivered
energy, analyze, charge, deliver the shock and appear defibrillator messages on the
display.
Description of Monitor Mode Menu Functions
1.
2.
Select monitor mode of defibrillator/monitor by rotating the Mode select knob.
When the manual mode of defibrillator/monitor is activated normally, the energy
select display will be displayed on the top of the screen and other parameter
information will be displayed.
Monitor mode does not provide action advice and provides up to 3 waves as shown
below.
Figure 18. Monitor mode menu – Full color mode
71
Figure 19. Monitor mode menu – Grayscale mode
Note: For displayed content, refer to the Using the Defibrillator/Monitor section.
Freeze
The defibrillator/monitor provides a freeze menu to check previous measured waveform
data. User can set the frozen screen via Freeze button in Waveform menu at the
bottom of the measurement screen. The defibrillator/monitor can freeze the waveforms
for 120 seconds.
Figure 20. Monitor mode menu – Freeze
Reviewing frozen waveforms
When waveforms are frozen, user can view the waveforms by rotating the Multi function
knob to move the frozen waveforms right or left. With each step or clock, the frozen time
changed at intervals of 1 second.
Unfreeze
To unfreeze the frozen waveforms, press the Unfreeze Soft key at the bottom of the
measurement screen.
72
PACING MODE
Use demand mode pacing whenever possible. Use Fixed mode pacing
when motion artifact or other ECG noise makes R-wave detection
unreliable.
Observe the patient continuously while the pacemaker is in use. Patient
response to pacing therapy (for example, capture threshold) may
change over time.
Prolonged noninvasive pacing may cause patient skin irritation and
burns, especially with higher pacing current levels. Discontinue
noninvasive pacing if skin becomes burned and another method of
pacing is available.
The ECG size must be properly adjusted so that the patient’s own beats
are detected. If ECG size is set too high or too low, pacing pulses may
not be delivered when required. Adjust ECG size so that pacing pulse
mark is placed on the patient’s QRS complexes.
If you are using the pacing function with battery power and the low
battery appears, plug the device into AC power. When the device
powers back up, pacing is no longer activated. Press Pacer to reactivate the pacing function.
Using other manufacturers’ combination pads with this device could
cause a decrease in pacing efficacy or the inability to pace because of
unacceptably high impedance levels and invalidate the safety agency
certifications. Use only the pads that are specified in these operating
instructions.
Use of other ECG monitoring devices may provide misleading
information due to the presence of pace artifacts.
Under certain conditions it may not be possible to properly
defibrillator/monitor or pace while electrosurgical apparatus is
operating.
When poor pads contact, dry skin and/or skin with hair causes
excessively high impedance, which restrain the generation of the
selected pacing current, and that close surveillance is essential to avoid
any risk caused by high impedance if it occurs, the ‘Pacer out ___ mA’
warning message is provided on the screen.
Do not pace with defibrillation pad.
Pacing rate should be set higher than the patient’s heart rate while
using fixed mode.
Close patient surveillance is required because ventricular fibrillation
could be induced when pacing pulse is activated on T-wave under fixed
mode while using fixed mode.
Monitor the patient condition continuously through other physiological
measurements or mechanical captures when pacing is activated.
73
General
Pacing therapy is used to deliver pace pulses to the heart. Pace pulses are delivered
through multifunction pads that are applied to the patient’s bare chest.
Note: Use only approved lead sets when pacing with the defibrillator/monitor.
Note: Waveforms, ECG monitoring, measurements, and most alarms remain active and
retain their settings when you convert from manual mode or monitor mode to
pacing mode.
Description of Pacing Mode Menu Functions
1
5
2
4
3
1 Operating mode
2 Instruction message
3 Pacing rate
4 Pacing current
5 Pacing output mode
Figure 21. Pacing mode menu
Note: For displayed content, refer to the Using the Defibrillator/Monitor section.
74
Demand Mode and Fixed Mode
The defibrillator/monitor can deliver pace pulses in either Demand mode or Fixed mode.
1. In Demand mode, the defibrillator/monitor only delivers pace pulses when the patient’s
heart rate is lower than the selected pacing rate.
2. In Fixed mode, the defibrillator/monitor delivers pace pulses at the selected rate.
Note: Use Demand mode pacing whenever possible. Use Fixed mode pacing when
motion artifact or other ECG noise makes R-wave detection unreliable or when
monitoring electrodes are not available.
The defibrillator/monitor requires a 3-, 5-, 12- lead ECG cable and monitoring electrodes
as the source of the ECG during standard pacing. Pace pulses are delivered through the
multifunction pads. However, the pads cannot be used to monitoring the ECG and deliver
pace pulses simultaneously.
Preparing for Pacing
1. Remove clothing to expose the patient’s chest. Wipe moisture from the patient’s chest
and if the patient has an excessively hairy chest, shave the area where the electrodes
are about to be applied.
2. Make sure the pads packaging is intact and within the expiration date shown.
3. Apply pads to the patient as directed on the pads package. Use the anterior-anterior
(anterior-lateral) pads placement.
4. If not pre-connected, insert the pads cable into paddle/pads connector located on the
front panel of the device. Push until you hear it click into place.
Operating the Pacing Mode of Defibrillator/Monitor
1. Align the Mode select knob to ‘Pacing’ to select the pacing mode.
2. When the pacing mode of defibrillator/monitor is activated normally, the pace rate and
current value will be displayed on the top of the screen and other parameter information
will be displayed.
3. Press the Pacing setup software key
4. Rotate the Multi function knob to the desired value of pacing current and pace pulse
per minute.
5. Select the pacing mode between demand mode and fixed mode.
6. Press the Resume pacing software key to start pacing.
Figure 22. Pacing display (Fixed mode)
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76
ECG MONITORING
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Mediana. Use accessories
according to the manufacturer’s directions for use and your facility’s
standards. It may cause burns to the patients or defibrillator/monitor
failure to use of pacing/defibrillation pads or adapters from sources
other than Mediana.
Line isolation defibrillator/monitor transients may resemble actual
cardiac waveforms and thus inhibit heart rate alarms. Such transients
may be minimized by proper electrode and cable placement, as
specified in this manual and electrode directions for use.
Do not use damaged ECG leads. Do not immerse ECG leads completely
in water, solvents, or cleaning solutions. Do not sterilize ECG leads by
irradiation, steam, or ethylene oxide. Follow the manufacturer’s
directions for use.
Do not use ECG electrodes with expired dates. Do not use defective
ECG electrodes. These might cause improper performance.
ECG cables may be damaged if they are connected to a patient during
defibrillation. Cables that have been connected to a patient during
defibrillation should be checked for functionality before using again.
It is possible for the patient to receive a burn due to an improperly
connected electrosurgical unit. Additionally, the defibrillator/monitor
could be damaged or measurement errors could occur. Place the ECG
cable and leads as far as possible from the site of the electrosurgical
unit and from the electrosurgical cables. This will minimize interference
and the risk of burns to the patient.
For pacemaker patients, the defibrillator/monitor may continue to count
pacemaker rate during occurrences of cardiac arrest or some
arrhythmias. To reduce the likelihood of this, ensure that the Pacer
Detect setting is On in the ECG waveform Menu when monitoring such
patients. Do not rely entirely upon the defibrillator/monitor alarms. Keep
pacemaker patients under close surveillance.
To ensure patient safety, the conductive parts of the ECG electrodes
(including associated connectors) and other patient-applied parts
should not contact other conductive parts, including earth ground, at
any time.
Correct the electrode placement. Improper electrode placement may
cause incorrect result. User must be aware of proper
defibrillator/monitor operation.
Use only high quality ECG electrodes. ECG electrodes are for rhythm
acquisition only. Do not attempt to defibrillate or pace through ECG
electrodes.
Precordial lead electrodes and lead wires may interfere with the
placement of standard paddles or pads. Before defibrillation, remove
any interfering precordial lead electrodes and lead wires.
77
General
The process of depolarization and repolarization of the myocardium generates electric
potentials that are sensed by ECG electrodes on the skin surface. These electrodes are
typically attached to the patient’s right arm, left arm, and left leg. The defibrillator/monitor
processes and amplifies these signals and presents the ECG waveform on the screen.
Also, the defibrillator/monitor computes the minute heart rate at least every second by
moving average. In addition to the acquisition of the QRS complex, the circuitry performs
a number of other functions. The defibrillator/monitor can display:
⚫ Heart rate in beats per minute
⚫ Detection of a ‘lead off’ condition if an electrode is disconnected or poorly connected
⚫ Detection of the presence of pacemaker signals within the ECG waveform complex
Note: Occasionally, electromagnetic interference beyond the range guaranteed from the
manufacturer’s EMC declaration may cause the defibrillator/monitor to display a
‘ECG: Chest lead off ’ alarm. This occurrence is rare, and duration should be short.
When the interference ceases, the defibrillator/monitor removes the alarm. Refer to
the Specification section.
Setup Connections
Note: Mediana recommends the use of silver/silver chloride electrodes (Ag/AgCl). When
dissimilar metals are used for different electrodes, the electrodes may be subject to
large offset potentials due to polarization, which may be severe enough to prevent
obtaining an ECG trace. Using dissimilar metals may also increase recovery time
after defibrillation.
1. Select the electrodes to be used. Use only one type of electrode on the same patient to
avoid variations in electrical resistance. Prepare the electrode sites according to the
electrode manufacturer’s instructions. See Figure 23 and Figure 24 for electrode
placement configurations.
Figure 23. Standard 3 electrode placement
78
Figure 24. 5 electrode placement
Note: One of 5-1 to 5-6 Lead electrode placement sites for the fifth lead.
2. Connect the ECG lead.
3. Connect the ECG lead to the ECG connector on the defibrillator/monitor’s front panel.
4. Attach the leads to the electrodes, and then apply the electrodes to the patient, using
the color-code guide in Table 24. Verify that the desired Lead Selection is active in the
ECG waveform area. Refer to Table 25. Lead II is best suited for most monitoring
situations.
Table 24. ECG lead colors
Lead
1. Right arm
2. Left arm
3. Left leg
4. Right leg
5-1 to 5-6. V (Chest)
AAMI
White (RA)
Black (LA)
Red (LL)
Green (RL)
Brown (V)
IEC
Red (R)
Yellow (L)
Green (F)
Black (N)
White (C)
Table 25. ECG lead pairs
Lead-Selection
I
II
III
V (Chest)
aVR
aVL
aVF
Electrode Differential (AAMI)
RA
LA
RA
LL
LA
LL
(RA+LA+LL)/3
Chest (V)
– (Lead I + Lead III/2)
(Lead I – Lead III)/2
(Lead II + Lead III)/2
Electrode Differential (IEC)
R
L
R
F
L
F
(R+L+F)/3
Chest (C)
– (Lead I + Lead III/2)
(Lead I – Lead III)/2
(Lead II + Lead III)/2
79
Description of HR/PR Menu Functions
The calculated Heart Rate/Pulse Rate may be derived from different sources (ECG or
SpO2) as shown by the icon in the HR/PR numerical area.
8
7
6
1
6
2
3
4
5
1
2
3
4
HR/PR source
Pacer pulse detection icon
Alarm audio icon
Alarm limit upper
5
6
7
8
Alarm limit lower
HR/PR value
HR/PR unit
HR/PR title
Figure 25. HR/PR display
Note: If the alarm limit display setting is set to ON, the alarm limit is displayed next to the
measured value.
Note: Even if the alarm limit display setting is set to on, the alarm limit may not be
displayed depending on some specifications.
Table 26. HR/PR menu
Level 1 Menu
HR/PR MENU
HR/PR source
Asystole time
HR/PR alarm limits
HR/PR limits audio alarm
Level 2 Menu or Response
Auto, HR, PR
3 sec, 4 sec, 5 sec, 6 sec, 7 sec, 8 sec, 9 sec, 10 sec
Upper/lower alarm limits
On, Off
HR/PR source
User may select Auto, HR or PR to decide the source of the heart rate or pulse rate. If
you select Auto, the defibrillator/monitor automatically derives the heart rate or pulse
rate from one of the monitoring parameters in this order of priority: ECG or SpO2. When
HR is selected, the heart rate is measured from ECG and the monitor can detect motion
artifact. When PR is selected, the pulse rate is measured from SpO 2. The HR/PR tone
volume can be adjusted in the Configure menu. Refer to the Using the
Defibrillator/Monitor section.
Limit alarm audio off
When limit alarm audio off is set to Off, the alarm audio for limit alarm is went off.
80
Description of ECG Waveform Menu Functions
9
8
7
6
5
4
1
2
3
1
2
3
4
5
ECG waveform
ECG size reference bar
ECG 25mm/s size bar
ECG pacer pulse detection
ECG filter
6
7
8
9
Pacer pulse marker
Filter mode setting value
ST level value
ECG waveform title
Figure 26. ECG waveform display
Table 27. ECG waveform menu
Level 1 Menu
ECG WAVEFORM MENU
Grid
Sweep speed
Size
Pacer pulse detection
ST level measurement position
Filter mode
Filter mode (Pads)
Level 2 Menu or Response
On, Off
12.5 mm/s, 25.0 mm/s, 50.0 mm/s
Auto, 5.0 mm/mV, 10.0 mm/mV, 15.0 mm/mV,
20.0 mm/mV
On, Off
60 ms, 62 ms, 64 ms, 66 ms, 68 ms, 70 ms, 72
ms, 74 ms, 76 ms, 78 ms, 80 ms
0.05 - 150 Hz, 0.05 - 40 Hz, 0.5 - 40 Hz, 0.5 - 30
Hz
0.05 - 150 Hz, 0.05 - 40 Hz, 0.5 - 40 Hz, 0.5 - 30
Hz, 1 - 21 Hz
Grid
User can turn the grid on or off that is behind the ECG waveform area.
