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Overview

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.

The released version of this document is 2.0.

Revision Date: May 2nd 2017

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Manufacturer’s information:
 Product name: ZQ-12 Series Digital Electrocardiograph Machine

 Product type: ZQ-1201, ZQ-1201G, ZQ-1203, ZQ-1203G

 Corporation name: Wuhan Zoncare Bio-medical Electronics Co., Ltd

 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

 Production Date: See the label

 Operating Life: 10 years

 After-sale service: Wuhan Zoncare Bio-medical Electronics Co., Ltd.

 Contact: Wuhan Zoncare Bio-medical Electronics Co., Ltd.

 TEL: +86(27)87170581

 TEL/FAX: +86(27)87770203

 Post Code: 430206

 Web site: http://www.zoncare.com/en/index.asp

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

without prior written permission from ZONCARE

 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

the patent laws.

 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

ultrahigh sensitivity, please contact Zoncare or local representatives for purchase.

Responsibility of the Manufacturer

Zoncare is responsible for the safety, reliability and performance of hardware supplied by Zoncare

only if the following conditions are met:

 Assembly operations, expansions readjustments, modifications or repairs are performed by persons

authorized by Zoncare.

 The electrical installation of the room where the device is used complies with the requirements of

appropriate local, state, and other government regulations;

 The device is used in accordance with the instructions for use.

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Safety Conventions

A Hazard is a source of potential injury to a person, property, or the system.

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.

Definitions of Safety Convetions

Safety Convention Definition

 It indicates a potential hazard or unsafe practice, which, if not


WARNING avoided, could result in death or serious injury.

 It indicates a potential hazard or unsafe practice, which, if not


CAUTION avoid, could result in moderate or minor injury.

 It indicates a potential hazard or unsafe practice, which, if not


NOTICE avoided, could result in the loss or destruction of property or
data. .

 Mandatory to refer to this manual for equipment use.

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Contents

Chapter1 Safety Information and Introduction...................................................................................1


1.1 Safety Information................................................................................................................1
1.1.1 WARNING.................................................................................................................1

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

1.2.2 Product Performance..................................................................................................6

1.2.3 Indications for use......................................................................................................6

1.2.4 Contraindication.........................................................................................................6

1.2.5 Working Principle......................................................................................................6

1.2.6 Main Features.............................................................................................................7

1.2.7 Safety Standards and Requirements..........................................................................7

1.2.8 Symbols Descriptions..............................................................................................10

Chapter 2 Structure Illustration of ECG machine.............................................................................11


2.1 Illustration of Control Button, Indicating Icons and Symbols............................................11
2.1.1 Frontal View.............................................................................................................11

2.1.2 LCD..........................................................................................................................14

2.1.3 Lateral View.............................................................................................................16

2.1.4 Rear View.................................................................................................................17

2.1.5 Bottom view.............................................................................................................18

2.2 Installing ECG machine......................................................................................................19


2.2.1 Environment Requirements.....................................................................................19

2.2.2 Connecting to AC Power.........................................................................................20

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2.2.3 Battery Power Supply..............................................................................................21

2.2.4 Installing Paper........................................................................................................23

2.3 Using ECG machine............................................................................................................24


2.3.1 Function Introduction...............................................................................................24

2.3.2 Lead Combination....................................................................................................24

2.3.3 Inspection Before Startup........................................................................................24

2.3.4 Opening ECG Machine............................................................................................25

2.3.5 Connecting Lead Wire.............................................................................................26

2.3.6 Thorax Electrode Placement....................................................................................27

2.3.7 Limb Electrode Placement.......................................................................................28

2.3.8 Lead Change Mode Selection..................................................................................29

2.3.9 Sensitivity Selection.................................................................................................30

2.3.10 Filter Selection.......................................................................................................30

2.3.10.1 AC Filter Selection......................................................................................30


2.3.10.2 Myoelectric Filter Selection.......................................................................31
2.3.11 Paper Speed Selection............................................................................................32

2.3.12 Lead Group Mode Selection..................................................................................33

2.3.13 Lead Selection........................................................................................................33

2.3.14 Synchronization Selection.....................................................................................34

2.3.15 Time Selection for Auto Lead Change..................................................................35

2.3.16 Recording Ahead of Time(only available for some types)..............................36

2.3.17 Recording Format Selection..................................................................................37

2.3.18 Rhythm Lead Selection..........................................................................................38

2.3.19 Options of Printing Analysis report (only available for the machine with analyzing

function)............................................................................................................................39

2.3.20 Saving ECG(only available for some types)....................................................40

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2.3.21 ECG Review (only available for some types).......................................................42

2.3.21.1 Printing Again.............................................................................................43


2.3.21.2 Case Demonstration....................................................................................44
2.3.21.3 Cancelling Case Demonstration.................................................................44
2.3.22 Speaker Volume Selection.....................................................................................45

2.3.23 HR Sound Selection (only available for some types)............................................45

2.3.24 Restore Factory Defaults.......................................................................................46

2.3.25 External Input Selection.........................................................................................47

2.3.26 Analog-out Selection..............................................................................................48

2.3.27 Adjusting Monitor Brightness................................................................................48

2.3.28 Clock Setup............................................................................................................49

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

2.3.30 Shortcut Operations...............................................................................................53

2.3.30.1 Auto Recording...........................................................................................53


2.3.30.2 Manual Recording.......................................................................................54
2.3.30.3 Single 1-minute Packed Recording............................................................54
2.3.30.4 Rhythm Analysis Recording.......................................................................55
Chapter 3 Equipment Maintenance...................................................................................................57
3.1 Cleaning and Disinfection...................................................................................................57
3.1.1 Cleaning...................................................................................................................58

