Professional Documents
Culture Documents
Defibrillator/Monitor D500
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
Local distributor
Manufacturer
Mediana Co., Ltd.
Wonju Medical Industry Park, 1650-1 Donghwa-ri,
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
Warranty
Trademark
Product brand names shown in this manual are likely to be the trademark or registered
trademark of the company concerned.
i
General ................................................................................................................................ 71
Preparing for Defibrillation ................................................................................................... 72
Operating the Manual Mode of defibrillator/monitor ............................................................. 72
Defibrillating (async mode) .................................................................................................. 73
Synchronized Cardioversion (sync mode) ........................................................................... 73
Description of Manual Mode Menu Functions ..................................................................... 75
MONITOR MODE ........................................................................................................................................ 81
General ................................................................................................................................ 81
Description of Pacing Mode Menu Functions ...................................................................... 81
PACING MODE ........................................................................................................................................... 87
General ................................................................................................................................ 87
Demand Mode (Sync Mode) and Async Mode .................................................................... 88
Operating the Pacing Mode of defibrillator/monitor ............................................................. 88
Demand Mode (Sync mode) Pacing .................................................................................... 89
Async Mode Pacing ............................................................................................................. 89
Description of Pacing Mode Menu Functions ...................................................................... 90
NIBP MONITORING .................................................................................................................................... 95
General ................................................................................................................................ 97
Setup Connections .............................................................................................................. 98
Description of NIBP Menu Functions ................................................................................... 99
SpO2 MONITORING ................................................................................................................................. 101
General .............................................................................................................................. 102
Setup Connections ............................................................................................................ 103
RESPIRATION MONITORING .................................................................................................................. 105
General .............................................................................................................................. 105
Setup Connections ............................................................................................................ 105
Description of Respiration Menu Functions ....................................................................... 106
CAPNOGRAPHY MONITORING .............................................................................................................. 109
General .............................................................................................................................. 110
Setup Connections ............................................................................................................ 110
Calibrating the CO2 Sensor.................................................................................................111
Description of EtCO2 Menu Functions ............................................................................... 113
TEMPERATURE MONITORING ............................................................................................................... 115
General .............................................................................................................................. 115
Setup Connections ............................................................................................................ 115
Description of Temperature Menu Functions ..................................................................... 115
IBP MONITORING .................................................................................................................................... 117
General .............................................................................................................................. 118
Setup Connections ............................................................................................................ 118
Description of IBP 1 Menu Functions ................................................................................ 119
Description of IBP 2 Menu Functions ................................................................................ 121
SELF-TEST FUNCTION ........................................................................................................................... 123
General .............................................................................................................................. 123
Functions to be tested in Self-test ..................................................................................... 123
Self-test result transmission (if configured with Wireless module option) .......................... 125
Self-test result printing ....................................................................................................... 125
Trouble shooting ................................................................................................................ 126
Button test.......................................................................................................................... 126
EVENT....................................................................................................................................................... 127
General .............................................................................................................................. 127
Event Data List Display...................................................................................................... 127
Event Review Display ........................................................................................................ 128
12 Lead Record Display .................................................................................................... 129
ID# ..................................................................................................................................... 129
MENU STRUCTURE ................................................................................................................................. 131
PRINTING ................................................................................................................................................. 149
ii
General .............................................................................................................................. 149
Printer Settings .................................................................................................................. 149
Print-Out ............................................................................................................................ 150
EXTERNAL INTERFACE .......................................................................................................................... 153
General .............................................................................................................................. 153
USB Host Type .................................................................................................................. 153
SD Memory Card ............................................................................................................... 153
Central System Communication ........................................................................................ 153
MAINTENANCE ........................................................................................................................................ 155
Recycling and Disposal ..................................................................................................... 155
Returning the defibrillator/monitor and System Components ............................................ 156
Service ............................................................................................................................... 156
Periodic Safety Checks...................................................................................................... 156
Cleaning............................................................................................................................. 156
Battery Maintenance .......................................................................................................... 157
Loading Printer Paper ........................................................................................................ 158
TROUBLESHOOTING .............................................................................................................................. 159
General .............................................................................................................................. 159
Obtaining Technical Assistance ......................................................................................... 159
EMI (Electromagnetic Interference) ................................................................................... 160
FACTORY DEFAULTS .............................................................................................................................. 163
General .............................................................................................................................. 163
Parameter Ranges and Default Settings ........................................................................... 163
SPECIFICATION ....................................................................................................................................... 171
Display ............................................................................................................................... 171
Controls ............................................................................................................................. 171
Alarms................................................................................................................................ 171
Physical Characteristics and Printer .................................................................................. 171
Electrical ............................................................................................................................ 172
Environmental Conditions .................................................................................................. 173
Tone Definition ................................................................................................................... 174
Measurement Parameters ................................................................................................. 175
Trend ................................................................................................................................. 180
Defibrillator (Technical specification) ................................................................................. 181
Compliance ........................................................................................................................ 196
Manufacturer’s Declaration ................................................................................................ 200
iii
Figures
Figure 1. Front panel components .............................................................................................................. 15
Figure 2. Top panel components ................................................................................................................. 17
Figure 3. Rear panel components ............................................................................................................... 18
Figure 4. Left panel components ................................................................................................................. 19
Figure 5. Right panel components .............................................................................................................. 19
Figure 6. Displays ........................................................................................................................................ 21
Figure 7. AC Power Connection .................................................................................................................. 28
Figure 8. DC Power Connection.................................................................................................................. 28
Figure 9. Battery Placement ........................................................................................................................ 32
Figure 10. Mode Select Knob ...................................................................................................................... 36
Figure 11. Select Date/Time Menu .............................................................................................................. 37
Figure 12. Setup: Display mode Menu ........................................................................................................ 38
Figure 13. Normal Screen (4 waveform, Defibrillation mode, Full option) .................................................. 38
Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option) .............................................. 39
Figure 15. Black-yellow Screen (4 waveform, Defibrillation mode, Full option) .......................................... 39
Figure 16. Volume Menu Display ................................................................................................................ 41
Figure 17. Alarm Limit Menu ....................................................................................................................... 47
Figure 18. Standard 3 Electrode Placement ............................................................................................... 52
Figure 19. 5 Electrode Placement ............................................................................................................... 53
Figure 20. Varying choice of baselines. ...................................................................................................... 56
Figure 21. Baseline at the level of QRS onset as used by the Glasgow program. ..................................... 56
Figure 22. Illustration of isoelectric segments I and K................................................................................. 56
Figure 23. Definitions for QRS end / ST junction ........................................................................................ 57
Figure 24. 12 lead Placement ..................................................................................................................... 58
Figure 25. 12-Lead ECG Preview Screen ................................................................................................... 59
Figure 26. HR/PR Display ........................................................................................................................... 60
Figure 27. ECG Waveform Display ............................................................................................................. 60
Figure 28. HR/PR Menu .............................................................................................................................. 60
Figure 29. AED Mode Menu ........................................................................................................................ 70
Figure 30. Patient Info: ID Menu ................................................................................................................. 70
Figure 31. Manual Mode Screen ................................................................................................................. 72
Figure 32. Manual Mode Menu ................................................................................................................... 75
Figure 33. Setup Menu ................................................................................................................................ 77
Figure 34. Alarm Limit Menu ....................................................................................................................... 78
Figure 35. Patient Info: ID Menu ................................................................................................................. 79
Figure 36. Monitor Mode Menu ................................................................................................................... 81
Figure 37. Setup Menu ................................................................................................................................ 83
Figure 38. Alarm Limit Menu ....................................................................................................................... 84
Figure 39. Patient Info: ID Menu ................................................................................................................. 85
Figure 40. Pacing mode screen .................................................................................................................. 88
Figure 41. Pacing Mode Menu .................................................................................................................... 90
Figure 42. Setup Menu ................................................................................................................................ 91
Figure 43. Alarm Limit Menu ....................................................................................................................... 93
Figure 44. Patient Info: ID Menu ................................................................................................................. 93
Figure 45. NIBP Display .............................................................................................................................. 99
Figure 46. NIBP Menu Display .................................................................................................................... 99
Figure 47. SpO2 Display ........................................................................................................................... 104
Figure 48. SpO2 Waveform Display .......................................................................................................... 104
Figure 49. SpO2 Menu Display ................................................................................................................. 104
Figure 50. Respiration Display .................................................................................................................. 106
Figure 51. Respiration Waveform Display ................................................................................................. 106
Figure 52. Respiration Menu Display ........................................................................................................ 106
Figure 53. Connection for mainstream ...................................................................................................... 111
Figure 54. Connection for sidestream ....................................................................................................... 112
Figure 55. EtCO2 Display .......................................................................................................................... 113
iv
Figure 56. EtCO2 Waveform Display ........................................................................................................ 113
Figure 57. EtCO2 Menu Display................................................................................................................ 113
Figure 58. Temperature Display ................................................................................................................ 115
Figure 59. Temperature Menu Display ...................................................................................................... 115
Figure 60. IBP connections ....................................................................................................................... 118
Figure 61. IBP 1 Display ............................................................................................................................ 119
Figure 62. IBP 1 Waveform Display .......................................................................................................... 119
Figure 63. IBP 1 Menu Display .................................................................................................................. 119
Figure 64. IBP 2 Display ............................................................................................................................ 121
Figure 65. IBP 2 Waveform Display .......................................................................................................... 121
Figure 66. IBP 2 Menu Display .................................................................................................................. 121
Figure 67. Auto Self-test display ............................................................................................................... 124
Figure 68. Event Data List Display ............................................................................................................ 127
Figure 69. Event Review Display .............................................................................................................. 128
Figure 70. 12 Lead Record Display ........................................................................................................... 129
Figure 71. Patient Info Menu ..................................................................................................................... 129
Figure 72. Printer setting Menu ................................................................................................................. 149
Figure 73. Print-out .................................................................................................................................... 150
Figure 74. Print-out on shock .................................................................................................................... 150
Figure 75. Print-out on 12 lead ECG data ................................................................................................. 150
Figure 76. Print-out on setting information ................................................................................................ 151
Figure 77. Printer Paper Replacement ...................................................................................................... 158
Figure 78. Biphasic Waveforms at 360 Joules and 360 Joules ................................................................ 185
Figure 79. Biphasic Waveforms at 200 Joules .......................................................................................... 185
Figure 80. Biphasic Waveforms at 175 Joules .......................................................................................... 186
Figure 81. Biphasic Waveforms at 150 Joules .......................................................................................... 186
Figure 82. Biphasic Waveforms at 125 Joules .......................................................................................... 187
Figure 83. Biphasic Waveforms at 100 Joules .......................................................................................... 187
Figure 84. Biphasic Waveforms at 75 Joules ............................................................................................ 188
Figure 85. Biphasic Waveforms at 50 Joules ............................................................................................ 188
Figure 86. Biphasic Waveforms at 40 Joules ............................................................................................ 189
Figure 87. Biphasic Waveforms at 30 Joules ............................................................................................ 189
Figure 88. Biphasic Waveforms at 20 Joules ............................................................................................ 190
Figure 89. Biphasic Waveforms at 10 Joules ............................................................................................ 190
Figure 90: Biphasic Waveforms at 9 Joules .............................................................................................. 191
Figure 91. Biphasic Waveforms at 8 Joules .............................................................................................. 191
Figure 92. Biphasic Waveforms at 7 Joules .............................................................................................. 192
Figure 93. Biphasic Waveforms at 6 Joules .............................................................................................. 192
Figure 94. Biphasic Waveforms at 5 Joules .............................................................................................. 193
Figure 95. Biphasic Waveforms at 4 Joules .............................................................................................. 193
Figure 96. Biphasic Waveforms at 3 Joules .............................................................................................. 194
Figure 97. Biphasic Waveforms at 2 Joules .............................................................................................. 194
Figure 98. Biphasic Waveforms at 1 Joules .............................................................................................. 195
Tables
Table 1. The defibrillator/monitor controls ................................................................................................... 16
Table 2. The defibrillator/monitor controls on paddle .................................................................................. 17
Table 3. Panel and Label Symbols .............................................................................................................. 20
Table 4. Display Symbols ............................................................................................................................ 22
Table 5. Display Colors Factory Defaults .................................................................................................... 23
Table 6. Standard Accessories .................................................................................................................... 26
Table 7. Optional Accessories ..................................................................................................................... 27
Table 8. Front Panel Indications for Power Source ..................................................................................... 32
Table 9. The defibrillator/monitor Battery Status Icon ................................................................................. 33
Table 10. Date/Time Menu .......................................................................................................................... 37
Table 11. High Priority Alarm ....................................................................................................................... 42
v
vi
SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the D500
defibrillator/monitor. Other important safety information appears throughout the manual.
The D500 defibrillator/monitor will be referred to as the defibrillator/monitor throughout
this manual.
Important! Before use, read carefully the manual, accessory directions for use, all
precautionary information and specifications.
Warning
Warnings alert you to potential serious outcomes (death, injury, or adverse events)
to the patient or user.
WARNING: Do not take into or use the defibrillator/monitor in locations where
highly combustible anesthetics or flammable gases are used or in high-pressure
oxygen rooms or inside oxygen tents, as this may cause a flammable explosion.
Turn off the gas source or move the source away from patient during defibrillation.
WARNING: When using the defibrillator/monitor with anesthetics, nitrous oxide or
high concentrations of oxygen, connect the gas outlet to a scavenger system.
WARNING: 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.
WARNING: Do not connect grounding wire to gas pipes. This could cause fire.
WARNING: 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.
WARNING: 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.
WARNING: 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.
WARNING: Do not take mobile phones or transceivers into a room where this
defibrillator/monitor is installed, as such devices may cause accidents.
WARNING: In order to avoid accidents, do not use any unauthorized accessories or
options.
WARNING: 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.
WARNING: 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.
7
WARNING: Do not use power source other than the specified voltage, (100-
240V~50/60Hz) as this may cause fire or electric shock.
WARNING: Pre-use inspection and preventive maintenance must be performed for
safe use.
WARNING: The defibrillator/monitor may be used with electrical surgical
equipment.
Follow the instruction manuals for medical instruments – notably electrosurgical
and diathermy instruments – when used, as their high–frequency energy units may
cause burns to patients via attachments.
WARNING: 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.
WARNING: 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.
WARNING: 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.
WARNING: Avoid connecting the patient to several devices at once. Leakage
current limits may be exceeded. Do not use a second defibrillator on the patient
while pacing with the Mediana defibrillator/monitor.
WARNING: 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.
WARNING: Do not place heavy objects on the power cord, as doing so may cause
fire or electric shock.
WARNING: Before conducting maintenance work, turn the power Off and unplug
the power cord from the wall socket to prevent electric shock.
WARNING: 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.
WARNING: Do not connect more than one patient to the defibrillator/monitor. Do
not connect more than one defibrillator/monitor to a patient.
WARNING: The defibrillator/monitor is a prescription device and is to be operated
by qualified personnel only.
WARNING: As with any medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.
8
WARNING: Never lift the defibrillator/monitor by the sensor cable, blood pressure
hose, power cord, or any other accessory. Such accessories could detach, causing
the defibrillator/monitor to fall on the patient.
WARNING: Do not make any clinical judgments based on this defibrillator/monitor’s
measurement only.
WARNING: 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).
WARNING: 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.
WARNING: The defibrillator delivers up to 360 joules of electrical energy. Unless
properly used as described in this manual, this electrical energy may cause serious
injury or death. Do not attempt to operate this defibrillator/monitor unless
thoroughly familiar with this manual and the function of all controls, indicators,
connectors and accessories.
WARNING: 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 patchers, etc. Such contact can cause electrical
arcing and patient skin burns during defibrillation and may divert defibrillating
energy away from the heart muscle.
WARNING: 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.
WARNING: If a person is touching the patient, bed, or any conductive material in
contact with the patient during defibrillation, the delivered energy may be partially
discharged through that person. Clear every away from contact with the patient,
bed, and other conductive material before discharging the defibrillator/monitor.
WARNING: 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.
WARNING: Conductive gel on the paddle handles can allow the electrical energy to
discharge through the operator during defibrillation. Completely clean the paddle
electrode surfaces, handles, and storage area after defibrillation.
WARNING: A gel pathway on the skin between the standard paddles will cause
defibrillating energy to arc between paddles and delivery energy away from the
heart muscle. Do not allow conductive gel (wet or dry) to become continuous
between paddle sites.
WARNING: During defibrillation checks, the discharged energy passes through the
cable connectors. Securely attach cable connectors to the simulator.
WARNING: 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.
WARNING: The defibrillator/monitor should be out of contact with water (puddles or
water spray). It may cause electrical shocks and device failure. Electrical safety of
the defibrillator/monitor may not work properly when wet.
WARNING: Defibrillation may cause implanted devices to malfunction. Place
standard paddles or pads away from implanted devices if possible. Check
implanted device function after defibrillation.
WARNING: Implanted pacemakers may cause the heart rate meter to count the
9
Cautions
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
10
INTRODUCTION
Indications Contraindications
Manual Manual defibrillation is Defibrillation is contraindicated
Defibrillation indicated for the termination of in the treatment of Pulseless
certain potentially fatal Electrical Activity (PEA), such
arrhythmias, such as as indioventricular or
ventricular fibrillation and ventricular escape rhythms,
symptomatic ventricular and in the treatment if
tachycardia. Delivery of this asystole.
energy in the synchronized
mode is a method for treating
atrial fibrillation, atrial flutter,
paroxysmal supraventricular
tachycardia, and, in relatively
stable patients, ventricular
tachycardia.
Automated External AED mode is to be used only AED is not intended for patient
Defibrillation on patients in cardiopulmonary who is conscious and has a
arrest. The patient must be pulse.
unconscious, pulseless, and
not breathing normally before
using the defibrillator to
analyze the patient’s ECG
rhythm.
External Pacing External pacing is indicated for External pacing is
symptomatic bradycardia in contraindicated for the
patients with a pulse. treatment of ventricular
fibrillation and asystole.
Electrocardiography The 12-lead electrocardiogram No known contraindications
is used to identify, diagnose
and treat patients with cardiac
11
disorders and is useful in the
early detection and prompt
treatment of patients with
acute myocardial infarction
(STEMI).
Noninvasive Blood Noninvasive blood pressure Noninvasive Blood Pressure is
Pressure monitoring is intended for not intended for use with
detection of hypertension or severe arrhythmia.
hypotension and monitoring Noninvasive Blood Pressure is
BP trends in patient conditions not intended for patients who
such as, but not limited to, are experiencing convulsion or
shock, acute dysrhythmia, or tremors.
major fluid imbalance.
Pulse Oximetry Pulse oximetry monitoring is Pulse Oximetry is not intended
intended to be used to monitor for use with severe peripheral
functional arterial oxygen vascular disease and severe
saturation and pulse rate. anemia (decreased
Hemoglobin).
