Cardioline ar1200view Service Manual

4.7 (3)
Cardioline ar1200view Service Manual

AR1200VIEW

TECHNICAL SERVICE MANUAL

ELECTROCARDIOGRAPH MODEL

Cardioline® AR 1200 VIEW

P/N: 80509531 80509532

 

 

 

CARDIOLINE® is an et medical devices SpA brand

 

 

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AR1200VIEW

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AR1200VIEW

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AR1200VIEW

1 Introduction

ar1200 view combines reliability, modularity, versatility and capacity to be updated which characterise the latest generation of cardioline® electrocardiographs.

ar1200 view is a portable electrocardiograph with dual power supply, (mains and rechargeable internal batteries), which in the basic configuration will:

record an ECG exam in automatic or manual mode;

reproduce the ECG signal on 120 mm paper in 3-6 channel format thanks to the high resolution thermal printer;

storage of the most recent recording in automatic mode and print additional copies.

*In just a few minutes, your ar1200 view can be equipped with:

“memory option”: to store up to 40 full ECG exams, with no need to print out immediately on paper (“paper saving” mode);

"ECG measurements option": automatic ECG parameter measurement program;

"ECG signal interpretive option": a useful and dependable diagnostics support provided by the “HES” program;

"arrhythmia option": program enabling detection of arrhythmia events during continuous recording;

“HRV analysis option”: program enabling detection of variations in heart rate;

"L.E.M.S - PC archive option": to store the exam to archive on a Personal Computer running “L.E.M.S.” (Local ECG Management System) software;

"R.T.E. - PC-ECG option": for real time display of the twelve leads on your computer screen to allow management of patient medical records and archiving of exams in digital format using " R.T.E" (Real Time ECG) software. R.T.E has an optional "HES" module for automatic interpretation of the ECG signal.

*By updating the firmware. Contact your distributor for further details.

 

 

 

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AR1200VIEW

1.1Particular recommendations and warnings

This service manual is for the use of competent technical staff only.

Always use the equipment according to the instructions in this manual.

The device is equipped with a set of standard accessories. For reasons of safety, reliability and conformity with the Medical Devices Directive 93/42/EEC, use only original accessories or accessories approved by the manufacturer.

The device is equipped with a special long-life thermal head writing system, which allows maximum writing precision. To avoid frequent and costly replacements and repairs, always use the original paper or paper approved by the manufacturer. The manufacturer will not accept liability for any damage to the device or any other adverse effect caused by the use of unsuitable paper.

Do not subject the device to impact or excessive vibrations.

Do not allow liquids to penetrate inside the device. If this should accidentally occur, have the device tested by an Authorized Assistance Centre to verify its functional efficiency, before using it again.

Make sure that the value of the supply voltage corresponds to that indicated on the data plate of the device.

If you are using the device in connection with others, ensure that: all connections are made by skilled persons; all connections comply with safety regulations; all other devices connected respond likewise to regulations. Non-compliance with these regulations can cause physical harm to the patient connected and to the person operating the device. Should it be difficult to obtain the necessary information for assessing the risk of the individual connections, apply directly to the manufacturers concerned or avoid making the connections.

In the event of other equipment being connected directly or indirectly to the patient, check for the possible risks caused by the sum of the leakage currents on the body of the patient.

The device is protected against defibrillation discharges in accordance with IEC standard 601-1-25; to ensure that the signal is restored, use only original electrodes or electrodes responding to IEC and AAMI standards.

If an electrosurgical scalpel is in use, the patient cable should be disconnected from the device.

In any event, the greatest care should be taken when using defibrillators or high-frequency surgical devices at the same time as the ECG. If you have any doubts while using such devices, disconnect the patient from the electrocardiograph temporarily.

The device recognizes the impulses generated by a pacemaker and does not interfere with its operation, as prescribed by standards in use at the time of drafting this manual.

Avoid exposing the equipment to extreme temperatures, excessive dust or dirt, and very salty or damp environments; observe the ambient conditions described in detail under the "Technical specifications” heading.

Periodically check the efficiency of all accessories and of the device itself. Use the built in test function to perform an initial efficiency check. Contact the Authorized Assistance Centre whenever the device seems to be operating irregularly.

To prolong the life of your ar1200view, have it periodically checked at an Authorised Assistance Centre

Warning: do not use the device in the presence of anaesthetics or volatile gases!

Warning: the indications obtained using automatic interpreting programs or other diagnostic aids must be reviewed and countersigned by a qualified medical person!