3.1.2 Disinfection..............................................................................................................60

3.1.3 Sterilization..............................................................................................................60

3.2 Regular Inspection and Test:...............................................................................................60


3.2.1 Daily Inspection.......................................................................................................60

3.2.2 Regular Inspection:..................................................................................................61

3.3 Battery Usage & Maintenance............................................................................................61


3.3.1 Overview..................................................................................................................61

3.3.2 Battery Charging......................................................................................................62

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3.3.3 Battery Replacement................................................................................................62

3.3.4 Battery Guidelines...................................................................................................62

3.3.5 Battery Maintenance................................................................................................63

3.4 Paper Usage and Maintenance............................................................................................65


3.5 Maintenance of Electrodes and Lead Wires.......................................................................65
Chapter 4 Solutions for Common Failures and Errors.....................................................................67
4.1 Interference Problem...........................................................................................................67
4.1.1 AC Interference........................................................................................................67

4.1.2 EMG Interference....................................................................................................68

4.1.3 Baseline Drift...........................................................................................................69

4.2 Recorder Failure:.................................................................................................................70


4.3 Fuse Tube Replacement......................................................................................................71
Chapter 5 After-sale Service.............................................................................................................73
Appendix I.........................................................................................................................................74
I.1 Performance Index...............................................................................................................74
I.2 Safety Index.........................................................................................................................75
I.3 Power Specifications...........................................................................................................75
I.4 Appearance Parameters........................................................................................................75
I.5 Environmental Conditions...................................................................................................76
I.6 Adherence to Standards.......................................................................................................76
Appendix II Electromagnetic Compatibility (EMC)........................................................................77
Appendix III Environmental Protection Declaration........................................................................83

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Chapter1 Safety Information and Introduction

1.1 Safety Information

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

 Use the accessories specified in this manual.


 When the device and its accessories will exceed the lifespan, dispose them
according to relevant local laws and regulations or the regime of local hospitals.
 Electromagnetic field can affect the performance of this device. Therefore other
devices used nearby this device must conform to corresponding EMC standards.
 Before connecting the device with power, please ensure that the power voltage and
frequency comply with the label on the device or the requirements specified in this
manual.
 Please properly install and carry this device. Prevent it from dropping, collision,
strong oscillation or damage by other external mechanical forces.
 Install the device in the place available to observe, operate and maintain.
 Place this manual near the device so that it is available when necessary.
 In order to describe and record electrocardiographs more accurately, the machine
should be placed and used in a quiet and comfortable environment.
 The unit and accessories shall be periodically checked and maintained at least every
half year.
 When connecting the ZQ-12 series to any instrument, verify proper operation before
clinical use. Both the ZQ-12 series and the instrument must be connected to a
grounded outlet. Accessories connected to the data interface of ZQ-12 series must be
certified according to IEC Standard 950 for data-processing equipment or IEC
Standard 60601-1 for electromedical equipment. All equipment combinations must
be in compliance with IEC Standard 60601-1-1 Systems Requirements. Anyone who
connects additional equipment to the signal input or output port (ZQ-12 series data
port connector) configures a medical system and is therefore responsible for
ensuring that the system complies with IEC Standard 60601-1-1 system
requirements and IEC Standard 60601-1-2 system electromagnetic compatibility.
The ZQ-12 series accuracy may degrade if it is connected to secondary I/O devices
when the instrument is not connected to earth reference.
 Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
 Dispose of battery in accordance with local requirements and regulations.
 Please refer to the accompanying manual.

1.1.3 Using with Defibrillator, Cardiac Pacemaker and Surgical Electrotome


Simultaneously

 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

electric burning to the patient.

 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

machine simultaneously with surgical devices.

1.2 Introduction

1.2.1 Ways of Using This Manual


Users should read through the instructions for use in this manual. Therefore, those users who

know well about the ECG machine can directly find corresponding subjects for desired

information.

1.2.2 Product Performance


 Performance: for details, please see appendix I.
 Composition: it composes of the cart, lead wires, limb electrodes and thorax electrodes.
1.2.3 Indications for use
The ZQ-12 Series Digital ECG machine is intended to extract human ECG wave group for its

form and rhythm analysis.

1.2.4 Contraindication
None

1.2.5 Working Principle


● Electrical Schematic Diagram: The circuit schematic diagram and list of components can

only be provided to the qualified maintenance station or personnel.

● 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.

1.2.6 Main Features


 It adopts the output system of high resolution and thermal array (vertically 8 dots per mm and

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,

which is easy for waveform interpretation.

 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.

 It has both AC and DC power modes. Rechargeable environmentally-friendly lithium-ion

battery is installed in the machine and is easy to replace. Also it has a dedicated battery

charging circuit, and a perfect battery management and protection system.

1.2.7 Safety Standards and Requirements

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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

and essential performance; IEC60601-2-25 Medical equipment, Part 2-25: Particular

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

no protective grounding terminal in power socket or the terminal is disconnected with

grounding wire, the user must use a dedicated one, whose one end is connected with the

grounding column and the other end with the ground.

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

devices, please connect them to the ground for protection.

 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.

 ECG machine is a continuously-working instrument, an ordinary device. Avoid it being wet

by water. This instrument is not anti-explosive, thus cannot be used in the presence of

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flammable anesthetics.