Invasive Blood Invasive pressure monitor is No known contraindications
Pressure indicated for use in measuring
arterial, venous, intracranial
and other physiological
pressures using and invasive
catheter system with a
compatible transducer.
End-Tidal CO2 EtCO2 monitoring is indicated No known contraindications
for detection of trends in the
level of expired CO2. It is used
for monitoring breathing
efficacy and treatment
effectiveness in acute
cardiopulmonary care, for
example, to determine if
adequate compressions are
being performed during CPR
or to rapidly detect whether an
endotracheal tube has been
placed successfully. It is
intended for use on adult and
pediatric patients.
Temperature Temperature monitoring is No known contraindications
indicated for use in patients
who require continuous
monitoring of body
temperature.
12
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.
13
This page is intentionally left blank.
14
DESCRIPTION OF THE DEFIBRILLATOR/MONITOR
12
13 - 16
17
18
2
3 19 - 21
4 22
5
6 23
24 - 25
7
8 26 - 30
9
10
11
31 32
1 Paddle 17 MIC
2 NIBP connector 18 Mode select knob
3 LCD 19 ANALYZE button
4 Temperature1 connector 20 CHARGE button
5 Temperature2 connector 21 Energy Level button
6 IBP1 connector 22 SHOCK button
7 IBP2 connector 23 Multi function knob
8 Soft key 24 RATE button
9 EtCO2 Connector 25 mA button
10 SpO2 connector 26 NIBP button
11 Printer door 27 PRINT button
12 Handle 28 ALARM button
13 AC/DC in LED 29 LEAD button
14 Battery A charging status LED 30 SIZE button
15 Battery B charging status LED 31 ECG connector
16 Service LED 32 Paddle/Pads connector
15
Table 1. The defibrillator/monitor controls
Symbols Description
ANALYZE button
analyzes the patient’s ECG to determine whether or not to
deliver a shock.
CHARGE button
charges to the desired energy level automatically.
SHOCK button
delivers a shock.
RATE button
adjusts the rate of pacing waveform.
mA button
adjusts the current of pacing waveform.
NIBP button
toggles between starting and stopping NIBP measurements.
PRINT button
prints measured data.
Alarm button
pauses the audible alarm temporarily.
turns off the audible alarm by pressing over 2 seconds.
LEAD button
selects to display the desired ECG lead on the screen.
SIZE button
adjusts and selects the amplitude of an ECG waveform.
16
Top Panel Components
1 2 3 4 5
CHARGE button
charges to the desired energy level automatically.
REC button
prints the measured data.
17
Rear Panel Components
3 4 5 6 7
Figure 3. Rear panel components
1 SMPS/battery push button 5 SMPS
2 External DC jack 6 Speaker
3 AC power inlet 7 Li-ion battery
4 GND terminal
18
Left Panel Components
19
Table 3. Panel and Label Symbols
Symbols Description Symbols Description
Environmental shipping/storage
IBP 1 connector
altitude limitations
Environmental shipping/storage
IBP 2 connector
humidity limitations
Environmental shipping/storage
EtCO2 connector
temperature limitations
20
Displays
1 2 3 4 5 6
11
7
8
10 12
13
Figure 6. Displays
21
Table 4. Display Symbols
Symbols Description Symbols Description
ECG lead pair Temperature unit: Celsius
Temperature unit:
ECG lead pair
Fahrenheit
ECG lead pair SpO2 unit or EtCO2 unit: %
Temperature 1 icon
Temperature 2 icon
22
Table 5. Display Colors Factory Defaults
Function Color
ECG Waveform Green
SpO2 Waveform Cyan
Respiration Waveform Light Blue
EtCO2 Waveform Light Purple
ECG Green
NIBP White
SpO2 Cyan
Respiration Rate Light Blue
EtCO2 Light Purple
Temperature1 Pink
Temperature2 Pink
IBP 1 Red
IBP 2 Yellow
General background Black
Ararm/Informative message Black background, Green font
Defibrillator message Black background, White font
Low priority alarm message Black background, Yellow font
Medium priority alarm message Black background, Yellow font
High priority alarm message Black background, Red font
Battery status icon (normal) White
Battery status icon (low battery) Yellow or Red (refer to Table 8)
Note: The display colors can only be changed by authorized personnel via the Service
Menu. The detailed information is described in the service manual.
23
This page is intentionally left blank.
24
SETTING UP THE DEFIBRILLATOR/MONITOR
CAUTION: Recharging the battery is strongly recommended when the battery has
not been recharged for 6 or more months.
CAUTION: The use of accessories, cables, transducers and sensors sourced from
manufacturers, which Mediana has not recommended may cause incorrect analysis.
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.
25
List of Components
The following items are standard in the package.
26
Table 7. Optional Accessories
Items Qty
External paddle for pediatric -
Paddle plate for adult -
Defibrillation / external pacing pads for adult -
Defibrillation / external pacing pads for pediatric -
NIBP cuff for neonate -
NIBP cuff hose for neonate -
ECG 3 leads cable (GRAB) -
ECG 5 leads cable (SNAP) -
ECG 5 leads cable (GRAB) -
ECG 12 leads cable (SNAP) -
ECG 12 leads cable (GRAB) -
SpO2 disposable sensor -
LoFlo CO2 cannula-adult box/10ea
LoFlo CO2 nasal cannula-pediatric box/10ea
LoFlo CO2 nasal cannula-infant box/10ea
LoFlo CO2 nasal cannula w/O2-adult box/10ea
LoFlo CO2 nasal cannula w/O2-pediatric box/10ea
LoFlo CO2 nasal cannula w/O2-infant box/10ea
LoFlo CO2 oral/nasal cannula-adult box/10ea
LoFlo CO2 oral/nasal cannula-pediatric box/10ea
LoFlo CO2 oral/nasal cannula w/O2-adult box/10ea
LoFlo CO2 oral/nasal cannula w/O2-pediatric box/10ea
LoFlo airway adapter-pediatric/adult box/10ea
LoFlo airway adapter-pediatric/infant box/10ea
LoFlo airway adapter w/nafion, pediatric/infant box/10ea
Straight sampling line box/10ea
Straight sampling line w/nafion box/10ea
Module mounting bracket 1ea
Single patient use adult airway adapter w/mouthpiece box/10ea
CAPNO2 mask-pediatric box/10ea
CAPNO2 mask-adult standard box/10ea
CAPNO2 mask-adult large box/10ea
Cable management straps box/10ea
Service manual (English) -
External DC-DC adaptor -
Carry bag -
Optional items may be ordered if needed. Contact your local supplier for pricing and
ordering information.
27
Power Cable Connections
AC Power
Make sure that the AC outlet is properly grounded and supplies the specified voltage and
frequency (100-240V~ 50/60 Hz).
1. Connect the female type connector end of the AC power cord to mains connector on
the defibrillator/monitor’s rear panel.
2. Plug the male type connector end of the AC power cord into a properly grounded mains
outlet.
3. If necessary, connect grounding wire. Connect the grounding wire connector to the
equipotential terminal on the rear panel. Now attach the clip end of the grounding wire
to the medical equipment grounding terminal on the wall.
4. Verify that the Battery charging status LED and AC/DC in LED on the
defibrillator/monitor’s front panel is lit.
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.
DC Power
The external DC power source can be used, when the defibrillator/monitor is used for the
emergency condition in the moving car.
28
1. Connect an external DC-DC adaptor (input: 12-16 Vdc output: 18Vdc) to
defibrillator/monitor rear panel connecter identified with the DC power symbol.
2. 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: Even if the defibrillator/monitor is not turned on, the Battery charging status LED
is lit when the External DC-DC adaptor is connected into an external DC jack.
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.
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.
29
ECG Cables and Leads
1. Connect an ECG cable to the “ECG” connector making sure that the connector arrow is
pointing panel. (see Figure 1)
1. Select an appropriate size cuff for the patient. (Refer to the NIBP Monitoring section.)
2. Connect the hose to the “NIBP” connector making sure to tighten the connector in the
clockwise direction. (see Figure 1)
3. Attach the cuff to the end of the hose.
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 1)
3. Attach the sensor to the end of the cable.
1. Select the appropriate probe(s) for the desired application. (Refer to the Temperature
Monitoring section.)
2. Connect the temperature probes to the “Temperature” connector on the
defibrillator/monitor’s side option case. (see Figure 1)
1. Select the appropriate CO2 sensor according to the operational mode. (Refer to the
Capnography Monitoring section.)
2. Connect Mainstream or Sidestream sensor to the CO2 connector on the
defibrillator/monitor’s side option case. (see Figure 1)
1. Connect the interface cable(s) for the transducer(s) to the “IBP” connector on the
monitor’s side option case. An interface cable for the transducer has to be selected
correctly as it depends on the transducer type. (see Figure 1, IBP Monitoring section)
2. Set up the patient circuit according to the directions for use of the transducer,
monitoring kit and IV set (6pin, red round connector).
Note: If leadwire cable, cuff/hose cable, sensor, probe and transducer are not connected
firmly, the defibrillator/monitor could lose signal from patient.
30
BATTERY OPERATION
WARNING: 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.
WARNING: 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.
WARNING: 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.
CAUTION: Recharging the battery is strongly recommended when it has not been
fully recharged for 6 or more months.
CAUTION: Do not install the battery into the defibrillator/monitor when storage may
exceed 90 days. Battery damage may occur.
CAUTION: When the voltage of the battery is very low, it is a possibility of not
operating.
31
CAUTION: 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: 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.
Note: The defibrillator/monitor can be powered with two batteries when a battery is
inserted instead of SMPS. When the defibrillator/monitor is equipped with two
batteries, two battery status icons appear on the screen
32
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 under the
following conditions:
White (charging)
A low priority alarm occurs when the remaining battery power is only enough for 15
minutes of operation. The “Low battery” message is displayed on the screen. Connect the
AC power or replace the battery with a fully charged battery immediately when alarm
occurs.
This alarm 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.
Connect the defibrillator/monitor to an AC power source immediately to avoid any loss of
trend data or settings.
Note: The battery will not be charged for safety if the operating temperature exceeds 40°C.
33
This page is intentionally left blank.
34
USING THE DEFIBRILLATOR/MONITOR
WARNING: Each time the defibrillator/monitor is used, check alarm limits to make
sure that they are appropriate for the patient being monitored.
WARNING: 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.
WARNING: 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.
WARNING: Be aware of patient cables, including ECG monitoring equipment
when used with high frequency surgical equipment.
WARNING: Do not analyze in a moving vehicle. Motion artifact may affect the ECG
signal resulting in an inappropriate SHOCK or NO SHOCK ADVISED message.
Motion detection may delay analysis. Stop vehicle and stand clear of patient
during analysis.
WARNING: To avoid risk of electrical shock, do not touch gelled area of the pads
while pacing or shock. When defibrillating with paddles use tour thumbs to
operate the SHOCK button in order to avoid inadvertent operator shock. No
portion of the hand should be near the paddle plates.
WARNING: Pediatric defibrillation energy levels should be set based on site-
specific clinical protocols.
WARNING: 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.
WARNING: Place the patient on a firm surface before performing CPR.
WARNING: 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.
WARNING: Pitted or damaged paddles may cause patient skin burns during
defibrillation.
WARNING: The ECG rhythm analysis function does not warn the operator of
patient asystole, as it is not a shockable rhythm.
WARNING: Determination of electrical capture should only be performed by
viewing the ECG on the screen with its ECG cable directly attached to the patient.
WARNING: Connect the device only to a three-wire, grounded, hospital grade
receptacle. The threeconductor 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.
CAUTION: The defibrillator does not automatically adjust energy when using
pediatric electrodes. Manually select the appropriate energy prior to defibrillating
the patient.
CAUTION: 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 to disarm itself.
35
CAUTION: Do not discharge the defibrillator except as indicated in the instructions.
CAUTION: When defibrillating with paddles use tour thumbs to operate the SHOCK
button in order to avoid inadvertent operator shock. No portion of the hand should
be near the paddle plates.
CAUTION: 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.
CAUTION: If using defibrillation pads, make sure that the size of the pad is large
enough to cover the entire paddle electrode area.
CAUTION: 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.
1. Rotate Mode select knob to select one mode from AED, manual, monitor or
pacing mode.
2. The defibrillator/monitor is turned on in select mode.
36
Setting Date and Time
You may set the date and time displayed on the screen and printed on the reports.
1. Rotate the Multi function knob to highlight Date/Time, and then press the Multi
function knob to select Date/Time Menu.
2. Soft key Menu will be changed to Date Format, Set Date, Set Time and Return. When
the soft key is pressed, the relevant Menu will appear. Rotate and press the Multi
function knob to change the desired format or number.
Continued use
37
Setting the Main Screen
You may select the main screen to be displayed; 4 waveform screen, large numeric
screen or Black-yellow invert screen.
1. Press Setup soft key to change main screen (4 waveform screen) to large numeric
screen or black-yellow invert screen.
2. Select Display mode menu. Display mode menu will be displayed on screen.
3. Rotate and press the Multi function knob to change the desired display mode.
38
Large Numeric Screen
Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option)
39
This page is intentionally left blank.
40
ALARMS AND LIMITS
WARNING: Each time the defibrillator/monitor is used, check alarm limits to make
sure that they are appropriate for the patient being monitored.
WARNING: 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.
WARNING: Always respond immediately to a system alarm since the patient may
not be monitored during certain alarm conditions.
CAUTION: 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:
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.
Note: Each key-control should result in some audible tone and that invalid key-controls
are ignored. Have the defibrillator/monitor serviced if the key-controls fail.
1. Select the Setup soft key and then the Setup menu will be displayed.
2. Rotate the Multi function knob to highlight Volume and then press the Multi function
knob to select Volume Menu.
3. Rotate the Multi function knob to highlight desired menu.
4. Selected menu is activated by pressing the Multi function knob.
5. Rotate the Multi function knob to adjust the volume.
6. Press the Multi function knob to save the desired volume and to select the other
menu.
7. Press the Return soft key. Then the current menu returns to the previous menu.
41
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.
High Priority
Table 11. High Priority Alarm
Medium Priority
Table 12. Medium Priority Alarm
Technical Alarm Message
Parameter Condition Messages
High Heart Rate/Pulse Rate limits High Heart Rate/Pulse Rate limits violated
violated
HR/PR
Low Heart Rate/Pulse Rate limits Low Heart Rate/Pulse Rate limits violated
violated
ECG ECG Signal Saturation ECG Signal Saturation
High SpO2 limits violated High SpO2 limits violated
%SpO2
Low SpO2 limits violated Low SpO2 limits violated
High Systolic blood pressure limits NIBP-High Systolic blood pressure limits
violated violated
High Diastolic blood pressure limits NIBP-High Diastolic blood pressure limits
violated violated
High MAP blood pressure limits NIBP-High MAP blood pressure limits
violated violated
NIBP
Low Systolic blood pressure limits NIBP-Low Systolic blood pressure limits
violated violated
Low Diastolic blood pressure limits NIBP-Low Diastolic blood pressure limits
violated violated
Low MAP blood pressure limits NIBP-Low MAP blood pressure limits
violated violated
High Respiration Rate limits violated High Respiration Rate limits violated
Resp
Low Respiration Rate limits violated Low Respiration Rate limits violated
IBP Over the systolic upper limit {label}: High systolic blood pressure limit
violated.
IBP Under the systolic lower limit {label}: Low systolic blood pressure limit
IBP
violated.
IBP Over the diastolic upper limit {label}: High diastolic blood pressure limit
violated.
42
Technical Alarm Message
Parameter Condition Messages
IBP Under the diastolic lower limit {label}: Low diastolic blood pressure
violated.
IBP Over the mean upper limit {label}: High MEAN blood pressure limit
violated.
IBP Under the mean lower limit {label}: Low MEAN blood pressure limit
violated.
High EtCO2 limits violated EtCO2 : High EtCO2 Limits violated
Low EtCO2 limits violated EtCO2 : Low EtCO2 Limits violated
EtCO2
High InCO2 limits violated EtCO2 : High InCO2 Limits violated
Low InCO2 limits violated EtCO2 : Low InCO2 Limits violated
High Temperature limits violated TEMP1 : High temperature limits violated
TEMP2 : High temperature limits violated
Temp
Low Temperature limits violated TEMP1 : Low temperature limits violated
TEMP2: Low temperature limits violated
Note : {label} : IBP label name. (label = P1, P2, ABP, CVP, PAP, LAP)
Low Priority
Table 13. Low Priority Alarm
Technical Alarm Message
Parameter Condition Messages
ECG Leads Off ECG : Leads off
ECG
Chest Lead off ECG : Chest lead off
Temperature Probe Disconnect TEMP1 : Probe disconnect
TEMP2 : Probe disconnect
Temp
Temperature – Out of range TEMP1 : Out of range
TEMP2 : Out of range
Abnormal Cuff NIBP : Abnormal cuff / EEE 11
NIBP : Abnormal cuff / EEE 21
Measurement Fail NIBP : Measurement fail / EEE 12
NIBP : Measurement fail / EEE 14
NIBP : Measurement fail / EEE 15
NIBP NIBP : Measurement fail / EEE 18
NIBP : Measurement fail / EEE 20
Overpressure NIBP : Overpressure / EEE 19
Artifact NIBP : Artifact / EEE 13
Artifact NIBP : Artifact / EEE 16
Time-Out NIBP : Time-out / EEE 17
Failed in zero calibration {label}: Unable to zero calibration.
(ex. {label}: P1,P2)
Out of range {label}: Out of range.
IBP
(ex. {label}: P1,P2)
Cable/Sensor disconnected. {label}: Cable/Sensor disconnected.
(ex. {label}: P1,P2)
43
Technical Alarm Message
Parameter Condition Messages
SpO2 - Technical Error SpO2 Error – EEE001
~ SpO2 Error:EEE511
SpO2 : Module reset
SpO2 : Reconnect / Replace SpO2 sensor
%SpO2
SpO2 : Reposition / Replace SpO2 sensor
SpO2 : Replace SpO2 Sensor
SpO2 Cable/Sensor Disconnect SpO2 : Cable/Sensor disconnect
Sensor Off from SpO2 Sensor SpO2 : Sensor off
Resp Respiration Leads Off RESP : Leads off
Adapter Calibration Failed EtCO2 : Adapter Calibration Failed
Check Adapter EtCO2 : Check Adapter
Faulty Sensor EtCO2 : Faulty Sensor
Occlusion or Leak EtCO2 : Occlusion or Leak
EtCO2 Out of Range EtCO2 : Out of Range
Sample Line Disconnected EtCO2 : Sample Line Disconnected
Sensor Disconnected EtCO2 : Sensor Disconnected
Adapter Calibration Failed EtCO2 : Adapter Calibration Failed
Check Adapter EtCO2 : Check Adapter
Printer out of paper SYSTEM : Printer out of paper
System
Low Battery SYSTEM : Low Battery
Note : {label} : IBP label name. (label = P1, P2, ABP, CVP, PAP, LAP)
Informative Messages
Note: There may be other informative messages that are not listed above.