Sweep Speed
The user-selectable sweep speed determines the speed at which the ECG waveform
trace moves across the screen. Sweep Speed can be selected from 12.5 mm/s, 25.0
mm/s and 50.0 mm/s.
Size
The user-selectable ECG waveform size allows user to adjust the amplitude of an ECG
waveform. The size can be selected from Auto, 5.0 mm/mV, 10.0 mm/mV, 15.0 mm/mV,
20.0 mm/mV. When the size is set to Auto, The monitor automatically determines the
optimal size of the ECG waveform to fit the space.
81
Pacer Pulse Detection
Pacer Pulse Detection should always be On for patients with pacemakers (refer to the
warning in this section). User can toggle Pacer pulse detection mode via Patient
Information menu and ECG menu in Waveform menu of Configure menu. When
Pacer Pulse Detection is On, the monitor detects and filters pacemaker-generated
signals so that they will not be calculated in determining a patient’s heart rate. When
monitoring patients without pacemakers, Pacer pulse detection should be set to Off to
avoid misdiagnosis.
Note: When pacer pulse detection is on, Pacer pulse is not included in QRS calculation
ST Level Measurement Position
ST level is measured by calculating average the range of 60 ~ 80msec after J point. ST
measurement point can be changed by QTc value according to heart rate.
Filter Mode
The defibrillator/monitor can filter ECG waveform noise with different ranges of
frequency response.
⚫ 0.05 Hz to 150 Hz: Choose this mode in the just low noise environment, assumes a
motionless for diagnostic information.
⚫ 0.05 Hz to 40 Hz: Expands the range to display very low frequencies down to 0.05 Hz.
⚫ 0.5 Hz to 40 Hz: Choose this mode to see just the ECG waveform monitoring.
⚫ 0.5 Hz to 30 Hz: Generally called a filter mode, it reduces ECG waveform noise.
⚫ 1 Hz to 21 Hz: Generally called a filter mode, it reduces ECG waveform noise.
Note: The clause 201.12.4.107.1 Frequency response of IEC60601-2-25 are tested only
for 0.05 Hz to 150 Hz of ECG filter mode menu.
82
SpO2 MONITORING
For best product performance and measurement accuracy, use only
accessories manufactured by Medtronic® or supplied by Mediana. Use
accessories according to the manufacturer’s directions for use and your
facility’s standards.
Tissue damage can be caused by incorrect application or use of an
SpO2 sensor. Harm can be caused, for example, by wrapping the sensor
too tightly, by applying supplemental tape, or by leaving a sensor on too
long in one place. Inspect the sensor site as directed in the sensor
directions for use to ensure skin integrity, correct positioning, and
adhesion of the sensor.
Do not use damaged SpO2 sensors. Do not use an SpO2 sensor with
exposed optical components. Do not immerse sensor completely in
water, solvents, or cleaning solutions because the sensor and
connectors are not waterproof. Do not sterilize SpO2 sensors by
irradiation, steam or ethylene oxide. Refer to the cleaning instructions in
the directions for use for reusable SpO2 sensors.
Inaccurate measurements may be caused by:
⚫ incorrect sensor application or use
⚫ significant levels of dysfunctional hemoglobin (such as
carboxyhemoglobin or methemoglobin)
⚫ intravascular dyes such as indocyanine green or methylene blue
⚫ exposure to excessive illumination, such as surgical lamps
(especially ones with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, or direct sunlight
⚫ excessive patient movement
⚫ high-frequency electrosurgical interference and defibrillators
⚫ venous pulsations
⚫ placement of a sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line
⚫ patient conditions such as hypotension, severe vasoconstriction,
severe anemia, hypothermia, cardiac arrest, or shock
⚫ arterial occlusion proximal to the sensor
⚫ environmental conditions
⚫ unspecified length of the extension cable
Do not attach any cable to the sensor port connector that is intended for
computer use.
Do not pull the cable because pulling the cable could cause the
disconnection of the cable from the defibrillator/monitor and can cause
the error for the measurement.
Do not use a damaged sensor or cable. Do not alter the sensor or cable
in any way. Alternations or modification may affect performance and/or
accuracy. Never use more than one cable between the pulse oximeter
and the sensor to extend the length.
Sensors exposed to ambient light when incorrectly applied to a patient
may exhibit inaccurate saturation readings. Securely place the sensor
on the patient and check the sensor’s application frequently to help
ensure accurate readings.
Do not rely solely on SpO2 reading: assess the patient at all times. SpO 2
readings may be inaccurate in the presence of significant levels of
carboxyhemoglobin or methemoglobin, in patients with restricted blood
flow to the extremities (such as those in severe shock or hypothermia),
83
or in the presence of excessive motion.
Failure to apply the sensor properly may reduce the accuracy of the
SpO2 measurement.
Inspection the sensor application site at least every two hours for
changes in skin quality, correct optical alignment, and proper sensor
application. If skin quality is compromised, change the sensor site.
Change the application site at least every four hours. More frequent
checking may be required due to individual patient’s condition.
Severe anemia, methemoglobin, intravascular dyes that change usual
blood pigmentation, excessive patient movement, venous pulsations,
electrosurgical interference, exposure to irradiation and placement of
the sensor on an extremity that has a blood pressure cuff, intravascular
line, or externally applied coloring(such as nail polish) may interfere
with oximeter performance. The operator should be thoroughly familiar
with the operation of the oximeter of the oximeter prior to use.
The pulsations from intra-arotic ballon support can be additive to the
pulse rate on the oximeter pulse rate display. Verify patient’s pulse rate
against the ECG heart rate.
Prolonged, continuous use of a sensor may cause irritation, blistering,
or pressure necrosis of the skin. Check the sensor site regularly based
on patient condition and type of sensor. Change the sensor site if skin
changes occur. Do not use tape to hold the sensor in place as this may
cause inaccurate readings or damage to the sensor or skin.
Carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
Carboxyhemoglobin and methemoglobin may erroneously increase
SpO2 readings. The amount that SpO2 increases is approximately equal
to the amount of carboxyhemoglobin or methemoglobin that is present.
The sensor disconnect error message and associated alarm indicate the
sensor is either disconnected or the wiring is faulty. Check the sensor
connection and, if necessary, replace the sensor, extension cable or
both.
Reusable sensors may be used on the same site for a maximum of 4
hours, provided the site is inspected routinely to ensure skin integrity
and correct positioning.
Refer to the notice below if the Medtronic SpO2 module is installed.
Note: Purchase of this instrument confers no express or implied license under any
Medtronic patent to use the instrument with any sensor that is not manufactured or
licensed by Medtronic.
Note: The user should check that the monitor is functioning while measurements are
being made and check display periodically.
Note: Check the display motion before accepting any displayed data as a current
measurement.
General
The defibrillator/monitor uses pulse oximetry to measure functional oxygen saturation in
the blood. Because a measurement of SpO2 is dependent upon light from the SpO 2
sensor, excessive ambient light can interfere with this measurement. SpO 2 and Pulse rate
are updated every second. This 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.
84
Setup Connections
When selecting a sensor, consider the patient’s weight and activity, adequacy of perfusion,
availability of sensor sites, need for sterility, and anticipated duration of monitoring. Refer
to Table 32, or contact Medtronic® or Mediana sales department for ordering information.
1. Select the proper sensor for the patient.
2. Connect the extension cable to the SpO 2 connector on the defibrillator/monitor’s front
panel and lock it.
3. Connect the sensor to the extension cable and lock it.
4. Carefully apply the sensor to the patient, as described
in the sensor directions for use. Observe all warnings
and cautions in the directions for use.
Note: Refer to directions for use to ensure the proper placement for various types of SpO2
sensors.
Note: Periodically check to see that the sensor remains properly positioned on the patient
and that skin integrity is acceptable. Refer to the sensor directions for use.
Table 28. SpO2 sensors
Module
For Mediana
Module
For
Medtronic
Module
Sensor
SpO2 reusable sensor
Model
YM-1
Patient Size
OXIMAX Durasensor ® Oxygen
transducer (Reusable, non-sterile)
OXIMAX oxygen transducer (Singleuse only, sterile)
DS-100A
>40 kg
MAX-N
MAX-I
MAX-P
MAX-A
<3 or >40 kg
3 ~ 20 kg
10 ~ 50 kg
>30 kg
85
Description of SpO2 Menu Functions
10 9
8 7
1
6
2
3
4
5
6
1
2
3
4
5
SpO2 title
Alarm audio status
Alarm limit upper
Alarm limit lower
SpO2 pulse amplitude
6
7
8
9
10
SpO2 value
SatSeconds setting
SatSeconds icon
Pulse rate value
Pulse rate title
Figure 27. SpO2 display
Table 29. SpO2 menu
Level 1 Menu
SpO2 MENU
SatSeconds
SpO2 alarm limits
SpO2 limits audio alarm
Level 2 Menu or Response
Off, 10, 25, 50, 100
Upper/lower alarm limits
On, Off
SetSeconds
The alarm management is provided for minor or temporary SpO 2 limit violations. When
the SatSeconds is enabled, the SatSeconds icon fills in the clockwise direction when the
SatSeconds alarm management system detects a SpO2 reading that is outside of the
limit settings. The SatSeconds icon will be blanked counterclockwise when the SpO 2
reading is within limits. When all the SatSeconds icons are filled, a medium priority alarm
will sound. User can set to Off, 10, 25, 50 and 100 SatSeconds through SpO2 menu.
Limit alarm audio off
When the limit alarm audio off is set to On, the limit alarm for SpO2 is went off.
86
Description of SpO2 Waveform Menu Functions
1
2
1
SpO2 title
2
SpO2 Waveform
Figure 28. SpO2 waveform display
Table 30. SpO2 waveform menu
Level 1 Menu
SpO2 WAVEFORM MENU
Sweep speed
Level 2 Menu or Response
12.5 mm/s, 25.0 mm/s, 50 mm/s
Sweep Speed
The user-selectable Sweep Speed determines the speed at which the SpO2 waveform
trace moves across the screen. Sweep Speed can be selected from 12.5 mm/s, 25.0
mm/s and 50.0 mm/s, and the SpO2 waveform is synchronized with the ECG waveform.
87
Theory of Operation
The defibrillator/monitor uses pulse oximetry to measure functional oxygen saturation in
the blood. Pulse oximetry works by applying a Medtronic™ pulse oximetry sensor to a
pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light
source and a 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 the pulsations. The ratio of light absorbed is
translated into a measurement of functional oxygen saturation (SpO2). Ambient conditions,
sensor application, and patient conditions can influence the ability of the pulse oximeter to
accurately measure SpO2. Pulse oximetry is based on two principles: oxyhemoglobin and
deoxyhemoglobin differ in their absorption of red and infrared light (measured using
spectrophotometry), and the volume of arterial blood in tissue (and hence, light absorption
by that blood) changes during the pulse (registered using plethysmography). A
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 sensor serve as light sources; a
photo diode serves as the photo detector. Since oxyhemoglobin and deoxyhemoglobin
differ in light absorption, the amount of red and infrared light absorbed by blood is related
to hemoglobin oxygen saturation. The defibrillator/monitor uses the pulsatile nature of
arterial flow to identify the oxygen saturation of arterial hemoglobin. 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.
Functional versus Fractional Saturation
This defibrillator/monitor measures functional saturation where 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
where 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 using the listed equation.
functional saturation =
fractional saturation
× 100
100 – (%carboxyhemoglobin + %methemoglobin)
Measured versus Calculated Saturation
When calculating saturation from a blood gas partial pressure of oxygen (PO 2), the
calculated value may differ from the SpO2 measurement of a defibrillator/monitor. This
usually occurs when saturation calculations exclude corrections for the effects of variables
such as pH, temperature, the partial pressure of carbon dioxide (PCO 2), and 2,3-DPG,
that shift the relationship between PO2 and SpO2.
88
Figure 29. Oxyhemoglobin dissociation curve
1 % Saturation Axis
2 PO2 (mmHg) Axis
3 Increased pH; Decreased temperature, PCO2, and 2,3-DPG
4 Decreased pH; Increased temperature, PCO2, and 2,3-DPG
Data Upload Period, Data Averaging and Signal Processing
The advanced signal processing of the Oximax™ algorithm automatically extends the
amount of data required for measuring SpO2 and pulse rate depending on the
measurement conditions. The Oximax™ algorithm automatically ex tends the dynamic
averaging time required beyond 7 seconds during degraded or difficult measurement
conditions caused by low perfusion, signal artifact, ambient light, electrocautery other
interference, or a combination of these factors, which results in a n increase in the
dynamic averaging. If the resulting dynamic averaging time exceeds 20 seconds for SpO 2,
the algorithm sets the pulse search bit while continuing to update SpO 2 and pulse rate
values every seconds.