Warning: the device is provided with an IR interface for the transfer of data to other devices. The IR interface must not be masked , even accidentally, as this will adversely affect its capability and its operation, interrupting and preventing the correct flow of data.

Warning: Environmental protection: When no longer in use the device must be disposed of according to local regulation, do not dispose as ordinary refuse.

The manufacturer will acknowledge liability for the safety, reliability and functional efficiency of the device only if:

modifications and repairs are performed by the manufacturer or by an Authorized Assistance Centre;

the a.c. mains power supply of the premises in which the device is used corresponds to current regulations;

the device is operated according to user instructions;

any accessories in use are those approved by the manufacturer.

 

 

 

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AR1200VIEW

2 Description of the device

The device consists of the following basic elements:

2.1Mother board

This is a “Fine line” multilayer printed circuit board for mounting SMD components.

It houses most of the electronic circuits of the device.

2.2Battery

Battery Pack made of 10 cells NiMH 12V.

2.3Display

Display assembly is composed of: frame, monochromatic LCD display 320 x 240 pixel (4,7 inch) as well as a step up converter.

2.4Keyboard

The keyboard card consists of the device functional keys and LED messaging devices.

2.5Printer unit

This consists of the thermal printer head support and the mechanical elements required to position it correctly.

2.6IR Module (RS232)

The function of the IR module is to transmit and receive data from an external PC.

2.7Motor assembly

The DC motor with gears for paper speed. Also included strobo disk for speed feedback.

 

 

 

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AR1200VIEW

3 Inputs and outputs

Direct connections from the ar2100 view to external equipment may only be made using the IR serial port, not by cable.

3.1Connection to the patient input port

 

 

 

 

 

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7

6

5

4

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2

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14

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Pin

1

=

IN

C2

(electrode C2)

 

 

 

 

 

 

Pin

2

=

IN

C3

(electrode C3)

 

 

 

 

 

 

Pin

3

=

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C4

(electrode C4)

 

 

 

 

 

 

Pin

4

=

IN

C5

(electrode C5)

 

 

 

 

 

 

Pin

5

=

IN

C6

(electrode C6)

 

 

 

 

 

 

Pin

6

=

AGND

 

(analogue ground)

 

 

 

 

 

 

Pin

7

=

NC

 

 

 

 

 

 

 

 

 

 

 

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8

=

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(digital ground)

 

 

 

 

 

 

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IN

R

(electrode R)

 

 

 

 

 

 

 

Pin

10 =

IN

L

(electrode L)

 

 

 

 

 

 

 

Pin

11 =

IN

F

(electrode F)

 

 

 

 

 

 

 

Pin

12 =

IN

C1

(electrode C1)

 

 

 

 

 

 

Pin

13 =

NC

 

(non connected)

 

 

 

 

 

 

Pin

14 =

IN

N

(electrode N)

 

 

 

 

 

 

 

Pin

15 =

NC

 

(non connected)

 

 

 

 

 

 

 

 

 

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AR1200VIEW

4 Testing the safety characteristics

The safety regulations envisage two important tests:

The leakage currents test measures the value of the currents lost in relation to the safety of the patient and the operator.

Warning: All safety tests must be performed according to standards EN.60601-1(1990 paragraphs 19 - 20) EN 60601-2-25 (1995) unless otherwise specified in the local safety regulations.

4.1Leakage currents test

Warning: This test must be performed every time the device has been opened for inspection and/or repair, and in any event every two years, unless otherwise specified by the local safety regulations.

Connect the electrocardiogram to the battery charger, and then connect this assembly to the measuring instrument according to the instrument’s manual, recalling that:

' The leakage current to the casing is measuring between the mains supply circuits and a metal sheet no greater than 20 x 10 cm pressed against the casing of the device.

' The leakage current in the patient is measured between the mains and the applied part. For connection to the applied part use the patient lead itself.

"' The leakage current in the patient with mains voltage directly on the applied part (first failure condition) is measured between the meta sheet connected to the device and the applied part.

' The auxiliary current in the patient is measured singly on each electrode (excluding the reference electrode) compared to all the other electrodes connected together.

Note: Make the measurements following the indications in the instrument user manual, and check that the leakage current values measured are less than or equal to those listed in table IV.

Table IV.

Admissible permanent values for leakage and auxiliary currents in the patient in mA (milliamperes).

