8107 ZQ-1203G User Manual 2.0
8107 ZQ-1203G User Manual 2.0
8107 ZQ-1203G User Manual 2.0
Welcome to use ZQ-12 Series Digital Electrocardiograph Machine (hereinafter referred as ECG
machine, also referred to as the “product”, “system”, or “device”) from Wuhan Zoncare Bio-medical
Electronics Co., Ltd. In order to enable you to skillfully operate the ECG machine as soon as possible,
we provide you this manual with specific instructions for use (technical instructions). Please read it
carefully when you install and use this machine for the first time. Be sure to put this manual together
with the machine. If it’s damaged or lost, please contact Zoncare to purchase a new one.
Based on the needs of improving the parts and the machine’s performance and reliability, some
modifications may be made to the machine (both hardware and software). Then relevant literal contents
will be modified and added. But there might be some descriptive inconformity, thanks for your kind
understanding. The contents in this manual are subject to change without notice.
If there are any errors and omissions in this manual, welcome you to correct.
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Manufacturer’s information:
Product name: ZQ-12 Series Digital Electrocardiograph Machine
Registered address: #380, High-tech 2nd road, Eastlake high-tech district, Wuhan, Hubei,
P. R. China
Production address: #380, High-tech 2nd road, Eastlake high-tech district, Wuhan, Hubei,
P. R. China
TEL: +86(27)87170581
TEL/FAX: +86(27)87770203
Authorized Representative:
Company Name: Well kang Limited
Company Address: The Black Church, St. Mary's Place, Dublin 7, Ireland
Tel: +353(1)4433560
Fax: +353(1)6864856
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Statement
Wuhan Zoncare Bio-medical Electronics Co., Ltd reserves the copyright of this manual published
non-publically.
Any part of this manual should not be photocopied, revised or translated into foreign languages
Zoncare does not assume any legal responsibility neither for the accidental or inevitable loss caused
by wrongful operation or installation errors, nor for the legal consequences caused by violation of
This manual has been strictly checked. But Zoncare does make any guarantee for its contents. We
reserve the rights of revising and modifying this manual at any time without prior notice.
All illustrations in this manual are for reference only, whose settings or data may be not completely
consistent with the actual display you would see on the product.
It’s suggested to use designated paper, whose specifications are Zoncare 50mm×20m (for single-
channel) and 80mm×20m (for multi-channel), grid, rolling outward, chemical thermal paper with
Zoncare is responsible for the safety, reliability and performance of hardware supplied by Zoncare
authorized by Zoncare.
The electrical installation of the room where the device is used complies with the requirements of
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Safety Conventions
This manual uses the term WARNING, CAUTION, and NOTICE to point out hazards and to designate a
degree or level of seriousness. Familiarize yourself with the following definitions and their significance.
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Contents
1.1.2 CAUTION..................................................................................................................4
1.1.3 Using with Defibrillator, Cardiac Pacemaker and Surgical Electrotome Simultaneously
.............................................................................................................................................5
1.2 Introduction...........................................................................................................................6
1.2.1 Ways of Using This Manual.......................................................................................6
1.2.4 Contraindication.........................................................................................................6
2.1.2 LCD..........................................................................................................................14
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2.2.3 Battery Power Supply..............................................................................................21
2.3.19 Options of Printing Analysis report (only available for the machine with analyzing
function)............................................................................................................................39
2
2.3.21 ECG Review (only available for some types).......................................................42
2.3.28.1 Year.............................................................................................................49
2.3.28.2 Month and Day...........................................................................................50
2.3.28.3 Hour and Minute.........................................................................................51
2.3.29 Language Setup......................................................................................................52
3.1.2 Disinfection..............................................................................................................60
3.1.3 Sterilization..............................................................................................................60
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3.3.3 Battery Replacement................................................................................................62
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Chapter1 Safety Information and Introduction
1.1.1 WARNING
WARNING
This ECG machine can only be used for a single patient at a time.
The user must inspect the machine, its cables and accessories before use in order to
ensure that they work normally and safely.
Watch out for explosion. Do not use the ECG machine in the presence of anesthetic
gas, flammable gas like oxygen and hydrogen, combustible chemicals and explosion
hazards. Otherwise there might be hazard of explosion or fire.
This machine is designed for operation by medical professionals only. ECG machine
is to work in an environment free from interferences caused by high-voltage cable,
X-ray machine, ultrasound scanner, and electrotherapeutic equipment. Do not use
the machine in an environment with high static electricity. Otherwise its normal
function might be affected by electromagnetic interference.
ZQ-12 series is not designed for operation in sterilized room or outdoor application.
Do not open the machine shell, or there might be risk of electrical shock. Only
maintenance personnel trained and authorized by Zoncare can service or upgrade the
machine.
Keep the ECG machine away from water. Use and store the machine in a place free
from high air pressure, temperature or excessive humidity, poor ventilation, dust,
sulfur and saline gas, or chemicals.
The ECG machine should be placed on a stable platform. Be gentle while moving it.
Avoid excessive vibration and tilting.
AC Power cord must be three-core cord accompanying the machine. Otherwise it
might cause electrical shock to the patient and operator. The frequency and voltage
of AC power supplying the ECG machine should comply with requirements as
mentioned in the specifications, and has enough current capacity. To avoid electrical
shock, the machine shell must be grounded well. Choose a place indoors where is
convenient for well grounding to store the machine.
For any question about the integrity of ECG machine wire with protective
grounding, please use built-in DC power.
Other instruments connected with the ECG machine must be Class I device
conforming to IEC 601-1-1 as the leak current sum might hurt the patient when the
machine is used with several sets of devices simultaneously. Therefore, the
manufacturers of the connected devices must assume relevant responsibility for the
leak current monitoring. Pay special attention to good connection so as to avoid
incorrect diagnosis or other errors. Consult a professional for advice if necessary.