Classification:

Type of protection against


Class I internally powered equipment
electrical shock
Degree of protection against
Type CF defibrillation-proof applied part
electrical shock
Degree of protection against This device is ordinary equipment (enclosed equipment
harmful ingress of liquids without protection against ingress of liquids).
Degree of safety of application in
Equipment is not suitable for use in the presence of
the presence of flammable
flammable anesthetic mixture with air or with oxygen
anesthetic mixture with air or with
or with nitrous oxide.
oxygen or with nitrous oxide
Signal input and output: With input and output parts

Mode of operation Continuous operation

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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

Ethernet port USB port

Manufacturing date Serial number

China Metrology EU authorized


Accreditation representative

Indoor use CE Certification

Keep Dry This Side UP

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Refer to this manual
Fragile
for equipment use

It indicates this device


contains electronic or
electrical components that
must not be disposed of as
unsorted municipal waste
Enviroment-friendly
but collected separately.
use period
Contact an authorized
representative of the
manufacturer for
information concerning the
decommissioning of your
device.

Chapter 2 Structure Illustration of ECG machine

2.1 Illustration of Control Button, Indicating Icons and Symbols

2.1.1 Frontal View

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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

status, for details, please see the table below.

3 Operation panel: control button, for details please see the table below;

4 Display screen: displays ECG parameters and waveforms.

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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

to set the functions of auto lead change mode and separation.

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

button to change leads manually.

Mode selection button, you can switch between auto and manual lead change

modes.

Start/stop button, start and stop recording.

Function illustration of indicator lights


Indicator light Function

AC power light

On: AC power connected

Off: AC power disconnected

Function illustration of indicator lights


Indicator light Function

DC power light

On: power supplied by battery

Off: battery does not supply the power or battery uninstalled.

Charging status light

On: battery being charged;

Off: battery uninstalled or fully-charged.

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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.

Fig. 2.2 Startup working status and menu

Display zone:

Displaying ECG waveforms at the left;

Displaying the top down at the right;

Heart rate display:

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”(

).

Lead change mode:

In auto lead change mode, it displays the time each lead takes to change automatically. You

can adjust the time between 3 and 20 seconds.

In manual lead change mode, it displays “changing leads manually”.

In long-time packed recording mode, it displays “one lead one minute”.

Lead:

12-lead: I, II, III, aVR, aV L, aV F, V1, V 2, V 3, V4, V 5, V 6

9-lead: I, II, III, aVR, aV L, aV F, V1, V 3, V 5

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Rhythm lead: if there is rhythm, display with rhythm, if not, no display.

Sensitivity:

With six-gear gain adjustment: 1.25mm/mV, 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV,

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%.

When lack of paper, it displays:

Filter:

No filtering

Only AC filtering

AC filtering and 25Hz myoelectricity (severe myoelectricity)

AC filtering and 35Hz myoelectricity (common myoelectricity)

AC filtering and 45Hz myoelectricity (common myoelectricity)

AC filtering and 75Hz myoelectricity (slight myoelectricity)

AC filtering and 100Hz myoelectricity (slight myoelectricity)

Only filtering 25Hz myoelectricity (severe myoelectricity)

Only filtering 35Hz (common myoelectricity)

Only filtering 45Hz (common myoelectricity)

Only filtering 75Hz (slight myoelectricity)

Only filtering 100Hz (slight myoelectricity)

Clock and battery capacity indication:

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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

automatically to prevent the battery from damage.

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

illustrations and instructions.

WARNING

 Never use sharp hard objects (pen nib, nail etc) to press the buttons. Otherwise it

might cause permanent damage to keyboard appearance.

2.1.3 Lateral View

Figure 2.3 Right lateral view

1. Lead socket: Used to connect ECG lead wires;

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

devices but dedicated ones.

3. SD card slot: External storage card.

4. Ethernet interface: To connect the Ethernet and used to be online.

5. USB port: To connect external USB device.

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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.

2.1.4 Rear View

Fig. 2.4 Rear view

1. Equipotential terminal: when ECG machine is used together with other devices, connect

their equipotential terminals via wires to eliminate potential difference among different

devices for safety insurance.

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

Fig. 2.5 Bottom view

1. Battery compartment: contains battery;

2. Hidden handle: used while carrying and moving this instrument;

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

2.2.1 Environment Requirements

Environment test on ECG machine complies with the following requirements:

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

cause permanent damage to keyboard appearance.

 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,

please use built-in DC power.

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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

patient from possible shock.

 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.

 Use only the hospital-grade power cord provided by BLT.

 Avoid using water piping as a grounding conductor,it may not provide a proper

ground. Avoid using gas piping as a grounding conductor,this is prohibited by law.

Metal dollies, window frames and TV antenna terminals do not work as grounds.

When a metal-framed bed is used,connect it to the ground terminal as well.

 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

other end with the ground wire reliably.

4. Well grounding not only guarantees safety but reduce AC interference and other

electromagnetic wave interference.

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.

7. Press to use the ECG machine normally.

Note: if the power light is off, please check:

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● Power cord

● Power switch

● Replaceable fuse

● AC power outlet

WARNING

 Never use a water pipe or other pipes as the ground wire.

 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.

2.2.3 Battery Power Supply

WARNING

 The battery must be inspected and replaced routinely. Please follow local

requirements and regulations for battery disposal.

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.

 Auto lead change mde

 Auto lead change time is 3 seconds.

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

 When the battery is installed, the charging light is off.

 When the battery is being charged normally, the light flashes.

 When it finishes charging the battery, the light is always on.

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

Insufficient, it needs charging

To be depleted, please charge it immediately

If all the following situations continue for about 5 minutes, ECG machine will power off

automatically.

 ECG machine is supplied with battery power.

 No pressing any button ( not in paper-feeding status)

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.

Then the battery will be guaranteed with sufficient capacity.

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

longer time, please recharge the battery.

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.

2.2.4 Installing Paper

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

thermal printer head or silicone rubber axis.

Please follow the steps below to install the paper:

 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

2.3.1 Function Introduction


This ECG machine is single/three-channel digital ECG machine with 32-bite processor of

high performance. Therefore, its functions are powerful and practical.

