Topmedic CONTEC 1200ECG User manual

Manual de Uso
www.topmedic.cl ([phone] ([phone] [email protected] Lunes - Viernes 09:30 a 18:00 hrs La Concepción 165, OF209, Providencia
ELECTROCARDIÓGRAFO
CONTEC 1200ECG

ECG1200G Electrocardiograph - User Manual
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Statement
Our company owns all rights to this unpublished work and intends to maintain it as confidential
information. This publication is used only for reference of operation, maintenance, or repair of
our device. No part of this can be disseminated to others.
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 publication 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 publication 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.
Content of this manual is subject to change without prior notice.

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Contents
Chapter1 Overview ....................................................................................1
1.1 Overview......................................................................................1
1.2 Main Technical Specifications .....................................................1
Chapter2 Safety Notes ...............................................................................2
Chapter3 Warranty Regulation...................................................................3
Chapter4 Product Main Characteristics .....................................................4
Chapter5 Electrocardiograph Panel Sketch Map .......................................6
5.1 Each Panel View and its Components..........................................6
5.2 Key Definition..............................................................................7
5.3 Indicator Light Definition ............................................................9
Chapter6 Notes Before Operating............................................................10
Chapter7 Preparations Before Operation .................................................11
Chapter8 Notes During Operation ...........................................................12
Chapter9 Usage of Recording Paper........................................................13
Chapter10 Electrode Placement ...............................................................14
10.1 Chest Electrode Placement.......................................................14
10.2 Limb Electrode Attachment .....................................................14
10.3 Check-List for Electrodes and ECG cables..............................15
Chapter11 Grounding and Power Connection of Device .........................16
Chapter12 Battery Operation Notes.........................................................17
Chapter13 Control Panels and Key Instructions ......................................18
13.1 Main Interface..........................................................................18
13.2 Sampling Interface ...................................................................19
13.3 Case Information Inputting ......................................................20
13.4 Case Management ....................................................................22
13.5 Case Querying..........................................................................22
13.6 Case Review.............................................................................23
13.7 Time and Data Settings ............................................................24
13.8 System Settings ........................................................................25
13.9 Sampling Settings ....................................................................27
13.10 Print Settings..........................................................................28

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13.11 Checking Electrodes Placement .............................................30
13.12 About Us ................................................................................31
Chapter14 Troubleshooting......................................................................33
14.1 Powering off Automatically .....................................................33
14.2 AC Interference ........................................................................33
14.3 EMG Interference ....................................................................33
14.4 Baseline Drift ...........................................................................33
14.5 Troubleshooting List ................................................................34
Chapter15 Maintenance ...........................................................................36
Appendix..................................................................................................37

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Chapter1 Overview
1.1 Overview
12-channel Electrocardiograph is such a kind of electrocardiograph, which gathers 12-lead ECG
signals simultaneously and prints out the ECG waveforms with thermal printing system. It's
major functions are as follows: recording and displaying ECG waveforms in manual/auto ways;
measuring and diagnosing ECG waveform parameters automatically; electrode-off and paper
lack prompt; optional interface languages (Chinese/English); powered either by AC or DC;
selectable rhythm lead to detect abnormal heart rate conveniently ;case database management,
etc.
800*600 dots high resolution LCD screen; 1728 dot wide, it can print 12-channel ECG
waveforms. You can operate either by buttons or touch screen, which is convenient and quick.
1.2 Main Technical Specifications
1.2.1 Environment conditions
Operation
a) Environment temperature: +5�~+35�
b) Relative humidity: 80%
c) Power supply: AC:100V~240V,50/60Hz
DC:14.8V, 3700 mAh rechargeable lithium battery
d) Atmospheric pressure: 86kPa~106kPa
Transportation and Storage
a) Environment temperature: -10�~55�
b) Relative humidity: 95%
c) Atmospheric pressure: 50kPa~106kPa
1.2.2 Input way: Floating and defibrillation protection
1.2.3 Lead: Standard 12 leads(model:BIP0057)
1.2.4 Patient leak current: <10µA
1.2.5 Input impedance: 50M
1.2.6 Frequency response: 0.05Hz~150Hz(-3dB~+0.4dB)
1.2.7 Time constant: Time constantı3.2s
1.2.8 CMRR: >60dB, >100dB( Adding filter)
1.2.9 EMG interference filter: 25Hz/35Hz(-3dB)
1.2.10 Recording way: Thermal printing system
1.2.11 Specification of recording paper: 210mm(W)*20m(L) high-speed thermal paper
1.2.12 Paper speed:
Auto record: 25mm/s, 50mm/s, error:±5%
Rhythm record: 25mm/s, 50mm/s, error:±5%
Manual record:5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s, error:±5%
1.2.13 Sensitivity selections: 2.5,5,10,20,40mm/mV, error:±5%. Standard sensitivity is
10mm/mV±0.2mm/mV.
1.2.14 Auto record: Record setup according to auto record format and mode, automatically
changing leads, measuring and analysing.
1.2.15 Rhythm record: record setup according to rhythm record format and mode, automatically
measuring and analysing.
1.2.16 Manual record: record setup according to manual record format, manually changing leads.
1.2.17 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), S(V1), R(V5)+S(V1).
1.2.18 Product safety type: Class I CF applied part; there is defibrillation and pacing protection
circuit in it.
1.2.19 Enduring polarization voltage: ±500mV
1.2.20 Noise level: 15µVp-p
1.2.21 Fuse specification: 2 pcs 5*20mm AC time lag; T1.6A/250V(Power supply 220V)
1.2.22 Size: 340mm(L)*320mm(W)*85mm(H)