Electrodes and connectors can only contact the patient, but not other conductive
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WARNING
parts, including the ground.
The operator shall not leave the exam room while the machine is working. They
shall keep careful observation on the patient, if necessary, turn off the power or
disconnect the electrodes to assure patient safety. Electrodes can only contact the
patient, but not other conductor parts. If an accident happens while operating the
machine, the operator must power it off immediately and have an inspection.
According to IEC 601-1-1, this ECG machine belongs to type CF Class I
defibrillation-proof equipment, which can be applied directly in human heart to
perform tests, safely and reliably. If the machine is used together with a cardiac
defibrillator or other electrical stimulators, you must use silver/silver-chloride thorax
electrodes and ECG lead wires provided by Zoncare. If the defibrillation costs more
than 5 seconds or the machine is used with HF equipment, please use the disposable
electrodes in case that metal electrodes will burn the patient’s skin. While using the
machine with other electrical stimulators, there must be professional technicians at
present for guidance.
Chemicals from a broken LCD display panel are toxic when ingested. Be cautious
when handling an ECG machine with a broken display panel.
ECG signal acquisition may be affected by special environment, wrongful operation
and some patients’ status. For associated safety information, please refer to the
corresponding chapter in this manual.
Using unspecified lead wire, limb clamp, and suction bulb may degrade anti-
interference performance of ECG machine. Connectivity of the lead wire should be
inspected regularly, at least once a month.
Using unspecified ECG paper may reduce the lifespan of printer parts and record
blurry ECG waveforms.
The ZQ-12 series is intended only as an adjunct in patient assessment. It must be
used in conjunction with clinical signs and symptoms, and the doctor’s diagnosis.
Physiological waveforms and parameters displayed in this ECG machine are for the
doctors’ reference only, which cannot be used as the basis of clinical treatment.
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1.1.2 CAUTION
CAUTION
When the machine is used with a defibrillator or pacemaker, all electrodes connected or
disconnected to the patient and the patient himself or herself should not be grounded.
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Before defibrillation, make sure that all persons around the patient do not affect the patient
body and all metal parts of ECG machine do not touch the patient. Otherwise it will cause
electric shock.
Before defibrillation, remove all the electrodes, creams and cloth on the patient thorax. When
the defibrillator oar touches those materials directly, its discharging ability will cause serious
Only use Zoncare designated defibrillation-proof lead wires. Otherwise, it might cause
serious electric burning on the sites where electrodes contact and damage to the ECG
machine.
Electrodes used in the ECG machine should be dedicated defibrillation-proof ones provided
by Zoncare.
To avoid burning, keep the electrodes away from surgical electrotome while using the ECG
1.2 Introduction
know well about the ECG machine can directly find corresponding subjects for desired
information.
1.2.4 Contraindication
None
● Principle Introduction:
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Weak millivolt electrical signals extracted from human body by lead electrodes, are linear
amplified by preamplifier unit , then sent to CPU of the control unit by A/D conversion, and
finally sent to the recorder after CPU pre-processing, digital filtering and conversion. Thermal
recorder head is a kind of thermal recording part, which integrates eight heating components per
mm with a sum of 576 within the recording width of 72 mm. Accurately design the control
program in the control unit, which not only makes the stepper motor drive the paper moving at a
constant speed, but also controls the heating components of the recorder. That is to say, you can
record any waveform and text on the paper. In addition, the control unit also deals with the
keyboard, monitor, etc. The power circuit supplies each unit with both AC and DC power. AC
power can be selected as priority and charge the built-in battery safely.
horizontally 40 dots per mm), without any adjustment, and its recording frequency response
reaches 150Hz.
The paper is 50 or 80 mm wide or of other formats, which can record clear and accurate ECG
waveform and such information as lead mark, sensitivity, paper speed, filter status etc.
It adopts unique highly-precise digital filter to eliminate baseline drift and other interferences
without causing the ECG waveform distortion, its anti-baseline drift ability enhances greatly,
Only one key pressing can start recording, which reduces work load and promote work
efficiency greatly.
Gently touch the keypad to control, which is very convenient for operation.
With LCD and LED display, the whole machine status is clear and easy to read.
Its design conforms to safety standard of IEC Class I Type CF. ECG amplifier is fully-floated
and well-protected.
battery is installed in the machine and is easy to replace. Also it has a dedicated battery
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ZQ-12 series is designed and manufactured in compliance with Standard No: EN 60601-
1:1990/AC: 1994 Medical electrical equipment Part 1: General requirements for basic safety
requirements for the safety of ECG machine, at the safety level of class I type CF; IEC60601-
2-51 Part 2-51: Particular requirements for the safety of nerve and muscle stimulators.
ECG machine is a continuously working instrument, an ordinary device. Avoid it being wet
by water; it’s not anti-explosive, thus cannot be used in the presence of flammable
anesthetics.
Within the room where the instrument works, power socket should be standard and three-
core. Its protective grounding terminal should be connected with a grounding wire. If there is
grounding wire, the user must use a dedicated one, whose one end is connected with the
WARNING
The user must suppress and lay the ground wire per associated standards or under the
guidance of experienced electricians.
When the machine is used with other medical devices, use an attached wire to connect the
equipotential column of ECG machine with the same grounding terminal of other devices,
which can prevent the examinee from electrical shock. Once there is leak current in other
Connect one end of the attached grounding wire with the equipotential column of ECG
machine, and the other end with the ground, which can enhance the reliability of grounding.
Never use a water pipe or other pipes as the ground wire. Otherwise safety precautions of
protective grounding will lose efficacy, and the examinee might have the risk of electric
shock.
by water. This instrument is not anti-explosive, thus cannot be used in the presence of
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flammable anesthetics.
Classification:
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1.2.8 Symbols Descriptions
The following table describes symbols or icons that may be on your device and its packaging.