2.3.2 Lead Combination


This ECG machine can not only select standard lead combination, some of its types can also

select standard two/one-channel combination and single-channel combination, standard three/two-

channel combination and 3+1 channel combination, 6-channel combination and 12-channnel

combination.

2.3.3 Inspection Before Startup


 Confirm that the grounding wire is well-kept;
 Confirm that the grounding wire is properly connected;

 Confirm that the grounding bolt does not fall off;

 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

within allowable range.

 Confirm that the power cord is properly connected and will not twine with other cables.

 Confirm that no X machine, ultrasound equipment or other electrical devices which

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

machine to a site without interference, or power off those devices.

 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

away from AC power cord as possible.

 Confirm that each electrode of the lead wire is properly and reliably connected with

corresponding one

 Confirm that electrodes are well installed;

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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,

without feeling cold, nervous, constraint and uncomfortable.

 Confirm that that the patient skins do not contact other metal parts (such as metal parts

of patient bed) except electrodes to avoid introducing interference.

 Confirm that the paper is sufficient.

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,

oxygen, hydrogen, and inflammable chemicals. Otherwise there will be hazards of

explosion or fire.

2.3.4 Opening ECG Machine

1. Press the button to open the ECG machine.

2. When supplied with AC power, the light on ECG machine’s frontal panel is

on; while supplied with DC power, the light is on.

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

initialization and can be used normally.

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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

representatives or Zoncare after-sale service department.

2.3.5 Connecting Lead Wire

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

same horizontal level.

Electrode and lead wire contrast table

Placement Symbols Color code

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

Electrode and lead wire contrast table

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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

fifth intercostal space.

C4: Left mid-clavicular line in the fifth

intercostal space.

C5: Left anterior axillary line on the same

horizontal level as C4.

C6: Left mid-axillary line on the same

horizontal level as C4.

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

other in case of short circuit.

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2.3.7 Limb Electrode Placement

Electrodes should be

placed on soft skins of two

hands and legs. Firstly clean the

skins on where electrodes are to

be placed, and then apply slight

electrode creams on prepared

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

indicates that patient ECG can be recorded.

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

27
errors, “READY” light will be on.

2.3.8 Lead Change Mode Selection

Start up to enter into main control screen.

Press mode selection button while not printing, lead change modes will be

switched by sequence below:

Auto →Manual → 1 lead 1 minute → Rhythm analysis → Auto

Press Mode while printing, lead change modes can only be switched between auto and

manual.

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2.3.9 Sensitivity Selection

Start up to enter into main control screen.

Press CAL/ SETUP, and the checkbox stops at “Sensitivity”. At the last row

displays the selectable range of sensitivity

Press the left/right LEAD SELECTOR, and sensitivity decreases/increases

progressively, or select “Auto”.

Press Start/Stop and exit from SETUP.

2.3.10 Filter Selection


2.3.10.1 AC Filter Selection

Start up to enter into main control screen.

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 Start/Stop and exit from SETUP.

2.3.10.2 Myoelectric Filter Selection

Start up to enter into main control screen.

Press CAL/ SETUP, and the checkbox stops at “Myoelectric Filter”.

Press the right LEAD SELECTOR, and filter increases progressively from 25Hz

to 150 Hz.

No myoelectric filter works at 150Hz.

Press the left LEAD SELECTOR, and filter decreases progressively from150Hz to 25Hz.

Press Start/Stop and exit from SETUP.

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2.3.11 Paper Speed Selection

Start up to enter into main control screen.

Press CAL/ SETUP, and the checkbox stops at “Paper Speed(mm/s)”.

Press the right LEAD SELECTOR, and paper speed increases progressively.

Press the left LEAD SELECTOR, and paper speed decreases progressively.

Press Start/Stop and exit from SETUP.

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2.3.12 Lead Group Mode Selection

Start up to enter into main control screen.

Press CAL/ SETUP, and the checkbox stops at “Standard” or “Cabrera”.

Press the left or right LEAD SELECTOR to select “Standard” or

“Cabrera”.

Press Start/Stop and exit from SETUP.

Standard: I II III aVR aVL aVF V1 V2 V3 V4 V5 V6

Cabrera: aVL I -aVR II aVF III V1 V2 V3 V4 V5 V6

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2.3.13 Lead Selection

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “12 ch”or “9 ch”.

Press the left or right LEAD SELECTOR to select “12 ch”or “9 ch”.

Press Start/Stop and exit from SETUP.

9- LEAD: I II III aVR aVL aVF V1 V3 V5

12- LEAD: I II III aVR aVL aVF V1 V2 V3 V4 V5 V6

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2.3.14 Synchronization Selection

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “Synchronous” or “Sequence”.

Press the left or right LEAD SELECTOR to select “Synchronous” or

“Sequence”.

Press Start/Stop and exit from SETUP.

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

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at N sec/LEAD (N=3~20).

Press the right LEAD SELECTOR, and auto lead change time progressively

increases to max 20s.


Press the left LEAD SELECTOR, and auto lead change time progressively
decreases to min 3s.

Press Start/Stop and exit from SETUP.

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2.3.16 Recording Ahead of Time(only available for some types)

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “Print ahead of 0~5s”.

Press the left or right LEAD SELECTOR to select “Print ahead of 0~5s”.

Press Start/Stop and exit from SETUP.

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

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “Format/ch”.

Press the left or right LEAD SELECTOR, and recording modes switch by

sequence below:

3/3ch → 3/2ch → 3/3ch

Press Start/Stop and exit from SETUP.

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2.3.18 Rhythm Lead Selection

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at Rhythm.

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

Press Start/Stop and exit from SETUP.