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1.2.23 Net Weight: 3.2Kg
Chapter2 Safety Notes
2.1 The power supply should be grounded properly before operation.
2.2 If there are any questions for the integrality of protective grounding cable, the device must be
run with built-in power supply.
2.3 Please pull out power supply plug before changing the fuse.
2.4 This device must be operated by medical staff trained technically and professionally,
preserved by special person.
2.5 The operator must read this instruction manual carefully before operation, and operate the
device according to operation regulations strictly.
2.6 The design of this device has mature consideration of security, but operator should never
neglect attention to device state and patient’s observation.
2.7 Please turn off the device and pull out power supply plug before cleaning and disinfection .
2.8 Please don’t use this device in the presence of flammable anaesthesia gas.
2.9 Don't rub the screen with edge tools or sharp materials.
2.10 If this device is used with cardiac defibrillator or other electric stimulating devices at the
same time, please choose Ag/AgCl chloride chest electrode and ECG lead cables with
defibrillation function. To prevent the metal electrode from burning patients' skin, the disposable
chest electrode should be used if the defibrillation time is over 5seconds. 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.
2.11 When connected with this ECG device, others must be Type I equipment complied with
IEC60601-1. Because the total leakage current may injure patient, the monitoring of leakage
current shall be carried out and taken charge by the connected devices.
2.12 Notes concerning ECG waveform measurement and analysis
(1) P wave and Q wave identify are not always reliable with intensive EMG or AC
interference. Neither are the ST segment and T wave with baseline drift.
(2) Winding and unclear end position of S wave and T wave may cause error in measurement.
(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.
(4) In case of QRS low voltage, ECG axis calculation and border-point identify of QRS wave
are not always reliable.
(5) Occasionally, frequent ventricular premature complexes may be identified as dominant
beat.
(6) Merging of versatile arrhythmias may result in unreliable measurement because of the
difficulty in distinguishing P wave in such situation.
(7) This device is designed with auto analysis function, which only analyses the ECG
waveforms it gathers and does not reflect all patient's states. Its analysis results may be not
in accordance with doctor's diagnoses. Therefore, the final conclusion concerning each
patient is up to the doctor basing on analysis results , patient symptoms, and other
examinations together.

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Chapter3 Warranty Regulation
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's 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 calling in, etc to
carry out warranty promise.
3.3 Even in warranty period , the following repairs are charged in principle:
3.3.1 Faults or injuries caused by misuse not according to user manual and operation notes.
3.3.2 Faults or injuries caused by dropping accidently when moving after purchasing.
3.3.3 Faults or injuries caused by repair, reconstruction, decomposition, etc not in our company.
3.3.4 Faults or injuries caused by natural disasters such as fire, flood, earthquake, etc.
3.3.5 Faults or injuries caused by 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 regulations are effective only in Chinese Mainland.
3.7 The warranty will be canceled if we find the protection label has been destroyed.
3.8 For charged maintenance beyond warranty period, our company advises to continue using
"Maintenance contract regulation". Please refer to our customer service department for details.