44
Defibrillator message
Defibrillator messages indicate a condition related to manual mode, AED mode and pacing
mode.
Note: Defibrillator messages are not displayed in monitor mode.
45
Visual Alarm Indication
Table 16. Visual Alarm Characteristics
Alarm Category Color Flashing Period Duty Cycle
High priority Red 700ms (about 1.43Hz) 57% (On: 400ms / Off: 300ms)
Medium priority Yellow 2000ms (about 0.5Hz) 60% (On: 1200ms / Off: 800ms)
Low priority Yellow - 100% (Always On)
When a high priority alarm is activated, a non-flashing alarm message is displayed. The
numerical area will flash red.
When a low priority alarm is activated, a non-flashing alarm message is displayed. The
numerical area will change to yellow.
WARNING: Do not turn off the audible alarm or decrease its volume if patient
safety could be compromised.
WARNING: Make sure that the defibrillator/monitor speaker is not obstructed.
Failure to do so could result in an inaudible alarm tone.
46
Changing Alarm Limits
WARNING: Each time the defibrillator/monitor is used, check alarm limits to make
sure that they are appropriate for the patient being monitored.
WARNING: 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.
CAUTION: Do not set the alarm limits to extreme values that can cause the alarm to
become useless.
You can change alarm limits from default values, if necessary. Alarm limits or Limit Alarm
Pause may be set in two ways:
Via interaction with HR/PR, SpO2, NIBP, Respiration, EtCO2, IBP and Temperature
Menu or
Via interaction with the Alarm Limits Menu that presents the limits in all the
parameters at one time.
1. Soft key is displayed on the lower of the normal screen. (Refer to figure 13.)
2. Press the Alarm Limit soft key located lower right corner of the screen.
3. Select the parameter menu to be changed by pressing the Multi function knob.
47
4. Change the alarm limit by rotating the Multi function knob.
5. Selected parameter menu is returned to normal screen by pressing the Return soft
key.
6. When the menu is returned, the other menu can be selected.
Table 18 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. The detailed
information is described in the service manual.
48
Parameters Upper Limit, Default Lower Limit, Default Resolution
-45 ~ 300 mmHg, 90 mmHg -50 ~ 295 mmHg, 50 mmHg 5 mmHg
Adult/Pediatric
(12.0 kPa) (6.7 kPa) (0.6 or 0.7 kPa)
P2 Systolic (mmHg, kPa)
-45 ~ 300 mmHg, 120mmHg -50 ~ 295 mmHg, 70 mmHg 5 mmHg
Adult/Pediatric
(16.0 kPa) (9.3 kPa) (0.6 or 0.7 kPa)
P2 MEAN (mmHg, kPa)
-45 ~ 300 mmHg, 90 mmHg -50 ~ 295 mmHg, 50 mmHg 5 mmHg
Adult/Pediatric
(12.0 kPa) (6.7 kPa) (0.6 or 0.7 kPa)
P2 Diastolic (mmHg, kPa)
-45 ~ 300 mmHg, 70 mmHg -50 ~ 295 mmHg, 40 mmHg 5 mmHg
Adult/Pediatric
(9.3 kPa) (5.3 kPa) (0.6 or 0.7 kPa)
49
Audio Paused and OFF
WARNING: Do not pause the audio or decrease its volume if patient safety could
be compromised.
WARNING: 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.
WARNING: 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.
WARNING: Check the audible alarm silence duration before temporarily silencing
the audible alarms.
When an alarm occurs, you can pause the audio for the audio pause time (30 sec, 60 sec,
90 sec, 120 sec) selected via Service menu. However, visual alarms continue during this
time. The factory default for audio pause time is 30 seconds
Table 19. Bell Icon
Limit
Alarm Active Audio paused Audio Off
alarm pause
To pause an audio:
1. Press the Alarm Off button to immediately pause the alarm tone. The alarm resumes
after the audio paused period if the alarm condition has not been corrected.
2. Check the patient and provide appropriate care.
During the audio paused period, you can press the Alarm Off button again to re-enable
the audio tones. Also, if another alarm occurs during the audio paused period, the audio
tones will be automatically re-enabled.
Note: The audio paused by some technical errors may be canceled by pressing the Alarm
Off button. However, battery failure and physiological alarms cannot be canceled
until the alarm condition is corrected.
To off an audio:
1. To initiate an audible alarm off, press the Alarm Off button and hold it for at least 2
seconds.
2. To cancel an audible alarm off condition, press the Alarm Off button for 2 seconds
again.
This action disables audible alarms for a user-defined audio off period (3 min, 5 min, 10
min or Indefinite) selected via the Service menu.
If audio off period is set to 3, 5 or 10 minutes, the audible alarm is not activated for the
specified time interval and the Audio Off icon is displayed.
Note: You may disable limit violation alarms of each vital sign via the HR/PR, SpO2, NIBP,
Respiration, EtCO2, IBP, Temperature or Alarm limit menus.
Note: The periods can only be changed by authorized personnel via the Service menu.
Note: Alarm Off may disable the visual alarm manifestation if sensors, probes, or modules
are intentionally disconnected by operator.
50
ECG MONITORING
WARNING: 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 device failure to use of pacing/defibrillation pads or
adapters from sources other than Mediana
WARNING: 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.
WARNING: 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.
WARNING: Do not use ECG electrodes with expired dates. Do not use defective
ECG electrodes. These might cause improper performance.
WARNING: 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.
WARNING: 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.
WARNING: 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
HR/PR Menu when monitoring such patients. Do not rely entirely upon the
defibrillator/monitor alarms. Keep pacemaker patients under close surveillance.
WARNING: 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.
WARNING: Correct the electrode placement. Improper electrode placement may
cause incorrect result. User must be aware of proper device operation.
WARNING: Use only high quality ECG electrodes. ECG electrodes are for rhythm
acquisition only. Do not attempt to defibrillate or pace through ECG electrodes.
WARNING: 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.
WARNING: The defibrillator/monitor may be used in conjunction with and must
not be damaged by typical electrosurgical equipment operation.
51
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:
Note: Occasionally, electromagnetic interference beyond the range guaranteed from the
manufacturer’s declaration may cause the defibrillator/monitor to display a "Check
ECG Leads & Electrodes" alarm. This occurrence is rare, and duration should be
short. When the interference ceases, the defibrillator/monitor removes the "Check
ECG Leads & Electrodes" 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 18 and 19 for electrode placement
configurations.
52
Figure 19. 5 Electrode Placement
Note: One of 5-1 to 5-6 Lead electrode placement sites for the fifth lead.
53
12-lead ECG
General
The optional 12 lead ECG function, using the GLA algorithm, is available in Monitor Mode
and allows you to Acquire, Setup, 12lead On and Patient Info. In addition, the 12 lead
function provides computerized ECG analysis. A report with measurements and
interpretive statements from the analysis is displayed, stored and printed, as configured.
Patient age and gender are used to define normal limits for heart rate, axis deviation, time
intervals, and voltage values, for interpretation accuracy in tachycardia, bradycardia,
prolongation or shortening of PR and QT intervals, hypertrophy, early repolarization,
myocardial infarction and culprit artery detection.
In a 12-lead ECG using 10 electrodes, an electrode is placed on the right arm, left arm,
right leg and left leg. Six V/C electrodes are placed on the chest as shown in Figure 34.
The right leg electrode is the standard.
Processing
Initially, a 50Hz or 60Hz notch filter is applied to remove any AC interference, if such a
filter has not already been applied within the acquiring device. The first stage of the
analysis is to compute any missing limb leads from the minimum of two leads that need to
be provided. The ECG data is then filtered to minimize the effects of noise. The next step
in the analysis is to calculate a form of spatial velocity combining the first difference of
each lead. From this function, the approximate locations of all the QRS complexes are
derived. Allowance has to be made for pacemaker stimuli, which are ideally detected by
the front end equipment and passed to the program in the form of a list of “spike” locations.
Given the QRS locations, it is then possible to check the quality of the recording for noise
and baseline drift. If the drift is excessive, it is removed by using a cubic spline technique
to obtain, for each lead affected, the baseline trend, which is then subtracted from the
original data. If the noise is excessive, it is possible to remove a whole lead from the
analysis or alternatively, 5 seconds of all leads are removed either from the first or second
half of the recording.
54
QRS typing
Thereafter, the various QRS complexes are typed according to their morphology. An
iterative process is used. Effectively, the first complex in lead I is compared with the
second using first differences of each cycle. The comparison takes the form of moving
one beat over the other and when the difference is minimal, optimal alignment is present.
This alignment point is used for averaging as discussed below. If the difference between
beats is less than a threshold value, they are deemed to belong to the same class. The
procedure is repeated with the third beat being compared with the second and so on. If a
new morphology is detected, i.e. if the threshold is exceeded, a new class is established.
The procedure continues with five leads being used in the typing process.
If more than one class of beat is present, then a decision has to be made as to which
morphology will be used for the averaging procedure, i.e. the cycle to be interpreted has
to be selected. A complex logic is used for this purpose. It has to allow for a single
normally conducted beat in the midst of demand pacemaker beats for example. It also
needs to take account of the QRS durations of different beat classes, RR intervals to
exclude extrasystoles, and to a limited extent, the number of beats in each morphological
class. The net effect is to choose one class of beats, of a similar morphology, that are
regarded as being conducted in the normal sequence through the ventricles.
Averaging
All beats in the selected class are averaged so that 12 such beats, one from each lead,
are then available. The “average” beat can be computed in several ways. Common to this
are the alignment points detected when wave typing was undertaken. They are used as
reference points in the averaging process. The average beat can be a straight average of
all corresponding aligned points, it can be a median calculated from the same points or it
can be a weighted average – the so called modal beat introduced into the program in
1977. In practice, the program forms the straight average, which is compared to individual
beats in the same class. If there is a significant difference at any point, then the median
beat is used. The modal beat is regarded as being computationally excessive, though it is
undoubtedly the best approach to use.
55
Wave Measurement
From the 12 average beats, a single combined function is formed and a provisional overall
QRS onset and termination is determined by thresholding techniques. The provisional
onset and termination are then used as starting points for a search for QRS onset and
termination within each individual lead. Basically the approach conforms to the
recommendations of the CSE working party (of which one of the Glasgow team was a
member), which were published in 1985.
Figure 20. Varying choice of baselines. Figure 21. Baseline at the level of QRS
onset as used by the Glasgow program.
In each individual lead, the QRS onset is taken as the baseline and hence Q, R, S, R'
waves are measured with respect to the QRS onset as shown in the accompanying
figures from the CSE paper (see Figures 30-33).
Isoelectric segments at the beginning of a QRS complex, i.e. a flat segment between the
provisional overall onset and the onset of an individual lead are excluded from the first
component (Q or R) of the QRS complex as recommended by the CSE group. Similar
considerations apply at the end of the QRS complex (see Figure 32). A sorting algorithm
is then applied to all 12 onsets to determine the global QRS onset as follows. The earliest
onset is excluded and the next onset that also lies within 20 ms of the next again is then
selected as the overall onset. This ensures that any true outliers are excluded. The
reverse process is used to find the overall QRS termination.
56
QRS Components
Within the QRS complex, the amplitude and duration of the various Q, R, S, R’ waves are
then measured. In keeping with the CSE recommendations, the minimum wave
acceptable has to have a duration >8 ms and an amplitude >20 V. With respect to global
QRS duration, the Glasgow program measures QRS duration from the global QRS onset
to the global QRS termination. This means that an isoelectric segment within one
particular QRS complex by definition will lead to a shorter QRS duration for that lead
compared to the global QRS duration.
ST segment
The ST segment has several measurements made. Figure 19 shows the J point as used
in the diagnosis of ST elevation myocardial infarction. However, measurements are also
made at equal intervals throughout the ST segment, e.g. 1/8 ST-T, 2/8 ST-T etc.
P and T waves
A search for the P wave is made in the interval preceding the QRS complex. A P wave
may not always be found in certain arrhythmias. P onset and termination are found using
a method involving second differences but the same P onset and termination is used over
all 12 leads in view of the difficulty in detecting low amplitude P waves in many leads. P
wave amplitude is determined with respect to the same baseline as for Q, R, S
amplitudes, namely the QRS onset. This was found to be more reliable than fitting a
straight line between P onset and P termination even in cases where the P wave was
superimposed on the T wave in the case of a tachycardia.
T end is determined for each lead using a template method. The global T end is derived
in a similar fashion to the global QRS offset. The other components of the ECG waveform,
namely the ST and T wave amplitudes, are also measured with respect to QRS onset.
Thus, the ST junction and the various ST amplitude measurements, such as ST 60 and
ST 80 as well as the positive and negative components of the T wave, are all measured
with respect to the QRS onset. The reason for this is that it is the most straightforward
approach to measurement.
57
Interval Measurement
With respect to intervals, the global QT interval is measured from the global QRS onset to
the global T end. On the other hand, because the P onset is taken as being simultaneous
in all 12 leads, the global PR interval measurement is from the P onset to the global QRS
onset
Normal Limits
The above methods were used to determine the normal limits of QRS waveforms from an
adult database of over 1500 normal, published in Comprehensive Electrocardiology, 1989
and a pediatric database derived from 1750 neonates, infants and children, published in
part in 1989 and 1998 and which will be published in much more detail in the next edition
of Comprehensive Electrocardiology. These normal limits are essentially an integral part
of the diagnostic software.
Proper skin preparation and electrode placement are the most important elements in
producing a high quality 12 lead ECG. The patient should be supine and relaxed when an
ECG is acquired. In preparation for acquiring the ECG:
1. Attach the electrodes to the patient as above figure 24. 12 lead Placement.
2. Attach the 12 lead cable lead wires to the electrodes on the patient.
3. Attach the 12 lead cable to the defibrillator/monitor’s front panel.
4. Turn on the manual mode of defibrillator/monitor by rotating the Mode select knob to
Manual Mode.
5. Enter patient information.
6. Check the patient’s pulse.
58
12 Lead Display
The 12 lead display allows you to see real-time 12 lead ECG data and verify signal quality
before acquiring the ECG. As shown in Figure 21, it displays patient information and
approximately 2.5 seconds of each of the 12 leads acquired. Waveforms are presented at a
rate of 25mm/s and the configured wave size. A dashed line is displayed if a lead cannot be
derived. The message (Lead-Wire) Lead Off is displayed if an electrode is not making
adequate contact with the patient.
The Patient info menu of 12 lead mode includes ID, name, age and gender. The Event ID is
displayed until you enter the patient’s ID. Age and sex are displayed once entered.
Although waveforms for monitored parameters such as ECG, SpO2, Invasive Pressures and
EtCO2 are not visible on the Preview Screen, related alarms, measurements and alarm
messages remain active and are reported in Parameter Blocks 1 and 2 and the general
status area.
59
Description of HR/PR Menu Functions
The calculated Heart Rate/Pulse Rate may be derived from different sources (ECG,
SpO2, NIBP or IBP) as shown by the icon in the HR/PR numerical area.
1
2
3
4 5 6 7
1 HR/PR icon 5 ECG size
2 HR/PR source icon 6 HR/PR value
3 Pacer pulse detection icon 7 Bell icon
4 HR/PR unit
Figure 26. HR/PR Display
60
HR/PR Source
You may select Auto, HR, 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, IBP, SpO2 or NIBP. When
HR is selected, the heart rate (HR) is measured from ECG. When PR is selected, the
pulse rate (PR) is measured from IBP, SpO2 or NIBP. The color of the HR/PR icon and
HR/PR source icon will be changed according to the current source. If the pulse rate is
derived from NIBP, the value will be displayed for only 180 minutes after the NIBP
measurement, then the value will be changed to “---”. The HR/PR tone volume can be
adjusted in the Setup menu.
Pacer Detect
Pacer detect should always be Enable for patients with pacemakers (refer to the warning
in this section). When Pacer detect is Enable, the defibrillator/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 detect should be set to
Disable to avoid misdiagnosis.
Filter Select
The defibrillator/monitor can filter ECG waveform noise with different ranges of frequency
response:
0.5 Hz to 21 Hz : Expands the range to display very low frequencies down to 0.05 Hz.
0.05 Hz to 40 Hz: Choose this mode to see just the ECG waveform monitoring.
1 Hz to 21 Hz : Generally called a filter mode, it reduces ECG waveform noise.
Note: The clause 50.102.8 Frequency and impulse response and 50.102.15 Heart rate
range, accuracy and QRS detection range of IE60601-2-27 are tested only for
Monitor(0.05Hz to 40Hz) of ECG filter.
61
This page is intentionally left blank.
62
AED MODE
WARNING: 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.
WARNING: The defibrillator/monitor should not be used on someone who is
responsive when shaken or breathing normally.
WARNING: 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 pads beyond expiration date. Check that pads adhesive
is intact and undamaged. Do not reuse disposable pads that are labeled for single
patient use.
WARNING: Do not use pediatric pads on adults or larger children. Delivery of
defibrillation energies equal to or greater than 100 joules (typically used on adults)
through these smaller pads increases the possibility of skin burns.
WARNING: Do not use paddles for AED mode. AED mode is enable only with pads.
WARNING: Disconnect non-defibrillation protected electronic devices or
equipment from patient before defibrillation.
WARNING: Do not administer a shock using the electrode monitoring cable.
WARNING: Do not place adult pads in the anterior-posterior position when
operating this defibrillator/monitor in AED mode. A shock or no shock decision
may be inappropriately advised. The shock advisory algorithm requires the
electrodes to be placed in the anterior-lateral (Lead II) position.
WARNING: In AED mode, this defibrillator is not designed or tested to interpret
pediatric rhythms or administer energy at pediatric joule settings for children
under 8 years old.
WARNING: Do not move the device during analysis. Moving the device during
analysis may affect the ECG signal resulting in an inappropriate shock or no shock
advised decision. Do not touch the patient or the device during analysis.
WARNING: The Adult pads must be used on patients over 8 years old. The
Pediatric pads must be used on patients less than 8 years old or less than 25 kg
(55lb). Do not use the AED on patient less than 1 years old.
WARNING: 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.
WARNING: 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.
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 appropriate apply the defibrillator and follow the audible instructions.
63
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 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 cardio-
pulmonary 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.
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.
64
Preparing for Defibrillation
WARNING: 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
65
Operating the AED Mode of defibrillator/monitor
WARNING: 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.
WARNING: 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 dried-out
multifunction pads.
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.
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.
Major changes in the 2010 AHA Guidelines for CPR and ECC
The BLS algorithm has been simplified, and “Look, Listen and Feel” has been removed
from the algorithm. Performance of these steps in inconsistent and time consuming.
Encourage Hands-only (compression only) CPR for the untrained lay rescuer. Hands-
Only CPR is easier to perform by those with no training and can be more readily
guided by dispatchers over the telephone.
Initiate chest compressions before giving rescue breaths. (Compression-Airway-
Breathing rather than Airway-Breathing-Chest compressions)
There is an increased focus on methods to ensure that high-quality CPR is performed.
