Marquette Cardiosmart Service Manual

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CardioSmart/CardioSmart ST

Servicing Instructions

Version 1.2 and 1.3

227 435 11 SA(e) Revision D

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Caution:

During repairs/service interventions, observe the protective measures against damage due to ESD.

* Marquette Hellige GmbH considers itself

responsible for the effects on safety, reliability , and performance of the equipment, only if:

- assembly operations, extensions, readjustments, modifications, or repairs are carried out by Marquette Hellige GmbH or by persons authorized by Marquette Hellige GmbH,

- the electrical installation of the relevant room complies with the applicable national and local requirements, and

- the instrument is used in accordance with the instructions for use.

* This manual contains service informati-

on; operating instructions are provided in the user manual of the instrument.

* This manual is in conformity with the

instrument at printing date.

* All rights are reserved for instruments,

circuits, techniques, and names appearing in the manual.

Marquette Hellige GmbH

Printed in Germany

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Marquette Hellige GmbH CardioSmart/CardioSmart ST V 1.2/ V 1.3

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227 435 11 D

Contents

1. Device .................................................................. 6

1.1 Block circuit diagram of entire instrument .................................... 9

1.2 Mechanical Components ................................................. 10

2. Functional description ...................................................... 11

2.1 PCB Power Supply_CS .................................................. 11

2.1.1 Switch on/off circuit ............................................... 11

2.1.2 Charging circuit for NC Battery ...................................... 11

2.1.3 Device behavoir depending on the state of battery charge ................... 12

2.2 PCB Control CS_S ..................................................... 13

2.2.1 Generation of the logic power supply +5V .............................. 13

2.2.2 ECG recording and front-end processing ............................... 13

2.2.3 Controller core .................................................. 14

2.2.4 Real-time clock.................................................. 14

2.2.5 Memory ....................................................... 14

2.2.6 Printhead control ................................................ 15

2.2.7 Motor controller ................................................. 15

2.2.8 RS-232 interface ................................................ 16

2.2.9 Keypad interface ................................................ 16

2.3 PCB Graphics Display_CS ............................................... 17

2.3.1 Power supply ................................................... 17

2.3.2 Background illumination ........................................... 17

2.3.3 Contrast control ................................................. 17

2.4 Internal interfaces ...................................................... 18

2.4.1 Mechanical interfaces ............................................. 18

2.4.2 Electronic interfaces .............................................. 19

2.4.2.1 Interface Character Display ........................................ 19

2.4.2.2 Interface Graphics Display .................................... 21

2.4.2.3 Interface PCB Power Supply_CS ............................... 21

2.4.2.4 Option interfaces .......................................... 23

2.5 Interfaces to peripherals ................................................. 24

2.5.1 Electronic interfaces .............................................. 25

2.5.1.1 RS-232 interface .......................................... 26

2.5.1.2 Patient input .............................................. 27

2.6 Limitations .......................................................... 27

3. System test functions ...................................................... 30

3.1 System test functions with graphics display .................................... 30

3.1.1. General information .............................................. 30

3.1.2 Test start ..................................................... 30

3.1.3 Display test (1) ................................................. 31

3.1.4 Key test (2) ................................................... 32

3.1.5 Motor test (3) .................................................. 32

3.1.6 Test results (4) ................................................. 33

3.1.7 Self-test ................................................ 34

3.1.8 Recording test (5) .............................................. 34

3.1.9 Interface test (6) ................................................ 35

3.1.10 Time and date (7) .............................................. 36

3.1.11 Electrode test (8) ............................................... 37

3.1.12 Test time constants (9) ......................................... 38

3.1.13 Setting the Device model (V) ..................................... 38

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3.1.14 Switching over the program for Interpretation (C) ...................... 40

3.2 Device test functions with character display ................................... 42

3.2.1 General information ............................................. 42

3.2.2 Test start..................................................... 42

3.2.3 Display test (1) ................................................ 42

3.2.4 Key test (2) .................................................. 43

3.2.5 Motor test (3) ................................................. 43

3.2.6 Test results (4) ................................................. 44

3.2.7 Self-test ..................................................... 45

3.2.8 Recording test (5) ............................................. 45

3.2.9 Interface test (6) ............................................... 46

3.2.10 Time and date (7) ............................................... 47

3.2.11 Electrode test (8) ............................................... 48

3.2.12 Test time constants (9) .......................................... 49

3.2.13 Setting the Device model (V) ..................................... 49

3.2.14 Switching over the program for Interpretation (C) ...................... 51

4. Repair instructions......................................................... 52

4.1. Safety instructions ..................................................... 52

4.2 Replacing components .................................................. 52

5. T r oubleshooting tips ....................................................... 56

6. Adjustment instructions ..................................................... 59

7. S e rvicing a nd ma inte na nce .................................................. 61

7.1 Technical inspection .................................................... 61

7.1.1 Visual check ...................................................... 61

7.1.2 Test functions ..................................................... 62

7.1.2.1 Recommended testing instruments and accessories ...................... 62

7.1.2.2 Test preparations ............................................... 62

7.1.2.3 Operating and display unit performance tests ........................... 62

7.1.2.4 Test for recording speeds 25 and 50 mm/s ........................... 63

7.1.2.5 Device test result check .......................................... 63

7.1.2.6 RS232 interface test............................................. 63

7.1.2.7 Analysis of the ECG signals and HR value ............................ 63

7.1.2.8 Pacemaker identification test....................................... 64

7.1.2.9 Identification of disconnected electrodes .............................. 65

7.1.2.10 Checking the charge status of the NC battery ......................... 65

7.1.2.11 Pump leakage ................................................ 65

7.1.3 Safety Analysis Tests ............................................... 66

7.1.3.1 General information ............................................. 66

7.1.3.2 Protective Earth Resistance Test.................................... 66

7.1.3.3 Measurement of Leakage Current ................................... 66

7.1.3.3.1 Enclosure Leakage Current Test ................................ 67

7.1.3.3.2 Patient Leakage Current Test .................................. 68

7.2 Maintenance, cleaning, disinfection .......................................... 69

8. Parts Lists .............................................................. 70

9. Specifications ............................................................ 73

9.1 Specifications CardioSmart ............................................... 73

9.2 Specifications CardioSmart ST............................................. 79

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10. Device documents ........................................................ 85

Annexe .................................................................. 86

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Re vision H istory

V 1.0 May 1995 Initial Release V 1.1 March 1996 Update 1 V 1.2 February 1997 Update 2 V 1.2/1.3 August 1997 Update 3

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1. D e vice de scription

This Service Manual for device versions V 1.2 and V1.3 describes both CardioSmart and CardioSmart ST. Unless indicated s pecifically, the description applies t o both CardioSmart and CardioSmart ST.

The device version V1.3 hardware components are identic al to those of device version V1.2. The new combinations of these component s in V1.3 result in new models, socalled regional models. Differences between device v ersions V1.2 and V1.3 are indicated clearly in the relevant sections .

The CardioSmart is a portable electrocardiograph with an int egrated printing unit. It is used to acquire, record and process ECG signals. It is designed for line-power and battery operation. O peration without a battery is not possible. Power supply unit and battery are integrated into the instrument.

CardioSmart ST has an additional ergometry mode opt ion with its own ergometry keypad.

The patient cable for the acquisition of E CG signals is connected by means of a 15pin connector as used in earlier ECG recorders. This means that the patient cables used in the past can still be used.

Stored patient data and ECGs can be transmitted to a PC via an RS-232 int erface. This requires a CardioProm version with additional patient dat a memory.

CardioSmart and CardioSmart ST are both bas ed on the same hardware platform V1.2 or V1.3 and represent diff erent types of the basic unit 101 116 x x.

With device version V1.2, the following models are available:

101 116 01 CardioSmart international 230V 101 116 02 CardioSmart US Version 115V 101 116 03 CardioSmart Russian 230V 101 116 04 CardioSmart international 230V wit h integrated pump 101 116 05 CardioSmart Russian 230V with integrat ed pump

101 116 10 CardioSmart ST international 230V 101 116 11 CardioSmart ST international 230V with integrated pump 101 116 12 CardioSmart ST US V ersion 115V 101 116 13 CardioSmart ST US V ersion 115V with integrated pump

With device version V1.3, the following models are additionaly available:

101 116 06 CardioSmart EUROPE 2 230V 101 116 07 CardioSmart EUROPE 2 230V with integrated pump

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101 116 14 CardioSmart ST Russian 230V 101 116 15 CardioSmart ST Russian 230V with integrated pump 101 116 16 CardioSmart ST EUROPE 2 230V 101 116 17 CardioSmart ST EUROPE 2 230V with integrated pump 101 116 18 CardioSmart ST A SIA 115V/230V 101 116 19 CardioSmart ST AS IA 115V/230V with int egrated pump

The CardioSmart entire instrument comprises t he following components:

Ca rdioS ma rt Ba sic I nstrume nt, wit hout display and CardioProm

C ardioP rom S t orage M odule , there are several modules wit h different features,

with or without ECG storage facility

CardioVision Display, there are 2 different dis plays available:

- CardioVision Text, LCD module 2-line

- CardioVision Graphics, graphics LCD

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The CardioSmart ST entire instrument c omprises the following components:

CardioSmart ST Basic Instrument, without display and CardioProm

C ardioP rom S T S t orage M odule , there are several modules wit h different

features, with or without ECG storage facilit y

C ardioV ision G ra phics, graphics LCD

CardioSmart ST is not enabled for CardioVis ion Text

This concept permits the user to conf igure an instrument himself to meet his own application specifications. It is also possible to upgrade the basic version.

The hardware comprises the following functional blocks:

- P CB Control CS_S (basic instrument)

- P ower supply unit with battery (basic instrument)

- Keypad (basic instrument)

- P rinting unit (basic instrument)

- P CB Energy Storage_CS (storage module)

- D isplay (character or graphics display)

The following functional blocks are constructed directly as PCBs:

- P CB Control_CS

- P CB Energy Storage_CS

- P CB Power Supply_CS with battery charging circuit

- P CB Graphics Display_CS

The applications, functions and operation of the CardioSmart are described in the

User’s Manual.

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1. 1 Block circuit diagra m of e ntire instrume nt

Config. Clock, RS232 Memory buffered Driver LCD

Keypad ECG Interf. Acquisit. Controller and Core LCD Condit- Display ioning Interf. (optional)

Motor Contr.

Internal Thermal RAM Printhead Generation Controller Motor + 5V

Printhead Line Filt.

Fuse

Generat. Voltage + 24V Selector EPROM RAM (Opt)

Battery Charge

Battery

PCB Control_CS

Power Supply Unit

Keypad

Character Displ.

Graphics Display

Graphics Controller

Printing Unit

CardioProm

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1 . 2 M ec hanica l C ompone nts

The main mechanical components comprise the uppe r a nd lowe r she ll of the

Ca rdioS ma rt Ba sic I nstrume nt. The lower shell serves as a basic unit to receive t he

following assemblies:

- M ains input module with instrument On/Off switch

- P CB Power Supply_CS

- Battery

- T hermal printing unit

- P aper container

- P CB Control_CS

The upper shell accommodates the keypad, which is connected to the PCB Control_CS via a 22-pin connector. The display (c haracter or graphics display) is also integrated into the upper shell.

CardioProm (program module) also has its own housing, comprising an upper

The and lower assembly section. It cont ains the PCB Energy Storage_CS , which is connected to the PCB Control_CS via a multipoint connector when inserted into the CardioProm slot.

The two available lower shell. The graphics display contains the graphic s LC display itself, as well as the

associated control electronics, it can be swivelled within the range from 0° to 45° with 5 lock-in positions. The character display only contains the character LCD and cannot be swivelled. The two displays can be connec ted to the PCB Control_ CS by insert ion into the depression in the upper shell of the basic instrument provided with a female multipoint connector.

