GIMA 1200G ECG 12 Channel With Monitor User Manual
- June 7, 2024
- GIMA
Table of Contents
1200G ECG 12 Channel With Monitor
PROFESSIONAL MEDICAL PRODUCTS
1200G ECG 12 CHANNEL WITH MONITOR
ECG1200G (33224)
CONTEC MEDICAL SYSTEMS CO., LTD No. 112 Qinhuang West Street, Economic &
Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF
CHINA Made in China Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537, Hamburg, Germany
0123
55°C
1060 hPa
95%
-20°C
500 hPa
0%
M33224-GB-Rev.0-05.21
Preface
Please read the User Manual carefully before using this product. The operating
procedures specified in this User Manual should be followed strictly.This
manual describes in detail the operation steps which must be noted, the
procedures which may result in abnormality, and possible damage to the product
or users. Refer to following chapters for details. Failed to follow the User
Manual may cause measuring abnormality, device damage or personal injury. The
manufacturer is NOT responsible for the safety, reliability and performance
issues of such results due to user’s negligence of this user manual for using,
maintenance or storage. The free service s and repairs do not cover such
faults either.
The content in this user manual complies with real product. For software
upgrade and some modifications, the content in this user manual is subject to
change without prior notice, and we sincerely apologize for that. Attentions
Before using this product, the safety and effectiveness described in the
following shall be considered: Ø Type of protection against electric shock:
class I (AC power supply), internal powered
equipment (power supplied by battery) Ø Degree of protection against electric
shock: type CF, defibrillation-proof function applied
part Ø Working mode: continuous running equipment Ø Enclosure protection
class: IPX0 Ø Measurement results shall be described by professional doctor
combined with clinical
symptoms. Ø The using reliability depends on whether the operation guide and
maintenance instructions
in this user manual is followed. Ø Service life: 5 years Ø Date of
manufacture: see the label Ø Contraindications: none
Warning: To ensure the device safety and effectiveness, please use the company
recommended accessories. The maintenance and repair of the device should be
done by
professional personal specified by the company. It is forbidden to refit the
device.
Responsibility of the operator Ø The device must be operated by a
professionally trained medical staff, and kept by a
special person. Ø The operator should read the User Manual carefully before
use, and strictly follow the
operating procedure described in the User Manual. Ø The safety requirements
have been fully considered in product designing, but the operator
can not ignore the observation of the patient and device. Ø The operator is
responsible for providing the information of product use to the company.
I
Responsibility of the company Ø The company supplies qualified products to
user in accordance with enterprise standard. Ø The company installs and debugs
the equipment and trains the physicians by contract. Ø The company performs
device repair in warranty period (a year) and maintenance service
after warranty period. Ø The company responds timely to the user’s request.
The user manual is written by Contec Medical Systems Co., Ltd. All rights
reserved.
II
Statement
Our company owns all rights to this unpublished work and intends to maintain
it as confidential information. This user manual is used only for reference of
operation, maintenance, or repair of our device. No part of this can be
disseminated to others. And our company takes no responsibilities for any
consequences and liabilities caused by using this user manual for other
purposes.
This document contains proprietary information, which is protected by
copyright. All rights reserved. Photocopy, reproduction or translation of any
part in the manual without our company’s written permission is prohibited.
All information contained in this user manual is believed to be correct. Our
company shall not be liable for incidental and consequential damages in
connection with the furnishing, performance, or use of this material. This
user manual may refer to information and protected by copyrights or patents
and does not convey any license under the patent rights of our company, nor
the rights of others.Our company does not assume any liability for arising out
of any infringements of patents or other rights of the third parties.
Our company owns the final explanation right to this user manual, and reserves
the right to change the content of this user manual without prior notice, and
the rights to change product technology and specification.
III
Contents
Chapter1 Overview………………………………………………………………………………………………………..1 1.1
Overview……………………………………………………………………………………………………….1 1.2 Intended use
…………………………………………………………………………………………………..1 1.3 Main technical specifications
………………………………………………………………………….1 1.4 Main
Characteristics……………………………………………………………………………………….2 1.5 Software
overview………………………………………………………………………………………….3
Chapter2 Safety Precautions …………………………………………………………………………………………..4 Chapter3
Warranty ………………………………………………………………………………………………………..7 Chapter4 Working Principle
and Structural Characteristics ………………………………………………8
4.1 Working principle and its block diagram………………………………………………………….8 4.2 Name
of each part and its function…………………………………………………………………..9 Chapter 5 Operation
Precautions …………………………………………………………………………………..14 5.1 Precautions before
use…………………………………………………………………………………..14 5.2 Precautions during operating
…………………………………………………………………………14 5.3 Precautions after
use……………………………………………………………………………………..14 Chapter 6 Preparations before
Operation ……………………………………………………………………….15 6.1 Installation of recording
paper……………………………………………………………………….15 6.2 Power supply connection
………………………………………………………………………………16 6.3 Lead cable
connection…………………………………………………………………………………..16 6.4 Electrode installation
…………………………………………………………………………………….17 Chapter 7 Operation Instructions and
Parameter Setting …………………………………………………20 7.1 Main
Interface………………………………………………………………………………………………20 7.2 Sampling
interface………………………………………………………………………………………..21 7.3 Case information input
interface ……………………………………………………………………24 7.4 Case
management…………………………………………………………………………………………25 7.5 Date and time setup
………………………………………………………………………………………28 7.6 System setup
………………………………………………………………………………………………..28 7.7 Sampling
setup……………………………………………………………………………………………..30 7.8 Print setup
……………………………………………………………………………………………………30 7.9 Lead
placement…………………………………………………………………………………………….32 7.10
About…………………………………………………………………………………………………………33
IV
Chapter 8 Troubleshooting……………………………………………………………………………………………34 8.1 Auto
shutdown……………………………………………………………………………………………..34 8.2 AC
interference…………………………………………………………………………………………….34 8.3 EMG interference
…………………………………………………………………………………………34 8.4 Baseline
drift………………………………………………………………………………………………..35 8.5 Troubleshooting
list………………………………………………………………………………………35
Chapter 9 Maintenance…………………………………………………………………………………………………37 9.1 Battery
…………………………………………………………………………………………………………37 9.2 Recording
paper……………………………………………………………………………………………38 9.3 Maintenance after
use……………………………………………………………………………………38 9.4 Lead cables and
electrodes…………………………………………………………………………….39 9.5 Silicone rubber
roller…………………………………………………………………………………….39 9.6 Cleaning of thermal print head
………………………………………………………………………39 9.7 Fuse replacement
………………………………………………………………………………………….39 9.8 Disposal of product
scrap………………………………………………………………………………40 9.9 Others
………………………………………………………………………………………………………….40
Chapter 10 Packing List and Accessories ………………………………………………………………………41 10.1
Accompanying accessories ………………………………………………………………………….41 10.2
Notes………………………………………………………………………………………………………….41
Appendix I ECG Automated Measurement&Interpretation Guide…………………………………..42 1.
Preface …………………………………………………………………………………………………………..42 2. Automated measurement
parameters and Automated interpretation items ………….42 3. Algorithm description
…………………………………………………………………………………….44 3.5 Interpretations judgment based on
parameters ………………………………………………..50 4. Data sources and data
preprocessing………………………………………………………………..54 4.5 Data coverage of verification
for automated interpretation ………………………………56
5. Process and Result of Verification …………………………………………………………………………….58 5.1
Verification of measurement function ……………………………………………………………58
Appendix II EMC Guidance and Manufacturer Declaration……………………………………………67
V
Chapter1 Overview
1.1 Overview
This product is a kind of electrocardiograph, which is able to sample 12 leads ECG signals simultaneously and print out the ECG waveform with thermal printing system. Its functions are as follows: recording and displaying ECG waveform in auto/manual mode; measuring ECG waveform parameters automatically, and automatic analysis and diagnosis; prompt for electrode-off and out of paper; optional interface languages(Chinese/English, etc.); built-in lithium battery, powered either by AC or DC; arbitrarily select the rhythm lead to conveniently observe abnormal heart rate; case database management, etc.
1.2 Intended use
This product is suitable for hospital, scientific research, wards, ambulances and carrying out medical consultations. It can be used by medical institutions to record human ECG signals, collect and extract the ECG waveform.
1.3 Main technical specifications
1.3.1 Environment conditions
Operation: a). Environment temperature: 5~40
b). Relative humidity: 25%~95%(no condensation)
c). Atmospheric pressure: 700 hPa~1060 hPa
d). Power supply: Voltage: 100-240 V
Frequency: 50 Hz, 60 Hz Input power: 150 VA
Battery: 14.8 V, 3500 mAh rechargeable lithium battery
Transportation and Storage: a). Environment temperature: -20 +55 b). Relative humidity: 95%
c). Atmospheric pressure: 500 hPa1060 hPa
1.3.2 Input way: Floating and defibrillation protection
1.3.3 Lead: Standard 12 leads 1.3.4 Patient leakage current: <10µA 1.3.5 Input impedance: 2.5 M
1.3.6 Frequency response:
Test
Input frequency and waveform
Relative output response
1.0
0.67Hz~40Hz, Sine wave
±10%a
0.5
40Hz~100Hz, Sine wave
+10 %, -30 %a
0.25
100Hz~150Hz, Sine wave
+10 %, -30 %a
0.5
150 Hz ~ 500 Hz, Sine wave
+10 %, -100 %a
1.5
1Hz,200ms, Triangle wave
+0 %, -10 %b
a relative to 10Hz b relative to 200 ms
1
1.3.7 Time constant: 3.2s 1.3.8 CMRR: >105 dB 1.3.9 Filter: AC Filter(50Hz/60
Hz), EMG Filter(25 Hz/35 Hz (-3 dB)), DFT Filter 1.3.10 Recording way: Thermal
printing system 1.3.11 Specification of recording paper: 210 mm(W)×20 m(L)
high-speed thermal paper 1.3.12 Time base selection(paper speed):
12.5 mm/s, 25 mm/s, 50 mm/s, error: ±5% 1.3.13 Gain control(sensitivity): 5,
10, 20 mm/mV, accuracy is ±2%;
Standard sensitivity: 10 mm/mV±0.2 mm/mV 1.3.14 Auto record: record setup
according to auto record format and mode, automatically change leads,
automatically measure and analyze. 1.3.15 Rhythm record: record setup
according to rhythm record format and mode, automatically measure and analyze.
1.3.16 Manual record: record according to manual record format. 1.3.17
Measurement parameters: HR, P-R interval, P Duration, QRS Duration, T
Duration, Q-T interval, Q-Tc, P Axis, QRS Axis, T Axis, R(V5) amplitude, S(V1)
amplitude, R(V5)+S(V1) amplitude 1.3.18 Product safety type: Class I type CF
defibrillation-proof function applied part 1.3.19 Polarization resistance
voltage: ±610 mV 1.3.20 Noise level: 12 µVp-p 1.3.21 ECG signal input sampling
frequency: 32 kHz 1.3.22 Waveform data processing sampling frequency: 1 kHz
1.3.23 Sampling precision: 24-bit 1.3.24 The minimum detection signal: 10 Hz,
20 µV(peak-peak value) deflected sinusoidal signal can be detected 1.3.25
Pacing detection channel: standard II 1.3.26 Accuracy of input signal: The
overall system error, ±5%. 1.3.27 Amplitude quantization: 5µV/LSB 1.3.28
Interchannel time deviation: <100 µs 1.3.29 Fuse specification: 2pcs 5×20mm AC
delay insurance: T1.6AL250V 1.3.30 Dimension: 340 mm(L)×320 mm(W)×85mm(H)
1.3.31 Net Weight: 3.2 kg
1.4 Main Characteristics
1.4.1 Display with 800*600 dots, 8″ high-resolution color LCD, operate either
by touch screen or function buttons, which is convenient and quick. 1.4.2 Sync
collection for 12-lead ECG, use digital signal processing technology to
conduct AC filter, baseline filter and EMG filter on ECG signals, in order to
get high-quality ECGs. 1.4.3 Display of 3/6/12-lead ECG on one screen, and
print mode, sensitivity, paper speed, filter state and other information,
which facilitates comparative diagnosis. 1.4.4 The device can be powered
either by AC or DC(can adapt to 50/60Hz AC frequency), with built-in
rechargeable lithium battery and charging circuit, perfect battery overcurrent
and
2
overvoltage protection circuit. 1.4.5 Multiple print mode and format,
including, automatic 12×1, 6×2+1(rhythm lead), 6×2, 3×4+2 (rhythm lead),
rhythm 12, rhythm 10, rhythm 8, rhythm 6 and manual. Trend graph and histogram
of RR interval can be printed. Printed waveform length is adjustable. With
timed print function to satisfy various application requirements. 1.4.6 Rhythm
leads can be arbitrarily selected to facilitate the observation of abnormal
heart rate. 1.4.7 Clinical information such as patient’s name, gender, age,
sampling mode and department can be input. 1.4.8 The built-in large-capacity
memory, making it easy for doctor to review medical records and statistical
information. 1.4.9 Multi-language (Chinese, English, Turkish, Portuguese,
German, Russian, Kazakhstan, etc.) interface and report. 1.5 Software overview
Name of software: ECG1200G embedded software Software specification: none
Software version: V1.6.1 Version naming rules: V
3
Chapter2 Safety Precautions
2.1 Ensure that the device is placed on a flat level worktable. Avoid strong
vibration or impact when moving it. 2.2 When working with AC power, the power
cord must be 3-core, the frequency and voltage value of the AC power source
must match the identification on the manual and have sufficient capacity. When
the provided three-core power cord cannot be used, please use the built-in DC
power supply or replace the three-core power cord that meets the standard
requirements. 2.3 A perfect power supply system and grounding are necessary in
the room.
