BeneHeart D3&D2 - Ops Manual (New Defib) - V4.0 - EN
BeneHeart D3&D2 - Ops Manual (New Defib) - V4.0 - EN
BeneHeart D3&D2 - Ops Manual (New Defib) - V4.0 - EN
Defibrillator/Monitor
Operator’s Manual
© Copyright 2017 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
Release time: August 2017
WARNING
• This equipment must be operated by skilled/trained clinical professionals.
• It is important for the hospital or organization that employs this equipment to carry out a
reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal
injury.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other charges or
liability for direct, indirect or consequential damages or delay resulting from the improper use or application of
the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray
authorized personnel.
This warranty shall not extend to:
■ Malfunction or damage caused by improper use or man-made failure.
■ Malfunction or damage caused by unstable or out-of-range power input.
■ Malfunction or damage caused by force majeure such as fire and earthquake.
■ Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service
people.
■ Malfunction of the instrument or part whose serial number is not legible enough.
■ Others not caused by instrument or part itself.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Website: www.mindray.com
E-mail Address: [email protected]
Tel: +86 755 81888998
Fax: +86 755 26582680
Intended Audience
This manual is geared for clinical professionals who are expected to have a working knowledge of medical
procedures, practices and terminology as required for monitoring of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data
displayed on your equipment.
Conventions
■ Italic text is used in this manual to quote the referenced chapters or sections.
■ [ ] is used to enclose screen texts.
■ → is used to indicate operational procedures.
5 Alarms .................................................................................................................................................................................5 - 1
7 AED ..................................................................................................................................................................................... 7 - 1
12 Monitoring PR ................................................................................................................................................................12 - 1
18 Review ............................................................................................................................................................................18 - 1
20 Recording .......................................................................................................................................................................20 - 1
23 Batteries .........................................................................................................................................................................23 - 1
26 Accessories .....................................................................................................................................................................26 - 1
A Specifications ....................................................................................................................................................................A - 1
DANGER
• Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING
• Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious
injury.
CAUTION
• Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal
injury or product/property damage.
NOTE
NOTE
• Provides application tips or other useful information to ensure that you get the most from your
product.
1.1.1 Dangers
DANGER
• The equipment delivers up to 360 J of electrical energy. Unless properly used as described in these
Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to
operate this defibrillator unless thoroughly familiar with these operating instructions and the
function of all controls, indicators, connectors, and accessories.
• Defibrillation current can cause operator or bystander severe injury or even death. Keep distance
with the patient or metal devices connected to the patient during defibrillation.
• Do not disassemble the defibrillator. It contains no operator serviceable components and
dangerous high voltages may be present. Contact authorized service personnel for repair.
• To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres,
flammable anesthetics, or other flammable agents (such as gasoline). Keep the equipment and the
operating environment dry and clean.
1.1.2 Warnings
WARNING
• Before putting the system into operation, the operator must verify that the equipment, connecting
cables and accessories are in correct working order and operating condition.
• Make sure the synchronous input system is applied to this equipment and the input signal is correct
if necessary.
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth. If the installation does not provide for a protective earth conductor, disconnect it
from the power line and operate it on smart lithium-ion batteries.
1.1.3 Cautions
CAUTION
•
N
Use of Manual Therapy security password requires the clinician to know and remember the
password. Failure to enter correct password will prevent the delivery of manual defibrillation,
synchronized cardioversion and pacing therapy.
• At the end of its service life, the equipment, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such products to avoid contaminating the
environment.
• Magnetic and electrical fields are capable of interfering with the proper performance of the
equipment. For this reason make sure that all external devices operated in the vicinity of the
equipment comply with the relevant EMC requirements. Mobile phones, X-ray equipment or MRI
devices are a possible source of interference as they may emit higher levels of electromagnetic
radiation.
• Before connecting the equipment to the power line, check that the voltage and frequency ratings of
the power line are the same as those indicated on the equipment’s label or in this manual.
• Always install or carry the equipment properly to avoid damage caused by drop, impact, strong
vibration or other mechanical force.
• Dry the equipment immediately in case of rain.
• Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage
could occur.
Unlocking Marker
The product bears CE mark indicating its conformity with the provisions of the Council
Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of
Annex I of this directive.
The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household waste. By
ensuring that this product is disposed of correctly, you will help prevent bringing potential
negative consequences to the environment and human health. For more detailed
information with regard to returning and recycling this product, please consult the
distributor from whom you purchased it.
* For system products, this label may be attached to the main unit only.
2.1 Overview
The BeneHeart (hereinafter called the equipment) is a lightweight and portable defibrillator/monitor. It provides
four operating modes: Monitor, Manual Defib, AED and Pacer.
In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple
physiological parameters and waveforms including ECG, pulse oximetry (SpO2), respiration (Resp), non-invasive
blood pressure (NIBP) and carbon dioxide (CO2).
In AED mode, the equipment automatically analyzes the patient’s ECG rhythm and indicates whether or not a
shockable rhythm is detected. Voice prompts provide easy-to-follow instructions and patient information to
guide you through the defibrillation process. Messages and flashing buttons are also presented to reinforce the
voice prompts.
In the Manual Defib Mode, the operator analyzes the patient’s ECG, and, if appropriate, follows this procedure:
1. Select the Manual Defib mode, adjust the energy level if necessary;
2. Charge; and
3. Deliver the shock.
Defibrillation may be performed through paddles or multifunction electrode pads. In Manual Defib Mode, you
can also perform synchronized cardioversion. If desired, use of Manual Defib Mode may be password protected.
The Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through
multifunction electrode pads. Use of Pacer Mode may also be password protected.
The equipment can be powered by smart lithium ion batteries which are rechargeable and maintenance-free.
You can easily determine the remaining battery charge by viewing the battery power gauge displayed on the
screen or by checking the indicator on the battery itself. An external AC mains or a DC power supply connected
through a DC/AC adapter may also be used as a power source and for continuous battery charging.
The equipment can be connected to a Central Monitoring System (hereinafter called CMS) through wired and
wireless networks.
The equipment automatically stores patient data in an internal storage card. You can also export the data
through the USB port for viewing and editing on a PC through the data management software.
2.2.1 AED
The AED mode is to be used only on cardio arrest patients. The patients must be:
■ Unresponsive
■ Not breathing or not breathing normally
2.2.4 ECG
The ECG monitoring function is used to monitor and/or record the patient’s ECG waveform and heart rate.
2.2.5 Resp
The respiration monitoring function is used to continuously monitor the patient’s respiration rate and
respiration waveform.
2.2.6 SpO2
The SpO2 function is intended to measure patient’s oxygen saturation in arterial blood.
2.2.7 NIBP
The NIBP function is intended for non-invasive measurement of a patient’s arterial blood pressure.
2.2.8 CO2
The CO2 function is intended for monitoring a patient’s exhaled carbon dioxide and to provide a respiration rate.
Alarm lamp
Area 3
Area 1
Area 2 Speaker
2 3 4 5 6
1. Display screen
2. AC power indicator
◆ Illuminated: when AC mains is connected.
◆ Off: when AC mains is not connected.
3. Battery indicator
◆ Yellow: when the battery is being charged.
◆ Green: when the battery is fully charged or the equipment is run on battery.
◆ Off: when no battery is installed or battery fails.
4. Status indicator (red cross)
◆ Flashing: when a failure is detected, or when battery is not installed if [No Battery] is
configured as [Status Indicator ON].
NOTE
• Both status indicators are off when AC mains is not connected if the equipment is turned off and no
failure is detected.
4 5 6 7 8
1 2
5
3
1. Start/Stop key
Press this key to start a recording or stop the current recording.
2. Indicator
◆ Illuminated: when the recorder works correctly.
◆ Flashes: when an error occurred to the recorder, or the recorder runs out of paper.
3. Paper outlet
4. Recorder door
5. Latch
Therapy port
2 6
3 4
1. Record
2. ECG: ECG cable connector
3. SpO2: SpO2 sensor connector
4. Gas oulet
5. CO2 sampling line connector
6. NIBP: NIBP cuff connector
2 6
1. Hook
2. Battery
3. Equipotential grounding terminal
When the defibrillator/monitor and other devices are to be used together, their equipotential grounding
terminals should be connected together to eliminate the potential difference between them.
4. External power input
It connects an AC power cord or a DC/AC adapter to run the equipment respectively on the external AC
mains or DC power supply.
5. Multifunctional connector
It connects a CPR sensor, provides ECG output and defib synchronization input.
6. USB connector
7. Network connector
It is a standard RJ45 connector.
Apex paddle
Sternum paddle
1. Shock button
2. Charge button
3. Energy Select button
1 2 3 4 5
6 7
(9) (10) 11
3.1 Installation
WARNING
• The equipment shall be installed by personnel authorized by the manufacturer.
• The software copyright of the equipment is solely owned by the manufacturer. No organization or
individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any
form or by any means without due permission.
• Devices connected to the equipment must meet the requirements of the applicable IEC standards
(e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety
standards for medical electrical equipment). The system configuration must meet the requirements
of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to the
equipment’s signal input/output port is responsible for providing evidence that the safety
certification of the devices has been performed in accordance to the IEC 60601-1. If you have any
question, please contact the the manufacturer.
• If it is not evident from the equipment specifications whether a particular combination is hazardous,
for example, due to summation of leakage currents, consult the manufacturers or else an expert in
the field, to ensure the necessary safety of all devices concerned will not be impaired by the
proposed combination.
CAUTION
•
CAUTION
The [docking station] is part of the equipment. Use only the specified [docking station].