The 15-pin input connector to

RS-232 interface are located directly on the PCB Control_CS.

the Models 101 116 04/05 have an added integrated suction pump, comprising the pump

module 303 442 91 and the PCB Pump 388 029 18.

displays are als o located in a housing, comprising an upper and

connect the pa tie nt ca ble and the 9-pin connect or for

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2 . F unctiona l descr iption

The block circuit diagra m of t he entire instrument in S e ction 1 . 1 and the functional

blocks of the P - pla ns

2 . 1 P C B P owe r S upply_ C S

The PCB Power Supply provides the f ollowing functions:

- S econdary clock-rated power supply unit to generat e the fundamental device voltage UVERS

- D evice switch on/off circuit

- Charging c ircuit for NC battery

- B attery almost empty identificat ion

- B attery empty instrument swit ch-off

2.1.1 Switch on/off circuit

describe the individual functional blocks.

The device on/off switch (momentary toggle switch) supplies the starting puls e. The actual stop signal comes from the P CB Control_CS via the DOFF cable.

In the line-power operating mode CardioSmart can be switc hed off by:

- D evice on/off switch

- P rocessor (DOFF)

In the battery operating mode CardioSmart can be s witched off by:

- D evice on/off switch

- P rocessor (DOFF)

- B attery empty identification

In the line-power operating mode recording can be switched off by:

- B attery empty identification

2. 1 . 2 C harging circuit for NC Ba tte ry

A charging IC is used to charge the batt ery. During charging it monitors the battery voltage function and switches ov er from rapid charging to trickle charging in conformity with the charging current.

The charging circuit is activated by applying the power supply voltage or battery. If a recording is made whilst the device is in t he operating mode the charging circuit is deactivated.

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2. 1 . 3 D e vice be ha voir de pe nding on the sta te of ba tte ry cha rge As a ge ne ra l rule the following a pplie s:

No applied line-power voltage:

Operation of the device without a batt ery is not possible

Applied line-power voltage, battery is charged:

Device completely operational

Applied line-power voltage, battery

depleted:

Device is only partially operational (everything ex cept recording)

Battery charging is triggered by:

Application of line-power voltage Switching off a current recording, manually with the Stop key or automatically when the cutoff volt age has been attained

D evice be ha voir:

State 1 Battery depleted, power supply system is connected up:

Battery charged in accelerated mode; when full, switchover to conservation charging, no time limit

State 2 Battery full, power supply system is connected up:

Battery charged in accelerated mode; when full, switchover to conservation charging, no time limit

State 3 Batt ery depleted, no line-power supply, device is swit ched on:

Device inoperative

State 4 Batt ery full, no line-power supply, device is swit ched on:

Device fully operative, when battery almos t empty message appears LEDBAT signal activat ed, when battery empty message appears the device becomes inoperative

State 5 Battery depleted, power system supply is connected, charging begins,

device is switched on: All functions except recording, as long as the battery cannot supply the printhead with sufficient power.

State 6 Battery full, power supply system is connected, device switched on:

Device fully operative. During recording charging is int errupted, at stop recharging begins until the charging IC switches to conservation charging.

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2.2 PCB Control CS_S

2. 2 . 1 G e ne ra tion of the logic powe r supply + 5 V

The logic power supply +5V is generated directly on t he PCB Control_CS. The stabilized voltage UVERS, which is generated by the PC B Power Supply_CS, serves as the input voltage.

The +5V power supply is generated by the clock -rated

"a djusta ble ve rsion" of the controller is us ed in order to be able to use it later for

The applications requiring other voltages, the output voltage is determined by appropriate dimensioning of the voltage divider at the feedbac k input of the voltage controller.

2. 2 . 2 E C G re cording a nd front- e nd proce ssing

The main element of this operational unit is a se t of chips comprising 4 AS I C s located on the PCB.

The patient lead is connected with a 1 5 - pin conne ctor. Overvoltage arresters at the electrode inputs provide high-voltage protecti on. A hybrid chip acts as a microfuse f or each electrode, it serves to identif y a disconnected electrode.

The patient input is classified as cardiac floating and is defibrillation-proof. Each electrode input is preamplified after t he hybrid chip with a low-noise operational

amplifier with a small input voltage, before it is fed into the two ASICs with t he sigmadelta resistors.

The filter time constants can be adjus ted by the controller core by a command. 8 time constants are available for selection (system test).

voltage controlle r.

N common-mode compensation ensures suppression of int erference, at the same time serving to improve the in-phase suppression of t he input electrodes.

To protect patients the ECG recorder and conditioning processor are assembled as floating components. Digital signals f rom and to the controller core are transmitted via optoelectronic couplers, the float ing power supply +/-5V is generated by a flyback converter from the logic power supply +5V.

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2.2.3 Controller core

The actual core comprises the Motorola Controller 68332, containing the following integrated components:

- C PU32, computer core, internal 32-bit register, external 16-bit processor

- T PU, an independently operative clock generat or processor

- QSM with SCI to implement a simple RS-232 interface and a serial QSPI interface with up to 16 channels

- SIM with chipselect generation, system monitoring, clock synthesizer

wat chdog/ re set gene ra tion is implemented with an integrated system monitoring

The chip. It has the following functi ons:

- P ower-up reset for the 68332 when the instrument is swit ched on

- V oltage monitoring with reset generation

- W atchdog function

- Switchover to battery for buffered RAMs

- A ccess protection for buffered RA Ms

2.2.4 Real-time clock

This provides the time of day and date. When t he device is operative it is powered by the logic power supply, when the device is sw itched off a 3-V lithium cell is switc hed in to keep the clock running.

The control signals for the clock (c hipselect read/write signal) are generated in the

PAL RTC_Control, which also contains the release sequenc e for the character display.

2.2.5 Memory

Static RAMs are used as R AM me mory with an internal organiz ation 128kbit x 8. They are equipped with 4 chips, providing an organisation of 256kbit x 16. It is possible to add 4 further chips to give a RAM memory area of 1MB yte. The access time is 70 ns, i.e., access

without wa it sta te s.

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2.2.6 Printhead control

The printhead controller takes on the complete cont rol of a 216-mm thermal printhead with a line width of 200 mm. It also contains t he printhead monitor, which reduces the heating time with increasing printhead temperature, t erminating the printhead power

supply when the printhead temperature reaches 55°C. The printhead power s upply is reactivated only when the printhead temperature drops below 50°C.

The core is a The speed-dependent heating parameters are transmitted s erially.

For the printhe ad monitoring t he temperature of the thermal array printhead is measured by a thermistor located on the printhead. A constant current source effec ts a temperature-dependent voltage drop at a comparator input, t he switching threshold being adjusted by hysteresis at the ot her comparator input. If a printhead temperature of 55°C is exceeded, the message PRINTHEADTE MP is activated and the current supply to the printhead prevented by the STROBE signal. Only after the temperature drops below 50°C is the PRI NTHEADTEMP message disabled and the current supply via STROBE reenabled.

A second comparator generates a VTE MP signal when the temperature reaches 45°C, it is disabled again when the temperature drops below 40°C. It repres ents a prewarning signal, so that the quantity of data at the printhead is reduced to prevent it being switched off.

In addition, a continuous reduction in the c urrent activation time occurs with inc reasing temperature, resulting in a regular type face throughout the entire temperature range.

printhe ad is ope ra te d dire ctly a t the ba tte ry, i.e., the printhead volt age is

The dependent on the state of battery charge. Compensation is achieved by reducing or extending the printhead current acti vation time accordingly, ensuring t hat the type face is maintained within the fluctuation range of t he battery voltage.

gat e a rra y, which t akes on the heating time management for each dot.

2.2.7 Motor controller

This activates the CardioSmart´ s DC motor. This motor does not have a speedo, control is achieved according to the principle of current compensation.

The main components are the speed selector, motor c ontroller, and motor current monitoring.

The resistor for the attached directly to the motor cas ing.

control according to the principle of current c ompensation is

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The voltage of +/- 12 V required to send control s ignals is generated from the supply voltage as follows: An in-phase regulator generates + 12 V, due to the small current requirements the voltage -12 V is generated by an inv erting voltage pump. The supply voltage +/-12 V is also used for the temperature monitoring system of the printhead controller. It is only enabled during printing!

When the motor current is raised > 140 mA (e.g., as a result of paper jam, transmission problems) the

transport and the message “Please insert paper and press return key” appears on the display.

motor current monitoring syste m terminates paper

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2.2.8 RS-232 interface

The CardioSmart has an RS-232 interface which, except for the RS-232 driver chip, is directly integrated into the controller. It has the following attributes:

- S oftware handshake with XON/X OFF

- N o HW handshake

- Transmission speed 1200 .... 19200 B aud

To achieve additional suppressor diodes.

prote ction a ga inst E S D up to 1 0 kV , the interface is equipped with

2.2.9 Keypad interface

The interface to the keypad is via the 2 2 - pin conne ctor AS . The keypad itself is a membrane keypad with touch-sensitive chec k-back.

The keypad comprises a The CardioSmart ST keypad has additional keys for ergometer/treadmill control.

Depending on the keypad used (CardioSmart or CardioSmart S T) the PC receives a corresponding signal, identifying the devic e used.

Identification of the key press ed is as follows: The controller activates a column, act ivation is via low-level, simultaneously it reads out the register for the lines and by a low-level signal ident ifies whether one or more keys had been pressed. Then the next column is activated. The run procedures are repeated automatically until all columns have been act ivated.

In addition, the LEDs for start and stop, for the power supply system display and the battery status control are locat ed directly on the keypad.

mat rix with 7 columns a nd 7 rows.

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2.3 PCB Graphics Display_CS

This PCB is only used in connecti on with the component parts of the CardioSmart graphics display unit. It comprises the following functional units:

- V oltage generation

- C PU interface, display control

- B ackground illumination

- C ontrast control

2. 3 . 1 P owe r supply

A negative voltage of -23 V is required for the power supply of the display. It is generated by an inverting switching controller f rom the 5-V power supply. The output voltage -23 V is enabled by the additional external wiring of the switching controller. The voltage -23 V also serves as a voltage s ource for the generation of the negative

contrast volta ge .

The functional unit LC D BLO C K ensures that t he logic power supply +5 V is active at the graphics display before the negative power supply and the contrast voltage. When the instrument is switched off the negative power supply and the contrast v oltage are switched off first.

2 . 3 . 2 Ba ckground illumination

The background illumination of the graphics display is effected by a C F L tube , which requires an alternating voltage of approx. 800 Vs s.

The alternating voltage is generated by a voltage invert er, driven by 5 V. Since the CardioSmart is a portable, battery-operated device, t he background illumination can

ena ble d a nd disa ble d (configuration).

2.3.3 Contrast control

The contrast control has an additional temperature compensation control. However, when there are rapid fluctuations in temperature it t akes a certain time until the compensation is complete, since the dis play itself has a greater thermal time const ant.

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2.4 Internal interfaces

2.4.1 Mechanical interfaces

The 3 following mechanical interfaces are important within t he CardioSmart:

- I nterface to CardioProm

- Interface to display CardioVision Text

- Interface to display CardioVision Graphic s

Interface to CardioProm

The CardioProm has its own housing, which is conduc ting to prevent damage by ESD. To shunt any possible static charge it has 3 rails on the underside which, on the PCB Control_CS in the CardioSmart basic devic e, when inserted make contact with the 3 rails on GND, thereby shunting the charge.

This mechanical insertion of the rails ensures t hat a fail-safe contact is made with the PCB Control_CS.

Furthermore, mechanical coding ensures that the non-c ompatible CardioProms of the EK56/EK512 series cannot be inserted into the slot. Similarly, the insertion of CardioSmart CardioProms into the EK 56/512 slot is not possible.

I nterfa ce to displa y C a rdioV ision T ext

The display CardioVision Text is placed into t he depression provided in the upper shell of the CardioSmart basic device. The mechanic al rail on the outside of the display ensures the electrical contac t is automatic and fail-safe. The display CardioVision Text can be replaced, e.g. , by a CardioVision Graphics using the appropriate tools without opening the device.