Adequate chest compressions require that compressions be provided at the
appropriate depth and rate, allowing complete recoil of the chest after each
compression and an emphasis on minimizing any pauses in compressions and
avoiding excessive ventilation.
66
CPR Guidelines 2010
Note: “Look, listen and feel” is removed from the CPR sequence for
assessment of breathing after opening the airway in 2010
guidelines. But 2010 guideline recommends that the healthcare
provider briefly checks for breathing when checking
Look, listen and feel
responsiveness to detect signs of cardiac arrest.
YES NO
67
Using AED Mode
1. Turn on the AED Mode of defibrillator/monitor by rotating the Mode select knob.
2. Verify the AED Mode of defibrillator/monitor is activated normally and follow audio
guidance and STEP icon.
STEP 1
“Check for response.”
“Are you all right?”
“Call for help.”
If pads are connected to
defibrillator/monitor during STEP1,
defibrillator/monitor will go on to
STEP4 directly.
STEP 2
STEP 3
“Begin CPR” [Beep]
“Give two breaths.”
“Stop CPR.”
If pads are connected to
defibrillator/monitor during STEP3,
defibrillator/monitor will go on to
STEP4 directly.
STEP 4
STEP 5
Note: The Step 5 should be performed at first when the AED Mode of defibrillator/monitor is
turned on and the pads are attached correctly to the patient.
68
STEP 6
STEP 7
Note: If you hear following voice while the AED Mode of defibrillator/monitor is analyzing
you should perform the following actions:
The defibrillator/monitor will remain in CPR mode for 2 minutes or 5 cycles. After 2
minutes of CPR you will hear the following voice prompt:
“Stop CPR.”
The defibrillator/monitor in AED mode will then return to Step 4. Ensure that no-one is in
contact with the patient and proceed as before.
69
Description of AED Mode Menu Functions
Patient Info
ID, Name, Age or Gender of patients can be entered in this menu.
70
MANUAL MODE
WARNING: Make sure that the ECG signal quality is good and that sync marks are
correctly display above each QRS complex prior to performing synchronized
defibrillation (cardioversion).
WARNING: Artifact introduced by paddle movement may resemble an R-wave and
trigger a defibrillation shock. When performing synchronized defibrillation
(cardioversion).
WARNING: Disconnect non-defibrillation protected electronic devices or
equipment from patient before defibrillation.
WARNING: 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
between 15 and 250 ohm.
This section explains how to prepare for and perform asynchronous defibrillation and
synchronous defibrillation (cardioversion) using multifunction 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.
71
Preparing for Defibrillation
Using adult 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.
72
Defibrillating (async mode)
If the device and paddles are prepared for defibrillation, perform the following steps;
Note: If do not press Select Energy Level button, defibrillator/monitor has default energy
level setting. To change default setting, enter the Service Menu.
Note: Clinicians must select an appropriate energy level for defibrillation of pediatric
patients.
Note: You may increase or decrease the selected energy at any time during charging or
after charging is complete.
Note: If paddles are used, the SHOCK button on the front side does not work. Only the
SHOCK button on the paddles works.
Note: Defibrillation current can cause operator or bystander injury. Do not touch the
patient, or equipment connected to the patient, during defibrillation.
If the device 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, press the Select Energy Level
button and rotate the Multi function knob to the desired energy
level. Energy choices range from 1 to 200. (To choose higher value
than 200J, enter the Service Menu by using extra passcode)
Note: Clinicians must select an appropriate energy level for defibrillation of pediatric
patients.
73
4. To charge the energy, press the CHARGE button. If using
external paddles, the CHARGE button on the paddles may be
used instead.
Note: You may increase or decrease the selected energy at any time during charging or
after charging is complete.
5. To shock the energy, press and hold the SHOCK button which is
placed on the front side of device. If external paddles are used,
simultaneously press and hold the SHOCK button located on the
paddles. The shock will be delivered when the next R-wave is
detected.
Note: It is important to continue to hold the SHOCK button (or the paddle SHOCK
button) until the shock is delivered. The defibrillator shocks with the next detected
R-wave.
Note: Defibrillation current can cause operator or bystander injury. Do not touch the
patient, or equipment connected to the patient, during defibrillation.
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.
74
Description of Manual Mode Menu Functions
75
Level 2 Menu Level 3 Menu Level 4 Menu
Level1 Menu
or Response or Response or Response
No
Erase event records Yes
No
Erase internal memory Yes
No
Waveform 2nd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
setting V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
3rd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
4th Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
Display Mode Large numeric display
Black-yellow Invert Mode
Clinical action
list
Manual self-
test
Button test
Service menu (Display 3 digit code)
Return
Alarm Limit
▲ Upper Alarm Limit
▼ Lower Alarm Limit
Patient Info
ID Confirm
Name Confirm
Age Confirm
Gender Male
Female
Event records Data review Print
ID# ID
Name
Age
Gender
Sync
On
Off
76
12 Lead
Acquire
To acquire the 12 lead ECG data, press the Acquire soft key.
Setup
This menu allows you to set Filter and Transmission. Filter can be selected between
0.05Hz~40Hz and 0.05Hz~150Hz. To transmit the result of 12 lead ECG diagnosis,
press the Transmission soft key.
12 lead ON
This menu allows you to set 12 lead display.
Patient info
ID, Name, Age, Gender of patients or 12 lead records setting can be entered in this
menu.
Setup
Volume
The Volume options allow you to adjust the volume of Alarm, Beep and Button. Alarm
volume can be set at level 1 to 8 and Beep volume and Button volume can be set at
level 1 to 7 or Off.
1. Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button
volume.
2. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button
volume will appear.
3. Rotate the Multi function knob to select a volume level.
4. Press the Multi function knob to enter a desired volume into the defibrillator/monitor.
Printer setting
This menu allows you to set Print on alarm, Print on shock, 12 lead auto printing or
Analyze auto printing.
1. Rotate the Multifunction knob to highlight Printer on alarm, Print on shock, 12 lead auto
printing or Analyze auto printing.
2. Press the Multifunction knob. Multifunction knob toggles between On and Off.
77
Erase data
To clear Erase 12lead records, Erase event records or Erase internal memory in the
defibrillator/monitor, set Erase data to Yes
Waveform setting
The defibrillator/monitor automatically detects the attached lead. For example, lead type
is selected only Lead I, II and III when 3 leads are attached. You can select the desired
ECG lead type.
Display Mode
This menu allows the user to change a display format of Black-yellow invert mode. Large
numeric screen can only be selected in monitor mode.
Manual self-test
This menu allows the user to perform a Self-test manually. Refer to the Self test function
section.
Button test
The user can check buttons for proper functioning. It can be performed by ‘Button Test’
function in the Setup Menu.
Service Menu
Only authorized personnel are allowed to change the Service Menu settings. A 3 digit
code is required for access. Refer to the service manual for instructions.
Alarm Limit
Press the Multi function knob to select Alarm limits. The defibrillator/monitor will display
all alarm limits that are currently in effect for all monitored parameters. Select the alarm
limits to set.
78
Patient Info
More details for Data Review and ID# in Event Records Menu, please refer to Event
Section.
Sync
Press the Sync soft key to operate the sync mode.
79
This page is intentionally left blank.
80
MONITOR MODE
General
In monitor mode, you can monitor Electrocardiography (ECG) acquired a 3-. 5-, or 10-
lead ECG electrodes. Optional monitoring of functional arterial oxygen saturation (SpO2),
respiration (RESP), temperature (TEMP), invasive blood pressure (IBP), noninvasive
blood pressure (NIBP), and end tidal CO2 (EtCO2), invasive blood pressure (IBP) 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.
81
Level 2 Menu Level 3 Menu Level 4 Menu
Level1 Menu
or Response or Response or Response
ID # ID
Name
Age
Gender
Setup
Volume Alarm
Beep
Button
Printer Print on alarm On
Setting Off
Print on shock On
Off
12 lead auto printing On
Off
Erase data Erase 12 lead records Yes
No
Erase event records Yes
No
Erase internal memory Yes
No
Waveform 2nd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
setting V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
3rd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
4th Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
Display Mode Large numeric display
Black-yellow Invert Mode
Clinical action
list
Manual self-
test
Button test
Service menu (Display 3 digit code)
Return
Alarm Limit
▲ Upper Alarm Limit
82
Level 2 Menu Level 3 Menu Level 4 Menu
Level1 Menu
or Response or Response or Response
▼ Lower Alarm Limit
Patient Info
ID Confirm
Name Confirm
Age Confirm
Gender Male
Female
Event records Data review Print
ID# ID
Name
Age
Gender
12 Lead
Acquire
To acquire the 12 lead ECG data, press the Acquire soft key.
Setup
This menu allows you to set Filter and Transmission. Filter can be selected between
0.05Hz~40Hz and 0.05Hz~150Hz. To transmit the result of 12 lead ECG diagnosis,
press the Transmission soft key.
12 lead ON
This menu allows you to set 12 lead display.
Patient info
ID, Name, Age, Gender of patients or 12 lead records setting can be entered in this
menu.
Setup
Volume
The Volume options allow you to adjust the volume of Alarm, Beep and Button. Alarm
volume can be set at level 1 to 8 and Beep volume and Button volume can be set at
level 1 to 7 or Off.
1. Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button
volume.
2. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button
volume will appear.
3. Rotate the Multi function knob to select a volume level.
4. Press the Multi function knob to enter a desired volume into the defibrillator/monitor.
83
Printer setting
This menu allows you to set Print on alarm, Print on shock, 12 lead auto printing or
Analyze auto printing.
1. Rotate the Multifunction knob to highlight Printer on alarm, Print on shock, 12 lead auto
printing or Analyze auto printing.
2. Press the Multifunction knob. Multifunction knob toggles between On and Off.
Erase data
To clear Erase 12lead records, Erase event records or Erase internal memory in the
defibrillator/monitor, set Erase data to Yes
Waveform setting
The defibrillator/monitor automatically detects the attached lead. For example, lead type
is selected only Lead I, II and III when 3 leads are attached. You can select the desired
ECG lead type.
Display Mode
This menu allows the user to change a display format of Large numeric screen or Black-
yellow invert mode.
Manual self-test
This menu allows the user to perform a Self-test manually. Refer to the Self test function
section.
Button test
The user can check buttons for proper functioning. It can be performed by ‘Button Test’
function in the Setup Menu.
Service Menu
Only authorized personnel are allowed to change the Service Menu settings. A 3 digit
code is required for access. Refer to the service manual for instructions.
Alarm Limit
Press the Multi function knob to select Alarm limits. The defibrillator/monitor will display
all alarm limits that are currently in effect for all monitored parameters. Select the alarm
limits to set.
84
Patient Info
More details for Data Review and ID# in Event Records Menu, please refer to Event
Section.
85
This page is intentionally left blank.
86
PACING MODE
WARNING: Use demand mode (sync mode) pacing whenever possible. Use async
mode pacing when motion artifact or other ECG noise makes R-wave detection
unreliable.
WARNING: Observe the patient continuously while the pacemaker is in use.
Patient response to pacing therapy (for example, capture threshold) may change
over time.
WARNING: Prolonged invasive 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.
WARNING: 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 sense markers are placed on the
patient’s QRS complexes.
WARNING: 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 re-activate the pacing function.
WARNING: 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.
WARNING: Use of other ECG monitoring devices may provide misleading
information due to the presence of pace artifacts.
WARNING: Under certain conditions it may not be possible to properly
defibrillator/monitor or pace while electrosurgical apparatus is operating.
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 transition from manual mode or monitor mode to
pacing mode.
87
Demand Mode (Sync Mode) and Async Mode
The defibrillator/monitor can deliver pace pulses in either demand mode (sync mode) or
Async mode.
1. In demand mode (sync mode), the defibrillator/monitor only delivers pace pulses when
the patient’s heart rate is lower than the selected pacing rate.
2. In async mode, the defibrillator/monitor delivers pace pulses at the selected rate.
Note: Use demand mode (sync mode) pacing whenever possible. Use async 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-, 10- 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.
88
Demand Mode (Sync mode) Pacing
When the pacing mode is turned on by rotating the Mode select knob, the demand
mode (sync mode) is operated automatically.
1. When the mA button ( ) is pressed, each color of output value is changed
and the output value can be modified.
2. The informative message is displayed to change the output value.
3. Press and rotate the Multi function knob to select the desired output. The value
is changed by 2 mA.
4. When set or lower pulse rate value is detected, relevant current (mA) is delivered
to patient.
Note: The pulse rate value in bpm unit is modified between 30 bpm and 180 bpm and the
output value is modified between 0 mA and 140 mA.
Note: When pacing in demand mode (sync mode), the ECG cable must be directly
connected from the patient to the defibrillator/monitor.
Note: If you are using the pacing function with battery power and the low battery alarm is
annunciated, connect the device to external power or insert a fully charged battery.
1. When the RATE button ( ) is pressed, each color of Pulse rate value is
changed and it can be modified.
2. The informative message is displayed to change the Pulse rate value.
3. Press and rotate the Multi function knob to select the desired number of pace
pulse per minute. The value is changed by 2 bpm.
4. When the mA button ( ) is pressed, each color of output value is changed
and the output value can be modified.
5. The informative message is displayed to change the output value.
6. Press and rotate the Multi function knob to select the desired output. The value
is changed by 2 mA.
7. The set current value is delivered continuously.
Note: To pause pacing, press Pause Pacing soft key and to resume pacing, press
Pause Pacing soft key again.
89
Description of Pacing Mode Menu Functions
90
Level 2 Menu Level 3 Menu Level 4 Menu
Level1 Menu
or Response or Response or Response
SpO2 waveform
Respiration waveform
IBP1 waveform
IBP2 waveform
EtCO2 waveform
4th Waveform ECG waveform I, II, III, aVL, aVF, aVR, V1, V2,
V3, V4, V5, V6, Pads
SpO2 waveform
Respiration waveform
IBP1 waveform
IBP2 waveform
EtCO2 waveform
Display Mode Black-yellow Invert Mode
Clinical action
list
Manual self-test
Button test
Service menu (Display 3 digit code)
Return
Alarm Limit
▲ Upper Alarm Limit
▼ Lower Alarm Limit
Patient Info
ID Confirm
Name Confirm
Age Confirm
Gender Male
Female
Event records Data review Print
ID# ID
Name
Age
Gender
Async
On
Off
Pause Pacing
When the Pause Pacing soft key is pressed, if pacing is operating, pacing will be
paused, if pacing is not operating, pacing will be resumed.
Setup
91
Volume
The Volume options allow you to adjust the volume of Alarm, Beep and Button. Alarm
volume can be set at level 1 to 8 and Beep volume and Button volume can be set at
level 1 to 7 or OFF.
1. Rotate the Multifunction knob to highlight Alarm volume, Beep volume or Button volume.
2. Press the Multifunction knob. Levels of Alarm volume, Beep volume or Button volume
will appear.
3. Rotate the Multi function knob to select a volume level.
4. Press the Multi function knob to enter a desired volume into the defibrillator/monitor.
Printer setting
This menu allows you to set Print on alarm, Print on shock, 12 lead auto printing or
Analyze auto printing.
1. Rotate the Multi function knob to highlight Printer on alarm, Print on shock, 12 lead auto
printing or Analyze auto printing.
2. Press the Multi function knob. Multi function knob toggles between On and Off.
Erase data
To clear Erase 12lead records, Erase event records or Erase internal memory in the
defibrillator/monitor, set Erase data to Yes.
Waveform setting
The defibrillator/monitor automatically detects the attached lead. For example, lead type
is selected only Lead I, II and III when 3 leads are attached. You can select the desired
ECG lead type.
Display Mode
This menu allows the user to change a display format of Black-yellow invert mode. Large
numeric screen can only be selected in monitor mode.
Manual Self-test
This menu allows the user to perform a Self-test manually. Refer to the Self test function
section.
Button Test
The user can check buttons for proper functioning. It can be performed by ‘Button Test’
function in the Setup Menu.
Service Menu
Only authorized personnel are allowed to change the Service Menu settings. A 3 digit
code is required for access. Refer to the service manual for instructions.
92
Alarm Limit
Patient Info
ID, Name, Age or Gender of patients can be entered in this menu.
More details for Data Review and ID# in Event Records Menu, please refer to Event
Section.
Async
Press the Async soft key to operate the Async mode pacing.
93
This page is intentionally left blank.
94
NIBP MONITORING
WARNING: 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.
WARNING: Inaccurate measurements may be caused by incorrect cuff application
or use. This can include placing the cuff too loosely on the patient, using the
incorrect cuff size, or not placing the cuff at the same level as the heart, leaky cuff
or hose or excessive patient motion.
WARNING: In some cases, rapid, prolonged cycling of an oscillometric,
noninvasive blood pressure defibrillator/monitor cuff has been associated with
any or all of the following: ischemia, purpura, or neuropathy. Periodically observe
the patient’s limb to make sure that the circulation is not impaired for a prolonged
period of time. Also make sure the cuff is placed according to directions in this
manual and the cuff directions for use.
WARNING: Do not place the cuff, the catheter or SpO2 sensor on an extremity
being used for intravenous infusion or any area where circulation is compromised
or has the potential to be compromised.
WARNING: As with all automatically inflatable blood pressure devices, continual
cuff measurements can cause injury to the patient being monitored. Weigh the
advantages of frequent measurement and/or use of CONT mode against the risk of
injury.
WARNING: Ensure the patient is quiet with minimal movement during NIBP
readings; minimize the patient’s shivering.
WARNING: Never place the cuff on an extremity being used for intravenous
infusion or any area where circulation is compromised or has the potential to be
compromised. Never fit NIBP system with Luer Lock adapters.
WARNING: Never use an adult monitor setting or cuff for an NIBP measurement
on a neonatal patient. Adult inflation limits can be excessive for neonatal patients,
even if a neonatal cuff is used.
WARNING: 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.
WARNING: Noninvasive pacing may cause patient skin irritation and burns,
especially with higher pacing current levels. Inspect underlying skin of the
electrode frequently after 30 minutes of continuous pacing. Discontinue pacing if
skin burn develops and another method of pacing is available. On cessation of
pacing, immediately remove or replace electrodes with new ones.
WARNING: Do not place the cuff over a wound as this could cause further injury
when pressuriesed.
WARNING: Application of the cuff to any limb where intravascular access or
therapy or an arterio-venous (A-V) shunt is present could result in injury due to
the temporary interference of blood flow during pressurization.
WARNING: The application of the cuff to the arm on the same side as a
mastectomy should be avoided.
95
CAUTION: Do not apply the blood pressure cuff to the same extremity as the one
to which the SpO2 sensor is attached. Cuff inflation can disrupt SpO2 monitoring
and lead to nuisance alarms.
CAUTION: Make sure that heavy objects are not placed on the cuff hose. Avoid
crimping or undue bending, twisting, or entanglement of the hose.