Warning: To avoid the risk of electric shock, the device must be connected a
power supply with protective grounding. 2.4 If there are any questions for the
integrality of protective grounding cable or the reliability of protective
grounding cable connection can not be guaranteed, the device must be run with
built-in DC power supply. 2.5 The safety requirements have been fully
considered in product designing, but the operator can not ignore the
observation of the patient and device. Cut off the power or take off the
electrode when necessary to ensure patient’s safety. 2.6 Please turn off the
device and unplug the power cord before replacing the fuse or cleaning and
disinfection. Don’t rub the screen with sharp materials. 2.7 Keep the device
from water, don’t use or store it in places with high air pressure, humidity
or temperature over the standard, bad ventilation, or too much dust. 2.8 Do
not use the device in the place with flammable anesthetic gases or other
flammable chemicals, otherwise there is a danger of explosion or fire. 2.9 Do
not use the device in medical hyperbaric oxygen chamber, otherwise there is a
danger of explosion or fire. 2.10 This device is not intended to act directly
on the human heart. If this device is used with cardiac defibrillator or other
electric stimulating devices at the same time, single-use electrodes and ECG
lead cables with defibrillation-proof function should be selected. It is
better not to use this device with other electric stimulating devices at the
same time. If it is necessary, there must be professional technician guiding
on the scene, and the selected accessories should be designated by our
company.
WarningDo not operate the instrument on parts of human body with wounds,and do
not perform measurements on parts with wounds on the surface. 2.11 When the
electrocardiograph is used together with a high-frequency electrosurgical
knife, the ECG electrode should be kept away from the contact of the
electrosurgical knife to prevent burns and burning of the electrode wires
caused by high-frequency sparks. 2.12 When the electrocardiograph is used
together with a defibrillator, the operator should avoid contact with the
patient or the sickbed. The defibrillation electrode should not directly touch
the ECG electrode to prevent sparks from burning the device and the patient.
2.13 Please do not use the electrocardiograph in the environment that is
interfered by high-power device such as high-voltage cables, X-rays,
ultrasonic machines and electrizer, keep the device away from emission sources
such as mobile phones.
4
2.14 If other equipment is connected with this ECG device, it must be a Class
I device that complies with IEC60601-1. Because the total leakage current may
hurt patient, the monitoring of leakage current is carried out and taken
charge by the connected equipment. 2.15 Notes related to EMC
The device complies with the safety standards for medical electrical equipment
or system electromagnetic compatibility in IEC60601-1-2. Electromagnetic
environments exceeding the IEC60601-1-2 standard may cause harmful
interference to the device or prevent the device from performing its intended
function or degrade its performance. Therefore, if there is a phenomenon that
does not match its function during use, be sure to confirm and eliminate
adverse effects before continuing to use it. Corresponding precautions for
this situation are given in this manual. n The device or system should not be
used near or stacked with other devices. If it must be
used near or stacked with other devices, it should be observed and verified
that the device is working normally under the configuration it is using. n Use
of accessories, transducers, and cables other than those specified by the
manufacturer of the device or system as spare parts for internal components
may result in increased emissions of the device or system and reduced
immunity. n Effect from radiated electromagnetic waves: The use of a mobile
phone may affect the operation of the device. When installing medical
electrical equipment, be sure to remind people around the device to turn off
mobile phones and small radios. n Effect from shock and conduction
electromagnetic waves: High frequency noise from other equipment can enter the
device through the AC socket. Please identify the source of noise, if
possible, stop using the equipment. If the equipment can not be deactivated,
use noise cancellation equipment or take other measures to reduce the impact.
n Effect from static electricity: Static electricity in a dry
environment(indoor) may affect the operation of the device, especially in
winter. Before using the device, humidify the indoor air or discharge the
static electricity from the cable and operator. n Effect from thunder and
lightning: If there is thunder and lightning nearby, it may cause a voltage
surge in the device. If you are concerned about danger, disconnect the AC
power and use the internal power supply. 2.16 Notes concerning ECG waveform
measurement and analysis 2.16.1 The identification of P wave and Q wave is not
always reliable with intensive EMG or AC interference. Neither are the ST
segment and T wave with baseline drift. 2.16.2 Winding and unclear end
position of S wave and T wave may cause error in measurement. 2.16.3 When R
wave is uninspected caused by some leads off or QRS wave low voltage, the
heart rate measurement may deviate greatly from the correct. 2.16.4 In case of
QRS low voltage, ECG axis calculation and border-point identify of QRS wave
are not always reliable. 2.16.5 Occasionally, frequent ventricular premature
complexes may be identified as dominant beat.
5
2.16.6 Merging of versatile arrhythmia may result in unreliable measurement
because of the difficulty in distinguishing P wave in such situation. 2.16.7
The device has an automatic analysis function that automatically analyzes the
obtained ECG waveform without reflecting all the patient’s status. The results
of the analysis may sometimes not comply with the doctor’s diagnosis.
Therefore, the final conclusion needs to be comprehensively analyzed by
doctors in combination with analysis results, patient clinical
characterization and other test results.
6
Chapter3 Warranty
3.1 In normal use, under strict observance of user manual and operation notes,
in case of failure, please contact with our customer service department. Our
company has the sales record and customer archives for each device. The
customer has one year free warranty service from the date of shipping
according to the following conditions. To supply all-around and quick
maintenance service for you, please mail the maintenance card to us in time.
3.2 Our company may adopt such ways as guidance, express to company or door-
to-door service, etc. to carry out warranty promise. 3.3 Even in warranty
period, the following repairs are charged. 3.3.1 Faults or injuries caused by
misuse that not according to user manual and operation notes. 3.3.2 Faults or
injuries caused by dropping accidentally after purchase. 3.3.3 Faults or
injuries caused by repair, reconstruction, decomposition, etc. not by our
company. 3.3.4 Faults or injuries caused by improper storage or force majeure
after purchase. 3.3.5 Faults or injuries caused by using improper thermal
recording paper. 3.4 The warranty period for accessories and fray parts is
half a year. Power cable, recording paper, operation manual and packing
material are excluded. 3.5 Our company is not responsible for the faults of
other connected devices caused by the faults of this device directly or
indirectly. 3.6 The warranty will be canceled if we find the protection label
has been destroyed. 3.7 For charged maintenance beyond warranty period, our
company advises to continue using “Maintenance contract regulation”. Please
refer to our customer service department for details.
7
Chapter4 Working Principle and Structural Characteristics
4.1 Working principle and its block diagram
4.1.1 The power supply unit
1Principle of power supply The switching power supply provides +24V working
voltage for the thermal print head,
provides constant voltage current limiting charging for the rechargeable
lithium battery in the device through the DC-DC circuit, and generates +5V and
+12V voltage through the power conversion to supply power to the corresponding
modules. At the same time, the lithium battery in the device can independently
satisfy working requirements of each module in the device through the buck-
boost circuit. 2Principle block diagram is shown in Figure4-1.
+24V
DC- DC conver si on
Ther mal pr i nt head
Di spl ay uni t
Char gi ng +14.8V
+14.8V
Bat t er y +5V
Acqui si t i on uni t Cont r ol uni t
Swi t chi ng power suppl y
DC- DC conver si on
+14.8V +12V
Mot or
AC100~240V 50/60Hz
Figure4-1 Block diagram of power principle
Note: The principle block diagram and component list are only available to service stations or maintenance personnel designated by our company.
4.1.2 Signal acquisition unit
The signal acquisition unit uses a floating setting, which is a signal
acquisition and processing system, including analog circuit part and A/D
conversion (with sampling accuracy of 24 bits) and data processing part. The
analog circuit consists of signal following, amplification, anti-aliasing low-
pass filtering, lead-off detection and overload detection. CPU system is
responsible for coordinating the work of each circuit such as the A/D
converter, the lead-off detection circuit and the overload detection circuit,
in order to achieve signal acquisition, processing, and lead-off detection.
Control information and A/D conversion and data acquisition between the
floating circuit and the solid circuit are transmitted through the
optoelectronic
8
coupler.
4.1.3 Control unit 1Principle of control unit
The control system consists of printing system, button system, liquid crystal
display system, and signal acquisition system. The ECG signal sent from the
signal acquisition system through the high-speed optoelectronic coupler is
received by the CPU system, after digital filtering, gain adjustment and motor
drive, it is sent to the printing system to print the ECG waveform. After the
printing is completed, the CPU system processes waveform measurement and
analysis. The CPU system also receives an interrupt signal and button code
from the button system to complete the interrupt processing. In addition, the
lead-off signal, paper out detection, battery voltage management, and
automatic power-off are also managed by the CPU system. The liquid crystal
controller receives data and commands from the CPU system to complete the
display of the control state of the device. 2Principle block diagram is shown
in Figure4-2.
But t on syst em Pr i nt i ng syst em
Cont r ol syst em
Si gnal acqui si t i on syst em
Di spl ay syst em
Power modul e
Figure 4-2 Block diagram of control unit
4.2 Name of each part and its function
4.2.1 Front view
2
1
3
Figure 4-3 Front view 9
1. Paper compartment cover Keep the paper compartment closed, hold the
printing paper
2. Display screen Display patient’s ECG and related information
3. Button area Control the operations of the device, and enter information.
Note
Ø Do not put heavy objects on the screen or hit against it, otherwise the
screen will be damaged.
Ø If the device is not in use, cover it to prevent liquid spills on the
screen. Ø Do not use sharp stuff to operate the buttons, otherwise it may case
permanent
damage to the buttons. 4.2.2 Side view
Figure 4-4 Side view 4. Lead cable interface
Connect with lead cables. 5. USB interface
Communicate with the computer. The ECG data can be transmitted to a computer,
by using the computer, many functions can be achieved, such as archiving,
managing, and analyzing ECG data, which facilitates clinical research,
organization teaching and training. 6. Network interface
Connect with the LAN, then perform case analysis and remote control by expert
in the LAN. 7. Mains power switch
A control button connecting with AC power. 8. Input socket
Connect with the AC power cord. 9. Equipotential terminal
Connect with the potential equalization conductor.
10
Figure 4-5 Bottom view 10. Battery compartment
Built-in rechargeable lithium battery. 11. Fuse
Built-in fuse tube, T1.6A L250V. It can avoid the damage to human body caused
by large voltage and large current generated by grid pollution.
Note Lead cables must be disconnected from patient before connecting with a
computer via the USB interface. Operator must not touch the USB interface and
patient at the same time. 4.2.3 Buttons
Figure 4-6 Schematic diagram of buttons 1. Startup indicator It lights in
green after turning on the device. 2. Power status indicator Green indicates
that the AC power supply is used. At this time, there is no battery in the
device or the battery is full. Red and green two colors indicate that the
battery is being charged. 3. Number buttons Input patient’s information,
hospital name, bed number and other information, both Chinese and
11
English are supported.
4. Backspace
Change entered information, long pressing it could clear the title.
5. ON/OFF
When the device is turned on, short press this button, it will prompt whether to shut down the
device, long press this button to turn off the device.
6. Direction buttons
Including up, down, left, right and OK buttons, quick and convenient
7. SPEED
Change the ECG recording speed
8. SEN
Adjust the sensitivity manually.
9. FILTER
Set the filter mode.
10. MODE
When the device in sampling interface, use MODE button to select the print mode.
11. PRINT
Print the sampled ECG waveform or end the printing.
12. Switch button of input method
Under the inputting state, use this button to switch between numbers, lowercase, capital and
symbols.
13. Setting button of acquisition system
Collect ECG waveform and set the display mode.
4.2.4 Symbols
AC
Alternating current
OFF
Alternating current–OFF
ON
Alternating current–ON
Equipotential point, the equipotential point of this device is combined with the protective grounding.
Caution! Refer to the accompanying document.