I nte rfac e t o display C a rdioV ision G ra phics

The display CardioVision Graphics is also plac ed in the above-mentioned depression, the mechanical rail on the outside also ensures a fail-s afe contact. In contrast t o the CardioVision Text, the CardioVisi on Graphics can only be replaced by opening the upper shell of the basic device.

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2.4.2 Electronic interfaces

This section describes the pinning, func tion and significance of the signals of the internal interfaces of the functi onal components.

2.4.2.1 Interface Character Display

The interface to the character display prov ides all the signals to connect the display CardioVision Text. It comprises the upper 8 bits of the data bus, control s ignals and the signal for the contrast cont rol.

Connection denotation: Female multipoint connector 2 x 7 - pin, upright (180 °), reverse terminal protecti on

achieved mechanically. The function of the individual pins is given in t he following table. The definition as an

Input/Output is seen with ref erence to PCB Control_CS.

Pin Number

1 Output GND System ground 2 Output + 5 V Voltage supply 3 Output CHAR_CONTR

4 Output AD_12 Controller address bus bit 12

Input/Output

AG/

Denotation Function

Contrast character display

0 .... 5V

5 Output RW_ Read/write signal 6 Output ENCHARD Enable character display 7 Bi-Direct,

tristate

8 Bi-Direct,

tristate

9 Bi-Direct,

tristate

DB_8 Controller data bus bit 8

DB_9 Controller data bus bit 9

DB_10 Controller data bus bit 10

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10 Bi-Direct,

tristate

11 Bi-Direct,

tristate

12 Bi-Direct,

tristate

13 Bi-Direct,

tristate

14 Bi-Direct,

tristate

DB_11 Controller data bus bit 11

DB_12 Controller data bus bit 12

DB_13 Controller data bus bit 13

DB_14 Controller data bus bit 14

DB_15 Controller data bus bit 15

2.4.2.2 Interface Graphics Display

The interface to the graphics display provides all the signals to connect the display CardioVision Graphics. It c omprises the upper 8 bits of the data bus, address bus, control signals and the signal for the cont rast control.

Connector denotation:

AH/

2. 4 . 2 . 3 I nte rfa ce P C B P owe r S upply_ C S

This has the voltages from the power supply unit to generate the + 5 V and the other voltages, the control of the LE Ds for the power lamp and battery monitoring, the control signals for battery charging and switc hing on the printhead and motor power supply as

well as the signal to switch off t he device on the controller´s part. Connector denotation: Male multipoint connector 2 x 1 0 - pin, upright (180 °), reverse terminal protection and

coding with coding pin 12. The function of the individual pins is given in t he following table. The definition as an

Input/Output is seen with ref erence to PCB Control_CS.

AE/

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Pin Number

1 Input LEDLIN Control of LED for power supply system

2 Output REG_ON Printhead power supply, motor enabled by

3 Output GOFF_ Switch on device with controller

4, 5 Input UVERS Input v oltage to generate +5 V 6 Output + 5 V Logic power supply 7,8,9,

Input/Output

Input COMMON_IN Input voltage to generate mot or- printhead

Denotation Function

"-" = mains not connected "AC" = mains connected

controller: "0" = Enable battery charging "1" = Enable printhead power supply

"0" = Device off "1" = Device on

voltage and +/- 12V

11 Input REG_OFF Printhead power supply, motor enabled by

power-supply unit: "0" = Enable battery charging

"1" = Enable printhead power supply 12 CODE Coding pin 13, 14,

15, 16 17 Input VRAM Buffered voltage to generate the RAM

18 Output COMMON_S Voltage switched in from COMMON_IN 19 NC NC 20 Input LEDBAT Charging status display for BATTERY:

Input GND System ground

standby power supply

"0" = battery needs charging

"1" = battery charged, normal operat.

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2.4.2.4 Option interfaces

O ption P owe r C heck

This constitutes a service c onnector to enable checking of all the voltages ac tive within the system. This power to other components!

is not a n ex te nsion port, the voltages must not be us ed to supply

Connector denotation: Male multipoint connector 1 x 6 - pin, upright (180 °), for se rvicing purpose s only!

The function of the individual pins is given in t he following table. The definition as an Input/Output is seen with ref erence to PCB Control_CS.

Pin Number

1 Output + 12 V Testing point power supply + 12 V 2 Output GND System ground 3 Output - 12 V Testing point power supply - 12 V 4 Output COMMON_S Testing point power supply motor voltage

Input/Output

AF/

Denotation Function

5 Output GND System ground 6 Output + 5 V Testing point logic power supply + 5 V

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2.5 Interfaces to peripherals

The CardioSmart has only 3 interfaces for peripherals :

- M ains input

- P atient Input

- R S-232 interface

mains input int erface on the device is a 3-pin standard cold appliance soc ket

The connection, which is integrated into t he mains input module. Connection to the mains is effected via a 3-pin power cord with a non-fused earth c onductor.

Although the mains input is not designed as a "wide range input ", adjustment to the two mains voltage ranges 110V~ ... 120V~ and 220V~ ... 240V~ is easily achieved without having to open the device or a wiring change of the bridges:

- C heck voltage setting in the inspection window of the interrupter of the mains input module

- I f the voltage value is not the same as the mains voltage:

D isconnect ma ins plug!

- O pen interrupter with appropriate tool

- T ake out fuse holder with fuses

- I nsert fuses rated according to the rating plat e specifications

- R einsert holder so that the required voltage is visible

- C lose interrupter

- T he required mains voltage should now appear in the inspection window

T his rea djustme nt is to be ca rrie d out by the ma nufa cture r or se rvicing age nt only!

No further description of the mechanical and elec tronic parameters of the mains input is given in Section 2.5.

The mechanics and the interface configuration as used in the EK53/EK56 and in the EK512 are implemented in the used up to date can still be used, this also being true for the suction system with its integrated pump.

A 9-pin sub-D connector with a standard configurat ion of the signals TXD, RXD and GND is implemented in the construction of the attached to the connected plug hous ing by means of threaded inserts. The E K53/56 and EK 512 RS-232 power cables can thus no longer be used.

The cable 223 362 03 is used as an RS-232 cable to the PC.

pat ie nt input. This means that all the pat ient cables

RS-232 interface. In addition, it is

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2.5.1 Electronic interfaces

2.5.1.1 RS-232 interface

This comprises the transmitter signal TX D, the incoming signal RXD and the reference ground GND. The pin configuration is the same as t hat used for a standard PC 9-pin sub-D socket. The interface does not operate with a hardware handshake.

Furthermore, a REMOTE START input is provided at pin 8. Transmission is in accordance with the st andard V-24 protocol, input and output

voltages are defined as follows:

- m aximum input voltage at RXD: +/- 15V

- minimum out put voltage at TXD: +/ - 5 V

- addit ional input protection against ESD ef fects: +/- 10kV

In addition, there is a REMOTE S TART input at pin 8 with the following specif ications:

- ex ternal short-circuiting contact v ia circuit reference referred to ground

- max. source resistor switch: Ri <300

- m ake time >100 ms

- c ontinuous load limits +/-10 V

- E SD protection to max. +/-10 kV

Connection principle to PC

CardioSmart PC RXDE 2 2 RXD

3 TXD TXDE 3

GND 5 5 GND Connection cable 223 362 03

The connector is denoted: AC/ Male multipoint connector sub- D socke t housing, 9 - pin, 9 0° off set

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The function of the individual pins is given in t he following table. The definition as an Input/Output is seen with ref erence to PCB Control_CS.

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Pin Number

1 NC NC 2 Input RXDE Receive RS-232 data 3 Output TXDE Transmit RS-232 data 4 NC NC 5 Output GND System ground 6,7,9 NC NC 8 Input REMOTE START Remote Start Input

Input/Output

Denotation Function

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2. 5 . 1 . 2 P a tie nt input

Below is a list of the most important features of the patient input:

- Classification: cardiac floating

- Defibrillation-proof

- S imultaneous data acquisition from all leads

- I ndividual electrode monitoring

- V oltage feed for floating power supply via float ing transformer

- C ontrol and data signals from and to floating part via opt oelectronic coupler

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The connector is denoted: Male multipoint connector sub- D socke t housing, 1 5 - pin

AA/

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The function of the individual pins is given in t he following table. The definition as an Input/Output is seen with ref erence to PCB Control_CS.

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Pin Number

1 Input C2 Input electrode C2 2 Input C3 Input electrode C3 3 Input C4 Input electrode C4

4 Input C5 Input electrode C5 5 Input C6 Input electrode C6 6 Output S Shielding 7 Output PLGND Identification of patient cable used 8 Input PL Identification of patient cable used 9 Input R Input electr ode R

Input/Output

Denotation Function

(Nap for Nehb cables)

10 Input L Input electrode L 11 Input F Input electrode F 12 Input C1 Input electrode C1 13 Input Nst Input elect rode Nst (for Nehb) 14 Output N Output electrode N (common mode

compensation)

15 Input Nax Input electrode Nax ( for Nehb)

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2 . 6 Limitations

The following operating modes are not implemented in the CardioSmart:

- N o ergometry

- No SAO2

- N o spirometry

- No late potentials, no RR variability

- N o phono, no US Doppler

A scope output is not available. No analog inputs. The existing RS-232 interface does not prov ide an ECG trigger output. Recording without or with an empty NC battery is not possible.

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Lead accumulators cannot be used. Primary cells cannot be used.

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3 . S yste m te st functions

With country default setting G erman all messages displayed during the self-test are in German, in all other country settings they appear in English.

3 . 1 Syste m te st functions with gra phics displa y

3 . 1 . 1 . G e ne ra l informa tion

The functions for the system test are mostly menu-guided. For complete execution some tests require special auxiliary resources. These include

interface testers or PC, c onnection cables, signal generators, etc . The tests that are necessary are described in the various test descriptions.

3.1.2 Test start

After simultaneously pressing t he keys

the initial display menu appears to enable selection of a s pecific test. (see below) Keys used for menu selection appear in parenthesis .

(1) Display test (2) Key test (3) Motor test (4) Test results (5) Recording test (6) Interface test (7) Time and date (8) Electrode test (9) Time constant test (V) Device model (from SW V4.21) (C) 12SL / HEART (from V4.21) Terminate with SH_MAN or SH_MODE key

S hift + Auto (CardioSmart) or S hift + M ode (CardioSmart ST)

S ystem te st

T est f unctions:

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3.1.3 Display test (1)

After pressing the “1" key the f ollowing menu appears:

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Pressing any other key t han one of those listed in the menu above leads back to the initial display menu.

Displa y te st

(1) Test pattern (2) Character set (3) Delete display (4) Inverse (5) Display illumination

Contrast control

- Shift_Cursor_Down

- Shift_Cursor_Up

Terminate with any key

(1) Test pattern

Pressing this key generat es a chessboard pattern. Each s ubsequent pressing generates the inverse display of its predec essor.

(2) Character set

The character set used for the display is out put.

(3) Delete display

All display pixels are inactive.

(4) Inverse

The contents of the existing dis play appear in reverse video.

( 5) D ispla y illumina tion

The illumination is switched on or off by pressing this key.

C ontrast control

The contrast setting can always be adjus ted as described above (cursor keys).

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3.1.4 Key test (2)

By pressing the “2" key the following menu appears :

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When a key is pressed this key or its f unction is displayed. This can either occ ur by a triple character display, e.g., “AAA” or as a text, e.g., "CURS_UP". Moreover, pressing the “P” key tests the bleeper (audible sound) and pres sing the “K” key tests a micro key to identify whether the cover f or the paper compartment is open or closed. The “E” key terminates this test and s imultaneously undergoes a self-test.