CAUTION: 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.
Note: Blood pressure measurements can be affected by the position of the patient, the
patient’s physiological condition and other factors.
96
General
The defibrillator/monitor performs Non-Invasive Blood Pressure measurements using the
oscillometric measuring technique. A motorized pump inflates the cuff to initially blocking
the flow of blood in the extremity. Then, under defibrillator/monitor control, the pressure
in the cuff is gradually reduced, while a pressure transducer detects air pressure and
transmits a signal to the NIBP circuitry.
When the cuff pressure is still above systolic pressure, small pulses or oscillations in the
cuff pressure begin to be sensed by the transducer. As the cuff continues to deflate,
oscillation amplitude increases to a maximum and then decreases. When maximum
oscillation amplitude occurs, the cuff pressure at that time is measured as mean arterial
pressure (MAP). The systolic and diastolic pressures are calculated based on analysis of
the oscillation amplitude profile.
Oscillometric Method
The blood pressure values are determined by measuring the small oscillations (changes)
in the cuff pressure caused by the heart’s contractions as the pressure in the cuff is
released. Mediana’s measurement technology utilizes a unique deflation technique,
Dynamic Linear Deflation. This cuff deflation technique allows the Mediana monitor to
measure each small change in the cuff pressure oscillations that directly correspond to
the measurement’s systolic, mean and diastolic blood pressure values.
The cuff is first increased in pressure until it reaches a pressure above arterial occlusion.
As the cuff starts to deflate, the pulse rate of the patient is determined and the deflation
speed of the cuff is modified to create a patient specific deflation speed. As the pressure
decreases, small cuff pressure oscillations are recorded that correspond to the applied
pressure of the blood under the
cuff as the heart contracts. These
oscillations increase in strength
as the cuff pressure approaches
the systolic blood pressure value.
A sudden increase in oscillation
amplitude indicates that the
patient’s systolic blood pressure
is now able to push blood
completely through beneath the
cuff. The oscillation amplitude
continues to increase as the
pressure in the cuff is decreases
until the mean blood pressure
value is reached. The oscillation
strength then starts to diminish
and finally drop off as the diastolic
blood pressure value is reached.
The oscillometric method does not determine an instantaneous blood pressure reading
like the auscultatory method employing a microphone-type auto blood pressure
defibrillator/monitor but, as described above, determines blood pressure from an
uninterrupted changing curve, which means that the oscillometric method is not easily
effected by external noise and electrosurgical instruments.
97
Setup Connections
1. Measure the patient’s limb and select a proper size cuff. As a general rule, cuff width
should span approximately two-thirds of the distance between the patient’s elbow and
shoulder.
2. Connect the cuff hose to the connector on the defibrillator/monitor’s side option case
and turn to right to lock (see Figure 2).
3. Connect a cuff to the cuff hose and turn the connector
to right to lock the hoses together. Firm connection
must be made.
4. Patient should be seated with back comfortably and arms supported.
5. Patient should have their legs uncrossed, feet flat on the floor with their back and arms
supported.
6. Wrap the cuff around a hare arm or around an arm covered in thin clothing. Thick
clothing or a rolled up sleeve will cause a major discrepancy in the blood pressure
reading.
7. Wrap the cuff around the patient’s arm so that the
center of the cuff’s rubber bladder sits on the artery of
the upper arm. The hose should be brought out from
the peripheral side without bending (The Brachial
artery is located on the inside of the patient’s upper
arm.) At this time, check that the index line on the
edge of the cuff sits inside the range. Use a different
sized cuff if the index line is outside of the range
because this will cause a major discrepancy in blood
pressure reading.
CAUTION: The adult cuff should be wrapped around the arm tightly enough so that
only two fingers can be inserted under it, above and below the cuff.
CAUTION: Refrain from talking during the measurement procedure, and at least 5
minutes should elapse before the first reading is taken.
8. Maintain the height of the cuff-wrapped upper arm artery to that of the heart’s right
ventricle during measurement.
9. Follow the cuff directions for use when applying the cuff to the arm.
Note: Obtaining NIBP readings can be more difficult in patients with arrhythmias. These
arrhythmias increase the beat-to-beat pressure fluctuations, which increases the
variability of the NIBP readings. Temporarily verify pressure using another method
if it becomes difficult to obtain readings in the presence of arrhythmias.
98
Description of NIBP Menu Functions
2 3 4 5
6 7 8 9 10
Note: Initial Inflate Pressures shown above are for Adult patient mode. In order to set
alarm limits to Neonatal mode, change Patient type via the Setup Menu.
Note: The NIBP unit can only be changed by authorized personnel via the Service Menu.
99
Inflate Pressure
The inflating pressure can be set from 120 to 280 mmHg for adult and pediatric, or from
80 to 140 mmHg for neonatal.
Auto Interval
The NIBP measurement interval can be selected as Off, 1, 2.5, 3, 5, 10, 15, 30, 60 or 90
min. The measurement time will be integral multiple of the selected interval starting from 0
minute.
Patient Type
The patient type can be selected as Adult/Pedi or Neonatal.
100
SpO2 MONITORING
WARNING: For best product performance and measurement accuracy, use only
accessories manufactured by Nellcor® or supplied by Mediana. Use accessories
according to the manufacturer’s directions for use and your facility’s standards.
WARNING: 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.
WARNING: 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.
WARNING: 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
WARNING: Do not attach any cable to the sensor port connector that is intended for
computer use.
WARNING: 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.
WARNING: 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.
WARNING: 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.
WARNING: Do not rely solely on SpO2 reading: assess the patient at all times. SpO2
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), or in the presence of
excessive motion.
WARNING: Failure to apply the sensor properly may reduce the accuracy of the
SpO2 measurement.
101
WARNING: 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.
WARNING: 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.
WARNING: 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.
WARNING: 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.
WARNING: Carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
WARNING: 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.
CAUTION: 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.
CAUTION: 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.
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 SpO2
sensor, excessive ambient light can interfere with this measurement. SpO2 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.
102
Measured versus Calculated Saturation
When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the
calculated value may differ from the SpO2 measurement of the defibrillator/monitor. This
usually occurs because the calculated saturation was not appropriately corrected for the
effects of variables that shift the relationship between PO2 and pH, temperature, the
partial pressure of carbon dioxide (PCO2), 2, 3-DPG, and fetal hemoglobin.
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 29, or contact Nellcor® or Mediana sales department for ordering information.
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.
103
Description of SpO2 Menu Functions
2 3
4
104
RESPIRATION MONITORING
WARNING: 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.
WARNINGS: The defibrillator/monitor does not detect apnea when the respiration
signal is measured by trans-thoracic impedance.
WARNING: 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.
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).
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 14.)
Refer to the Capnography Monitoring section to detect the respiration signal by the
airway adapter in case that the CO2 equipped.
Note: Impedance respiration monitoring is active only if the paddles are not connected to
the unit or if pads are not connected to pads cable. In case pads or paddles are
connected, the respiration rate shows --.
105
Description of Respiration Menu Functions
1
4
2
3
5
1 Respiration rate icon 4 Respiration icon
2 Respiration rate source icon 5 Measurement Value
3 Bell icon
Figure 50. Respiration Display
Respiration
When respiration is set to On, The measurement value for respiration rate and respiration
waveform are displayed on the screen. And when the respiration is set to Off, respiration
rate is not measured and respiration value is displayed with “---”. Respiration rate icon is
only displayed when the respiration is set to On.
106
RR Source
User can select either Airway or Impedance for source of the respiration rate. If the Auto
is selected, the defibrillator/monitor will automatically drive the respiration rate from one
of the monitoring parameters in this order of priority; Airway and Impedance.
Note: You can select Airway as the source when CO2 module is installed.
Size
Size allows you to adjust the waveform size. Size can be selected as X 0.5, X 1, X 1.5 or
X 2.0.
When the defibrillator/monitor does not detect a respiration signal from the impedance
measurement for 40 seconds, the defibrillator/monitor will activate a loss of respiration
alarm.
Check the condition of the patient, then check the connections of the patient cables.
107
This page is intentionally left blank.
108
CAPNOGRAPHY MONITORING
WARNING: For best product performance and measurement accuracy, use only
accessories supplied or recommended by Mediana. Use accessories according
to your facility’s standards and the manufacturer’s recommendation. Always
refer to the manufacturer’s Directions for Use for instruction about operation,
cleaning, and replacement.
WARNING: The EtCO2 readings do not always correlate closely with blood gas
values, especially in patients with pulmonary disease, pulmonary embolism or
inappropriate ventilation.
WARNING: If uncertain about the accuracy of any measurement, first check the
patient’s vital signs by alternate means, and then make sure the
defibrillator/monitor is functioning correctly.
WARNING: The defibrillator/monitor should not be used as an apnea monitor.
WARNING: To ensure patient safety, do not place the defibrillator/monitor in
any position that might cause it to fall on the patient.
WARNING: To ensure accurate performance and prevent device failure, do not
expose the defibrillator/monitor to extreme moisture, such as rain.
WARNING: The use of accessories, transducers, sensors and cables other than
those specified may result in increased emission and/or decreased immunity of
the equipment and/or system.
WARNING: CO2 readings and respiratory rate can be affected by sensor
application errors, certain ambient environmental conditions, and certain
patient conditions.
WARNING: The defibrillator/monitor is a prescription device and is to be
operated by qualified healthcare personnel only.
WARNING: Ensure that the components of the airway are secure. If they
become loose, external air may be sucked in the tube and the sampling gas will
be diluted, causing incorrect measurement values.
WARNING: Ensure that selection of a volatile anesthetic is done carefully. If an
improper selection is made, the measurement values may be incorrect.
WARNING: Do not use accessories other than which are specified. Different
sampling tube lengths or inside diameters may have an effect on the
measurement.
WARNING: The mainstream/sidestream capnography module should not be
used in the presence of flammable anesthetics or other flammable gases. Use
of this device in such an environment may present an explosion hazard.
WARNING: Do not use device without rectifying a gas calibration failure, as
correct measurement readings will not be obtained.
WARNING: Do not use device on patients that cannot tolerate the withdrawal of
50 cc/min ±10cc /min from airway.
109
CAUTION: If the patient’s airway is configured with a closed suctioning system,
make sure the airway adapter is placed closed to the suctioning system (on the
ventilator side). This will help ensure that the sampling adapter is not impaired
during and after suctioning.
CAUTION: The disposable airway adapter, nasal and nasal/oral sampling cannulas,
and the airway adapter kit are intended for single patient use. Do not reuse or
sterilize these disposable adapters, because system performance will be
compromised.
CAUTION: Do not insert any object other than the sidestream sample cell into the
inlet port of the CO2 module.
CAUTION: Inspect the mainstream CO2 sensor and airway adapter connection to
ensure correct positioning.
CAUTION: Position sidestream airway adapter with the tubing in an upright position.
This help keep patient secretions from pooling into the tubing.
CAUTION: To prevent moisture from during into the mainstream airway or into the
sidestream airway adapter tubing, do not place the adapter in a gravity dependent
position.
General
The defibrillator/monitor capnography option supports mainstream and sidestream gas
analysis designed to measure the concentration of carbon dioxide in a gas mixture and to
aid in determining the patient’s ventilatory, circulatory, and metabolic status. Mainstream
(nondiverting) and sidestream (diverting) capnography are highly accurate methods of
measuring respiratory gas values. When monitoring capnography, the defibrillator/monitor
automatically compensates for the ambient barometric pressure to ensure accurate
readings.
Setup Connections
The defibrillator/monitor has one capnography sensor receptacle which may be used for a
mainstream capnography sensor or a sidestream capnography sensor.
Note: Capnograpy is not analyzed during unit warm-up however, the capnography does
display to indicate that the monitor is working properly.
Note: The typical initial warm-up period can take up to two minutes. This time varies
based of the temperature of the sensor at the start of the initial warm-up.
Note: The airway adapter may require cleaning or replacement if the capnograph is used
on patients that emit excessive mucous.
110
Calibrating the CO2 Sensor
You must calibrate the CO2 sensor the first time it is connected to the defibrillator/monitor,
when the CO2 sensor is changed. You do not need to calibrate the sensor when you
power on the monitor. Once calibrated, the sensor may be disconnected and
reconnected without calibration.
Note: To maintain optimum performance of the sensor and capnograph, you should
perform a sensor calibration verification at least once a week.
Mainstream Operation
Mainstream monitoring uses an external, self-calibrating CO2 sensor to ensure continuous
monitoring without interruption of connection. Reusable, lightweight, or single-use airway
adapters are available for both adult and neonatal (low dead space) patients. Respiration
can be monitored via an airway adapter and endotracheal or tracheostomy tube using the
mainstream function of the module.
The external capnography device includes a small, lightweight sensor that continuously
measures the end-tidal and minimum carbon dioxide levels in the patient’s airway. The
sensor head contains a small infrared transducer that accurately measures the CO2 in the
airway. The sensor is connected to the airway by a disposable or reusable airway adapter.
These adapters are available in adult and neonatal size.
1 Y-piece 4 Elbow
2 Airway adapter 5 Mainstream CO2 sensor
3 Patient connector (Adult/Pedi)
111
Sidestream Operation
Sidestream monitoring uses an external, sidestream sensor that plug into the
capnography port on the monitor. Adult, pediatric, or infant sampling lines are then
plugged into the sensor receptacle. Respiration can be monitored for intubated or non-
intubated patients via an airway adapter, nasal cannula, or nasal/oral cannula using the
sidestream function of the module. Sidestream monitoring diverts patient gases at a rate
of 50 ml/min (±10ml/min).
The sidestream sampling lime consists of a sample cell on one end that into the
sidestream sensor receptacle on the monitor. The other end of sampling line is connected
to the patient either via a cannula or a sample-T, as shown in Figure 54.
1 Cannula 3 Sampling-T
2 Sampling cell 4 Sidestream CO2 sensor
112
Description of EtCO2 Menu Functions
5
1
6
2
7
3
4
1 EtCO2 icon 5 EtCO2 unit
2 EtCO2 value 6 Bell icon
3 InCO2 icon 7 InCO2 unit
4 InCO2 value
Figure 55. EtCO2 Display
Note: The EtCO2 unit can only be changed by authorized personnel via the Service Menu.
113
EtCO2
When the capno measurement is On, EtCO2, InCO2 and capno waveform measurement
are activated.
EtCO2 Setting
O2 Gas
As the N2 in the sample gas is replaced by O2, the effect is a decrease in IR absorption.
This results in a lower than actual measured CO2 value (CO2 measured).
It is recommended O2 Gas is set to On to correct for the O2 effect when the O2
concentration is greater than 50%. At O2 levels equal to or less than 50%, the correction
should not be used.
N2O Gas
As the N2O in the sample gas, an assumption is made: if N2O is administered to the
patient, then the remaining balance of the administered mixture is O2. The combined
effect of these gases is two-fold: O2 presence decreases IR absorption, and N2O
presence increases absorption. Though N2O does not directly absorb the filtered IR
energy, it cause the CO2 molecule to absorb and pass along some of it energy to the
N2O molecule of similar molecular weight. By passing off some of this energy, the CO2
molecule is free to absorb even more energy which leads to an increase in absorption.
Since the increased absorption effect due to N2O presence is greater than the decrease
due to O2 presence, an optimal administered mixture of 25% N2O and 75% O2 effectively
cancels the combined effect. The effect of desflurane on the CO2 measurement is similar
to the effect of N2O. It is recommended N2O Gas is set to On when N2O or desflurane
concentrations is above 12%.
Calibration
When the calibration is set to Enter, the EtCO2 calibration will be performed
automatically.
Scale
The user can select the scale of capno waveform. When Auto is selected, the monitor
will automatically set the scale upon the measurement value.
114
TEMPERATURE MONITORING
WARNING: For best product performance and measurement accuracy, use only
YSI 400 and 700 series temperature probes recommended by Mediana. Use
accessories according to the manufacturer’s directions for use and your facility’s
standards.
General
Measurement of patient temperature is accomplished by processing the signal from a
probe containing a resistance element whose impedance is temperature dependent.
These devices are called thermistors. The measuring time required to obtain accurate
readings at the specific body site is about 10 seconds.
Setup Connections
The defibrillator/monitor is designed to accept signals from the temperature probes, YSI
400 series and 700 series for skin, rectal or etc.
115
▲ Temperature1 Upper Limit Adjust
▼ Temperature1 Lower Limit Adjust
▲ Temperature2 Upper Limit Adjust
▼ Temperature2 Lower Limit Adjust
(Limit Alarm Pause) On, Off
Return
Note: The temperature unit can only be changed by authorized personnel via the
Service Menu.
116
IBP MONITORING
CAUTION: 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.
CAUTION: Verify the IBP zero (per hospital procedures) and alarm at least once
daily and whenever the patient’s position changes to ensure that IBP
measurements are accurate.
117
General
The invasive blood pressure measurement measures the systolic pressure, mean
pressure, diastolic pressure and pulse rate for up to 2 blood pressure line channels using
blood pressure transducers, and displays the blood pressure waveform.
Setup Connections
1. Connect the interface cable for the transducer to the IBP connector (6pin, red round
connector) on the defibrillator/monitor’s side option case. An interface cable for the
transducer has to be selected correctly as it depends on the each transducer type.
2. Set up the patient circuit according to the directions for use of the transducer,
monitoring kit and IV set.
118
Description of IBP 1 Menu Functions
1 4
5
2
3 6
Zero Setting
When Zero Setting is set to Enter, IBP 1 channel is calibrated.
119
Scale
The user-selectable pressure waveform scale allows you to adjust the scale of a pressure
waveform. The scale can be selected as 0 to 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg,
0 ~ 300mmHg or Auto.
Label
The label can be selected as P1 or ABP.
120
Description of IBP 2 Menu Functions
1 4
2
5
3 6
121
Zero Setting
When Zero Setting is set to Enter, IBP 2 channel is calibrated.
Scale
The user-selectable pressure waveform scale allows you to adjust the scale of a pressure
waveform. The scale can be selected as 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~
300mmHg or Auto. When the Auto is selected, the defibrillator/monitor automatically set
the scale upon the IBP measurement value.
Label
The label can be selected as P2, CVP, PAP or LAP.
122
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.
Manual Self-test
If the user wants to perform a Self-test manually, High-voltage module operational test,
Body impedance test, ECG circuit and algorithm test, internal shock test, internal pacing
output test, pads/paddle connection test, system ROM test, system RAM test, battery
test, real time clock test and installed module alive test, it can be performed by ‘Manual
Self-test’ function in Setup Menu.
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 Self-
test 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 Menu.
Button test
Also defibrillator/monitor has a Button Test function. The user can check buttons for
proper functioning by pressing the button in person. It can be performed by ‘Button Test’
function in the Setup Menu.
123
Figure 67. Auto Self-test display
124
Table 37. Self-test functions
No. Test Description
1 High-Voltage module To check if the High-Voltage module is operational and
operational test available to communicate.