Type CF equipment, with defibrillation-proof function
USB interface
PATIENT
FUSE T1.6AL250V
5×20
Lead cable socket Fuse specification Serial number
12
Manufacturer
Date of manufacture Batch code
Latex free Atmospheric pressure limitation
Temperature limitation
Humidity limitation For indoor use only
Polarity of d.c. power connector Waste disposal symbol. This symbol indicates
that electrical and electronic equipment waste cannot be disposed of as
unsorted municipal waste and must be recycled separately. This way up
Fragile, handle with care
Keep away from rain
Stacking limit by number
Refer to instruction manual/booklet This item is compliant with Medical Device
Directive 93/42/EEC of June 14,1993,a directive of the European Economic
Community.
Catalogue number
Authorized representative in the European Community General warning sign NOTE
Background col our: yellow Triangular band: Black
13
Chapter 5 Operation Precautions
5.1 Precautions before use 5.1.1 For safe and effective use, please read the
user manual carefully before operation. 5.1.2 Check to ensure that the device
is in good condition. 5.1.3 The device shall be placed on a flat surface, and
moves gently to avoid strong vibration or shock. 5.1.4 Check to ensure that
the lead cables are correctly connected, and the device grounding is correct.
5.1.5 The AC frequency and voltage should comply with the requirements, and
enough current capacity should be guaranteed. 5.1.6 When using the battery for
power supply, check to ensure that the battery voltage and battery status are
in good condition, and the battery has enough power. 5.1.7 When the device is
used together with other equipment, all devices and equipment should be
equipotential grounded in order to protect the user and operator. 5.1.8
Install the device where easily grounded in the room. Do not allow the patient
and patient-connected lead cables and electrodes to come into contact with
other conductor parts, including the earth or a hospital bed. 5.1.9 Clean the
lead cable with neutral solvent. Do not use alcohol-based cleaners or
gemicides. 5.1.10 Ensure that the device is running within the normal ambient
temperature range of 5 to 40. If the device is stored at a higher or lower
temperature, leave it in the operating environment for approximately 10
minutes before use in order to ensure the normal work. 5.2 Precautions during
operating 5.2.1 The printing can be started after the ECG waveform is stable.
5.2.2 During using, the doctor should observe the patient carefully and cannot
leave the operating site. If necessary, turn off the power or remove the
electrode to ensure patient safety. 5.2.3 The patient and the device can only
be connected via lead cables through the electrodes, in order to avoid patient
touches other parts of device or conductors. 5.2.4 Patient can not move during
operating. 5.2.5 Maintenance or repair to the device or accessory is not
allowed during using. 5.3 Precautions after use 5.3.1 Set the states of all
functions to initial states. 5.3.2 Cut off the power, gently remove the
electrodes and limb clips, then remove the lead cables, do not pull with
force. 5.3.3 Clean the device and all accessories, and store them for the next
use.
14
Chapter 6 Preparations before Operation
6.1 Installation of recording paper 6.1.1 The device adopts high-speed
recording paper, its specification is 210 mm(W)×20 m(L). 6.1.2 The
installation method of recording paper is described as below: 1. As shown in
Figure 6-1, use both hands to lift both sides of the paper compartment cover
at the same time to open it. Take out the roller, insert it into the roll
paper as shown in the figure. The paper side with grids should be faced
downwards, and then install it to proper position in the paper compartment.
Figure 6-1 Installation of recording paper 2. Pull out the recording paper
from the slot of the paper compartment cover, and close the cover.
Note Ø When opening the paper compartment cover, it is not allowed to open one
side
separately, otherwise the operation of the device will be affected. Ø The
recording paper should be aligned with the slot of the paper compartment
cover.
It is recommended to leave 2cm paper outside. 6.1.3 If the recording paper
runs out during recording, the device will stop printing automatically, and
the screen will display a prompt of lack of paper, as shown in Figure 6-2.
15
Figure 6-2 Lack of paper prompt 6.2 Power supply connection 6.2.1 AC
Insert one end of the provided three-core power cord into the device’s input
socket, and insert the other end into a three-core power socket that meets the
requirements. Ensure that the connection is secure and reliable, and the
device is automatically grounded.
When the device is used in conjunction with other medical equipment, use the
supplied potential equalization wire to connect the equipotential terminal of
the device to the equipotential terminal of the connected equipment to prevent
leakage current and protect the device. 6.2.2 Battery
The device has a built-in rechargeable lithium battery, which does not need to
be re-installed by user. Check the battery’s power and status before use.
Note: Connect one end of the potential equalization wire to the equipotential
terminal of the device, and connect the other end to the ground to enhance the
reliability of the grounding. Do not use other pipes as ground wire,
otherwise, the patient may be in danger of electric shock. 6.3 Lead cable
connection
Connect the lead cable to the lead cable interface on the device, and fasten
it to the device with the fixing knobs at both sides of the lead cable in
order to prevent bad connection and affecting the detection.
Note: The lead cable interface can not be used for other purposes except as
the input interface of ECG signals.
16
6.4 Electrode installation Proper installation of the electrodes is an
important part of accurately recording the
electrocardiogram. Make sure the electrodes are in good contact. Old and new
electrodes or reusable electrodes and disposable electrodes cannot be used at
the same time. If different types of electrodes are used together, it will
seriously affect the ECG recording. The electrode or lead plug must not touch
other object surfaces or conductors, such as metal beds. Please replace them
all when updating the electrodes. 6.4.1 Chest electrodes As shown in Figure
6-3:
Figure 6-3 Installation of chest electrode The chest electrodes should be
installed to the following parts: C1Vl: the fourth intercostal space at the
right sternal margin C2V2: the fourth intercostal space at the left sternal
margin C3V3: between C2 and C4 C4V4: the intersection between midclavicular
line and the fifth intercostal space C5V5: left anterior axillary line on the
same plane as C4 C6V6: left midaxillary line on the same plane as C4 Clean the
chest skin where the electrodes to be installed with alcohol, and apply some
conductive pastes to these skin (about 25 mm-diameter range) and the edge of
the chest electrode suction cup. Squeeze the suction ball to install the chest
electrode at the positions of Cl-C6. Note: The conductive paste coating should
be separated from each other, and the chest electrodes should not touch each
other to avoid short circuit. Note: Please use qualified conductive paste to
avoid damaging the skin. 6.4.2 Limb electrodes The limb electrodes should be
placed on the soft skin of both hands and feet. Before connecting, clean the
skin of the electrode installation area with alcohol, and then apply a small
amount of conductive paste on the cleaned skin. The electrode connection of
the limbs is shown in Figure 6-4.
17
Figure 6-4 Installation of limb electrodes
6.4.3 Colors of lead cables As shown in Table 6-1:
Table 6-1 Colors of lead cables
Electrode position
European standard
Mark
Color
American standard
Mark
Color
Right arm
R
Red
RA
White
Left arm Left leg Right leg
L F N/RF
Yellow Green Black
LA
Black
LL
Red
RL
Green
Chest 1
Cl
Chest 2
C2
Chest 3
C3
Chest 4
C4
Chest 5
C5
Chest 6
C6
Red Yellow Green Brown Black Purple
Vl
Red
V2
Yellow
V3
Green
V4
Blue
V5
Orange
V6
Purple
Note n It is recommended to install the lead cables after turning off the
device. n Apply appropriate amount of conductive paste on the electrode when
installing the
electrode. n If the ECG waveform does not appear for a long time, check if the
electrode is in
good contact with the skin.
18
6.4.4 Lead method and system As shown in Figure 6-5:
Figure 6-5 Lead system 6.4.5 Lead-off and overload indication
The device can check the connection status of the lead at any time. If lead-
off or overload is detected, the screen will display corresponding lead code
on the top left corner, as shown in Figure 7-2.
Note Ø In the lead-off prompt area, red font represents lead-off, yellow font
represent
overload. Ø When the connection between lead cable and patient/the device is
not reliable, and
the ECG signal can not correctly transmitted, the device displays lead-off.
19
Chapter 7 Operation Instructions and Parameter Setting
7.1 Main Interface
Status bar 1. Time
Figure 7-1
System time can be set in
, so the detail time of ECG recording can be noted.
2. Memory usage
It directly shows the capacity of memory space according to actual usage. The green part
represents the memory usage, the white part represents the remaining memory space.
3. Total number of cases stored in memory
4. Input method indication
Current input method is marked by green color. Use
button to switch input methods.
20
5. Battery level (refer to 9.1) Menus 6.Functional panel:
to enter the sampling interface to collect and display waveform, and print
report.
to enter the case management interface, in this interface, user can query,
modify, delete and export case information or review the case to view and
print the diagnosis report.
to view the placement of leads
to set time and date
to perform system setting
to perform sampling setting
to set the print mode, print style and print content, etc.
to view software version and other information
Quick switch: use the
buttons on the keyboard to switch between each
functional module, after selecting, press
button to enter its setting.
Quick setup: Click the functional module on the screen to quickly set the corresponding function.
7.Friendly tips.
7.2 Sampling interface
Click
on the main interface or press the
button to enter the sampling interface.
Note: There is input time of cases in the system setting, therefore, in default, case
information should be input before sampling. (refer to 7.3 for details)
21
The sampling interface provides several lead display modes, including 1-lead,
3-lead, 6-lead and 12-lead. The following figure uses 12-lead as an example:
Status bar
Display field
Operation field
Figure 7-2
Status bar
1. HR: current sampled heart rate value
2. Lead-off and overload: In demo mode, it displays “DEMO ECG”. In sampling mode, it
displays the detected lead status. A red lead icon represents lead-off. A yellow lead icon
represents overload.
3. Std 12: It shows the sampling method. Before sampling, the sampling method can be set in
patient information input dialog box, settings include standard 12-lead, additional 6-lead, and
standard 12-lead+additional 6-lead.
4. System status indication:
Display content
Explanation
Process…
It is printing.
Waiting…
It is finishing printing.
No Paper.
Lack of paper, user should restart printing after loading paper.
Print Timeout
Communication failure between this system and printing sub-system.
ECG Timeout
Communication failure between this system and sampling sub-system.
Low Power!
Low power, it cannot start printing.
No USB device
No external printer connected, user should restart printing after connected to the external printer.
Gather Time Less
The sampling time is not enough, the print shall be started after reaching the required time period.
22
Display field The screen displays sampled 12-lead ECG waveform, by double
clicking the waveform,
you can switch between 1-lead, 3-lead, 6-lead and 12-lead. Operation field
Control the print display mode of the device through corresponding operation
settings.
1. Speed: use the
button to switch the speed between 5 mm/s, 6.25 mm/s, 10 mm/s,
12.5 mm/s, 25 mm/s and 50 mm/s.
2. Gain (sensitivity): use the
button to switch the gain between 2.5 mm/mV, 5
mm/mV, 10 mm/mV, 20 mm/mV and 40 mm/mV. The overall gain (sensitivity) can be checked
by calibration function.
3. Filter: use the
button to switch the filter between NONE, AC, EMG, AC+EMG,
DFT, AC+DFT, EMG+DFT and AC+EMG+DFT.
In which: AC EMG DFT
AC filter EMG filter Baseline filter
4. Print mode: in print setup, when the data type is set to “After Print”, use the
button
to switch the print mode between Manual, Auto 12×1, Auto 6×2+1, Auto 6×2+1_H, Auto 6×2,
Auto 6×2_H, Auto 3×4+1, Auto 3×4+2, Auto 1×12, Rhythm 12, Rhythm 10, Rhythm 8 and
Rhythm 6.
5. Print/End print: use the
button to start or end the printing operation.
1)Auto mode: After starting to print, the system automatically prints and stores the real-time
12-lead ECG waveform. The length is determined by the relevant settings in the print setup.
Based on the settings, the automatic analysis data and conclusions are printed, and the system
automatically ends printing.
2)Manual mode: After starting to print, user need to switch the lead to print the waveform of
different leads, that is, the ECG printed in the manual mode is asynchronous, and the data is not
saved. User need to press the PRINT button again when the print needs to be terminated.
3)If lead-off occurs during sampling process, the printed waveform will be marked with “*”.
4)If lead overload occurs during sampling process, the printed waveform will be marked with
“+”.
6. During sampling process, press the PRINT button and wait until the printing is competed, it
will pop up a dialog box, which includes “Delete check box”, “Review”, “OK” and prompts (If
lead-off or overload occurs during sampling process, there will be a prompt in this dialog box).
Clicking “Review” could enter the case management to view sampled cases; Select the delete
check box and click “OK” to delete the case.
7. End sampling: After the device starts sampling, use the
button to end the sampling,
23
and back to the main interface. 7.3 Case information input interface
The case information input dialog box is shown as below:
Figure 7-3 Select “Get” to obtain the latest 10 pieces of patient information. For the same patient information, selecting it could add to the edit box. Custom content can be set according to your needs. “*” represents required content, it can be set after inputting the password in “Servicing” under the System Setup (initial password is 888888).