WARNING
• Package material may contaminate the environment. Properly dispose of the package material
according to applicable waste control regulations and keep it out of children’s reach.
• The equipment might be contaminated during storage and transport. Before use, please verify
whether the packages are intact, especially the packages of single use accessories. In case of any
damage, do not apply it to patients.
NOTE
NOTE
• Save the packing case and packaging material as they can be used if the equipment must be
reshipped.
NOTE
• Make sure that the operating environment of the equipment meets the specific requirements.
Otherwise unexpected consequences, e.g. damage to the equipment, could result.
• The equipment use a mains plug as isolation means to the mains power supply. Do not locate the
equipment in a place difficult to operate the mains plug.
WARNING
• Do not use the equipment for any monitoring or therapy procedure on a patient if you suspect it is
not working properly, or if it is mechanically damaged. Contact your service personnel or us.
NOTE
NOTE
• Check that visual and auditory alarm signals are presented correctly when the equipment is
powered on. Do not use the equipment for any monitoring procedure on a patient if you suspect it is
not working properly, or if it is mechanically damaged. Contact your service personnel or us.
NOTE
• To completely disconnect the power supply, unplug the power cord.
Other menus are similar to the main menu and contain the following parts:
1. Heading
2. Main body: displays options, buttons, prompt messages, etc. Pressing the menu button with “>>” enters a
submenu to reveal more options or information.
3. Exit button
4.1 Overview
Patient information management function enables you to edit and manage information of the current patient.
Alarms triggered by a vital sign that appears abnormal or by technical problems of the equipment, are indicated
to the user by visual and audible alarm indications.
WARNING
• A potential hazard exists if different alarm presets are used for the same or similar device in any
single area, e.g. an intensive care unit or cardiac operating room.
• If the equipment is connected to a CMS, remote suspension, inhibition, silence and reset of
monitoring alarms via the CMS may cause a potential hazard. For details, refer to the operator’s
manual of the CMS.
• Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a
low level may result in a hazard to the patient. Always make sure that the audio alarm volume level is
adequate in your care environment. Always keep the patient under close surveillance.
NOTE
• When multiple alarms of different levels occur simultaneously, the equipment will select the alarm
of the highest level and give visual and audible alarm indications accordingly. Alarm messages will
be displayed circularly.
• Some physiological alarms, such as Asystole, are exclusive. They have identical alarm tones and
alarm lights with normal high level physiological alarms, but their alarm messages are displayed
exclusively. That is to say, when an exclusive physiological alarm and a normal high level
physiological alarms are triggered simultaneously, only alarm message of the exclusive
physiological alarm is displayed.
NOTE
• You cannot adjust alarm volume when an alarm is switched off.
WARNING
• Do not rely exclusively on audible alarm system. Setting alarm volume to a low level may result in a
hazard to the patient. Always keep the patient under close surveillance.
NOTE
• You cannot simultaneously switch on HR and PR alarms. In the case that PR alarm is on, switching on
HR alarm will automatically turn off PR alarm, and vice versa.
You can also set parameter alarm properties by selecting a parameter window and select [Para. Alarm >>] in the
pop-up menu.
WARNING
• Make sure that the alarm limits settings are appropriate for your patient before patient monitoring.
• Setting the alarm limit to an extreme value may cause the alarm system to be ineffective. For
example, high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a
consideration, do NOT set the SpO2 high alarm limit to 100%, which is equivalent to switching the
alarm off.
• When monitoring patients that are not continuously attended by a clinical operator, properly
configure the alarm system and adjust alarm settings as per the patient's condition.
Adult/pediatric:
HR×0.8 or 40 (HR-30) or 90 HR×1.25 or 240 (HR + 40) or 200
35 to 240
ECG HR bpm (whichever bpm (whichever bpm whichever is bpm whichever
Neonate: 55 to
is greater) is greater) lower) is lower)
225
RR×0.5 or 6/min (RR-10) or 30/ RR×1.5 or 30/min (RR+25) or 85/ Adult/pediatric:
Resp RR (whichever is min (whichever (whichever is min (whichever 6 to 55
greater) is greater) lower) is lower) Neonate: 10 to 90
Same as the Same as the Same as the Same as the Same as the
SpO2 default alarm default alarm default alarm default alarm measurement
limit limit limit limit range
SpO2 Adult/pediatric: 35
PR×0.8 or 40 (PR-30) or 90 PR×1.25 or 240 (PR + 40) or 200
to 240
PR bpm (whichever bpm (whichever bpm whichever is bpm whichever
Neonate: 55 to
is greater) is greater) lower) is lower)
225
Adult: 45 to 270
(SYS-15) or (SYS + 15) or
Pediatric: 45 to
SYS×0.68 + 45mmHg SYS×0.86 + 105mmHg
NIBP-S 185
10mmHg (whichever is 38mmHg (whichever is
Neonate: 35 to
greater) lower)
115
(Dia-15) or (Dia + 15) or Adult: 25 to 225
Dia×0.68 + 20mmHg Dia×0.86 + 80mmHg Pediatric: 25 to
NIBP NIBP-D
6mmHg (whichever is 32mmHg (whichever is 150
greater) lower) Neonate: 20 to 90
Adult: 30 to 245
(Mean-15) or (Mean + 15) or
Pediatric: 30 to
Mean×0.68 + 35mmHg Mean×0.86 + 95mmHg
NIBP-M 180
8mmHg (whichever is 35mmHg (whichever is
Neonate: 25 to
greater) lower)
105
0-32mmHg: 0-32mmHg: 0-32mmHg: 0-32mmHg:
remains remains remains remains
unchanged unchanged unchanged unchanged
32-35mmHg: 32-35mmHg: 32-35mmHg: 32-35mmHg:
29mmHg 29mmHg 41mmHg 41mmHg
Same as the
35-45mmHg: 35-45mmHg: 35-45mmHg: 35-45mmHg:
EtCO2 measurement
etCO2-6mmHg etCO2-6mmHg etCO2+6mmHg etCO2+6mmHg
range
45-48mmHg: 45-48mmHg: 45-48mmHg: 45-48mmHg:
39mmHg 39mmHg 51mmHg 51mmHg
CO2
>48mmHg: >48mmHg: >48mmHg: >48mmHg:
remains remains remains remains
unchanged unchanged unchanged unchanged
Same as the Same as the Same as the
FiCO2 N/A N/A default alarm default alarm measurement
limit limit range
awRR×0.5 or 6/ awRR-10 or 30/ awRR×1.5 or 30/ awRR+25 or 85/ Adult/pediatric:
awRR min (whichever min (whichever min (whichever is min (whichever 6 to 55
is greater) is greater) lower) is lower) Neonate: 10 to 90
NOTE
• You can enable auto alarm limits only when the current parameter measurement is within the auto
alarm limits range.
■ The hardkey is pressed. In this case, the equipment enters the alarm paused status and the alarm
volume is reset to the default level. The symbol is displayed in the sound symbol area.
■ The [Alarm Reset] soft key is pressed. In this case, the equipment enters the audio paused status and the
alarm volume is reset to the default level. The symbol is displayed in the sound symbol area.
■ Operating mode is switched. Then the equipment enters the default alarm status of corresponding
operating mode. Or
■ Alarm volume is changed to a value between 1 and 10.
For some technical alarms, all their alarm indications are cleared after the hardkey or [Alarm Reset] soft key
is pressed. After the equipment restores the normal alarm status, it can give alarm indications correctly in case
these alarms are triggered again.
For others, their alarm tones are cleared but the alarm lamp flashing and alarm messages remain after the
hardkey or [Alarm Reset] soft key is pressed. After the equipment restores the normal alarm status, all the alarm
indications will continue if the alarm conditions still present.
6.1 Overview
The electrocardiogram (ECG) measures the electrical activity of the heart and displays it as waveforms and
numerics. The equipment enables ECG monitoring through 3-, 5-lead ECG sets, external paddles and
multifunction electrode pads. If both ECG sets and paddles/pads are connected, the configured ECG waveforms
are displayed in the waveform area.
6.2 Safety
WARNING
• ECG monitoring is not suitable for direct cardiac application.
• Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes,
replace the electrodes or change the application site.
• Use defibrillation-proof ECG cables during defibrillation.
• When monitoring a patient implanted with a pacemaker, be sure to select correct paced status.
Otherwise, the pacing pulses may be counted in the case of cardiac arrest or some arrhythmias. Do
not completely rely on the heart rate reading or the heart rate alarms. Always keep paced patients
under close surveillance.
• PACEMAKER PATIENTS – On ventricular paced patients, episodes of Ventricular Tachycardia may not
always be detected. Do not rely entirely upon the system’s automated arrhythmia detection
algorithm.
CAUTION
• Interference from a non-grounded instrument near the patient and electrosurgery interference can
cause problems with the waveform.
NOTE
• When connecting electrodes and/or patient cables, make sure that the connectors never come into
contact with other conductive parts, or with earth. Particularly make sure that all of the ECG
electrodes are attached to the patient.
• If selected lead cannot provide valid ECG signals, a dash line is shown in the ECG waveform area.
• Avoid using external paddles for ECG monitoring if possible.
• Use the same type of ECG electrodes when monitoring ECG through ECG lead set.
You can access Monitor mode by switching the Mode Select knob to the Monitor position. When operating in
Monitor mode, the equipment displays up to two ECG waveforms, the heart rate reading, other available
parameter values and active alarm settings.
3-Lead Placement
The following is a typical AHA electrode placement for a 3-lead ECG set:
■ RA placement: directly below the clavicle and near the right shoulder.
■ LA placement: directly below the clavicle and near the left shoulder.
