BPL ECG Machine - Cardiart 6208 ViewPlus
BPL ECG Machine - Cardiart 6208 ViewPlus
Technologies
User Manual
0843
www.bplmedicaltechnologies.com Follow us on
Responsibility of the Manufacturer
BPL considers itself responsible for any defects on safety, reliability and performance
of the equipment as specified only if:
- The electrical, other installation and the environment in the installation room
are met as per the safety, regulatory and statutory requirements mentioned in this
manual and
Caution
- Use of accessories other than those recommended by BPL may compromise product
performance
Notice
- The information in this document is subject to change without notice.
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Operating Manual
CARDIART 6208 VIEW / VIEW PLUS
Version: 1.0
This monitor has been compiled to the users of CARDIART 6208 VIEW / VIEW PLUS in
installation, operation and routine maintenance
Specifications and Operating Characteristics are subject to change without notice for
improvements.
Copyright:
11th KM,
Bannerghatta Road,
Arekere,
Bangalore - 560 076
Contact Details
BPL Medical Technologies Pvt. Ltd. BPL Medical Technologies Pvt. Ltd.
11th KM Bannerghatta Road, BPL Works, Palakkad, 0843
Arekere, Bangalore – 560076 Kerala – 678007
www.bplmedicaltechnologies.com EC REP
OBELIS S.A
Bd. Général Wahis 53
1030 Brussels, Belgium
Email:[email protected]
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Content
Chapter 1 Safety Guidance 1
1.1 Safety Information 1
1.2 Warnings and Cautions 1
1.2.1 Safety Warnings 1
1.2.2 Battery Care Warnings 2
1.2.3 General Cautions 3
1.2.4 Cleaning & Disinfection Cautions 3
Chapter 2 Introduction 5
2.1 Function Features 5
2.2 List of Symbols 6
v
5.8.2.1 Lead Settings 28
5.8.2.2 Sample Mode Settings 28
5.8.2.3 Recording Settings 28
5.8.2.4 Measurement and Interpretation 29
5.8.2.5 Parameter Options 29
5.8.3 GENERAL Settings 30
5.8.3.1 Filter Settings 30
5.8.3.2 External Input/Output Settings 31
5.8.3.3 Key Beep & QRS Beep Settings 31
5.8.3.4 IP Settings 31
5.8.3.5 Save Option Settings 31
5.8.3.6 Transfer Settings 31
5.8.3.7 Parameter Options 32
5.8.4 SYSTEM Settings 32
5.8.4.1 Display Mode Settings 33
5.8.4.2 Parameter Options 34
5.8.5 Settings (6208 View) 35
5.9 ECG Record 36
5.10 RHYTHM mode record 37
5.11 USBPRT mode record 38
5.12 Switch Off 40
Chapter 9 Accessories 48
Chapter 10 EMC Information - Guidance and Manufacture’s
Declaration 49
10.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS 49
10.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS 49
10.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS
that arenot LIFE-SUPPORTING 51
10.4 Recommended Separation Distances 52
Chapter 1
Safety Guidance
1.1 Safety Information
The design of CARDIART 6208 View Plus/ 6208 View complies with international standard IEC/EN 60601-1
Medical Electrical Equipment: General Requirements for Safety and IEC/EN 60601-2-25 Particular Requirements
for the Safety of Electrocardiographs etc. The classification of this equipment is Class 1, type CF, which means a
higher degree of protection against electric shock and the patient connection is fully isolated and defibrillation
protected.
This equipment is not explosion-proof. Do not use it in the presence of flammable anesthetics.
This equipment is designed for continuous operation and is ‘ordinary’ (i.e. not drip or splash-proof).
Classification:
2) Anti-electric-shock degree : CF
3) Degree of protection against harmful ingress of water : Ordinary equipment (Sealed equipment
without liquid proof)
7) EMC : Group
Please pay more attention to the following warning and caution information.
WARNING :
The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained. And they
should be familiar with the contents of this user manual before operation.
Only qualified service engineers can install this equipment. And only service engineers authorized by BPL can open
the shell.
Only qualified installation or service engineers can shift the mains shift switch (100V~115V/220V~240V)
1
according to local mains supply.
The results given by the equipment should be examined with respect to the overall clinical condition of the patient.
And it can not substitute for regular checking.
WARNING :
EXPLOSION HAZARD-Do not use the electrocardiograph in the presence of flammable anesthetic
mixture with oxygen or other flammable agents.
SHOCK HAZARD-The power receptacle must be a hospital grade grounded outlet. Never try to adapt the
three-prong plug to fit a two-slot outlet.
If the integrity of external protective conductor in installation or arrangement is in doubt, the equipment
should be operated from the built-in rechargeable battery.
Do not use this equipment in the presence of high static electricity or high voltage equipment which
may generate sparks.
This equipment is not designed for direct cardiac application.
WARNING :
Only patient cable and other accessories supplied by BPL can be used. Or else, the performance and
electric shock protection can not be guaranteed.
Be sure that all electrodes have been connected to the patient correctly before operation.
Ensure that the conductive parts of electrodes and associated connectors, including neutral electrode,
do not come in contact with earth or any other conducting objects.
Electrodes with defibrillator protection should be used while defibrillating.
There is no danger for patients with pacemaker. However, if a pacemaker is used, the results given by the
equipment may be invalid, or lose the clinical significance.
Do not touch the patient, bed, table and the equipment while using defibrillator or pacemaker
simultaneously.
In order to avoid burning, please keep the electrode far away from the radio knife while using
electrosurgical equipment simultaneously.
Always use electrode gel with reusable electrodes during defibrillation as ECG recovery will be greater
than 10 seconds. BPL recommends the use of disposable electrodes at all times.
WARNING :
Accessory equipment connected to the analog and digital interfaces must be certified according to the
respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1
for medical equipment). Furthermore all configurations shall comply with the valid version of the
standard IEC/EN 60601-1-1. Therefore anybody, who connects additional equipment to the signal input
connector or output connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our
technical service department or your local distributor.
The summation of leakage current should never exceed leakag current limits while several other units
are used at the same time.
The potential equalization conductor can be connected to that of other equipment when necessary,
to make sure that all these equipment are connected with the potential equalization bus bar of the
electrical installation.
WARNING :
Improper operation may cause the battery to be hot, ignited or exploded, and it may lead to the
declination of battery’s capacity. It is necessary to read the user manual carefully and pay more attention
to warning messages.
Only qualified service engineer authorized by BPL can open the battery compartment and replace the
battery. And the battery of same model and specification provided by manufacturer should be used.
Danger of explosion -- Do not reverse the anode and cathode when connecting the battery.
2
When leakage or foul smell found, stop using the battery immediately. If your skin or cloth comes into
contact with the leakage liquid, cleanse it with clean water at once. If the leakage liquid splashes into
your eyes, do not wipe them. Irrigate them with clean water first and go to see a doctor immediately.
When the battery’s useful life is over, contact the manufacturer or local distributor for disposal or
dispose the battery according to local regulations.
CAUTION :
Avoid liquid splash and excessive temperature. The temperature must be kept between 5°C and 40°C
while working. And it should be kept between -20°C and 55°C during transportation & storage.
Do not use the equipment in dusty environment with bad ventilation or in the presence of corrosive.
Be sure that there is no intense electromagnetic interference source around the equipment, such
as radio transmitter or mobile phone etc. Attention: large medical electrical equipment such as
electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment etc. are
likely to bring electromagnetic interference.
CAUTION :
Before use, the equipment, patient cable and electrodes etc. should be checked. Replacement should
be taken if there is any evident defectiveness or aging symptom which may impair the safety or
performance.