After selecting a edit box, pressing
button could pop up a soft keyboard shown as
below. Click “CN” or “EN” to switch between Chinese and English. Clicking “Caps” can switch
between numbers, lowercase letters, capital letters and symbols. “Space” is the space key, press
it to enter a space; “Backspace” is the backspace key, press it to delete the last character entered.
Click “OK” to confirm the entry and exit the interface.
Figure 7-4 The keyboard may have input restrictions according to the
limitation of content. The restricted keys will be grayed out and unavailable,
as shown below:
24
Figure 7-5 In addition, you can use the number buttons on the control panel
for editing, and press
button to switch between numbers, lowercase letters, capital letters and
symbols. Press button to delete the last character entered. According to the
limitation of the content, the selected input method is displayed in green
when switching input method, and the restricted input method is grayed out and
unavailable. 7.4 Case management
In the main interface, click below:
to enter the case management interface, as shown
Figure 7-6 The above interface shows all medical records stored in the device.
User can search
25
necessary cases by the query function in the interface (refer to 7.4.1), modify or delete case information by edit function, and review stored case information (refer to 7.4.2).
Click
to jump to the first page of case list.
Click
to jump to the last page of case list.
Click
to jump to the previous page.
Click
to jump to the next page.
In the operation field, “Adv-opr” contains menus of “list ALL” “Query” “Export ECG” and
“Return”.
“Export ECG”: export the cases in the device to a U-disk via the USB interface. Export
path can be self-defined (symbols such as ” / : ? < > |” are excluded), the type of files is
shown as below:
1.JPEG, BMP: the format of report.
2.aECG: case data that conform to the HL7 standard
3.DAT: case data, self-defined format
“Query”: see 7.4.1
7.4.1 Query
Click “Query” in the “Adv-opr” setting to enter the query interface shown below. Input
query conditions and click “Select” to obtain expected results. After clicking “Clear”, the system
will clear all query conditions that entered.
Figure 7-7 “Cond.And” and “Cond.Or” indicate the matching mode of the query
conditions. You can choose one of the two. If you select “Cond.And”, the
displayed query results will satisfy all the input conditions at the same
time; if you select “Cond.Or”, the displayed query results only need to meet
any of the conditions entered. Suggestion: When there are many cases, it would
be better to input accurate query conditions and choose “Cond.And” to quickly
find the case.
26
7.4.2 Review In the case management interface, select a case to be reviewed,
click “Review” to enter the
following dialog box, which displays the case information. User is allowed to
modify patient information, after clicking “Save”, the information will be
changed. Please note that the modification is irreversible.
Figure 7-8 Make sure the input information is correct, click “Review” to enter
the review interface, which is similar with the sampling interface
Figure 7-9 27
Status bar 1.It shows detailed examination time of the reviewed case. 2.The
sampled time length of this case is displayed. Setting field 3.To analyze data
information and get diagnosis result of the case.
Note:
1.In this interface, user can use
button to change the print mode.
2.In this interface, user can use
button to print.
3.If lead-off occurs during sampling process, the reviewed waveform and the printed waveform
will be marked with “*”.
4.If lead overload occurs during sampling process, the reviewed waveform and the printed
waveform will be marked with “+”.
7.5 Date and time setup
In the main interface, click
to enter the following interface to set date and time.
Figure 7-10
In current interface, user can switch the items via
buttons, and adjust the content
of the item by
buttons. It can also be changed through the touch screen function,
which is convenient and quick.
7.6 System setup
In the main interface, click
to enter the system setup interface. The optional 28
content of each setting item and its description are shown in the following table:
Item Back-light
Light-degree
Auto Off
Low Power
AC filter EMG filter
DFT Filter
Low-pass Filter Language Hospital Heartbeat Sound
K-B Sound
Demo Mode
Sync
Mode
Sync
Sync setup
Host Sync Port
MAC
Addre
ss
Default
Options
[30Seconds]/[1Minute]/ [2Minutes]/[5Minutes]/ [10Minutes]/[Always On]
[10%degree]/[20% degree]/ [30%degree]/[40% degree]/ [50%degree]/[60% degree]/
[70%degree]/[80% degree]/ [90%degree]/[100%degree] [None]/[1Minute]/[3
Minutes]/[5Minutes]/[10 Minutes]/[15Minutes]/[30 Minutes]/[60 Minutes]
[None]/[Only once]/[Always] [50Hz]/[60Hz] [25Hz]/[30Hz]/[35Hz]/[40 Hz]/[45Hz]
[0.05Hz]/[0.5Hz]/[1Hz]/[0. 15Hz]/[0.25Hz]/[0.32Hz]/[ 0.67Hz]/[0.01Hz]
[OFF]/[75Hz]/[100Hz] /[150Hz] [English]/[Chinese], etc 0-64 characters
Description If there is no operation after reaching the set time, screen
backlight will turn off. If it is set to “Always On”, the backlight will
always keep on.
After setting light degree, the screen will display different backlight
strength.
If there is no operation after reaching the set time, the system will
automatically turn off. If it is set to “None”, the system will always keep
on. It determines the alarm method that the device uses in low power. If it is
set to “None”, the system will not prompt for low power. To set the parameters
of AC filter.
To set the parameters of EMG filter.
To set the parameters of Baseline filter.
To set the parameters of low pass filter.
To set the default language of system. To fill in the name of hospital in
report.
ON/OFF
To turn on or off the heartbeat sound.
ON/OFF ON/OFF
Set to on, the button makes sound while pressing, set to off, there will be no sound. Set to on, the system will run in Demo mode; set to off, the system will run in sampling mode.
[USB]/[Wi-Fi]
Set the sync mode.
——–
Sync the IP address of host.
6000 by default
Set the sync serial port.
——–
It is updated automatically after connected.
All above settings will restore to default after clicking this button.
29
7.7 Sampling setup
In the main interface, click
to enter the sampling setup interface. The optional
content of each setting item and its description are shown in the following table:
Item AC Filter EMG Filter DFT Filter Show Style Sort Lead
Show Gain
Show Speed Background Grid Premature Pause Time Tachycardia Bradycardia
Options ON/OFF ON/OFF ON/OFF [1leads]/[3leads]/[6leads]/ [12 leads] [Routine Lead]/[Cabrera Lead] [2.5mm/mV]/[5mm/mV]/[10 mm/mV]/[20mm/mV]/[40m m/mV] [5mm/s]/[6.25mm/s]/[10mm /s]/[12.5mm/s]/[25mm/s]/[50 mm/s]
Description Turn on or off the AC filter. Turn on or off the EMG filter. Turn
on or off the Baseline filter. Set the display method of ECG. Set the
arrangement of the leads.
Set the gain of displayed ECG.
Set the speed of displayed ECG.
[Show]/[Not Show]
Set to use the background grid or not.
0~100 1200~3000 0~250 0~99
The system will use the input value as a standard of judging premature beat. The system will use the input value as a standard of judging beat pause. The system will use the input value as a standard of judging tachycardia. The system will use the input value as a standard of judging bradycardia.
Default
All above settings will restore to default after clicking this button.
7.8 Print setup
In the main interface, click
to enter the print setup interface. The optional
content of each setting item and its description are shown in the following table:
Item Print Mode
Options [Auto 12×1]/[Auto 6×2+1]/[Auto 6×2+1_H]/[Auto 6×2]/[Auto 6×2_H]/[Auto 3×4+1]/[Auto 3×4+2]/[Auto
Description The system takes the selected option as default print mode.
30
Lead Gain
Auto Strip
Rhythm Strip
Average QRS Auto-Diagn osis Period
Print Device Print Depth Timing Marker Arrhythmia
1×12]/[Rhythm 12]/[Rhythm 10]/[Rhythm 8]/ [Rhythm 6] [Smart]/[Current] [2.5 sec]/[3 sec]/[4 sec]/[5 sec]/[6 sec]/[8 sec]/[10 sec]/[15 sec]/[20 sec]/[25 sec] [10 sec]/[15 sec]/[20 sec]/[25 sec]/[30 sec] [3×4 + Mark]/[3×4]/[Not Print] [All]/[Only Data]/[Only Conclusion]/[Not Print] [Off]/[per 1 min]/[per 2 min] /[per 3 min] /[per 5 min]/[per 10 min]/[per 20 min]/[per 30 min]/[per 60 min] [Inside]/[Outside A4] [1]/[2]/[3]/[4] ON/OFF ON/OFF
The option selected will be used as printing gain mode. “Smart” means the
system will adjust gain automatically to fit paper height; “Current” means it
will use screen waveform gain as that of printing. The system takes the
selected option as the print time length of each strip.
When “Print Mode” is set to “Rhythm 12” “Rhythm 10” “Rhythm 8” or “Rhythm 6”,
the system takes the selected option as the print time length of each
waveform. When “Print Mode” is set to “Auto” or “Rhythm”, the system uses the
selected format to print the average QRS waveform. The diagnosis contains data
and conclusion two parts, which can be chosen by user as demand. During the
ECG acquisition process, the system will automatically activate the printing
operation according to the selected time interval. When the printing mode is
manual mode, the printing will output “Auto 12×1” format, otherwise, it will
output according to the current setting mode. Choose to print out the ECG
waveform by thermal printing system or USB external printer Set the waveform
depth according to necessary. Set to display the time mark on the print paper
or not Set to turn on or off the arrhythmia analysis
Note 1: The settings of auto strip, rhythm strip, average QRS, auto diagnosis
and period are only optional in auto mode and rhythm mode.
Note 2: If print time length is less than 8s, the sampling and analysis time
will be 8s; if the print time length is equal to or greater than 8s, the
sampling and analysis time keeps the same with print time.
31
In the print setup interface, click “Adv-opr” to enter advanced setup interface. The optional
content of each setting item and its description are shown in the following table:
Item
Options
Description
Auto-Print ON/OFF
Set to open the automatic print or not
Data Type
[Begin Print]/[After Print]
Set to print the data before clicking the PRINT button, or after clicking
Rhythm 1
[I]/[II]/[III]/[aVR]/[aVL]/ [aVF]/[V1]/[V2]/[V3]/[V 4]/[V5]/[V6]
Set the rhythm lead that used for printing under rhythm mode
Rhythm 2
[I]/[II]/[III]/[aVR]/[aVL]/ [aVF]/[V1]/[V2]/[V3]/[V 4]/[V5]/[V6]
Set the “Auto 3*4+2” mode that used for printing under rhythm mode
Conclusion title
[Conclusions] by default
Set the printed conclusion title
Physician [Physician]/[Specialist] Set doctor’s signature in printed report
7.9 Lead placement
In the main interface, click European Standard is shown as below:
to view the schematic diagram of lead placement, the
Figure 7-11 32
The American Standard is shown as below:
Figure 7-12 Click “Std 12” to switch the schematic diagram of lead placement of “Std 12” and “Add 6”. Click “Return” to exit. 7.10 About
In the main interface, click
to view the information about the device, which
including the following content:
1. App Version: the version number of current software 2. Firm Info: click it see the firmware information of the device. 3. Return: click it to exit the interface.
33
Chapter 8 Troubleshooting
8.1 Auto shutdown Ø The battery is almost running out, which causes
overdischarge protection circuit action. Ø The voltage of AC power supply is
too high, which causes overvoltage protection circuit
action. 8.2 AC interference
Ø Whether the device is grounded reliably? Ø Whether the electrode or lead
cable is connected correctly? Ø Whether the electrodes and skin are daubed
with enough conductive paste?. Ø Whether the metal bed is grounded reliably? Ø
Whether the patient is touching the wall or metal parts of the bed? Ø Whether
the patient touches other people? Ø Whether there is high power electric
equipment working nearby? Such as X-ray machine
or ultrasonic device, etc. Note: If the interference can not be removed after
taking above measures, please use a AC filter. 8.3 EMG interference
Ø Whether the room is comfortable? Ø Whether the patient is nervous? Ø Whether
the bed space is narrow? Ø Whether patient speaks during recording? Ø Whether
the limb electrode is too tight?
Note: If the interference can not be removed after taking above measures,
please use a EMG filter. The ECG waveform recorded at this time will be
slightly attenuated.
34
8.4 Baseline drift
Ø Whether the electrode installation is stable? Ø Whether the connection of
lead cables or electrodes is reliable? Ø Whether the electrodes and patient
skin are cleaned and are daubed with enough
conductive paste? Ø Whether it is caused by patient’s movement or breathing? Ø
Whether the electrodes or leads are in bad connection?
Note: If the interference can not be removed after taking above measures,
please use a
baseline filter. 8.5 Troubleshooting list
Phenomenon Too large interference, disorderly waveform
Baseline burr
Not regular waveform, large up-and-down, beeline figure
Cause of failure 1. Grounding cable is not connected reliably. 2. Lead cables
are not connected reliably. 3. There is AC interference. 4. Patient is nervous
and can not keep quiet.
1. AC interference is large. 2. Patient nervous, and EMG interference is
large.
