Gima 600G ECG User manual

PROFESSIONAL MEDICAL PRODUCTS
600G ECG - 3/6 CHANNEL WITH MONITOR
ECG600G (
GIMA
33222)
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
0123
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
55°C
1060 hPa 95%
- 20°C
500 hPa
0%
M33222-GB-Rev.
6
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01
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4

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:
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Type of protection against electric shock: class I (AC power supply), internal powered
equipment (power supplied by battery)
Degree of protection against electric shock: type CF, defibrillation-proof applied part
Working mode: continuous running equipment
Enclosure protection class: IPX0
Measurement results shall be described by professional doctor combined with clinical
symptoms.
The using reliability depends on whether the operation guide and maintenance instructions
in this user manual is followed.
Service life: 5 years
Date of manufacture: see the label
Contraindications: none
Warning: To ensure the device safety and effectiveness, please use the company
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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
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The device must be operated by a professionally trained medical staff, and kept by a
special
person.
The operator should read
the User Manual carefully before use, and strictly follow the
operating procedure described in the User Manual.
The safety
requirements have been fully considered in product designing, but the operator
can not
ignore the observation of the patient and device.
The operator is responsible for providing the information of product use to the company.
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Responsibility of the company
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The company supplies qualified products to user in accordance with enterprise standard.
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The company installs and debugs the equipment and trains the physicians by contract.
The company performs device repair in warranty period (a year) and maintenance service
after warranty period.
The company responds timely to the user's request.
The user manual is written by Contec Medical Systems Co., Ltd. All rights reserved.
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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
4.1.1 The power supply unit...............................................................................
8
4.1.2 Signal acquisition unit...............................................................................
8
4.1.3 Control unit ...............................................................................................
8
4.2 Name of each part and its function .........................................................................
9
4.2.1 Front view.................................................................................................
9
4.2.2 Side view ................................................................................................10
4.2.3 Buttons ...................................................................................................10
4.2.4 Symbols..................................................................................................11
Chapter 5 Operation Precautions ..........................................................................................13
5.1 Precautions before use..........................................................................................13
5.2 Precautions during operating................................................................................
13
5.3 Precautions after use.............................................................................................
13
Chapter 6 Preparations before Operation..............................................................................
14
6.1 Installation of recording paper..............................................................................
14
6.2 Power supply connection......................................................................................
14
6.2.1 AC ..........................................................................................................
14
6.2.2 Battery ....................................................................................................
15
6.3 Lead cable connection..........................................................................................
15
6.4 Electrode installation............................................................................................
15
6.4.1 Chest electrodes ......................................................................................
15
6.4.2 Limb electrodes ......................................................................................
16
6.4.3 Colors of lead cables...............................................................................
16
6.4.4 Lead method and system.........................................................................
17
6.4.5 Lead-off and overload indication ............................................................
17
Chapter 7 Operation Instructions and Parameter Setting ......................................................
18
7.1 Main Interface......................................................................................................
18
7.2 Sampling interface ...............................................................................................
19
7.3 Case information input interface ..........................................................................
21
7.4 Case management ................................................................................................
22
7.4.1 Query......................................................................................................23
IV

