Cardioline AR600 ADV, ar600 Service Manual

AR600

AR600 ADV

TECHNICAL SERVICE MANUAL

ELECTROCARDIOGRAPH MODELS

Cardioline® AR 600

P/N: 80409501

P/N: 80409502

Cardioline® AR 600 ADV

P/N: 80409511

P/N: 80409512

			CARDIOLINE® is an et medical devices SpA brand
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					AR600
					AR600 ADV
Index
	Introduction and special notes				pag. 4
	Programming for the installer				pag. 4
	Serial number				pag. 6
	Aim of the manual				pag. 6
	Reference standards				pag. 7
	Special notes				pag. 7
1.	Technical characteristics				pag. 8
2.	Description of the equipment				pag. 10
2.1	Casing				pag. 10
2.2	Battery				pag. 10
2.3	Mother board				pag. 10
2.4	Keyboard				pag. 11
2.5	Mark sensor board				pag. 11
2.6	Printer mechanical assembly complete with thermal head				pag. 11
2.7	Paper transport mechanical assembly				pag. 11
2.8	Battery charger				pag. 11
3.	Inputs and outputs				pag. 13
3.1	Connection to the patient input socket				pag. 13
4.	Checking the safety characteristics				pag. 14
4.1	Necessary instruments				pag. 14
4.2	Testing the applied voltage				pag. 14
4.3	Testing the leakage currents				pag. 15
5.	Checking the main technical features of the electrocardiograph				pag. 17
5.1	Necessary instruments				pag. 17
5.2	Checking sensitivity				pag. 17
5.3	Testing the ECG leads				pag. 17
5.4	Checking the paper transport speed				pag. 18
5.5	Checking the frequency response				pag. 18
5.6	Checking the battery charging system				pag. 19
5.7	Self-test to check the printer				pag. 19
6.	Identifying faulty circuits and analysis of the principal malfunctions				pag. 20
6.1	Foreword				pag. 20
6.2	Aim pag. 20
6.3	The equipment does not switch on				pag. 21
6.4	Illustration of the supply voltages				pag. 23
6.5	Malfunctions during printing				pag. 25
6.6	Malfunctions caused by faulty paper transport				pag. 27
6.7	Malfunctions during page set-up and sensing the presence of paper				pag. 29
6.8	Acquisition of the Ecg signal faulty or absent				pag. 31
6.9	The equipment does not accept the keyboard commands correctly				pag. 32
6.10		Led and/or display fault			pag. 33
7.	How to disassembly and reassembly the equipment				pag. 34
7.1	Introduction				pag. 34
7.2	Opening and closing the equipment				pag. 34
7.3	Removing the motherboard				pag. 34
7.4	Removing the battery				pag. 35
7.5	Removing the keyboard board				pag. 35
7.6	Removing the paper transport motor assembly				pag. 35
7.7	Removing the printer assembly				pag. 35
7.8	Removing the mark sensor board				pag. 36
7.9	Removing the paper compartment door				pag. 36
7.10 Removing and replacing the keyboard plate					pag. 36
7.11		Charging the batteries			pag. 37
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		AR600
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8.	Calibrations	pag. 38
8.1	General information	pag. 38
8.2	ECG AR 600	pag. 38
8.3 ECG AR 600 ADV		pag. 39
9.	General maintenance instructions	pag. 41
9.1	Introduction	pag. 41
9.2	Principal messages	pag. 41
9.3	Inspection frequency	pag. 41
9.4	Cleaning the thermal head	pag. 42
10.	List of spare parts	pag. 44
10.1 General information		pag. 44
	APPENDIX A
	Procedures for handling and storing	pag. 46
	electronic components sensitive to electrostatic discharge (ESD)
	Illustrated tables and figures	pag. 48

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INTRODUCTION AND SPECIAL NOTES

This equipment, produced in two models without and with display, is a portable electrocardiograph with up to 3 print channels, with internal battery pack rechargeable with a specific class two battery charger.

The patient input is CF type protected against defibrillation discharges.

This equipment is used with the patient cables not protected against defibrillation supplied by the manufacturer. The recording may be made using heat-sensitive grid paper in a Z-fold pack or roll.