The following safety checks should be performed at least every 24 months by a qualified person who
has adequate training, knowledge, and practical experience to perform these tests.
a) Inspect the equipment and accessories for mechanical and functional damage.
c) Inspect the fuse to verify compliance with rated current and breaking characteristics.
d) Verify the device functions properly as described in the instructions for use.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.2 ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 uA, SFC 1000uA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10 uA (CF).
h) Test the patient leakage current under single fault condition with mains voltage on the
applied part according to IEC/EN 60601-1: Limit: 50uA (CF).
The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the
above tests, the device has to be repaired.
Ruptured fused must only be replaced with the same type and rating as the original.
When the effective lifetime of the equipment and accessories is over, collect and classify them, and
dispose them according to local regulations.
Federal (US) law restricts this device to sale by or on the order of a physician.
CAUTION :
Turn off the power before cleaning and disinfection. If mains supply used, the power cord should be
3
drugged out of the outlet also. And prevent the detergent from seeping into the equipment.
Do not immerse the unit or patient cable into liquid under any circumstances.
Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes.
Any remainder of detergent should be removed from the unit and patient cable after cleaning.
Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
4
Chapter 2
Introduction
CARDIART 6208 View Plus / 6208 View is a 3-channel electrocardiograph with 12 leads gathered simultaneously,
visual display of operation menu, ECG parameters as well as electrocardiogram.
6208 View is the device with 192×64 dot single color LCD Screen; 6208 View Plus is the device with 320×240
dot single color LCD Screen.
3-channel ECG can be viewed on the LCD (liquid crystal display) screen of CARDIART 6208 View Plus / 6208 View
simultaneously. And it can be recorded by high-quality thermal printer.
Auto, manual, rhythm, USB print and off mode can be chosen conveniently.
Either mains supply or built-in rechargeable Lithium battery can be used as power.
With a high resolution thermal printer, 32-bit processor and huge capacity memorizer, CARDIART 6208 View Plus
/ 6208 View has advanced performance and high reliability. And the compact size makes it suitable for clinic,
hospital and ambulance use.
Configurations : Main unit and accessories (power cord, earth wire, patient cable, electrodes and thermal
record paper)
Intended use : The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric
patients through body surface ECG electrodes. The electrocardiograph is only intended to
be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.
The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose
heart disease. However the ECG with measurements and interpretive statements is offered to
clinician on an advisory basis only.
WARNING
This equipment is intended for use in adult and pediatric patients only.
WARNING
This equipment is not designed for direct cardiac application.
WARNING
The results given by the equipment should be examined with respect to the overall clinical
condition of the patient. And it can not substitute for regular checking.
Auto mode, manual mode, rhythm mode, USB print mode and off mode optional
LOGIN/PRINT/GENERAL/SYSTEM menu for parameters setting (Only for CARDIART 6208 View)
5
Built-in rechargeable Li battery with high capacity
Prompt information for lead off, lack of paper and low battery capacity etc.
Standard input/output interface and RS232 communication interface for linking to special network and
setting up ECG database
External output
External input
Potential equalization
Mains supply
On (mains supply)
Battery indicator
Recall key
Print/Stop key
ON/OFF key
Menu key
6
Left Arrow/ Right Arrow key
Recycle
Part Number
Serial Number
Date of Manufacture
EC REP
Authorized Representative in the European Community
7
Chapter 3
General Information
3.1 Top Panel
ECG
LCD Screen
Recorder
Control Panel
Product Information:
1) Trade Name
ECG
2) Classification Symbol
The LCD Screen has 2 specifications: 320×240 dot single color LCD Screen or 192×64 dot single color LCD
Screen.
8
ID: 210605- Female Age 30 AUTO 11:01:43
1812
60
RLF
C1 C2C3
C4 C5 C6
10mm/mV
25mm/s
AC ON
EMG OFF
current time and battery capacity(only when the built-in battery is used)
Electrodes and electrode status (Black background shows the status of Lead OFF)
Sensitivity (×2.5mm/mV, ×5mm/mV, ×10mm/mV, ×20mm/mV, AGC while in manual mode and
auto sensitivity symbol while in auto mode)
Normally, the contents displayed on the LCD screen include: (descript from left to right in row order)
First Row:
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Record mode(AUTO, MANUAL, RHYTHM, USBPRT or OFF)
Second Row:
Current lead (I,II,III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6)
Sensitivity (×2.5mm/mV, ×5mm/mV, ×10mm/mV, ×20mm/mV, AGC while in manual mode and
+auto sensitivity symbol while in auto mode)
Third Row:
ECG wave
1) Indicator Lamp
Mains supply indicator lamp: when mains supply is used, the lamp will be light.
Battery indicator lamp: when the built-in rechargeable Lithium battery is used, the
lamp will be light.
Battery recharging indicator lamp: when the battery is recharged, this lamp will
usually be light.
3) RECALL Key
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Press this key to review the patient files that saved in the recall window.
4) 1mV/COPY Key
Under manual mode, this key can be pressed to record a 1mV calibration pulse at any time while
recording.
Under auto mode, once the prompt information “COPY” appears in the prompt information field on
the LCD screen, this key can be pressed to recall the electrocardiogram that recorded last time.
5) MODE/RST Key
This key can be pressed to select record mode between AUTO mode, MANUAL mode RHYTHM mode,
USBPRT mode and OFF.
The switching order of lead groups in each mode is listed in Table 3-1.
Recording under the Manual mode, this key can be pressed to reset the waveform quickly.
WARNING :
When using the device with defibrillator, after the defibrillator discharge,
the MODE/RST key should be pressed to reset the waveform quickly.
Under manual mode, press the key to switch the lead. For 192×64 dot single color LCD screen
electrocardiograph, this key can be pressed to turn the pages in Recall window or Menu window.
7) PRINT/STOP Key
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Used to begin recording and stop recording.
8) ON/OFF Key
When the unit has been powered on, press this key to turn on it. Press again to turn off it.
9) MENU Key
Press the Up Arrow to select the items of main interface on the LCD screen counterclockwise while
press the Down Arrow to select the items of main interface on the LCD screen clockwise.
(hereinafter called Up/Down) During MENU setting, the two keys can also be pressed to select the
item of which the setting is to be changed.
Press these keys to change the content of the selected item. During MENU setting, these keys can
also be pressed to change the content of the selected item. (hereafter called Left/Right)
USB Interface
External Input/Output Socket
Patient Cable Socket
RS232 Socket
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1) Patient Cable Socket
1 C2 (input) 6 SH 11 F (input)
2 C3 (input) 7 NC 12 NC
3 C4 (input) 8 NC 13 C1(input)
4 C5 (input) 9 R (input) 14 NC
5 C6 (input) 10 L (input) 15 N or RF (input)
2) RS232 Socket
WARNING :
RS232 interface is 1500V AC isolated intensity and the maximum voltage applied should not exceed +15V
DC.
Definition of corresponding pins:
1 NC 4 SH 7 NC
2 RxD (input) 5 GND 8 NC
3 TxD (output) 6 NC 9 NC
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Pin Signal Pin Signal
1 GND 4 GND
2 GND 5 ECG Signal (input)
3 GND 6 ECG Signal (output)
4) USB Interface
WARNING
Only the USB equipments recommended by BPL can be connected to the USB interface.
1 VBUS 3 D+
2 D- 4 GND
WARNING :
Accessory equipment connected to the interfaces must be certified according to the respective IEC/
EN standards (e.g. IEC/EN60950 for data processing equipment and IEC/EN 60601-1 for medical
equipment). Furthermore all configurations shall comply with the valid version of the standard IEC/EN
60601-1-1. Therefore anybody, who connects additional equipment to the input or output connector
to configure a medical system, must make sure that it complies with the requirements of the valid
version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department
or your local distributor.