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Chapter4 Product Main Characteristics
4.1 Display with 800*600 dots color LCD, operate either by buttons or touch screen, which is
convenient and quick.
4.2 With high resolution thermal print system (8 dots/mm), it needs no adjustment, and the
record frequency is up to 150Hz.
4.3 Real-time and continuously record clear and exact 12 channel ECG waveforms and remarks.
The remarks include lead sign, sensitivity, paper speed and filter state,etc.
4.4 In auto mode, one button operation to complete record, which will improve work efficiency.
4.5 Full digital filter design, against baseline draft, AC and EMG interference.
4.6 Baseline auto adjusted, optimized print setup, selectable rhythm lead.
4.7 Full touch keyboard control makes operations more convenient and the device status are
clear and easily read through LCD screen.
4.8 The device can be powered either by AC or DC, with built-in lithium rechargeable battery
and auto protection circuit, without operation, auto powering off time can be set up.
4.9 This device can record 300 pieces of ECG and print 180 minutes continually in the best DC
state.
4.10 This device can store more than 1000 cases, more convenient for data review and statistic.
4.11 The figure of whole device is elegant and gliding.
4.12 One button operation to complete printing and storing.
4.13 The device adopts digital signal processor, through AC, DFT and EMG filters to obtain
electrocardiogram of high quality.
4.14 The device has such functions as measuring, analysing and diagnosing conventional ECG
parameters automatically to reduce doctor’s burden and improve work efficiency.
4.15 The device gathers 12-channel ECG signals synchronously and then analyses record modes
of such channels as 12*1, 6*2+1, 6*2, rhythm row12, row10, row8, row6,etc, with multiply
report formats.
4.16 With multiply lead display modes, the device can observe 3,6,or 12 lead real-time
waveforms, and display such information as lead-off and printer paper lack, etc, also with ECG
parameter auto-detected and analysis reports, and record waveforms in auto/manual mode, with
database to store patient information.
4.17 Safety Classification: Class I, defibrillator-proof type CF applied part .
4.18 The degree of protection against entry liquids: IPX0.
4.19 According to the degree of safety of application in the presence of a flammable anaesthetic
mixture with air: Equipment not suitable for use in the presence of the gas above.
4.20 According to the mode of operation: Continuous operation.
4.21 Explanation of some symbols in this device:
~AC AC work mode
OFF Power supply is disconnected
ON Power supply is connected
Equipotential grounding post
Refer to instruction manual/booklet
Type CF applied part with defibrillation protection function
RS232 I/O
USB port

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PATIENT Lead connector
WEEE (2002/96/EC)
This item is compliant with Medical Device Directive 93/42/EEC of
June 14,1993,a directive of the European Economic Community.

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Chapter5 Electrocardiograph Panel Sketch Map
5.1 Each Panel View and its Components
Figure 5-1 Front view
Figure 5-2 Side view
1ǃLead Connector
2ǃUSB Port
12345
Display Screen
Paper Carriage
Button Panel

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3ǃPower Switch
4ǃAC Input
5ǃGrounding Post
Figure 5-3 Bottom view
5.2 Key Definition
Function key: This key is used to turn the device on or off.
Function key: This key is used to begin or stop sampling.
Function key: This key is used to select filter function.
Function key: This key is used to adjust paper speed.
Function key: This key is used to adjust gain.
Function key: This key is used to switch printing modes.
Function key: This key is used to start printing.
Fuse Socket

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Function key: This key is used to confirm the operation you have done.
Function key: This key is backspace.
Function key: This key is used to switch input methods.
Direction key: Up
Direction key: Down
Direction key: Left
Direction key: Right
Number/Capital and Small letter/Character key: 0/Space/,
Number/Capital and Small letter/Character key: 1/.
Number/Capital and Small letter/Character key: 2/abc/ABC/:
Number/Capital and Small letter/Character key: 3/def/DEF/;
Number/Capital and Small letter/Character key: 4/ghi/GHI/*
Number/Capital and Small letter/Character key: 5/jkl/JKL/%
Number/Capital and Small letter/Character key: 6/mno/MNO/"
Number/Capital and Small letter/Character key: 7/pqrs/PQRS/#
Number/Capital and Small letter/Character key: 8/tuv/TUV/(

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Number/Capital and Small letter/Character key: 9/wxyz/WXYZ/)
5.3 Indicator Light Definition
When green, the light indicates that the device is powered by AC supply;
while red and green, it indicates the battery is charging.
Powering on indicator light.

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Chapter6 Notes Before Operating
6.1 To use the device safely and effectively, you should read the user manual carefully before
operation.
6.2 Notes for installation and storage:
6.2.1 The device shall be keep away from high voltage cable, X-ray equipment, ultrasound
device or electrotherapeutics machine, etc.
6.2.2 Avoid using and storing the device in the places with high air pressure, temperature and
humidity beyond common standard, bad ventilation, excessive dust or salt-alkali gas and
chemical medicine.
6.3 The device should be put on flat place and taken and put lightly when moved. Avoid too
strong vibration and shock.
6.4 AC frequency and voltage value should be in accordance with the requirements to ensure
enough current capacity.
6.5 Please place the device indoor where is easy to be grounded. Do not connect the patient and
his connected cables with other conductors, including ground or beds which can be conducted
well with ground.