The equipment has an IR infrared serial interface with the following functions:

Model AR 600 (without display) for:

∙Loading the single-language software ( contact et medical devices for available languages).

∙Enabling the setup options such as:

-implementation of the number of print channels;

-program for main electrocardiographic parameters measurement ;

-PC archive function;

-PC ECG function.

Model AR 600 ADV for:

∙Loading the single-language software ( contact et medical devices for available languages).

∙Enabling the setup options such as:

-program for main electrocardiographic parameters measurement ;

-program for diagnostic interpretation of the electrocardiogram;

-PC archive function;

-PC ECG function;

-program for monitoring arrhythmia and/or ST.

PROGRAMMING FOR THE INSTALLER

The equipment is supplied with the firmware in the language requested and the requested options enabled.

Subsequent enabling of the setup options is carried out according to the procedures contemplated and requested et medical devices. Programming of the equipment in user mode is carried out according to the indications given in the user manual in the section “configuration of the electrocardiograph”.

Starting of the serial installation of the software is activated within 12 seconds of selecting the command in the “update firmware” service menu.

Ecg AR 600

The service menu is enabled by setting service mode and then pressing the filter, amplitude and speed keys in sequence and activating printing, then select and confirm “update firmware”.

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Ecg AR 600 ADV

The service menu is managed on the display.

With the “select” key and the “arrows” key, activate and confirm the menus:

! " #$ % & ' !"(

"%#$% # %& )** ' " #"%+ & '+#$# & %' %$,+ % #-% % # . % # #$/

1.Language of the print messages;

2.Options supported.

Any Customer who wants to update the firmware of his equipment must communicate the following information to et medical devices spa

1.Part Number;

2.Serial Number;

3.Language;

4.Options requested;

Et Medical Devices will then prepare a package containing:

1.A customized firmware binary file for that particular equipment according to the Customer's requests;

2.A special Applications Software (Loader) to be installed on a PC for managing the updating procedure;

3.Operating Instructions;

4.If necessary, an interface device RS 232 – IR.

The updating procedure performs data transfer through the IR interface between the equipment and a PC according to a proprietary protocol and, once activated, it is completely clear to the user.

NOTE:

Since the updating phase must never be interrupted for any reason, it is recommended to perform it always with the batteries fully charged or with the equipment connected to the mains.

At the end of update procedure (indicated by a message on the screen), the equipment restart according to the new configuration.

If the firmware update procedure is not properly ended (indicated by an error message on the screen), the malfunction is almost certainly due to communication problems. The correct relative positioning between the two IR devices must therefore be checked, bringing them as close together as possible; eliminate any possible sources of interference (fluorescent lights) and try programming again.

Depending on the stage of the updating procedure at which the interruption occurred, the following cases may be considered:

-the Flash memory containing the firmware has not yet been modified: the equipment switches off and switches on again exactly as it was before the programming phase.

-part of the Flash memory has been modified: the equipment switches off and switches on again, but, recognizing that it no longer has a valid code, it automatically prepares for the programming procedure, attempting to connect via IR with the PC. After a few attempts it switches off, but it is still possible to try programming again, switching it back on.

In this case, after programming, the speeds and the mark must be calibrated.

SERIAL NUMBER

"# " + '$ %$# # % % %' %& # , # " 0.(

The label is divided into three parts:
1	- The top part shows the data concerning the dealer.
2	- The center part shows:
	The model (MOD)	________	the year of manufacture	________
	The code number (REF)	________	the attention triangle	________
	The serial number (SN)	________	CE 470 marking	________
3	- The bottom part shows:

the identification data of the Manufacturer ________

The code number of the model attributed by the Manufacturer ________

NOTE:

Always use the serial number and the code of the equipment in any communications with the Dealer or with the Assistance Service.

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CE 0470 marking

The mark of conformity CE 0470 shown on the name label of the device, applied on the bottom of the casing, certifies the conformity of the device with the essential requirements prescribed in enclosure I of the Directive 93/42/EEC, assimilated in Italy with the Decree Law No. 46 of 24 February 1997. The number 0470, shown alongside the CE mark, corresponds to the number of the Notified Body responsible for the application of the procedures contemplated in enclosure V of the Directive 93/42/ EEC. (In the specific case the Notified Body is NEMKO)

AIM OF THE MANUAL

The aim of this manual is as follows:

a)to give a functional description of the unit;

b)to give a description of the procedures necessary to perform a complete test of the equipment;

c)to give a description of the procedures necessary to perform the safety tests according to the IEC safety standards;

d)to identify and isolate faulty functional blocks;

e)to describe the maintenance jobs necessary for correct and lasting operation of the equipment;

f)to supply the list of spare parts.