2 Body Impedance test To check impedance of internal fixed resistance from 25Ω
to 175Ω
3 ECG circuit and To check the result of diagnosis for normal sinus rhythm
algorithm test and Ventricular Fibrillation for ECG input.
4 Internal Shock test To check the energy accuracy for discharge of set energy
to internal discharge resistance.
5 Internal Pacing output To check the normal condition of pacing output of fixed
test value of current and bmp.
6 Pads/Paddle To check if paddles or pads are connected correctly.
connection test
7 System ROM test To check if the internal program is normal.
8 System RAM test To check if the Read/Write performance of RAM is
normal.
9 Battery test To check the status of the battery.
10 Real time clock test To check the accuracy of the time.
11 Installed module alive To check if installed measurement parameter modules
test are operational and working correctly.
125
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.
Button test
The defibrillator/monitor has the button test function. User can check buttons that are
working correctly. It can be performed by ‘Button Test’ function in Setup Menu.
Button test is to check button is working correctly by pressing the denotative buttons.
Button test can be divided into two types, Front panel and paddles. ‘Shock’, ‘Charge’,
‘Analyze’, ‘Energy Select’, ‘BPM’, and ‘mA’ buttons can be checked on the front panel,
and ‘Shock’, ‘Charge’, ‘Energy Up’, ‘Energy Down’, and ‘Recording’ buttons can be
checked on the paddles.
126
EVENT
General
Trend data in either graphical or tabular format may be displayed on 3rd and 4th waveform
display area.
The event data is stored in memory. When the defibrillator/monitor turns on and starts to
measure vital signs, the defibrillator/monitor saves data of elapsed time before and after
10 seconds from the point of event generation. The events are including Defibrillation,
Pacer mode, Heart rate alarm, and VF alarm. Also, the defibrillator/monitor saves all NIBP
measurements events. The data remains even if the defibrillator/monitor is powered off.
After the defibrillator/monitor has stored 250 trend data, “SYSTEM : Not enough memory”
message or “SYSTEM : Not enough memory(Internal memory)” message is displayed on
the screen.
127
Event Review Display
Event information in graphical format for ECG data is displayed in a graph. The
defibrillator/monitor displays the event information through recent 10sec after and before
event occurred. When printing the event information, all the parameters like ECG, SpO2,
NIBP, Temp, EtCO2, IBP and Respiration are printed.
The event review display of each parameter is indicated by the symbols specified in table.
The vertical range of a graphical trend is presented with fixed value, and the horizontal
range is 20 seconds. The newest data appears at the right of graphical trend. Use the
scroll function to view more data.
128
12 Lead Record Display
The 12 lead data is displayed in tabular format as shown in Figure 70. Patient ID, name,
age, gender and time are displayed. The newest data appears at the top of tabular trends.
To scroll the event data list, rotate the Multi function knob when the 12 lead data list is
displayed.
ID#
To display ID Menu, press the ID soft key on the lower side of Event records. ID Menu is
displayed equal to Patient Info menu. Refer to Figure .
129
This page is intentionally left blank.
130
MENU STRUCTURE
131
- - - Return
- - Erase data
- - - Erase 12lead records
- - - - Yes
- - - - No
- - - Erase event records
- - - - Yes
- - - - No
- - - Erase internal memory
- - - - Yes
- - - - No
- - - Return
- - Waveform setting
- - - 2nd Waveform
- - - - ECG
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 3rd Waveform
- - - - ECG
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 4th Waveform
- - - - ECG
- - - - - l
- - - - - ll
132
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - Return
- - Display Mode
- - - Large Numeric Display
- - - Black-yellow Invert Mode
- - - Return
- - Clinical action list
- - Manual self-test
- - Button test
- - Service Menu
- - - Display 3 digit code
- - - Return
- Alarm Limit “Alarm limits adjustment/Limit Alarm Pause for each parameters”
133
- - - Male
- - - Female
- - Event records
- - - Data review
- - - - Print
- - - - Return
- - - ID#
- - - - ID
- - - - Name
- - - - Age
- - - - Gender
- - - - Return
- - - Return
- - Return
- Sync
- - On
- - Off
- - Return
134
AED MODE MENU
- Patient Info
- - ID
- - - Confirm
- - - Return
- - Name
- - - Confirm
- - - Return
- - Age
- - - Confirm
- - - Return
- - Gender
- - - Male
- - - Female
- - Event records
- - - Data review
- - - - Print
- - - - Return
- - - ID#
- - - - ID
- - - - Name
- - - - Age
- - - - Gender
- - - - Return
- - - Return
- - Return
135
PACING MODE MENU
- Pause Pacing
- Setup
- - Volume
- - - Alarm
- - - Beep
- - - Button
- - - Return
- - Printer setting
- - - Print on alarm
- - - - On
- - - - Off
- - - Print on shock
- - - - On
- - - - Off
- - - 12 lead auto printing
- - - - On
- - - - Off
- - - Analyze auto printing
- - - - On
- - - - Off
- - - Return
- - Erase data
- - - Erase 12lead records
- - - - Yes
- - - - No
- - - Erase event records
- - - - Yes
- - - - No
- - - Erase internal memory
- - - - Yes
- - - - No
- - - Return
- - Waveform setting
- - - 2nd Waveform
- - - - ECG
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 3rd Waveform
- - - - ECG
136
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 4th Waveform
- - - - ECG
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - Return
- - Clinical action list
- - Display Mode
- - - Large Numeric Display
- - - Black-yellow Invert Mode
- - - Return
- - Manual self-test
- - Button test
- - Service Menu
- - - Display 3 digit code
- - - Return
- - Return
- Alarm Limit “Alarm limits adjustment/Limit Alarm Pause for each parameters”
137
- -
Off Off Off Off Off Off Off
NIBP P1 CVP
SYS MAP DIA SYS MEAN DIA SYS MEAN DIA
160 110 90 120 90 70 120 90 70
90 60 50 70 50 40 70 50 40
- -
On On On On On On On On On
- -
Off Off Off Off Off Off Off Off Off
- - Return
- Patient Info
- - ID
- - - Confirm
- - - Return
- - Name
- - - Confirm
- - - Return
- - Age
- - - Confirm
- - - Return
- - Gender
- - - F
- - - M
- - Event records
- - - Data review
- - - - Print
- - - - Return
- - - ID#
- - - - ID
- - - - Name
- - - - Age
- - - - Gender
- - - - Confirm
- - - - Return
- - - Return
- - Return
- ASync
- - On
- - Off
- - Return
138
MANUAL MODE MENU
- 12 lead
- - Acquire
- - Setup
- - - Filter
- - - - 0.05Hz ~ 40Hz
- - - - 0.05Hz ~ 150Hz
- - - - Return
- - - Transmission
- - - Return
- - 12 lead ON
- - - On
- - - Off
- - Patient info
- - - ID
- - - - Confirm
- - - - Return
- - - Name
- - - - Confirm
- - - - Return
- - - Age
- - - - Confirm
- - - - Return
- - - Gender
- - - - Male
- - - - Female
- - - - Return
- - - 12 lead records
- - - - Print
- - - - Transmission
- - - - ID #
- - - - Return
- - Return
- Setup
- - Volume
- - - Alarm
- - - Beep
- - - Button
- - - Return
- - Printer setting
- - - Print on alarm
- - - - On
- - - - Off
- - - Print on shock
- - - - On
- - - - Off
- - - 12 lead auto printing
- - - - On
- - - - Off
- - - Analyze auto printing
- - - - On
- - - - Off
- - - Return
- - Erase data
- - - Erase 12lead records
139
- - - - Yes
- - - - No
- - - Erase event records
- - - - Yes
- - - - No
- - - Erase internal memory
- - - - Yes
- - - - No
- - - Return
- - Waveform setting
- - - 2nd Waveform
- - - - ECG
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 3rd Waveform
- - - - ECG
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 4th Waveform
- - - - ECG
- - - - - l
- - - - - ll
- - - - - lll
- - - - - aVL
- - - - - aVF
140
- - - - - aVR
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - - Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - Return
- - Display Mode
- - - Large Numeric Display
- - - Black-yellow Invert Mode
- - - Return
- - Clinical action list
- - Manual self-test
- - Button test
- - Service Menu
- - - Display 3 digit code
- - - Return
- Alarm Limit “Alarm limits adjustment/Limit Alarm Pause for each parameters”
141
- - - Data review
- - - - Print
- - - - Return
- - - ID#
- - - - ID
- - - - Name
- - - - Age
- - - - Gender
- - - - Return
- - - Return
- - Return
142
MONITORING PARAMETER (It is applied to 4 modes equally)
HR/PR MENU
- HR/PR Source
- - Auto
- - HR
- - PR
- - Return
- Pacer Detect
- - Enable
- - Disable
- - Return
- Filter Select
- - 0.5Hz ~ 21Hz
- - 0.5Hz ~ 40Hz
- - 1Hz ~ 21Hz
- - Return
- Alarm Limit
“Alarm limit”
- HR/PR
120
50
“Limit Alarm Pause”
-
On
-
Off
- Return
SpO2 MENU
- Alarm Limit
“Alarm limit (%)”
- %SpO2
100
90
“Limit Alarm Pause”
-
On
-
Off
- Return
143
NIBP MENU
- Inflate Pressure
- - “Adult/Pediatric”
- - 120 mmHg
- - 140 mmHg
- - 160 mmHg
- - 180 mmHg
- - 200 mmHg
- - 220 mmHg
- - 240 mmHg
- - 260 mmHg
- - 280 mmHg
- - Return
- - “Neonatal”
- - 80 mmHg
- - 100 mmHg
- - 120 mmHg
- - 140 mmHg
- - Return
- Auto Interval
- - Off
- - 1 min
- - 2.5 min
- - 3 min
- - 5 min
- - 10 min
- - 15 min
- - 20 min
- - 30 min
- - 60 min
- - 90 min
- - Return
- Patient Type
- - Adult / Pedi
- - Neonatal
- - Return
- Alarm Limit
“Alarm limit (mmHg)”
- SYS MAP DIA
160 110 90
90 60 50
“Limit Alarm Pause”
-
On
-
Off
- Return
144
IBP1 MENU
- Zero Setting
- - Enter
- - Return
- Scale
- - 0~50mmHg
- - 0~100mmHg
- - 0~200mmHg
- - 0~300mmHg
- - Auto
- - Return
- Label
- - P1
- - ABP
- - Return
- Alarm Limit
“Alarm limit (mmHg)”
- SYS MEAN DIA
120 90 70
70 50 40
“Limit Alarm Pause”
-
On
-
Off
- Return
IBP2 MENU
- Zero Setting
- - Enter
- - Return
- Scale
- - 0~50mmHg
- - 0~100mmHg
- - 0~200mmHg
- - 0~300mmHg
- - Auto
- - Return
- Label
- - P2
- - CVP
- - PAP
- - LAP
- - Return
- Alarm Limit
“Alarm limit (mmHg)”
- SYS MEAN DIA
120 90 70
70 50 40
“Limit Alarm Pause”
-
On
-
Off
- Return
145
EtCO2 MENU
- EtCO2
- - On
- - Off
- - Return
- Average
- - 1 breaths
- - 10 seconds
- - 20 seconds
- - 30 seconds
- - Return
- Alarm Limit
“Alarm limit”
- EtCO2 InCO2
80 20
0 0
“Limit Alarm Pause”
-
On
-
Off
- Return
146
RESPIRATION MENU
- Respiration
- - On
- - Off
- - Return
- Respiration Setting
- - PR Source
- - - Auto
- - - Impedance
- - - Airway
- - - Return
- - Size
- - - X 0.5
- - - X1
- - - X 1.5
- - - X2
- - - Return
- - Return
- Apnea time setting
- - Off
- - 10 seconds
- - 20 seconds
- - 30 seconds
- - 40 seconds
- - 50 seconds
- - 60 seconds
- Alarm Limit
“Alarm limit”
- RESP
30
8
“Limit Alarm Pause”
-
On
-
Off
- Return
TEMPERATURE MENU
- Alarm Limit
“Alarm limit (ºC)”
T1 T2
39.0 39.0
36.0 36.0
“Limit Alarm Pause”
-
On On
-
Off Off
- Return
147
DATE TIME MENU
- Date Format
- - YY/MM/DD
- - MM/DD/YY
- - DD/MM/YY
- - Return
- Set Date
- - Year
- - Month
- - Day
- - Return
- Set Time
- - Hour
- - Minute
- - Second
- - Return
- Return
148
PRINTING
General
The defibrillator/monitor prints real-time graphical and numeric information after that event
in accordance with current mode until Print soft key is pressed. Printing may be set in
two ways:
1. When the print is displayed on the screen, select the Print soft key.
2. To start printing, press the PRINT button and to stop printing during print out, press the
PRINT button again. (Refer to Figure 73.)
Printer Settings
1. Press the Setup soft key. (Setup is displayed on the initial screen of each mode.)
2. Rotate the Multi function knob to highlight Printer setting via Setup Menu, and then
press the Multi function knob to select Printer setting.
Print on alarm
If Print on alarm is set to On, the defibrillator/monitor will automatically print out
information before and after 10 seconds when a physiological alarm condition is activated.
Print on shock
If Print on shock is set to On, the defibrillator/monitor will automatically print out
information before and after 10 seconds when a shock is generated.
149
Print-Out
Print-out
The defibrillator/monitor prints numeric data and waveforms by pressing PRINT button.
Print-out on shock
The defibrillator/monitor prints shock information by pressing SHOCK button. Shock can
be delivered when the defibrillator/monitor is turned on in Manual or AED mode.
150
Print-Out on setting information
When the defibrillator/monitor is in Service Menu, the defibrillator/monitor will print out all
internal settings by pressing the PRINT button. Refer to the service manual for the
detailed instructions.
151
This page is intentionally left blank.
152
EXTERNAL INTERFACE
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.
Note: This equipment is to be used on a network and the wireless communication (3G or
Wi-Fi) are limited to inside of the building.
The USB Host is used to install the new system software. Only memory stick can be used
for the USB Host.
SD Memory Card
The SD Memory Card is used to extend the save space, to download data and to load
voice prompt data.
153
This page is intentionally left blank.
154
MAINTENANCE
CAUTION: Do not ultrasonically clean or immerse the paddles and paddles cables.
CAUTION: Do not soak or immerse the sensors or cables in any liquid solution. Do
not attempt to sterilize.
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.
155
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.
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.
The cleaning method for paddles and paddle plates are same as defibrillator/monitor.
For cables, sensors, cuffs, and probes, follow the cleaning instructions in the directions
for use shipped with those components.
156
Battery Maintenance
CAUTION: Recharging the battery is strongly recommended when the battery has
not been recharged for 6 or more months.
CAUTION: Do not short-circuit the battery, as it may generate heat. To avoid short-
circuiting, do not let the battery come in contact with metal objects at any time,
especially when transporting.
CAUTION: Do not solder the battery directly. Heat applied during soldering may
damage the safety vent in the battery’s positive cover.
CAUTION: Do not deform the battery by applying pressure. Do not throw, hit, drop,
fold or impact the battery.
CAUTION: 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.
CAUTION: 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.
CAUTION: Do not mistreat the battery, or use the battery in applications not
recommended by Mediana.
CAUTION: Keep the battery out of reach of babies and children to avoid any
accidents.
CAUTION: 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 Li-ion 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 5 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.
157
Loading Printer Paper
CAUTION: Using other manufacturers’ printer paper may cause the printer to
function improperly or damage the print head. Use only Mediana printer paper.
Note: To make sure that the paper is aligned in the slot and has not been pinched in the
door.
158
TROUBLESHOOTING
WARNING: 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.
WARNING: The cover should be removed only by qualified service personnel.
There are no user-serviceable parts inside except for the battery.
WARNING: 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.
159
EMI (Electromagnetic Interference)
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.
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.
160
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.
161
This page is intentionally left blank.
162
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.