■ LL placement: on the left lower abdomen.
5-Lead Placement
Sternum
paddle
RA
LL
Apex paddle
NOTE
• Anterior - lateral placement is the only placement that can be used for ECG monitoring with paddles/
pads accessories.
Heartbeat icon
Alarm limits
PVC values
HR value
PVCs values is shown only when arrhythmia analysis is switched on. When external paddles or multifunctional
electrode pads are used for ECG monitoring, the PVCs values is shown as “---”.
NOTE
• For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the system may
mistake an internal pace pulse for a QRS or fail to alarm when the pacer is broken.
NOTE
• The setting of Notch Filter will not be changed by restoring to factory default settings nor shutting
down the system.
WARNING
• Arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to
detect atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of
an arrhythmia. Therefore, a physician must analyze the arrhythmia information with other clinical
findings.
• Arrhythmia analysis is not intended for neonate patients.
*: indicates that this arrhythmia alarm is not presented when [Paced] is set to [Yes].
**: indicates that this arrhythmia alarm is not presented when [Paced] is set to [No].
■ When multifunctional electrode pads are used for ECG monitoring, the equipment provides only 4
arrhythmia alarms, including asystole, ventricular fibrillation/ventricular tachycardia, PNP, and PNC.
■ When paddles are used, the equipment provides only 3 arrhythmia alarms, including ventricular
fibrillation/ventricular tachycardia, PNP, and PNC.
NOTE
• The alarm level for asystole, ventricular fibrillation, ventricular tachycardia, ventricular bradycardia,
extreme bradycardia, and extreme tachycardia alarms is always high and unchangeable. These
alarms are always on. As long as the alarm condition occurs, corresponding alarm will be triggered
whether arrhythmia analysis is switched on or off.
NOTE
• Arrhythmia relearning in the case of ventricular tachycardia may affect correct arrhythmia alarm.
7.1 Overview
This chapter describes how to operate the equipment in AED Mode. While operating in AED Mode, the
equipment analyses the patient’s ECG waveforms and guides you through the defibrillation process.
The equipment starts analyzing the patient’s heart rhythm immediately after entering AED mode. When a
shockable rhythm is detected, the equipment gives a prompt and automatically starts charging. If a shockable
rhythm is not detected, a “No shock advised” prompt is given. Smart defibrillation analysis goes through
automated external defibrillation until the equipment enters CPR or abnormal pads connection occurs.
While operating in AED Mode, the capabilities of the device are limited to those essential to the performance of
semi-automated external defibrillation. Only ECG signals acquired through pads are displayed. Previously set
alarms and scheduled measurements are indefinitely paused and entry of patient information is disabled.
Additionally, the Lead Select, Alarm Pause, NIBP Start/Stop and Main Menu buttons are inactive.
7.2 Safety
DANGER
• Defibrillation current can cause operator or bystander severe injury or even death. Never touch the
patient or any equipment connected to the patient (including the bed or gurney) during
defibrillation.
• Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive
fluids such as gel, blood, or saline, and metal objects such as a bed frame or a stretcher which may
provide unwanted pathways for the defibrillating current.
• Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring
electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical arcing and
patient skin burns during defibrillation and may divert current away from the heart.
• To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres,
flammable anesthetics, or other flammable agents (such as gasoline). Keep the equipment and the
operating environment dry and clean.
WARNING
• During defibrillation, air pockets between the skin and multifunction electrode pads can cause
patient skin burns. To help prevent air pockets, make sure defibrillation pads are completely
adhered to the skin.
• Do not use dried-out pads.
CAUTION
• Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads.
Discard the pads if they become damaged.
• For patients with implantable pacemaker, the sensitivity and specificity of AED algorithm may be
impaired.
• The patient’s muscle response to defibrillation shock does not reliably indicate proper energy
delivery or defibrillator performance.
In AED mode, HR numeric and one ECG waveform acquired from the multifunction electrode pads are displayed.
Below the ECG is the information area which displays the defibrillation mode, prompt message, contact
impedance indicator, selected energy and a shock counter.
For details about the contact impedance indicator, refer to 8.7 Contact Impedance Indicator.
Heart rhythm analysis continues while the equipment charges. If a rhythm change is detected before the shock
is delivered and a shock is no longer appropriate, the stored energy is removed internally.
Once you are prompted "Do Not Touch Patient! Press Shock Button", if you do not do so within the configured
Auto Disarm time interval, the equipment disarms itself and resumes analyzing.
When the equipment is being charged or have been fully charged, you can remove the charged energy at any
time by pressing the [Pause for CPR] soft key.
You can rotate the navigation knob to switch the patient category between [Adu] and [Ped].
For defibrillation of adult patients, recommended energy level is 200 Joules.
For defibrillation of paediatric patients, recommended energy level is 50 Joules.
7.7 CPR
If [Initial CPR Time] is not configured as Off, the system enters initial CPR if AED mode is entered. You can set
[Initial CPR Time] to an appropriate time or switch it off through configuration management.
After the shock series, ECG analysis pauses and the equipment enters the CPR status. Analysis resumes at the
completion of the pause period or when you press the [Resume Analyzing] soft key in CPR status.
In current shock series, the equipment enters the CPR status if you press the [Pause for CPR] soft key after a
shock is delivered. The CPR pause time is defined by setting [CPR Time] through configuration management.
NOTE
NOTE
• You can start analyzing patient’s heart rhythm again at any time by pressing the [Resume Analyzing]
soft key in CPR status.
WARNING
•
WARNING
The CPR 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.
NOTE
• CPR metronome and its volume is affected by the settings of [Voice Prompt] and [Voice Volume] in
the AED Setup menu.
8.1 Overview
This chapter explains how to prepare for and perform asynchronous defibrillation and synchronous
cardioversion using multifunction electrode pads and external paddles.
In Manual Defib Mode, you must assess the ECG waveforms, decide if defibrillation or cardioversion is indicated,
select appropriate energy setting, charge the equipment, and deliver the shock. Text messages and a contact
impedance indicator on the screen provide relevant information to guide your throughout the defibrillation
process.
While operating manual defibrillation, besides ECG you can select to monitor parameters from SpO2, NIBP and
CO2. You can define the parameters to be monitored through configuration management. All the monitored
parameters, except ECG, are switched off by default.
Alarms are turned off automatically when you enter Manual Defib mode. Pressing the Alarm Pause button can
turn on the alarms.
8.2 Safety
DANGER
• Defibrillation current can cause operator or bystander severe injury or even death. Never touch the
patient or any equipment connected to the patient (including the bed or gurney) during
defibrillation.
• Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive
fluids such as gel, blood, or saline, and metal objects such as a bed frame or a stretcher which may
provide unwanted pathways for the defibrillating current.
• Do not allow multifunction electrode pads and paddles to touch each other or to touch other ECG
monitoring electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical
arcing and patient skin burns during defibrillation and may divert current away from the heart.
• During manual defibrillation, make sure your hands are dry and free from conductive gel to avoid
shock hazard.
• Use care when operating this equipment close to oxygen sources (such as bag-valve-mask devices or
ventilator tubing). Turn off gas source or move source away from patient during defibrillation. This
can cause an explosion hazard.
WARNING
• During synchronous cardioversion, if monitoring patient’s ECG through external paddles, artifact
introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock.
• Do not use conductive liquid. Use only conductive gel specified by the equipment manufacturer.
• If external paddles are used for defibrillation, apply the paddles tightly and evenly to the patient’s
chest to ensure good skin contact.
• Never apply the paddles to human body to verify paddle connection.
• Clinicians must select an appropriate energy level for defibrillation of pediatric patients.
• Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage
could occur.
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. If the “Impedance too high. Shock not delivered” message appears,
make sure 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.
• Alarms are switched off automatically and the “Alarm Off” message is displayed when the
equipment enters the asynchronous defibrillation mode. Alarms remain off until toggled on by
pressing the Alarm Pause button, the Sync mode is entered, or the Mode Select knob is moved to
Monitor or Pacer.
In the enlarged ECG area, an ECG waveform and related parameters are displayed. In the middle of the screen,
defibrillation mode, synchronous icon, prompt message, selected energy, contact impedance indicator
(configurable), and a shock counter are displayed.
WARNING
• Hold only the insulating parts of the paddle handles to avoid shock hazard during charging or shock
delivery.
NOTE
• Defibrillation is always performed through paddles or pads. However, during defibrillation you may
choose to monitor the ECG using an alternate ECG source (3- or 5-lead monitoring electrodes). If an
alternate ECG source is connected, any available lead may be displayed.
• When external paddles are used, the Shock button on the equipment’s front panel is disabled.
• For defibrillation of adult patients, recommended energy level is 200 Joules.
• For defibrillation of pediatric patients under 8 years, pediatric electrode pads should be used. If
pediatric electrode pads are not available, the adult electrode pads may be used instead, and set the
patient category to [Ped].
• For defibrillation of neonatal patients, set the energy level according to the patient’s clinical
condition. The energy level for neonatal patient should be lower than the default setting.
NOTE
• When internal paddles are used for defibrillation, the energy selection is automatically limited to 50
joules because of possible cardiac damage from higher energies.
• Sterilize the internal paddles before each use. Otherwise, severe infection may result.
• Clean the internal paddles after each use.
Sync marker
R-wave marker
NOTE
• When you enter synchronous cardioversion, monitoring alarms is reactivated autonomously.
NOTE
• During synchronized cardioversion, it is important to continue to hold the shock button (or the
paddle’s Shock buttons) until the shock is delivered. The equipment shocks with the next detected
R-wave.