Familiarity with these symbols assists in the use and disposal of the equipment.
Symbol Description Symbol Description
Type CF equipment
Attention!Consult
equipped with
accompanying
protector against
documentation
defibrillation.
Protective Earth
External Inlet and Outlet
(ground).
Equipotential
Storage Card Slot
terminal
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Refer to this manual
Fragile
for equipment use
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Fig. 2.1 Frontal view
1 Recorder paper compartment: contains paper, and print clear ECG waveforms and
characters;
2 Indicator light: displays power supplying status, battery charging status and device working
3 Operation panel: control button, for details please see the table below;
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Function buttons Illustration
Buttons Function
Power switch, press this button to turn on/off the ECG machine.
Calibration /function setup button. When paper feeds, you can print a CAL
symbol with this button; while paper does not feed, combine left and right keys
In function setup, this button can be used to set the functions of auto lead
change mode and separation. When you exit from function setup, press this
Mode selection button, you can switch between auto and manual lead change
modes.
AC power light
DC power light
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2.1.2 LCD
The TFT 480×272 liquid crystal display (LCD) at the top of the Keyboard Control Module is
designed to display operation mode/status and control menu. When the machine is powered on for
the first time, it is to display the model name and software version of ECG machine followed by
the default values preset at the manufacturing factory. Then display the main menu.
Display zone:
Measured heart rate displays the number between 30 and 240 times per minute, displaying
with lower than 30 times per minute, and with higher than 240 times per
minute; when overload signals lead to abnormal working, it displays “Breaking Bounds”(
).
In auto lead change mode, it displays the time each lead takes to change automatically. You
Lead:
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Rhythm lead: if there is rhythm, display with rhythm, if not, no display.
Sensitivity:
40mm/mV; conversion error range is ±5%, with auto gain conversion function, displaying the icon
(auto sensitivity). It is 10mm/mV for normal signals, while for signals of overlarge amplitude
it reduces to half.
Paper speed:
Select among 5mm/s, 6.25/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s with error range of ±5%.
Filter:
No filtering
Only AC filtering
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It displays current time. It indicates battery capacity with 4 gears only when battery supplies
the power. When the battery capacity is over low, the system will stop battery supply
The contents described above apply to main menu. After the user pressed the status menu
setup button, the contents displayed on LCD will change. For details, please refer to relevant
WARNING
Never use sharp hard objects (pen nib, nail etc) to press the buttons. Otherwise it
2. External inlet and outlet: after dedicated cable is connected, print external input signals with
10mm/V, or output the selected rhythm lead signals with 1V/mV. Prohibit connecting the port to
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CAUTION
The user must use dedicated lead wires designated by Zoncare. Except that the lead
wires are connected to lead sockets, they cannot be connected to any other ports.
1. Equipotential terminal: when ECG machine is used together with other devices, connect
their equipotential terminals via wires to eliminate potential difference among different
2. AC power port: connect the power cord to provide AC power for ECG machine.
3. AC power switch
CAUTION
This machine is Class I type CF equipment designed per IEC standard. While using
AC power, be sure to connect the attached power cord with well-earthed AC power
outlet.
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2.1.5 Bottom view
3. Fuss holder: make sure that fuse tube of specifications designated by this machine is used.
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2.2 Installing ECG machine
Ambient Ambient
Atmosphere
WARNING temperature humidity
Operation +5℃~+40℃ 20%~85% 70kpa~106kpa
To ensure patient safety, don’t put the instrument in the place from where it might fall
Shipment -20℃~+55℃
onto the patient. 10%~95% 50kpa~106kpa
Storage
Carefully lay-20℃~+55℃
out the wires to reduce 10%~95%
the possibility of entanglement or strangulation.
50kpa~106kpa
Never use sharp hard objects (pen nib, nail etc) to press the button. Otherwise it might
ECG shall work with tree-plugged AC power cable to avoid possible hazard of
electric shock to the patient and the operator. Whenever the three-plugged AC power
cable is unable to work, you shall operate the unit by the built in battery.
For any question about the integrity of ECG machine wire with protective grounding,
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2.2.2 Connecting to AC Power
WARNING
When ECG is used in combination with other equipments, you are required to
connect the grounding cable together with that of the others so as to protect the
The grounding cable must be connected between ECG's grounding post and the
ground. It is not permitted to connect the grounding cable between a pipe and the
grounding post.
Avoid using water piping as a grounding conductor,it may not provide a proper
Metal dollies, window frames and TV antenna terminals do not work as grounds.
Please make sure that optional supply indication is consistent with local supply
voltage.
Conform that AC power switch (shown as section 3 fig .2.4) is turned off.
1. Insert the three-core plug on power cord into AC power socket at the back of the
machine (shown as section 3 fig. 2.4).
2. Insert the power plug into the nearby outlet, which should be three-core with center line
grounded.
3. Connect one end of grounding wire with the grounding column of this machine, the
4. Well grounding not only guarantees safety but reduce AC interference and other
5. When connections are inspected without error, turn the power switch on.
6. Inspect the light on panel, if it’s on, it indicates that the machine is connected
with AC power.
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● Power cord
● Power switch
● Replaceable fuse
● AC power outlet
WARNING
When the machine is used with other medical devices, use the grounding wire
provided by Zoncare. Connect the grounding terminal of ECG machine with the same
terminal of other devices to prevent the examinee from electric shock. Once there is
leak current in other devices, connect other devices with the ground for protection.
WARNING
The battery must be inspected and replaced routinely. Please follow local
There is rechargeable battery built in ECG machine, which can be used when there is no AC
power supply. A newly and fully charged battery could record several cases continuously.
ECG machine has perfect auto charging and discharging monitor system. If the battery runs
out of power, ECG machine will power off automatically in case that excessive discharging will
cause permanent damage to battery. Before you try to turn on the ECG machine whose battery
has been depleted, the machine must be plugged into AC power outlet to charge the battery for
several minutes, or select AC power to supply the machine and then power it on.