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REFERENCE STANDARDS

The safety characteristics of the medical electrical class equipment comply with the standards:

#$%% 1 #" #$#$&% #& %& '$ #" '

# &'$%% # &'$%%( # &' )$%%(

#$%%) 1 #" #$#$&% #& %&

'$ #" ' (

# ($%%( #"# #& #$#$&% "%#$% # *& ( &$ #"# #& #$#$#$#"%$#$# #"

&% '#%& " # " #$' " # " "%#$% # (

SPECIAL NOTES

a)Remember that correct and efficient maintenance of the equipment and its accessories, following the instructions in this manual, ensures a long and safe working life of the equipment and its accessories.

b)Remember that this service manual is intended only for competent technical personnel.

c)Remember that all the instrumentation described or indicated in this service manual is necessary for correctly performing tests and calibrations, and for checking the safety features of the equipment.

d)Remember that, whenever the equipment is opened for inspection or for servicing, a complete check of the safety characteristics must be made, as described in chapter 4, before it is returned to the user.

e)Remember that this equipment has been designed using CMOS technology.

Most of the electrical components belong to the family of ELECTROSTATIC SENSITIVE DEVICES (ESD). It is therefore necessary to follow particular working procedures.

The particular procedures required when dealing with electrostatic sensitive devices (E.S.D.) are listed in appendix A.

The manufacturer declines all responsibility for any damage sustained by the equipment, caused by an inadequate or inexistent working procedure necessary when dealing with E.S.D. devices.

NOTE:

The transport of the equipment in a non original package or packed in an incorrect way, relieves the manufacturer of all responsibility for damage sustained by the equipment and accessories and renders the guarantee void .

f)This technical assistance manual has been prepared by et medical devices SpA, via De Zinis n. 6 - Cavareno (TN) Italia, which reserves all rights to modify it without notice and all copyright rights.

g)Read the whole contents of this manual before starting the assistance service.

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1. TECHNICAL CHARACTERISTICS
Mains power supply	Device with power supply specified class II (second) REF
	type: 6308.
Maximum absorption	100 mA	at 117 V~ ± 10%
	50 mA	at 230 V~ ± 10%
Mains power supply protection	Fuse: T 0.5 A
Internal electrical source	Set of rechargeable NiMH batteries
	8 x 1.2 Vdc 1500 mAh
Battery protection	PolySwitch 1.5 A - 40 °C in ambient conditions
Internal power supply protection	Pico fuse SHF SLO-BLO T 2 A Littelfuse
Applied part	CF type
Protection against defibrillation	Internal
Input dynamics	± 300 mV @ 0 Hz.
	± 5 mV in the bandwidth
Input impedance	> 100 Mohm on each electrode
Common mode rejection	> 90 dB
Frequency response	0.5 to 150 Hz (-3dB) with anti-drift filter
Time constant	3.3 seconds
Acquisition	11 bits
	1000
	0500 samples/sec/channel in calculation and filters
	Resolution 5μ V/bit
Leads	12 STANDARD leads
	12 CABRERA leads (AR 600 ADV)
	acquired 8
	reconstructed 4 (III - aVR - aVL - aVF)
Signal memory	10 seconds for each lead in auto isochronous
Sensitivity of recording:
manual	5 – 10 – 20 mm/mV ± 5%
automatic	depends on the number of channels being printed
	2.5 – 5 – 10 – 20 mm/mV ± 5%
Writing system	Thermal printer, 8 dots/mm
	Usable print height 50 mm
Print channels	1 – 2 – 3
Paper transport speed	25 - 50 mm/s ± 5%
Heat-sensitive paper	Dot Card® in rolls : height 60 mm, length 15 m, gridded
	Dot Card® pack of Z-Fold : length 20 m, page 70x60 mm,
	gridded
Filters	Mains disturbances:
	Digital filter notch modified 50 – 60 Hz with 32Hz -3db
	response to linear phase – switch on/switch off filter
	Anti drift:
	Digital filter 0.5Hz high pass with linear phase, always
	enabled and cannot be switched off
Serial interface	Infrared
Keyboard AR 600	Membrane type with 9 function and number with 13 LED
	function indicators