The summation of leakage current should never exceed leakage current limits while several other units
are used at the same time.
14
1) Potential Equalization Terminal
Potential equalization conductor provides a connection between the unit and the potential
equalization bus bar of the electrical installation.
3) Power Switch
: Switch on
: Switch off
Fuse Label
Label
1) Battery Compartment
The battery label indicates the rated voltage and rated capacity of rechargeable
Lithium battery pack. Rated voltage: 14.8V, Rated capacity: 2000mAh /2200mAh
/2400mAh.
Attention
general warning (see accompanying document)
WARNING :
Improper operation may cause the battery to be hot, ignited or exploded, and it may lead to the
decrease of battery’s capacity. Therefore, it is necessary to read the user manual carefully and pay more
attention to warning messages.
WARNING :
When leakage or foul smell found, stop using the battery immediately. If the leakage liquid gets to your
skin or cloth, cleanse it with clean water at once. If the leakage liquid gets into your eyes, do not wipe
them. Irrigate them with clean water first and go to see a doctor immediately.
WARNING :
Only qualified service engineer authorized by BPL can open the battery compartment and replace the
15
battery. And the battery of same model and specification provided by manufacturer must be used.
Mains supply with rated input voltage 230V (220V~240V) or 115V (100V~115V) can be chosen by the
shift switch according to local mains supply specification.
WARNING:
Only qualified installation or service engineer can shift the mains shift switch according to local mains
supply.
3) Fuse
There are two same fuses installed on the bottom of the main unit. The specification is showed on the
fuse label: AC220V-240V: T200mA; AC100V-115V: T400mA; 5×20.
WARNING :
Ruptured fused must only be replaced with the same type and rating as the original.
16
Chapter 4
Operation Preparations
CAUTION :
Before use, the equipment, patient cable and electrodes should be checked. Replace it if there is any
evident defectiveness or aging which may impair the safety or performance. And be sure that the
equipment is in proper working condition.
Power Supply
The electrocardiograph can be powered either by mains supply or the built-in rechargeable lithium
battery pack.
Mains supply
The mains connection socket is on the left of the unit. If mains supply used, connect the power cord to
the socket first, and then connect the plug of the cord to the hospital grade outlet.
Make sure the mains supply meets the above requirements before power on. And then press the
mains power switch to power on the unit. Then the mains supply indicator lamp ( ) will be lit.
If the built-in rechargeable battery is weak when mains supply used, it will be recharged automatically
at the same time. And both the mains supply indicator lamp ( ) and the battery recharging indicator
lamp ( ) will be lit.
While using the built-in rechargeable lithium battery pack, turn on the unit by pressing ON/OFF key on
control panel directly and the battery indicator lamp ( ) will be lit.
The battery symbol will be displayed on the LCD screen. Because of the consumption during storage
and transport, the capacity of battery may not be full. If the symbol and the prompt information
“BAT WEAK” are displayed, which means the battery capacity is weak, please recharge the battery first.
Please refer to the maintenance section for how to recharge the battery. During recharging the battery,
6208 VIEW can be powered by mains supply at the same time.
WARNING
Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the
17
electrical installation when necessary.
Note: When using folded thermal paper, the Paper Roller is unnecessary, and it can be taken out.
When there is no record paper loaded or it reaches the end of record paper, warning message “Paper?”
will be given on the screen. Under this circumstance, record paper should be loaded or replaced immediately.
Paper Tray
Casing
Paper Roller
1) Place fingers under the flange of the recorder casing, pull upwards directly to release the casing;
2) Take out the paper roller, and remove remain paper from the left of roller if necessary;
3) Take off the wrapper of thermal paper roll, and then put through the roller from the left with the
paper’s grid side facing downward;
4) Place the paper and roller gently in the recorder with the roller pin on the roller’s left side facing to
the groove;
5) Pull about 2cm of paper out, and put down the recorder casing;
1) Place fingers under the flange of the recorder casing, pull upwards directly to release the casing;
3) Take off the wrapper of folded thermal paper, and then put it in the Paper Tray with the paper’s grid
side facing the thermal print head while put the free end of paper upright;
4) Pull about 2cm of paper out, and put down the recorder casing;
Patient cable includes two parts, main cable and lead wires with associated connectors, which can be
distinguished from the color and identifier on the connectors.
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Main Cable
Lead Wires
Screw
Electrode Connectors
Connector
Plug the connector of main cable into the patient cable socket on the right side of the unit according to the
direction of arrow on the plug, and then secure it with two screws.
Suction Bulb
Limb Electrode:
Electrode
Reed
Clamp
The identifier and color code of electrodes used complies with IEC/EN requirements. In order to avoid incorrect
connections, the electrode identifier and color code is specified in Table 4-1. Moreover the equivalent code
according to American requirements is given in Table 4-1 too.
As the following figure shows, the chest electrodes’ position on body surface is
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C1: Fourth intercostals space at right border of sternum
C1
C4
C6
C2
C5
C3
The contacting resistance between the patient and the electrode will affect the quality of ECG greatly. In order to
get a high-quality ECG, the skin/electrode resistance must be minimized while connecting electrodes.
WARNING
Be sure that all electrodes have been connected to the patient correctly before operation.
WARNING
Be sure that the conductive parts of electrodes and associated connectors, including neutral
electrode, should not contact with earth or any other conducting objects.
2) Align all lead wires of patient cable to avoid twisting, and connect the associated electrode
connectors with corresponding electrodes according to the color and identifier;
4) Daub the round area of 25mm diameter on each electrode site with gel evenly;
5) Place a small mount of gel on the brim of chest electrode’s metal cup;
6) Place the electrode on chest electrode site and squeeze the suction bulb.
Unclench it and then the electrode is adsorbed on chest. Attach all chest electrodes in the same way.
2) Align lead wires of patient cable to avoid twisting, and connect the electrode connectors to
corresponding electrodes according to the color and identifier;
3) Clean electrode area on a short distance above the ankle or wrist with alcohol;
5) Place a small amount of gel on the metal part of limb electrode clamp;
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6) Connect the electrode to limb, and be sure that the metal part be placed on the electrode area
above the ankle or wrist. Attach all limb electrodes in the same way.
1) Environment:
Check and make sure that there is no electromagnetic interference source around the
equipment, especially large medical electrical equipment such as electrosurgical equipment,
radiological equipment and magnetic resonance imaging equipment etc. Switch off these
devices when necessary.
Keep the examination room warm to avoid muscle action voltages in ECG signal caused by cold.
2) Power Supply:
If mains power used, please check whether the power cord has been connected to the unit
well. And the grounded three-phase outlet should be used.
Recharge the battery first when the battery capacity is weak before use.
3) Patient Cable:
Check whether the patient cable has been connected to the unit firmly, and keep it far away
from the power cord.
4) Electrodes:
Check whether all electrodes have been connected to lead wires of patient cable correctly
according to the identifier and color.
Ensure that the chest electrodes haven’t contacted with each other.
5) Recorder Paper:
6) Patient:
The patient should not contact with conducting object such as earth, and metal part of bed etc.
WARNING
The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained. And they
should be familiar with the contents of this user manual before using.
21
Chapter 5
Operation Instructions
5.1 Switching On
While using main supply press the power switch on the left side of the unit first, and the
mains supply indicator lamp ( ) is lit. Then press ON/OFF key on the control panel to turn on the
unit. Equipment information such as device name, version No. will be displayed on LCD screen after
self-test. Then 6208 VIEW is ready for examination and recording.