1.Bad electrode conductivity. 2. Low battery. 3. Bad connection between
electrodes and patient skin. 4. Loose connection between lead cables and the
Solutions
1. Check the power cord and lead cables. 2. Let the patient prepare for the
measurement.
1. Improve the environment. 2. If the bed is made of steel, replace it. 3.
The power cable and lead cables are not parallel or too close to each other.
- Use alcohol of high quality. 2. Clean electrode slice and the skin under the electrode with alcohol. 3. Charge the battery.
35
Baseline draft Unclear waveform
device’s plug. 5. Bad connection between electrodes and lead cables.
1. Low power. 2. Patient movement.
1. Low battery. 2. The printer head surface is dirty. 3. The thermal paper
problem.
1. Charge the battery. 2. Keep patient still. 1. Charge the battery. 2. Cut off the power, clean the printer head with alcohol, air dry. 3. Replace the thermal print paper with specified one.
36
Chapter 9 Maintenance
9.1 Battery
9.1.1 The device is designed with built-in full-sealed and maintenance-free rechargeable lithium
battery, also equipped with perfect auto-charging-discharging monitor system. When the device
is connected to AC power supply, turn the mains power switch to ON state, the battery will be
charged automatically. Battery status will be displayed on right edge of LCD screen in powering
on state, as shown in Table 9-1. After absolutely discharged, the battery needs 4.5 hours to
charge to 90%, and 5 hours to charge to full capacity.
Table 9-1 Battery status display
No.
Icon
Description
a
The battery status is unknown, generally it appears within 1 min after turning on.
b
Using AC power supply, and the battery is full or no battery in the device
c
Using battery, and battery is full
d
Using battery, and battery level is 3/4 of battery full
e
Using battery, and battery level is 1/2 of battery full
f
Using battery, and battery level is 1/4 of battery full
g
Using battery, and the battery is low. It is recommended to charge the battery before use or adopt AC power supply.
Note: When charging the battery, the displayed status of battery level
switches between icon f to icon c. 9.1.2 The device can continuously print for
3 hours or work for more than 10 hours in standby mode when battery is
completely charged. When the device is powered by battery, a battery icon will
be displayed on the LCD screen, showing the battery capacity in 5 modes. When
the battery capacity is too low for the device to operate, the device will
turn off automatically to avoid permanent damage to the battery.
Note: The above data is obtained by printing demo waveform under the test
environment of temperature 25, speed 25mm/s and gain 10mm/mV. In actual use,
the operation time may be shorten due to operation condition and environment.
9.1.3 The battery should be recharged in time after discharged completely. If
not used for long period, the battery should be recharged every 3 months,
which can extend the life of the battery. 9.1.4 When the battery can not be
recharged or works no more than 10 minutes after fully charged, please replace
the battery.
Note
Ø Do not try to dismantle the sealed battery without permission.The
replacement of battery shall be carried out by professional maintenance
personal authorized by our company, and the same model of rechargeable battery
provided by our company
37
should be used. Ø Do not touch the positive and negative terminals of the
battery directly with wire,
otherwise there is a danger of fire. Ø Do not use the battery near fire
sources or in environments where the temperature
exceeds 60°C. Do not heat the battery or throw it into fire, water and avoid
splashed by water. Ø Do not puncture, hammer or strike the battery or destroy
it by other ways, otherwise it will cause battery overheat, smoke, deform or
burn dangers. Ø Keep away from the battery when it appears leakage or emitting
unpleasant smell. If the battery electrolyte leaks onto the skin or clothes,
clean with water immediately. If the electrolyte accidentally enters your
eyes, do not rub your eyes, immediately clean with water and see a doctor. Ø
If the battery reaches its service life, or battery smell, deform, discolor or
distorted appears, please stop using the battery and dispose it in accordance
with local regulations. 9.2 Recording paper
In order to ensure the quality of the ECG waveform, please use the high-speed
thermal recording paper supplied or specified by the company. If you use
unspecified recording paper, the recorded ECG waveform may be blurred, faded,
and the paper feeding may not be smooth. This may even increase the wear of
the device and shorten the service life of important parts such as the thermal
print head. For information on how to purchase such recording paper, please
contact your dealer or the company. Please be careful! 9.2.1 When using
recording paper, it is absolutely not allowed to use recording paper with wax
on the surface or in grayish/black color. Otherwise, the wax will stick to the
heating part of the print head, resulting in abnormal work or damage of the
print head. 9.2.2 High temperature, humidity and sunlight may cause the
recording paper to change color. Please keep the recording paper in a dry and
cool place. 9.2.3 Please do not place the recording paper under fluorescent
light for a long time, otherwise it will affect the recording effect. 9.2.4
Please do not to put the recording paper together with the PVC plastic,
otherwise the color of recording paper will change. 9.2.5 Please use the
recording paper with specified dimension. Recording paper that does not meet
the requirements may damage the thermal print head or silicone rubber roller.
9.3 Maintenance after use
9.3.1 Press
button to shutdown the device.
9.3.2 Unplug the power cord and lead cables. Hold the header of plug to disconnect, and do not pull the cable with force directly. 9.3.3Clean the device and accessories, cover them up to against dust. 9.3.4 Store the device in a cool and dry place, avoid strong vibration when moving.
38
9.3.5 When cleaning the device, do not immerse it in the cleaner. Power supply
must be cut off before cleaning. Use neutral detergents for cleaning. Do not
use any detergent or disinfectant containing alcohol. 9.4 Lead cables and
electrodes
9.4.1 The connectivity of the lead cable can be detected by the multimeter.
Check whether each wire of the lead cable is in good contact according to the
following table. The resistance of each wire from the electrode plug to the
corresponding pin in the lead cable plug should be less than 10. The integrity
of the lead cable must be checked regularly. Any lead wire damage will cause a
false waveform of the corresponding lead or all leads on the ECG. The lead
cable can be cleaned with neutral solvent. Do not use the detergent or
germicide containing alcohol (Please do not immerse the lead cables in liquid
for cleaning).
Note: The resistance of lead cable with defibrillation-proof function
protection function is about 10K.
Table 9-2 Lead cable mark and pin position table
Mark
L R C1 C2 C3 C4 C5 C6 F N
Pin position
10 9 12 1 2 3 4 5 11 14
9.4.2 Bending or knotting will shorten the service life of the lead cable. When using it, please straighten the lead cable first. 9.4.3 The electrode should be well stored. After long time use, the surface of the electrode may oxidize and discolor due to corrosion and other factors, which may affect the signal acquisition. In this case, the electrode must be replaced.
9.5 Silicone rubber roller
The silicone rubber roller should be smooth and free of stains, otherwise it will affect the ECG recording effect. In order to remove the stains on the roller, please use a clean soft cloth damped with a small amount of alcohol to wipe it along the longitudinal direction, and scroll the roller in the paper conveying direction while wiping until it is clean. 9.6 Cleaning of thermal print head
Dirt and dust on the surface of the TPH can affect the clarity of the waveform. To clean the print head surface, open the paper compartment cover after turning off the device, use a clean and soft cloth dampened with alcohol to wipe the surface gently. For the residual stains on print head, moist it with a little alcohol first, then wipe with a soft cloth. Never use hard objects to scratch the surface, otherwise the print head will be damaged. Wait until the alcohol has evaporated, then close the paper compartment cover. The print head should be cleaned at least once a month during normal use.
9.7 Fuse replacement
Use a cross screwdriver to remove the fuse holder in the direction of the arrow (counterclockwise), and replace the damaged fuse with a primary fuse provided or approved by our company. Screw the fuse holder in the opposite direction to fasten it. The replacement method is shown in Figure 9-1:
39
Note
Figure 9-1 Replacing the fuse
Ø If the fuse blows again after replacing a fuse of the same specification,
the device may exists other problems, please cut off the power supply and
contact the after-sales service of our company or designated service center.
Ø Press the fuse holder downward and rotate it counterclockwise as shown in
Figure 9-1. After removing the damaged fuse replacing a new one, press down
the fuse holder and rotate it clockwise.
9.8 Disposal of product scrap The disposal of packaging materials, waste
battery and end-of-life device should obey the
local laws and regulations, and user should treat the scrapped products and
materials properly according to the laws and regulations, and try to support
the classification and recycling work. 9.9 Others 9.9.1 Do not open the device
enclosure to avoid electric shock danger. 9.9.2 The device associated circuit
schematics and critical parts list are only available to authorized service
station or maintenance personnel, who is responsible for maintenance of the
device. 9.9.3 The device belongs to measuring instrument. User should send the
device to national designated inspection institution for inspection according
to the requirements of the national metrological verification procedure. The
device shall be inspected at least once per year, and all the accessories
should be inspected and maintained regularly (at least once every six months).
40
Chapter 10 Packing List and Accessories
10.1 Accompanying accessories
When the device is shipped from the factory, the intact packaging should contain the
following contents, as shown in Table 10-1:
Table 10-1 Packing list and accessories
Name
Quantity
Electrocardiograph
1 pc
Chest electrodes (suction cup/electrode slice)
1 set (6 pcs)
Limb electrodes (limb clip)
1 set (4 pcs)
ECG lead cable
1 pc
Potential equalization wire
1 pc
Power cord
1pc
User manual
1 pc
Recording paper
1 pc
10.2 Notes
10.2.1 Please follow the instructions on the package when opening the package. 10.2.2 After unpacking, please check the accessories and accompanying documents in accordance with the packing list, then start inspecting the device. 10.2.3 If the packaging content does not meet the requirement or the device does not work properly, please contact our company immediately. 10.2.4 Please use the accessories provided by our company, otherwise the performance and safety of the device may be affected. If accessories provided by other company need to be used, please first consult the after-sales service of our company, or we will not responsible for any caused damages. 10.2.5 The package shall be kept properly for future use in regular maintenance or device repair.
41
Appendix I ECG Automated Measurement&Interpretation Guide
1. Preface
The appendix describes the functions of ECG automated measurement and
automated interpretation. It explains the specific implementation method,
algorithm and formulas related to these two functions, as well as the content
output by the automated measurement and automated interpretation.
According to the requirement of IEC60601-2-51:2003 Medical electrical
equipment – Part 2-51: Particular requirements for safety, including essential
performance, of recording and analysing single channel and multichannel
electrocardiographs, Clause 50 Accuracy of operating data, the appendix gives
a description of verification process and results of the performance for
automated measurement and automated interpretation. 2. Automated measurement
parameters and Automated interpretation items
The output measurement parameter, interpretation item and others that require explanation
are as follows:
2.1 Measurement parameters
No.
Parameter
Unit
1
HR
bpm
2
PR-interval
ms
3
P-duration
ms
4
QRS-duration
ms
5
T-duration
ms
6
QT/QTc
ms
7
P/QRS/T electric axis
deg
8
R(V5)/S(V1)
mV
9
R(V5)+S(V1)
mV
2.2 Interpretation items
No.
Item
1
No abnormal
2
Sinus mode Bradycardia
3
Sinus mode Tachycardia
4
Left atrium Hypertrophy
5
Right atrium Hypertrophy
6
Dual atrium Hypertrophy
7
QRS low voltage
8
Cardiac electric axis normal
9
Left axis deviation
10
Right axis deviation
42
11
Completeness Right Bundle branch block
12
Completeness Left Bundle branch block
13
No Completeness Right Bundle branch block
14
No Completeness Left Bundle branch block
15
V1 shows RSR’ type
16
Left anterior fascicular block
17
Left posterior fascicular block
18
Left ventricular hypertrophy
19
Right ventricular hypertrophy
20
I atrioventricular block
21
Early anteroseptal MI
22
Possible acute forepart anteroseptal MI
23
Old anteroseptal MI
24
Early anterior MI
25
Possible acute anterior MI
26
Old anterior MI
27
Early extensive anterior MI
28
Possible acute extensive anterior MI
29
Old extensive anterior MI
30
Early apical MI
31
Acute apical MI
32
Old apical MI
33
Early anterolateral MI
34
Possible acute anterolateral MI
35
Old anterolateral MI
36
Early high lateral MI
37
Possible acute high lateral MI
38
Old high lateral MI
39
Early inferior MI
40
Possible acute inferior MI
41
Old inferior MI
42
Early inferolateral MI
43
Possible acute inferolateral MI
44
Old inferolateral MI
43
45
ST depression, mild anteroseptal myocardial ischemia
46
ST depression, mild anterior myocardial ischemia
47
ST depression, mild extensive anterior myocardial ischemia
48
ST depression, mild apical myocardial ischemia
49
ST depression, mild anterolateral myocardial ischemia
50
ST depression, mild high lateral myocardial ischemia
51
ST depression, mild inferior myocardial ischemia
52
ST depression, mild inferolateral myocardial ischemia
53
ST depression, anteroseptal myocardial ischemia
54
ST depression, anterior myocardial ischemia
55
ST depression, extensive anterior myocardial ischemia
56
ST depression, apical myocardial ischemia
57
ST depression, anterolateral myocardial ischemia
58
ST depression, high lateral myocardial ischemia
59
ST depression, inferior myocardial ischemia
60
ST depression, inferolateral myocardial ischemia
2.3 Intended use
The intended use of the Automated Measurement&Interpretation function is shown as
below:
Application To detect the abnormal of heart of human body, examination items refer to
and diagnosis above description
Population Teenagers and adults, age range: 12-87
Application site
Accuracy
Others
hospitals
The accuracy of this function is reflected by the balance performance of
sensitivity and specificity. This function does not generate any alarm when
using, so it should be operated by professional or trained personal.