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	AR600 ADV
Keyboard AR 600 ADV	Membrane type with 11 function keys, 10 alphanumeric keys
	and 1 LED function indicator
Display AR 600 ADV	graphic LCD 120x32 dots, rear-lit
Interpretation program	Interpretation ECG HES (AR 600 ADV):
(optional)	Developed by the Medizinische Hochschule Hannover
	Calculate parameters:
	Developed at the Institute of Clinical Physiology (National
	Research Council), Pisa - Italy
Operating modes	Manual: real time acquisition
	Automatic: isochronous
Autonomy	Internal set of batteries:
	3 hours in 1 channel mode
	10 mm/mV
	25 mm/sec.
	10 Hz p.v.
Recharging time	Internal set of batteries: 14 hours 100%
Degree of protection of the casing	IP20
Ambient conditions:	Ambient temperature: from +10°C to +40°C
Operation
	Relative humidity: from 25% to 95% (without condensation)
	Atmospheric pressure: from 700 hPa to 1060 hPa
Transport and storage	Ambient temperature: from -10°C to +40°C
	Relative humidity: from 10% to 95% (without condensation)
	Atmospheric pressure: from 500 hPa to 1060 hPa
Dimensions	250 x 60 x 185 mm (length x height x depth)
Weight	1000 grams with batteries, without paper
Conformity to standards	EN 60601-1: 1990
	EN 60601-1/A1: 1992
	EN 60601-1/A2: 1995
	EN 60601-1/A13: 1995
	General standards for safety of electromedical equipment
	EN 60601-1-2: 1993
	Standards on electromagnetic compatibility of medical
	equipment.
	EN 60601-2-25: 1995
	Particular safety standards for electrocardiographs
	*& ( &$
	#"# #& #$#$#$#"%$
	#$ # #" &% '# %& " # " #$ ' "
	# " "%#$% # (

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2. DESCRIPTION OF THE EQUIPMENT

All the internal parts of the equipment must be considered an applied part.

The equipment is composed of the following main elements:

-casing complete with paper compartment door, battery compartment door, keyboard plate and screen printing;

-set of 8 NiMH batteries, 9.6 Volt;

-principal electronic board referred to below as the “mother board”;

-keyboard board;

-mark sensor board;

-printer mechanical assembly complete with thermal head;

-paper transport mechanical assembly;

-battery charging assembly outside the equipment.

2.1 CASING

The casing is made of polycarbonate Lexan 940 color RAL 7035.

2.2 BATTERY

Set of NiMH batteries with the following characteristics:

-the set of batteries is protected against short circuits by a 1.5 A poly switch with self reset;

-voltage 9.6 Vdc;

-capacity 1500 mAh;

-type supplied by the manufacturer of the equipment.

NOTE ON SAFETY

The battery may be replaced only with the type supplied as a spare by the manufacturer.

2.3 MOTHER BOARD

This is a multilayer printed circuit board (four layers) in “fine-line” technology for mounting SMD (Surface Mounting Devices) components.

It houses most of the equipment's electronic circuits. It may be subdivided into the following sections according to the electric block diagram with file name: TOP_LEVEL (I series) and 60_COMPL_II SERIE.

2.3.1 Section on battery charging

The section on battery charging is composed of two parts:

∙an external part with a mains adapter AC/AC, 230/14.5 Vac or 115/14.5 Vac, protected by a fuse for short circuits and by PTC against overheating;

∙a part inside the equipment fed with 14.5 Vac composed of the following circuits:

-rectifying, filtering and current limiting circuits.

These circuits do not allow operation of the equipment with the batteries run down or absent.

2.3.2 Section on the power supply to internal circuits

It is composed of the following power supplies:

∙+5 V generated by a linear voltage regulator which feeds the control logic;

∙± 5 VI – VL for supplying power to the patient input analog circuits on the hybrid circuit;

∙+ 3.3 V generated by a linear regulator for supplying power to the analog/digital converter built into the microprocessor;

∙+ 3 V reference voltage for the A/D converter.