NOTE
• During remote synchronous defibrillation, the local defibrillator/monitor does not display the ECG
waveform. To view the patient’s ECG, check the remote monitor.
• When you use an remote monitor as the ECG source, a biomedical technician must verify that the
remote monitor and the defibrillator/monitor combination will deliver a synchronized shock within
60 ms of the peak of the R-wave.
Contact Impedance
Indicator
■ indicates the impedance is too high for the defibrillation or the pads or paddles are
not properly connected to the patient.
NOTE
• It is recommended to perform defibrillation on a patient when the contact impedance is in normal
range. However, you can also perform defibrillation when the contact impedance is slightly higher.
9.1 Overview
This chapter describes how to operate the equipment when a CPR sensor is connected. For more information,
refer to CPR Sensor Operator’s Manual (P/N: 046-010423-00).
9.2 Safety
WARNING
•
G
Do not use the CPR sensor on patients under 8 years old or below 25kg weight.
• The CPR sensor is used for single patient at a time.
• The CPR sensor can be used together with Mindray defibrillator/monitor supporting the CPR
function.
• When the CPR sensor is used together with a defibrillator, make sure to follow the defibrillator
manufacturer’s instructions. Stop compressions, remove hands from the CPR sensor and remain
clear of all patient contact during defibrillation or when otherwise required, in accordance with a
proper defibrillation protocol.
• When performing CPR on a patient lying on a mattress, a backboard must be used to limit the
amount of compressed depth which is absorbed by the mattress. Depending on characteristics of
the mattress, backboard and patient, the accuracy of compensation depth cannot be guaranteed.
• Do not interrupt CPR in any case, such as low battery or self-test error. Continue CPR without
feedback from the CPR sensor.
• The CPR sensor can bear at most 80kg applied force. Applying force over this limit may result in
sensor damage.
• The CPR sensor is not intended for use in a moving environment, such as an ambulance. If used
during patient transport, the CPR sensor may provide inaccurate feedback. If CPR is indicated in a
moving environment, do not rely on the CPR sensor depth feedback during such conditions.
• Do not use the CPR sensor in conjunction with any mechanical or automated compression device.
• Do not use the CPR sensor on top of defibrillation pads.
• Cleaning or disinfection should be performed on the CPR sensor housings after each use.
• If there are signs of fluid entry, stop using the CPR sensor immediately and contact your service
personnel.
• Do not open the CPR sensor housings. All servicing and future upgrades must be carried out by
trained and authorized personnel.
• Properly performed CPR may result in fracturing of the patient’s ribs, external chest wall bruising or
abrasion.
• If there are externally visible damages on the CPR sensor or the sensor cable, stop using the CPR
sensor immediately and contact your service personnel.
NOTE
• The CPR sensor is not available in the markets of UK, Germany and France.
• If the CPR sensor is used for the first time, you should power it on by connecting it to this equipment.
The CPR feedback provides compression waveform, CCI graph, compression rate and compression depth.
■ Compression waveform area
◆ Compression waveform: a real-time waveform depicted when you performing CPR.
◆ Compression depth scale
◆ Interruption time: displays interruption time in seconds since the last compression. When stopping
CPR, the compression waveform becomes a straight line. The system starts timing the CPR
interruption.
◆ Prompt message: gives instructions for the current poor compression.
NOTE
• A CPR event is automatically saved in the equipment when the interruption time exceeds five
minutes.
• You should select [Refresh] to save a CPR event before disconnecting the CPR senosr from the
equipment.
10.1 Overview
In pacer mode, the patient’s ECG is monitored through ECG lead set and pace pulses are delivered through
multifunction electrode pads. The pads cannot be used to monitoring ECG rhythm and deliver pacing current at
the same time.
A white pacing marker is shown on the ECG waveform each time a pacer pulse is delivered to the patient. If
pacing in demand mode, white R-wave marker also appears on the ECG waveform until capture occurs.
During pacing, parameters except Resp continue to be monitored and parameter alarms remain active.
In demand mode pacing, a 3-lead or 5-lead ECG cable and electrodes are required to acquire ECG signal. Pace
pulses are delivered through multifunction electrode pads. However, the pads cannot be used to monitor the
ECG and deliver pace pulses simultaneously.
NOTE
• In Pacer mode, arrhythmia analysis is supported and available arrhythmia alarms are asystole,
ventricular vibrillation and ventricular tachycardia.
10.2 Safety
WARNING
• Heart rate displays and alarms function during pacing, but they can be unreliable. Observe the
patient closely while pacing. Do not rely on the indicated heart rate or heart rate alarms as a
measure of the patient’s perfusion status.
• To avoid explosion hazard when pacing a patient who is receiving oxygen delivery, properly route
the oxygen delivery tube. Do not keep it close to the multifunction electrode pads.
• Monitoring ECG alone is sometimes not enough to verify that the patient’s heart is providing cardiac
output.a patient’s response to pacing shall be verified by signs of improved cardiac output, such as:
a palpable pulse rate the same as the rate which pace pulses are being delivered, a rise in blood
pressure, and/or improved skin color.
CAUTION
• Use of Pacer mode may be password protected. Make sure the operator knows and remembers the
password as defined in Configuration. Failure to enter correct password will prevent the delivery of
pacing therapy.
• For treatment of patients with implanted devices such as permanent pacemakers or cardioverter-
defibrillators, consult a physician and the instructions for use provided by the device’s manufacturer
• Prolonged noninvasive pacing may cause patient skin irritation and burns. Periodically inspect the
underlying skin and change ECG electrodes and multifunction electrode pads.
NOTE
NOTE
• If pacing is interrupted for any reason, the [Start Pacing] soft key must be pressed to resume pacing.
• In pacer mode, you cannot change the patient’s internal paced status from the ECG Setup menu.
• In the case that pads poorly contact the patient, the alarm “Pacer Stopped Abnormally” and “Pads
Off” may be presented.
• Pads are not an available choice for the source of ECG waveform in Pacer mode.
In pacer mode, an ECG waveform, related parameters and waveforms are displayed. The pacer information area
shows the pacer mode, pacer rate and output, as well as pacer-related prompts and alarms. Soft keys available
for setting pacing functions are also displayed.
CAUTION
•
CAUTION
Use demand mode pacing whenever possible. Use fixed mode pacing if noise or artifact interferes
with proper sensing of R-wave or when monitoring electrodes are not available.
• During fixed mode pacing, R-wave markers do not appear on the paced beats.
• During demand mode pacing, spontaneous beats may be presented which are not associated with
the delivery of pace pulse. If the patient’s heart rate is above the pacer rate, pace pulses are not
delivered and, therefore, pacing markers do not appear.
4. Select pacer rate. If necessary, select initial pacer output. To select pacer rate or pacer output, rotate the
Navigation knob to select an appropriate value and press it to confirm the selection. Do not forget to press
the Navigation knob to exit the setting after desired value is selected.
5. Press the [Start Pacing] soft key to start pacing. The message “Pacing” appears in the pacer information
area.
NOTE
NOTE
• Pacing will not start if there is a problem with the pads cable connection, pad patient connection, or
ECG monitoring electrodes connection. If either situation occurs, a message will appear in the pacer
information area to alert you that a lead is disconnected or that the pads have a poor connection.
6. Verify that white pacing markers appear on the ECG waveform, as shown below:
Pacing mark
7. Adjust pacer output: increase pacer output until cardiac capture occurs (capture is indicated by the
appearance of a QRS complex after each pacing marker), and then decrease the output to the lowest level
that still maintains capture.
8. Verify the presence of a peripheral pulse.
You can temporarily withhold pacing pulse and observe the patient’s underlying rhythm by pressing and
holding the [4:1] soft key. This causes pacing pulse to be delivered at 1/4 of the defined pacer rate. To resume
pacing at set rate, release this key.
To stop pacing, press the [Stop Pacing] soft key. Pressing the [Start Pacing] soft key can resume pacing.
CAUTION
•
CAUTION
Pacer mode
hot key
3. If ECG electrodes are applied, use the Lead Select button to select the desired lead for viewing.
4. Select pacer rate. If necessary, select pacer output. To select pacer rate or pacer output, rotate the
Navigation knob to select an appropriate value and press it to confirm the selection.
5. Start pacing.
Press the [Start Pacing] soft key to start pacing. The message “Pacing” appears in the pacer information
area.
6. Verify that white pacing markers appear on the ECG waveform.
7. Adjust pacer output: increase pacer output until cardiac capture occurs (capture is indicated by the
appearance of a QRS complex after each pacing marker), and then decrease the output to the lowest level
that still maintains capture.
8. Verify the presence of a peripheral pulse.
You can temporarily withhold pacing pulse and observe the patient’s underlying rhythm by pressing and
holding the [4:1] soft key. This causes pacing pulse to be delivered at 1/4 of the defined pacer rate. To resume
pacing at set rate, release this key.
To stop pacing, press the [Stop Pacing] soft key.
WARNING
•
WARNING
Use care when handling the multifunction electrode pads on the patient to avoid shock hazard
during pacing.
• If you are using the pacing function with battery power and the Low Battery alarm is presented,
connect the equipment to external power or install a fully charged battery.
CAUTION
•
CAUTION
The monitoring or pacing function may be unstable in the presence of ESU or other electronic
devices.
11.1 Overview
Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of
air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is
calculated from these impedance changes, and a respiration waveform appears on the equipment screen.
11.2 Safety
WARNING
• When monitoring the patient’s respiration, do not use ESU-proof ECG cables.