While using built-in rechargeable lithium battery, press ON/OFF key on the control panel
directly to turn on the unit, and then the battery indicator ( ) is lit. After self-test, 6208 VIEW is ready
for examination and recording.
Operation Method:
1) Press MODE/RST key to choose AUTO mode, which will be displayed in the top right corner
on LCD screen;
2) Press MENU key to enter the Menu window to set the record settings. Press it again to return
after setup;
3) Press PRINT/STOP key to begin recording. It will stop automatically after recording a full 12 lead ECG.
Pressing PRINT/STOP again during the course of recording can stop recording. However, when begin recording
later, ECG will be recorded from the first lead group again. And ID number will change automatically according to
the current time. If the ID number needs to keep unchanged, the user should adjust it before recording.
Note:
Whether under auto or manual mode, recording mode can not be changed during the course of
recording. Stop recording before choose recording mode.
Operation Method:
1) Press MODE/RST key to choose MANUAL mode, which can be discerned by the identifier in
the top right corner of LCD screen;
2) Press MENU key to enter the Menu window to set the record settings. Press it again to return
after setup;
3) Press LEAD left arrow or right arrow key to select leads to be recorded;
22
4) Press PRINT/STOP key to begin recording;
5) 1mV/COPY key can be pressed to print out 1mV mark in the record while ECG recording;
LEAD left and right arrow key can be pressed to switch the lead group during the course of recording. Pressing
PRINT/STOP again during the course of recording can stop recording. However, when begin recording later, ID
number will change automatically according to the current time. If the ID number needs to keep unchanged, the
user should adjust it before recording.
1) Press MENU key to enter the Menu window to set the RHYTHM LEAD or other settings. Press
it again to return after setup;
3) Press PRINT/STOP key and the prompt information “Sampling” will be displayed in the
prompt information field, at the same time, response time will be counted. When the response time
reaches 60s, it begins to record;
Pressing PRINT/STOP again during the course of recording can stop recording.
2) Press MENU key to enter the Menu window to set corresponding options. Press it again to
return after setup;
4) Press PRINT/STOP key to begin recording. It will stop automatically after recording a full ECG
report.
0610051702
0610051718
Recall Window (a)
0610051725
0710051230
23
0610051702
Recall Window (b)
0610051718
0610051725
0710051230
ERROR
Please Select Auto Transfer Option
first! Press PRINT/STOP return
WARNING (a)
YES
Note: Before transmitting patient files, please set the AUTO TRANSFER option in Menu window. Refer to
5.8.3.6 Transfer Settings for detail.
3) If the user wants to delete all the files, press Up or Down to choose DEL ALL, and then press PRINT/STOP or
MENU key to pop up the WARNING(b). Then press RECALL to delete all the files or PRINT/STOP to cancel deleting;
WARNING
4) If the user wants to copy all the files from the electrocardiograph to the U disk, press Up or Down to choose
ALL to USB, and then press PRINT/STOP or MENU key to begin to copy; after a while, all the files will be copied
into the ECGDATA folder of the U disk automatically.
During the course of ALL to USB, if something wrong happens, the electrocardiograph will give the error infor
mation. And then the user should check whether the U disk is connected well, and correct it.
If the user wants to import files (The extended-name should be “.dat”) from the ECGDATA folder of the U disk
to the electrocardiograph, press Up or Down to choose USB to ECG, and then press PRINT/STOP or MENU key to
begin to import;
Note: To import files in U disk to electrocardiograph, there should be some files in the folder named ECGDATA in
the U disk. The folder name “ECGDATA” must be capital letters. And the user should not change the name of files
in the ECGDATA folder.
During the course of USB to ECG, if something wrong happens, the electrocardiograph will give the error informa-
tion. And then the user should do the following operations:
Firstly, check whether the U disk is connected well, and correct it.
If the error information is still displayed, the user should check whether some files exist in the ECGDATA folder
24
of the U disk. If nothing is found, the user should build a folder named ECGDATA in the U disk and put some files
(The extended-name is “.dat”) into the ECGDATA folder.
If the error information is still displayed, then the user should check whether the total number of files in the EC
GDATA folder of the U disk and in the recall window of the electrocardiograph has exceeded the limit (The limit of
6208 View is 120; The limit of 6208 View Plus is 144). If the total number has exceeded the limit, the user should
remove some files from the ECGDATA folder of the U disk and then continue to import.
If the error information is still displayed, then the user should check whether there are some files in the U disk
having the same name with the files in the electrocardiograph. If it is true, the user should remove these files
from the U disk, or delete these files in the electrocardiograph, and then continue to import.(Under this situation,
this error information is “The same file found! Press PRINT/STOP return”.)
After finishing importing files, the electrocardiograph will give a distinct indication.
Note: The process of TRANS ALL, ALL to USB or USB to ECG needs long time to be finished, and the user
should be patient to wait. During the course of copying, the U disk should not be pulled out.
Note: Only FAT format should be selected when formatting the U disk.
5) For one file, press Up, Down, Left or Right to choose one of the files in the recall window; Press PRINT/STOP or
MENU key, and five operation buttons will come up on the bottom of recall window. They are DELETE., TRANSMIT,
RECORD, TO USB and BACK (See Recall Window(b));
Press Up or Down to choose DELETE button, and then press PRINT/STOP or MENU key to pop up the WARNING(c).
Then press RECALL to delete this file or PRINT/STOP to cancel deleting;
WARNING
Press Up or Down to choose TRANSMIT button, and then press PRINT/STOP or MENU key to transmit the file; If
the “Auto Transfer” option is not selected before transmitting, WARNING (a) will pop up to remind the user to do it
first.
Press Up or Down to choose RECORD button, and then press PRINT/STOP or MENU key to begin recording; Press-
ing PRINT/STOP again during the course of recording can stop recording.
Note: Before recording, please set the RECORD options in RECORD settings window.
Note: If the user selects USBPRT mode to print, when PRINT/STOP key or MENU key is pressed, the elec
trocardiograph begins to analyze data, and after 8 seconds, the USB printer begins to print.
Note: MANUAL or RHYTHM mode can not support recall printing. If the user selects MANUAL or RHYTHM mode to
record, WARNING (d) will pop up.
ERROR
MANUAL or RHYTHM mode can not recall printing,
WARNING (d) Press PRINT/STOP return
YES
Press Up or Down to choose To USB, and then press PRINT/STOP or MENU key to begin to copy;
6) After finish recording, press Up or Down to choose BACK button, and then press PRINT/STOP or MENU
key to return to the recall window(a);
7) Press RECALL key to return to the main interface.
Note: To save the ECG data to the recall window as patient files, please refer to 5.8.3.5 Save Option Settings.
25
Note: After recording is finished, if RECORD FORMAT or SAMPLE MODE is changed, ECG Copy is not permitted.
DOCTOR :
ABCDEFGHIJKLM : Prev
NOPQRSTUVWXYZ
0123456789_- Next
DEL OK
AC Filter :On
EMG Filter : Off
DFT Filter :0.15Hz
Lowpass Filter : 100Hz
6208 View LCD Screen
5.7.2 Moving in the Sub-menus
Press Up or Down to choose the setting items;
5.7.3 Parameter Modification
Press Left or Right to modify a parameter;
Note: When modifying Record Mode or Sensitivity on the main interface, to save the modifications, the user
should enter the menu window and exit. After that, the user will see the modifications in the main interface when
he turns on the electrocardiograph again.
5.7.4 Switching between the Setup Windows (only for 6208 View Plus)
Press Up or Down to choose Prev or Next, and then press Left or Right to switch to the previous or next setup
window;
26
LOGIN RECORD GENERAL SYSTEM
DOCTOR :
ABCDEFGHIJKLM : Prev
NOPQRSTUVWXYZ
0123456789_- Next
DEL OK
Note: The patient information can not be set or changed during the course of recording.