While charging the battery of low power or of no power, please connect the ECG machine to
AC power. Once ECG machine connected to AC power outlet, it starts charging the battery
automatically. It takes about 3.5 hours to fully charge the depleted battery.
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While charging the battery, battery light changes will indicate different charging status
While using the ECG machine with battery power, the light is on, a battery
symbol appears at lower right of LCD, displaying four status to indicates battery
capacity.
Abundant
Sufficient
If all the following situations continue for about 5 minutes, ECG machine will power off
automatically.
Note: if only ECG machine is connected with AC power, the battery will be charged.
Therefore, it’s suggested to connect the ECG machine with AC power while not using it.
It’s suggested to replace the built-in battery every 24 months by professional maintainers.
Please follow local laws and regulations for used battery disposal.
WARNING
If ECG machine needs to be stored for 3 months or longer time, please inform
maintainers to take out the battery. If the battery has not been charged for 2 months or
CAUTION
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When the battery is used for the first time, it must be charged for more than 10 hours
in advance. Please charge and discharge the battery at least once a month.
To full play the recorder’s features and to prolong its lifespan, please use the paper
designated by Zoncare.
Paper used for ZQ-12 series ECG machine is outward-rolling chemical thermal paper. Please
pay special attention to its size and specification. Paper out of suitable size might damage
Hold two sides of the paper compartment door and pull it upward to open it.
Unpack the grid thermal roll paper, pull it out 10cm and put it into paper
compartment, please make the paper’s thermal layer (printed with grids) facing
down.
Close the compartment door and note that both sides are stuck tightly;
At this time “No paper” disappears from LCD, if there is no other error, “ERROR” light will
not flash but “READY” light is on. After you power on the ECG machine and enter into main
control screen, if no paper is installed, “No Paper” will display in the first row of LCD and
“ERROR” light will flash to remind the user to install paper. If the paper runs out during printing,
the machine will automatically stop feeding paper, and “No Paper” will display to prompt
exchanging paper. When the paper is used with the last 2 m left, there will be a red line at the edge
of paper to prompt that the paper is running out, then you should prepare spare paper.
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2.3 Using ECG machine
channel combination and 3+1 channel combination, 6-channel combination and 12-channnel
combination.
Confirm that ground wire connector is properly connected with grounding wire.
Confirm that temperature and humidity of the site where the ECG machine is used are
Confirm that the power cord is properly connected and will not twine with other cables.
could generate radio frequency interference (RFI) and power interference are used
around the site, as they might cause interference to ECG machine. Please move the ECG
Confirm that ECG machine is placed stable and reliable, easy for the doctor to operate.
Confirm that lead wire is properly and reliably connected with ECG machine, and stays
Confirm that each electrode of the lead wire is properly and reliably connected with
corresponding one
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Confirm that the patient skin sites contacting with electrodes are well prepared;
Confirm that electrode parts contacting with the patient is stain-free and oxide-free.
Confirm that the patient is lying in bed, safely and naturally, stretching and relaxing,
Confirm that that the patient skins do not contact other metal parts (such as metal parts
For examinee safety and recording stable ECG, please perform the inspections listed above.
After confirming that the instrument and the patient are well prepared, then start recording.
WARNING
Prohibit using the device in the presence of inflammable gases like anesthetic gas,
explosion or fire.
2. When supplied with AC power, the light on ECG machine’s frontal panel is
3. LCD displays the booting screen for about 2 seconds with a “Dingdong” sound.
4. After entering into main control screen, it indicates that the ECG machine finishes its
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WARNING
If the light and LCD are not lit or there is no “Dingdong” sound while booting, please
don’t use the ECG machine. Please contact professional maintainers, local Zoncare
Connect the attached lead wire to the cart lead socket. Correct installation of electrodes is a
key link in whether the ECG can be accurately recorded. Please make sure that electrodes are well
contacted. To avoid interference, patient lead and ECG machine power cord should not be on the
Left arm
R Red
Right arm
L Yellow
Left leg
F Green
Right leg
RF Black
Thorax
C1 Red
Thorax C2 Yellow
Thorax C3 Green
Thorax C4 Brown
Thorax C5 Black
Thorax C6 Purple
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2.3.6 Thorax Electrode Placement
Sites placed with thorax electrodes
C1: Fourth intercostal space at the right
sternal border.
C2: Fourth intercostal space at the left
sternal border.
C3: Midway between C2 and C4 in the
intercostal space.
Clean thorax skins on where electrodes are to be placed with alcohol, Apply electrode creams
on the sites within 25mm diameter range and edges of thorax electrode bulbs. Press thorax
electrode bulbs, and make them absorbed onto sites from C1 to C6.
CAUTION
Electrode cream layers should be seperated. Thorax electrodes can’t contact with each
26
2.3.7 Limb Electrode Placement
Electrodes should be
skins.
If electrodes are not well connected with the patient, ECG macine will prompt an error
message “Lead-off” , and “ERROR” light on frontal panel will flash. When signals are too large
or unstable to be recorded, it will display “ Breaking bounds”. When all electrodes are well
connected with the patient.,“Lead-off” light goes out. If thre is no other error statuses of paper
lack and low battery power at this time, nor will the “ERROR” light flash. Then ZQ-12 series
ECG machine will wait for 3 or 5 minutes usually until patient ECG signals become stable. The
time will be prolonged if thre is interference in suroundings or the patient is nervous. When
ECG machine detects that patient ECG signals are stable, “READY” light will be lit, which
CAUTION
If you press start/stop button when “READY” light is not lit, ECG machine will not
response.
Only when auto lead change mode is selected, when all thorax and limb electrodes are
well connected with the patient, when there are no other errors, “READY” light will
be on. While manual lead change mode is selected, only when the patient is well
connected with electrodes related to the currently-selected lead, and there are no other
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errors, “READY” light will be on.