• The respiration measurement does not recognize obstructive and mixed apneas: it only indicates an
alarm when a pre-adjusted time had elapsed since the last detected breath. The safety and
effectiveness of the respiration measurement method in the detection of apnea, especially the
apnea of prematurity and apnea of infancy, has not been established.
RR unit
RR alarm
high limit
RR reading
RR alarm
low limit
NOTE
• To optimize the respiration waveform, place the RA and LA electrodes horizontally when monitoring
respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration
with ECG Lead II.
NOTE
• Respiration monitoring is not for use on the patients who are very active, as this will cause false
alarms.
12.1 Overview
The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart. You can
display a pulse from SpO2 or any arterial pressure. The displayed pulse numeric is color-coded to match its
source.
PR unit
13.1 Introduction
SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated haemoglobin and
pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes
through the tissue and is converted into electrical signals by the photodetector in the probe. The SpO2 module
processes the electrical signal and displays a waveform and digital values for SpO2 and pulse rate.
This device is calibrated to display functional oxygen saturation. It provides the following measurements.
5 6
1. Pleth wave: visual indication of patient’s pulse. The waveform is not normalized.
2. SpO2 unit
3. SpO2 alarm high limit
4. SpO2 alarm low limit
5. Oxygen saturation of arterial blood (SpO2): percentage of oxygenated hemoglobin in relation to the sum of
oxyhemoglobin and deoxyhemoglobin.
6. Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation.
13.2 Safety
WARNING
• Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and
adhere to all warnings and cautions.
• When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a
laboratory co-oximeter to completely understand the patient’s condition.
• Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced current could
potentially cause burns.
• Prolonged continuous monitoring may increase the risk of undesirable changes in skin
characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two
hours and move the sensor if the skin quality changes. Change the application site every four hours.
For neonates or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor
site more frequently.
NOTE
• The SpO2 simulator can be used to check if the SpO2 sensor works properly. However, it cannot be
used to verify the accuracy of the SpO2 sensor.
SpO2%
Seconds
Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Normally, the
patient’s SpO2 may fluctuate above and below an alarm limit, re-entering the non-alarm range several times.
During such fluctuation, the system sums the number of SpO2 points, both positive and negative, until either the
Sat-Seconds limit is reached, or the patient’s SpO2 re-enters the non-alarm range and remains there.
NOTE
• In the case that the SpO2 low limit alarm value is set below the Desat limit, the the SpO2 low limit is
automatically adjusted to the Desat value.
■ Masimo Patents
This device may be covered by one or more of the following US patents and foreign equivalents: 5,758,644,
6,011,986, 6,699,194, 7,215,986, 7,254,433, 7,530,955.
■ No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device with
unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of
one or more of the patents relating to this device.
14.1 Introduction
Automatic non-invasive blood pressure monitoring uses the oscillometric method of measurement. It is
intended for adult, pediatric and neonatal patients. To understand how this method works, we’ll compare it to
the auscultative method.
With auscultation, the clinician listens to the blood pressure and determines the systolic and diastolic pressures.
The mean pressure can then be calculated with reference to these pressures as long as the arterial pressure
curve is normal.
Since the equipment cannot hear the blood pressure, it measures cuff pressure oscillation amplitudes.
Oscillations are caused by blood pressure pulses against the cuff. The oscillation with the greatest amplitude is
the mean pressure. Once the mean pressure is determined, the systolic and diastolic pressures are calculated
with reference to the mean.
Simply stated, auscultation measures systolic and diastolic pressures and the mean pressure is calculated. The
oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.
As specified in ISO 80601-2-30, NIBP monitoring is allowed while an electrosurgical operation is in progress or a
defibrillation shock is being delivered.
NIBP diagnostic significance must be decided by the doctor who performs the measurement.
NOTE
• Blood pressure measurements determined with this device are equivalent to those obtained by a
trained observer using the cuff/stethoscope auscultatory method or an intra-arterial blood pressure
measurement device, within the limits prescribed by the American National Standard, Manual,
electronic, or automated sphygmomanometers.
14.2 Safety
WARNING
• Be sure to select the correct patient category setting for your patient before measurement. Do not
apply the higher adult settings for pediatric or neonatal patients. Otherwise it may present a safety
hazard.
• Do not measure NIBP on patients with sickle-cell disease or any condition where skin damage has
occurred or is expected.
• Use clinical judgment to determine whether to perform frequent unattended blood pressure
measurements on patients with severe blood clotting disorders because of the risk of hematoma in
the limb fitted with the cuff.
• Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This
could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff
inflation.
• If you doubt the NIBP readings, determines the patient’s vital signs by alternative means and then
verify that the equipment is working correctly.
• Do not use the NIBP cuff on the arm on the side of a mastectomy.
• Continuous CUFF pressure due to connection tubing kinking may cause blood flow interference and
resulting harmful injury to the patient.
NOTE
• It is recommended that the patient relaxes as much as possible before performing measurement
and that the patient does not talk during NIBP measurement.
• It is recommended that 5 min should elapse before the first reading is taken.
• The operator should not touch the cuff or tubing during NIBP measurement.
WARNING
•
WARNING
Continuous non-invasive blood pressure measurements may cause purpura, ischemia and
neuropathy in the limb with the cuff. Inspect the application site regularly to ensure skin quality and
inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If any abnormity
occurs, move the cuff to another site or stop the blood pressure measurements immediately.
1 2
3 7
4
8
5
1. Measurement mode
2. Pressure unit: mmHg or kPa
3. NIBP alarm high limit
4. NIBP alarm low limit
5. Time of last measurement
6. Systolic pressure
7. Diastolic pressure
8. Mean pressure at the completion of measurement, or cuff pressure during the measurement
NOTE
NOTE
• Setting initial cuff inflation pressure is disabled during NIBP measurement.
• The initial cuff inflation pressure is restored to the default setting if NIBP module has been reset or
patient category has been changed.
15.1 Introduction
CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the
patient’s airway by measuring the absorption of infrared (IR) light of specific wavelengths. The CO2 has its own
absorption characteristic and the amount of light passing the gas probe depends on the concentration of the
measured CO2. When a specific band of IR light is passed through respiratory gas samples, some of IR light will
be absorbed by the CO2 molecules. The amount of IR light transmitted after it has been passed through the
respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the
concentration of CO2 is calculated.
CO2 measurements are used to monitor the patient’s respiratory status.
CO2 monitoring is intended for adult, pediatric and neonatal patients.
15.2 Safety
WARNING
• Remove the airway sampling line from the patient’s airway while nebulized medications are being
delivered.
• Leakage in the breathing or sampling system may cause the displayed EtCO2 values to be
significantly low. Always make sure that all components are securely connected.
• EtCO2 values measured from the CO2 module may differ from those of from the blood gas analysis.
• Route all tubing away from the patient’s throat to avoid strangulation.
• Inspect the airway adapter for a tight connection and proper operation before attaching it to the
patient.
• Squeezing or bending the sampling line during the CO2 measurement may cause inaccurate CO2
reading or no reading.
4
3
1 2
1. A CO2 waveform.
2. End tidal CO2 value (EtCO2): the CO2 value measured at the end of the expiration phase.
3. Fraction of inspired CO2 (FiCO2): the smallest CO2 value measured during inspiration.
4. Airway respiration rate (awRR): the number of breaths per minute, calculated from the CO2 waveform.
CO2 adapter
Sampling line
Airway adapter
◆ For non-intubated patients, place the nasal cannula onto the patient.
4. Connect the gas outlet to the scavenging system using an exhaust tube.
After the CO2 module is connected, it enters measure mode by default and the equipment displays CO2 Starting.
CO2 can be measured after the start-up is complete.
CAUTION
• Connect the gas outlet to the scavenging system when measuring CO2.
NOTE
• If not necessary, do not disconnect the CO2 adapter from the equipment after the first installation.
This reduces the risk of the CO2 adapter becoming lost or damaged.
NOTE
• The CO2 module temporally stops measuring during zeroing.
WARNING
• Make sure that the appropriate compensations are used. Inappropriate compensations may cause
inaccurate measurement values and result in misdiagnosis.
WARNING
• When taking the CO2 measurement on patients who are receiving or have recently received
anesthetics, connect the outlet to a scavenging system, or to the anesthesia machine/ventilator, to
avoid exposing medical staff to anesthetics.
To remove the sample gas to a scavenging system, connect an exhaust tube to the gas outlet connector of the
module.
During patient monitoring or therapy, some events may exert effects on the patient and as a result change
related waveforms and parameter values. To help analyzing the waveforms or numerics at that time, you can
mark these events.
Before marking an event, you can define events A to L, for example, define event D as injecting Atropine. You can
only define an event through configuration management. Event A is always [Generic] and cannot be changed.
To mark an event,
1. In Monitor mode, Manual Defib mode, or Pacer mode, press the [Event] button on the front panel to access
the [Mark Event] menu.
2. Select an event you want to mark from [A] to [L], or select [Exit] to return to the main screen.
In AED mode, pressing the [Event] button directly marks Event A “Generic”.
When you mark an event, the event name and the time when the event is triggered will be displayed at the
prompt information area. This information disappears automatically after a period of 5 seconds.
During patient monitoring, the freeze feature allows you to freeze the currently displayed waveforms on the
screen so that you can have a close examination of the patient’s status. Besides, you can select any frozen
waveform for recording. Waveforms can be frozen only in the Monitor Mode.
NOTE
• Pausing or switching off alarms will not be recorded as events. The time of these operations will not
be recorded in the system log.
• A total loss of power has no impact on the saved events.
• Earlier-recorded events might be overwritten by later ones if it reaches capacity.
19.1 Introduction
The data management function enables you to:
■ Edit patient information;
■ Review patient events; and
■ Export patient data to USB memory.