163
Parameter Ranges / Selections (Adjust step) Factory Defaults
(4.0 to 35.3 kPa) (12.0 kPa)
neonatal neonatal
40 to 125 mmHg 40 mmHg
(5.3 to 16.7 kPa) (5.3 kPa)
(5 mmHg, 0.7kPa steps)
NIBP DIA High Alarm Limits adult/pediatric adult/pediatric
15 to 250 mmHg 90 mmHg
(2.0 to 33.3 kPa) (12.0 kPa)
neonatal neonatal
25 to 90 mmHg 60 mmHg
(3.3 to 12.0 kPa) (8.0 kPa)
(5 mmHg, 0.7kPa steps)
NIBP DIA Low Alarm Limits adult/pediatric adult/pediatric
10 to 245 mmHg 50 mmHg
(1.3 to 32.7 kPa) (6.7 kPa)
neonatal neonatal
20 to 85 mmHg 20 mmHg
(2.7 to 11.3 kPa) (2.6 kPa)
(5 mmHg, 0.7kPa steps)
NIBP MAP High Alarm Limits adult/pediatric adult/pediatric
25 to 260 mmHg 110 mmHg
(3.3 to 34.7 kPa) (14.7 kPa)
neonatal neonatal
35 to 110 mmHg 70 mmHg
(4.7 to 14.7 kPa) (9.3 kPa)
(5 mmHg, 0.7kPa steps)
NIBP MAP Low Alarm Limits adult/pediatric adult/pediatric
20 to 255 mmHg 60 mmHg
(2.7 to 34.0 kPa) (8.0 kPa)
neonatal neonatal
30 to 105 mmHg 30 mmHg
(4.0 to 14.0 kPa) (4.0 kPa)
(5 mmHg, 0.7kPa steps)
IBP1 MENU
IBP1: Scale Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, Auto
0~300mmHg
IBP1: Label P1, ABP P1
IBP 1 SYS High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 160 mmHg
(-6 to 40 kPa) (21.3 kPa)
(5 mmHg, 0.7kPa steps)
IBP 1 SYS Low Alarm Limits adult/pediatric adult/pediatric
-50 to 295mmHg 90 mmHg
(-6.7 to 39.3 kPa) (12.0 kPa)
(5 mmHg, 0.7kPa steps)
IBP 1 DIA High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 90 mmHg
(-6 to 40 kPa) (12.0 kPa)
(5 mmHg, 0.7kPa steps)
IBP 1 DIA Low Alarm Limits adult/pediatric adult/pediatric
-50 to 295 mmHg 50 mmHg
(-6.7 to 39.3 kPa) (6.7 kPa)
(5 mmHg, 0.7kPa steps)
IBP 1 MEAN High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 110 mmHg
164
Parameter Ranges / Selections (Adjust step) Factory Defaults
(-6 to 40 kPa) (14.7 kPa)
(5 mmHg, 0.7kPa steps)
IBP 1 MEAN Low Alarm Limits adult/pediatric adult/pediatric
-50 to 295 mmHg 60 mmHg
(-6.7 to 39.3 kPa) (8.0 kPa)
(5 mmHg, 0.7kPa steps)
IBP2 MENU
IBP2: Scale Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, Auto
0~300mmHg
IBP2: Label P2, CVP, PAP,LAP P2
IBP 2 SYS High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 160 mmHg
(-6 to 40 kPa) (21.3 kPa)
(5 mmHg, 0.7kPa steps)
IBP 2 SYS Low Alarm Limits adult/pediatric adult/pediatric
-50 to 295mmHg 90 mmHg
(-6.7 to 39.3 kPa) (12.0 kPa)
(5 mmHg, 0.7kPa steps)
IBP 2 DIA High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 90 mmHg
(-6 to 40 kPa) (12.0 kPa)
(5 mmHg, 0.7kPa steps)
IBP 2 DIA Low Alarm Limits adult/pediatricl adult/pediatric
-50 to 295mmHg 50 mmHg
(-6.7 to 39.3 kPa) (6.7 kPa)
(5 mmHg, 0.7kPa steps)
IBP 2 MEAN High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 110 mmHg
(-6 to 40 kPa) (14.7 kPa)
(5 mmHg, 0.7kPa steps)
IBP 2 MEAN Low Alarm Limits adult/pediatric adult/pediatric
-50 to 295mmHg 60 mmHg
(-6.7 to 39.3 kPa) (8.0 kPa)
(5 mmHg, 0.7kPa steps)
IBP unit* mmHg, kPa mmHg
EtCO2
EtCO2 On, Off ON
N2O Gas On, Off OFF
O2 Gas On, Off OFF
Scale 0~40 mmHg, 0~60 mmHg, 0~80 mmHg, Auto Auto
Average 1 breath, 10 seconds, 20 seconds, 30 seconds 1 breath
EtCO2 High Alarm Limits adult/pediatric adult/pediatric
1 to150 mmHg 80 mmHg
(0.13 to 20.0 kPa), (0.13 to 20.0 %) (10.7 kPa), (10.5 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
EtCO2 Low Alarm Limits adult/pediatric adult/pediatric
0 to 149 mmHg 0 mmHg
(0 to 19.87 kPa), (0 to 19.9 %) (0 kPa), (0 %)
(1 mmHg, 0.13 kPa steps)
InCO2 High Alarm Limits adult/pediatric adult/pediatric
1 to 20 mmHg 20 mmHg
(0.13 to 2.7 kPa), (0.13 to 2.6 %) (2.7 kPa), (2.6 %)
(1 mmHg, 0.13 kPa steps)
InCO2 Low Alarm Limits adult/pediatric adult/pediatric
165
Parameter Ranges / Selections (Adjust step) Factory Defaults
0 to 19 mmHg 0 mmHg
(0 to 2.5 kPa), (0 to 2.5 %) (0 kPa), (0 %)
(1 mmHg, 0.13 kPa steps)
EtCO2 unit* mmHg, kPa, % mmHg
Temperature MENU
TEMP1 High Alarm Limits 0.1 to 50.0 °C 39.0 °C
(32.2 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1°F steps)
TEMP1 Low Alarm Limits 0.0 to 49.9 °C 36.0 °C
(32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1°F steps)
TEMP2 High Alarm Limits 0.1 to 50.0 °C 39.0 °C
(32.2 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1°F steps)
TEMP2 Low Alarm Limits 0.0 to 49.9 °C 36.0 °C
(32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1°F steps)
TEMP Unit* °C, °F °C
Respiration MENU
Respiration ON ON
OFF
RR Source Auto Auto
Impedance
Airway
Size x0.5, x1, x1.5, x2 x1
Apnea time setting Off, 10 seconds, 20 seconds, 30 seconds 10 seconds
40 seconds, 50 seconds, 60 seconds
RR High Limits IM: 4 to 120 BPM (1 BPM step) 30 BPM
AW: 1 to 150 BPM (1 BPM step)
RR Low Limits IM: 3 to 119 BPM (1 BPM step) 8 BPM
AW: 0 to 149 BPM (1 BPM step)
Manual, AED, Pacing, Monitor Mode MENU
Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8 5
Beep Volume OFF, 1, 2, 3, 4, 5, 6, 7 4
Button Volume OFF, 1, 2, 3, 4, 5, 6, 7 4
2nd Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG SpO2 Waveform
aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
3rd Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG IBP1 Waveform – P1
aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
4th Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG EtCO2 Waveform
aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
Print on alarm** On, Off Off
Print on shock** On, Off Off
12lead auto printing** On, Off On
Analyze auto printing** On, Off Off
Elapsed time display* Enable, Disable Enable
CPR guide display* Enable, Disable Disable
Message display* Enable, Disable Enable
Voice prompt* Enable, Disable Enable
Basic auto energy escalation* Enable, Disable Enable
Above 200J setting* Enable, Disable Disable
166
Parameter Ranges / Selections (Adjust step) Factory Defaults
Manual mode shock energy – 1~200J 125J
1st energy*
Manual mode shock energy – 1~200J 150J
2nd energy*
Manual mode shock energy – 1~200J 200J
3rd energy*
Analyze continuous mode* On, Off On
Auto charge* On, Off On
Remain in sync mode after On, Off On
shock*
Charging hold time* 15 sec, 60 sec 60 sec
ECG display under paddle On, Off On
open*
Setup Menu* Enable, Disable Disable
Alarm Limit Menu* Enable, Disable Disable
12 Lead Menu* Enable, Disable Disable
AED display setting – Enable, Disable Enable
Waveform display*
AED display setting – Enable, Disable Enable
Icon display*
AED display setting – Enable, Disable Disable
Value display*
AED display setting – Enable, Disable Disable
AED step 1 display*
AED display setting – Enable, Disable Disable
AED step 2 display*
AED display setting – Enable, Disable Disable
AED step 3 display*
AED shock energy – Enable, Disable Disable
Above 200J setting*
AED shock energy – 1~200J 125J
1st energy*
167
Parameter Ranges / Selections (Adjust step) Factory Defaults
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - RESP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 9696C8(Light blue)
6464FA(Light blue), FA96FA(Pink), FA0000(Red),
FAFA00(Yellow), 9696C8(Light purple), FA9600,
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - TEMP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FA96FA(Pink)
6464FA(Light blue), FA96FA(Pink), FA0000(Red),
FAFA00(Yellow), 9696C8(Light purple), FA9600,
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - IBP 1* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FA0000(Red)
6464FA(Light blue), FA96FA(Pink), FA0000(Red),
FAFA00(Yellow), 9696C8(Light purple), FA9600,
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - IBP 2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FAFA00(Yellow)
6464FA(Light blue), FA96FA(Pink), FA0000(Red),
FAFA00(Yellow), 9696C8(Light purple), FA9600,
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - EtCO2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 9696C8(Light purple)
6464FA(Light blue), FA96FA(Pink), FA0000(Red),
FAFA00(Yellow), 9696C8(Light purple), FA9600,
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Audio pause time* 30 sec, 60 sec, 90 sec, 120 sec 60 sec
Audio off time* 3 min, 5 min, 10 min, Indefinite Indefinite
Alarm reminder tone* 3 min, 10 min, Off 3 min
Alarm activate at power up* Enable, Disable Enable
Voice recording* On, Off Off
Auto self-test : 0 ~ 23 o‘clock 0 o‘clock
Self-test time*
Auto self-test : 24 hours, 48 hours, 72 hours, Off Off
Self-test time interval*
Auto self-test : 5J, 10J, 20J, 30J, 40J, 50J, 100J, 200J 50 J
Internal shock energy*
Clinical action list* None, CPR, EPI, Atrop, DOPA, PHEN, Bicarb, Aspirin, None
Oxygen, IV, Morphine, Valium, β-block, LIDO, Mag
Sulf, Thrombo, Sedation, Heparin, Procain, Cordar,
Thiamine, Dilantin, Intubate, Narcan, Atrovent,
Adenosin, Fentanyl, Digoxin, Vasopr, Dextrose,
Paralytic, Nitro, Albuterol, Amrinon, Benadryl,
Demerol, Oral Glu, Lasix, Calcium
Manual mode protection* Disable, Confirm, Passcode Disable
Manual mode locking 000~999 (Passcode)
passcode*
Pacing mode protection* Disable, Confirm, Passcode Disable
Pacing mode locking 000~999 (Passcode)
passcode*
Service menu passcode* 000~999 (Passcode)
Print on charge** On, Off Off
Print on mark** On, Off Off
168
Parameter Ranges / Selections (Adjust step) Factory Defaults
Print on BP** On, Off Off
Print on self-test** On, Off Off
Power on waveform select – ECG I, ECG II, ECG III, Pads ECG I
1st waveform*
Power on waveform select – ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG SpO2
2nd waveform* aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
Power on waveform select – ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG IBP1
3rd waveform* aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
Power on waveform select – ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG EtCO2
4th waveform* aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
Wi-Fi* On, Off Off
Wireless Channel* Channel 1 ~ 13 Channel 1
Wireless security mode* None, WEP, WPA, WPA2, Return None
Wireless WEP key* WEP key 1, WEP key 2, WEP key 3, WEP key 4 WEP key 1
WEP key length* 64 bit (10 hex digits), 128 bit (24 hex digits) 64 bit (10 hex digits)
Note: An asterisk (*) by a parameter in the above table indicates that the parameter can only be changed by authorized
personnel as described in the service manual
Note: Asterisks (**) by a parameter in the above table indicate the settings only when an optional printer is installed in the
defibrillator/monitor.
169
This page is intentionally left blank.
170
SPECIFICATION
Display
Screen Size 8.4” measured diagonally across the TFT-LCD screen
Screen Type Liquid Crystal Display (LCD) Color
Size 170 x 128 mm
Number of Traces 4 waveforms
Controls
Multi function knob; Mode select knob (Off, AED, Manual,
Pacing and Monitor); 11 buttons (Shock, Energy Level,
Standard
Charge, Analyze, NIBP, LEAD, Alarm, Size, Print, Rate, mA);
5 soft key
Alarms
Categories Patient Status and System Status
Priorities Low, Medium and High Priorities
Notification Audible and Visual
Setting Default and Individual
Alarm Volume Level 45 to 85 dB
171
Electrical
Instrument
Power Requirements AC Mains
100 to 240 V, 50/60 Hz, 160 VA
DC Mains
18Vdc, 7.0A with DC/DC adapter, Model:MDD150-1218
(MDD150-1218: Input: 12-16Vdc, 160VA,
Output: 18Vdc, 7.0A)
Note: For 120 Volt applications, use only UL Listed detachable power cord with
NEMA configuration 5-15P type (parallel blades) plug cap. For 240 Volt applications
use only UL Listed Detachable power supply cord with NEMA configuration 6-15P
type (tandem blades) plug cap.
Battery (option)
Type Li-ion battery
Dimension 150 × 90 × 20 (mm) (W×H×D)
Voltage/Capacity 4S2P 14.4V/5200mAh
Discharge A minimum of 200 shocks at 200 Joules (per battery)
Operating time 5 hours (per battery)
At the following condition:
no printing
no external communication
no audible alarm sound
room temperature : 25°C
Recharge Over 5 hours with defibrillator/monitor turned on/off
(It would take about 5 hours to fully charge the battery from
the moment that low battery alarm is activated.)
24 months, new battery fully-charged
(- The battery life cycle may vary with the number of
recharging, operating temperature, and storage condition.
Typically, about 80% capacity of battery may remain after
300 cycles of recharge. If one cycle of recharging would be
Life Cycle about 2 or 3 days, the battery may have 80% capacity after
about 24 months.
- The battery is designed not to be charged for safety
reason when it reaches 40°C.)
After 2 months storage the defibrillator/monitor would run for
50% of stated battery life.
172
Environmental Conditions
Operation
Temperature 0 to 50°C (32 to 122°F)
Humidity 15 to 95% RH, non-condensing
Altitude -170 to 4,877m (-557 to 16,000 ft)
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
Note: The battery will not be charged for safety if the operating temperature exceeds
40°C.
Shipping and Storage (in shipping container)
Temperature −20°C to 70°C (−4°F to 158°F)
Humidity 15 to 95% RH, non-condensing
Altitude -304 to 6,096m (-1,000 to 20,000ft)
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
173
Tone Definition
High Priority Alarm Tone
Volume level Adjustable (level 1~8)
Pitch (± 48.8Hz) 976 Hz
Pulse width (± 10msec) 210 msec
Number of pulses 10 pulses per 4 sec, 10 sec inter burst
Repetitions Continually
Medium Priority Alarm Tone
Volume level Adjustable (level 1~8)
Pitch (± 34.85Hz) 697 Hz
Pulse width (± 10msec) 210 msec
Number of pulses 3 pulses per 1 sec, 15 sec inter burst
Repetitions Continually
Low Priority Alarm Tone
Volume level Adjustable (level 1~8)
Pitch (± 9.4Hz) 488 Hz
Pulse width (± 10msec) 210 msec
Number of pulses 1 pulse per 0.25 sec, 30 sec inter burst
Alarm Reminder Tone
Volume level Not changeable
Pitch (± 40Hz) 800 Hz
Pulse width (± 10msec) 200 msec
Number of pulses 1 pulse per 1 second, 3 min, 10 min inter burst
Repetitions Continually
HR/PR Tone
Volume level Not changeable
650 Hz (ECG)
Pitch (± 32.5Hz)
(162 + 5*SpO2) Hz
Pulse width (± 5msec) 100 msec
Number of pulses N/A
Repetitions No repeat
Key Beep
Volume level Adjustable (Off, level 1~7)
Pitch 440 (± 22) Hz (valid)
168 (± 8.4)Hz (invalid)
Pulse width (± 5msec) 100 msec
Number of pulses N/A
Repetitions No repeat
174
Measurement Parameters
Pacing Mode
Pacing Mode
Pacing rate Variable from 30 bpm to 180 bpm ± 1.5% (increments
or decrements by a value of 2bpm)
Resolution 2 bpm
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 Variable 0 mA to 140 mA ± 5% or 5 mA, whichever is
greater. Digitally displayed on the defibrillator/monitor
(increments or decrements by a value of 2 mA)
Defibrillator
AED mode
Lead Lead ll
Patient Impedance 25 to 175 Ohm
Heart Rate 20 to 300 BPM
Accuracy 1 per min
Detection V/F ≤ 200 µV
V/T ≤ 160 per min
Charging Time to 200J* Within 6 seconds with rated main voltage/DC main
voltage
*Charging time for other cases, refer to defibrillator (technical specification)
Manual Mode
Shock Energy Level External paddles:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100,
125, 150, 175, 200, 300, 360 J
Automatic Discharge Time 60 seconds
Charging time to 360J Within 8 seconds with rated main voltage/DC main
voltage
*Charging time for other cases, refer to defibrillator (technical specification)
ECG
Heart Rate
Measurement Range 0, 20 to 300 BPM
Resolution 1 BPM
Accuracy ± 5 bpm
Average Response Time 5 seconds (from 80 to120 BPM)
9 seconds (from 80 to 40 BPM)
Tall T-wave Rejection maximum T-wave amplitude 1.8 mV
ECG (Electrocardiograph)
Leads 3 / 5 / 12 Lead (Lead I, II, III, aVR, aVL, aVF, V, V1, V2,
V3, V4, V5, V6)
Paddle / Pads
Lead Off Detection Detected and displayed
Pacer Detection Detect pacer pulses of ±2mV to ±700mV with pulse
175
widths of 0.1 to 2msec and rise times 10% of width not
to exceed 100msec
Input
Input Impedance 5 Mohm or more
Input Dynamic Range ±5 mV AC, ±300 mV DC
Voltage Range ±0.5 mV ~ ±5 mV
Signal Width 40 to 120 ms (Q to S)
Output
Filter mode 0.5 to 21 Hz
0.05 to 40 Hz
1 to 21 Hz
ECG Size Auto, 5.0, 10.0, 15.0, 20.0, 30.0 mm/mV
Display Sweep Speeds 25.0 mm/s
Wave Size x0.5, x1, x1.5, x2, x3
Display Sensitivity 10 mm/mV (×1)
Pacing Pulse Detection On, Off
Electrode Disconnect Alarm Display and/or sound
CMRR 90 dB or more
Defibrillator Discharge <5 sec per IEC60601-2-27
Recovery
Defibrillator Protection Protected
176
Respiration
IM Respiration
Technique Impedance Pneumography
Range 0, 3 to 120 breaths/min
Resolution 1 breaths/min
Leads RA to LA
Base impedance 500 to 2000 ohm
Delta impedance 0.5 to 3 ohm
Lead Off Condition Detected and displayed
Defibrillator Protection Protected
Display Sweep Speeds 25 mm/s
Wave Size x0.5, x1, x1.5, x2
AW Respiration
Technique Nondispresive Infrared Spectroscopy
Range 0 to 150 breaths/min
Accuracy ±1 breaths/min
NIBP
Pulse Rate
Pulse Rate Range Adult/Pediatric 40 to 200 BPM
Neonatal 40 to 240 BPM
Resolution 5 BPM
Pulse Rate Accuracy ±2 BPM or ±2%, whichever is greater
NIBP (Non-Invasive Blood Pressure)
Technique Oscillometric Measurement
Measurement Modes Off, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 minutes
Measurement Range Adult/Pediatric
SYS 60 to 250 mmHg
MAP 45 to 235 mmHg
DIA 40 to 200 mmHg
Neonatal
SYS 40 to 120 mmHg
MAP 30 to 100 mmHg
DIA 20 to 90 mmHg
NIBP Accuracy Mean error and standard deviation per ANSI/AAMI
SP10:2002+A1:2003+A2:2006
Pressure Display Range Adult/Pediatric 0 to 300 mmHg
Neonatal 0 to 150 mmHg
Pressure Display Adult/Pediatric ± 10mmHg
Accuracy Neonatal ± 5 mmHg
Initial Cuff Inflate Adult/Pediatric
Pressure 120, 140, 160, 180, 200, 220, 240, 260, 280 mmHg
(16.0, 18.7, 21.3, 24.0, 26.7, 29.3, 32.0, 34.7, 37.3 kPa)
Neonatal
80, 90, 100, 110, 120, 130, 140 mmHg
(10.7, 12.0, 13.3, 14.7, 16.0, 17.3, 18.7 kPa)
Automatic Cuff Deflation Measurement time exceeding 180s in adult/pediatric (90s
in neonatal) or maximum pressure value exceeding 300
mmHg in adult (150 mmHg in neonatal).