Key T e s t

(P) Bleeper test (K) Cover for paper compartment (E) End

3.1.5 Motor test (3)

When the “3" key is pressed the following menu appears:

Motor/Speed Test

- Speed select key

- Start/Stop

- (A) Measurement marking pulse ON

- (S) Measurement marking pulse OFF

The speed select key is used to set t he required speed and the motor set into motion with Start/Stop. Whilst running the motor speed can be controlled by using t he “A” key to activate the setting of the measurement marking pulse and t o deactivate it with the “S” key. A making pulse is set once every second. The running speed can then be calculated or its accuracy checked from t he distance between marking pulses. Any other k ey pressed not included in this menu leads to the initial dis play menu.

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3.1.6 Test results (4)

Pressing the “4" key triggers the output of the test res ults. The output of the test protoc ol supplies data on the software integrat ed in the device

(Part No., Version No., product ion date of the firmware), printhead voltage and the t est results on the memory test performed during power-up. The areas listed under RAM have the following meaning:

CardioSmart

0 - 080000h 512 kByte RAM area on the PCB Control CS_S

100000 - 140000h 256 kByte RAM area on the CardioProm (depending on CardioProm type)

140000 - 1C0000h 512 kByte RAM area buffered on the CardioProm (dep. on CardioProm type)

CardioSmart ST

0 - 080000h 512 kByte RAM area on the PCB Control CS_S

100000 - 180000h 256 kByte RAM area on the CardioProm (depending on CardioProm type)

180000 - 200000h 512 kByte RAM area buffered on the CardioProm (dep. on CardioProm ty pe)

Values may deviate from those given above, depending on the device or software version used.

A specification in the form 100000 - 100000 permits the conclusion that this RAM area does not exist in the device. However, if it does exist in conformity wit h the software version implemented, this means that this RAM cell at address 100000H is defective. The memory could also be defective when the initial and fi nal addresses of the memory area differ and do not correspond to the above-mentioned limits . This then means, for example, that the specificat ion 100000 - 123000 on the defective cell at address 123000H.

Following output the initial display menu reappears automatically .

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3.1.7 Self-test

The test results elucidated in Sect ion 3.1.6 are ascertained during the self-test , which is always performed on power-up. Should errors be detected, a message appears on the display after the test, indicat ing the possible errors. The following error codes are used to identify the error.

E rror code s

The following error codes appear on the display together with the mes sage “Self-test failed”:

ERROR_CODES: 0 - reserved

1 VEKT - error in vector table 2 ERAM - RAM error on PCB Control 3 LCDR - LCDRAM error (Graphics Display) 4 - reserved 5 - reserved 6 RAMB - RAM error on the CardioProm 7 GRAM - error in buffered RAM on the CardioProm 8 ROMB - ROM error (checksum) on the CardioProm

9 - 10 not used

3.1.8 Recording test (5)

The recording test is activated by pres sing the "5" key and interrupted with the "Start/Stop" key .

Immediately after pressing the "5" key t he printer begins to record the first channels at 25mm/s and 20mm/mV. In addition, the message “Recording test ” appears on the display. In this test only t he first two channels are passed on to t he printer. No other channels can be configured.

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3.1.9 Interface test (6)

Several possibilities are available to test the serial interface. Moreover, on the one hand, the signal transmission and rec eiving of the interface can be test ed by an internal feedback from TXD and RXD and, on t he other hand, the signal transmission and receiving with a remote station. For the test with a remote station a st andard PC cable is required for a serial interface (zero modem cable). In addition, the following trans mission protocol should be adjusted at the remote station:

1 start bit, 8 data bits, parit y even 1 stop bit Baud rate 9600

Pressing the “6" key calls up the f ollowing menu:

Interface test

(1) Transmitting and receiving (2) Transmit test string to device (3) Transmitting and receiving with device

( 1) T ra nsmitting a nd re ce iving

This test enables complete testing of the RS232 signal path for transmitting and receiving, including RS232 driver and connector. This test requires an RS232 connector with an int ernal bridge from pin 2 (RXDE) to pin (TXDE). Depending on the result of the t est, the following message appears:

Test result : OK or Test result : Error

This procedure requires a software version as from V 4.1. Earlier software versions only permit internal testing of the RS232 interf ace without including the RS232 driver.

(2 ) T ra nsmit te st string to de vice

In this test a remote station, e.g., PC must be connected up and hav e a terminal program which can receive signals and be configured for the abov e-mentioned protocol. If the remote stat ion is on receive, then every time the “2" key is pressed the test string “Interface tes t” is transmitted to the remote st ation. Simultaneously, the following message appears on the display:

Transmitting : interface test

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( 3) T ra nsmitting a nd re ce iving with de vice

Transmitting and receiving can be tested with a remot e device by pressing the “3" key. The device should be connected as described in (2). After pressing the “3" key a tes t string is sent the remote station. The following message appears on the display:

Transmitting: interface test Receiving:

A subsequent input at the remote st ation is sent back to the device and display ed there. Moreover, it should be noted that an input must take place within 10 s and the input terminated with “return”. If the k ey is pressed a second time, then the st ring "CardioSmart Test" is transmitted. Altogether there are three test st rings available, which are sent in the following sequence with repeated key activation: "Schnittstellenest", "CardioS mart-Test", "Sieht doch gut aus, oder?" ("Interface Test", CardioSmart Tes t", Looks good, doesn't it?")

The last string corresponds to the expec ted test result. This test is terminated with any other k ey not used for a test.

3.1.10 Time and date (7)

This section deals with the quick chec king and setting of the time and date. Pressing the “7" key calls up the f ollowing display:

Time / Date 10:12:03 10.11.1994 (S) Set

End with any key From this screen the clock can be adjust ed by pressing the “S” key, the following mas k

appearing: Time Date [ ] [ ]

The first mask is for the time and t he second for the date. Example: [1012] [10119] for 10:12 o´clock and 10.11.94

Pressing the return key terminates the entry. The adjusted data are subsequently accepted and seconds set t o zero.

The test is terminated with any other key not used for a test.

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3.1.11 Electrode test (8)

The electrode test is started by pres sing the “8" key. The electrode test is terminated by press ing any key. To evaluate the electrode states t he following status WORD is available.

Status = 0 -> Electrode OK Status = 1 -> Electrode disconnected

Bit15 Bit0

----------------------------------------------------------------------| x | x |DAT|ELN|NAP|NST|NAX| C6 | C5 | C4 | C3 | C2 | C1 | F | L | R |

-----------------------------------------------------------------------

And precisely this status WO RD extended to LONG is displayed on the s creen during the electrode test to be performed. I t is important to note, however, that this status WORD is not displayed as a binary number but as a hexadec imal number.

However, to make the status of a part icular electrode quickly recognizable, defec tive electrodes are represented by an ID c ode. EX_R, for example, stands f or the defective electrode R and C1 for electrode C1. This permits the identification of ev ery individual electrode. Naturally, since s everal electrodes can become disconnected simult aneously, it was necessary to set a certain priority in the display of disconnected elec trodes.

The following display priority was programmed: EX_R, EL_N, EX_L, EX_F, C1, C2, C3, C4, C5, C6, NAX, NST, NAP For example, if electrodes R and N have become disconnec ted, then first R is reported

with EX_R as having become disconnect ed. Only after R is OK is E L_N displayed.

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3.1.12 Test time constants (9)

The test is started by pressing t he “9" key and interrupted with the "Start/S top" key. Immediately after the “9" key has been act uated the printer begins to record the first

two channels at 25 mm/s and 20 mm/mV. Moreover, the message “Testing time cons tants” appears on the display. In this test only the first two channels send signals to the printer. No ot her channels can be configured. The default time const ant is output on the printout as a control.

S etting the time consta nts

As a general rule, the time const ants are adjusted to 2.04 s. This setting can be changed with the CORR_CO NFIG key. The following settings are available:

Time constants: (1) 0.260s (2) 0.130s (3) 0.033s (4) 0.004s (5) 4.080s (6) 2.040s (7) 1.020s (8) 0.510s

The figures given in parentheses indicate the key used to select the corresponding time constant.

Verification of the currently ac tive time constant is only poss ible by printing out the selftest results (see Section 3. 1.6) or by testing the time constant s.

3.1.13 Setting the Device models (V)

The setting of the Device model is act ivated by pressing the “V” key, t he following display image appears:

D e v i c e mode l

(1) INT (2) USA (3) EU_2 (4) ASIA (5) RUSS

Terminate with any key.

The currently selected device model appears in reverse v ideo.

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Warning! C hanging the de vice mode l a ffe cts the se le ction of the output forma ts a nd la ngua ges

ava ila ble , can switch the program for I nte rpreta tion from HE AR T to 1 2 SL, or vice versa . Also a ff ecte d a re the de fa ult configura tion se ttings, e . g. , ove rride function yes/no, line filter 50/60 Hz.

T he de vice mode l configure d during ma nufa cture should only be cha nge d whe n deemed really necessary.

The following table shows the most important combinat ions:

Device model Interpretation Output

formats

01 INT HEART International g,e,f,i,s no 50 Hz 02 USA 12SL USA e,f,s yes 60 Hz 03 EU_2 12SL Int. +H1 +H2 e,g,f,sw yes 50 Hz 04 ASIA HEART International g,e,f no 50 Hz 05 RUSS HEART International g,e,f no 50 Hz

Languages Default settings

Override

function enabled

Line filter

Output formats: - International: 12_FS, 12_F1, 12_F2, 6_F1, 6_F2, 3_F1

- USA: STND1, STND3, 1x10, 2x5, 2x5_ex, 3RHY1

The required device model is selected by pressing the appropriat e key, “1" to “5". Quit selection menu by pressing any key . Quit the self-test with “Shift ” + “Man” or “Shift” + “Mode”. CardioSmart configures the appropriate items and init iates a cold start automatically. Thus, when the device is rebooted automatically all the new settings are adopted.

Selecting a particular device model leads to t he configuration of the program for Interpretation as indicated in the table above, even when the interpretation program was configured differently beforehand as desc ribed in section 3.1.14.

N ote on sa ve d E C G s whe n configuring the de vice mode l:

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Interpretation, although the results are based on the program previously configured. In this case, the saved E CGs should be printed out or transf erred to a PC before configuration of the new model.

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3.1.14 Switching over the program for Interpretation(C)

Switching over the program for Interpretat ion is activated by pressing the “C” key , the following display image appears:

I n t e r p r e t a t i o n (1) HEART

(2) 12SL Terminate with any key.

The currently enabled interpretation program appears in reverse video.

Warning! S witching ove r to anot her progra m for I nte rpre ta tion a ffe cts the me a sure me nt re sults

and the inte rpreta tion! T he progra m for I nt erpre ta tion conf igured during ma nufa cture should only be cha nge d

when deemed really necessary!

The required program for Interpretation is selected by pres sing the appropriate key, “1" or “2". Quit the selection menu by pressing any key. Quit the self-test with “Shift ” + “Man” or “Shift” + “Mode”. CardioSmart configures the appropriate items and init iates a cold start automatically. Thus, when the device is rebooted automatically all the new settings are adopted.

N ote on sa ve d E C G s whe n switching ove r the progra n for I nte rpre ta tion:

Saved ECGs are not los t. After switching over to a diff erent program for Interpretation when printing the saved ECGs the display in the st atus line (12SL, or without in the case of HE ART) is related to the newly selected interpretation program, alt hough the results are based on the program previously configured. In this cas e the saved ECGs should be printed out or transferred to a PC before switc hing over to the new program for Interpretation.

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3 . 2 D evice te st functions with cha ra cte r displa y

( only Ca rdioS ma rt)

3 . 2 . 1 G e ne ra l informa tion

In contrast to the graphics display , at the current time the device tes t functions all require menu-guided execution. This is because the renditi on of the character display of max. 80 characters is very limit ed.

To be performed in their entirety some tests require special auxiliary aids, e.g., interface tester or PC, connec tion cables, signal generators, etc. Just what is required for which test are given in the various tes t descriptions.