ID : Patient ID No. HEIGHT<cm>: Patient Height (Range: 0~255)
NAME : Patient Name (Within 11 character) WEIGHT<kg>: Patient Weight
(Range: 0~255)
AGE : Patient Age (Range: 0~99)
BP<mmHg>: Patient Systaltic Pressure/Diastole Pressure
SEX : Patient Gender (Male/Female) HOSPITAL: Hospital Name
DOCTOR: Doctor Name
27
5.8.2.1 Lead Settings
LEAD SEQUENCE: Standard/Cabrera
Lead Sequence Lead group 1 Lead group 2 Lead group 3 Lead group 4
Standard I, II,III aVR, aVL, aVF V1, V2, V3 V4, V5, V6
Cabrera aVL, , -aVR II, aVF,III V1, V2, V3 V4, V5, V6
RHYTHM LEAD:
The rhythm lead can be one of 12 standard leads: , I, II,III , aVR, aVL, aVF, V1, V2, +V3, V4, V5, and V6.
RECORD SPEED
Under MANUAL/RHYTHM mode, RECORD SPEED can be set as 5, 6.25, 10, 12.5, 25 or 50mm/s.
Under AUTO/OFF/USBPRT mode, RECORD SPEED can be set as 25 or 50mm/s.
RECORD GRID
When RECORD GRID is On, the dashed grids which are 5 mm by 5 mm will be recorded on the paper.
When RECORD GRID is Off, dashed grids will not be recorded on the paper.
RECORD FORMAT
In Auto mode : 3CH, 3/2 CH, 3CH+1R, 1CH, 1CH+1R
In Manual mode : 3CH, 3/2 CH, 1CH
When RECORD FORMAT is 3Ch/3Ch, all leads will be recorded in 4 groups of 3.
28
When RECORD FORMAT is 3Ch/2Ch, lead I, II, III, aVR, aVL and aVF will be
recorded in 2 groups of 3, and lead V1, V2, V3, V4, V5 and V6 will be recorded in 3 groups of 2.
When RECORD FORMAT is 1Ch+1R, all leads will be recorded one by one in a
sequence, with one rhythm lead at the bottom of recoding paper.
When RECORD FORMAT is 1Ch, all leads will be recorded one by one in a sequence.
When RECORD FORMAT is 3Ch+1R, all leads will be recorded in 4 groups of 3, with one rhythm lead at the
bottom of recoding paper.
RR ANALYSIS
When RR ANALYSIS is On, RR Analysis results, including RR Interval
measurement information, RR Histogram and RR Trend Chart, will be recorded after
rhythm wave is recorded in RHYTHM mode.
When RR ANALYSIS is Off, there will be no RR Analysis results after rhythm
wave is recorded in RHYTHM mode.
AVERAGE TEMPLT
When AVERAGE TEMPLT is 2×6+1R/4×3, AVERAGE TEMPLT will be recorded with the format of 2×6+1R
or 4×3.
The format of 2×6+1R means that leads are averaged over the entire 10 second recording and recorded in 2
groups of 6, with the one rhythm lead at the bottom of page.
The format of 4×3 means that leads are averaged over the entire 10 second recording and recorded in 4 groups
of 3. When AVERAGE TEMPLT is Off, there will be no average template when recording.
5.8.2.4 Measurement and Interpretation
In MEASUREMENT function, those common parameters, such as Heart Rate, P-R interval, QRS complex
duration, Q-T interval, P/QRS/T axis, RV5/SV1 amplitude etc. can be automatically measured. The INTERPRETATION
function provides automatic diagnosis for hundreds of abnormal cases, such as Arrhythmia, AV Block, Ventricular
Conduction Block, Myocardial Infarction, Ventricular Hypertrophy and Atrial Enlargement, ST-T Abnormality and
Electrical Axes Deviation.
MEASUREMENT
When MEASUREMENT is On, the measure information will be recorded when recording in AUTO mode.
When MEASUREMENT is Off, there will be no measure information when recording.
INTERPRETATION (Optional)
When INTERPRETATION is On, interpretation information will be recorded when recording.
When INTERPRETATION is Off, there will be no interpretation information when recording.
Note: To get the content of MEASUREMENT and INTERPRETATION, please refer to Chapter 5.9 ECG Record.
29
No. Items Options
1 LEAD SEQUENCE Standard, Cabrera
2 RHYTHM LEAD I, II, , aVR, aVL, aVF, V1, V2, V3,
V4, V5, V6
3 SAMPLE MODE 1CH Sequential, 3CH Sequential,
12CH Simultaneous
4 RECORD LENGTH Short, Medium, Long, Longest
5 RECORD SPEED 25mm/s, 50mm/s, 5mm/s, 6.25mm/s,
10 mm/s, 12.5mm/s
6 RECORD GRID Off ,On
7 RECORD FORMAT 3Ch/3Ch, 3Ch/2Ch, 1Ch+1R, 1Ch,
3Ch+1R
8 RR ANALYSIS Off ,On
9 AVERAGE TEMPLATE 2×6+1R, Off, 4×3
10 MEASUREMENT Off ,On
11 INTERPRETATION(Optional) Off ,On
5.8.3 GENERAL Settings
AC FILTER :On
DFT FILTER :0.15Hz
EMG FILTER :Off
LOWPASS FILTER :150Hz
EXTERN INP/OUTP :Off
KEY BEEP :On
Prev
QRS BEEP :Off
REMOTE IP : 192.168.1 .245 Next
LOCAL IP : 192.168.1 .21
AUTO TRANSFER :Off
AC FILTER
AC FILTER suppresses AC interference without attenuating or distorting the ECG. Select On to turn on the function
and select Off to turn off.
DFT FILTER
DFT FILTER greatly reduces the baseline fluctuations without affecting the ECG signal. The purpose of this filter is
to keep the ECG signals on the baseline of the printout. The setting value is the low limit of the frequency range,
including 0.05Hz, 0.15Hz, 0.25Hz, 0.5Hz, and is normally set to 0.15Hz.
EMG FILTER
30
EMG FILTER suppresses disturbances caused by strong muscle tremor. The cutoff frequency is user defined at
25Hz, 35Hz or 45Hz. Select Off to turn off the function.
LOWPASS FILTER
LOWPASS FILTER restricts the bandwidth of input signal. The cutoff frequency is user defined at 150Hz, 100Hz
or 75Hz. All the input signals whose frequency is higher than the setting cutoff frequency will be attenuated.
External input/output signal interface is equipped in 6208 View/ 6208 View Plus, through which 6208 View/
6208 View Plus can receive ECG signal from external equipment, or output ECG signal to other external equip-
ment. Set this item as On to turn on the function and Off to turn off.
5.8.3.4 IP Settings
REMOTE IP
IP address of the remote computer which receives ECG data from electrocardiograph through net
LOCAL IP
IP address of electrocardiograph
When SAVE OPTION is On, the ECG data will be saved into the recall window automatically while it is being
recorded in AUTO recording mode.
When SAVE OPTION is Off, the ECG data will not be saved into the recall window while it is being recorded in
AUTO recording mode.
Note: When there is no space for more files to be stored in the recall window, the message ”MemFull” is
displayed.
Note: To transfer ECG data to PC machine, Smart ECG-Viewer software of BPL must be installed in PC machine.
Receive ECG Data window in the software should be opened up, transfer type should be selected, and
other settings should be finished.