As such measurement conditions extend, the amount of data required may continue to inc
rease. If the dynamic averaging time reaches 40 seconds and/or 50 seconds for pulse rat
e, a low priority alarm state results: the algorithm sets the Pulse Timeout bit and the monit
or reports a zero saturation indicating a loss of pulse condition, which should result in an a
larm audio.
89
Clinical Studies
Clinical studied conducted for the Mediana Sensors
Overview
Pulse oximeters are routinely used clinically for functional arterial oxygen saturation
(SpO2), a physiologically important measure. The accuracy of the pulse oximeter is
usually performed by a CO-oximeter comparison. Comparisons will be made of SpO 2
measurements using calculated values of deoxygenated hemoglobin concentrations from
arterial blood using mediana modules and oxy- and CO-oximeters. Monitor safety will be
closely monitored through clinical investigations.
Methods
Data from 10 healthy volunteers were included in the analysis for 2 days. The study
participants are based in Severinghaus and have been approved by the IRB of the
Medical University of Wisconsin and the Milwaukee VA Medical Center. Subjects signed a
consent form and completed a case report form prior to the clinical investigation. Subjects
with health problems, such as diabetes or asthma, smokers, or subjects who do not
provide informed consent, cannot participate in the clinical investigation. The study
subjects received oral or written consent, and the radial arterial catheter was inserted by
the anesthesiologist. The sensors are located on the second, third, fourth, and fifth fingers.
The monitor is connected to a computer data acquisition system through a device for
serial multiplexing.
Study Population
Table 31. Demographic data
Type
Gender
Race
Age
Weight
Class
Male
Female
Caucassian
Hispanic
African American
-
Total
6 people
4 people
6 people
3 people
1 people
19 ~ 48 years
105 ~ 225 lb
Study Results
Accuracy was calculated using the root mean square difference (RMSD).
Conclusion
When the pooled results indicate that for a saturation range of 70-100% for SpO2, the
acceptance criterion was met.
90
Clinical studied conducted for the Medtronic™ Sensors
Overview
This appendix contains data from clinical studies conducted for the Medtronic™ sensors
used with the defibrillator/monitor.
One (1) prospective, controlled hypoxia clinical study was conducted to demonstrate the
accuracy of Medtronic™ sensors when used in conjunction with the defibrillator/monitor.
The study was performed with healthy volunteers at a single clinical laboratory. Accuracy
was established by comparison to CO-oximetry.
Methods
Data from 11 healthy volunteers were included in the analysis. Sensors were rotated on
digits and brow to provide a balanced study design. SpO 2 values were continuously
recorded from each instrument while inspired oxygen was controlled to produce five
steady state plateaus at target saturations of approximately 98, 90, 80, 70 and 60%. Six
arterial samples were taken 20 seconds apart at each plateau resulting in a total of
approximately 30 samples per subject. Each arterial sample was drawn over two (2)
respiratory cycles (approximately 10 seconds) while SpO 2 data were simultaneously
collected and marked for direct comparison to CO 2. Each arterial sample was analyzed by
at least two of the three IL CO-oximeters and a mean SaO2 was calculated for each
sample. End tidal CO2, respiratory rate, and respiratory pattern were continuously
monitored throughout the study.
Study Population
Table 32. Demographic data
Type
Gender
Race
Age
Weight
Skin pigment
Class
Male
Female
Caucasian
Hispanic
African American
Asian
Very light
Olive
Dark olive/Medium black
Extremely dark/Blue black
Total
5 people
6 people
8 people
2 people
1 people
0 people
19 ~ 48 years
108 ~ 250 lb
2 people
5 people
3 people
1 people
91
Study Results
Accuracy was calculated using the root mean square difference (RMSD).
Table 33. SpO2 accuracy for Medtronic™ sensors
SpO2
Decade
60-70
70-80
80-90
90-100
MAX-A
Data
Arms
Points
71
3.05
55
55
48
1.84
117
1.23
MAX-N
Data
Arms
Points
71
2.89
55
2.32
48
1.73
117
1.68
MAX-FAST
Data
Arms
Points
71
2.22
55
1.28
48
1.48
117
0.98
Figure 30. Modified bland-altman plot
1
Test Sensor:
Avg CO-oximeter value 70-100% SpO2
Oximetry board with MAX-A sensor
2
Avg CO-oximeter value 70-100% SpO2
Trendline of MAX-A sensor
Oximetry board with MAX-N sensor
Trendline of MAX-N sensor
Oximetry board with MAX-FAST sensor
Trendline of MAX-FAST sensor
Adverse Events or Deviations
The study was conducted as expected with no adverse events and no deviations from the
protocol.
Conclusion
The pooled results indicate that for a saturation range of 60-80% for SpO2, the acceptance
criterion was met for the defibrillator/monitor when tested with MAX-A, MAX-N and MAXFAST sensors. The pooled results indicate that for a saturation range of 70-100% for
SpO2, the acceptance criterion was met.
92
RESPIRATION MONITORING
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Mediana. Use accessories
according to the manufacturer’s directions for use and your facility’s
standards.
The defibrillator/monitor does not detect apnea when the respiration
signal is measured by trans-thoracic impedance.
Keep patients under close surveillance when monitoring respiration.
Respiration signals are relatively more sensitive to interference from
radiated electromagnetic signals. Thus, it is possible, although unlikely,
that radiated electromagnetic signals from sources external to the
patient and defibrillator/monitor can cause inaccurate respiration
readings. Do not rely entirely on the defibrillator/monitor respiration
readings for patient assessment. If measured waveforms are not
appropriate readings, check external conditions to ensure there is no
equipment causing electromagnetic interference.
Impedance respiration technology is very sensitive to any of artifacts. If
impedance respiration is doubtful due to artifacts, it is not
recommended to assess the clinical state of patient only with
impedance respiration parameter.
General
The patient’s respiration is detected by using two of the three leads of the ECG electrodes
and cable. Real-time respiratory information is presented as a waveform and numeric
data; Impedance respiration source (IM).
The airway respiration measurement uses gases coming into the airway adapter in case
of the CO2 equipped. The defibrillator/monitor detects respiration rate by computing each
breath cycle form the continuous EtCO2 waveform; Airway respiration source (AW).
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.
Setup Connections
Refer to the ECG Monitoring section for how to acquire the respiration signal by patient
impedance using the ECG electrodes, leads and cable.
The performance of impedance respiration can be improved by the particular placement
of the Left arm (LA) and Right arm (RA) electrodes. (See Standard ECG electrode
placement in Figure 23.)
93
Description of Respiration Menu Functions
6
1
2
3
4
5
1
2
3
Respiration title
Alarm audio status
Alarm limit upper
4 Alarm limit lower
5 Respiration rate value
6 Respiration unit
Figure 31. Respiration display
Note: If the RESP measurement setting is OFF, the indication related to RESP is not
displayed.
Note: If the alarm limit display setting is set to ON, the alarm limit is displayed next to the
measured value.
Note: Even if the alarm limit display setting is set to on, the alarm limit may not be
displayed depending on some specifications.
Table 34. Respiration menu
Level 1 Menu
RESPIRATION MENU
Apnea time
Respiration alarm limits
Respiration limits audio alarm
Level 2 Menu or Response
10 sec, 15 sec, 20 sec, 25 sec, 30 sec, 35 sec, 40
sec
Upper/lower alarm limits
On, Off
Apnea time
When the defibrillator/monitor does not detect a respiration signal from the impedance
measurement for Apnea time, the defibrillator/monitor will activate a loss of respiration
alarm.
Limit alarm audio off
When the limit alarm audio off is set to On, the limit alarm for Respiration is went off.
94
Description of Respiration Waveform Menu Functions
1
2
1
Respiration waveform title
2
Respiration waveform
Figure 32. Respiration waveform display
Table 35. Respiration waveform menu
Level 1 Menu
RESPIRATION WAVEFROM MENU
Sweep speed
Size
Level 2 Menu or Response
6.25 mm/s, 12.5 mm/s, 25.0 mm/s
Auto, 5.0 mm/Ω, 10.0 mm/Ω, 15.0 mm/Ω, 20.0 mm/Ω
Sweep Speed
The user-selectable sweep speed determines the speed at which the respiration
waveform trace moves across the screen. Sweep Speed can be selected from 6.25 mm/s,
12.5 mm/s, and 25.0 mm/s.
Size
Size allows user to adjust the waveform size. When the size is set to Auto, 5.0 mm/Ω,
10.0 mm/Ω, 15.0 mm/Ω or 20.0 mm/Ω. The monitor automatically determines the optimal
size of the respiration waveform to fit the space.
95
Theory of Operation
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 ohm/cm and the one of air is
5=000 ohm/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.
96
SELF-TEST FUNCTION
General
This defibrillator/monitor incorporates a Self-test function. The defibrillator/monitor should
be checked at regular intervals so that it will always be ready-to-use for emergency
situations. There are three modes: Manual Self-test, Auto Self-test and Button test.
Additionally, the external shock test should be performed prior to use.
Manual Self-test
Manual self-test covers the following items:
• Therapy module alive test
• Impedance test
• ECG circuit test
• Internal shock test
• Internal pacing output test
• Installed module alive test
• Real-time clock test
• Battery test
If any of above items fails, the service indicator will be illuminated. If mainboard,
Defib/Pacer function, or monitor function fails, a low level technical alarm ‘Last user test
failed’ will be displayed in the Physiological/Technical Alarm Message Area. We
recommend you to perform a successful User Test to clear this alarm.
Auto Self-test
When the defibrillator/monitor has been turned off, Auto Self-test (or scheduled Self-test)
is operated automatically according to the user’s setting. The Self-test interval can be
selected as Off, 24, 48, and 72 hours. If the residual of battery power is less than 60%
without using the AC or DC, the Self-test will not be performed.
If the defibrillator/monitor is in use at the time of a scheduled Auto Self-test, the Auto Selftest will be canceled. If the defibrillator/monitor is turned on when the Auto Self-test is in
process, the Auto Self-test will be canceled and the defibrillator/monitor will be operated
normally.
Note: The setting of the Auto self-test (time and interval) can only be changed by
authorized personnel via the Service Setting Menu.
Button test
Button Test covers the following items. Refer to the Service manual for detail.
• Operating mode selection knob
• All hardware buttons on the front panel of Defibrillator/monitor
LCD test
LCD test can be used to verify that the LCD is working properly. Refer to the Service
manual for detail.
Sound test
Sound test can be used to verify that the sound is working properly. Refer to the Service
manual for detail.
97
External Shock Test
The 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 surfaces of the paddle and
paddle tray.
2. Place the paddles on the paddle tray. (see Figure 2)
3. Turn on the defibrillator/monitor.
4. Select the defibrillation energy by pressing the Energy level button on paddle.
5. Charge the selected energy to pressing the Charge button on paddle.
6. When completing the charge, the charge indicator of the paddle turns on in red.
Before 7 steps, check the charge indicator.
7. Press the Shock button on paddle.
8. Confirm the energy level on the display.
Using pads extension cable
1. Connect the test road to the pad extension cable.
2. Turn on the defibrillator/monitor.
3. Select the defibrillation energy by pressing the Energy level button on the device.
4. Charge the selected energy by pressing the Charge button on the device.
5. When completing the charge, the shock indicator of the device turns on in red. Before
step 6, check the shock indicator.
6. Press the Shock button on the device.
7. Confirm the energy level on the display.
Trouble Shooting
After finish the auto self-test, the defibrillator/monitor will be turned off itself again. If there
was no fail, the service LED will be blinking. But if any fail was detected, service LED and
buzzer sound will be generated. (when the defibrillator/monitor is using the AC or DC
power, the result of auto self-test will be displayed). But when the residual of battery
power has dropped less than 60 %, those LED and buzzer will be turned off for saving the
power.
98
EVENT REPORT
General
The event data is stored in memory. The defibrillator/monitor saves data of elapsed time
before and after 10 seconds from the point of event generation. The events are saved
including Defibrillation, Pacer mode, Heart rate alarm, VF alarm or Mark event. The data
remains even if the defibrillator/monitor is powered off. When the saved data is more than
250 data, the defibrillator/monitor will delete the oldest data and save the new data.
Note: When storage space is exceeded, the defibrillator/monitor will delete the oldest data
sequentially.
Figure 33. Event report
1. Press the Configure Soft key.
2. Rotate the Multi function knob to Review menu and press the Multi function knob
to display.
3. Rotate the Multi function knob to Event report menu and press the Multi function
knob to display.
Scroll
User can scroll the event data by using the scroll button.
Review
User can review the event data by using the review button.
99
Figure 34. Event review
Print
User can print the event data by using the print button.
Report
User can be back into the event report screen by using the report button.
Scroll
User can scroll the event data by using the scroll button.
100
TRENDS
General
The Trend data is stored in memory. When the defibrillator/monitor turns on and starts to
measure the vital signs, the defibrillator/monitor saves the data at 1 minute intervals. The
data remains even if the defibrillator/monitor is powered off. When the trend data are
saved more than 5,000 data, the defibrillator/monitor will delete the oldest data and save
the new data.
Please erase the trend data for the patient information before applying
for the equipment to other patient for prevention of the mixing of
personal data.
Note: When storage space is exceeded, the defibrillator/monitor will delete the oldest data
sequentially.