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2.3.19 Options of Printing Analysis report (only available for the machine with
analyzing function)

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “ECG report”.

Press the left/right LEAD SELECTOR, and select ECG report “on” or “off”.

Press Start/Stop and exit from SETUP.

39
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.

 When there is huge myoelectric or power current interference, identifications of P-

wave and Q-wave are not reliable sometimes. Due to baseline drift, identifications of

waves in ST and T segment might be unreliable.

 End positions of S-wave and T-wave are displayed squiggly and unclear, which will

cause measurement errors sometimes.

 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

QRS-wave cut-off point are unreliable sometimes. When Ventricular Premature

Contraction (VPC) happens frequently, even occasionally, it will also be detected as

cardiac activity. When many types of arrhythmias are combined, P-wave is difficult to

identify and relevant parameters might be unreliable.

40
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.

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “Save ECG”.

Press the left/right LEAD SELECTOR or Start/Stop to enter

into “Save ECG” setup.

41
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

from 001 by increasing automatically and progressively each day.

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

return to main interface automatically.

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.

2.3.21 ECG Review (only available for some types)

Review refers to, printing the ECG to be printed at last, or DEMO cases or cases in local HD

and storage card with the recording way selectedcurrently.

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “OPEN ECG”.

42
Press the left/right LEAD SELECTOR or Start/Stop to enter

into “OPEN ECG” setup.

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

the cases in storage card” and “Case demonstration”.

2.3.21.1 Printing Again

43
Press Start/Stop to print the last case again and exit from setup.

2.3.21.2 Case Demonstration

Press Start/Stop to activate Review and Print of demo case, and then exit from

setup.

2.3.21.3 Cancelling Case Demonstration


Only when you are currently under “Case Demo”, can you cancel it.

44
Press Start/Stop to cancel displaying or printing demo case, and then exit from

setup.

2.3.22 Speaker Volume Selection

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at Speaker Volume.

Press the left/right LEAD SELECTOR to turn off the speaker or switch its

volume among 1 to 12.

When the speaker is turned off, it displays:.

Press Start/Stop and exit from SETUP.

2.3.23 HR Sound Selection (only available for some types)

45
Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at HR Sound.

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 Start/Stop and exit from SETUP.

2.3.24 Restore Factory Defaults

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at Load Default.

Press the right LEAD SELECTOR, and it displays Are you sure to restore all

46
parameters to factory defaults? Confirm with Start/Stop, and then exit.

Press Start/Stop again to restore factory defaults.

2.3.25 External Input Selection

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at EXT Input.

Press the left/right LEAD SELECTOR to turn “On/Off external input.

Press Start/Stop and exit from SETUP.

47
2.3.26 Analog-out Selection

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at Analog-out.

Press the left/right LEAD SELECTOR to turn On/Off Analog-out.

Press Start/Stop and exit from SETUP.

48
2.3.27 Adjusting Monitor Brightness

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at Monitor Brightness.

Press the left/right LEAD SELECTOR, monitor brightness progressively

decreases/increases.

Press Start/Stop and exit from SETUP.

49
2.3.28 Clock Setup
2.3.28.1 Year

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “Year”.

Press the left/right LEAD SELECTOR, year progressively decreases from

2099 to 2010 /increases from 2010 to 2099.

Press Start/Stop and exit from SETUP.

50
2.3.28.2 Month and Day

Start up to enter into main control screen.

Press CAL/SETUP, and the checkbox stops at “Month and Day”.

Press the left/right LEAD SELECTOR, month circulates from 01 to 12/day

circulates from 01 to 31.

Press Start/Stop and exit from SETUP.

Note: the largest day of current month is based on the month set for day. The largest day of

February is based on the month and year set for day.

51
2.3.28.3 Hour and Minute

Start up to enter into main control screen.

Press CAL/SETUP several times, and the checkbox stops at Hour and

Minute.

Press the left/right LEAD SELECTOR, hour circulates from 00 to 23 and is

displayed in 24-hour format /Minute circulates from 00 to 59.

Press Start/Stop and exit from SETUP.

52
2.3.29 Language Setup

Start up to enter into main control screen.

Press CAL/SETUP several times, and the checkbox stops at Language.

Press the left/right LEAD SELECTOR, language changes from English to

Simplified Chinese/ language changes from Simplified Chinese to English.

Press Start/Stop and exit from SETUP.

53
2.3.30 Shortcut Operations
2.3.30.1 Auto Recording

Start up to enter into main control screen.

Press MODE until LCD displays auto lead change mode, based on the

method introduces in Auto Lead Change Mode Selection, select a desired

mode of auto lead change.

Confirm that READY light is lit.

Press Start/Stop to activate ECG recording, which automatically stops after an

ECG is printed.

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.

54
2.3.30.2 Manual Recording

Start up to enter into main control screen.

Press MODE until LCD displays manual lead change mode.

Press the left/right LEAD SELECTOR to select the desired lead wire.

Confirm that READY light is lit.

Press Start/Stop to start ECG recording.

Press Start/Stop to stop printing.

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.

2.3.30.3 Single 1-minute Packed Recording

Start up to enter into main control screen.

Press MODE until LCD displays 1-minute packed recording mode.

Press the left/right LEAD SELECTOR to select the desired lead wire.

Confirm that READY light is lit.

55
Press Start/Stop to start ECG recording.

A Progress Bar appears at upper right of the display screen, dynamically

indicating ECG acquisition status.

One minute after acquisition, the Progress Bar is full, and it automatically

prints out a compressed ECG with paper speed of 12.5 mm/s.

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.

2.3.30.4 Rhythm Analysis Recording

Start up to enter into main control screen.

Press MODE until LCD displays rhythm analysis recording mode.