3. Algorithm description
This section describes the algorithm, formulas and judgment conditions for
interpretation items related to functions of ECG automated measurement and
automated interpretation.
The 12-lead sync ECG waveform passes through the filter (AC, EMG, DFT (if has,
and open)) into the module of automated measurement and automated
interpretation.
The module of automated measurement and automated interpretation mainly
includes process of find the cardiac impulse location, find the beginning/end
for each wave, amplitude calculation, parameters calculation, and
interpretations judgment based on known parameters.
44
The workflow is shown as below: Start
ECG waveform sampling
Recognize all R points by slope method
Waveform superposition taking R point as center
Determine the positions of each wave
Calculate the amplitudes of each wave
Get measurement parameter, interpretation item
End 3.1 Find the cardiac impulse location
-
Data preprocessing, obtain the absolute value trend of slope for each lead; then superimpose each absolute value, obtain the superimposed graph of absolute value of slope.
-
Smoothing filter the superimposed graph on average of width 80ms, obtain the analytical data source DDD.
-
Find the cardiac impulse location, give an initial threshold for searching, orderly scan the data in the analytical data source DDD, then compare it with the threshold value:
When the value is greater than the threshold, it may be the beginning of qrs- complex. If the distance from the previous qrs-complex to the current location is less than 150ms, then give up the location. Otherwise, take the 1/4 of threshold value as a reference, find the beginning of qrs-complex within 100ms before the current location. When the value is less than the threshold value, it may be the end of qrs-complex. Take the 1/4 of threshold value as a reference, find the end of qrs-complex. If the found qrs-complex is wide, this qrs-complex shall be excluded. Otherwise, save the found qrs-complex. 4) Locate: after found the qrs-complex, search the max value point between the beginning point and end point in the ecg original data, mark the point as cardiac impulse location.
45 -
Dynamically threshold adjustment: after found the cardiac impulse location, use the value at the cardiac impulse location for the dynamically adaptive adjustment of the threshold value. Define the threshold value as 1/3 of the average of the nearest three cardiac impulses.
-
After found the cardiac impulse location, compute the RR-interval and accumulate it with the previous RR-intervals, then count the number of accumulated RR-intervals.
-
Continue searching until the end of data, and calculate the global average value for RR-intervals at the same time. 3.2 Find the beginning/end for each wave
The beginning/end of qrs-complex has been approached in above cardiac impulse locating process, but it is mainly in order to assist to find the cardiac impulse location; in addition, the location is searched based on the slope threshold value, which is imprecise. Here, according to the found cardiac impulse location, the beginning/end of qrs-complex will be sought accurately. Name the cardiac impulse location as the peak of R-wave. 1. Read data 1) Read one data of qrs-complex: take the peak of R-wave as reference, locate directly to the original ecg file, read a piece of data containing the qrs-complex. 2) Preprocessing: superimpose the absolute value of slope for 12-lead signals. 3) Use the preprocessed data to carry on the searching of QRS-complex, P-wave and T-wave as the followings. 4) Read the next data of qrs-complex, repeat step 2 and step 3 until the analyzing of all qrs-complex are finished. 2. Find QRS- complex 1) Calculate the threshold value of S-wave: search the minimal value within 200ms after the peak of R-wave, take the value that equals to minimal value plus 0.4, as the threshold value for finding the end of S-wave. 2) Find the beginning of Q-wave: take 0.5 as the threshold vale, search forwardly starting from R-wave, a point that less than the threshold value, within 0ms- 200ms before the peak of R-wave, which is the beginning of Q-wave. 3) Find the end of S-wave: search backwardly starting from R-wave, a point that less than the threshold value of the end of S-wave, within 0ms-200ms after the peak of R-wave, which is the end of S-wave. 3. Find P-wave 1) Peak of P-wave: search the max value within 30ms-100ms before the beginning of Q-wave, temporarily mark the point as the peak of P-wave. 2) Find the end of P-wave: search the minimal value between the peak of P-wave and the beginning of Q-wave, the minimal value plus 0.05 is the threshold value, use the threshold value to find the end of P-wave. 3) Find the beginning of P-wave: search the minimal value within 150ms before the peak of P-wave, the minimal value plus 0.06 is the threshold value, use the threshold value to find the beginning of P-wave. -
If the found P-wave is narrow, research the P-wave according to the following steps. 5) Change the searching range of 30ms-100ms to 100ms-350ms in step 1, repeat step 1-4.
46 -
If the found P-wave is still narrow, it means that P-wave doesn’t exist. 4. Find T-wave 1) Peak of T-wave: search the max value within 30ms-300ms after the end of QRS-complex, save it as the peak of T-wave. 2) Threshold value of the beginning of T-wave: search the minimal value within 0ms-100ms after the end of QRS-complex, the minimal value plus 1/10 of the peak value of T-wave is the threshold for finding the beginning of T-wave. 3) Threshold value of the end of T-wave: search the minimal value within 200ms after the peak of T-wave, the minimal value plus 1/10 of the peak value of T-wave is the threshold for finding the end of T-wave. 4) Find the beginning of T-wave: in the range between the minimal value in step2 and the peak of T-wave, find a point that less than the threshold value of the beginning of T-wave, the point is the beginning of T-wave. 5) Find the end of T-wave: in the range between the minimal value in step3 and the peak of T-wave, find a point that less than the threshold value of the end of T-wave, the point is the end of T-wave. 5. Explanation of equipotential segment In searching the QRS-complex, this algorithm adopts the analysis method of superposition of the slopes for all leads, therefore, the equipotential segments before and after the QRS-complex are partly included in the start and end points of the QRS-complex. It is depends on the number of leads containing equipotential segments. If there are more leads containing equipotential segments, the slope value will be smaller after superposition, so it is difficult to meet the threshold condition, and only a small part of the equipotential segments is counted to the start and end points of the QRS-complex. On the contrary, if there are less leads containing equipotential segments, a large part of the equipotential segments will be counted to the start and end points of the QRS-complex. Anyway, the equipotential segments before and after the QRS-complex are partly included in the QRS-complex duration.
3.3 Amplitude measurement
After finding the position of each wave, i.e. the start and end points of P wave, QRS complex and T wave, use the following method to measure P, Q, R, S, ST and T waves of each lead.
1. P-wave Calculate the average value of the data 20ms before the start point of P wave, and use this average value as the baseline of P wave. Find the max value between the start point and end point of P wave, the difference between the max value and the baseline would be the amplitude of P wave.
2. Q/R/S wave Calculate the average value of the data 10-30ms before the start point of QRS complex, and use this average value as the baseline of QRS complex. Search boundary points that exceeding the baseline from the start point of Q wave to the end point of S wave. Each adjacent two boundary points forms a sub-wave. Determine whether each sub-wave is a recognizable minimum wave
47
(see the definition below). If it is a recognizable minimum wave, first
identify its direction. If it is above the QRS baseline, it is R wave, if it
is below the baseline, it is Q wave or S wave. Find the extreme value of this
wave, and the difference between the extreme value and the baseline is the
amplitude of Q/R/S wave.
Note: If there is only one downward wave, its amplitude should be respectively
recorded in the amplitude of Q wave and S wave.
3. ST segment Take above baseline of QRS complex as the ST baseline.
Calculate the differences between the ST baseline and the points at 40ms and
60ms after the end point of QRS complex, and calculate the average value of
these two differences, the average value is the amplitude of ST segment.
4. T-wave Calculate the average value of the data 20-50ms after the end point
of T wave, and
average this value with the QRS baseline in 2, then use the result as the
baseline of T wave. Find the max value between the start point and end point
of T wave, the difference between the max value and the baseline would be the
amplitude of T wave.
5. Recognition of minimum wave The minimum wave can be recognized by the
algorithm according to the requirement of IEC60601-2-51:2003 Medical
electrical equipment – Part 2-51: Particular requirements for safety,
including essential performance, of recording and analysing single channel and
multichannel electrocardiographs, Annex GG, Clause GG.5 Definition of
waveforms, measurement of minimum waves. The wave that meet the following
conditions is the minimum wave that can be recognized by the algorithm. 1The
signal part under consideration shows clearly two opposite slopes with at
least one turning point in between; 2The signal part under consideration
deviates at least 30V from the reference level for a duration of at least 6ms;
3The minimum observable duration of wave under consideration is 12ms and
amplitude 30V. 3.4 Calculation after intervals determination The following
parameters are determined according to the requirement of IEC60601-2-51:2003
Medical electrical equipment – Part 2-51: Particular requirements for safety,
including essential performance, of recording and analysing single channel and
multichannel electrocardiographs, Annex GG Definitions and rules for the
measurement of ELECTROCARDIOGRAMS.
No.
Parameter
Calculation
1
HR
2
PR-interval
3
P-duration
4
QRS-duration
60 / RR Qs – Ps Pe – Ps Se – Qs
48
5
T-duration
6
QT
Te – Ts Te – Qs
7
QTc
QT
RR
Electric axis formula:
arctan(2.0´(SIII +SI ),SI ´ 3 ) ´180 PI
P electric axis:
SIII: voltage sum from the beginning point to the end
point of P-wave on lead III
SI : voltage sum from the beginning point to the end
P/QRS/T electric point of P-wave on lead I
8
axis
QRS electric axis:
SIII : voltage sum from the beginning point to the end point of QRS-complex on lead III
SI : voltage sum from the beginning point to the end
point of QRS-complex on lead I
T electric axis:
SIII : voltage sum from the beginning point to the end point of T-wave on lead III
SI : voltage sum from the beginning point to the end point of T-wave on lead I
9
R(V5)
Height (voltage value) of R-wave on lead V5
10
S(V1)
Height (voltage value) of S-wave on lead V1
Note: RR: RR-interval Qs: beginning of the Q-wave Ps: beginning of the P-wave
49
Pe: end of the P-wave Se: end of the S-wave Ts: beginning of the T-wave Te:
end of the T-wave PI: 3.1415926
3.5 Interpretations judgment based on parameters
No.
Item
1
No abnormal
Rule of interpretation No any abnormal are detected
Sinus P-wave, PR-interval between
2
Sinus mode Bradycardia
110ms-210ms, HR/min, general =50
Sinus P-wave, PR-interval between
3
Sinus mode Tachycardia
110ms-210ms, HR /min, general =100
P-wave of leads I, II, aVL shall meet the
conditions: width increase of P-wave110ms,
4
Left atrium Hypertrophy
or P-wave displays in double-peak type,
value of peak to peak 40ms
For leads I, II, aVF, amplitude of P-wave
5
Right atrium Hypertrophy
0.25mV, or P-wave is sharp
For leads I, II, aVF, amplitude of P-wave
6
Dual atrium Hypertrophy
0.25mV and P-wave duration >110ms
Voltage of I-aVF limb leads 0.5mV,
7
QRS low voltage
and voltage of V1-V6 chest leads 0.8mV
8
Cardiac electric axis normal
QRS-axis between 30 to 90 degree
9
Left axis deviation
QRS-axis between -90 to-30 degree
10
Right axis deviation
QRS-axis between 120 to 180 degree
Completeness Right Bundle branch
QRS-duration>120ms, R-wave of lead
11
block
V1 or aVR is wide (width of R-wave>80ms)
Completeness Left Bundle branch 12
block
QRS-duration>120ms, R-wave of lead V5 or V6 is wide
No Completeness Right Bundle 13
QRS-duration<120ms, R-wave of lead
branch block
V1 or aVR is wide (width of R-wave>80ms)
14
No Completeness Left Bundle
QRS-duration<120ms, R-wave of lead V15
branch block
or V6 is wide (width of R-wave>80ms)
15
V1 shows RSR’ type
QRS-complex of lead V1 is RSR’ type
QRS-duration<110ms, QRS-axis <-30
16
Left anterior fascicular block
degree, lead I and lead aVL are qR type, and
Q-wave duration<20ms, lead II, III and aVF
50
are rS type.
QRS-duration<110ms, QRS-axis >90
degree, lead I and lead aVL are rS type, lead
17
Left posterior fascicular block
II, III and aVF are qR type, and Q-wave of
lead II and III <20ms.