Figure 35. Trend – Tabular trend
1. Press the Configure Soft key.
2. Rotate the Multi function knob and select the Review menu.
3. Rotate the Multi function knob and select the Trend menu.
Print
User can print the tabular trend data by using the print button.
Display data type
User can select the display data type.
- All: All trend data.
- by interval: Data saved automatically according to the set storage interval.
- by alarm occurrence: Data saving when the alarm occurs.
Display Interval
User can select the display interval of the trend displayed on the monitor of 1, 2, 5, 10, 30
or 60 min. The display interval button can be used only when the display data type is
selected in ‘by interval’.
101
Scroll speed
User can select the scroll speed of x1, x10 or x100.
Scroll
User can scroll the trend data by using the scroll button.
102
DATA MANAGEMENT
General
The data is stored in memory. The defibrillator / monitor will automatically generate and
save an Event summary for the patient event. Event summary can be stored up to 40
hours of cumulative storage, and when the maximum storage time has elapsed, the
defibrillator / monitor will clear the oldest data and save the new data.
Please erase the patient information before disposal of equipment for
prevention of the personal data leakage.
Note: When storage space is exceeded, the defibrillator/monitor will delete the oldest data
sequentially.
Event summary
Event summary can save up to 8 hours for each event. After 8 hours, it stops recording,
creates and saves a new event summary.
Note: The number of event summaries that can be stored depends on the duration of
each individual event summary. For example, the defibrillator/monitor may store
about 50 event summaries with a duration of 30 minutes and about 5 event
summaries with a duration of 8 hours.
Collected Event summary data
Collected Event summary data are as follows.
• 1 ECG waveform
• Add the Patient event information:
- Patient ID, Type, Name, Gender, Birth Date
- Parameter information/Trend Data
- Physiological alarm and alarm limits
- Shock and Pacing event
- Shock decision
- Mark event
• Add the technical/Device event information:
- Power On/Off
- Technical alarm
- Initial mode and mode change
- Initial battery status and change
103
Data Management Mode
Data Management Mode is non-clinical mode used to manage the event data record. The
event summary can be reviewed or downloaded by printing and SD card.
Figure 36. Data management
1. Press the Configure Soft key.
2. Rotate the Multi function knob and select the Review menu.
3. Rotate the Multi function knob and select the Data management menu.
4. Select YES on the message screen stopping the monitor mode.
Exit
User can exit to the Data management screen by using the Exit button.
Export
User can move to the Export menu screen by using the Export button.
Scroll
User can scroll the event summary by using the scroll button.
104
Export Event summary window
Figure 37. Data management – Export
Export data
User can download Event summary report to SD card by using the Export button. When
there are the records using the voice recording, download the event summary report
including voice recording file.
Return
User can return the Data management display by using the return button.
Scroll
User can scroll or select the event summary by using the scroll button.
105
Event summary review window
Figure 38. Data management – Review
Return
User can return the Data management display by using the return button.
Print
User can print the event summary review data by using the print button.
Scroll
User can scroll or select the list table by using the scroll button.
106
PRINTING
General
The defibrillator/monitor can print the real-time measurement data, trend data, event data,
event summary and system setting.
⚫ Set up Print on shock delivery, Print on shock decision, Print on pacing output, Print on
alarm, Print on mark event, Print on self-test or Printing waveform by using printing
menu on setting menu.
⚫ Start printing by pressing PRINT button.
Note: The defibrillator/monitor only supports English version regardless setting languages.
Note: In critically low battery or low battery status, the defibrillator/monitor has invalid tone
and the message is displayed.
Note: User can set Printing Date and Time in “YYYY/MM/DD”, ”MM/DD/YYYY” or
“DD/MM/YYYY” on Service Menu.
Table 36. Printer Menu
Level 1 Menu
Print Menu
Print on shock delivery
Print on shock decision
Print on pacing output
Print on alarm
Print on mark event
Print on self-test
Printing waveform
Level 2 Menu or Response
On, Off
On, Off
On, Off
On, Off
On, Off
On, Off
Printing speed, Printing time
Print on shock delivery
When Print on shock delivery is On, automatically print whenever shock delivery event
occurs.
Print on shock decision
When Print on shock decision is On, automatically print whenever shock decision event
occurs.
Print on pacing output
When Print on pacing output is On, automatically print whenever pacing output starts.
Print on alarm
When Print on alarm is On, automatically print whenever alarm status occurs.
Print on mark event
When Print on mark event is On, automatically print whenever the event by pressing mark
event button is marked.
Print on self-test
When Print on self-test is On, automatically print whenever self-test is completed.
107
Printing waveform
The Printing waveform can be changed on Printing waveform menu. Printing speed,
Printing time and Waveform can be set.
Table 37. Printing waveform menu
Level 1 Menu
Printing waveform menu
Printing speed
Printing time
Level 2 Menu or Response
25 mm/s, 50 mm/s
10 sec, 20 sec, Continuous
Note: Printing detail parameter is active only when Printing diagnosis/detection result is
On.
108
Type of Print-Out
Measurement data printing
User can print the data by pressing PRINT button on Home screen.
2021/01/01 01:00:00
Printing type: Manual input
Operating mode: Monitor
Runtime: 01:00:00
Patient.
ID: 21010100000001
Name:
Gender: Male
Type: Adult
Birth data:
HR : 60/min
RR : 15/min
SpO2 : 100%
I
Sweep speed: 25mm/s
Gain: 10.0 mm/mV
Filter : 1 ~ 21 HZ
II
Sweep speed: 25mm/s
Gain: 10.0 mm/mV
Filter : 1 ~ 21 HZ
III
Sweep speed: 25mm/s
Gain: 10.0 mm/mV
Filter : 1 ~ 21 HZ
00:59:50
Figure 39. Measurement data printing
Trend data printing
User can print Trend data by pressing PRINT button on Tabular trend screen.
Date & Time
|
HR
|
RR
|
SpO2
------------------- -------- ------------ ------------2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
2021/01/01 01:00:00
|
60
|
15
|
100
Figure 40. Trend data printing
Event data printing
User can print Event data by pressing PRINT button on review screen of event report.
2021/01/01 01:00:00
Printing type: Shock delivered
Operating mode: Manual
Runtime: 01:00:00
Patient.
ID: 21010100000001
Name:
Gender: Male
Type: Adult
Birth data:
Pads
Sweep speed: 25mm/s
Gain: 10.0 mm/mV
Filter : 1 ~ 21 HZ
Number of shock: 1
Shock impedance: 50 ohm
Selected energy: 125 J
Delivered energy: 125 J
HR : 60/min
00:59:50
Figure 41. Event data printing
109
Event summary review data printing
User can print the Event summary review data by pressing PRINT button on event
summary review screen of Data management.
Case
---------------------------------------------------------------------Start time: 2014-12-26 15:18:49
Data duration : 00:01:55
Comments:
Patient Info.
---------------------------------------------------------------------Patient ID:
Patient name:
Gender:
Age:
Weight:
Height:
Total Shocks: 3
Total time paced: 00:00:00
Total 12-Lead ECG: 0
Device Info.
---------------------------------------------------------------------Device type:
Operator:
Serial number: 000000000000
ECG-Nr. 1
15:18:49
I
25mm/s
10mm/mV
Time
Event
ECG-Nr.
----------------------------------------------------------------------------------------------------------15:18:49 Power on
AED mode
Start ECG
1
15:18:50 Adult pads
15:18:52 Analyzing heart rhythm
15:18:54 Low heart rate limits violated
15:19:02 ECG: V-FIB
2
Shock advise
15:19:04 Charging (125J)
15:19:08 Shock ready
15:19:11 Shock delivered (1, 125J, 51ohm)
3
15:19:13 CPR
15:20:14 Manual mode: NO SYNC
15:20:15 Charging (125J)
15:20:19 Shock ready
15:20:20 Shock delivered (2, 125J, 51ohm)
4
15:20:30 Charging (125J)
15:20:33 Shock ready
15:20:37 Shock delivered (3, 125J, 51ohm)
5
15:20:43 Power off
Time
Shock# Energy
-------------------------------------15:19:11
1
125J
15:20:20
2
125J
15:20:37
3
125J
Time
HR/PR RR SpO2
------------------------------------15:18:54
0↓ --- --15:19:02
51
15:18:49
I
15:19:54
Figure 42. Event summary review data printing
110
--- ---
Setting value printing
User can print System setting of the defibrillator/monitor by pressing PRINT button on
System setting screen of Service Menu. For details, refer to the service manual
2021/01/01 01:00:00
Printing type: All settings of Monitor
Voice prompt volume: 3
Other sound volume: 3
Display-------------------------------------Display patient information: ID
Brightness: 3
Menu timeout: 10 sec
Color filter: Full color
--Parameter color-ECG: Color 1
Respiration: Color 4
SpO2: Color 2
Waveform---------------------------------------Waveform setting-ECG 4mv: Off
Waveform 1: I
Waveform 2: SpO2
Waveform 3: IBP1
Waveform 4: CO2
--ECG-Grid: Off
Sweep speed: 25.0 mm/s
Size: 10.0 mm/mV
Pacer pulse detection: Off
St level position: 70 ms
Filter mode: 1 – 21 Hz
Number of waveforms: All 12 lead
Sound--------------------------------------Alarm volume: 3
HR/PR tone volume: 3
Key beep volume: 3
Defibrillator sound volume: 3
--Respiration-Sweep speed: 6.25 mm/s
Size: 10.0 mm/ohm
--SpO2-Sweep speed: 25.0 mm/s
Parameter-------------------------------------------HR/PR-HR/PR source: Auto
Asytole time: 5 sec
High limit: 120
Low limit: 50
Limit audio alarm: On
--RR-Apnea time: 20 sec
High limit: 30
Low limit: 5
Limit audio alarm: On
Figure 43. Setting value printing
Self-test result printing
User can print Self-test result on Self-test screen in Setting menu after Self-test.
2021/01/01 01:00:00
Serial number: 21010100000001
System version: 1.00.00
Therapy module alive test : PASS
Impedance test : PASS
ECG circuit test : PASS
Internal shock test : PASS
Internal pacing test : PASS
Installed module alive test : PASS
Real-time clock test : PASS
Battery test : Not connected
Figure 44. Self-test result printing
111
Replace printer paper
Use only printer paper supplied by Mediana. Using other printer paper
may cause the printer to perform improperly and be damaged.
Replace printer paper as follows.
1. Open the printer door.
2. Remove the printer paper.
3. Insert the new printer paper with the striped side up.
4. Close the printer door by pushing it.
Note: Check the printer paper is properly positioned and is not jammed in the door.
Figure 45. Replace print paper
112
EXTERNAL COMMUNICATIONS
General
The defibrillator/monitor provides external connectors on the right panel to support
communication with external equipment and functions such as software upgrade or data
download. The defibrillator/monitor with its optional wireless module, functionality
performs the same as a defibrillator/monitor connected to the central system. The
defibrillator/monitor with a wireless network can send and receive patient data through the
central system.
Any connections between this defibrillator/monitor and other devices
must comply with applicable medical systems safety standards such as
IEC 60601-1. Failure to do so could result in unsafe leakage current and
grounding conditions.
Inserting or removing the data card while the defibrillator/monitor is on
or reading and writing on the data card can corrupt the Data Card and
prevent the defibrillator/monitor from powering on again. If this occurs,
see Troubleshooting Tips.
Use only a Mediana defibrillator/monitor-compatible SD Card. These
cards, or other types of cards (such as memory cards) will not work,
and may cause the defibrillator/monitor to malfunction.
Do not turn off the Mediana defibrillator/monitor by using Mode
selection knob or disconnecting the power cord or battery. The data
stored will be damaged.
Note: The defibrillator/monitor is to be used on a wireless network are limited to inside of
the building.
SD Memory Card
The SD Memory Card is used to the new system software and to load voice prompt data
and to download the trend data. Trend data downloaded on SD card can be viewed on PC.
Wireless Connection
The defibrillator/monitor can connect to a network using a wireless network. The wireless
connection can only be set by authorized personnel via the Service Setting Menu.
Central System Communication
The transmitted data by using the wireless module is divided as follows;
- All vital signs are transmitted to the medical person in the hospital.
- The self-test result and the log file are transmitted to the biomedical engineer in the
hospital.
The defibrillator condition, service action according to the self-test and the history of the
key pressing are transmitted by the wireless network. All vital sign can be transmitted in
real-time.
Note: The details are provided in the central system manual. Please contact the
representative of Mediana for more information.