Press the left/right LEAD SELECTOR to select the desired lead wire.

Confirm that READY light is lit.

Press Start/Stop to start ECG recording.

A Progress Bar appears at upper right of the display screen, dynamically

indicating ECG acquisition status.

5 minutes after acquisition, the Progress Bar is full, and it automatically

prints out a compressed ECG with paper speed of 12.5 mm/s.

56
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

 Only by leadwires can the patient be connected with ECG machine.

 Pay special attention while ECG machine is working, never move the patient and the

machine.

57
58
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

device, please follow the regulations below:

 Please dilute the cleaner and disinfectant according to Zoncare's instructions, or use the

cleaner and disinfectant whose concentration is as low as possible;

 Never submerge the device into liquid;

 Never pour liquid onto the device or its accessories;

 Never let liquid enter into the machine shell ;

 Never use abrasive materials (such as steel wool or silver polisher), or any strong solvents

(such as acetone or acetone detergent).

 You must turn off the power, and disconnect the power cord and the socket before

cleaning and disinfecting the device;

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

using other materials or methods;

 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.

59
3.1.1 Cleaning
Available options for cleaning the cart are listed as follows:

NaClO (Bleaching)

Oxydol (3%)

Ethanol (75%)

Isopropyl alcohol (70%)

It is recommended to use 75% ethanol to clean the accessories.

Cleaning the host:

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.

While cleaning the device:

 Turn off the power, and disconnect the power cord, its accessories and other devices

connected to the ECG machine before cleaning;

 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

and back of the device;

 Wipe off the remaining cleaner with a dry cloth if necessary;

 Put the device in a place with cool ventilation to dry it naturally.

Cleaning the cable and lead wires of ECG machine:

 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%

ethanol. Avoid the metal connector;

 Wipe off the remaining cleaner with a dry cloth if necessary;

 Put the cable and lead wires in a place with cool ventilation to dry them naturally.

Cleaning reusable electrodes:

60
 Reusable electrodes must be cleaned after each use.

 Use a soft cloth to wipe the surface of electrodes with some 75% ethanol;

 Wipe off the remaining cleaner with a dry cloth if necessary;

 Put the electrodes in a place with cool ventilation to dry them naturally.

Cleaning the printer head:

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

recorder head needs cleaning.

Please follow the steps below to clean the recorder head:

 Turn off the ECG machine;

 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

swab dipped with 75% alcohol;

 Dry the recorder head gently with a clean cotton swab;

 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

temperature is pretty high at that time.

3.1.2 Disinfection
Disinfection may damage the ECG machine or its accessories to some extent. It’s

recommended to perform disinfection only when it is necessary according to your hospital’s

service plan. Perform cleaning before disinfection.

61
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

accessories with 75% ethanol.

3.1.3 Sterilization
It is not recommended to sterilize the ECG machine and its accessories unless otherwise

requested in this manual of instructions for accessories.

3.2 Regular Inspection and Test:

3.2.1 Daily Inspection


Before the first use each day, the machine appearance should be inspected. If the ECG

machine is found damaged, please stop using it immediately, and contact equipment engineers in

your hospital or Zoncare maintainers.

Inspection items include:

 No stain on ECG machine shell; the panel and display screen are not broken or damaged;

 All buttons are in good condition;

 Interfaces, plugs and cables are not damaged or winded;

 The power cord, ECG machine and its cable are firmly connected;

 The paper is installed properly and adequate;

 The battery is installed and fully charged;

 Thorax electrode bulbs are free of cracks, and the limb electrodes are well clamping.

3.2.2 Regular Inspection:


When the ECG machine is used continuously for 6 to 12 months, after maintenance or

upgrading, it should be tested completely by the qualified service personnel, making sure that the

ECG machine works normally.

Inspection items are listed as follows:

 The environment and power meet the requirements;

62
 The device and it accessories are not mechanically damaged;

 The power cord, ECG machine cable and lead wire are not worn;

 The battery performance is in good condition;

 Function test: used for inspecting the internal state of the device. This project needs to be

performed by Zoncare professionals or authorized personnel under the guidance of Zoncare’s

technicians.

CAUTION

 For accidents or damage caused by lack of necessary maintenance, Zoncare will not

assume any responsibility.

3.3 Battery Usage & Maintenance

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

failure, we suggest the user to always install a full-charged battery in it.

 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

by connection with AC power or charging the battery.

3.3.2 Battery Charging

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

light will go out

63
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%

for no more than 3.5 hours.

3.3.3 Battery Replacement

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

the polarity “+” and “-”of corresponding terminals.

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.

3.3.4 Battery Guidelines


The battery’s life depends on its usage frequency and time. If the lithium-ion battery is

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

battery’s life, please pay attention to the following guidelines:

 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

shortens, optimize it once.

 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.

64
 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

machine and lay it aside again.

 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

 Place the battery in a place out of children’s reach.

 Use the battery designated by manufacturers.

 If the battery has the signs of damage and leak, please replace it immediately. Don’t

use faulty battery in ECG machine.

3.3.5 Battery Maintenance

Battery Performance Optimization

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.

Please optimize the battery by following steps:

1. Disconnect ECG machine with the patient;

2. Connect ECG machine with AC power, continuously charge the battery till it is fully

charged, and then the light goes out.

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

power, then the light goes out.

65
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

the battery’s supply time shortens obviously, please replace it.

Battery Performance Inspection

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

be fault cause, the battery’s performance should be inspected.

Please inspect the battery according to the following steps:

1. Disconnect ECG machine with the patient

2. Connect ECG machine with AC power, and constantly charge the battery to full power,

then the light goes out.

3. Disconnect AC power, supply ECG machine by battery until it shuts down.

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

maintainer to replace the battery.