∙VTPH voltage obtained from the battery for feeding the thermal head. This voltage is limited in current to 2 A (± 0.2 A) and stabilized in voltage at + 7.5 V (± 0.5 V).

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2.4 KEYBOARD

AR 600

2% # 3 #$04 #$ &% %''# % + '% %%$$ #$#" " (

AR 600 ADV

Contains 21 keys, 1 LED, 1 rear-lit liquid crystal display, graphic type, and the circuits for communication with the microprocessor by dedicated serial line.

2.5 MARK SENSOR BOARD

2% # % + $ %& "#'# &% # %'## (

2.6 PRINTER MECHANICAL ASSEMBLY COMPLETE WITH THERMAL HEAD

2%' %$%& ## % '#" #$#$%& '##" " '# &% %

% % %& #$(

The complete assembly is supplied as a spare part.

2.7 PAPER TRANSPORT MECHANICAL ASSEMBLY

Composed of the transport motor complete with support and gears.

The complete assembly is supplied as a spare part.

2.8 BATTERY CHARGER

The accessory defined as a battery charger is an AC/AC mains adapter, class II (second class), 230V~/14.4V~ or 115V~/14.5V~ which guarantees the insulation of the electrocardiograph with respect to the mains and feeds its battery charging circuit.

IMPORTANT SAFETY WARNINGS

The battery charger is a specific accessory that complements the electrocardiograph with the particular function of ensuring the electrical insulation of the patient and the operator with respect to the mains, when connected.

For this reason, as well as guaranteeing the operation of the equipment, it has an essential safety function.

Other similar accessories MUST NOT be used; the manufacturer declines all responsibility for damage due to tampering. The battery charger is a class II power supply and does not require ground connection of the electrical system

PRECAUTIONS FOR USE

∙The battery charger can be damaged if dropped, struck or tampered with.

∙Do not immerse in water or other liquids;

∙When using it, do not place it on or near sources of heat.

∙Do not damage the cables for connection to the mains and to the electrocardiograph

∙Do not use or connect the electrocardiograph differently from the specifications.

∙Use the battery charger only at the specified mains voltage.

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3. INPUTS AND OUTPUTS

AR 600 – AR 600 ADV do not allow direct connections by cable to external equipments, but only with the use of IR infrared serial connection.

3.1 CONNECTION TO THE PATIENT INPUT SOCKET (table T1)

8

7

6

5

4

3

2

1

15

14

13

12

11

10

9

Socket seen from the connection side

Pin

1

=

IN

C2

(electrode C2)

Pin

2

=

IN

C3

(electrode C3)

Pin

3

=

IN

C4

(electrode C4)

Pin

4

=

IN

C5

(electrode C5)

Pin

5

=

IN

C6

(electrode C6)

Pin

6

=

AGND

(analog ground)

Pin

7

=

PAT5_10

(patient cable recognition line 5 – 10 electrodes)

Pin

8

=

DGND

(digital ground)

Pin

9

=

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

(not connected)

Pin 14

=

IN

N

(electrode N)

Pin 15

=

NC

(not connected)

The inputs have the following characteristics:

a)Sensitivity 1 mV/ 5 - 10 - 20 mm. depending on the sensitivity selected and 1 mV/2.5 mm with automatic sensitivity;

b)Input impedance greater than 100 MOhm each electrode;

c)Input dynamics +/- 300 mV at 0 Hz.

+/- 5 mV in the bandwidth; d) The inputs are protected against defibrillation

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4. CHECKING THE SAFETY CHARACTERISTICS

The safety standard requires two important tests:

a)The applied voltage test:

checks the efficiency of the insulation of the feeding circuits and of the circuits for connections with the patient.

b)Testing of the leakage currents:

measures the value of the leakage currents with relation to patient and operator safety.

c)The equipment examined is composed of an external battery charger which can remain connected to the electrocardiograph connected to the patient.

The insulation of the battery charger, between the mains supply and the socket for connection to the electrocardiograph, is ensured in class II (second class).

The electrocardiograph is type CF.