113
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114
MENU STRUCTURE
Configure
Display
Display patient information
ID
Name
None
Brightness
1
5
Menu timeout
Off
10 sec
20 sec
30 sec
Color filter
Full color
Grayscale
Parameter color
ECG
Color 1
Color 17
Respiration
Color 1
Color 17
SpO2
Color 1
Color 17
Sound
Alarm volume
1
5
HR/PR tone volume (Step: 1)
Off
1
5
Key beep volume (Step: 1)
Off
1
5
Defibrillator sound volume (Step: 1)
1
5
Voice prompt volume (Step: 1)
1
5
Other sound volume (Step: 1)
Off
1
5
Waveform
Waveform setting
115
-
-
ECG
-
-
-
-
116
ECG 4mV
On
Off
Waveform 1
Pads
I (ECG, 3, 5 lead wire)
II (ECG, 3, 5 lead wire)
III (ECG, 3, 5 lead wire)
aVR (ECG, 5 lead wire)
aVL (ECG, 5 lead wire)
aVF (ECG, 5 lead wire)
V (ECG, 5 lead wire)
Waveform 2 ~ 3
Pads
I (ECG, 3, 5 lead wire)
II (ECG, 3, 5 lead wire)
III (ECG, 3, 5 lead wire)
aVR (ECG, 5 lead wire)
aVL (ECG, 5 lead wire)
aVF (ECG, 5 lead wire)
V (ECG, 5 lead wire)
RESP
SpO2
Grid
On
Off
Sweep speed
12.5 mm/mV
25.0 mm/mV
50.0 mm/mV
Size
Audo
5.0 mm/mV
10.0 mm/mV
15.0 mm/mV
20.0 mm/mV
30.0 mm/mV
40.0 mm/mV
Pacer pulse detection
On
Off
ST level measurement position
60 ms
80 ms
Filter mode
0.05 - 150 Hz
0.05 - 40 Hz
0.5 - 40 Hz
0.5 - 30 Hz
Filter mode (Pads)
0.05 - 150 Hz
0.05 - 40 Hz
0.5 - 40 Hz
0.5 - 30 Hz
1 - 21 Hz
-
-
-
Respiration
Sweep speed
6.25 mm/mV
12.5 mm/mV
25.0 mm/mV
Size
Auto
5.0 mm/Ω
10.0 mm/Ω
15.0 mm/Ω
20.0 mm/Ω
SpO2
Sweep speed
12.5 mm/mV
25.0 mm/mV
50.0 mm/mV
Parameter
HR/PR
HR/PR Source
Auto
HR
PR
Asytole time (Step: 1 sec)
3 sec
10 sec
HR/PR high
25 ~ 300 BPM
HR/PR low
20 ~ 295 BPM
HR/PR limit audio alarm
On
Off
Respiration
Apnea time
10 sec
40 sec
RR high
4 ~ 150 /min
RR low
3 ~ 149 /min
RR limit audio alarm
On
Off
SpO2
SatSeconds
Off
10
25
50
100
SpO2 high (Step: 1 /min)
21 ~ 100 %
SpO2 low
20 ~ 99 %
SpO2 limit audio alarm
On
117
118
Off
Alarm Setup
Alarm limits
HR/PR high
25 ~ 300 BPM
HR/PR low
20 ~ 295 BPM
HR/PR limit audio alarm
On
Off
RR high (Step: 1 /min)
4 ~ 150 /min
RR low
3 ~ 149 /min
RR limit audio alarm
On
Off
SpO2 high (Step: 1 /min)
21 ~ 100 %
SpO2 low
20 ~ 99 %
SpO2 limit audio alarm
On
Off
Alarm limit display
On
Off
Audio alarm pause/off
On
Off
Patient
Patient information
Discharge patient
Modify
New patient
Patient ID
Patient type
Adult
Pediatric
Neonatal
Pacer pulse detection
On
Off
Name
First name
Last name
Middle name
Gender
None
Male
Female
Other
Birth date
Year
Month
Date
-
Cancel button
Save button
Printer
Print on shock delivery
On
Off
Print on shock decision
On
Off
Print on pacing output
On
Off
Print on alarm
On
Off
Print on mark event
On
Off
Print on self-test
On
Off
Printing waveform
Printing speed
25 mm/s
50 mm/s
Printing time
10 sec
20 sec
Continuous
Review
Event report
Tabular trend
Data management
Clear event report
Clear trends
Clear data management
Service setting
Password
Numeric keyboard
OK button
Cancel button
Others
Date & Time
Year
2000 ~ 2037
Month
1 ~ 12
Date
1 ~ 28 / 1 ~ 29 / 1 ~ 30 / 1 ~ 31
Hour
0 ~ 23
Minute
0 ~ 59
Set button
User test
119
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120
MAINTENANCE
The cover should be removed only by qualified service personnel.
There are no internal user-serviceable parts except for the battery.
Do not use the defibrillator/monitor when the case appears damaged.
Do not spray, pour, or spill any liquid on the defibrillator/monitor, its
accessories, connectors, switches or openings in the chassis.
Unplug the power cord from the defibrillator/monitor before cleaning
the defibrillator/monitor.
Disposal of the defibrillator/monitor with the battery inserted presents a
potential shock hazard.
Do not autoclave, ultrasonically clean, or immerse the Mediana
defibrillator/monitor. Do not use abrasive cleaners or strong solvents
such as acetone or acetone-based cleaners.
Do not ultrasonically clean or immerse the paddles and paddles cables.
Do not ultrasonically clean, immerse, autoclave or steam sterilize the
pads cable.
Do not ultrasonically clean, immerse, autoclave or steam sterilize the
ECG cable. Do not clean the ECG cable with alcohol. Alcohol can cause
the plastic to become brittle and may cause the cable to fail
prematurely.
Do not clean any part of this defibrillator/monitor or accessories with
bleach dilution or phenolic compounds. Do not use abrasive or
flammable cleaning agents. Do not attempt to sterilize this
defibrillator/monitor or any accessories unless otherwise specified in
accessory operation instructions.
Do not soak or immerse the sensors or cables in any liquid solution. Do
not attempt to sterilize.
Recycling and Disposal
When the defibrillator/monitor, battery, or accessories reach the end of useful life,
recycle or dispose of the equipment according to appropriate local and regional
regulations.
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.
121
Returning the Defibrillator/Monitor and System Components
Pack the defibrillator/monitor with sensors, cable or other accessory items in its original
shipping carton. If the original carton is not available, use a suitable carton with
appropriate packing material to protect the defibrillator/monitor during shipping.
Service
The defibrillator/monitor requires no routine service other than cleaning, battery
maintenance, and service activity which is mandated by the user’s institution. For more
information, refer to the defibrillator/monitor service manual. Qualified service personnel in
the user’s institution should perform periodic inspections of the defibrillator/monitor. If
service is necessary, contact qualified service personnel or your local supplier.
Periodic Safety Checks
It is recommended that the following checks be performed every year.
⚫ Inspect the equipment for mechanical and functional damage.
⚫ Inspect the external safety labels for legibility.
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.
⚫
70% Isopropyl alcohol
The cleaning method for paddles and paddle plates are same as defibrillator/monitor.
For cables and sensors follow the 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 unit to qualified service personnel for
checking.
122
Battery Maintenance
Recharging the battery is strongly recommended when the battery has
not been recharged for 6 or more months.
Follow local government ordinances and recycling instructions regarding
disposal or recycling of defibrillator/monitor components, including
batteries.
Do not short-circuit the battery, as it may generate heat. To avoid shortcircuiting, do not let the battery come in contact with metal objects at any
time, especially when transporting.
Do not solder the battery directly. Heat applied during soldering may
damage the safety vent in the battery’s positive cover.
Do not deform the battery by applying pressure. Do not throw, hit, drop,
fold or impact the battery.
Do not connect the battery reversed in positive (+) and negative (-)
terminals. Do not charge the battery with polarities reversed, as it may
swell or explode.
Do not use any chargers not specified by Mediana.
Do not use the battery with other maker’s batteries, different types or
models of batteries such as dry batteries, nickel-metal hydride batteries,
or Li-ion batteries together, as they might leak electrolyte heat or
explode.
Do not mistreat the battery, or use the battery in applications not
recommended by Mediana.
Keep the battery out of reach of babies and children to avoid any
accidents.
If there are any problems with the battery, immediately put the battery in a
safe place and contact qualified service personnel.
If the defibrillator/monitor has not been used for 6 months, the battery will need charging.
To charge the battery, connect the defibrillator/monitor to an AC or DC power source as
described in the Battery Operation section.
Note: Storing the defibrillator/monitor for a long period without charging the battery may
degrade the battery capacity. It would take about 8 hours to fully charge the battery
from the moment that low battery alarm is activated.
Note: The battery should be removed from the defibrillator/monitor if placed in storage or if
it will not be used for a long period.
It is recommended that the defibrillator/monitor’s Li-ion battery be replaced every 24
months. Refer to the service manual for battery replacement and general service
instructions.
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124
TROUBLESHOOTING
If you are uncertain about the accuracy of any measurement, check the
patient’s vital signs by alternate means; then make sure the
defibrillator/monitor is functioning correctly.
The cover should be removed only by qualified service personnel. There
are no user-serviceable parts inside except for the battery.
The large current draw required for defibrillator charging may cause the
defibrillator to reach a shutdown voltage level with no low battery
indication.
General
If the defibrillator/monitor detects an error or potential problem during use, it displays a
system or momentary message. If service is necessary, contact qualified service
personnel. Before calling to qualified service personnel or your local supplier, make sure
it meets environmental conditions provided in the manual as temperature, humidity,
altitude and so on.
Note: For repair instructions or for additional technical information, refer to the
defibrillator/monitor Service Manual.
Obtaining Technical Assistance
For technical information and assistance, or to order a service manual, call your local
supplier. The service manual provides information required by qualified service personnel
when servicing the defibrillator/monitor.
When calling your local supplier, you may be asked to provide the software version
number of your defibrillator/monitor. The software version can confirm in Service Setting
Menu.
125
EMI (Electromagnetic Interference)
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and defibrillator/monitor can cause inaccurate
measurement readings. Do not rely entirely on the defibrillator/monitor
readings for patient assessment.
It is possible that any radio frequency transmitting equipment and other
nearby sources of electrical noise may result in disruption in the
defibrillator/monitor operation. Operator’s manual is attached for the
minimum recommended separation distance between the RF emitting
equipment and the device.
It is possible, although unlikely, that large equipment using a switching
relay for its power on/off may affect defibrillator/monitor operation. Do
not operate the defibrillator/monitor in such environments.
Using cables, electrodes or accessories not specified for use with this
device may result in increased emissions or decreased resistance to
electromagnetic interference which could affect the performance of this
defibrillator/monitor or of equipment in close proximity. Use only parts
and accessories specified in this manual.
Defibrillator/monitor may cause electromagnetic interference (EMI)
especially during charge and energy transfers. EMI may affect the
performance of equipment operating in close proximity. If possible,
verify the effects of defibrillator discharge on other equipment prior to
using the defibrillator in an emergency situation.
Operating high frequency electrosurgical equipment in the vicinity of
the
defibrillator/monitor
can
produce
interference
in
the
defibrillator/monitor and cause incorrect measurements.
Do not use the defibrillator/monitor with nuclear spin tomography (MRT,
NMR, NMT) as the function of the defibrillator/monitor may be disturbed.
This device has been tested and found to comply with the limits for medical devices to
the IEC60601-1-2, and the Medical Device Directive 93/42/EEC. These limits are
designed to provide reasonable protection against harmful interference in a typical
medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in health care environments (such as electrosurgical
equipment, defibrillator, cellular phones, mobile two-way radios, electrical appliances,
and high-definition television), it is possible that high levels of such interference due to
close proximity or strength of a source may affect defibrillator/monitor operation.
126
The defibrillator/monitor is designed for use in environments in which
the signal can be obscured by electromagnetic interference. During
such interference, measurements may seem inappropriate or the
defibrillator/monitor may not seem to operate correctly.
The defibrillator/monitor disruption may be indicated by erratic readings, cessation of
operation, or other incorrect functioning. If this occurs, survey the site to determine the
source of this disruption. Try the following actions to see if they eliminate the disruption:
⚫ Turn equipment in the vicinity off and on to isolate the offending equipment.
⚫ Reorient or relocate the interfering equipment.
⚫ Increase the separation between the interfering equipment and this equipment.
The defibrillator/monitor generates, uses, and can radiate radio frequency energy. If the
defibrillator/monitor is not installed and used in accordance with these instructions, the
defibrillator/monitor may cause harmful interference with other devices in the vicinity.
If assistance is required, contact your local supplier.
127
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128
FACTORY DEFAULTS
General
The defibrillator/monitor is shipped with factory default settings. Authorized personnel
can use the procedures described in the service manual to change default settings.
