CG-7000D.pdf 222KB

Device Classification
• The CG-7000D is internally-powered equipment
with applied parts of type BF, suitable for continuous operation.
• The device is not suitable for use in the presence
of a flammable anesthetic mixture with air or with oxygen or
with nitrous oxide.
• The CG-7000D has been proved to be compliant with
IEC-601-1-2 (Medical Electrical Equipment). However, this does
not preclude electromagnetic interference from other
equipment. In such a case, use the device as far as possible
from potential sources of interference.
Card Guard’s quality system conforms to ISO-9002 and
EN-46002.
U.S. Federal Law restricts the sale of this device other than by or on
the order of a physician.
0459

Table of Contents:
Introduction.....................................................................1
CG-7000D User’s Kit .....................................................2
Physical Features ..........................................................3
Using the CG-7000D .....................................................5
• Preparing the skin and placing the electrodes .......................5
• Insert Batteries........................................................................8
• Performing the test .................................................................9
• Reviewing the recording (optional) .......................................10
• Transmitting the ECG to the receiving station......................11
• Storing the CG-7000D ..........................................................12
Maintenance.................................................................13
• Battery maintenance.............................................................13
• Preventive maintenance .......................................................14
Troubleshooting ...........................................................15
Technical Specifications ..............................................16

Introduction
The CG-7000D is a Trans-Telephonic 12-Lead
Electrocardiogram (ECG) Transmitter, intended for diagnostic
evaluation of cardiac symptoms. This easy-to-use portable
device allows you to record a patient’s ECG waveform data,
and store it in memory for later transmission. To assess the
quality of the recorded data, you can view the ECG waveform
on the CG-7000D’s graphic display (not for diagnostic
purposes), one lead at a time. At your convenience, transmit
the data over the telephone to a remote receiving station for
analysis by a specialist.
Note: The CG-7000D is fully compatible with the Card Guard
Receiving Center equipment. The physician is
responsible for ascertaining the compatibility of the
device with other receiving equipment used.
1

CG-7000D User’s Kit
1. The CG-7000D unit
2. Patient’s Cable
3. User’s Guide
4. Battery (9 V Alkaline ) – optional
DISPLAY
ON/OFF
2

Physical Features
Parts:
1. CG-7000D Unit
2. Patient’s Cable (USA: C/G 321315 or
C/G 322602; Europe: C/G 321307
or C/G 322595)
3. Patient’s Cable Connector
(on the CG-7000D Unit)
4. Patient’s Cable Terminator
5. Display Screen
6. Speaker Outlet
7. Battery Compartment with cover
8. Disposable pregelled electrodes
biocompatible in accordance
with ISO 10993-1 (not supplied by
manufacturer)
Control Panel:
9. RECORD/PLAY pad
10. CLEAR MEMORY pad
11. LOW BATTERY indicator light
Display buttons
12. SCROLL FORWARDS button
13. SCROLL BACKWARDS button
14. ON/OFF button
3
13
14
3
DISPLAY
ON/OFF
1
5
12
6
7
LOW BAT
CLEAR
MEMORY
RECORD
PLAY
11
10
9
2
4

Symbols
Indicates that the button is used for data recording and
playback.
Indicates that the button is used for clearing the memory.
Indicates that the button is used for scrolling forwards.
Indicates that the button is used for scrolling backwards.
ON/OFF Indicates that the button is used for turning the LCD display
on/off
Indicates the Speaker Outlet.
Indicates that the device contains applied parts of type BF.
Indicates low voltage of the battery.
0459 CE conformity marking.
4

Using the CG-7000D
Preparing the skin and placing the electrodes
Before attaching the electrodes, it is important to prepare the patient’s
skin, to ensure obtaining a stable base line and high-quality ECG
signals.
To prepare the skin
• Apply ECG gel or water where the electrodes will be attached.
To place the electrodes
IMPORTANT:
• When in use, there should be no contact between the
device or cable and any metallic surface.
• Perform the following steps in the specified sequence!
5