Overpressure Protector Adult/Pediatric: 300 mmHg
Neonatal: 150 mmHg
Defibrillator Protection Protected
177
Measurement Speed About 20 seconds
At the following condition:
Adult
Cuff size 12 cm
SYS 120 mmHg
MAP 90 mmHg
DIA 80 mmHg/ PR 80 BPM
Manual Measurements (180 mmHg)
IBP
Pulse Rate
Pulse Rate Range 20 to 250 BPM
Accuracy ± 1 % or ± 1 bpm
Pulse Rate Resolution 1 BPM
IBP (Invasive Blood Pressure)
Parameter Displayed P1, ABP
P2, CVP, PAP, LAP
Measurement Range -50 mmHg to 300 mmHg
20 bpm to 250 bpm
Resolution 1 mmHg
Accuracy ± 3 mmHg
Input sensitivity 5µV/V/mmHg
Transducer Volume 0.1mm3/100mmHg
Displacement
Zero calibration range ± 100mmHg
Frequency response DC - 10 Hz ± 1 Hz, -3db
Wave Size 0 to 50, 0 to 100, 0 to 200, 0 to 300, Auto Size
Display Sweep Speeds 25.0 mm/s
Defibrillator Protection Protected
SpO2
Measurement Ranges
SpO2 saturation range 1% to 100%
Pulse rate range 20 to 300 beats per minute (bpm)
Perfusion range 0.03% to 20%
Display sweep speed 25.0 mm/s
Measurement Accuracy
Pulse rate accuracy 20 to 250 beats per minute (bpm) ±3 digits
SpO2 saturation accuracy 70% to 100% ±2 digits, neonates: ±3 digits
Note: SpO2 saturation accuracy - Monitoring system measurements are statistically distributed; about two-thirds of
monitoring system measurements can be expected to fall in this accuracy (ARMS) range. Reference the Clinical Studies
section for test results. For a complete listing of SpO2 accuracy across the full line of available Nellcor™ sensors, contact
Covidien, a local Covidien representative, or locate it online at www.covidien.com.
Operating Range and Dissipation
Red Light Wavelength Approximately 660 nm
Infrared Light Wavelength Approximately 900 nm
Optical Output Power Less than 15 mW
Power Dissipation 52.5 mW
178
Capnography
Capnography
Parameter Displayed EtCO2, InCO2
Range 0 mmHg ~ 150 mmHg (0kPa ~ 20kPa, 0% ~ 20%)
Accuracy 0-40mmHg ±2mmHg of reading
41-70mmHg ±5% of reading
71-100mmHg ±8% of reading
101-150mmHg ±10% of reading
Display Accuracy ±2mmHg
Response Time Mainstream: Less than 60ms
Sidestream: Less than 3sec.
Baromatric Pressure -152.4 to 4572 meters
Correction (-500 to 15,000 feet),
775 to 429 mmHg, Automatic
Gas Compensation User selective at O2 >60% and N2O >50%
Stability and drift Short term drift: Less than 0.8 mmHg over 4 hours.
Long term drift: Accuracy specification will be maintained
over a 120 hour period.
Accuracy Change for 0-40 mmHg ±1 mmHg additional error
interfering Gases and 41-70 mmHg ±2.5% additional error
Vapors Anesthetic and 71-100 mmHg ±4% additional error
interfering agents 101-150 mmHg ±5% additional error
Temperature
Thermistor Temp
Probe Type Thermistor probe YSI compatible type
Measurement Method Thermistor
Range 0 to 50°C (32.0 to 122°F)
Resolution ±0.1°C
Defibrillator Protection Protected
179
Trend
Type 12 lead, Event
Data storage Internal memory, SD card
Memory 12 lead
saves total 100 data
saves ECG waveform
saves ECG analysis result data
saves ECG analysis date and time
saves HR/PR, NIBP, SpO2, Respiration,
Temperature, IBP 1, IBP 2, EtCO2 numeric data
saves alarm condition
Event
saves total 250 data
saves defibrillation shock information (number of
shock, energy level, actual passed energy,
impedance)
saves pacing information (pace rate, pace current,
async mode)
saves clinical action list
saves 1 channel ECG waveform
saves Event date and time
saves HR/PR, NIBP, SpO2, Respiration,
Temperature, IBP 1, IBP 2, EtCO2 numeric data
saves alarm condition
180
Defibrillator (Technical specification)
AED Mode
AED Mode
Charging Time - 200J Charging condition Time (sec)
With Rated Mains Voltage 5.8
With DC Mains Voltage 5.9
With fully charged battery 6.4
Charging Time - 200J Charging condition Time (sec)
(including time from the With Rated Mains Voltage 18.1
initiation of rhythm With DC Mains Voltage 18.4
analysis with a clear ECG With fully charged battery 19.3
signal to readiness for With Mains Voltage of 90% of the Rated
discharge.) 18.1
value
With DC Mains Voltage of 90% of the
18.8
Rated value
After 15 maximum energy discharges
19.6
taken from a new fully charged battery
With Mains Voltage of 90% of the Rated
value, but measured from initially
26.4
switching power on to ready for
discharge at maximum energy
With DC Mains Voltage of 90% of the
Rated value, but measured from initially
26.3
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 26.7
power on to ready for discharge at
maximum energy
Note: A used battery normally takes more time than the
charging time specified in above.
Waveform parameters The defibrillator/monitor delivers shocks to load
impedances from 25 to 175 ohms. The duration of each
pulse of the waveform is dynamically adjusted based on
delivered charge, in order to compensate for patient
impedance variations, as shown below:
(When 200J is selected)
Load resistance (Ω) Delivered energy(J)
25 195
50 200
75 196
100 199
125 199
150 200
175 200
181
Manual Mode
Manual Mode
Charging Time – 200J Charging condition Time (sec)
With Rated Mains Voltage1) 5.8
With DC Mains Voltage2) 5.9
3)
With fully charged battery 6.4
With Mains Voltage of 90% of the
5.8
Rated value4)
With DC Mains Voltage of 90% of the
6.4
Rated value5)
After 15 maximum energy discharges
taken from a new fully charged 6.6
battery6)
With Mains Voltage of 90% of the
Rated value, but measured from
11.7
initially switching power on to ready for
7)
discharge at maximum energy
With DC Mains Voltage of 90% of the
Rated value, but measured from
11.9
initially switching power on to ready for
8)
discharge at maximum energy
After 15 maximum energy discharges
taken from a new fully charged battery,
but measured from initially switching 12.5
power on to ready for discharge at
maximum energy9)
Note: A used battery normally takes more time than the
charging time specified in above.
Charging Time – 360J Charging condition Time (sec)
With Rated Mains Voltage 7.4
With DC Mains Voltage 7.5
With fully charged battery 8.0
With Mains Voltage of 90% of the
7.4
Rated value
With DC Mains Voltage of 90% of the
8.0
Rated value
After 15 maximum energy discharges
8.5
taken from a new fully charged battery
With Mains Voltage of 90% of the
Rated value, but measured from
13.0
initially switching power on to ready for
discharge at maximum energy
With DC Mains Voltage of 90% of the
Rated value, but measured from
14.0
initially 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 14.3
power on to ready for discharge at
maximum energy
182
Note: A used battery normally takes more time than the
charging time specified in above.
Number of discharges The number of maximum energy discharges which are
available from a new and fully charged battery at 20°C
ambient temperature is above 200 times for 360J and
250 times for 200J
183
Biphasic Waveform Characteristics
The efficiency of Mediana’s Biphasic waveform has been clinically verified during a
ventricular fibrillation (VF) and ventricular tachycardia (VT) defibrillation study. This study
(which was conducted using D500 defibrillator/monitors) and the findings are described
below.
Table 40. Delivered Energy at Every Defibrillator Settings into a Range of Loads
Selected Load Accuracy
Energy 25 50 75 100 125 150 175
1J 1.0 1.0 1.0 1.0 1.0 1.0 1.0 15%
2J 2.0 2.0 2.0 2.0 2.0 2.0 2.0 15%
3J 3.0 3.0 3.0 3.0 3.0 3.0 3.0 15%
4J 4.0 4.0 4.0 4.0 4.0 4.0 4.0 15%
5J 5.0 5.0 5.0 5.0 5.0 5.0 5.0 15%
6J 6.0 6.0 6.0 6.0 6.0 6.0 6.0 15%
7J 7.0 7.0 7.0 7.0 7.0 7.0 7.0 15%
8J 8.0 8.0 8.0 8.0 8.0 8.0 8.0 15%
9J 9.0 9.0 9.0 9.0 9.0 9.0 9.0 15%
10J 11.0 10.0 10.0 10.0 10.0 10.0 10.0 15%
15J 16.0 15.0 15.0 15.0 15.0 15.0 15.0 15%
20J 21.0 20.0 20.0 20.0 20.0 20.0 20.0 15%
30J 31.0 30.0 30.0 30.0 30.0 30.0 30.0 15%
40J 41.0 40.0 40.0 40.0 39.0 39.0 39.0 15%
50J 51.0 50.0 50.0 50.0 49.0 49.0 49.0 15%
75J 77.0 76.0 75.0 75.0 74.0 74.0 74.0 15%
100J 102 101 101 100 99.0 99.0 99.0 15%
125J 127 126 126 124 124 122 123 15%
150J 152 151 150 150 148 147 148 15%
175J 177 174 173 173 173 172 172 15%
200J 203 198 200 199 198 197 197 15%
300J 304 302 300 298 296 297 296 15%
360J 370 371 365 363 363 356 356 15%
Figure through show the biphasic waveforms that are produced when the
defibrillator/monitor is discharged into loads of 25, 50, 75, 100, 125, 150 and 175 ohms
at each energy setting (360, 300, 200, 175, 150, 125, 100, 75, 50, 40, 30, 20, 15, 10, 9,
8, 7, and 6 joule[s]).
The vertical axis shows the voltage in volts (V); the horizontal axis shows the duration in
milliseconds (ms).
184
Figure 78. Biphasic Waveforms at 360 Joules and 360 Joules
185
Figure 80. Biphasic Waveforms at 175 Joules
186
Figure 82. Biphasic Waveforms at 125 Joules
187
Figure 84. Biphasic Waveforms at 75 Joules
188
Figure 86. Biphasic Waveforms at 40 Joules
189
Figure 88. Biphasic Waveforms at 20 Joules
190
Figure 90: Biphasic Waveforms at 9 Joules
191
Figure 92. Biphasic Waveforms at 7 Joules
192
Figure 94. Biphasic Waveforms at 5 Joules
193
Figure 96. Biphasic Waveforms at 3 Joules
194
Figure 98. Biphasic Waveforms at 1 Joules
195
Compliance
Item Standard Description
Classification IEC60601-1:1988 Class I (on AC power)
+A1:1991+A2:1995, Internally powered (on battery power)
EN60601-1:1996
Type of protection IEC60601-1:1988 Type CF – Applied part
+A1:1991+A2:1995,
EN60601-1:1996
Mode of operation IEC60601-1:1988 Continuous
+A1:1991+A2:1995,
EN60601-1:1996
Degree of protection IEC60529:2001, IP34 (provided by enclosures)
EN60529:1991
+A1:2000
General 93/42/EEC as Directives for medical devices
amended by
2007/47/EC
21CFR820 Code of federal regulations
2002/96/EC Waste electrical and electronic equipment directive
(WEEE)
93/86/EEC Battery disposal directive
2006/66/EC as Battery directive
amended by
2008/103/EC
ISO13485:2003, Quality systems - Medical Devices - Requirements
EN ISO13485:2003 for regulating purposes
ISO14971:2007, Risk analysis managements – medical devices
EN ISO14971:2009
IEC60601-1:1988 General requirements for safety of medical
+A1:1991+A2:1995, electrical equipment
EN60601-1:1996
IEC60529:2001, Degree of protection provided by enclosures (IP34)
EN60529:1991
+A1:2000
ISO14155-1:2003, Clinical investigation of medical devices for human
EN ISO14155-1:2009 subjects – part 1: General requirements
ISO14155-2:2003 Clinical investigation of medical devices for human
EN ISO14155-2:2009 subjects – Part2: Clinical investigation plans
AAMI HE75:2009 Human factors engineering guidelines and
preferred practices for the design of medical
devices
IEC60601-1-1:2000, Collateral standard for medical electrical systems
EN60601-1-1:2001
IEC60601-1-4:2000, Collateral standard for programmable medical
EN60601-1-4:1996 systems
+A1:1999
IEC60601-1-6:2006, Collateral standard for usability
EN60601-1-6:2007
196
Item Standard Description
ISO10993-1:2009, Biological evaluation of medical devices – Part 1:
EN ISO10993-1:2009 Evaluation and testing
ISO10993-5:2009, Biological evaluation of medical devices – Part 5:
EN ISO10993-5:2009 Tests for in vitro cytotoxicity
ISO10993-10:2010, Biological evaluation of medical devices – Part 10:
EN ISO10993-10:2010 Tests for irritation and delayed-type hypersensitivity
IEC60601-2-49:2001, Particular requirements for multifunction patient
EN60601-2-49:2001 monitoring equipment
IEC62366:2007 Medical devices – Application of usability
EN62366:2008 engineering to medical devices
IEC60601-1-9:2007 Medical electrical equipment - Part 1-9: General
EN60601-1-9:2008 requirements for basic safety and essential
performance - Collateral Standard: Requirements
for environmentally conscious design
IEC62304:2006 Medical device software – Software life-cycle
EN62304:2006 processes
EN1789:2007+A1:2010 Medical vehicles and their equipment – road
ambulance
EN13718-1:2008 Medical vehicles and their equipment – Air
ambulances – Part1:Requirements for medical
devices used in air ambulances.
Alarms IEC60601-1-8:2006, Alarm systems requirements, tests and guidance in
EN60601-1-8:2007 medical electrical equipments systems
Electrocardiograph IEC60601-2-27:2005, Particular requirements for the safety of
EN60601-2-27:2006 Electrocardiographic monitoring equipment
AAMI EC13:2002 Cardiac monitors, heart rate meters and alarms
AAMI EC53:1995 ECG cable and leads
+A1:1998
Non-invasive blood AAMI SP10:2002 Electronic or automated sphygmomanometers
pressure +A1:2003+A2:2006
EN1060-1:1995 Non-invasive sphygmomanometers
+A2:2009
EN1060-3:1997 Supplementary requirements for electrical-
+A2:2009 mechanical blood pressure measuring systems
EN1060-4:2004 Non-invasive sphygmomanometers - Test
procedures to determine the overall system
accuracy of automated non-invasive
sphygmomanometers
IEC60601-2-30:1999, Particular requirements for the safety, including
EN60601-2-30:2000 essential performance, of automatic cycling indirect
blood pressure monitoring equipment
Oxygen saturation ISO9919:2005, Basic safety & essential performance of pulse
EN ISO 9919:2009 oximeter for medical use
Temperature EN12470-4:2000 Performance of electrical thermometers for
monitoring +A1:2009 continuous Measurement
197
Item Standard Description
Capnography ISO21647:2004, Particular requirements for the basic safety and
EN ISO 21647:2009 essential performance of respiratory gas monitors
Defibrillator IEC 60601-2-4:2002 Safety of cardiac defibrillators
EN 60601-2-4:2003
AAMI DF80:2003 Safety of cardiac defibrillators (including automated
external defibrillators)
Electromagnetic IEC60601-1, sub Electromagnetic compatibility-requirements & test
compatibility clause 36, and
IEC60601-1-2:2007,
EN60601-1-2:2007
IEC61000-3-2:2009, Harmonic emission Ed 3.2
EN61000-3-2:2006
+A2:2009
IEC61000-3-3:2008, Voltage fluctuations/Flicker emission Ed 2.0
EN61000-3-3:2008
IEC61000-4-2:2008, Electrostatic discharge Ed 2.0
EN61000-4-2:2009
IEC61000-4-3:2008, Radiated RF electromagnetic field Ed 3.1
EN61000-4-3:2006
+A1:2008
IEC61000-4-4:2004, Electrical fast transient/burst Ed 2.0
EN61000-4-4:2004
IEC61000-4-5:2005, Surge current Ed 2.0
EN61000-4-5:2006
IEC61000-4-6:2008, Conducted disturbances, induced by RF field Ed
EN61000-4-6:2009 3.0
IEC61000-4-8:2009, Power frequency (50/60Hz) magnetic field Ed 2.0
EN61000-4-8:2010
IEC61000-4-11:2004, Voltage dips, short interruption and voltage
EN61000-4-11:2004 variation on power supply input lines Ed 2.0
CISPR11:2009 Limits and methods of measurement of radio
+A1:2010 disturbance characteristics of industrial scientific
EN55011:2009 and medical (ISM) radio-frequency equipment RF
+A1:2010 Emissions Group 1, Class B
Package ISTA (Procedure 1A, Pre-Shipment test procedures (Package)
2001)
ASTM D4169:2005 Standard practice for performance testing of
shipping containers and system
IEC60068-1:1998 Environmental testing, Part1: General guidelines
+A1:1992
EN 60068-1:1994
IEC60068-2-1:2007 Environmental testing - Part 2-1: Tests - Test A:
EN60068-2-1:2007 Cold
IEC60068-2-2:2007 Environmental testing - Part 2-2: Tests - Test B:
EN60068-2-2:2007 Dry heat
IEC60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db:
EN60068-2-30:2005 Damp heat, cyclic (12 h + 12 h cycle)
Reliability IEC60068-2-27:2008, Environmental testing – Shock
EN60068-2-27:2009
198
Item Standard Description
IEC60068-2-6:2007, Environmental testing – Vibration
EN60068-2-6:2008
IEC60068-2-64:2008, Environmental testing: vibration, broad-band
EN60068-2-64:2008 random (digital control) and guidance
Labeling EN1041:2008 Information supplied by the manufacturer with
medical devices
Marking IEC /TR60878:2003 Graphical symbols for electrical equipment in
medical practice
EN980:2008 Graphical symbols for use in the labeling of medical
devices
ISO7000:2004 Graphical symbols for use on equipment-index and
synopsis
EN60417-1:2002 Graphical symbols for use on equipment-overview
and application
EN60417-2:1999 Graphical symbols for use on equipment-symbol
originals
EN50419:2006 Marking of electrical and electronic equipment in
accordance with article II (2) of directive
2002/96/EC (WEEE)
199
Manufacturer’s Declaration
WARNING: 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.
200
Immunity Test IEC 60601-1-2 Compliance Electromagnetic
Test Level Level Environment Guidance
magnetic field 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.
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.
201
Immunity Test IEC 60601 Compliance Electromagnetic environment
test level level guidance
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
Maximum
Cables and Sensors Complies with
Length
AC Power Cable 2.5m
DC In Cable 1.8 m -RF emissions, CISPR 11, Class B/ Group 1
NIBP Hose 3.5 m -Harmonic emissions, IEC 61000-3-2
Cuff Hose 0.5 m -Voltage fluctuations/flicker emission,
IBP Cable 3.0 m IEC 61000-3-3
ECG Lead Cable 3.0 m -Electrostatic discharge (ESD), IEC 61000-4-2
Defibrillator/AED Cable 3.0 m -Electric fast transient/burst, IEC 61000-4-4
Temperature Cable 3.0 m -Surge, IEC 61000-4-5
EtCO2 Cable 2.0 m -Conducted RF IEC 61000-4-6
SpO2 Cable 4.0 m -Radiated RF, IEC 61000-4-3
SpO2 Sensor 1.0 m
202