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.

3.3.6 Battery Recycle


If the battery is obviously damaged or cannot store power, it should be replaced and recycled

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

66
or leakage may cause personal injury.

3.4 Paper Usage and Maintenance

Please follow the principles below while storing the paper:

 Store it in cool and dry environment, and prevent it from high temperature, humidity and

direct sunlight.

 Do not put it in fluorescent light

 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.

 Using the paper provided by Zoncare or of specification designated by Zoncare. Otherwise it

may shorten thermal recorder head’s life, recorded waveforms will become fuzzy and the

paper will feed poorly.

3.5 Maintenance of Electrodes and Lead Wires

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

suggested once a month.

Slightly bending or entangling the lead wires will shorten their life. Please keep them in good

order as possible before use.

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.

67
68
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

solve it with effective solutions.

WARNING

 ECG machine’s shell should be removed only by qualified service personnel. Inside

the ECG machine, there are no parts to be adjusted by users.

4.1 Interference Problem

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

environment or non-standard operation during use.

4.1.1 AC Interference

Figure 4.1Waveform with AC interference

1) Environment cause:

 Both ECG machine and metal bed are properly grounded.

 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

69
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

with each other,

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

frequency filtering is activated.

4.1.2 EMG Interference

Figure 8.2Waveform with EMG interference

1) Environment cause:

Inspect whether the exam room is comfortable; Check whether the indoor temperature is

too low; Check whether the bed is small and narrow.

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.

Let the examinee not move or talk.

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

Figure 8.3 Baseline drift waveform

1) Environment cause:

Inspect whether the exam room is comfortable; Check whether the indoor temperature is

too low, Check whether the bed is small and narrow.

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.

Let the examinee not move or talk.

3) Electrode cause:

Inspect whether limb electrodes are installed too tightly, which makes the examinee feel

uncomfortable,

Inspect whether the electrodes are loose or poorly connected.

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

batteries will also cause interference.

If the interference can't be ruled out by the solutions above, please make sure whether

frequency filtering is activated.

71
4.2 Recorder Failure:

Failures Possible causes Solutions


As the paper-feeding device has been used Adjust and tighten the transmission
for a long time, its transmission is decreased device, add some lubricants to the gear
by worn gear or loose connector. and two sides of the paper axis.
As the paper-feeding device has been used Contact Zoncare service department for
for a long time, its transmission resistance maintenance or replacement.
increases
The recorder is deformed by external force Contact Zoncare service department for
collision, thus affecting the paper speed. maintenance or replacement.
The paper feeds
The paper is out of specification, thus the Select the specified paper.
slowly and
resistance becomes over-high.
unevenly.
The paper has been placed for a long time, Replace the paper
it gets heated or moistened, which makes
local viscosity increase, thus affecting the
paper speed.
ECG machine is not well cleaned and Inspect and clean the ECG machine to
maintained. The recorder’s transmission get rid of moisture and dust.
device is dusty, thus decreasing
transmission.
The motor is damaged. Contact the service department for
The paper replacement.
doesn’t feed. Main control board fails. Return to Zoncare for service.

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.

72
Failures Possible causes Solutions
Printer head is dusty. Clean the printer head.

Paper is installed backwards. Black mark Reinstall the paper.


direction is wrong
After pressing
Stop, the Paper is out of specification. Select the paper with black mark.
recorder still
works, but
Black mark detection sensor head is dusty. Clean the sensor head with a cotton
prints nothing.
swab dipped in medical alcohol.

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.

4.3 Fuse Tube 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

fuse tube of AC power.

1)Remove the power cord;

2 ) Unscrew the fuse box lid at the bottom of the machine with screwdriver, and remove

burnt fuse tube;

3)Replace the fuse tube per designated specification, and put on the lid .

Specification of fuse tube: 5T T250L250V

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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

after-sale service department.

 Power cord must be removed before replacing the fuse tube; Only use the fuse tube of
designated specification.

74
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

stipulated time in warranty card since the purchase day.

3. Zoncare may fulfill its warranty promise by ways of visiting your place, telephone guidance

or delivery back to Zoncare. .

4. Even within warranty period, the following services will be charged:

①Fault and damage caused by users’ improper operation;

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

④Fault and damage caused by fire or natural disaster after purchase;

⑤Fault and damage caused by Zoncare unspecified thermal paper;

⑥Fault and damage caused by connection with other devices;

⑦Warranty seal is broken. Users privately alter and replace the series numbers of the

machine and lead wire. .

5. Zoncare will assume no responsibility for fault of other connected devices directly or

indirectly caused by this product’s fault.

6. If warranty label is damaged, Zoncare has the right to exempt free service within stipulated

time on warranty card.

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.

75
Appendix I

I.1 Performance Index

Standard or Cabrera 12-lead, synchronous


Lead
acquisition

Sampling acquisition 8000Hz

Take 10Hz as benchmark, 0.05Hz ~ 150Hz


Amplitude-frequency characteristic
(-3.0db - +0.4db)

Time constant ≥3.2 秒

CMRR >89dB

Input circuit current ≤0.1μA

Noise level ≤15μVp-p

Polarization resistance voltage ±300 mV

Calibration voltage 1mV ±5%

Filter AC 50Hz≥20dB;

1.25mm/mV, 2.5 mm/mV, 5 mm/mV, 10


Sensitivity mm/mV, 20 mm/mV, 40 mm/mV, automatic;
Switching error is ±5%
5 mm/s, 6.25 mm/s, 10 mm/s, 12.5 mm/s,
Paper speed
25 mm/s, 50mm/s, error is ±5%

Recording mode thermal array printing

Printing resolution Y axis ≥8 dot/mm

X axis ≥40 dot/ mm (paper speed 25mm/s)