1. Attach 10 disposable pregelled electrodes to the patient’s chest at
the standard locations.
The electrodes are labeled as follows:
Europe US
C1, C2,
C3, C4,
C5, C6
V1, V2,
V3, V4,
V5, V6
R RA
L LA
N RL
F LL
RA(R)
6
1
2 3 4 6
5
RL(N) LL(F)
Electrode 1: 4 th intercostal space – right of sternum
Electrode 2: 4 th intercostal space – left of sternum
Electrode 3: Halfway between electrodes 2 and 4
Electrode 4: Left midclavicular line in 5 th intercostal space
Electrode 5: left anterior axillary line in 5 th intercostal space
Electrode 6: left midaxillary line in 5 th intercostal space
LA(L)

2. Insert the
serrated silver ring at
the end of the
Patient’s Cable into
the Patient’s Cable
Connector, and
rotate it until it falls
into place.
3. Gently snap
the Patient’s Cable
into the Patient’s
Cable Connector (on
the CG7000D unit).
4. Attach the
lead wires to the
disposable
electrodes according
to the markings on
the Patient’s Cable
Terminator.
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Patient’s cable connector
Patient’s cable

Insert Batteries
Insert the battery by removing the battery compartment cover, lifting
out the battery connection from within the battery compartment and
firmly snapping the battery to its connector. Place the battery in the
battery compartment and close the battery compartment cover.
4 2
Note:
8
1
3
1) Battery compartment
2) Battery
3) Battery compartment
cover
4) Battery connector
Note:
Ensure the proper
connection of the battery
with regard to the polarity.
• To conserve the battery, the display shuts off automatically
after one minute of disuse. The display is reactivated by
pressing the Power Key.
Press the Power Key for at least one second to activate the device.
The Power Key is set to prevent accidental activation by contact of
less than one second.

Performing the test
Performing the test involves two stages – clearing the memory of
previous data, and actual recording.
Note: To record the ECG data you do not have to press the ON/OFF
button – this button controls the graphic display screen only.
ECG recording must be performed with the graphic
display OFF.
1. Press the CLEAR MEMORY pad and hold it down
for at least one second.
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CLEAR
MEMORY
• The CG-7000D emits a six-tone audio signal,
indicating that its memory is now clear and ready to record new
data.
Note: To prevent you from losing data by accidentally pressing the
CLEAR MEMORY pad, the memory is not cleared unless you
hold the pad down for at least one second.
2. Press the RECORD/PLAY pad to start the
recording.
• The CG-7000D emits a cycling audio signal while
it initializes (about 12 seconds).
x
RECORD
PLAY
• During the recording period that follows, the CG-7000D emits
recording sounds (about 15 seconds).
• The end of the recording sounds indicates that the recording is
done.
Note: If the LOW BATTERY indicator light comes ON
during the recording, stop the operation, replace
the battery, and start the recording from the
beginning.
LOW BAT
3. Disconnect the Patient’s Cable from the disposable electrodes.
4. Remove the electrodes from the patient’s body and dispose of
them.

Reviewing the recording (optional)
Reviewing the recording allows you to assess the quality of the ECG
trace, and to get a general impression of its form (not for diagnostic
puposes).
Note:
• The graphic display is not intended for measuring the ECG
waveform.
• It is recommended that the Patient Cable be disconnected
when you view the ECG.
To view the ECG trace
1. Press the ON/OFF button to turn ON the graphic display screen.
I Page-1
• The recording is displayed on the screen, one lead at a time.
For each lead, the recording consists of two pages. The lead
name and page appear at the bottom of the screen.
2. Use the SCROLL FORWARDS and SCROLL BACKWARDS
buttons to scroll through the ECG trace.
3. When you have finished examining the waveform, press the
ON/OFF button to turn OFF the graphic display.
10