R amplitude of lead I >1.5mV, R
amplitude of lead V5 >2.5mV, R amplitude
of lead aVL >1.2mV, R amplitude of lead
18
Left ventricular hypertrophy
aVF >2mV, R amplitude of lead V5 minus S
amplitude of lead V1 >4mV (male) or 3.5mV
(female).
R amplitude of lead aVR >0.5mV, R
amplitude of lead V1 >1mV, R amplitude of
lead V1 minus S amplitude of lead
19
Right ventricular hypertrophy
V5 >1.2mV, R amplitude of lead V1 is larger
than S amplitude, R amplitude of lead V5 is
smaller than S amplitude.
20
I atrioventricular block
PQ interval >210ms
Early myocardial infarction change of leads
21
Early anteroseptal MI
V1, V2, V3, no change of leads V4, V5.
Possible acute forepart anteroseptal
Acute myocardial infarction change of
22
MI
leads V1, V2, V3, no change of leads V4, V5.
Old myocardial infarction change of
23
Old anteroseptal MI
leads V1, V2, V3, no change of leads V4, V5.
Early myocardial infarction change of leads
24
Early anterior MI
V3, V4, V5, no change of leads V1, V2, V6.
Acute myocardial infarction change of leads
25
Possible acute anterior MI
V3, V4, V5, no change of leads V1, V2, V6.
Old myocardial infarction change of leads
26
Old anterior MI
V3, V4, V5, no change of leads V1, V2, V6.
Early myocardial infarction change of leads
27
Early extensive anterior MI
V1, V2, V3, V4, V5.
28
Possible acute extensive anterior Acute myocardial infarction change of leads
MI
V1, V2, V3, V4, V5.
29
Old extensive anterior MI
Old myocardial infarction change of leads V1, V2, V3, V4, V5.
51
Early myocardial infarction change of leads
30
Early apical MI
V4, V5, no change of leads V1, V2, V3.
Acute myocardial infarction change of leads
31
Acute apical MI
V4, V5, no change of leads V1, V2, V3.
32
Old apical MI
Old myocardial infarction change of leads V4, V5, no change of leads V1, V2, V3.
Early myocardial infarction change of leads I,
33
Early anterolateral MI
aVL, V4, V5, V6
Acute myocardial infarction change of leads
34
Possible acute anterolateral MI
I, aVL, V4, V5, V6.
Old myocardial infarction change of leads I,
35
Old anterolateral MI
aVL, V4, V5, V6
Early myocardial infarction change of leads I,
36
Early high lateral MI
aVL, no change of leads II, III, aVF, V4, V5,
V6.
Acute myocardial infarction change of leads
37
Possible acute high lateral MI
I, aVL, no change of leads II, III, aVF, V4,
V5, V6.
Old myocardial infarction change of leads I,
38
Old high lateral MI
aVL, no change of leads II, III, aVF, V4, V5,
V6.
Early myocardial infarction change of leads
39
Early inferior MI
II, III, aVF, no change of leads I, aVL.
Acute myocardial infarction change of leads
40
Possible acute inferior MI
II, III, aVF, no change of leads I, aVL.
Old myocardial infarction change of leads II,
41
Old inferior MI
III, aVF, no change of leads I, aVL.
Early myocardial infarction change of leads I,
42
Early inferolateral MI
II, III, aVL, aVF.
Acute myocardial infarction change of leads
43
Possible acute inferolateral MI
I, II, III, aVL, aVF.
Old myocardial infarction change of leads I,
44
Old inferolateral MI
II, III, aVL, aVF.
45
ST depression, mild anteroseptal Mild ST-segment depression of leads V1, V2,
myocardial ischemia
V3, and no change of leads V4, V5.
46
ST depression, mild anterior
Mild ST-segment depression of leads V3, V4,
52
myocardial ischemia
V5, and no change of leads V1, V2, V6.
ST depression, mild extensive Mild ST-segment depression of leads V1, V2,
47
anterior myocardial ischemia
V3, V4, V5.
48
ST depression, mild apical
Mild ST-segment depression of leads V4, V5,
myocardial ischemia
and no change of leads V1, V2, V3.
ST depression, mild anterolateral Mild ST-segment depression of leads I, aVL,
49
myocardial ischemia
V4, V5, V6.
Mild ST-segment depression of leads I, aVL,
ST depression, mild high lateral
50
and no change of leads II, III, aVF, V4, V5,
myocardial ischemia
V6.
51
ST depression, mild inferior
Mild ST-segment depression of leads II, III,
myocardial ischemia
aVF, and no change of leads I, aVL.
52
ST depression, mild inferolateral
Mild ST-segment depression of leads I, II,
myocardial ischemia
III, aVL, aVF.
53
ST depression, anteroseptal
Severe ST-segment depression of leads V1,
myocardial ischemia
V2, V3, and no change of leads V4, V5.
ST depression, anterior myocardial Severe ST-segment depression of leads V3,
54
ischemia
V4, V5, and no change of leads V1, V2, V6.
55
ST depression, extensive anterior
Severe ST-segment depression of leads V1,
myocardial ischemia
V2, V3, V4, V5.
ST depression, apical myocardial Severe ST-segment depression of leads V4,
56
ischemia
V5, and no change of leads V1, V2, V3.
57
ST depression, anterolateral
myocardial ischemia
Severe ST-segment depression of leads I, aVL, V4, V5, V6.
Severe ST-segment depression of leads I,
ST depression, high lateral
58
aVL, and no change of leads II, III, aVF, V4,
myocardial ischemia
V5, V6.
59 ST depression, inferior myocardial Severe ST-segment depression of leads II, III,
ischemia
aVF, and no change of leads I, aVL.
ST depression, inferolateral
Severe ST-segment depression of leads I, II,
60
myocardial ischemia
III, aVL, aVF.
Note: Early myocardial infarction: normal Q-wave, ST elevation or ST slope
elevation Acute myocardial infarction: abnormal Q-wave, ST elevation or ST
slope elevation Old myocardial infarction: abnormal Q-wave, no ST elevation.
Abnormal Q-wave:
53
For leads I, II, III, avR, avL, avF, V3, V4, V5, V6, voltage of Q-wave
<-0.3mV, or 4 times of negative wave of Q-wave> voltage of R-wave and R’-wave,
and/or Q-duration>40ms.
For leads V1, V2, voltage of Q-wave <-0.08mV and Q-duration>10ms. ST
elevation: For leads I, II, III, avR, avL, avF, V4, V5, V6, the voltage of ST
segment at 60ms point >0.1mV, and for leads V1, V2, V3, the voltage at 60ms
point >0.3mV. ST slope elevation: Voltage of ST segment at 20ms point>=voltage
of J point, voltage at 40ms point >= the one at 20ms, voltage at 60ms point >=
the one at 40ms, with change of ST elevation. 4. Data sources and data
preprocessing
4.1 Data sources
According to the requirement of IEC60601-2-51:2003 Medical electrical equipment – Part
2-51: Particular requirements for safety, including essential performance, of recording and
analysing single channel and multichannel electrocardiograph, the CSE measurement database,
CSE diagnostic database, CTS calibration database and customized data shall be used to evaluate
the function of automated measurements and automated interpretations.
Verification Database
Database items
Automated CTS database
CAL05000 CAL10000 CAL15000 CAL20000
measurement
CAL20002 CAL20100 CAL20110 CAL20160
CAL20200 CAL20210 CAL20260 CAL20500
CAL30000 ANE20000 ANE20001 ANE20002
CSE measurement
MA_0001MA0125
database
Automated CSE diagnostic database D_0001D_1220
interpretation Customized data
000001000549
4.2 CTS introduction
The CTS computerized ECG conformance testing project was launched in 1989 by the
European Union. This project laid the foundation for computerized ECG conformance testing
service. Currently, about 20 types of waveform have been designed derived from the test signals
having an infinite length, these signals are part of the CTS-ECG test database, and have proven
their effectiveness in a series of official tests. According to the requirement of
IEC60601-2-51:2003 Medical electrical equipment – Part 2-51: Particular requirements for
safety, including essential performance, of recording and analysing single channel and
multichannel electrocardiograph Clause 50.101.1, 13 data (CAL05000, CAL10000, CAL15000,
CAL20000, CAL20002, CAL20100, CAL20110, CAL20160, CAL20200, CAL20210,
CAL20260, CAL20500, CAL30000) are used in the automated parameters verification for this
test.
4.3 CSE introduction
The EU CSE (Common Standards for Quantitative Electrocardiography) ECG database
contains 3-lead measurement database of collection1 and collection2, 12-lead measurement
54
database of collection3 and collection4, and a diagnostic database of collection5. In which, the
12-lead measurement database contains 250 groups of interference data; Diagnostic database contains 1220 cases of short-term ECG recording. The primary development purpose of using
12-lead or 15-lead is to evaluate the performance of the automatic ECG analyzer. In addition to
the normal data, the database also includes clinically confirmed ECGs of variety cases, such as left ventricular hypertrophy, right ventricular hypertrophy, every part of myocardial infarction and ventricular hypertrophy accompanying myocardial infarction. The database has made a great
contribution to the study of electrocardiology, which is, the CSE group published a report on the recommended standard for general ECG measurements based on the investigation and study of the database, which has been widely recognized by the world.
CSE database diagnostic items:
Item
Number
Normal
382
Left ventricular hypertrophy
183
Right ventricular hypertrophy
55
Biventricular hypertrophy
53
Anterior myocardial infarction
170
Inferior myocardial infarction
273
Complex myocardial infraction
104
Synthetical accuracy
1220
4.4 Customized data
4.4.1 Data description
Customized
Description
data
Total recording 549
number
Race
Yellow race
Coverage of
Aged from 17 to 87, average age 57.23, standard deviation 21.32;
age, gender
326 male, average age 55.54, standard deviation 19.81;
Sampling data
223 female, average age 59.70, standard deviation 22.63. 12-lead ECG data (I, , , AVR, AVL, AVF, V1, V2, V3, V4, V5, V6),
sampling frequency of each channel: 1kHz, amplitude quantization:
2.4µV/LSB.
Remark The interpretation conclusion of customized data is determined by the
physician diagnostic results of cardiac catheterization and ultrasonic
examination, and the ECG judgment result in physical examination, the
details as blow:
- Normal ECG
Determined by the diagnostic result that judged as normal in cardiac
55
catheterization and ultrasonic examination, and the result that judged as
normal in physical examination. 2) Atrium hypertrophy Determined by the
diagnostic results of ultrasonic examination. 3) Myocardial infarction and
myocardial ischemia Determined by the physician diagnostic results of cardiac
catheterization. 4) Tachycardia, bradycardia, low voltage, axis Determined by
the diagnostic results of ultrasonic examination. 5)Conduction block
Determined by the physician diagnostic results of cardiac catheterization. The
standard of normal population in the customized database: physical examination
is normal, no heart disease or other diseases that may affect cardiac
functions or shape. 4.5 Data coverage of verification for automated
interpretation Analyzing the content of CSE diagnostic database and customized
data, the overall condition and coverage of statistical samples are shown as
below:
56
Note: The heart abnormalities such as posterior myocardial ischemia, early
posterior MI and old posterior MI are not included in the database. These
abnormalities and other heart disorders not contained in above sheet won’t be
regarded as the judgment object for the verification of automated
interpretation accuracy. 4.6 Data preprocessing 4.6.1 CTS preprocessing
The 16 cases (CAL05000, CAL10000, CAL15000, CAL20000, CAL20002, CAL20100,
CAL20110, CAL20160, CAL20200, CAL20210, CAL20260, CAL20500, CAL30000,
ANE20000, ANE20001, ANE20002) from CTS-ECG shall be processed for voltage
conversion and frequency conversion for resampling as the applicable format in
the system. Then cases will be imported to the device. After that, the
verification of automated measurement parameters will be carried on. 4.6.2 CSE
preprocessing
The cases (MA_0001~MA0125, D_0001~D_1220) from the CSE shall be processed for
voltage conversion and frequency conversion for resampling as the applicable
format in the system. Then cases will be imported to the device. After that,
the case of MA_0001~MA0125 shall be used for the following verification of
automated measurement parameters, and the case
57
of D_0001~D_1220 shall be used for the following verification of automated
interpretation. 4.6.3 Customized data preprocessing
The customized initial case files shall be processed for voltage conversion
and frequency conversion for resampling as the applicable format in the
system. Then cases will be imported to the device. After that, the
verification of automated interpretation will be carried on. 5. Process and
Result of Verification 5.1 Verification of measurement function 5.1.1
Verification and Process for CTS measurement database The cases (CAL05000,
CAL10000, CAL15000, CAL20000, CAL20002, CAL20100, CAL20110, CAL20160,
CAL20200, CAL20210, CAL20260, CAL20500, CAL30000, ANE20000, ANE20001,
ANE20002) imported to the device shall be used to verify the automated
measurement parameters.