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Chapter7 Preparations Before Operation
7.1 Ensure the device is grounded and all the cables are connected reliably.
7.2 Ensure the electrodes, directly connected with patient, are placed correct and reliable.
7.3 If you have selected to purchase UPS, check whether the output voltage is normal or not.
7.4 Electric gel coats should be separated and chest electrodes should not connect with each
other , so as to avoid short circuit.
7.5 AC power cable should not enlace with ECG lead cables.

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Chapter8 Notes During Operation
8.1 Pay attention to the patient and device status at any moment.
8.2 Patient and device can only be connected through ECG lead cables.
8.3 Keep close observation of the patient and device to make sure they are still during operation.
8.4 Turn off the device after using.
8.5 Disconnect the power, and remove the ECG lead cables gently without strong force.
8.6 Properly keep the device and its accessories for operation next time.
8.7 Recording Paper Loading
8.7.1 The device adopts high-speed thermal recording paper with the specification of
210mm(W)*20m(L).
8.7.2 Open the cover of paper carriage, take out the paper roll and install it into recording paper
then load them at the proper position inside the carriage.
8.7.3 Close the cover of paper carriage. It's recommended to leave 2cm paper outside.

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Chapter9 Usage of Recording Paper
9.1 When recording, the device will stop paper trace in case of paper lack, and the LCD screen
will display as the figure below to prompt paper lack.(See Figure 9-1)
Figure 9-1
9.2 It is recommended to use the thermal recording paper specified by our company to ensure
ECG waveforms of good effect. Bad recording paper will result in unclear ECG waveforms,
fading or unsmooth paper trace, etc, even pricking up the device's worn up and shortening the
service cycle of such important components as printer head. Please consult your manufacture or
our company for purchasing this recording paper.
9.3 High temperature, humidity or direct sunniness may all be the causes for recording paper
failure.The paper ,which will not be used for long, shall be stored in place cool, dry and dark.
9.4 Substance may contaminate surface of the recording paper:
Gel, glue, and half-dry diazo compound copy paper, etc, including their organic solvent.
9.5 Substance may cause the waveforms to disappear:
Soft PVC folders, plastic, etc; demagnetization machine and tape containing plasticizer;
Some fluorescence ink pen and stamp-pad ink,etc.

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Chapter10 Electrode Placement
It is better to attach chest electrodes first, then the limb electrodes.
10.1 Chest Electrode Placement
See Figure 10-1:
Figure 10-1
Attach the chest electrodes to the locations as following:
V1: Fourth inter-costal space at right border of sternum.
V2: Fourth inter-costal space at left border of sternum.
V3: Midway between V2 and V4.
V4: Fifth inter-costal space at left mid-clavicular line.
V5: Left anterior axillary line at the horizontal lever of V4.
V6: Left mid-axillary line at the horizontal lever of V4.
Clean the skin where chest electrodes are to be attached with alcohol, then apply ECG cream to
here around 25mm in diameter and to the edge of chest electrodes, then press and attach the
electrodes to the positions from V1-V6.
Note: Keep in mind that the electrodes’ coming into contact with each other or cream’s
overlap from one position to another is not allowed to avoid short circuit.
10.2 Limb Electrode Attachment
Electrodes should be placed on the soft skin of hands and feet. Clean all the limb electrodes and
the positions where limb electrodes are to be attached with alcohol before applying ECG cream
to them, then firmly attach the electrodes to the positions.(See Figure 10-2)
Figure 10-2

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Note: Screw tightly the knob of ECG cable's plug after it is inserted to the ECG connector.
10.3 Check-List for Electrodes and ECG cables
Electrode Location Electrode Symbol Plug No.
Right Arm RA/R 9
Left Arm LA/L l0
Left Leg LL/F 11
Right Leg RL/N 14
Chest 1 Vl/Cl 12
Chest 2 V2/C2 1
Chest 3 V3/C3 2
Chest 4 V4/C4 3
Chest 5 V5/C5 4
Chest 6 V6/C6 5

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Chapter11 Grounding and Power Connection of Device
Make sure power supply is off, plug the 3-line connector in the device, the other end into power
receptacle which should be center grounded. It is prohibited to use water pipe or other pipeline as
grounding cable. Properly grounded can ensure the safety and reduce the interference of AC and
other electromagnetic wave.