Transmitting the ECG to the receiving station
After recording the ECG, you can transmit the data over the phone to
the Receiving Station for analysis by a specialist.
Note: Before transmission, make sure that the graphic display
is OFF. If you accidentally turn the graphic display ON during
transmission, turn it back OFF and re-transmit.
To transmit the data
1. Dial the Receiving Station.
2. Follow the instructions of the Receiving
Station operator.
3. When instructed to do so, place the
telephone mouthpiece firmly over the
speaker outlet at the front of the CG-
7000D.
Note: It is recommended that you place
both the CG-7000D and the
telephone on a desk during
transmission.
4. Press the RECORD/PLAY button to start the transmission.
• The CG-7000D emits a brief whining tone, followed by
transmission signals (about 30 seconds).
• The end of the transmission signals indicates that the
transmission is done.
5. When the transmission signals stop, resume the conversation with
the operator.
Note:
• After the transmission, the data remain stored in memory,
available for re-transmission, until the CLEAR MEMORY button
is pressed.
• If the LOW BATTERY indicator light comes ON during
transmission, complete the transmission and replace the
battery.
11

Storing the CG-7000D
When not in use, always store the CG-7000D and the Patient’s Cable
in the pouch.
To re-pack the CG-7000D
1. Pull back the serrated silver ring at the end of the Patient’s Cable,
and gently pull the Patient’s Cable out of the Patient’s Cable
Connector.
2. Return the CG-7000D and Patient’s Cable to the pouch.
12

Maintenance
Battery maintenance
Battery
• Use only a 9V Alkaline battery.
• Check the battery at least once a month by pressing the
RECORD/PLAY button. If the LOW BATTERY light comes ON
(and stays ON), replace the battery immediately.
• If the CG-7000D is not likely to be used for 3 months, remove
the battery.
• Dispose of used batteries at designated battery-disposal
locations only.
! CAUTION:
• If the LOW BATTERY light comes ON while you record an ECG
trace, complete the test, transmit the data, and replace the
battery.
• Data stored in the memory are lost when the battery is
replaced, —start the procedure once more from the beginning..
13

Preventive maintenance
Perform the following preventive maintenance tasks monthly to ensure
that the CG-7000D continue to perform at maximum capacity, and to
reduce the possibility of a failure.
Mechanical inspection of the CG-7000D
• Check the lead wires for splits or cracks. If you have any
questions or doubts, contact your service provider.
Cleaning the CG-7000D
• Wipe the outside surface of the CG-7000D and the snaps at the
ends of the lead wires with an alcohol-soaked pad (95%).
Caution:
• Do not allow any liquid to enter the CG-7000D casing, and
avoid pouring water or other liquid onto the CG-7000D while
cleaning (IPX0 equipment).
• Never use abrasive materials such as wire wool or metal polish.
• During cleaning, make sure you do not expose the CG-7000D
to temperatures in excess of 45°C.
14

Troubleshooting
Problem Possible Causes Solutions
No sound is
heard when the
RECORD/PLAY
or CLEAR
MEMORY
buttons are
pressed.
When the
RECORD/PLAY
or CLEAR
MEMORY
buttons are
pressed, the CG-
7000D keeps
repeating the
same audio
signal over and
over.
The battery is very low. Replace the battery.
The CG-7000D has gone
into a loop and needs
resetting.
Problems detected by the Receiving Station:
The base line is
unstable.
The ECG signal
is very noisy.
No data is
received at the
Receiving
Station.
• The resistance of the
electrode contacts is high.
• The skin is not prepared
properly.
• There is a communications
problem.
• The CG-7000D may be
damaged.
NOTE: If the problem persists, call the service provider.
15
Take the batteries out to
stop the CG-7000D. Put
the battery back in, and try
again.
Repeat the skin
preparation procedure.
Repeat the skin
preparation procedure.
Repeat the test and
transmission procedure.

Technical Specifications
Parameter Value
Input impedance 100 Mohm
Input current (max) 0.2 μA
CMRR 60 dB
Input dynamic range 5 mV p-p
Band width 0.05 - 100 Hz
Carrier frequency 1700 Hz
Frequency deviation 100 Hz/mV
A-to-D sampling rate 500 samples/sec
Resolution 8 bit
Display:
View area 49×49 mm
Number of dots 128×128
Dot size 0.32×0.32 mm
Operating temperature 0 to +45°C
Storing temperature -20 to +65°C
Relative humidity 5 to 95%
Dimensions 160×80×40 mm
Weight 450 gr
Current consumption (max) 70 mA
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