7.4.2 Review....................................................................................................24
7.5 Date and time setup ..............................................................................................25
7.6 System setup ........................................................................................................26
7.7 Sampling setup.....................................................................................................27
7.8 Print setup ............................................................................................................28
7.9 Lead placement ....................................................................................................29
7.10 About.................................................................................................................30
Chapter 8 Troubleshooting ...................................................................................................31
8.1 Auto shutdown .....................................................................................................31
8.2 AC interference ....................................................................................................31
8.3 EMG interference.................................................................................................
31
8.4 Baseline drift........................................................................................................
32
8.5 Troubleshooting list .............................................................................................
32
Chapter 9 Maintenance.........................................................................................................
34
9.1 Battery .................................................................................................................
34
9.2 Recording paper...................................................................................................
35
9.3 Maintenance after use ..........................................................................................
35
9.4 Lead cables and electrodes...................................................................................
36
9.5 Silicone rubber roller ...........................................................................................
36
9.6 Cleaning of thermal print head .............................................................................
36
9.7 Disposal of product scrap .....................................................................................
36
9.8 Others ..................................................................................................................
36
Chapter 10 Packing List and Accessories.............................................................................
38
10.1 Accompanying accessories.................................................................................
38
10.2 Notes..................................................................................................................
38
Appendix I ECG Automated Measurement&Interpretation Guide .......................................
39
1. Preface ...................................................................................................................
39
2. Automated measurement parameters and Automated interpretation items..............
39
2.1 Measurement parameters ...........................................................................
39
2.2 Interpretation items....................................................................................
39
3. Algorithm description ............................................................................................
42
3.1 Find the cardiac impulse location...............................................................
42
3.2 Find the beginning/end for each wave .......................................................
43
3.3 Amplitude measurement ............................................................................
45
3.4 Calculation after intervals determination....................................................
46
3.5 Interpretations judgment based on parameters......................................................
47
4. Data sources and data preprocessing ......................................................................
51
4.1 Data sources ..............................................................................................
51
4.2 CTS introduction .......................................................................................
51
4.3 CSE introduction .......................................................................................
51
4.4 Customized data ........................................................................................
52
4.4.1 Data description......................................................................................52
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4.5 Data coverage of verification for automated interpretation ...................................53
4.6 Data preprocessing.....................................................................................54
4.6.1 CTS preprocessing ..................................................................................54
4.6.2 CSE preprocessing ..................................................................................54
4.6.3 Customized data preprocessing ...............................................................55
5. Process and Result of Verification....................................................................................55
5.1 Verification of measurement function ..................................................................55
5.1.1 Verification and Process for CTS measurement database........................55
5.1.2 Verification and Process for CSE measurement database........................56
5.1.3 Verification results..................................................................................58
5.1.3.1 Accuracy of amplitude measurements..................................................58
5.1.3.2 Accuracy of absolute interval and wave duration measurements..........58
5.1.3.3 Accuracy of interval measurements on biological ECGs......................58
5.1.3.4 Stability of measurements against NOISE............................................59
5.2 Verification of interpretation function........................................................60
5.2.1 Verification process ................................................................................
60
5.2.2 Verification results..................................................................................
62
Appendix II EMC Guidance and Manufacturer Declaration.................................................65
VI

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, po
wered 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: 7.4 V, 3500 mAh rechargeable lithium battery
Transportation and Storage:
a). Environment temperature: -20 ℃～+55 ℃
b). Relative humidity: ≤95%
c). Atmospheric pressure: 500 hPa～1060 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 MΩ
1.3.6 Frequency response:
1
Rated input
amplitude
Input frequency and waveform Relative output response
1.0 0.67Hz~40Hz, Sine wave ±10%a
0.5 40Hz~100Hz, Sinewave +10 %, -30 %a

1.3.7 Time constant: ≥3.2s
1.3.8 CMRR: >105 dB
1.3.9 Filter: power frequency(AC50/60 Hz), myoelectricity(25 Hz/35 Hz (-3 dB)), baseline drift
filter
1.3.10 Recording way: Thermal printing system
1.3.11 Specification of recording paper: 110 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 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: ±5%
1.3.27 Amplitude quantization: ≤5µV/LSB
1.3.28 Dimension: 315 mm(L)×215 mm(W)×92 mm(H)
1.3.29 Net Weight: 1.7 kg
1.3.30 Interchannel time deviation: <100 µs
1.4 Main Characteristics
1.4.1 Adopt 7" high-resolution color LCD screen, 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
2
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
arelative to 10Hz brelative to 200 ms

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 c
harging circuit, perfect battery overcurrent and
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 number, name, gender, age, height and weight can be
input.
1.4.8 The built-in large-capacity memory can store 1,000 medical records, making it easy for
doctor to review medical records and statistical information.
1.4.9 Multi-language (Chinese, English, Turkish, Portuguese, German, Russian, Kazakstan, etc.)
interface and report.
1.5 Software overview
The ECG analysis program shows the results after analyzing the form of the
electrocardiogram, providing auxiliary reference for doct
ors to make diagnosis. The analysis
result cannot be used as the only standard for diagnosis. A comprehensive evaluation should be
made by professional electrocardiogram technicians and physicians according to clinical
experience and other test results.
The device is intended for use on all patient populations, which is decided by the clinical
doctor. The analysis program only provides ECG analysis for patients above 3 years old
(including 3 years).
Name of software: ECG600G embedded software
Software specification: none
Software version: V1.6.7
Version naming rules: V<major version number>.<minor version number>.<revision version
number>
The version of the software can be obtained in “About”.
Involved algorithm:
Name: ECG algorithm
Type: mature algorithm
Use: to convert ECG signals of human body into intuitive waveform images and then analyzing.
Clinical function: Electrocardiogram is an important method for clinical diagnosis of
cardiovascular disease. How to use computer to quickly, automatically and accurately analyze
ECG has been a hot topic for scholars at home and abroad. The ECG algorithm is the key to the
analysis and diagnosis of ECG signals, and its accuracy and reliability determine the
effectiveness of diagnosis and treatment of patients with heart disease.
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