 

 

 

 

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AR1200VIEW

5 Testing the main technical characteristics of the ecg

Warning: All tests must be performed in compliance with the provisions of the related general, detailed and performance safety regulations listed in the technical characteristics section

5.1Instruments necessary:

a)sample mV generator with the following characteristics:

b)low frequency sine wave generator;

c)ECG simulator.

5.2Sensitivity test

set the device up to record 6 channels on leads V1 to V6 with sensitivity of 20 mm/mV;

connect the patient cable to the device;

connect terminals C1 C6 of the patient cable connected to the device to the positive pin of instrument 5.1.a);connect all the other cable terminals to the negative pin of instrument 5.1 a);

record the signal for a few seconds;

check that the amplitude of the recorded signal is 20mm. +/- 5% on all channels.

5.3Testing the ECG leads

switch the device on;

connect the patient cable to the device;

connect the red termination of the patient cable to the positive pin of the instrument specified in point 5.a.a and the remaining wires to the negative pin.

start recording and check that the amplitude in mm of the signal, and its polarity (positive or negative) comply with the values indicated in table 5.3.

repeat the measurements in sequence with the remaining active terminations G - V - C1 - C2 - C3 - C4 - C5 - C6 of the patient cable using the method described in c), and check that the values correspond to those indicated in table 5.3.

 

 

 

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AR1200VIEW

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5.4Testing the paper feed rate

switch on the device and connect the patient cable;

connect terminals C1 C6 of the patient cable to the positive pin of instrument 5.1.a);

connect all the other cable terminals to the negative pin of instrument 5.1 a);

using the instrument with a square wave of 1 Hz and an amplitude of 1 mVpp;

record the signal on leads V1 V6;

measure the length of the wave cycle recorded on the paper.

The results should be as follows:

Period = 50 mm +/- 5% for a feed rate of 50 mm/s;

Period = 25 mm +/- 5% for a feed rate of 25 mm/s;

Period = 5 mm +/-10% for a feed rate of 5 mm/s;

5.5Frequency response test

switch on the device and connect the patient cable;

connect terminals C1 C6 of the patient cable to the positive pin of instrument 5.1.a);

connect all the other cable terminals to the negative pin of instrument 5.1 a);

set the sine wave generator to 10Hz with an amplitude of c. 1mVpp;

select leads V1 V6 and a sensitivity of 10 mm/mV.;

make a recording and adjust the amplitude of the generator so as to obtain a 10 mm excursion of the signal recorded;

vary the generator frequency from 0.5Hz to 100Hz with constant amplitude;

check that the frequency response is in accordance with the values in table 5.5.

 

 

 

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AR1200VIEW

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Note: The 0.5 Hz pitch linear phase anti-drift filter is always on and cannot be switched off.

The 50 or 60 Hz filter eliminates modified notch digital type mains disturbances in the linear phase, with a frequency response of 32 Hz - 3dB.

 

 

 

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AR1200VIEW

6 Functional blocks

6.1Mother board

The motherboard is based on the following principal components:

6.1.1Processor

32 bit Fujitsu MB91101 RISC microprocessor with 12 MHz clock

2 x 4 Mb static rams

2 x 8 Mb flash memories including the following software:

boot code;

operating system software;

applications software;

calibration data;

ECG archive.

Execution of static ram self test.

6.1.2Connection to mains

The equipment must be connected to a mains voltage 115 V~ or 230 V~ ± 10%, 5060 Hz . The mains voltage switch is located under the label (see table T1, rif. 5-6).

Changing mains voltage imply the replacement of the mentioned label. Only original ones can be used to assure proper electrical isolation.

In order to change mains voltage move the 3 jumper as illustrated in the picture below. Changing mains voltage does not require mains fuses rate modification.

#+ +* 5

Warning: Changing mains voltage imply the replacement of the mentioned label. Only original ones can be used to assure proper electrical isolation.

In order to change mains voltage move the 3 jumper as illustrated in the picture below.

The Manufacturer declines all responsibility for any damage caused as a result of tampering.

6.1.3Battery charger

The battery charger section consists of the following parts:

Adapter circuit, 230/115Vac, switched trough jumper on the equipment bottom, out 22 Vac, fuse protected, and PTC protection against overheating.

Mains filter against electromagnetic disturbances.

Rectification, voltage stabilisation and current limitation circuits.

Testing the battery charger circuit (see sheet 2 el diag)

If the mains on led does not light up, check using the following procedure:

Disconnect the mains cable;

Check the externally accessible mains fuses;

Disconnect the battery from the device as indicated in chapter 8.4;

 

 

 

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