Parameter Ranges and Default Settings
Table 38. Parameter ranges and factory defaults
Parameter
ECG
ECG Waveform Grid
ECG Sweep Speed
ECG Size
Ranges/Selections
Factory Defaults
HR/PR Source
Asystole Time
HR/PR Upper Alarm Limits
On, Off
12.5, 25.0, 50.0 mm/s
Auto, 5.0, 10.0, 15.0, 20.0, 30.0, 40.0
mm/mV
On, Off
60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80
ms
0.05 - 150, 0.05 - 40, 0.5 - 40, 0.5 - 30 Hz
0.05 - 150, 0.05 - 40, 0.5 - 40, 0.5 - 30 , 1
- 21 Hz
Auto, HR, PR
3, 4, 5, 6, 7, 8, 9, 10 sec
25 to 300 BPM (5 BPM step)
HR/PR Lower Alarm Limits
20 to 295 BPM (5 BPM step)
HR/PR Limit Alarm Audio Off
Respiration
Respiration Sweep Speed
Respiration Size
Respiration Apnea time
RR Upper Alarm Limits
On, Off
RR Lower Alarm Limits
3 to 149 /min (1 /min step)
RR Limit Alarm Audio Off
SpO2
SpO2 Sweep Speed
SatSeconds
%SpO2 Upper Alarm Limits
%SpO2 Lower Alarm Limits
On, Off
%SpO2 Limit Alarm Audio Off
Others
Patient Type
Display Patient Information
On, Off
25.0 mm/s
Off
100 %
Adult/Pediatric: 90 %
Neonatal: 85 %
On
Adult, Pediatric
ID, Name, None
Adult
ID
ECG Pacer Pulse Detection
ST Level Measurement
Position
Filter Mode
Filter Mode (Pads)
6.25, 12.5, 25.0 mm/s
Auto, 5.0, 10.0, 15.0, 20.0 mm/Ω
10, 15, 20, 25, 30, 35, 40 sec
4 to 150 /min (1 /min step)
12.5, 25.0, 50.0 mm/s
Off, 10, 25, 50, 100
21 to 100 % (1 % step)
20 to 99 % (1 % step)
Off
25.0 mm/s
10.0 mm/mV
Off
70 ms
0.05 - 40 Hz
1 - 21 Hz
Auto
5 sec
Adult: 120 BPM
Pediatric: 160 BPM
Neonatal: 200 BPM
Adult: 50 BPM
Pediatric: 70 BPM
Neonatal: 100 BPM
On
6.25 mm/s
10.0 mm/Ω
20 sec
Adult: 30 /min
Pediatric: 40 /min
Neonatal: 65 /min
Adult: 5 /min
Pediatric: 10 /min
Neonatal: 65 /min
On
129
Parameter
Pacer pulse detection
Brightness
Menu Timeout
Color Filter
ECG Color
Respiration Color
SpO2 Color
Alarm Volume
HR/PR Tone Volume
Key Beep Volume
Defibrillator Sound Volume
Voice Prompt Volume
Other Sound Volume
ECG 4mV
Waveform 1
Waveform 2
Waveform 3
Alarm Limit Display
Print On Shock Delivery
Print On Shock Decision
Print On Pacing Output
Print On Alarm
Print On Mark Event
Print On Self-test
Printing Speed
Printing Time
Power On Default*
Date Format*
Language*
Demo mode*
AC Line Filter*
Respiration Measurement*
Manual Mode Access*
Pacing mode Access*
Audio Alarm Pause/Off Period*
Audio Alarm Acknowledged
Period*
Audio Alarm Reminder*
High Priority Audio Alarm
130
Ranges/Selections
Factory Defaults
On, Off
1, 2, 3, 4, 5
Off, 10, 20, 30 sec
Full color, Grayscale
Color 1, Color 2, Color 3, Color 4, Color 5,
Color 6, Color 7, Color 8, Color 9, Color
10, Color 11, Color 12, Color 13, Color 14,
Color 15, Color 16, Color 17
Color 1, Color 2, Color 3, Color 4, Color 5,
Color 6, Color 7, Color 8, Color 9, Color
10, Color 11, Color 12, Color 13, Color 14,
Color 15, Color 16, Color 17
Color 1, Color 2, Color 3, Color 4, Color 5,
Color 6, Color 7, Color 8, Color 9, Color
10, Color 11, Color 12, Color 13, Color 14,
Color 15, Color 16, Color 17
1, 2, 3, 4, 5
Off, 1, 2, 3, 4, 5
Off, 1, 2, 3, 4, 5
1, 2, 3, 4, 5
1, 2, 3, 4, 5
Off, 1, 2, 3, 4, 5
On, Off
Pads, I, II, III, aVR, aVL, aVF, V
Pads, I, II, III, aVR, aVL, aVF, V,
Respiration, SpO2
Pads, I, II, III, aVR, aVL, aVF, V,
Respiration, SpO2
On, Off
On, Off
On, Off
On, Off
On, Off
On, Off
On, Off
25 mm/s, 50 mm/s
10, 20 sec, Continuous
Back up, Custom, Factory Default
YYYY/MM/DD,
MM/DD/YYYY,
DD/MM/YYYY
English, Korean, Turkish, Russian,
French,
Polish,
Spanish,
Italian,
Romanian,
Czech,
Hungarian,
Portuguese, Greek, German
On, Off
Off, 50, 60, 50 + 60 Hz
On, Off
Direct, Confirm, Passcode
Direct, Confirm, Passcode
Off, 1, 3, 5, 10, 20, 30, 60 min, Indefinite
30, 60, 90, 120 sec
Off
3
10 sec
Full color
Color 1
Off, 3, 10 min
2.5, 3, 9, 15 sec
3 min
9 sec
Color 4
Color 2
3
3
3
3
3
4
Off
Il
SpO2
Respiration
Off
Off
Off
Off
Off
Off
On
25 mm/s
20 sec
Back up
YYYY/MM/DD
English
Off
50 Hz + 60 Hz
On
Direct
Direct
Indefinite
60 sec
Parameter
Interval*
Medium Priority Audio Alarm
Interval*
Low Priority Audio Alarm
Interval*
Manual Mode - Display
parameters*
Manual Mode - Time To Auto
Disarm*
Sync After Shock Delivery*
Manual Mode – Contact
Indicator*
Paddles Open Circuit Display*
Default Energy (Adult) *
Default Energy (Pediatric) *
Advisory Mode - Time To Auto
Disarm*
Auto Charging*
Continuous Mode*
Voice Prompt*
Advisory Mode - Energy
Escalation*
Advisory Mode - Energy 1
(Adult) *
Advisory Mode - Energy 2
(Adult) *
Advisory Mode - Energy 3
(Adult) *
Advisory Mode - Energy 1
(Pediatric) *
Advisory Mode - Energy 2
(Pediatric) *
Advisory Mode - Energy 3
(Pediatric) *
AED Mode - Time To Auto
Disarm*
AED Mode - Display
parameters*
CPR First*
AED Mode – Contact
Indicator*
AED Mode - Energy
Escalation*
AED Mode - Energy 1 (Adult) *
AED Mode - Energy 2 (Adult) *
AED Mode - Energy 3 (Adult) *
AED Mode - Energy 1
(Pediatric) *
AED Mode - Energy 2
(Pediatric) *
AED Mode - Energy 3
(Pediatric) *
CPR Metronome Sound*
Compression Rate*
Ranges/Selections
Factory Defaults
3, 15, 30 sec
15 sec
15, 30, 60 sec
30 sec
On, Off
Off
20, 60 sec
60 sec
On, Off
On, Off
Off
On
On, Off
100, 125, 150, 175, 200 J
10, 15, 20, 30, 40, 50, 75, 100 J
20, 60 sec
Off
125 J
30 J
20 sec
On, Off
On, Off
On, Off
On, Off
On
On
On
On
100, 125, 150, 175, 200 J
125 J
100, 125, 150, 175, 200 J
150 J
100, 125, 150, 175, 200 J
200 J
10, 15, 20, 30, 40, 50, 75, 100 J
30 J
10, 15, 20, 30, 40, 50, 75, 100 J
40 J
10, 15, 20, 30, 40, 50, 75, 100 J
50 J
20, 60 sec
60 sec
On, Off
Off
On, Off
On, Off
Off
On
On, Off
On
100, 125, 150, 175, 200 J
100, 125, 150, 175, 200 J
100, 125, 150, 175, 200 J
10, 15, 20, 30, 40, 50, 75, 100 J
125 J
150 J
200 J
30 J
10, 15, 20, 30, 40, 50, 75, 100 J
40 J
10, 15, 20, 30, 40, 50, 75, 100 J
50 J
On, Off
100, 105, 110, 115, 120 CPM
On
100 CPM
131
Parameter
Adult Compression-ToVentilation Ratio*
Adult CPR Time*
Adult CPR Set*
Pediatric Compression-ToVentilation Ratio*
Pediatric CPR Time*
Pediatric CPR Set*
Default Pacing Mode*
Default Pacing Rate*
Pacing Current Step*
Auto Self-test Time*
Auto Self-test Interval*
Internal Shock Energy*
Ranges/Selections
Compression only, 30:2, 15:2
Factory Defaults
30:2
60, 90, 120, 150, 180 sec
3, 4, 5, 6, 7 cycles
Compression only, 30:2, 15:2
120 sec
5 cycles
30:2
60, 90, 120, 150, 180 sec
120 sec
3, 4, 5, 6, 7, 8, 9, 10 cycles
5 cycles
Demand mode, Fixed mode
Demand mode
30 ~ 180 ppm
70 ppm
2, 5 mA
5 mA
0 ~ 23 o’clock
0 o’clock
Off ,24, 48, 72 hours
24 hours
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 10 J
50 J
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
132
SPECIFICATION
Display
Screen Size
Screen Type
Resolution
Number of Traces
Language
7’ TFT-LCD screen
Liquid Crystal Display (LCD) Color
800 x 480 pixel
3 waveforms
English, Korean, Turkish, Russian, French, Polish, Spanish,
Italian, Romanian, Czech, Hungarian, Portuguese, Greek,
German
Controls
Standard
Multi function knob; Mode selection knob (Power Off, AED,
Manual, Monitor and Pacing); 12 buttons (Paddle Energy
Level(+, -), Patient type, ECG Lead, ECG Size, Print, Energy
Level, Charge, Analyze, Shock, Sync, Event and Alarm
button), 4 Soft key (Refer to the soft key section)
Alarms
Categories
Priorities
Notification
Setting
Alarm Volume Level
Distributed
Alarm
System Delay
Patient Status and System Status
Low, Medium and High Priorities
Audible and Visual
Default and Individual
45 to 85 dB
Less than 3 sec.
Physical Characteristics and Printer
Dimensions
Weight
Degree of Protection
against Electric
Shock
Mode of Operation
Type
Weight
Resolution
Number of Channels
Paper Type
Paper Width
Printer Speed
Instrument
310 x 220 x 215 mm (W x H x D)
5.5kg
ECG:
Type CF with defibrillator protection
SpO2:
Type CF with defibrillator protection
External Paddle:
Type BF with defibrillator protection
Pads:
Type BF with defibrillator protection
Continuous
Printer
Thermal
150g (without the printer paper)
8 dot/mm
1 to 3 channels
Thermal
50 mm
25 mm/sec, 50 mm/sec
133
Electrical
Instrument
Power Requirements
AC Mains
100 - 240Vac, 50/60Hz, 140 - 130VA
DC Mains
19Vdc, 8A Used with Cradle/External AC adaptor
(Cradle/External AC adaptor: Input:100 - 240Vac, 50/60Hz,
140 - 130VA, Output: 19Vdc, 8A)
18V, 7A Used with Cradle/External DC adaptor)
(Cradle/External DC adaptor: Input:12 - 16Vdc, 12A, Output:
18V, 7A)
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
144.70 x 91.60 x 27.40 mm (W x H x D)
Voltage/Capacity
4S2P 14.4V/6800mAh
Discharge
A minimum of 200 shocks at 200 Joules (per battery)
Operating time
5 hours (per battery) in Monitor mode or 2 hours monitoring
operation in Pacing mode (pacing rate: 80 ppm, pacing
output: 60mA, load resistance: 50Ω)
At the following condition:
No audible alarm sound
No data output, No communication (Communication
system is installed)
No printing out (Printer module is installed)
All monitoring parameters are active
LCD Backlight: default
Ambient temperature: 25°C
Recharge
Over 8 hours with defibrillator/monitor turned on
Over 5 hours with turned off
(It would take about 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
Life Cycle
300 cycles of recharge. If one cycle of recharging would be
about 2 or 3 days, the life cycle of the battery is about 24
months. - After 2 months storage the defibrillator/monitor
would run for 50% of stated battery life.
Note: The battery will not be charged for safety if the operating temperature exceeds
40°C.
134
Environmental Conditions
Operation
Temperature
0 to 45°C (32 to 113°F)
Humidity
5 to 95% RH, non-condensing
Atmospheric pressure
583.28 ~ 1013.25 hpa (0 ~ 4,575m at 25℃)
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℃~60℃ (-4℉~140℉)
Humidity
5 ~ 95% RH, non-condensing
Atmospheric pressure
200.36 ~ 1013.25 hpa (0 ~ 12,192m at 25℃)
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
Tone Definition
Volume level
Pitch (± 48.8Hz)
Pulse width (± 10msec)
Number of pulses
Repetitions
Volume level
Pitch (± 34.85Hz)
Pulse width (± 10msec)
Number of pulses
Repetitions
Volume level
Pitch (± 9.4Hz)
Pulse width (± 10msec)
Number of pulses
Volume level
Pitch (± 40Hz)
Pulse width (± 10msec)
Number of pulses
Repetitions
Volume level
Pitch (± 32.5Hz)
Pulse width (± 5msec)
Number of pulses
High Priority Alarm Tone
Adjustable (level 1~5)
540 Hz
250 msec
10 pulses per sec, 10 sec inter burst
Continually
Medium Priority Alarm Tone
Adjustable (level 1~5)
480 Hz
270 msec
3 pulses per sec, 15 sec inter burst
Continually
Low Priority Alarm Tone
Adjustable (level 1~5)
400 Hz
270 msec
1 pulse per 0.25 sec, 30 sec inter burst
Alarm Reminder Tone
Adjustable (level 1~5)
800 Hz
200 msec
1 pulse per sec, 3 min, 10 min inter burst
Continually
HR/PR Tone
Adjustable (Off, level 1~5)
650 Hz (ECG)
158 to 662 Hz (SpO2)
100 msec
N/A
135
Repetitions
Volume level
Pitch
Pulse width (± 5msec)
Number of pulses
Repetitions
No repeat
Key Beep
Adjustable (Off, level 1~5)
440 (± 22) Hz (valid)
168 (± 8.4)Hz (invalid)
110 msec
N/A
No repeat
Measurement Parameters
Pacing Mode
Pacing Mode
Variable from 30 bpm(ppm) to 180 bpm(ppm) ± 1.5%
(increments or decrements by a value of 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 ms constant current pulse
Pulse Amplitude
40 ms ±2 ms
*Output current can be low because of impedance difference according to pad attach
or patient status.