To access data management: press the Main Menu button on the front panel to enter the Main Menu, and then
select [Others>>] → [Archives>>] → [Yes].
Only in Monitor, Manual Defib and Pacer mode can you access archive mode. When you enter the Archives Main
screen, patient monitoring and therapy automatically end and the patient last admitted will be saved as the
latest archived patient.
NOTE
• Do not remove the USB flash memory from the equipment before data is completely exported.
NOTE
• If you change the ECG Lead, Gain or Filter during recording, the recorded ECG waveform changes
accordingly, but the label of Lead, Gain or Filter recorded remains unchanged.
CAUTION
• Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s print head, the
recorder may be unable to print, or poor print quality may result.
• Never pull the recorder paper with force when a recording is in process. Otherwise, it may cause
damage to the recorder.
• Do not leave the recorder door open unless you have to reload paper or remove troubles.
CAUTION
• Do not use anything that may destroy the thermal element.
• Do not add unnecessary force to the thermal head.
21.1 Overview
The equipment supports the network function. The equipment can send real-time data to the CMS through
wired and wireless networks, send HL7 messages.
NOTE
• The design, installation, restruction and maintenance of the wireless network’s distribution shall be
performed by authorized service personnel of our company.
• The existence of obstacles (such as wall) will exert impact on data transferring or even cause
network interruption.
• The Central Monitoring System is capable of connecting up to 4 bedside monitors via the wireless
network.
22.1 Introduction
Configurations management enables you to customize you equipment to best meet your needs. With this
function, you can:
■ Change system configuration
■ Record system configuration
■ Restore the factory default configuration
After the system configurations have been changed, the equipment restarts and new configuration settings take
effect immediately.
WARNING
•
WARNING
22.2 Password
Accessing configuration management is password protected. The required password is set to 315666 before the
equipment leaves the factory.
WARNING
•
WARNING
Never connect the equipment with the patient while performing configuration management.
Neo 200
PR Low Adu 20 to (High-2) 50
Ped 75
Neo 100
QRS Volume 0 to 10 2 This setting is linked with
the [QRS Volume] setting
in the [ECG Setup] menu
23.1 Introduction
The equipment is designed to operate on battery power when external power supply is not available. The
battery is charged whenever the equipment is connected to AC mains or the DC power supply through an
external DC/AC adapter, regardless of whether or not the equipment is currently turned on. In case of power
failure, the equipment will automatically run power from internal batteries. So we recommend you always install
a fully charged battery in the equipment.
The equipment is configured with one smart lithium ion batteries which are free of maintenance.
On-screen battery symbols indicate the current battery charge status:
■ ≤100%, but >80% of capacity
■ ≤80%, but >60% of capacity
■ ≤60%, but >40% of capacity
■ ≤40%, but >20% of capacity
■ ≤ 20% of capacity
■ Low battery and charging is required immediately
■ Battery is not installed
You can also check the battery’s charge status by pressing the fuel gauge button on the battery to illuminate the
battery gauge. The fuel gauge consisting of 5 LEDs, each LED represents a charge of approximately 20% of
capacity.
If the battery charge is too low, a technical alarm will be triggered and the “Low Battery” message displayed in
the Technical Alarm Area. At this moment, change the battery or apply external power to the equipment.
WARNING
• Keep the batteries out of children’s reach.
• Use only specified batteries.
• The batteries should be charged in this equipment or in a device approved by the equipment
manufacturer.
NOTE
• Always connect the equipment to AC mains whenever it is possible.
• Always install a fully charged battery in the equipment.
• After long term use, the power capacity indicated by the battery symbol may be different from the
actual capacity. Always observe the alarm information displayed on the screen.
• Remove the battery before transporting the equipment or if the equipment will not be used for a
long time.
NOTE
• The Low Battery alarm means that the battery is beginning to weaken and should be replaced at the
first opportunity. At least 20 minutes of monitoring and six full energy shocks can be performed
when the Low Battery alarm is activated. Replace the battery or connect the equipment to AC mains
as soon as possible.
NOTE
• Battery operating time depends on the device configuration and operation. For example, measuring
NIBP repeatedly will shorten the battery operating time.
NOTE
• Do not store a battery in the equipment if the equipment is not used for an extended period of time.
• Storing batteries at temperature above 38°C (100°F) for an extended period of time significantly
shorten the life expectancy of a battery
Use only the substances approved by the equipment manufacturer and methods listed in this chapter to clean
or disinfect your equipment. Warranty does not cover damages caused by unapproved cleaning and disinfection
substances or methods.
We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling
infection. For the method to control infection, consult your hospital’s infection control officer or epidemiologist.
In this chapter we only describe cleaning and disinfection of the main unit. For the cleaning and disinfection of
external paddles and other reusable accessories, refer to instructions for use of corresponding accessories.
WARNING
• The responsible hospital or institution shall carry out all cleaning and disinfection procedure
specified in this chapter.
WARNING
• Be sure to shut down the system, disconnect the power cord and other cables, and remove the
batteries before cleaning the equipment.
CAUTION
• Contact your service personnel in case of spilling liquid on the equipment or accessories.
NOTE
NOTE
• To clean or disinfect reusable accessories, refer to the instructions for use delivered with the
accessories.
24.2 Cleaning
Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of dust and sand in your
place, the equipment should be cleaned more frequently. Before cleaning the equipment, consult your hospital’s
regulations for cleaning the equipment.
Recommended cleaning agents are:
■ Water
■ sodium hypochlorite bleach (10%, Sodium hypochlorite)
■ Hydrogen peroxide (3%)
24.3 Disinfecting
Disinfect the equipment as required in your hospital’s servicing schedule. Cleaning equipment before
disinfecting is recommended.
24.4 Sterilization
Sterilization is not recommended for this monitor, related products, accessories, or supplies unless otherwise
indicated in the Instructions for Use that accompany the products, accessories or supplies.
WARNING
• Failure for the responsible individual, hospital or institution employing this equipment to
implement a satisfactory maintenance schedule may cause undue equipment failure and possible
health hazards.
• The safety checks or maintenance involving any disassembly of the equipment should be performed
by professional servicing personnel. Otherwise, undue equipment failure and possible health
hazards could result.
• If you find a problem with any of the equipment, contact your service personnel or the
manufacturer.
• No modification of this equipment is allowed.
• The service personnel must be properly qualified and thoroughly familiar with the operation of the
equipment.
• Do not open the equipment housings. All servicing and future upgrades must be carried out by the
service personnel.
• Do not touch, connect or apply any electrode pads and paddles during user test and automated test.
Otherwise, electric shock could result.
25.1 Overview
Attending to routine maintenance is vital to keeping the defibrillation ready to respond in an emergency.
Routine maintenance involves:
■ Shift check
■ Automated tests
■ User test
■ Recorder inspection
■ ECG cable test
■ Manual defibrillation test
■ Pacing test
■ NIBP tests
■ NIBP overpressure protection test
■ CO2 calibration test
■ Electrical safety tests
Paddles and cables are critical parts for defibrillation but damageable. We recommend you to check the
appearance and performance of these parts every day and replace them every 3 years.
The ECG cables are critical parts for data acquisition and analysis but damageable. We recommend you to
inspect the cable as described in C BeneHeart Defibrillator Shift Checklist.
In case of any damage or abnormality, remove the equipment from use. Contact the hospital’s biomedical
engineers or your service personnel immediately.
Automated Daily Test can be initiated between 0:00 am to 5:00 am. To set auto test time, enter the Configuration
Main men, and select [Test Setup] → [Auto Test Time]. The default setting is 3:00 am.
The equipment displays no information on the screen during Auto Test.
In the case that Auto Test fails, the red status indicator is illuminated and the equipment gives a beep
periodically till the equipment is restarted. Then a low level technical alarm “Last Auto Test Failed” will be
displayed. The “Last Auto Test Failed” alarm is cleared if Auto Test is passed for the next time or the failed Routine
Test or Energy Delivery Test is passed during User Test. We recommend you to perform the User Test if Auto Test
failed.
At the completion of Auto Test, a report is saved automatically. Enter the Configuration Main menu → select
[Record Setup] → [Auto Test Report] → select [On], [Off], or [Only if Failed], you can choose to print the Auto
Test report or not after the tests are completed, or print it only if Auto Test Failed.
If the equipment is connected to the CMS, the Auto Test Report will be automatically transmitted to the CMS at
the completion of Auto Test. For details on connecting to the CMS, refer to 21.3 Connecting the CMS.
You can review the result of Auto Test by selecting the [History] softkey from the User Test Main menu.
NOTE
NOTE
• When the Auto Test is passed with the message “Test load not connected with cable”, this means the
equipment only passes the internal discharge test. The discharge test by connecting the test load is
not performed.
• With power off, Auto Test is performed only when AC mains is connected.
• Thoroughly clean the paddles and properly place them in the paddle tray after each use. Automated
test passes only when paddles properly contact the metal parts of the paddle tray.
• Install at least one battery and properly place the external paddles in the paddle tray or connect the
pads cable and 50 Ω test load. Otherwise the Auto Test will fail
WARNING
• Do not perform user test when a patient is connected to the equipment.
NOTE
• Before user test or after each use, thoroughly clean the paddles and properly place them in the
paddle tray. User test passes only when paddles properly contact the metal parts of the paddle tray.
• If the impedance value indicated by impedance indicator changes greatly, check that paddles and
metal parts of the paddle tray are clean.
• Install at least one battery and properly place the external paddles in the paddle tray or connect the
pads cable and 50 Ω test load. Otherwise the User Test will fail.