AUTO TRANSFER
When AUTO TRANSFER is OFF, the patient files cannot be transferred;
31
When AUTO TRANSFER is UART AUTO, firstly connect the serial port of PC machine and the RS232 socket of
3-channel electrocardiograph with serial cable recommended by the manufacturer. Then open the Receive ECG
Data window of Smart ECG-Viewer software in PC, select the transfer type “Serial Trans”, set the right PortNum
and press Connect button. Under AUTO mode or OFF mode, ECG data can be transferred through UART port auto-
matically after ECG recording is finished.
When AUTO TRANSFER is Net AUTO, firstly connect the net interface of PC machine and the net interface of
3-channel electrocardiograph with Ethernet cable recommended by the manufacturer. Secondly open the Re-
ceive ECG Data window of Smart ECG-Viewer software in PC, select the transfer type “Net Trans” and press Con-
nect button. Then set the REMOTE IP and LOCAL IP in Menu window in 3-channel electrocardiograph. Under AUTO
mode or OFF mode, ECG data can be transferred through net automatically after ECG recording is finished.
Note: During the course of transferring or saving data, if the power supply is suddenly cut off, File System error
may arise in the electrocardiograph. After the error is displayed, the user should format the File System.
32
5.8.4.1 Display Mode Settings
Three display modes can be selected: 3CH, 6CH and 12CH. And the display interface shows as follows.
60
RLF
C1 C2 C3
C4 C5 C6
10mm/mv
25mm/s
AC ON
EMG OFF
3CH Display Mode
33
ID: 210605-1730 Female Age 30 60 11:01:43
34
5.8.5 Settings (6208 View)
Note: The common menu items of the two kinds of device have common functions. Please refer to the function
explanation of 6208 View Plus.
AC Filter :On
EMG Filter : Off
DFT Filter :0.15Hz
Lowpass Filter : 100Hz
6208 View LCD Screen
Press Up or Down to switch to the next setting interface and view the setting items. The setting items in the
menu of 6208 View are as follows:
35
32 ID Refer to Chapter 5.8.1
33 Password Password for entering the advanced
control interface
(a)
(b)
(c)
36
Figure (b) shows the AVERAGE TEMPLET when set the item as 2×6+1R in the Menu window.
Figure (c) shows the MEASUREMENT and INTERPRETATION when set the two items as ON in the Menu window. And
the items of the MEASUREMENT include:
ID, Name, Age, Sex, BP, Height, Weight, HR (Heart Rate)
P Dur----P wave duration: mean of duration of P-wave from several of 12 selected dominant beats;
PR int----P-R interval: mean of P-R interval from several of 12 selected dominant beats;
QRS Dur----QRS complex duration: mean of duration of QRS complexes from several of 12 selected dominant
beats;
QT/QTC int----Q-T interval: mean of Q-T interval from several of 12 selected dominant beats/Normalized QT inter-
val;
P/QRS/T axis----dominant direction of the average integrated ECG vectors;
RV5/SV1 amP---- The maximum of amplitude of R or R’ wave of one selected dominant beat from lead V5/ The
maximum of amplitude of S or S’ wave of one selected dominant beat from lead V1;
RV5+SV1 amP---- Sum of RV5 and SV1;
RV6/SV2 amP---- The maximum of amplitude of R or R’ wave of one selected dominant beat from lead V6/ The
maximum of amplitude of S or S’ wave of one selected dominant beat from lead V2;
The items of the INTERPRETATION include: Minnesota Code, Diagnosis Information and Report Confirmed by.
Note: Recording under AUTO mode or MANUAL mode, if the Sensitivity is set as 20mm/mV, only one calibration
mark will be displayed on the paper.
(a)
37
(b)
Figure (a) shows the following content:
10mm/mV (Sensitivity)
0.15~100Hz (Filter information)
AC50 (50Hz AC Filter)
60 (Heart rate)
Figure (b) shows RR Analysis Results, including RR Interval measurement information, RR Histogram and RR Trend
Chart.
RR Interval measurement information includes the following content:
Current Date & Current Time
Patient Information (ID, Name, Age, Sex, BP, Height, Weight)
Measure Time
Total R Num (Total R-wave number)
HR (Heart Rate)
RR Avg Interval (Average RR interval)
RR Max Interval (Maximum RR interval)
RR Min Interval (Minimum RR interval)
Max/Min (Ratio of Maximum RR interval to Minimum RR interval)
SDNN (Standard Deviation of Normal to Normal Intervals)
RMSSD (The Root Mean Square of Successive Difference)
38
As figure above shows, the USBPRT mode record includes:
ID, Record speed, Sensitivity, Date and time;
Name, Age, Sex, BP, Height, Weight;
Heart Rate, P duration, PR interval, QRS duration, QT/QTC interval, P/QRS/T axis,
RV5/SV1 amplitude, RV5+SV1 amplitude, RV6/SV2 amplitude;
Minnesota code;
Diagnosis information;
Unconfirmed Report, Review By;
ECG waveform of 12 leads;
39
5.12 Switch Off
When built-in battery pack used, press ON/OFF key directly to turn off the unit after finishing ECG record.
When mains supply used, press ON/OFF key first after finishing ECG record and then switch off the mains supply
by pressing the switch on the left side of the unit. Pull off the plug from the outlet last.
Note: When switching off the device, please operate it according to the sequence above strictly, or else there will
be something wrong on the screen.
40
Chapter 6
Prompt Information
Prompt information will be displayed in the bottom right corner of LCD screen when there is something wrong.
Prompt information provided by 6208 View/ 6208 View Plus and corresponding cause is listed in Table 6-1.
Table 6-1 Prompt Information and Causes
41
Chapter 7
Technical Specifications
42
Power Supply Mains Supply: Rated input voltage
=100V~115V/220V~240V
Rated frequency = 50/60Hz
Rated input power = 35VA
Built-in Lithium Rated voltage = 14.8V
Battery Pack: Rated capacity = 2000mAh /2200mAh
/2400mAh
When the capacity of battery is full,
6208 View/ 6208 View Plus can work
continuously at least 249 minutes.
Charge mode: Constant current/voltage
Charge current (standard) = 0.2C5A
(320mA)
Charge voltage (standard) = (17±0.1V)
Cycle life 300 times
Power Consumption: 35VA (max)
Fuse: T400mA250V Ø5×20/T200mA 250V
Ø5×20
Recording Recorder: Thermal dot-matrix printer
Record Paper: Folded thermal paper, 80mm width
Rolled thermal paper, 80mm width
Effective Width: 72mm
Paper Speed: 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s,
25mm/s, 50mm/s(±3%)
Accuracy of data: ±5% (x-axis), ±5%(y-axis)
HR Technique: Peak-peak detection
Recognition HR Range: 30 BPM ~300 BPM
Accuracy: ±1BPM
ECG Unit Leads: 12 standard leads
Acquisition Mode: simultaneously 12 leads
A/D Resolution: 12 bits
Time Constant: 3.2s
Frequency Response: 0.05Hz ~ 150Hz
Sensitivity: 2.5, 5, 10, 20 (mm/mV)
Input Impedance: 50MΩ(10Hz)
Input Circuit Current: 50nA
Input Voltage Range <±5 mVpp
Calibration Voltage: 1mV±3%
DC Offset Voltage: ±500mV
Noise: <12.5μ Vp-p
Multichannel crosstalk 0.5mm
Filter AC Filter: On/Off
DFT Filter: 0.05/0.15/0.25/0.5
EMG Filter: 25Hz/35Hz/45Hz/OFF
LOWPASS Filter:150Hz/100Hz/75Hz
CMRR 110dB
Sampling Frequency 1000Hz
43
Patient Leakage Current: <10μ A (220V~240V)
Patient Auxiliary Current: <0.1μ A (DC)
Dielectric Strength: 4000V rms
External Input 100kΩ; Sensitivity 10mm/V±5%;
Input/Output Single ended
(Optional)
44
Chapter 8
Clean, Care and Maintenance
8.1 Clean
CAUTION :
Turn off the power before cleaning and disinfection. Mains supply must be switch off if it has been in use.