3.2.2 Test start

After simultaneous pressing of t he keys

S hift + Auto (CardioSmart) or S hift + M ode (CardioSmart ST)

the following initial display image appears:

END TEST: with Shift MAN

(CardioSmart ST)

Key used to select menu options are given in parentheses.

S Y S T E M T E S T

(CardioSmart) or Shift + Mode

3.2.3 Display test (1)

After pressing the “1" key the f ollowing menu appears:

Display test (3) Delete display (4) Inverse

Pressing any other key than thos e given above leads back to the initial display image.

(3) Delete display

All the display pixels are disabled.

(4) Inverse

Inverse here does not mean inverse display of the rendered t ext, but inverse to delete display, i.e., all the display pixels are enabled.

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C ontrast control

Furthermore, the contrast control c an also be adjusted under this option “Display test”. Moreover, there are 7 levels available which can be run though with the CURSOR_UP and CURSOR_DOWN keys.

3.2.4 Key test (2)

Pressing the “2" key calls up the f ollowing screen:

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(E) End When a key is pressed this or its meaning is display ed. This can either occur by a

triple character display, e.g., “AAA” or as a text, e.g., "CURS_UP". Moreover, pressing the “P” key tests the bleeper (audible sound) and pres sing the “K” key tests a micro key to identify whether the cover f or the paper compartment is open or closed. The “E” key terminates this test and s imultaneously undergoes a self-test. The initial dis play image appears.

K e y T e s t

3.2.5 Motor test (3)

When the “3" key is pressed the following menu appears:

The speed select key is used to set t he required speed and the motor set into motion with Start/Stop. Whilst running the motor speed can be controlled by using t he “A” key to activate the setting of the measurement marking pulse and t o deactivate it with the “S” key. A marking pulse is set once every second. The running s peed can then be calculated or its accuracy checked from t he distance between marking pulses. Any other key pressed not included in t his menu leads to the initial display menu.

Motor/Speed Test

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3.2.6 Test results (4)

Pressing the “4" key triggers the output of the test res ults. The output of the test protoc ol supplies data on the software integrat ed in the device

(Part No., Version No., product ion date of the firmware), printhead voltage and the t est results on the memory test performed during power-up.

The areas listed under RAM have the following meaning:

Car dioSmart

0 - 080000h 512 kByte RAM area on the PCB Control CS_S

100000 - 140000h 256 kByte RAM area on the CardioProm (depending on CardioProm type)

140000 - 1C0000h 512 kByte RAM area buffered on the CardioProm (dep. on CardioProm type)

CardioSmart ST

0 - 080000h 512 kByte RAM area on the PCB Control CS_S

100000 - 180000h 256 kByte RAM area on the CardioProm (depending on CardioProm type)

180000 - 200000h 512 kByte RAM area buffered on the CardioProm (dep. on CardioProm type)

Values may deviate from those given above depending on t he device or software version used.

The output can be interrupted with the Start /Stop key. Following output the initial

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display menu reappears automatically.

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3.2.7 Self-test

The test results elucidated in Sect ion 3.2.6 are ascertained during the self-test , which is always performed on power-up. Should errors be detected, a message appears on the display after the test indicating t he possible errors. The following error codes are used to identify the error.

E rror code s

The following error codes appear on the display together with the mes sage “Self-test failed”: ERROR_CODES: 0 - reserved

1 VEKT - error in vector table 2 ERAM - RAM error on PCB Control 3 LCDR - LCDRAM error (G raphics Display) 4 - reserved 5 - reserved 6 RAMB - RAM error on the CardioProm 7 GRAM - error in buffered RAM on the CardioProm 8 ROMB - ROM error (checksum) on the CardioProm

9 - 10 not used

3.2.8 R e cor ding te st (5)

The recording test is activated by pres sing the "5" key and interrupted with the "Start/Stop" key .

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3.2.9 Interface test (6)

Pressing the “6" key calls up the f ollowing menu:

Interface test Keys (1), (2), (3)

‘1' key te sts transmission and re ce iving

( 1) T ra nsmitting a nd re ce iving

Test result : OK or Test result : Error

This procedure requires a software version as from V 4.1. Earlier software versions only permit internal testing of the RS232 interf ace without including the RS232 driver.

(2 ) T ra nsmit te st string to de vice

In this test a remote station, e.g., PC must be connected up and hav e a terminal program which can receive signals and be configured for the abov e-mentioned

protocol. If the remote stat ion is on receive, then every time the “2" key is actuated the test string “Interface tes t” is transmitted to the remote st ation. Simultaneously, the following message appears on the display:

Transmitting : interface test

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( 3) T ra nsmitting a nd re ce iving with de vice

Interface test Keys (1), (2), (3) A subsequent input at the remote st ation is sent back to the device and display ed

there. A received text would then be dis played on the second line of the screen. Moreover, it should be noted that an input must take place within 10 s and the input

terminated with “return”. If the key is actuated a second time then the string "CardioSmart Test" is transmitted. Altogether there are three test st rings available, which are sent in the following sequence with repeated key actuation:

"Interface Test", "CardioSmart Tes t", "Looks good, doesn´t it?" The last string corresponds to the expec ted test result.

This test is terminated with any other k ey not used to start a test.

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3.2.10 Time and date (7)

This section deals with the quick chec king and setting of the time and date. Pressing the “7" key calls up the f ollowing display:

Time / Date 10:12:03 10.11.1994

From this screen the clock can be adjust ed by pressing the “S” key the following mask appearing:

Time Date [ ] [ ]

The first mask is for the time and t he second for the date. Example: [1012] [10119] for 10:12 o´clock and 10.11.94

Pressing the return key terminates the entry. The adjusted data are subsequently accepted and seconds set t o zero.

The test is terminated with any other key not used for a test.

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3.2.11 Electrode test (8)

The electrode test is started by pres sing the “8" key. The electrode test is terminated by press ing any key. To evaluate the electrode states t he following status WORD is available.

Status = 0 -> Electrode OK Status = 1 -> Electrode disconnected

Bit15 Bit0

----------------------------------------------------------------------| x | x |DAT|ELN|NAP|NST|NAX| C6 | C5 | C4 | C3 | C2 | C1 | F | L | R |

-----------------------------------------------------------------------

This permits the identification of ev ery individual electrode. Naturally, since s everal electrodes can become disconnected simult aneously, it was necessary to set a certain priority in the display of disconnected elec trodes.

The following display priority was programmed: EX_R, EL_N, EX_L, EX_F, C1, C2, C3, C4, C5, C6, NAX, NST, NAP For example, if electrodes R and N have become disconnec ted, then first R is reported

with EX_R as having become disconnect ed. Only after R is OK is E L_N displayed.

3.2.12 Test time constants

(9)

The test is started by pressing t he “9" key and interrupted with the "Start/S top" key. Immediately after the “9" key has been act uated the printer begins to record the first

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S etting the time consta nts

As a general rule, the time const ants are adjusted to 2.04 s. This setting can be changed with the CORR_CO NFIG key. The following settings are available:

Time constants: (1) 0.260s (2) 0.130s (3) 0.033s (4) 0.004s (5) 4.080s (6) 2.040s (7) 1.020s (8) 0.510s

The figures given in parentheses indicate the key used to select the corresponding time constant.

Verification of the currently ac tive time constant is only poss ible by printing out the selftest results (see Section 3. 2.6) or by testing the time constant s (see Section 5.2.8).

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3.2.13 Setting the Device model (V)

This setting is only available form Sof tware Release V4.21.

Setting the Device model is acti vated by pressing the “V” key, the f ollowing display image appears:

D e v i c e M o d e l --> (1) INT

(1) INT (2) USA (3) EU_2 (4) ASIA (5) RUSS Terminate with any key.

The currently enabled device model appears in line 1.

Warning! C hanging the de vice mode l a ffe cts the se le ction of the output forma ts a nd la ngua ges

T he de vice mode l configure d during ma nufa cture should only be cha nge d whe n deemed really necessary.

The following table shows the most important combinat ions:

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Device model Interpretation Output

formats

Languages Default settings

Override

function enabled

Line filter

Output formats: - International: 12_FS, 12_F1, 12_F2, 6_1F, 6_F2, 3_F1

- USA: STND1, STND3, 1x10, 2x5, 2x5_ex, 3RHY1

N ote on sa ve d E C G s whe n configuring the de vice mode l:

Saved ECGs are not los t. If when a new device model is selected, the program f or Interpretation is switched over, however, when printing out the saved ECGs t he display in the status line (12SL, or without in the case of HEART) is related to the currently enabled program for Interpretation, although the results are based on the program previously configured. In this case, the saved E CGs should be printed out or transf erred to a PC before configuration of the new model.

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3.2.14 Switching over the program for I nterpretation (C)

Switching over the program for interpretation is activated by pressing the “C” key, the following display image appears:

I n t e r p r e t a t i o n --> (1) HEART

Terminate with any key. The currently enabled device model appears in line 1.

Warning! S witching ove r to anot her progra m for I nte rpre ta tion a ffe cts the me a sure me nt re sults

and the inte rpreta tion! T he progra m for I nt erpre ta tion conf igured during ma nufa cture should only be cha nge d

when deemed really necessary!

The required program for Interpretation is selected by pres sing the appropriate key, “1" or “2":

“1" for HEART, or “2" for 12SL. Quit the selection menu by pressing any key. Quit the self-test with “Shift ” + “Man” or “Shift” + “Mode”. CardioSmart configures the appropriate items and init iates a cold start automatically. Thus, when the device is rebooted automatically all the new settings are adopted.

N ote on sa ve d E C G s whe n switching ove r the progra n for I nte rpre ta tion:

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Page 50

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4 . R e pa ir instructions

4.1. Safety instructions

R epa irs ma y only be conducte d by a pprove d spe cialist personne l. Be fore ope ning the C a rdioS ma rt switch off de vice a nd disconne ct ma ins plug! N eve r conne ct ma ins plug whe n the whe n the device is ope n!

Be fore re pla cing the prima ry fuse s in the powe r input module or whe n rese tt ing the volta ge se le ctor switch to a diffe re nt volta ge ra nge the de vice should also be switche d off a nd the mains plug disconne cte d!

When replacing electronic components implement E S D prote ct ion. Return replaced PCBs in E S D pa cka ging only.

Defective batteries, empty bat teries should be

applica ble le ga l stipula tions

Batteries returned to the factory should be labeled “F or disposa l”.

or returned to the factory.

disposed of in accorda nce with the

4 . 2 R e pla cing components

F or all the following points t he sa fe ty instruct ions in S ect ion 4. 1 . a re to be obse rve d!

The CardioProm (program module) can be unlocked with a coin and then pulled out. The character display CardioVision Text c an be disengaged without opening the device by applying a screwdriver three times left, right and in the middle between the display housing and the upper housing shell of the CardioSmart.

Warning: The device must be switched off! O pening the de vice

To open the CardioSmart undo the 5 fastening s crews on the underside of the device, open the paper feed flap, carefully raise the upper s hell of the housing, disconnect keypad. The display remains in the upper shell of the c asing.

During reassembly ensure that no cables are pinched. E xert gentle pressure in the vicinity of the display to ens ure that the display is in contact with t he PCB and that it remains snapped into position in the upper shell.

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R epla cing the ma ins input module

After opening the device undo the sc rew located on the underside of the housing used to secure the holding angle bracket for the mains input module and the device poweron switch. Disconnect the primary connector DC and switch on/off connect or DA from the PCB Power Supply. Replace mains input module (snap-in connection).

Warning: Only use fuses indicat ed on the rating plate! (see Chapter 8, Parts List )

For safety reasons insert the fus e holder such that the correct mains voltage range is adjusted!

Visual check at the inspect ion window of the mains input module. (see Section 2.4)

R epla cing the ba tte ry

Disconnect and lift out the batt ery compartment on the underside of the device by raising the middle fastening catch. Remove t he battery and disconnect the battery plug DD from the PCB Power Supply.