Press mode selection button while not printing, lead change modes will be
Press Mode while printing, lead change modes can only be switched between auto and
manual.
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2.3.9 Sensitivity Selection
Press CAL/ SETUP, and the checkbox stops at “Sensitivity”. At the last row
Press CAL/ SETUP, and the checkbox stops at “HUM 50Hz ON”.
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Press the left/right LEAD SELECTOR, and AC filter is selected ON/OFF.
Press the right LEAD SELECTOR, and filter increases progressively from 25Hz
to 150 Hz.
Press the left LEAD SELECTOR, and filter decreases progressively from150Hz to 25Hz.
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2.3.11 Paper Speed Selection
Press the right LEAD SELECTOR, and paper speed increases progressively.
Press the left LEAD SELECTOR, and paper speed decreases progressively.
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2.3.12 Lead Group Mode Selection
“Cabrera”.
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2.3.13 Lead Selection
Press the left or right LEAD SELECTOR to select “12 ch”or “9 ch”.
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2.3.14 Synchronization Selection
“Sequence”.
Synchronous Acquisition: each lead starts acquisition synchronously, and ends at the same time.
Sequential Acquisition: the next lead group starts at the end of last lead group.
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2.3.15 Time Selection for Auto Lead Change
Press the right LEAD SELECTOR, and auto lead change time progressively
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2.3.16 Recording Ahead of Time(only available for some types)
Press the left or right LEAD SELECTOR to select “Print ahead of 0~5s”.
Indications for use: easy to firstly observe the waveform displayed on screen. While it starts
recording after occasional abnormal waveform appears, still abnormal waveform can be recorded.
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2.3.17 Recording Format Selection
Press the left or right LEAD SELECTOR, and recording modes switch by
sequence below:
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2.3.18 Rhythm Lead Selection
Press the right LEAD SELECTOR, and rhythm lead can be selected by
sequence below.
Ⅰ → V6 →Rhythm off→Ⅰ
Press the left LEAD SELECTOR, and rhythm lead can be selected by sequence
below.
V6 →Ⅰ→Rhythm off → V6
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2.3.19 Options of Printing Analysis report (only available for the machine with
analyzing function)
Press the left/right LEAD SELECTOR, and select ECG report “on” or “off”.
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CAUTION
This ECG machine has auto analyzing function, which only automatically analyzes its
acquired ECG waveforms, but not reflect all patient statuses. Sometimes, its analysis
result might not be consistent with what doctors diagnose. Therefore, the final
conclusion must be made after the doctor has performed overall analysis and
diagnosis in combination with analysis result, clinical manifestation and other test
results.
wave and Q-wave are not reliable sometimes. Due to baseline drift, identifications of
End positions of S-wave and T-wave are displayed squiggly and unclear, which will
When R-wave is missed due to QRS low voltage, there might be a huge error in HR
measurement.
Under QRS low voltage, measurement of cardiac electrical axis and identification of
cardiac activity. When many types of arrhythmias are combined, P-wave is difficult to
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2.3.20 Saving ECG(only available for some types)
After startup, Save ECG can be selected only after ECG is printed at least once.
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First option is “No saving”, you can press any key except SET to exti from “Save ECG”
setup immediately.
While pressing SET refers to adjusting the serial number before saving ECG.
Case number consists of year, month, day and 3 numbers, those 3 numbers start counting
For “Gender”, press Left/Right to select among “---“, “Male” or “Female”. “---“ means
unimportant.
For “Age”, press Left/Right to decrease progressively from “---“ to “120”. “---“ means
unimportant.
For “Saving to local HD”, on the right displays “local total capacity is------case(s), with
------case(s)(---%)saved.
For “Saving to storage card”, on the right displays “local total capacity is------case(s), with
------case(s)(---%)saved.
After selection, press Start/Stop or Right to activate saving. After that “Succeed in saving to
local HD” or “Succeed in saving to storage card” is displayed at the lowest part for 2s, and then
If capacity is full, it will display “Storage failed, local HD has reached its capacity” or
“Storage failed, storage card has reached its capacity”and return to main interface. At this
momentm, delete cases or clear local HD or storage card in “ECG Review” setup to restore space.
Review refers to, printing the ECG to be printed at last, or DEMO cases or cases in local HD
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Press the left/right LEAD SELECTOR or Start/Stop to enter
Press SET to switch among “Print Again” “Review from local HD”, “Review
from storage card”, “Cases moving to storage card”, “Empty the cases in local
HD”, “Empty cases in storage card”, “Delete the cases in local HD”, “Delete
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Press Start/Stop to print the last case again and exit from setup.
Press Start/Stop to activate Review and Print of demo case, and then exit from
setup.
44
Press Start/Stop to cancel displaying or printing demo case, and then exit from
setup.
Press the left/right LEAD SELECTOR to turn off the speaker or switch its
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Start up to enter into main control screen.
Press the left/right LEAD SELECTOR to turn on/off the speaker. When you
choose to turn “On” the HR Sound, it will make a “Du” sound each time
heart beats.
Press the right LEAD SELECTOR, and it displays Are you sure to restore all
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parameters to factory defaults? Confirm with Start/Stop, and then exit.
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2.3.26 Analog-out Selection
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2.3.27 Adjusting Monitor Brightness
decreases/increases.
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2.3.28 Clock Setup
2.3.28.1 Year
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2.3.28.2 Month and Day
Note: the largest day of current month is based on the month set for day. The largest day of
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2.3.28.3 Hour and Minute
Press CAL/SETUP several times, and the checkbox stops at Hour and
Minute.
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2.3.29 Language Setup
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2.3.30 Shortcut Operations
2.3.30.1 Auto Recording
Press MODE until LCD displays auto lead change mode, based on the
ECG is printed.