Pacing rate
Defibrillator
Patient Impedance
Heart Rate
Accuracy
Detection
Shock Analysis Time
AED mode
25 ~ 175 Ohm
20 to 300 BPM
±1 BPM or ±1%, whichever is greater
Ventricular Fibrillation at a amplitude greater than or
equal to 0.2mV,
Ventricular Tachycardia at a heart rate greater than or
equal to 150 bpm (Adult)
Ventricular Tachycardia at a heart rate greater than or
equal to 180 bpm (Pediatric)
< 10 seconds typical
Note: Shock analysis time will take up to 20 seconds if the
signal is disturbed by movement and etc.
Charging Time to 200J*
Within 6 seconds with rated AC/DC voltage
Within 7 seconds with fully charged battery
*Charging time for other cases, refer to defibrillator (technical specification)
Manual Mode
Shock Energy Level
Adult: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75,
100, 125, 150, 175, 200 J
Pediatric: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50,
75, 100 J
Automatic Discharge Time
20, 60 seconds
Charging Time to 200J*
Within 6 seconds with rated AC/DC voltage
Within 7 seconds with fully charged battery
*Charging time for other cases, refer to defibrillator (technical specification)
136
ECG
Measurement Range
Resolution
Accuracy
Maximum Response Time
Leads
Lead Off Detection
Input Impedance
Input Dynamic Range
Voltage Range
Signal Width
Signal Saturation Range
Lead fail detection
Heart Rate
0, 20 to 300 BPM
1 BPM
±1 BPM or ±1%, whichever is greater
10 seconds (For all measurement ranges)
ECG (Electrocardiograph)
3 Lead: Lead I, II, III
5 Lead: Lead I, II, III, aVR, aVL, aVF, V
Detected and displayed
Input
2.5 M ohm or more (for 0.05 to 40 Hz, with lead cable
and relay cable)
±5 mV AC, ±300 mV DC
±0.3 mV ~ ±5 mV
±5 mV
±800 mV DC or more
Yes
Output
Filter mode
Interpretation
0.05 to 150 Hz
Low
0.05 to 40 Hz
Med
0.5 to 40 Hz
High
0.5 to 30 Hz
Hum filter
50 Hz and 60 Hz (None or 60 dB or more)
ECG Size
Auto, 5.0, 10.0, 15.0, 20.0, 30.0, 40.0 mm/mV
ECG (Arrhythmia Supplemental Information as required by AAMI EC13)
Respiration,
leads-off Lead off sensing current : Maximum DC 24nA
sensing, and active noise
suppression
Tall
T-wave
rejection Maximum T-Wave amplitude 1.8 mV
capability
Accuracy of input signal Displacement: 0.1 mV, Slope: 0.1 mV/s
reproduction
Heart rate meter accuracy Provides correct heart rates, as follows:
and response to irregular Ventricular bigeminy: 79 ~ 82 BPM
rhythm
Slow alternating ventricular bigeminy: 60 ~ 62 BPM
Rapid alternating ventricular bigeminy: 120 BPM
Bidirectional systoles: 90 BPM
Response time of heart rate HR change from 80 to 120 BPM: 8.78 sec
meter to change in heart HR change from 80 to 40 BPM: 9.77 sec
rate
Time
to
alarm
for Vent Tachycardia 1 mVpp, 206 BPM:
tachycardia
Amplitude 0.5 mV: 3.88 sec
Amplitude 1 mV: 11.95 sec
Amplitude 2 mV: 6.05 sec
Vent Tachycardia 2 mVpp, 195 BPM:
Amplitude 1 mV: 8.23 sec
Amplitude 2 mV: 6.13 sec
Amplitude 4 mV: 4.17 sec
Time to alarm for heart rate Fast ECG
alarm conditions
137
Pacemaker pulse rejection
capability
CMRR
Defibrillator Discharge
Recovery
Pacer Pulse Detection
Rhythm Analysis
Range
Accuracy
Resolution
Rejection of pacemaker pulses with amplitudes from
±2mV to ±700mV with pulse widths of 0.1 to 2msec,
Overshoot time constant 4 ms, Test method B (with
overshoot)
ECG (Miscellany)
90 dB or more
<5 sec per IEC60601-2-27
On, Off
(Detect pacer pulses of ±2mV ~ ±700mV with pulse
width of 0.1 to 2.0 msec)
Bradycardia, Normal, Tachycardia
ST Level
-2 ~ 2 mV
±15% or ±0.05 mV (whichever is greater)
0.01 mV
Respiration
Technique
Carrier Frequency
Current
Range
Resolution
Accuracy
Input
Base Impedance
Delta Impedance
Respiration Detection
Lead Off Detection
Output
Waveform Size
IM Respiration
Thoracic Impedance Measurement
64 kHz
≤100µA
0 ~ 150 /min
1 BPM
±3 BPM
500 ~ 2000 ohm
≥3 ohm
≥0.3 ohm
Yes
Auto, 5.0, 10.0, 15.0, 20.0 mm/ohm
SpO2
Range
Accuracy
Range
Accuracy
138
Pulse Rate
Mediana module:
30 to 300 BPM
Medtronic module: 20 to 300 BPM
Mediana module:
±2 % or ±2 BPM (whichever is greater)
Medtronic module:
±3 digits (at 20 ~ 250 BPM, Adult/Pediatric/Neonatal)
±3 digits (at 20 ~ 250 BPM, Low Perfusion)
±5 digits (at 20 ~ 250 BPM, Adult/Pediatric/Neonatal with
Motion)
SpO2
Mediana module:
0 to 100 %
Medtronic module:
1 to 100 %
Mediana module:
Adult/Pediatric/Neonatal
±2 digits (at 70 to 100 %)
(less than 70% is unspecified)
Medtronic module:
Adult/Pediatric/Neonatal
±2 digits
(at 70 to 100 %)
Adult/Pediatric/Neonate Low Saturation
±3 digits
(at 60 to 80 %)
Low Perfusion
±2 digits
(at 70 to 100 %)
Adult/Pediatric/Neonate with Motion
±3 digits
(at 70 to 100 %)
Note: The wavelength range of the light emitted are near 660 nm and 890 nm with the energy
not exceeding 15mW.
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 Medtronic™ sensors,
contact Medtronic, a local Medtronic representative, or locate it online at
www.medtronic.com.
Note: Specification applies to monitoring system performance. Reading accuracy in the
presence of low perfusion (detected IR pulse modulation amplitude 0.03% - 1.5%) was
validated using signals supplied by a patient simulator. SpO 2 and pulse rate values were
varied across the monitoring range over a range of weak signal conditions and compared
to the known true saturation and pulse rate of the input signals.
139
Event/Trend
Type
Data storage
Memory
140
Event, Trends
Internal memory, SD card
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,
async mode)
saves clinical action list
saves 1 channel ECG waveform
saves Event date and time
saves HR/PR, SpO2, RESP numeric data
saves alarm condition
Trend
saves total 5,000 data
saves date and time
saves HR/PR, SpO2, RESP numeric data
saves alarm condition
Defibrillator (Technical Specification)
AED Mode
Charging Time - 200J
Charging Time - 200J
(including time from the
initiation
of
rhythm
analysis with a clear ECG
signal to readiness for
discharge.)
AED Mode
Charging condition
Time (sec)
With Rated Mains Voltage
5.8
With DC Mains Voltage
5.8
With fully charged battery
6.4
Charging condition
Time (sec)
With Rated Mains Voltage
17.9
With DC Mains Voltage
17.9
With fully charged battery
18.6
With Mains Voltage of 90% of the Rated
17.4
value
With DC Mains Voltage of 90% of the
17.4
Rated value
After 15 maximum energy discharges
18.5
taken from a new fully charged battery
With Mains Voltage of 90% of the Rated
value, but measured from initially
23.6
switching power on to ready for
discharge at maximum energy
With DC Mains Voltage of 90% of the
Rated value, but measured from initially
23.6
switching power on to ready for
discharge at maximum energy
After 15 maximum energy discharges
taken from a new fully charged battery,
but measured from initially switching 24.5
power on to ready for discharge at
maximum energy
Note: A used battery normally takes more time than the
charging time specified in above.
141
Manual Mode
Charging Time – 200J
142
Manual Mode
Charging condition
Time (sec)
With Rated Mains Voltage
5.8
With DC Mains Voltage
5.8
With fully charged battery
6.4
With Mains Voltage of 90% of the Rated
5.8
value
With DC Mains Voltage of 90% of the
5.8
Rated value
After 15 maximum energy discharges
6.8
taken from a new fully charged battery
With Mains Voltage of 90% of the Rated
value, but measured from initially
11.7
switching power on to ready for
discharge at maximum energy
With DC Mains Voltage of 90% of the
Rated value, but measured from initially
11.7
switching power on to ready for
discharge at maximum energy
After 15 maximum energy discharges
taken from a new fully charged battery,
but measured from initially switching 12.7
power on to ready for discharge at
maximum energy
Note: A used battery normally takes more time than the
charging time specified in above.
ECG Analysis Accuracy
Table 39. ECG analysis algorithm accuracy: Adult
Rhythm
Sample
no.
Defibrillation enable
Rough VF
291
Fast VT
Objective
Observed specification
90% one-sided
confidence error limit
> 90% Sensitivity
Meet IEC 60601-2-4
requirements and AHA
recommendations
Meet IEC 60601-2-4
requirements and AHA
recommendations
> 92.99%
Meet IEC 60601-2-4
requirements and AHA
recommendations
Meet IEC 60601-2-4
requirements and AHA
recommendations
Meet IEC 60601-2-4
requirements and AHA
recommendations
> 99.11%
90
> 75% Sensitivity
Defibrillation disable
NSR
2043
> 99% Specificity
Asystole
121
> 95% Specificity
Other rhythm
837
> 95% Specificity
> 90.12%
> 92.60%
> 98.13%
Table 40. ECG analysis algorithm accuracy: Pediatric
Rhythm
Sample
no.
Defibrillation enable
Rough VF
18
Fast VT
Objective
Observed specification
90% one-sided
confidence error limit
> 90% Sensitivity
Meet IEC 60601-2-4
requirements and AHA
recommendations
Meet IEC 60601-2-4
requirements and AHA
recommendations
> 86.67%
Meet IEC 60601-2-4
requirements and AHA
recommendations
N/A
Meet IEC 60601-2-4
requirements and AHA
recommendations
> 98.88%
33
> 75% Sensitivity
Defibrillation disable
NSR
265
> 99% Specificity
Asystole
Other rhythm
N/A
> 95% Specificity
0
391
> 91.32%
N/A
> 96.34%
Database for ECG Analysis
⚫ AHA DB, MIT-BIH DB, CU DB, VF DB, EUROPEAN ST-T DB
ECG rhythm to determine if a shock is appropriate
⚫ Ventricular Fibrillation at a amplitude greater than or equal to 0.2mV
⚫ For adult, Ventricular Tachycardia at a heart rate greater than or equal to 150 bpm
⚫ For pediatric, Ventricular Tachycardia at a heart rate greater than or equal to 180 bpm
Reference
• Young KD, Lewis RJ: ‘What is confidence? Part 2: Detailed definition and
determination of confidence intervals.’ Annals of Emergency Medicine, September
1997; 30; 311-218
143
• Automatic External Defibrillators for Public Access Defibrillation: Recommendations
for Specifying and Reporting Arrhythmia Analysis Algorithm Performance,
Incorporating New Waveforms, and Enhancing Safety. American Heart Association
(AHA) Task Force on Automatic External Defibrillation, Subcommittee on AED
Safety and Efficacy. Circulation. 1997: Vol. 95: 1677-1682.
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 D100 defibrillator/monitors) and the findings are described
below.
Table 41. Delivered energy at every defibrillator settings into a range of loads
Selected
Energy
1
2
3
4
5
6
7
8
9
10
15
20
30
40
50
75
100
125
150
175
200
144
25
1.0
2.1
3.3
4.4
5.4
6.5
7.5
8.6
9.7
10.7
16.1
21.3
32.0
42.7
53.3
79.8
105.4
131.7
144.8
167.6
194.3
50
1.0
2.2
3.3
4.4
5.4
6.5
7.5
8.6
9.7
10.7
16.0
21.3
31.9
42.5
53.1
79.6
106.0
132.2
158.9
185.1
211.2
75
1.0
2.1
3.2
4.3
5.3
6.4
7.5
8.5
9.6
10.7
15.9
21.0
31.6
41.9
52.5
78.5
105.6
131.9
158.2
183.0
208.8
Load
100
1.0
2.2
3.2
4.3
5.3
6.4
7.4
8.4
9.5
10.6
15.8
20.9
31.3
41.8
52.2
77.8
104.8
130.8
157.0
182.8
208.1
Accuracy
125
1.0
2.1
3.2
4.2
5.2
6.2
7.3
8.3
9.5
10.5
15.7
20.8
31.2
41.6
52.0
77.6
104.4
130.4
156.4
182.3
207.7
150
0.9
2.1
3.2
4.2
5.2
6.3
7.3
8.4
9.3
10.5
15.6
20.8
31.1
41.4
51.7
77.6
103.9
129.9
155.9
181.5
207.2
175
1.0
2.1
3.1
4.2
5.2
6.3
7.3
8.4
9.4
10.5
15.6
20.9
31.1
41.6
51.9
77.7
103.9
129.8
155.6
181.3
206.6
2J
2J
2J
2J
2J
2J
2J
2J
2J
2J
15%
15%
15%
15%
15%
15%
15%
15%
15%
15%
15%
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 (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).