Warning: Only original Marquett e Hellige batteries may be used! (see Chapter 8, Part s

List)

Defective batteries, empty bat teries should be

applica ble le ga l stipula tions

Batteries returned to the factory should be labeled “F or disposa l”. Before putting in the new battery insert plug DD. Push in battery compartment, s ecure

by pressing on the fastening cat ch.

or returned to the factory.

disposed of in accorda nce with the

R epla cing the P C B P owe r S upply

After opening the device first of all disconnect the primary connector DC and the sw itch on/off connector DA from the P CB Power Supply. Open the bat tery compartment and

disconnect the battery connect or DD (see "Replacing the battery”). Disconnect connector AE f rom the PCB Control. Remove PCB Control (see "Replacing the PCB Control"). Undo the 2 fastening screws next to the transformer and fuse Si 500.

PCB Control has 2 soldered fuses:

SI 500: B attery fuse SI 501: S econdary circuit fuse

No adjustments on the PCB Cont rol are necessary.

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R epla cing the P C B C ontrol

With the transition to device version V 1.2 the PCB Control has a new part number:

PCB Control CS_S equipped: 388 032 13, S pare Part No: 389 004 16 Before replacing the PCB, if still possible, printout the settings configured by the user. After opening the device first of all disconnect the plug-in connector AE t o the power

supply unit, then disconnect the remaining c onnectors to the recording unit. Undo the 6 PCBs fastening screws . Remove shielding plate under the patient input section (1 s crew, 3 x snap-in catches) and assemble it on the new PCB.

Check whether the lithium battery for the real-t ime clock (BA 500) is correctly soldered. Insert new PCB and plug in connectors.

Since the motor controller is located on t he PCB Control, the motor adjustment for speed and compensation must be carried out. Motor adjus tment is described in Chapter 6. In addition, disengage the retaining clips by press ing them together, then remove from the upper shell and plug into the connector AG (c haracter display) or AH (graphics display). However, simpler is a character LCD module c onnected to connector AG via a flat strip cable. Connect keypad in the upper shell using connector A S.

Setting the time (Sec tion 3.1.10 / 3.2.10). If known, adopt the user-programmed configurat ion; otherwise, default setting. If known, reset the user-programmed time c onstants; otherwise by outputti ng the self-

test results (Section 3. 1.6 / 3.2.6). Check default setting is 2.04 s , and adjust to 2.04 s if necessary (S ection 3.1.12 /

3.2.12) Adjust contrast with the appropriat e display.

R epla cing the motor

After replacing the motor the motor adjust ment of speed and compensation must be carried out as described in Chapter 6.

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R epla cing the gra phics displa y

The CardioSmart must be opened to be able to replace the graphics display. Disengage the graphics display from the upper shell of t he housing by pressing together the retaining clips and remove it. Reassemble the upper shell. Then carefully insert t he graphics display into the basic device until the retaining clips snap securely int o place.

Adjust the contrast with t he new display.

Replacing the character display

The character display CardioVision Text c an be disengaged without opening the device by applying a screwdriver three times to the left, right and in the middle between the display housing and the upper shell of the CardioSmart hous ing. Carefully insert the new display (character or graphics ) into the basic device until the retaining clips snap securely into place. Adjust the contrast with t he new display.

R epla cing pump module

Open device, take care in removing the upper shell t o avoid damage to vacuum tubing. Detach the vacuum tubing from the upper shell. Dis connect power plug SA from the pump module. The module can be replaced after unscrewing the two f astening screws and detaching the evacuated air tubes. After replacement perform a performance check as described in section 7.1.2.11.

Take the negative pressure reading at PTT aft er approx. 10 s. This value must lie within the range 225...265 mmHg (300...350 mbar).

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5 . T rouble shooting tips

D evice ca nnot be switche d on e ve n though powe r plug is plugge d in

- green power lamp LED is off and device cannot be swit ched on:

- power c able defective or not plugged in correctly?

- primary fuses in the mains input module defective?

- c onnecter DC on PCB Power Supply plugged in correct ly?

- m ains input module defective?

- k eypad via connector AS on PCB Control plugged in correctly?

- are all above-mentioned point s OK: ===> PCB Power Supply defective (transformer or rectifier)

- green power lamp LED is on, but device still cannot be switched on:

- device on/off switch or it s lead defective?

- connector DA on PCB P ower Supply plugged in correctly?

- keep device on switch depressed and measure v oltage UVERS on connector AE pins 4 + 5 on PCB Control: UV ERS greater that 25V-?

- if not: - fuse SI501 on P CB Power Supply defective?

- if SI501 OK ===> PCB Power S upply defective.

- if so: ===> PCB Power Supply defective.

D evice ca nnot be switche d on whe n be ing ba tte ry- opera te d only

- Is the battery empty?

- Plug in power plug, green power lamp LED should glow and the device can be activated, if not, refer t o "Device cannot be switched on even though power plug is

plugged in”.

- By connecting the power plug rapid charging is act ivated, LED1 on PCB Power Supply should glow, via the PTC resi stor R500 a power supply of approx 1 V should be available on PCB Power Supply. (measured with a multimeter):

- if so: bat tery charging circuit OK.

- if not: battery disconnected or defective?

- if not: ===> error on PCB Power Supply

- After charging for 10 minutes disconnect power plug, can the device be switched on and trigger a recording?

- if not: - fuse SI500 on PCB Power Supply defect ive? (Device does not switch on)

- if SI500 OK ===> battery defective or capacity too small.

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No displa y on the scre e n

- does the yellow Stop LED on the keypad glow af ter the device is switched on?

- if not: - refer to "Device cannot be switched on ....”

(if the green Start LED glows CardioProm c an also be defective)

- contrast badly adjusted (adjust cont rast)

- graphics display: can the background illumination be activated by pressing a key?

- does a beep sound approx. 10s after switc hing on the CardioSmart? (indicates that the self-test is over)

- if so: - display correctly engaged?

- if so: ===> display defective? ===> or driver on the PCB Control defective

- if not: - error in basic device: ===> PCB Control defective? ===> or CardioProm defective

E rror in self- te st ide ntifie d

When an error is detected during the self-test, in addition to the message “Self-test failed” the error code number and a short description also appear on t he display. The meaning of the error codes is described in Sect ion 3.1.7 / 3.2.7. The error codes refer to the PCB Control, graphics dis play and the CardioProm:

- error code 1, 2: PCB Control

- error code 3: PCB Graphics Display

- error code 6,7,8: CardioProm

Ca rdioS ma rt fa ils to give printout, no pape r tra nsport

Perform the following test in the manual operating mode:

- Paper available? Paper correctly inserted? P aper transport defective?

- Paper feed flap correctly engaged on bot h sides?

- after pressing the Start key the green Start LED must glow

- if not: ===> CardioProm defective? ===> or PCB Control defective

- Power supply +/-12V at test c onnector AF/pin 1 and pin 3 of PCB Control

available?

- if not: - Signal REG _ON on high-level? (Measure at connector AE/ pin 2)

- if not: ===> CardioProm defective? ===> or PCB Control defective

- Signal REG_OFF on high-level (Measure at connec tor AE/pin 11)

- if not: ===> Battery depleted or defective? ===> or PCB Power Supply defective

- Motor feed line defective? Connector AK plugged in correctly?

- Motor blocked? (check roller, transmiss ion)

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- Measuring voltage COMMON_S at test connector AF/pin 4 of the PCB Control available in the range 16V ... 23V?

- if so: ===> Motor defective? ===> or PCB Control defective (Motor controller)

- if not: - Battery v oltage too low, recharge

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P ape r tr ansport f unctions, no printout

- Paper feed flap correctly engaged on bot h sides?

- Printhead impact pressure switch OK? In addition, in the system test Sections

3.1.4/3.2.4 use the “K” key to check whether opening/closing of the s witch is identified.

- if not: - Is connector AJ on PCB Control inserted c orrectly?

- Good feed line contact on printhead impact pres sure switch?

- Printhead impact pressure switch def ective?

- Printhead power supply on? Measurement at plus terminal of C500 on PCB Control, voltage in range 16V ... 23V

- if not: - Signal REG_ON on high-level? (Measure at connector AE /pin 2)

- if not: ===> CardioProm defective? ===> or PCB Control defective

- Signal REG_OFF on high-level? (Measure at connec tor AE/pin 11)

- if not: ===> Battery depleted or defective? ===> or PCB Power Supply defective

- if both signals are on high:

===> PCB Control defective (common/VDD1 switch)

- Printhead power supply cable (connector AO ) defective, or not plugged in correctly?

- Printhead data feed line (connector AL) defec tive, or not plugged in correctly?

- After an extensive printjob, printhead still overheated? Allow to cool.

- none of the above-mentioned errors apply:

===> PCB Control defective? ===> or thermal array printhead defective

C ardioS ma rt only print s on the upper or lowe r se ction of t he print out

- Paper feed flap is only engaged on one side.

C ardioS ma rt print s, but only ba se lines a re printe d out

- Electrodes applied correctly?

- Electrode cables plugged into the patient t runk cable terminal box correctly?

- Patient trunk cable defecti ve (e.g., N core defective)

- Contact problems at the patient input of the CardioSmart?

- none of the above-mentioned errors apply: ===> PCB Control defecti ve

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6 . Adjustme nt instructions

CardioSmart only requires motor adjustment. Adjustment is necessary when a new motor (replacement of paper feed flap) or a new PCB Cont rol is implemented.

Motor Adjustme nt

What to adjust or to check?

Motor speed under small load, slow down driving roller by applying a finger (recorder flap open), adjust on stationary motor pinion.

Adjust motor speed on the slowed down driving roller, so that there is no difference in the RPM. Slow down the driving roller with a finger sufficiently, so that the LED500 just remains illuminated. (Recorder flap open)

What to measure with?

Flash at motor pinion with a stroboscope (LED)

see above

How to adjust test mode?

1. Shift + Auto

2. “3" key

3. “A” key

4. With mm/s key adjust to 25mm/s 5. START key

see above

Where to turn? How much and

Speed adjuster R505

Speed compensation R506

exact?

Stroboscope frequency =

283.6 Hz

When an LED driven by a square-wave generator is used, a small key ratio should be observed.

see above

What else to note?

Motor should be at room temperature be switched on for only 5 s for each adjustment.

If the RPM has changed after compensation adjustment, it should be corrected again with R505.

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Whe n a stroboscope is not a va ila ble :

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What to adjust or to check?

Adjust motor speed with the recorder flap closed.

With an increased load adjust motor speed (additional speed reduction, finger on the driving roller until LED 500 just goes out)

What to measure with?

Check the measurements of the grid with a ruler. min. 200mm

see above

How to adjust test mode?

1. Shift + Auto

2. “3“ key

3. “A” key

4. With mm/s key adjust to 25mm/s 5. START key

see above

Where to turn? How much and

Speed adjuster R505

Speed compensation R506

exact?

< 0,5% Motor should be

see above

What else to note?

at room temperature be switched on for only 5 s for each adjustment.

The adjustment procedure is complete when the RPM is 25 mm/s both under normal and increased load.

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7 . S e rvicing a nd ma inte na nce

7.1 Technical inspection

A technical inspection is to be perf ormed once a year. The following items, including the accessories used, are to be performed:

- Check device and accessories for mechanic al defects which impair their function.

- Perform a function check as det ailed in Section 3 “System test f unctions”.

- Check labels and inscriptions on the device relat ing to safety are clearly legible.

- Measure the resistance of the non-fus ed earth conductor as per measuring circuit

from VDE 0751:1990

- Measure the device leakage current as per measuring circ uit from VDE 0751:1990

- Measure the patient leakage current as per measuring circ uit fromVDE 0751:1990

Warning!

The following checks may only be performed by persons whose training, knowledge and practical experience enable them to carry out such checks reliably and correctly.