NOTE
• The tested controls are indicated in green during controls test.
If any of above items fails, the red status indicator will be illuminated and a low level technical alarm “Last User
Test Failed” will be displayed in the technical alarm area when the equipment is restarted. We recommend you to
perform a successful User Test to clear this alarm.
NOTE
• The “Off” position of the Mode Select knob is not tested during the Controls Test. If you turn the
knob to “Off” for more than 3 seconds. The equipment is turned off.
NOTE
• In case that automated Routine Test is not performed, we recommend you to run Routine Test once
per day through User Test.
Charge/discharge
1. Remove the batteries and connect the equipment with AC mains. Turn the Mode Select knob to Manual
Defib.
2. Connect the external paddles to the equipment and place the paddles on the defibrillator/pacer analyzer.
3. Enter the Configuration Main screen. From the Record Setup menu set [Shock Event] to [On] so that shock
events can be recorded automatically if happened.
4. Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as 0 or
blank.
5. Select the energy level to 1J.
6. Charge/discharge the equipment to verify the energies measured by the analyzer meet the following
accuracy:
Energy Disarming
1. Run the equipment on fully charged battery. Move the Mode Select knob to Manual Defib.
2. Connect the external paddles to the equipment and place the paddles on the defibrillator/pacer analyzer.
3. Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as 0 or
blank.
4. Select the energy level to 360J.
5. Charge the equipment.
6. Verify that the charge tone is issued during charging.
7. Press the “Disarm” soft key to discharge the energy internally.
8. Verify that a prompt “Charge Removed” appears on the screen and the charge done tone stops.
9. Verify that the value measured by the analyzer is 0J or blank.
10. Enter the Configuration Main menu, select [Manual Therapy Setup] and set [Time to Auto Disarm] to
[60s].
11. Exit “Configuration Management”. The equipment restarts automatically.
12. Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as 0 or
blank.
13. Select the energy level to 360J.
14. Charge the equipment. Count time after charging is completed. Verify that the prompt “Shock Removed”
appears on the equipment and the energy measured by the analyzer is 0J or blank after 60 seconds.
15. Use multifunctional electrode pads. Repeat Step 3 to Step 14.
Synchronous Defibrillation
1. Connect the external paddles and ECG cable to the equipment. Place the paddles ECG electrodes on the
defibrillator/pacer analyzer.
2. Set the analyzer to Time Measurement Mode and output normal sinus rhythms, e.g. amplitude value 1mV
and HR 60bpm.
3. Enter Configuration Management. In the [Manual Therapy Setup] menu, set [Sync After Shock] to [On].
4. Adjust the energy setting of the equipment to be 10J.
5. Press the [Enter Sync] soft key to start synchronous defibrillation. If Remote Sync is switched on, press the
[Enter Sync] soft key and select [Local] to start synchronous defibrillation
6. Select Pads as the ECG source and begin charging.
7. When charging finishes, press and hold the “Shock” button to deliver a shock.
8. Verify that synchronous discharge succeeds and the delivered energy measured by the analyzer is 10J±2J.
9. Verify that the delay time of synchronous defibrillation measured by the analyzer is less than 60ms.
10. Verify that the synchronous discharge mark appears on the R wave.
11. Verify that the prompt messages are correct during testing.
12. Select lead II as ECG source and perform charging. Repeat steps 7 to 11.
13. Use multifunctional electrode pads. Repeat steps 2 to 12.
2. Before inflation, the reading of the manometer should be 0. If not, disconnect the airway and reconnect it
until the readings is 0.
3. In the Installation Mode Main menu, select [Maintain NIBP] → [Start Accuracy Test].
4. Compare the value of manometer with the value displayed on the equipment’s screen. The difference
should be no greater than 3 mmHg.
5. Raise the pressure in the metal vessel to 50 mmHg with the balloon pump. Repeat steps 3 and 4.
6. Raise the pressure in the metal vessel to 200 mmHg with the balloon pump. Repeat steps 3 and 4.
When the accuracy test is completed, the result will be displayed.
If the difference between the values of the manometer and defibrillator/monitor is greater than 3 mmHg,
contact your service personnel.
When you select the [Start Accuracy Test] button, it turns to be [Stop Accuracy Test]. Select [Stop Accuracy
Test], accuracy test stops and the button turns to be [Start Accuracy Test] again.
Defibrillator/monitor Cylinder
4. In the Installation Mode Main menu, select [Maintain NIBP] → [Start Leakage Test].
After about 20 seconds, the equipment automatically deflates. This means the leakage test is started.
When the accuracy test is completed, the result will be displayed. If the message “NIBP Pneumatic Leak” is
displayed, it indicates that the NIBP airway may have leakages. Check the tubing and connections for leakages,
and then perform a leakage test again.
If the problem persists, contact your service personnel.
Tubing
Gas valve
Defibrillator/
monitor
Gas cylinder
CAUTION
• Data transmission via wireless transmission module may sometimes be unreliable. A strong signal
and stationary transmission will improve the transmission success rate.
• Periodically test your equipment transmission function to ensure that the equipment and
transmission accessories are ready for use.
The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be
in compliance with ISO 10993-1.
WARNING
•
WARNING
Use accessories specified in this chapter. Using other accessories may cause damage to the
equipment or not meet the claimed specifications.
• Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and
affect the measurement accuracy.
• Check the accessories and their packages for any sign of damage. Do not use them if any damage is
detected.
• At the end of its service life, the equipment, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such products to avoid contaminating the
environment.
• When using the accessories, consider the accessories’ operating temperature. Refer to
corresponding accessory’s instruction for use for details.
ECG Electrodes
Lead Sets
Adapting Cable
Extension Cables
SpO2 Sensors
The SpO2 sensor material that patients or other staff will come into contact with have undertaken the bio-
compatibility test and is verified to be in compliance with ISO 10993-1.
Tubing
26.6 Miscellaneous
Description Model PN
Rechargeable lithium ion battery LI24I005A 022-000296-00
LI24I001A 022-000047-00
Test load MR6901 0651-20-77032
Test load MR6905 040-000413-00
Wireless transmission module kit / 115-006297-00
Y-cable / 009-000829-00
Synchronous defibrillation input cable / 0651-20-77046
Grounding cable UL1015/14AWG 1000-21-00122
DC/AC adapter / 0010-30-12471
Patient data management software kit / 0651-30-77145
Carrying case and shield cover / 115-018610-00
D3 back pouch / 115-008708-00
Conducting gel mount kit / 115-007857-00
Pothook kit / 115-007587-00
Size
Width × depth × height, 288×203×275 mm
without external paddles
Maximum Weight
6.1 kg, including a battery, external paddles and 3-leadwire.
Display
Type TFT Color LCD
Size 7 inch
Resolution 800×480 pixels
Viewed waveforms Max. 3
Wave viewing time Max. 16s (ECG)
Equipment connectors
USB connector Connects USB flash memory
Multifunctional connector Connects a cable for analog output or a cable for defibrillator
synchronization.
RJ45 connector Connects standard network cable.
Voltage (V)
Time (ms)
AED
Shock series Energy level: 100 to 360J, configurable for adult;
10 to 100J, configurable for pediatric
Shocks: 1, 2, 3, configurable;
Meeting AHA guidelines 2015 by default.
Shockable rhythm VF, VT (HR>150bpm and QRS width>120ms)
Resp
Technique Trans-thoracic impedance
Measurement range 0 to 200 rpm
Resolution 1 rpm
Accuracy 121 to 200 rpm: ±2 rpm
0 to 120 rpm: ±1 rpm
Respiration excitation waveform <300 μA, sinusoid, 62.8 kHz (±10%)
Minimum respiration 0.3Ω
impedance threshold
Bandwidth 0.2 to 2.5 Hz (-3 dB)
Reference impedance range 2200 to 4500Ω, using an ECG cable with 1 kΩ resistor
Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
NIBP
Standards Meet standard of ISO 80601-2-30
Technique Oscillometry
Mode of operation Manual, Auto and STAT
Auto mode repetition intervals 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 60, 90, 120, 180, 240 or 480 min
STAT mode cycle time 5 min
Static pressure measurement 0mmHg to 300mmHg
range
*Measurement accuracy verification: In adult and pediatric modes, the blood pressure measurements measured
with this device are in compliance with the Standard for Non-invasive sphygmomanometers (ISO 81060-2)in
terms of mean error and stardard deviation by comparing with intra-arterial or auscultatory measurements
(depending on the configuration) in a typical patient population. For auscultatory reference, the 5th Korotkoff
sound was used to determine the diastolic pressure.
In neonatal mode, the blood pressure measurements measured with this device are in compliance with the
American National Standard for Non-invasive sphygmomanometers (ISO 81060-2) in terms of mean error and
stardard deviation by comparing with intra-arterial measurements (depending on the configuration) in a typical
patient population.
CO2 Module
Measurement range 0 to 150 mmHg
Accuracy* Full accuracy mode:
0 to 40 mmHg: ±2 mmHg
41 to 76 mmHg: ±5% of reading
71 to 99 mmHg: ±10% of reading
100 to 150 mmHg: ±3 mmHg+8% of reading
ISO accuracy mode: Add ±2mmHg to the full accuracy mode
Sart-up time 20 s (typical), 90 s (maximum)
Accuracy drift Meets the requirement for measurement accuracy within 6 hours.
Resolution 1mmHg
Sample flowrate Connecting the Oridion sampling line: 50 ml/min
Sample flowrate tolerance ±15% or ±15 ml/min, whichever is greater.