PADS / External Paddle
Figure 46. Biphasic waveforms at 200 joules
Figure 47. Biphasic waveforms at 175 joules
145
Figure 48. Biphasic waveforms at 150 joules
Figure 49. Biphasic waveforms at 125 joules
146
Figure 50. Biphasic waveforms at 100 joules
Figure 51. Biphasic waveforms at 75 joules
147
Figure 52. Biphasic waveforms at 50 joules
Figure 53. Biphasic waveforms at 40 joules
148
Figure 54. Biphasic waveforms at 30 joules
Figure 55. Biphasic waveforms at 20 joules
149
Figure 56. Biphasic waveforms at 10 joules
Figure 57. Biphasic waveforms at 9 joules
150
Figure 58. Biphasic waveforms at 8 joules
Figure 59. Biphasic waveforms at 7 joules
151
Figure 60. Biphasic waveforms at 6 joules
Figure 61. Biphasic waveforms at 5 joules
152
Figure 62. Biphasic waveforms at 4 joules
Figure 63. Biphasic waveforms at 3 joules
153
Figure 64. Biphasic waveforms at 2 joules
Figure 65. Biphasic waveforms at 1 joule
154
Compliance
Item
Standard
Description
Classification
IEC 60601-
Class I (on AC power)
1:2005+AMD1:2012+AMD2:2020
Internally powered (on battery power)
EN 60601-1:2006+A1:2013
Type of protection
IEC 60601-
Type BF and Type CF – Applied part
1:2005+AMD1:2012+AMD2:2020
EN 60601-1:2006+A1:2013
Mode of operation
IEC 60601-
Continuous
1:2005+AMD1:2012+AMD2:2020
EN 60601-1:2006+A1:2013
Degree of
IEC 60529:1989+A1:1999+A2:2013,
IP44 (provided by enclosures)
protection
EN 60529:1991+A1:2000
IP22 (provided by Cradle / External adaptor)
+A2:2013
General
ISO 13485:2016
Quality
systems
-
Medical
Devices
-
Requirements for regulating purposes
ISO 14971:2019,
Risk analysis managements – medical
EN ISO14971:2019
devices
IEC 60601-1-6:2010+A1:2013
Collateral standard for usability
EN 60601-1-6:2010
Ambulatory
IEC 62366-1:2015,
EN 62366-1:2010
Medical devices - Application of usability
engineering to Medical devices
IEC 80601-2-49:2018
EN 80601-2-49:2019
Particular requirements for multifunction
patient monitoring equipment
IEC 62304:2006+A1:2015
Medical device software – Software life-
EN 62304:2006/AC:2008
cycle processes
EN 1789:2007+A2:2014
Medical vehicles and their equipment – road
ambulance
IEC 60601-1-12:2014+A1:2020
Collateral Standard: Requirements for
EN 60601-1-12:2015
medical electrical equipment and medical
electrical systems intended for use in the
emergency medical services environment
Alarms
IEC 60601-1-
Alarm systems requirements, tests and
8:2006+A1:2012+A2:2020
guidance in medical electrical equipments
EN 60601-1-
systems
8:2007+A1:2013/AC:2014
Electrocardiograph
Oxygen saturation
IEC 60601-2-27:2011,
Particular requirements for the safety of
EN 60601-2-27:2014
Electrocardiographic monitoring equipment
ISO 80601-2-61:2017
EN ISO 80601-2-61: 2019
Medical electrical equipment - Part 2-61:
Particular requirements for basic safety and
essential performance of pulse oximeter
equipment
155
Item
Defibrillator
Standard
Description
IEC 60601-2-4:2010+A1:2018
Safety of cardiac defibrillators
EN 60601-2-4:2011+A1:2019
156
Electromagnetic
IEC 60601-1-2:2014+A1:2020
Electromagnetic compatibility-requirements
compatibility
EN 60601-1-2:2015+A1:2021
& test
Package
ISTA (Procedure 2A, 2011)
Battery
IEC 62133-2:2017
Pre-Shipment test procedures (Package)
Secondary cells and batteries containing
alkaline or other non-acid electrolytes –
Safety requirements for portable sealed
secondary cells, and for batteries made
from them, for use in portable applications
Manufacturer’s EMC Declaration
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Mediana. Use accessories
according to the manufacturer’s directions for use and your facility’s
standards. The use of accessories, transducers, and cables other than
those specified may result in increased emission and/or decreased
immunity of the defibrillator/monitor.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the D100, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
The defibrillator/monitor is suitable for use in the specified electromagnetic
environment. The customer and/or user of the defibrillator/monitor should assure that it
is used in an electromagnetic environment as described below;
Table 42. Electromagnetic emissions (IEC60601-1-2)
Emission Test
RF emission
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emission
IEC 61000-3-3
Compliance
Group 1,
Class B
Class A
Complies
Electromagnetic Environment
The defibrillator/monitor is suitable for use
in all establishments
The defibrillator/monitor is suitable for use
in all establishments.
The defibrillator/monitor is suitable for use
in all establishments.
Table 43. Electromagnetic immunity (IEC60601-1-2)
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electric fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
IEC 60601-1-2
Test Level
±8 kV contact
±2, 4, 8, 15 kV air
Compliance
Level
±8 kV contact
±2, 4, 8, 15 kV air
±2 kV for
power supply lines
±1 kV for
input/output lines
(Input Power
Ports)
± 0.5, 1 kV
differential mode
±0.5, 1, 2 kV
common mode
(Signal
input/output)
2 kV
common mode
Voltage dips
>95 % U T
for 0.5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
±2 kV for
power supply lines
±1 kV for
input/output lines
(Input Power
Ports)
± 0.5, 1 kV
differential mode
±0.5, 1, 2 kV
common mode
(Signal
input/output)
2 kV
common mode
Voltage dips
>95 % U T
for 0.5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
Electromagnetic
Environment Guidance
Floor should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30 %.
Mains power quality should be
that of a typical commercial
and/or hospital environment
Mains power quality should be
that of a typical commercial
and/or hospital environment
Mains power quality should be
that of a typical commercial
and/or hospital environment. If
the user of the
defibrillator/monitor requires
continued operation during
157
Immunity Test
IEC 61000-4-11
Power
frequency
(50/ 60 Hz)
magnetic field
IEC 60601-1-2
Test Level
Voltage dips
>95 % U T
for 1 cycle
At 0°
Voltage dips
30 % U T
for 25/30 cycle
At 0°
Voltage
interruption
>95 % U T
for 250/300 cycle
At 0°
30 A/m
Compliance
Level
Voltage dips
>95 % U T
for 1 cycle
At 0°
Voltage dips
30 % U T
for 25/30 cycle
At 0°
Voltage
interruption
>95 % U T
for 250/300 cycle
At 0°
30 A/m
Electromagnetic
Environment Guidance
power mains interruption, it is
recommended that the
defibrillator/monitor be
powered from an
uninterruptible power supply or
battery.
It may be necessary to position
the defibrillator/monitor further
from the sources of power
frequency magnetic fields or to
install magnetic shielding. The
IEC 61000-4-8
power frequency magnetic field
should be measured in the
intended installation location to
assure that it is sufficiently low.
Note: UT is the AC mains voltage prior to application of the test level.
158
Table 44. Electromagnetic immunity (IEC60601-1-2)
Immunity Test
IEC 60601
Compliance
Electromagnetic environment
test level
level
guidance
The defibrillator/monitor is intended for use in the electromagnetic environment specified
below. The customer or the user of the defibrillator/monitor should assure that it is used in
such an environment.
Portable and mobile RF
communications equipment should
be used no closer to any part of the
defibrillator/monitor including cables,
than the recommended separation
distance calculated from the
equation appropriate to the
frequency of the transmitter.
Conducted RF
IEC 61000-4-6
3 V RMS outside
the ISM band
3 Vrms
Recommend separation distance
d = 1.2 p
6 V RMS in the ISM
and amateur
radio bands
6 Vrms
d = 0.6
p
3 V/m
80 MHz to 2.5 GHz
(80 % AM at 2 Hz)
According to
IEC60601-1-2:2007
3 V/m
d = 1.2
p
80 MHz to 800 MHz
d = 2.3
p
800 MHz to 2.5 GHz
10 V/m
80 MHz to 2.7 GHz
(80 % AM at 1
kHz)
According to
IEC60601-1-2:2014
10 V/m
d = 0.4
p
80 MHz to 800 MHz
d = 2.3
p
800 MHz to 2.7 GHz
d = 0.2
p
80 MHz to 800 MHz
d = 0.4
p
800 MHz to 2.5 GHz
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
20 V/m
20 V/m
80 MHz to 2.5 GHz
(80 % AM at 1
kHz)
According to
particular standards
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
metres (m).
Field strengths from fixed RF
transmitters as deter-mined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
159
Immunity Test
IEC 60601
test level
Compliance
level
Electromagnetic environment
guidance
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Note: According to the standard IEC60601-1-2: 2014, there is no difference in the safety and
performance of Life-Supporting and not Life-Supporting equipment.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the defibrillator/monitor is used exceeds the applicable RF
compliance level above, the defibrillator/monitor should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the defibrillator/monitor.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m
Table 45. Electro-surgical unit interference (IEC60601-2-27)
Interference Test
Test in cut mode
Test in coagulation mode
IEC 60601 test level
Output power 300W,
5 times
Output power of 100W,
Working frequency of 400 kHz ± 10 %
5 times
Complies with
IEC 60601-2-2
Table 46. Recommended separation distances
Recommended separation distance between
portable and mobile RF communications equipment and the defibrillator/monitor
The defibrillator/monitor is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the defibrillator/monitor can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the defibrillator/monitor as
recommended below, according to the maximum output power of the communications
equipment.
Rated
Separation distance according to frequency of transmitter in meter
Maximum
150 kHz to
150 kHz to
80 MHz to
800 MHz to
Output Power
80MHz
80MHz
800MHz
2.5GHz
of Transmitter
d = 1.2 p
(ISM and
(Test level
(Test level
in watt
amateur
20 V/m)
20 V/m)
0.01
0.12
radio bands)
d = 0.6 p
0.06
d = 0.2 p
d = 0.4 p
0.02
0.04
0.1
0.38
0.19
0.06
0.13
1
1.2
0.6
0.2
0.4
10
3.8
1.9
0.63
1.3
100
12
6
2
4
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
160
Table 47. Immunity to proximity fields from RF wireless communications equipment (IEC60601-1-2)
Test
frequency
(MHz)
Band a
(MHz)
Service a
385
360 – 390
TETRA
400
450
430 – 470
GMRS
460, FRS
460
710
745
780
704 – 787
LTE Band
13, 17
810
870
930
800 – 960
1720
1845
1970
1700 –
1990
2450
2400 –
2570
GSM
800/900,
TETRA
800,
iDEN 820,
CDMA 850,
LTE Band
5
GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE Band
1, 3, 4, 25;
UMTS
Bluetooth,
WLAN,
802.11
b/g/n,
RFID 2450,
LTE Band
7
Maximum
power
(W)
Distance
(m)
Immunity
test level
(V/m)
1.8
0.3
27
2
0.3
28
0.2
0.3
9
Pulse
modulation b
18 Hz
2
0.3
28
Pulse
modulation b
217 Hz
2
0.3
28
Pulse
modulation b
217 Hz
2
0.3
28
Modulation b
Pulse
modulation b
18 Hz
FM c
± 5 kHz
deviation
1 kHz sine
Pulse
modulation b
217 Hz
5240
Pulse
5100 –
WLAN
5500
modulation b
0.2
0.3
9
5800
802.11 a/n
5785
217 Hz
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the
transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
The 1 m test distance is permitted by IEC 61000-4-3.
a For some services, only the uplink frequencies are included.
b The carrier shall be modulated using a 50 % duty cycle square wave signal.
c As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because
while it does not represent actual modulation, it would be worst case.
Table 48. Cables (IEC60601-1-2)
Cables and Sensors
AC Power Cable
ECG Lead Cable
Pad Extension Cable
SpO2 Cable (MEX03)
SpO2 Cable (DOC-10)
Maximum Length
2.6m
4.0 m
3.5 m
3.7 m
4.2 m
Complies with
-RF emissions, CISPR 11, Class B/ Group 1
-Harmonic emissions, IEC 61000-3-2
-Voltage fluctuations/flicker emission,
IEC 61000-3-3
-Electrostatic discharge (ESD), IEC 61000-42
-Electric fast transient/burst, IEC 61000-4-4
-Surge, IEC 61000-4-5
-Conducted RF IEC 61000-4-6
-Radiated RF, IEC 61000-4-3
161