Notes:

The operational and functional reliability of the device is checked using the following checklists. They serve the experienced technician when chec king the device. A knowledge of device operation as detailed in the “Us er’s Manual” is assumed.

The checklist items are based on the tes ting instruments given below. The tests should be carried out using the cus tomer’s accessories, so that defec tive accessories are also detected automat ically. If other testing instruments are used besides those mentioned, the items on the c heck list and tolerance specifications may need to be modified.

7.1.1 Visual check

Device and accessories are to be c hecked to ensure that

- fuse cartridges comply with vendor’s spec ifications;

- labels and inscriptions on the device relating t o safety are clearly legible;

- the mechanical state of the device permit s its further use;

- there is no fouling which could cause any reduction in s afety.

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7.1.2 Test functions

7 . 1 . 2 . 1 R e comme nde d te sting instr ume nts a nd a cce ssorie s

1x Multi-parameter simulator Lionheart 1x RS232 interface connec tor with internal connection between pins 2 and 3

(TXD and RXD)

1x Patient t runk cable and customer electrode leads,

or 1X patient trunk cable, 10-pin 233 402 04 with 1 set of electrode leads (10 leads) with 4 mm plugs 38401129

1x Pneumatic Transdurcer Tester P TT, for example: X - Caliber (Display in mmHg)

1x 1 x Y-Adapt er 303 444 89

7.1.2.2 Test preparations

The following descriptions apply to device vers ion V1.2 and software version V4.2. In general, the device test funct ions implemented in CardioSmart are used for the test s.

These are described in Section “3. Device t est functions”. Connect CardioSmart up to the mains, t he green LED for standby must glow.

Switch the device on, the self -test runs automatically, no error mess age should appear. When the self-test has finished t he device is in the automatic mode, the yellow LE D for still disabled operating mode must glow.

Modifications in the user-programmed configuration may need to be made in order to carry out the test. S hould such a change need to be made to enable testing, make a printout of all the modified configuration list s and mark the changes made.

Important: After completing the test t he original user-programmed configuration is to

be retrieved and activated.

7. 1 . 2 . 3 O pe ra ting a nd displa y unit pe rforma nce te sts

- Carry out the “Display test (1)” as detailed in S ections 3.1.3 and 3.2.3, respect ively.

- Carry out the “Keypad test (2)” as det ailed in Sections 3.1.4 and 3.2.4, respec tively.

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7.1.2.4 Test for recording speeds 25 and 50 mm/s

- Carry out the “Mot or test (3)” as detailed in Sections 3.1. 5 and 3.2.5, respectively.

- Enable measurement marks by pressing the “A” key.

- Should there be feed speed dev iations of > 2%, adjust motor as det ailed in Section

“6 Adjustment instructions”.

7. 1 . 2 . 5 D e vice te st re sult che ck

- Output “Test results 4)” as detailed in Sections 3.1. 6 and 3.2.6, respectively.

- Main parameters: - all memory stores free from error?

- ASIC test O.K?

- Sample rate 1000?

- Selected time constants: 2.04 s (or 4.08 s)?

- Printhead voltage > 18V, battery c harge O.K?

- Printout clearly legible and without any lapses or

interference?

7.1.2.6 RS232 interface test

- Carry out the “I nterface test (6)” test item “(1) Transmit ting and receiving”.

Note: For devices with CardioProms V3.0x the RS232 driver is not yet tested in

this test; therefore, in t his case test item “(3) Transmitting and receiving wit h device” should be carried out.

- Remote start input test:

- Adapt push button (NO contact ) between RS232 interface pin 8 and pin 5

- Select manual mode

- Press push button once: initiates recording in manual mode

- Press again: terminates recording in manual mode

7.1.2.7 Analysis of the ECG signals and HR value

Carry out the following settings on the E CG simulator:

- Amplitude 1 mV

- Heart rate (RATE) 60 bpm

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Connect the electrode leads as indicated below:

R red -----> RA L yellow -----> LA F green -----> LL N black -----> RL C1 white/red -----> V1

: : :

C6 white/violet -----> V6

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Switch in By pressing the lead scrolling key check whether all leads

The ECG traces must be

Record one page in the “manual” operating mode. The following annotations must be present:

- Heart rate (top right)

- Lower status line - date and time

The recording.

Activate the square-wave func tion on the ECG transmitter at 1 mV . Using the lead scrolling key select lead II. The square-wave pulse trace must correspond in transmitter only).

manua l ope ra ting mode and start recording by pressing the Start key.

are being recorded.

noise-free .

- recording speed

- sensitivity

- active filter, e.g., 50/ 60 Hz, 35/20 Hz, ADS

- frequency range of the recording (not at SW lev el V3.0x)

hea rt ra te of 60 bpm +/ - 2 bpm appears on the display and is printed out on the

amplitude with the displayed 1 mV reference pulse (applicable to named

Switch back to ECG s ignal on the ECG transmitter. Start the recording in manual mode. Increase the

signal

signal no longer sounds.

must sound for about 1s. Reduce the heart rat e back to 60 bpm, the warning

heart rate to 200 bpm on t he ECG transmitter. The acous tic wa rning

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7.1.2.8 Pacemaker identification test

Make the following settings on the multif unction simulator:

- pace setting

- pace amplitude 6 mV

- pace duration 0.2 ms

Adjust manual mode on CardioSmart device to be t ested and select lead groups I, II and III. Start the recording. The pace pulses must be visible as needles on the recording output.

7. 1 . 2 . 9 I de ntifica tion of disconne cte d e le ctrode s

Reset the simulator to ECG s ignal at a heart rate of 60 bpm. Remove one electrode after the other from the ECG t ransmitter.

Activate the automatic mode in t he CardioSmart device to be tested without activating it by pressing the Start k ey. Check to ensure that each disconnect ed electrode is displayed correctly and that an acoustic alarm signal sounds.

7.1.2.10 Checking the charge status of the NC battery

The NC battery can, among other things, be chec ked as follows: discharging the battery, followed by charging up c ompletelyl (duration 4 h), followed by discharging in standby mode without recording. If the operating time for this procedure is under 2.5 h, the battery should be replaced.

7.1.2.11 Pump leakage

Start the pump by< blowing against the suction pipe still open and then closing the pipe with your finger as shown in the test set up (within 3 s). Take the negative pressure reading at PTT after approx. 10 s. This value must lie within the range

225...265 mmHg (300...350 mbar). Then switch off the negative pressure pump (ECG

recorder or power supply unit). The drop in negative pressure must not exceed max. 1 mmHg/s (1.33 mbar/s).

I f this va lue is not observe d, the pump in the C a rdioS ma rt must be re pla ce d .

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7.1.3. Safety Analysis Test

7.1.3.1 General Information

The suggested Safety Analysis Test refer to the international Standard IEC 601-1. The tests are generally performed with Safety Testers, on most of them, the measuring circuits according IEC 601 are already implemented. The tests which have to be performed are described generally, for the handling of your Safety Tester follow the user manual.

The tests may be performed under normal ambient conditions of temperature, humidity and pressure and with line voltage. The leakage currents correspond to 110 % of rated voltage for the tested unit. Most Safety Testers take this into account, otherwise the measured values have to be calculated.

Re comme nde t te st e quipment

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- Safety Tester for measurements according IEC 601.

- Testing connector according the following description.

Te sting conne ctor for me a suring patie nt le a ka ge current.

For testing the ECG input,a patient cable, with all leads connected together,is used.

7.1.3.2 Protective earth resistance te st

The protective earth resistance test has to be performed including its power cord. This test determins whether the device has a power ground fault.

- The protective earth resistance from power connector to any protective earth

connected exposed conductive part is measured.

- Specs. of test circuit: AC current source 50 Hz/60 Hz of at least 10 A up to 25

A with limited output voltage of 6 V.

- If resistance is greater than 100 mOhm

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7.1.3.3 Measuring of leakage current

To proceed the suggested measurements, the unit under test has to be separated from any interconnection to a system. If the unit is part of a system, extended tests according IEC 601-1-1 have to be performed. The following diagram shows the needed Measuring Circuit [M] for leakage current. The reading in mV corresponds to uA (leakage current). The Safety Testers generally work with this Measuring Circuit [M] and the displayed values are already converted to leakage current.

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7.1.3.3.1 Enclosure Leakage Current Test

This test is performed to measure leakage current from chassis to ground during normal conditions (N.C.) and single fault conditions (S.F.C.). In any case, the leakage current is measured from any exposed conductive parts to ground, the unit under test has to be switched on and off.

Connect the unit under test to your Safety Tester.

- During normal conditions (N.C.), referring to the electrical diagram, measurements

have to be done under following conditions:

* Polarity switch Norm and RVS * GND switch GND closed * S1 closed and open

- During single fault conditions (S.F.C.), referring to the electrical diagram, the

measurements have to be done under following conditions: * Polarity switch NORM and RVS

* GND switch GND open * S1 closed

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Test has failed if the measured values are greater than: N.C. S.F.C

100 µA 500 µA

300 µA (U.L. requirements)

Electrical diagram for Enclosure Leakage Current Test

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7.1.3.3.2 Patient Leakage Current Test

This test performs a leakage current test under single fault conditions (S.F.C.) dependent of domestic power outlet with 115 or 230 V AC as source into the floating inputs.

In any case, the leakage current is measured from Input Jack, of unit under test, to ground.

For testing the ECG input, a patient cable, with all leads connected together, is used. Connect the unit under test to your Safety Tester.

- Referring to the electrical diagram, measurements have to be done under following

conditions * Polarity switch NORM and RVS * GND switch GND closed *S1 closed

Test has failed if the measured values are greater than 50 µA

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Electrical Diagram for Patient Leakage Current Test

For protection of the test person the following values of resistor R may be used:

Page 69

Typ BF 22 kOhm (120 to 130 V) 47 kOhm (220 to 240 V) Typ CF 100 kOhm (220 to 240 V)

7 .2 M a inte na nce , cle a ning, disinfe ction

CardioSmart maintenance, cleaning, disinfection is performed in accordance with the

CardioSmart or CardioSmart ST User’s Manual, Chapter 11, "Cleaning, disinfection and maintenance", as applicable.

Applications requiring extensive recordings may result in deposits on the thermal array printhead which normally do not, however, have any adverse effect on the printing quality. This can be removed with a soft, fluff-free cloth soaked in an alcohol-based cleaning agent (e.g., surgical spirit).