NOTE:

All the safety tests must be carried out according to standards EN 60601-1 (1990 paragraphs 19 - 20) EN 60601-2-25 (1995).

4.1 NECESSARY INSTRUMENTS

a)Instrument for testing dielectric rigidity:

Manufacturer R/B model "UH28 M" Elektrotechn. Laboratorium D - 7015 Korntal Germany or equivalent;

b)Instrument for measuring leakage currents:

model “AMPLAID ST 10“ - Division Amplifon S.p.A. Italy, or model METRON QA 80” Electrical Safety Analyser, or

model “BIO-TEK 601-PRO” Division Amplisim srl - Italy or equivalents.

4.2 TESTING THE APPLIED VOLTAGE

The test must be performed in a suitable room complying with safety standards using the instrument 4.1 a).

4.2.1 Testing the equipment connected to the battery charger

a)Apply the test voltage between all the pins of the patient connector and the pins of the mains plug of the battery charger connected to the electrocardiograph, see table T3.

b)Test procedure:

(class II electrocardiograph (second class).

Apply a test voltage of 2 KVac for 10 seconds, then raise it to 4 KVac and keep it at this value for 1 minute. Then decrease it gradually within 10 seconds.

c)Apply the test voltage between all the pins of the patient connector and a metal sheet with maximum

dimensions 20x10 cm, pressed against the casing of the equipment, which is shifted in such a way as to control all the parts of the outer surface of the casing.

Test procedure : (type CF electrocardiograph).

Apply a test voltage of 0.750 KVac for 10 seconds, then raise it to 1.5 KVac and keep it at this value for 1 minute. Then decrease it gradually within 10 seconds.

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AR600 AR600 ADV

4.2.2 WARNINGS

Check that no superficial or destructive discharges are noted during the test.

Slight discharges due to a corona effect may be overlooked, as long as they stop when the voltage is temporarily lowered to a lower value, which must however remain higher than the reference voltage U (250V), on condition that the discharges do not cause drops in the test voltage.

Battery charger

The battery charger is impregnated on the inside with polyurethane resin, so it is not repairable.

So the test of dielectric rigidity between the applied part of the ECG and the mains must not be repeated, unless in the case of particular requirements.

Electrocardiograph

Performing the test between the applied part and the metal sheet in contact with the equipment is advised in the case of repairs.

4.3 TESTING THE LEAKAGE CURRENTS

THIS TEST MUST BE PERFORMED AFTER EACH OPENING FOR INSPECTION AND/OR REPAIR USING THE INSTRUMENT 4.1 b AND IN ANY CASE EVERY TWO YEARS.

Proceed as follows:

4.3.1Connect the electrocardiograph connected to the battery charger to the measuring instrument following the instructions in the user

manual of the instrument, remembering that:

a)The leakage current towards the casing is measured between the mains power supply circuits and a metal sheet with dimensions no larger than 20 x 10 cm. which must be pressed against the casing of the equipment and of the battery charger together, see Fig. 18.

b)The leakage current to the patient is measured between the mains and the applied part, see Fig. 20. For the connection with the applied part, use the same patient cable.

c)The leakage current to the patient with mains voltage directly on the applied part (first fault condition) is measured between the metal sheet connected to the equipment and to the battery charger together and the applied part, see Fig. 21.

d)The auxiliary current to the patient is measured individually on each electrode (except the black one) with respect to all the other electrodes connected together, see Fig. 26.

4.3.2Set the measuring instrument according to the type (CF) and the class II (second) of the electrocardiograph.

4.3.3Take the measurement following the indications in the user manual of the instrument and check that the values of the leakage currents measured are less than or equal to those given in table IV.

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Table IV

Permanent admissible values of the leakage currents and of the auxiliary currents to the patient in mA (milliamperes).

Current pathway	CF type
	N.C.(+)	S.F.C.(++)
Leakage current to casing	0.1	0.5
Leakage current to patient	0.01	0.05
Leakage current to patient with	-----	0.05
(mains voltage in the applied part)
Auxiliary current to patient	0.01	0.05
(+) N.C. = Normal condition
(++) S.F.C. = First fault condition
NOTE:
For the measuring system and the figures mentioned, refer to the standards:
EN 60601-1: (1990) and EN 60601-2-25: (1995) paragraph 19.

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