Gently remove electrodes and bulbs from the patient, during which, never strongly
pull lead wires in case of accidental injury to the patient and damage to lead
wires.
Put away the instrument and all accessaries for next time.
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2.3.30.2 Manual Recording
Press the left/right LEAD SELECTOR to select the desired lead wire.
Gently remove electrodes and bulbs from the patient, during which, never strongly
pull lead wires in case of accidental injury to the patient and damage to lead
wires.
Put away the instrument and all accessaries for next time.
Press the left/right LEAD SELECTOR to select the desired lead wire.
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Press Start/Stop to start ECG recording.
One minute after acquisition, the Progress Bar is full, and it automatically
Gently remove electrodes and bulbs from the patient, during which, never strongly
pull lead wires in case of accidental injury to the patient and damage to lead
wires.
Put away the instrument and all accessaries for next time.
Press the left/right LEAD SELECTOR to select the desired lead wire.
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Shut down and standby.
Gently remove electrodes and bulbs from the patient, during which, never strongly
pull lead wires in case of accidental injury to the patient and damage to lead
wires.
Put away the instrument and all accessaries for next time.
WARNING
Pay special attention while ECG machine is working, never move the patient and the
machine.
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Chapter 3 Equipment Maintenance
3.1 Cleaning and Disinfection
Please keep your ECG machine and its accessories clean. And in order to avoid damaging the
Please dilute the cleaner and disinfectant according to Zoncare's instructions, or use the
Never use abrasive materials (such as steel wool or silver polisher), or any strong solvents
You must turn off the power, and disconnect the power cord and the socket before
WARNING
The device can be cleaned or disinfected only by the materials and methods listed in
this chapter. Zoncare will not provide warranty for any damage or accident caused by
Zoncare will not assume any responsibility for the effectiveness of using the listed
chemicals or methods as infection control ways. For ways of infection control, please
consult the infection prevention department in hospitals or epidemiologists.
CAUTION
If you accidently pour liquid onto the device or its accessories, and make the device
damaged, please contact Zoncare service department.
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3.1.1 Cleaning
Available options for cleaning the cart are listed as follows:
NaClO (Bleaching)
Oxydol (3%)
Ethanol (75%)
The device should be cleaned regularly. In those areas where the environment is seriously
polluted or sand blows heavily, it should be cleaned more frequently. Please consult to know
about hospital regulations of cleaning the device before you clean it.
Turn off the power, and disconnect the power cord, its accessories and other devices
Use a soft cotton ball to wipe the display with some cleaner;
Use a soft cloth to clean the device surface with some cleaner. Avoid ports at the sides
Please remove the cable from ECG machine before cleaning it and lead wires.
Use a soft cloth to wipe the surface of the cable and lead wires with some 75%
Put the cable and lead wires in a place with cool ventilation to dry them naturally.
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Reusable electrodes must be cleaned after each use.
Use a soft cloth to wipe the surface of electrodes with some 75% ethanol;
Put the electrodes in a place with cool ventilation to dry them naturally.
Stains and dirt on the surface of thermal recorder head will influence the record’s definition.
Therefore the recorder head should be cleaned regularly (at least once a month). If you find that
the characters on the record report are light or the recorder doesn’t work, it indicates that the
Open the paper compartment door by pressing its switch, and take out the paper;
Clear out the stains and dirt on the surface of thermal recorder head with a cotton
Dry the recorder head naturally, reinstall the paper and close the paper compartment
door.
CAUTION
Please don’t clean the printer head immediately after recording, because its
3.1.2 Disinfection
Disinfection may damage the ECG machine or its accessories to some extent. It’s
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Disinfectants recommended for the cart contain 75% ethanol, 70% isopropyl alcohol, Shu US
sterilization agent (C/D level) with R active oxygen. It is recommended to disinfect the
3.1.3 Sterilization
It is not recommended to sterilize the ECG machine and its accessories unless otherwise
machine is found damaged, please stop using it immediately, and contact equipment engineers in
No stain on ECG machine shell; the panel and display screen are not broken or damaged;
The power cord, ECG machine and its cable are firmly connected;
Thorax electrode bulbs are free of cracks, and the limb electrodes are well clamping.
upgrading, it should be tested completely by the qualified service personnel, making sure that the
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The device and it accessories are not mechanically damaged;
The power cord, ECG machine cable and lead wire are not worn;
Function test: used for inspecting the internal state of the device. This project needs to be
technicians.
CAUTION
For accidents or damage caused by lack of necessary maintenance, Zoncare will not
3.3.1 Overview
This ECG machine is configured with rechargeable lithium-ion battery, making sure that it
works normally while moving in the yard or power cut. When the power is cut suddenly, the
system uses the battery to supply the ECG machine automatically, thus the machine won’t stop
working. .
CAUTION
In order to prevent the machine from working interruption caused by sudden power
When ECG machine is supplied by battery, if the battery is short of power, the
machine will crash with black screen. This normal phenomenon could be eliminated
When ECG machine is connected with AC power, no matter it is turned on or off, the battery
will be charged. When the battery is being charged, its light will be lit. Once fully charged, the
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When charging the battery with the ECG machine turned off, in the environment temperature
range of 25℃±5℃, the battery is charged to 90% for no more than 3 hours, and charged to 100%
While replacing the battery in ECG machine, please turn off the cart power switch, unplug
the power cord and confirm that lights with icons “ ”, “ ” are off. Open the battery
compartment door at bottom of the machine, and then replace a new dedicated rechargeable
battery. Before inserting battery leads, please be sure that the battery is properly connected with
Batteries are consumables, whose life is associated with the times of charging and
discharging circulation. It’s suggested that professional maintainers replace the built-in battery
every 24 months. Please dispose the used battery according to local laws and regulations.
properly maintained and stored, its life will last for about 3 years. If not properly used, its life will
be shortened. We suggest replacing the battery every three years. In order to guarantee the
The battery’s performance must be inspected once a year. Even before repairing the ECG
machine or when the battery is suspected to be faulty, the battery’s performance should be
inspected.