Start
CTS preprocessing
Import preprocessing data to device
ECG automated measurement parameter
Calculate the difference of measurement and reference
Calculate mean differences
Eliminate the largest two deviations from the mean
Recalculate mean difference and standard deviation
End
58
5.1.2 Verification and Process for CSE measurement database Import the
converted case files into the device, add appropriate database records, then
waveform for all case files can be reviewed in the device, therefore the
automated measurement parameters can be obtained.
Eliminate the cases existing obvious error for the diagnostic parameters
(P-wave location is wrong) from the CSE database.
Make a comparison between the ECG analytical parameters (the beginning/end of
P-wave, QRS-complex and T-wave) and the diagnostic parameters (the
beginning/end of P-wave, QRS-complex and T-wave) provided by CSE database.
Draw the two groups of waveform and mark the location of the beginning/end of
P-wave, QRS-complex and T-wave corresponding to each case. The picture
provides a visualized comparison, so the mean and standard deviation of the
differences can be calculated. According to the requirement of
IEC60601-2-51:2003 Medical electrical equipment – Part 2-51: Particular
requirements for safety, including essential performance, of recording and
analysing single channel and multichannel electrocardiograph, the four largest
deviations from the mean shall be eliminated before recalculation of mean and
standard deviation of the differences.
Flow diagram of CSE measurement database verification process
59
60
5.1.3 Verification results
5.1.3.1 Accuracy of amplitude measurements
Calibration and analytical ECGs shall be used to measure the amplitude value, the summary
as follows:
Amplitude
Mean difference (uV)
Standard deviation (uV)
P-wave
-1.70
5.72
Q-wave
7.51
18.07
R-wave
-18.05
21.70
S-wave
7.77
18.58
ST-segment
0.15
4.24
T-wave
-5.81
8.03
Note: In amplitude measurement, for large-amplitude ECG, such as CAL30000, it is
necessary to adjust to 0.5 times the gain before testing.
5.1.3.2 Accuracy of absolute interval and wave duration measurements
Calibration and analytical ECGs shall be used to measure the global interval and wave
duration (including Q-wave ,R-wave ,S-wave), the summary as follows:
Interval&Duration
Mean difference (ms)
Standard deviation (ms)
P-duration
-5.70
1.88
PQ-interval
-2.58
1.94
QRS-duration
-0.23
3.26
QT-interval
-6.70
4.37
5.1.3.3 Accuracy of interval measurements on biological ECGs
CSE database shall be used to evaluate the accuracy of interval measurements on biological
ECGs, the summary as follows:
Interval&Duration
Mean difference (ms)
Standard deviation (ms)
P-duration
0.99
13.46
PR-interval
3.65
9.68
QRS-duration
-1.69
6.11
QT-interval
-2.32
20.69
5.1.3.4 Stability of measurements against NOISE
The test is carrying on according to MA-series data (008, 011, 013, 014, 015, 021, 026, 027,
042, 061) in CSE database.
Global measurement parameters
Type of added NOISE
Disclosed differences
Mean (ms)
Standard deviation
(ms)
P-duration
High frequency
-5.65
12.33
P-duration
Line frequency
-0.25.
12.71
P-duration
Base-line
-4.90
33.15
QRS-duration
High frequency
-0.95
5.13
QRS-duration
Line frequency
1.35
4.71
61
QRS-duration
Base-line
-1.55
7.68
QT-interval
High frequency
-14.55
6.51
QT-interval
Line frequency
-8.55
20.73
QT-interval
Base-line
36.20
64.47
The biological ECGs are fed into the device in form of digital signals, then the
measurement value can be obtained by calculation.
Test condition:
a) without NOISE
b)with 25uV high frequency
c) with 50uV peak to valley 50Hz/60Hz sinusoidal line frequency NOISE
d) with 1mV peak to valley 0.3Hz sinusoidal base-line NOISE
For each NOISE level above, the differences of measurements between the NOISE- free
ECGs and the ECGs with NOISE shall be determined. The two largest deviations from the mean
shall be estimated before calculation of mean and standard deviation of differences.
5.2 Verification of interpretation function
5.2.1 Verification process
5.2.1.1 CSE diagnostic database
62
5.2.1.2 Customized database 63
5.2.2 Verification results
ECGs Sensitivit
No.
Item
number y %
1
No abnormal
585
2
Sinus mode Bradycardia
191
3
Sinus mode Tachycardia
78
4
Left atrium Hypertrophy
51
5
Right atrium Hypertrophy
43
6
Dual atrium Hypertrophy
22
7
QRS low voltage
5
8
Cardiac electric axis normal
733
9
Left axis deviation
168
10
Right axis deviation
107
11 Completeness Right Bundle branch 28
block
12 Completeness Left Bundle branch 32
block
13
No Completeness Right Bundle
41
branch block
14
No Completeness Left Bundle
47
branch block
15
V1 shows RSR’ type
13
16
Left anterior fascicular block
26
17
Left posterior fascicular block
18
18
Left ventricular hypertrophy
236
19
Right ventricular hypertrophy
108
20
I atrioventricular block
13
21
Early anteroseptal MI
10
22 Possible acute forepart anteroseptal 27
MI
23
Old anteroseptal MI
26
24
Early anterior MI
77
25
Possible acute anterior MI
10
26
Old anterior MI
13
27
Early extensive anterior MI
24
28
Possible acute extensive anterior
16
MI
29
Old extensive anterior MI
30
30
Early apical MI
15
92.01 96.68 97.44 51.09 42.64 93.58 96.37 98.36 98.65 98.23
97.00
97.73
96.86
94.68
90.32 91.43 89.29 41.37 39.75 94.58 83.33
16.67
92.00 93.90 80.00 24.00 79.67
81.82
90.91 88.32
Specific ity %
79.16 99.73 96.49 99.89 99.66 99.14 99.36 89.13 89.40 88.99
89.50
89.65
89.83
89.83
91.14 93.25 97.37 92.65 93.47 91.67 99.94
98.73
98.90 88.22 99.72 99.66 99.43
99.66
88.05 87.21
Positive predictive value %
97.38 98.64 96.90 81.82 50.00 60.19 63.25 98.79 98.18 94.90
95.45
91.43
82.35
89.66
65.12 71.11 52.63 70.36 65.39 80.64 90.91
91.89
86.47 71.96 44.44 50.00 41.18
75.00
37.04 88.54
64
31
Acute apical MI
21
32
Old apical MI
19
33
Early anterolateral MI
36
34
Possible acute anterolateral MI
9
35
Old anterolateral MI
14
36
Early high lateral MI
16
37
Possible acute high lateral MI
8
38
Old high lateral MI
23
39
Early inferior MI
31
40
Possible acute inferior MI
11
41
Old inferior MI
101
42
Early inferolateral MI
73
43
Possible acute inferolateral MI
29
44
Old inferolateral MI
28
45 ST depression, mild anteroseptal 7
myocardial ischemia
46
ST depression, mild anterior
5
myocardial ischemia
47
ST depression, mild extensive
13
anterior myocardial ischemia
48
ST depression, mild apical
17
myocardial ischemia
49 ST depression, mild anterolateral 25
myocardial ischemia
50
ST depression, mild high lateral
21
myocardial ischemia
51
ST depression, mild inferior
12
myocardial ischemia
52 ST depression, mild inferolateral 20
myocardial ischemia
53
ST depression, anteroseptal
4
myocardial ischemia
54 ST depression, anterior myocardial 12
ischemia
55 ST depression, extensive anterior 7
myocardial ischemia
56 ST depression, apical myocardial 18
ischemia
57
ST depression, anterolateral
13
myocardial ischemia
65
78.12 79.63 77.51 28.57 70.00 79.65 81.60 81.82 88.89 76.00 96.07 98.77 11.11
84.62 75.36
81.24
79.83
76.97
77.54
80.64
79.73
80.59
85.41
87.66
84.78
79.95
87.42
78.66 89.94 79.94 99.77 93.60 95.78 99.94 99.66 95.00 99.60 99.24 96.82 99.94
99.83 99.55
99.94
99.13
99.14
99.08
99.14
99.60
99.26
99.72
98.58
98.04
99.14
98.97
53.85 80.00 83.33 33.33 50.00 80.42 85.71 60.00 40.00 61.11 93.44 75.94 50.00
78.57 46.67
33.33
53.59
43.13
37.64
47.39
55.16
50.61
44.44
34.85
67.75
55.12
59.09
58
ST depression, high lateral
myocardial ischemia
16
90.06
99.31
57.14
59 ST depression, inferior myocardial 12
ischemia
89.88
99.13
40.08
60
ST depression, inferolateral
myocardial ischemia
6
91.39
99.16
50.47
Sensitivity: probability that a “True sample” would be determined as certain “Item” by
automated interpretation function;
Specificity: probability that a “True unfit sample” would be determined as certain “Unfit
item” by automated interpretation function;
Positive predictive value: probability that a determined “Unfit item” is a “True unfit item”.
66
Appendix II EMC Guidance and Manufacturer Declaration
Warning
l The use of ACCESSORIES, transducers and cables other than those specified, with
the exception of transducers and cables sold by the MANUFACTURER of the the
device as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM. The following cable types must be used to ensure that they comply with interference
radiation and immunity standards:
No.
Name
Cable length (m)
1
Power cord
1.7
2
ECG lead cable
3.4
3
Potential equalization conductor
3.0
l Active medical devices are subject to special EMC precautions and they must
be installed and used in accordance with these guidelines.
l Portable and mobile communication radiation equipment may affect the normal
use the medical device.
l The device should not be used when they are close to or stacked with other
equipment, if necessary, please observe and verify that they can operate
normally in the configurations.
l Basic performance: Stability of working state: Waveform noise and
measurement error appeared during measuring are automatically eliminated 10s
after removing the interference, the working state of device are not changed,
it could collect and record data continuously, and the waveform does not show
obvious changes before and after the test.
Electromagnetic emission
Guidance and manufacture’s declaration-electromagnetic emission
The device is tended for use in the electromagnetic environment specified below. The purchaser or the user of the device should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment-guidance
RF emissions CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Harmonic emissions
Class B Class A
The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low
67
IEC 61000-3-2
Voltage fluctuations/
flicker emission
Applicable
IEC 61000-3-3
Electromagnetic immunity
voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacture’s declaration-electromagnetic immunity
The device is intended for use in the environment specified below. Buyer or operator should
assure that it is used in such environment.
Immunity test
IEC60601 level
test Compliance level
Electromagnetic environment-guidance
Electrostatic
±6kV contact
±6kV contact Floors should be wood,
discharge (ESD)
±8kV air
±8kV air
concrete or ceramic tile. If
IEC 61000-4-2
floor is covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical
fast
transient/burst
IEC 61000-4-4
±2kV for power supply lines ± 1 kV for input/output line
±2kV for power supply lines ± 1 kV for input/output line
Mains power quality should be that of a typical commercial or hospital environment.
±1 kV lines to ±1 kV lines to Mains power quality should
Surge
lines
lines
be that of a typical
IEC 61000-4-5
±2 kV lines to ±2 kV lines to commercial or hospital
earth
earth
environment.
Voltage dips, short interruptions and voltage vatiations on power supply input lines IEC 61000-4-11
<5%UT(>95%dip in UT) for 0.5 cycle 40% UT(60%dip in UT) for 5 cycle 70%UT(30%dip in UT) for 25 cycle <5%UT(>95%dip in UT) for 5 sec
<5%UT(>95%d ip in UT) for 0.5 cycle 40% UT(60%dip in UT) for 5 cycle 70%UT(30%dip in UT) for 25 cycle <5%UT(>95%d ip in UT) for 5 sec
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user
requires
continued
operation during power
mains interruptions, it is
recommended that the
device be powered from an
uninterruptible
power
supply or a battery.
68
Power frequency
(50/60
Hz)
magnetic field
IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration-electromagnetic immunity
The device is intended for use in the environment specified below. Buyer or operator should
assure that it is used in such environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic environment -guidance
Conducted RF IEC61000-4 -3
3 Vrms 150kHz 3 Vrms 80MHz
Portable and mobile RF communications equipment should be used no closer to
any part of the device, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the
transmitter. Recommended separation distance d=1.2P
d=1.2P 80MHz-800MHz
d=2.3P 800MHz-2.5GHz
Radiated RF IEC61000-4 -3
3 V/m 80 MHz 3 V/m 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m). 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.b Interference may occur in the
vicinity of
equipment marked with the following symbol:
69
NOTE 1: At 80MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device or system is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as adjusting the direction or location of the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended safety distance
Recommended separation distances between portable and mobile RF communications
equipment and the device
The device is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended below,
according to the maximum output power of the communications equipment.
Rated power of transmitter(W)
Separation distance according to power of transmitter (m)
150 k Hz 80 MHz d=1.2P
80 MHz 800 MHz d=1.2P
800 MHz 2.5 GHz d=2.3P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the separation distance for 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.
70
Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specific
recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.
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