8.1.1 Clean the Main Unit and Patient Cable
The surface of the main unit and patient cable can be wiped with a clean soft cloth damped in soapy water or
non-caustic neutral detergent. After that, remove detergent remainder with a clean dry cloth.
8.1.2 Clean the Electrodes
Remove the remainder gel from the electrodes with a clean soft cloth first. Take the suction bulb and mental cup
of chest electrodes apart, and take the clamp and the metal part of the limb electrodes apart. Clean them in warm
water and be sure there is no remainder gel. Dry the electrodes with a clean dry cloth or air dry naturally.
8.1.3 Clean the Print Head
Dirty and soiled thermal print head will deteriorate the record definition. So it should be cleaned at least once
a month regularly. Open the recorder casing and remove the paper. Wipe the print head gently with a clean soft
cloth damped in 75% alcohol. For stubborn stain, soak it with a little alcohol first and wipe it off with a clean soft
cloth. After air dried, load the record paper and shut the casing of the recorder.
CAUTION :
Prevent the detergent from seeping into the main unit while cleaning. Do not immerse the unit or patient cable
into liquid under any circumstances.
CAUTION : Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes.
8.2 Disinfection
To avoid permanent damage to the equipment, disinfection can be performed only when it has been considered
as necessary according to your hospital’s regulations. Before disinfection clean the equipment first. Then wipe the
surface of the unit and patient cable with hospital standard disinfectant.
CAUTION :
Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
45
the course of recharging, the symbol “ ” will flash in the top right corner of LCD screen. When the capacity of
battery is full, the symbol “ ” will stop flashing, and the battery recharge indicator lamp ( ) will usually be
black. But if 6208 View/ 6208 View Plus is power off, the lamp will still lit just because the equipment will not
monitor the recharge status; so you need to power on the device to verify the status.
Because of the capacity consumption during storage and transport, the capacity of battery is not full while using
at the first time. Battery recharge should be considered before first usage.
Note: If the battery has not been used for two or three months above, recharge should be done before use the
bat tery again.
3) Replacement
When the useful life of battery is over, or foul smell and leakage has been found, please contact with manufac-
turer or local distributor for replacement of battery.
WARNING :
Only qualified service engineer authorized by BPL can open the battery compartment and replace the
bat tery. And the battery of same model and specification provided by manufacturer must
be used.
Danger of explosion -- Do not reverse the anode and cathode when connecting the battery.
When the battery’s useful life is over, contact with the manufacturer or local distributor for disposal or
dispose the battery according to local regulations.
8.3.2 Record Paper
Note: Record paper provided by manufacturer should be used. Other paper may shorten thermal print head’s life.
And the deteriorated print head may lead to illegible ECG record and block the advance of paper etc.
Storage requirements:
Record paper should be stored in dry, dark and cool area, avoiding excessive temperature, humidity and
sunshine.
Do not put the paper under fluorescence for long time.
Be sure that there is no polyvinyl chloride or other chemicals in the storage environment, which will l
ead to color change of the paper.
Do not overlap the recorded paper long time, or else the ECG record may trans-print each other.
8.3.3 Maintenance of Main Unit, Patient Cable & Electrodes
The following safety checks should be performed at least every 24 months by a qualified person who has ad-
equate training, knowledge, and practical experience to perform these tests.
a) Inspect the equipment and accessories for mechanical and functional damage.
b) Inspect the safety relevant labels for legibility.
c) Inspect the fuse to verify compliance with rated current and breaking characteristics.
d) Verify the device functions properly as described in the instructions for use.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.2ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500uA, SFC 1000uA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10uA (CF).
h) Test the patient leakage current under single fault condition with mains voltage on the applied part ac
cording to IEC/EN 60601-1: Limit: 50uA (CF).
The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the de-
vice is not functioning properly or fails any of the above tests, the device has to be repaired.
WARNING : Failure on the part of the responsible individual hospital or institution employing the use of this
equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible
health hazards.
1) Main Unit
Avoid excessive temperature, sunshine, humidity and dirt.
Put on the dustproof coat after use and prevent from shaking violently when moving it to another place.
Prevent any liquid from seeping into the equipment, for it will affect the safety and performance of elec
trocardiograph.
46
2) Patient Cable
Integrity of patient cable, including main cable and lead wires, should be checked regularly. And be sure
that it is conductible.
Do not drag or twist the patient cable with excessive stress while using. Hold the connector plugs in
stead of the cable when connect or disconnect the patient cable.
Align the patient cable to avoid twisting, knotting or crooking in closed anglen while using.
Store the lead wires in bigger wheel to prevent any people from stumbling.
Once damage or aging of the cable patient has been found, replace it with a new one immediately.
3) Electrodes
Electrodes must be cleansed after use and be sure there is no remainder gel on them.
Keep the suction bulb of chest electrode from sunshine and excessive temperature.
After long-term use, the surface of electrodes will be oxidized because of erosion and other causes. By
this time, electrodes should be replaced to achieve high-quality ECG.
CAUTION :
The equipment and reusable accessories can be sent back to the manufacturer for recycling or proper disposal
after their useful lives.
47
Chapter 9
Accessories
WARNING: Only patient cable and other accessories supplied by BPL can be used. Or else, the performance
and electric shock protection can not be guaranteed.
Table 9-1 Accessories List
No. Accessory
1 Power cord
2 Patient cable
3 Precordial suction electrode
4 Limb electrodes
5 Paper roller
6 Thermal paper
7 ECG GEL
8 Battery
9 Fuse
10 User Guide
6208 View/ 6208 View Plus and accessories are available by contacting the manufacturer or your local distribu-
tor.
48
Chapter 10
EMC Information - Guidance and Manufacture’s Declaration
10.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS
49
Surge ±1 kV differential mode ±1 kV differential mode Mains power
quality should
IEC 61000-4-5 ±2 kV common mode ±2 kV common mode
be
that of a typical
commercial or
hospital environ-
ment.
Voltage dips, <5% UT <5% UT Mains power
quality should
short (>95% dip in UT) (>95% dip in UT)
be
interruptions and for 0.5 cycle for 0.5 cycle
that of a typical
voltage variations 40% UT 40% UT commercial or
on power supply (60% dip in UT) (60% dip in UT) hospital environ-
ment.
input lines for 5 cycles for 5 cycles
IEC 61000-4-11 70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3A/m 3A/m Power frequency
magnetic fields
(50Hz) magnetic
should be at lev-
field
els characteristic
IEC 61000-4-8
of a typical loca-
tion in a typical
commercial or
hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
50
10.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not LIFE-
SUPPORTING
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion 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 pre-
dicted 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
Electrocardiograph is used exceeds the applicable RF compliance level above, the Electrocardiograph should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Electrocardiograph.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
51
10.4 Recommended Separation Distances
52
WARRANTY CERTIFICATE
BPL Medical Technologies Private Limited., warrants to the purchaser
of the equipment that it is free from all defects in material and
workmanship. BPL provides One year warranty to the following
equipment as per BPL warranty policy given overleaf :
OWNER/EQUIPMENT DETAILS
IMPORTANT NOTE:
The warranty registration card is enclosed with this user manual. The warranty will
be strictly as per BPL warranty policy given overleaf. You are requested to fill up the
warranty registration card send it to the company address given below within one
month from the date of purchase. The service provider will assist you in filling up the
form and sending the card to us. This is to ensure that the service provider is in touch
with you. Hence, properly secure the user manual having warranty card.