When the battery has been used or stored for three months or its working time obviously
Before the ECG machine is shipped, or not used for more than 3 months, please remove its
battery.
If the ECG machine has not been used for a long time without removing the battery, the
battery’s life will shorten. The battery should be charged and discharged at least once every
three months.
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When the li-on battery is laid aside with 50% of its full power, it can be stored for about 6
months. After 6 months, the battery must be charged again to full power, and then use it to
supply ECG machine. When its power reduces to 50% of the full power, take it out of ECG
While storing the battery, please make sure that its electrodes do not touch mental objects. If
the battery needs to be stored for a long time, put it in a cool environment, which can delay
battery aging. Ideally, the battery should be stored in a cool environment whose temperature
is 15℃. If the battery is placed in high heat for a long time, its life will obviously shorten. Do
not store the battery in the environment whose temperature is not within the range of -20 ℃~
60℃.
CAUTION
If the battery has the signs of damage and leak, please replace it immediately. Don’t
The battery should be optimized for its initial use. A complete optimization period refers to
that, continuously charge the battery to full power, and then discharge it until the ECG machine
shuts down. During use, the battery should be optimized to sustain its life every year.
2. Connect ECG machine with AC power, continuously charge the battery till it is fully
3. Disconnect AC power, and supply ECG machine by battery until it shuts down
4. Connect ECG machine with AC power again, and continuously charge the battery to full
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CAUTION
As the time of using the battery increases, its actual power capacity will decrease. For
the used battery, full-power icon indicates that neither its power capacity nor supply
time can still meet the manufacturer’s specification. While optimizing, if you find that
Battery performance will degrade as times of using the battery increase, thus it should be
inspected once a year. Even before repairing the ECG machine or when the battery is suspected to
2. Connect ECG machine with AC power, and constantly charge the battery to full power,
The Battery’s supply time reflects its performance. After announced charging time, if its
supply time is obviously lower than the time declared in specification, please contact the
CAUTION
If the battery’s supply time is too short after fully charged, it might be damaged or
faulty. Its supply time depends on the machine’s configuration and operation.
properly. When disposing the old battery, please follow relevant laws and regulations.
WARNING
Do not dismantle the battery or throw it into fire or short it out. Its burning, explosion
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or leakage may cause personal injury.
Store it in cool and dry environment, and prevent it from high temperature, humidity and
direct sunlight.
Do not contact it with polyvinyl chloride (PCC), which will cause its color change.
Do not store the used paper overlaid, which may cause the printed contents transferring with
each other.
may shorten thermal recorder head’s life, recorded waveforms will become fuzzy and the
Conduction of each branch of lead wires will directly affect recorded ECG. If it conducts
poorly (any one branch conducts poorly), it will cause virtual image of corresponding lead wire on
recorded ECG. Therefore the lead wires’ conduction must be inspected regularly, which is
Slightly bending or entangling the lead wires will shorten their life. Please keep them in good
Electrodes must be properly stored. After long-term use, their surfaces may become oxidized
and discolored because of corrosion, at this moment, it’s better to replace them.
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Chapter 4 Solutions for Common Failures and Errors
To record a stable and accurate ECG, when a failure occurs, please find out its cause, and
WARNING
ECG machine’s shell should be removed only by qualified service personnel. Inside
During use, ECG machine will inevitably be interfered by the environment, itself, human
static electricity etc. The ECG machine has its own functions of EMG filtering, baseline drift
filtering and frequency filtering. But the filter’s frequency band is limited, it cannot filter out
interference signals completely. Therefore, please avoid the interference caused by the
4.1.1 AC Interference
1) Environment cause:
Avoid such electrical devices of large power as X-Ray machine or ultrasound instrument etc
working nearby.
2) Examinee cause:
Inform the examinee of not touching the wall or metal parts of the bed. Don’t let others touch
the examinee.
3) Electrode cause:
Inspect whether the electrodes or the lead wires are connected properly, Electrodes and skins
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are well applied with conductive pastes, clean the examinee’s skins by medical alcohol, apply
conductive pastes on the skins evenly, Electrodes with conductive pastes can't be cross-linked
Inspect whether the lead wire is too close to or interlaces with the power cord.
Inspect whether the joint metal of lead wire and electrode is rusty or dirty, if it is, it should be
cleaned,
Inspect whether the lead wire has poor contact, please replace a new wire and try again.
If the interference can't be cleared out by the solutions above, please make sure whether
1) Environment cause:
Inspect whether the exam room is comfortable; Check whether the indoor temperature is
2) Examinee cause:
Inform the examinee that ECG examination is very simple, which will not injury his or
her body, or have sequelae; Make the examinee relax physically and mentally, and
breathe gently.
3) Electrode cause:
Inspect whether limb electrodes are installed too tightly, which makes the examinee feel
uncomfortable,
Inspect whether the joint metal of lead wire and electrode is rusty or dirty, if it is, it
should be cleaned.
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4.1.3 Baseline Drift
1) Environment cause:
Inspect whether the exam room is comfortable; Check whether the indoor temperature is
2) Examinee cause:
Inform the examinee that ECG examination is very simple, which will not injury his or
her body, or have sequelae; Make the examinee relax physically and mentally, and
breathe gently.
3) Electrode cause:
Inspect whether limb electrodes are installed too tightly, which makes the examinee feel
uncomfortable,
Inspect whether the joint metal of lead wire and electrode is rusty or dirty.
Make sure that all electrodes are of the same specification; mixed use of new and old
If the interference can't be ruled out by the solutions above, please make sure whether
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4.2 Recorder Failure:
Printing with Transmission gear is stuck by some hard Clear out the hard object
noises but the object.
paper doesn’t Transmission gear is damaged. Contact Zoncare service department for
feed. replacement.