Rise time Measured with a Oridion sampling line: ≤250 ms @ 50 ml/min (standard
sampling line) or ≤280 ms @ 50 ml/min (extended sampling line)
Response time Measured with a Oridion sampling line: ≤5 s @ 50 ml/min (standard
sampling line) or ≤6.5 s @ 50 ml/min (extended sampling line)
awRR measurement range 0 to 150 rpm
awRR accuracy <60 rpm: ±1 rpm
60 to 150 rpm: ±2 rpm
awRR resolution 1 rpm
Battery
Battery type Smart lithium ion battery, rechargeable and free of maintenance, one battery can
be installed, two types of batteries can be configured
Battery LI24I005A: 15.1V, 5600mAh
Battery LI24I001A: 14.8V, 3000mAh
Charged by the equipment Less than 3 hours to 90% and less than 4 hours to
connected to the AC power 100% with equipment power off;
Battery LI24I005A charge Less than 5 hours to 90% and less than 6 hours to
time 100% with equipment power on.
Charged by the charger Less than 5 hours to 90% and less than 6 hours to
station 100%.
Charged by the equipment Less than 2 hours to 90% and less than 3 hours to
connected to the AC power 100% with equipment power off;
Battery LI24I001A charge Less than 3.5 hours to 90% and less than 4.5 hours
time to 100% with equipment power on.
Charged by the charger Less than 2.5 hours to 90% and less than 3 hours
station to 100%.
Note: The specifications above base on a new battery, and at 20ºC±5 °C of ambient temperature.
WARNING
• The equipment may not meet the performance specifications if stored or used outside the specified
temperature and humidity ranges.
Operating environment
Operating temperature 0 to 45ºC (at least 60 minutes of working time when the temperature
reduces from room temperature to – 20ºC)
(5 to 40ºC for CO2 module)
Operating humidity 10 to 95%, non-condensation
Operating altitude -381mmHg to + 4575mmHg (106.2kPa to 57kPa)
430mmHg to + 790 mmHg for CO2 module (57.3kPa to 105.3kPa)
Storage environment
Storage temperature -30 to 70ºC
(-20 to 60ºC for CO2 module)
Storage humidity 10 to 95%, non-condensation
Storage altitude -381mmHg to +4575 mmHg (106.2kPa to 57kPa)
430mmHg to + 790 mmHg for CO2 module (57.3kPa to 105.3kPa)
Vibration
Complies with requirements of 21.102, ISO9919.
Bump
Complies with the requirements of 6.3.4.2, EN1789.
Peak acceleration: 15g
Duration: 6ms
Number of impacts: 1000
Impact direction: vertical impacts are applied when the equipment under test is placed at normal operating
position.
Free fall
Complies with the requirements of 6.3.4.3, EN1789.
Drop height: 0.75 m
Number of drops: once for each of the six surfaces
B.1 EMC
The equipment meets the requirements of IEC 60601-1-2.
WARNING
•
WARNING
Use of accessories, transducers, and cables other than those specified may result in increased
emission and/or decreased electromagnetic immunity of the defibrillator/monitor.
• The equipment or its components should not be used adjacent to or stacked with other devices. If
adjacent or stacked use is necessary, the equipment should be observed to verify normal operation
in the configuration in which it will be used.
• Other devices may affect this equipment even though they meet the requirements of CISPR.
• When the inputted signal is below the minimum amplitude provided in technical specifications,
erroneous measurements could result.
NOTE
NOTE
• The equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided below.
• Portable and mobile RF communications equipment may affect this equipment.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b Compliance level in the ISM frequency bands between 150 kHz to 80 MHz and in the frequency range 80
MHz to 2.5 GHz are intended to decrease the likelihood that portable/ mobile communication equipment
could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor
of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency
ranges.
c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur 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
device is used exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the device.
d Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m.
The device comply with the essential requirements and other relevant provisions of Directive 2014/53/EU.
WARNING
•
WARNING
Keep a distance of at least 20 cm away from the monitor when Wi-Fi function is in use.
Inspect the defibrillator/monitor once every day. Place a “√” in the “Pass/Fail” box as you check the item , or place
a "-" if not applicable. Describe the problem if there is any abnormity.
Equipment Name: _____________ Serial Number: _______________ Department: _________________
*: Perform this test only when automatic selftest is not performed using pads cable or when selftest fails.
**: Perform this test only when automatic selftest is not performed using paddles or when selftest fails.
NOTE
• Remember to disconnect the test load when the test is finished. Otherwise, delay could happen in
patient treatment.
This chapter lists only the most important physiological and technical alarm messages. Some messages
appearing on your equipment may not be included.
In this chapter:
■ The “I” column indicates how indications of technological alarms are cleared after the hardkey or
[Alarm Reset] softkey is pressed: “A” means all alarm indications are cleared; “B” indicates alarm light and
alarm tones are cleared and the alarm messages change to prompt messages; and “C” indicates only alarm
tone is disabled, but alarm light and alarm message remain presented.
■ The “L” column indicates the alarm level: “H” refers to high, “M” refers to medium, and “L” refers to low. “*”
means the alarm level is user-adjustable.
■ XX represents a measurement or parameter label, such as ECG, NIBP, HR, PVCs, RR, SpO2, PR, etc.
In the “Cause and solution” column, corresponding solutions are given instructing you to troubleshoot
problems. If the problem persists, contact your service personnel.
Vent. Brady H
Extreme Tachy H
Extreme Brady H
Brady M*
Tachy M*
R on T M*
PVC M*
VT>2 M*
Couplet M*
Bigeminy M*
Trigeminy M*
Missed Beats M*
Vent. Rhythm M*
Multif. PVC M*
Nonsus. Vtac M*
Pause M*
Irr. Rhythm M*
A-Fib M*
PNP M* The pacer appears abnormal. Check the pacer.
PNC M*
NIBP Pneumatic Leak L A Check the NIBP cuff and pump for leakages.
NIBP Cuff Type Wrong L A The cuff type applied mismatches the patient
category. Verify the patient category and replace the
cuff.
NIBP Air Press. Err L A An error occurred to the air pressure. Verify that the
equipment application site meets the
environmental requirements and check if there is
any source that affects the air pressure.
NIBP Weak Signal L A The patient’s pulse is weak or the cuff is loose. Check
the patient’s condition and change the cuff
application site. If the problem persists, change the
cuff.
NIBP Sig. Saturated L A The NIBP signal is saturated due to excess motion or
other sources.
NIBP Overrange L A The patient’s NIBP value may be beyond the
specified measurement range.
NIBP Excessive L A Check the patient’s condition and reduce the
Motion patient motion.
NIBP Equip Err H A An error occurred during NIBP measurement and
NIBP Time Out L A therefore the equipment cannot perform analysis
correctly. Check the patient’s condition and NIBP
NIBP Measure Failed L A connections, or replace the cuff.
NIBP Reset For Err L A An illegal reset occurred during NIBP measurement.
Check if the airway is occluded.
The following electrical safety tests are recommended as part of a comprehensive preventive maintenance
program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to
either the patient or the operator. Additional tests may be required according to local regulations.
All tests can be performed by using commercially available safety analyzer test equipment. These procedures
assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular testers
complying with IEC 60601-1 used in Europe, such as Fluke, Metron or Gerb, may require modifications to the
procedure. Please follow the instructions of the analyzer manufacturer.
The electrical safety inspection should be periodically performed per year. The safety analyzer also proves to be
an excellent troubleshooting tool to detect abnormalities of line voltage and grounding, as well as total current
loads.
LIMITS
For all countries, R = 0.2 Ω Maximum
LIMITS
For UL60601-1,
◆ 300 μA in Normal Condition
◆ 1000 μA in Single Fault Condition
For IEC60601-1,
◆ 500 μA in Normal Condition
◆ 1000 μA in Single Fault Condition
LIMITS
For CF applied parts
◆ 10μA in Normal Condition
◆ 50μA in Single Fault Condition
LIMITS
■ For CF applied parts: 50 μA
■ For BF applied parts: 5000 μA
LIMITS
For CF applied parts,
◆ 10μA in Normal Condition
◆ 50μA in Single Fault Condition
For BF applied parts,
◆ 100μA in Normal Condition
◆ 500μA in Single Fault Condition
NOTE
NOTE
• Make sure the safety analyzer is authorized comply with requirement of IEC61010-1.
• Follow the instructions of the analyzer manufacturer.
F.1 Units
μA microampere
μV microvolt
A ampere
Ah ampere hour
bpm beat per minute
bps bit per second
ºC centigrade
cc cubic centimeter
cm centimeter
dB decibel
DS dyne second
ºF fahrenheit
g gram
GHz gigahertz
GTT gutta
h hour
Hz hertz
in inch
J Joule
k kilo
kg kilogram
kPa kilopascal
L litre
lb pound
m meter
mAh Milliampere hour
Mb mega byte
mcg microgram
mEq milli-equivalents
mg milligram
min minute
ml milliliter
mm millimeter
mmHg millimeters of mercury
ms millisecond
mV millivolt
mW milliwatt
MΩ megaohm
nm nanometer
rpm breaths per minute
s second
F.2 Symbols
– negative, minus
% percent
/ per; divide; or
+ plus
= equal to
< less than
> greater than
≤ less than or equal to
≥ greater than or equal to
± plus or minus
× multiply
© copyright
In order to provide high quality product and perform better service, we are going to track our product. Please
contact us with the device tracking information when you have received your defibrillator/monitor:
Please fill the information in the next page, cut the table and fax it to +86 755 26582934. You can also email your
information to [email protected].
User Information
Customer Name
Department name
Address
Contact Person
Email Address
Device Information