97
BPL WARRANTY POLICY
BPL Medical Technologies Private Limited, (herein after called “BPL”), warrants that each equipment distributed
by BPL and sold by an authorised BPL dealer will be free, from any defects in material and workmanship at the time
of manufacture subject to the following conditions:
1. Qualification
To qualify for this warranty
a) The equipment must be purchased directly from BPL or an authorised dealer and serviced by BPL authorised
dealer/service center.
b) The warranty certificate given overleaf must be completed by the dealer or purchaser at the time of delivery of
the equipment (Read important Note overleaf).
2. Term
The term of the warranty shall be one year from the date of purchase to the first owner. The warranty will be valid
only on receipt of warranty registration cards by BPL within one month from the date of purchase.
4 . Extent of Warranty
This warranty is the entire written warranty given by BPL for BPL equipment and no dealer or his agent or employee
is authorized to alter any terms of this warranty and no dealer or his agent or employee is authorized to make any
oral warranty on BPL’s behalf.
BPL reserves the right to add any improvements or change of design of any model at any time with no obligation
to make the same changes on units previously sold.
5. Warranty Service
To obtain warranty service, the complete equipment with accessories must be presented at the owner’s expenses
to any authorized BPL service centre. However, field service can be availed of within the Municipal limits of towns
where BPL authorized service centres are situated.
7. Limitation
This warranty shall not apply :
a) To the accessoriews (they are warranted for only 3 months from the date of purchase).
b) To any defects caused by misuse, negligence or insufficient care.
c) To repairs or replacement required as a result of accidents or fluctuations in AC mains supply voltage.
d) If any equipment has been modified or altered by anyone other than BPL service center/ authorised dealer.
e) If any equipment has not been operated in accordance with the operating instructions.
f) If any equipment has been assembled, disassembled, adjusted or repaired by anyone other than an BPL Service
center/authorised dealer.
g) If damage or deterioration has been caused by insect droppings or rat bite.
h) To insignificant defects which do not affect the function of the instrument.
i) To body scratches or aesthetic defacing
98
BPL MEDICAL TECHNOLOGIES PVT. LTD.
INSTALLATION REPORT
CUSTOMER NAME & ADDRESS: Supplied by
(Dealer Name/Code)
Invoice /Bill No.
Date
Model Number Serial Number
INSPECTION REPORT:
PARAMETER REMARKS
AC Mains
L-N Voltage Volts
Volts
L-GND Voltage
Volts
N-GND Voltage
Stabilizer/any other
regulating device connected
Generator availability
Working condition of all the YES NO
functions
Accessories availability as YES NO
per list
Demonstration to customer YES NO
Tips on user maintenance to YES NO
the product
Details provided on after YES NO
sales service & consumables
availability
Engineer's remarks (if any)
Customer Remarks:
99
100
CUSTOMER SATISFACTION SURVEY
Model Date of
Purchase
Serial No.
1 APPEARANCE 10%
3 FEATURES 30%
4 DELIVERY 30%
Signature
1.
2.
101
104
CUSTOMER SATISFACTION SURVEY
Model Date of
Purchase
Serial No.
1 APPEARANCE 10%
3 FEATURES 30%
4 RELIABILITY 30%
Signature
1.
2.
103
106
CUSTOMER SATISFACTION SURVEY
Model Date of
Purchase
Serial No.
1 APPEARANCE 10%
3 FEATURES 30%
4 RELIABILITY 30%
Signature
1.
2.
105
106
WARRANTY REGISTRATION CARD - CUSTOMER COPY
MODEL NO:
MACHINE SL NO:
WARRANTY: NIL
PERIOD OF WARRANTY:
6 MONTHS
FROM:
12 MONTHS
TO:
OTHER
CRM ID:
SALUTATION: DR MR MS M/S
NAME OF PURCHASER:
ADDRESS:
Note: ONLY COMPLETELY FILLED FORMS WILL BE ELIGIBLE FOR WARRANTY CLAIMS
MODEL NO:
MACHINE SL NO:
WARRANTY: NIL
PERIOD OF WARRANTY:
6 MONTHS
FROM:
12 MONTHS
TO:
OTHER
CRM ID:
SALUTATION: DR MR MS M/S
NAME OF PURCHASER:
ADDRESS:
Note: ONLY COMPLETELY FILLED FORMS WILL BE ELIGIBLE FOR WARRANTY CLAIMS
107
108
SALES OFFICES
Ahmedabad : BPL Medical Technologies Pvt. Limited, 313, “ Samaan” Complex, 3rd Floor
Opp. Mansi Apt, Near Satellite Area, Ahmedabad - 380 015,
PH : 079 - 40031471
Bangalore : BPL Medical Technologies Pvt. Limited, 11th KM, Bannerghatta Road,
Arakere, Bangalore - 560 076, PH : 080-26484388 / 26484314 / 26484350
Bhopal : BPL Medical Technologies Pvt. Limited, 215, 2nd Floor, M.P.Nagar, Zone 1
Bhopal(M.P.) 462011, PH : 0755 - 4059311
Chandigarh : BPL Medical Technologies Pvt. Limited, Plot No: E-110, Industrial Area, Phase-VII,
SAS Nagar, Mohali-160055, Punjab, PH : 0172-4626572 / 4626573
Chennai : BPL Medical Technologies Pvt. Ltd, New No. 46/1, Old No. 151/1
“Archway Apartments”, Eldams Road, Teynampet, Chennai 600018,
PH : 044 -24333074
Cochin : BPL Medical Technologies Pvt. Limited, No. 35 - 261, Milma Dairy -
Methanam Road Koonamthai, Edapally North PO, Kochi-682 024,
PH : 0484-4014406/2558418
Hyderabad : BPL Medical Technologies Pvt. Limited, C/o. M/s. Crystal Marketing Corporation,
B-3, IDA Uppal, Uppal, Hyderabad – 500 039, PH : 040-27208855
Jaipur : BPL Medical Technologies Pvt. Limited, A-654 Ground floor, Royal Paradise,
Calgiri hospital road, Opp Malviya Nagar Police Station and Rungta Hospital,
Malviya Nagar, Jaipur- 302017, PH : 0141-2525933
Kolkata : BPL Medical Technologies Pvt. Limited, Shrachi Tower, 686 Anandapur, 6th Floor,
E. M. Bypass, Rubby Connector, Kolkata – 700107, PH : 033 - 23648951/ 23648952
Mumbai : BPL Medical Technologies Pvt. Limited, 207, INIZIO, Cardinal Gracious Road, Near Procter &
Gamble Plaza, Chakala Naka. Andheri (East), Mumbai: 400 099, PH: 022 - 61046000
New Delhi : BPL Medical Technologies Pvt. Limited, 304, Ashok Bhavan, 93, Nehru Place,
New Delhi - 110 019, PH : 011 - 30865001/ 30865005
Factory : BPL Medical Technologies Pvt. Limited, BPL Works, Kootupatha Junction,
Chandranagar P.O, Palakkad - 678 007, PH : 0491 - 2573100,
Tin No.32090277093
Visit us at : www.bplmedicaltechnologies.com
Contact Service Call Center on
Toll Free Number: 1800 - 425-2355
109
Our reach, quick response time
and easy availability of spares
and consumables make us more
accessible anywhere, anytime.
Always close to you
Toll Free: 1800-4252355
Head Office
Factory
0843
111
© 2014 BPL Medical Technologies Private Limited. All rights reserved. BPL Medical Technologies Private Limited reserves the right to make changes in product
features, specifications, aesthetics and/or to discontinue the same at any time without notice or obligation