Paper is not well placed or the recorder’s Place the paper again and well close the
It’s detected out paper compartment door is not well closed. paper compartment door.
of paper.
Paper detector probe is dusty. Clean the probe with Anhydrous
ethanol.
It prints unclear Recording paper is out of specification. Replace the paper from Zoncare or
or with better paper of the same specification.
breakpoints
Paper axis is dusty. Clean the paper axis.
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Failures Possible causes Solutions
Printer head is dusty. Clean the printer head.
Paper is installed backwards Properly install the paper, with grid side
It prints empty right facing to the print head.
The solutions above can solve common printing failures. If there are still some failures
unsolved, please contact Zoncare service department, or return the ECG machine to Zoncare for
maintenance or replacement.
Well connect AC power cord, and turn on the power switch at the back of the machine, but
the AC power light is off, and the machine cannot boot by pressing the boot key or it displays the
battery working status after boot. If you confirm that the power is supplied by AC outlet
normally, then the power fuse might be burnt out. At this time, you should consider replacing the
2 ) Unscrew the fuse box lid at the bottom of the machine with screwdriver, and remove
3)Replace the fuse tube per designated specification, and put on the lid .
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Note: If the fuse tube is unburnt, or burnt again after replacing a new one of the same
specification, there might be other failures of the machine, please power off and contact Zoncare
Power cord must be removed before replacing the fuse tube; Only use the fuse tube of
designated specification.
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Chapter 5 After-sale Service
1. When the users begin to use the ECG machine, they should fill out each item in warranty
card and send it back to Zoncare in time, Zoncare will build the users’ profiles and contact
them to know about the usage, which will help provide targeted first-rate services constantly.
2. During normal use per this manual and operation notes, if the machine fails, please contact
Zoncare after-sale service center immediately. Users can enjoy free service within the
3. Zoncare may fulfill its warranty promise by ways of visiting your place, telephone guidance
②Fault or damage caused by falling down while moving the machine after purchase;
③Fault and damage caused by repairing, transforming or decomposing the machine out of
Zoncare
⑦Warranty seal is broken. Users privately alter and replace the series numbers of the
5. Zoncare will assume no responsibility for fault of other connected devices directly or
6. If warranty label is damaged, Zoncare has the right to exempt free service within stipulated
7. For chargeable services out of warranty period, please continue to follow “Service Contract
Rules”. For details, please consult the customer service center of Zoncare.
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Appendix I
CMRR >89dB
Filter AC 50Hz≥20dB;
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I.2 Safety Index
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Operation
78
60601-1-2.
NOTE
Using the accessories, transducers, and cables out of stipulated range may increase EMC
This device should not be used adjacent to or stacked with other devices. Closely observe the
The device needs special precautions regarding its EMC, and should be installed and
Even if those other devices meet the emission requirements of CISPR, still they may cause
When input signal amplitude is lower than the stipulated minimum in technical
Portable and mobile communication equipment will affect the performance of this device.
WARNING
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● This machine can be used by professional medical staff only. The device/system might cause
interference or disturbance to the operation of nearby equipment. There might be a need
to take alleviating measures, such as adjusting the direction, placing the machine again or
shielding relevant fields.
The customer or the user of this machine should assure that it is used in such environment.
EMC environment-
Immunity test IEC 60601 Test level Compliance level
guidance
±2 kV power cord
Electrical fast ±2 kV power cord Mains power quality should
±1 kV be that of typical
transient (EFT)/burst ±1 kV I/O cables
input/output cables commercial or hospital
IEC 61000-4-4 (Length >3m). environment.
(>3m)
±1 kV differential
Mains power quality should
±1 kV differential mode mode be that of typical
Surge IEC 61000-4-5
±2 kV common mode ±2 kV common commercial or hospital
environment.
mode
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<5% UT <5% UT
for 0.5 cycle for 0.5 cycle Mains power quality should
be that of typical
40% UT 40% UT
Voltage dips, commercial or hospital
(60% dip in UT) (60% dip in UT) environment. If the user of
Short interruptions
for 5 cycles for 5 cycle this equipment requires
and voltage variation continued operation during
70% UT 70% UT power mains interruptions,
on power supply input
(30% dip in UT) (30% dip in UT) It is recommended that our
lines IEC 61000-4-11 product be powered from an
for 25 cycles for 25 cycle
uninterruptible power
<5% UT <5% UT supply or a battery.
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s
Level characteristics of
Power frequency
power frequency magnetic
(50/60 HZ) field should be that of a
3 A/m 3 A/m
magnetic field typical location in a typical
commercial or hospital
IEC 61000-4-8
environment.
Note1: UT is the A.C. mains voltage prior to application of the test level.
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Guidance and manufacturer’s declaration-- electromagnetic emissions
The equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of this machine should assure that it is used in such environment
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.
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 equipment is used exceeds the applicable RF
compliance level above, the equipment should be observed to verify normal operation. If abnormal
performance is observed, additional measures may
82 be necessary, such as reorienting or relocating the
equipment.
Recommended separation distances between portable and mobile RF communication and
the equipment
The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance
are controlled. The customer or the user of the equipment can help prevent electromagnetic interference
For transmitters at a maximum output power not listed above, the recommended separation distanced in
meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
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Appendix III Environmental Protection Declaration
84
Built-in PCB ○ ○ ○ ○ ○ ○
Plug-in connector ○ ○ ○ ○ ○ ○
Sheet-metal parts ○ ○ ○ ○ ○ ○
Shell ○ ○ ○ ○ ○ ○
Display unit ○ ○ ○ ○ ○ ○
Package materials ○ ○ ○ ○ ○ ○
Accessories ○ ○ ○ ○ ○ ○
○: It indicates that toxic or hazardous substances contained in this part’s all homogeneous
NO.3510000202
85