≥20 dot/ mm (paper speed 50mm/s)
80mm(W) or 50mm(W), 20m(L), fast
Paper specification
thermal rolling paper

Indication for poorly-contacted electrodes Individual indication for each electrode

76
I.2 Safety Index

Safety floated and defibrillation proof

normal status d.c.≤0.01mA a.c.≤0.01mA


Patient leak current
single failure status d.c.≤0.05mA a.c.≤0.05mA
class I, type CF, with protective circuit for defibrillation and pace-
Safety
making

Continuous working time more than 10 hours

I.3 Power Specifications

AC Power 220V±22V, 50Hz±1Hz, 75VA

rechargeable li-ion battery (12V/1500mAh)


Battery
continuously working for more than 3 hours

I.4 Appearance Parameters

Size (L × W × H) 290mm ×200mm ×55mm

Weight about 2.2kg

I.5 Environmental Conditions

77
Operation

Ambient Temperature ﹢5℃~﹢40℃

Ambient Humidity 20%~85%

Atmospheric Pressure 70kpa~106kpa

Transport and Storage

Ambient Temperature -20℃~+55℃

Ambient Humidity 10%~95%

Atmospheric Pressure 50kpa~106kpa

I.6 Adherence to Standards

GB/T 191-2008 Packaging-Pictorial marking for handling of goods

General principles for preparation of instructions for use of


GB/T 9969-2008
industrial producets
Environmental requirement and test methods for medical
GB/T 14710-2009 electrical equipment

Medical electrical equipment Part2-25:Particular requirements


IEC 60601-2-25: 2011
for the safety of electrocardiographs
Rubber insulated cables of reted voltages up to and including
IEC 60245-1:2003
450/750V-Part 1:General requirements
Polyvinyl chloride insulated cables of rated voltages up to and
IEC 60227-1:2007
including 450/750V- Part 1:General requirements
Medical electrical equipment Part 1:General requirments for
IEC 60601-1:2006
basic safety and essential performance
YY 1139-2000 Single and multi-channel ECG machine
Electromagnetic compatibility (EMC) standards for medical
YY 0505-2012
electrical equipment.

Appendix II Electromagnetic Compatibility (EMC)


The product meets the requirements of EMC-Medical Electrical Equipment in EMC standard: IEC

78
60601-1-2.

NOTE
 Using the accessories, transducers, and cables out of stipulated range may increase EMC

emission and/or decrease EMC immunity of this device.

 This device should not be used adjacent to or stacked with other devices. Closely observe the

device if necessary to make sure that it runs normally in its configuration.

 The device needs special precautions regarding its EMC, and should be installed and

repaired in the environment where the following EMC information is satisfied.

 Even if those other devices meet the emission requirements of CISPR, still they may cause

interference to this device.

 When input signal amplitude is lower than the stipulated minimum in technical

specifications, it may lead to inaccurate measurement.

 Portable and mobile communication equipment will affect the performance of this device.

Guidance and manufacturer’s declaration-- electromagnetic emissions

This machine is intended for use in electromagnetic environment specified below.


The customer or the user of this machine should assure that it is used in such environment.

Emissions test Compliance EMC environment — guideline

The equipment uses RF energy only for its


RF emissions internal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any
interference to nearby electronic equipment.
RF emissions
Class A
CISPR
Harmonic
The equipment is intended for use in all
Emissions Class A
establishments including domestic establishments
IEC 60601-1-2
and those directly connected to the public low-
Voltage voltage power supply network that supplies
Fluctuation/Flicker Compliance buildings used for domestic purposes.
emissions
IEC 60601-1-2

WARNING

79
● 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.

Guidance and manufacturer’s declaration-- electromagnetic emissions

This machine is intended for use in electromagnetic environment specified below.

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

Floors must be wood,


Electrostatic concrete or ceramic tile.
±6 kV contact ±6 kV contact If floors are covered with
discharge (ESD)
±8 kV air ±8 kV air synthetic material, the
IEC 61000-4-2 relative humidity should be
at least 30%.

±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

80
<5% UT <5% UT

(>95% dip in UT) (>95% dip in 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.

81
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

IEC 60601 Compliance


Immunity test Electromagnetic environment — guidance
Test level level

Conduced 3 Vrms 3Vrms Portable and mobile RF communications


RF IEC 150kHz to Equipment should be used no closer to any
61000-4-6 80MHz part of the machine, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.2 x √P

d = 1.2 x √P 80 MHz to 800 MHz


d = 2.3 x √P 800 MHz to 2.5GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
Radiated 3V/m recommended separation distance in meters
RF IEC 80MHz to 3 V/m (m).
61000-4-3 2.5GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a

should be less than the compliance level in


each
frequency range

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

by maintaining a minimum distance between portable and mobile RF communication equipment

(transmitters) and the equipment as recommended below,

Rated Output power of Separation Distance According to Frequency of Transmitter


Transmitter M (Meters)
(Watts)
Rated Maximum 150 kHz~ 80 MHz 80 MHz~ 800 MHz 800 MHz~ 2.5 GHz
Output power of(W)
d= 1.2 d = 1.2

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.20 1.20 2.30

10 3.80 3.80 7.30

100 12.00 12.00 23.00

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

absorption and reflection from structures, objects and people.

83
Appendix III Environmental Protection Declaration

Names and contents of toxic or hazardous substances or elements in products


Toxic or hazardous substances or elements
Name
Pb Hg Cd Cr(VI) PBB PBDE

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

materials are below the stipulated limits of SJ/T11363-2006 standard.


The equipment and its parts should be disposed according to the
Cautions
local laws and regulations. Do not discard them as useless together

with household garbage.

NO.3510000202

85

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