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Servicing Instructions

8. Parts Lists

Part Number Description

CardioSmart

101 116 01 CardioSmart (int.) Basic unit without Pump 101 116 02 CardioSmart (USA) Basic unit without Pump 101 116 03 CardioSmart (russ.) Basic unit without Pump 101 116 04 CardioSmart (int), Basic unit with Pump 101 116 05 CardioSmart (russ), Basic unit with Pump 101 116 06 CardioSmart ( Europe2 ) Basic unit without Pump 101 116 07 CardioSmart ( Europe2 ) Basic unit with Pump

CardioSmart ST

101 116 10 CardioSmart ST (int.) Basic unit Stress Test

without Pump

101 116 11 CardioSmart ST (int.) Basic unit Stress Test

with Pump

101 116 12 CardioSmart ST (USA.) Basic unit Stress Test

without Pump

101 116 13 CardioSmart ST (USA.) Basic unit Stress Test

with Pump

101 116 14 CardioSmart ST (russ.) Basic unit Stress Test

without Pump

101 116 15 CardioSmart ST (russ) Basic unit Stress Test

with Pump

101 116 16 CardioSmart ST (Europe 2.) Basic unit Stress Test

without Pump

101 116 17 CardioSmart ST (Europe 2.) Basic unit Stress Test

with Pump

101 116 18 CardioSmart ST (ASIA) Basic unit Stress Test

without Pump

101 116 19 CardioSmart ST (ASIA) Basic unit Stress Test

with Pump

User Manual CardioSmart:

227 435 15 User Manual CardioSmart (d) V 1.1 227 435 16 User Manual CardioSmart (e) V 1.1 227 435 17 User Manual CardioSmart (f) V 1.1 227 435 41 User Manual CardioSmart (d) V 1.3 227 435 42 User Manual CardioSmart (e) V 1.3 227 435 43 User Manual CardioSmart (f) V 1.3

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Servicing Instructions

227 435 45 User Manual CardioSmart (i) V 1.3 227 435 46 User Manual CardioSmart (sp) V 1.3 227 43518 User Manual CardioSmart (USA) V 1.3 227 435 52 User Manual CardioSmart (e) for UK V 1.3 227 435 53 User Manual CardioSmart (f) for BeneluxV 1.3 227 435 58 User Manual CardioSmart (sw) V 1.3

User Manual CardioSmart ST:

227 465 01 User Manual Cardio Smart ST ( d ) V. 1.2 227 465 02 User Manual Cardio Smart ST ( e ) V. 1.2 227 465 03 User Manual Cardio Smart ST ( f ) V. 1.2 227 465 11 User Manual Cardio Smart ST ( d ) V. 1.3 227 465 12 User Manual Cardio Smart ST ( e ) V. 1.3 227 465 13 User Manual Cardio Smart ST ( f ) V. 1.3 227 465 15 User Manual Cardio Smart ST ( i ) V. 1.3 227 465 16 User Manual Cardio Smart ST ( sp ) V. 1.3 227 465 24 User Manual Cardio Smart ST (US) V. 1.3 227 465 17 User Manual Cardio Smart ST (russ) V. 1.3 227 465 32 User Manual Cardio Smart ST (e) for UK V. 1.3 227 465 33 User Manual Cardio Smart ST (f) for Benelux V. 1.3 227 465 38 User Manual Cardio Smart ST (sw) V. 1.3 227 465 42 User Manual Cardio Smart ST (asia) V. 1.3 227 435 11 Service Manual .d/e, 101116.. Cardiosmart

Housing / Driving unit

432 521 90 Unter -case shell 924 017 14 Rubber foot 432 521 98 Battery cover 303 445 33 Upper case with keypad (russ)

303 443 18 Upper case with keypad (Int) 303 444 50 Upper case with keypad (USA) 303 446 14 Upper case with keypad (Europe 2) 303 445 34 Upper case with keypad ST (Int ) 303 446 16 Upper case with keypad ST (Russ) 303 44617 Upper case with keypad ST (Europe2) 303 44615 Upper case with keypad ST (US) 303 446 13 Upper case with keypa ST (ASIA) 303 443 19 Handle 303 443 20 Drive Flap 303 438 29 Code reader

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Servicing Instructions

303 442 79 Motor 914 326 69 Microswitch 432 523 54 Stop for Microswitch 801 777 62 Screw for Stop 432 522 05 Plate for Driver Flap 504 657 60 Tinplate 929 166 45 Luer- connection kit ( female ) 929 166 54 Luer-cap

Electronic components / pcb‘s

929 166 40 Line filter with fuse holder 914 325 94 Rocker switch 303 442 71 Comb 303 442 70 Battery 388 029 10 pcb.Printhead connection 388 028 14 pcb. Power Supply

912 084 37 FuseT 4 A TR5 912 084 35 FuseT 1,25 A 912 084 04 FuseT 0,25 A 912 084 14 FuseT 0,5 A 388 028 12 pcb. Control (usable up to V 1.1 ) 389 004 05 Exchange pcb. Control (usable up to V 1.1 ) 303 446 18 pcb. Control ST (compatible for all CardioSmarts ) 389 004 16 Exchange pcb. Control ST (compatible for all CardioSmarts) 929 165 73 Battery 3 V 0,8 Ah 303 442 91 Pump 12 V (Standard)

Display-Modul Graphics

235 066 01 CardioVision Graphics -Module for CardioSmart 235 066 02 CardioVision Graphics -Module for CardioSmart( USA ) 388 028 87 pcb Mother board 388 028 11 pcb digital Display 930 117 17 LCD-Graphics Display 303 443 1 Upper-Case Part 303 442 80 Joint 432 522 01 Display Bottom Part 423 203 04 Insulation

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Display-Modul Text

235 06 701 CardioVision Text Display-Modul for CardioSmart 235 067 02 CardioVision Text Display-Modul for CardioSmart ( USA ) 388 028 88 pcb. Mother board 303 442 87 LCD Modul 432 522 03 Display Top Part 432 522 04 Display Bottom Part

931 098 80 Instrument Bag for CardioSmart, nylon material, with pockets for

accessories

Connectioncable ( for CardioSmart )

223 330 04 Connection cable M(L)700 - C’Smart(ST) 5m lang 223 362 03 Connection cable 5 m long for

CardioSmart to PC

223 366 04 Connection cable EC1200-CardioSmart(ST) 5m long 223 378 01 Connection cable for ECG- Transmission

CardioSmart to Modem ELSA,9 pin.,3m long

223 378 02 Connection cable for ECG- Transmission

CardioSmart to Modem Multitech 25 pin.,3m long

Connectioncable ( Only for CardioSmart-ST )

223 362 04 Connection cable EC(B)560/561-C’Smart ST 5m long 223 380 02 Connection cable ERG900(L) - C’Smart ST 5m long 223 368 02 Connection cable TM400AC - C’Smart ST 5m long 223 390 03 Connection cable T2000-CardioSmart ST 5m long,

(RS232 to RS 232)

384 017 67 Upgrade Interface Kit T 2000 (RS 422 to RS 232)

—> CardioSmart for 230 V

384 017 68 Upgrade Interface Kit T 2000 (RS 422 to RS 232)

—> CardioSmart für 115 V

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9. Technical Specifications

For operation of the CardioSmart it is necessary to

plug in one CardioProm module and one of the

two available displays. The following technical

specifications apply to all CardioSmart versions.

Recording

direct recording of waveforms and alphanumeric characters with rectangular coordinates by means of thermal-array printhead printing on thermosensitive paper.

* recording channels: 3 or 6, 12 in automatic mode;

overlapping

* space between baselines3 channels: 62 mm

(arrhythmia)

6 channels: 31 mm (manual)

12 channels: 16 mm (auto.)

* writing width 200 mm max.

* annotation of device settings, date, time of day

and patient name, if entered, in margin of recording strip

To prevent debris from collecting on the printhead, use the Marquette Hellige CONTRAST chart paper only!

Chart transport

* paper speed

5  25  50 mm/s (key-selectable) error limits at 25 and 50 mm/s typically ±1%

at 5 mm/s ±10% max.

* when supply of chart paper is depleted, recorder

switches off and sounds an alarm; the last pages of the pad bear a red stripe in the margin

Membrane keypad

membrane keys with tactile feedback

* function keys for all important routine operations

* alphanumeric keypad for entry of texts

Display

alphanumeric LCD, 2 x 40 characters, contrast adjustable, or

* with appropriate software module documentation

of analysis results and report in each mode on separate pages

* resolution of the recording:

vertically 8 dots/mm horizontally 25 µm at 25 mm/s

Chart paper

Marquette Hellige CONTRAST® Z-fold pad, 150 pages per pad, equivalent to a chart length of 45 m

paper width 210 mm or 8.5 in. (US format) sheet length 300 mm or 11 in. (US format)

graphics display for 24 x 40 characters, contrast adjustable

resolution of 320 x 240 pixels, backlit

Indicators (LEDs)

for mains supply, battery charge level and start/stop function

Lead selection

manual selection of individual lead groups or automatic sequencing of lead groups

* lead programs (c):

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EINTHOVEN, GOLDBERGER, WILSON, NEHB, CABRERA lead sequence, custom lead programs in manual mode

Automatic functions

assisting and facilitating device operation:

* automatic amplifier blocking

* automatic lead sequencing, paper feed, calibra-

tion (c)

* report formatting (c)

* automatic baseline adjustment

* anti-drift system compensating for polarization

voltage fluctuations (c)

Detection of pacing pulses

* electrode connections for R, L, F, N, C1 to C6,

Nax, Nst and Nap (=C4)

* input impedance for differential signals applied

between any two electrode connections >10 MΩ for 10 Hz

* input impedance for common-mode signals re-

ferred to N >50 MΩ for up to 60 Hz

* dynamic range for differential signals between any

two electrode connections for AC voltage ±10 mV, for superimposed DC voltage (polarization voltage) ±600mV

* dynamic range for common-mode signals referred

to N±1V, referred to chassis 263 V AC voltage (rms)

* quiescent input current via any electrode connec-

tion for 1-kΩ termination referred to N <50 nA

* pulse duration between 0.1 and 2.5 ms

* marks irrespective of pulse polarity

* pulse amplitude between ±5 mV and ±700 mV

Heart-rate display

derivation of the heart rate from all ECG signals

* display range 30 to 300 BPM

* display update with every heart beat, max. every 2

Signal inputs

isolated patient signal input, type CF according to IEC, high-voltage protection for all lead connections and Nelectrode connection, interference compensation via neutral electrode (N), monitoring for detection of open leads

* patient leakage current (rms values) according to

IEC class CF: under normal conditions <10 µA, in single-fault condition (e.g., patient in contact with line voltage) <20 µA

* non-destructive range for lead-electrode connec-

tions and the N-connection referred to N ±50 V, referred to chassis ±1500 V

* pulse voltage resistance of all lead-electrode

connections and of the N-connection referred to chassis (e.g., defibrillation) 5000 V

* monitoring of each electrode for disconnection: R,

L, F, N, C1, C2, C3, C4, C5, C6, Nap, Nax, Nst audible alarm signal upon program start

Data interface

one serial RS 232 interface for exchange of data with adapted peripherals and software handshake

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Servicing Instructions

RS 232 interface (standard V.24 interface):

* input voltage range ±15 V max.

* output voltage range ±5 V min.

* ESD interface protection for up to ±10 kV

Remote start

remote start connection for paper feed (irrespective of selected operating mode), external make contact referred to chassis via circuit reference:

* source impedance R

* dwell of contact >100 ms

* non-destructive load ±10 V

<300 Ω

* low cut-off frequency (-3-dB limits) 0.08 Hz,

equivalent to a time constant of 2.04 s

* high cut-off frequency (-3-dB limits)

in Auto and manual modes: 150 Hz (IEC/AHA) in Arrhy mode: 100 Hz (IEC)

* signal sampling rate 1000/s

* resolution, referred to the input, 5 µV

* output rate to recorder 2000/s

* for all leads adjustment of sensitivity in four steps:

40-20-10-5 mm/mV

* with muscle filter (low-pass characteristic)

switched on, 3-dB drop of the amplitude frequency response at approx. 35 Hz or 20 Hz

* ESD interface protection up to ±10 kV max.

Pin assignment of data port

2 RXDE 3 TXDE 5 circuit reference 8 remote start

Signal transmission

Patient signal input to recording

after lead formation and digitization simultaneous transmission of all electrode signals to the digital processing system; muscle filter, AC filter, pacing pulse identification, automatic or manual sensitivity adjustment, automatic baseline adjustment and drift compensation by means of the anti-drift system (A.D.S.) can be enabled or disabled simultaneously for all channels; digital output of processed signals via thermal-array printhead

* with AC filter switched on, identification and com-

pensation of periodic 50 or 60-Hz frequency components (depending on recorder model: attenuation > 40 dB)

* non-linear distortion below values specified in IEC

and AHA recommendations

* coincidence error limits between any two channels

±0.5mm

* identification of pacing pulses in C2 or other C-

leads and marking in all channels for signals referred to patient input: duration + 0.1 ms, amplitude > 5 mV

* noise in the signal-transmission path below values

specified in IEC and AHA recommendations: ≤ 2.5 µV rms

* common-mode rejection for 50 or 60-Hz signals

(depending on CardioSmart model) with AC filter switched on > 140 dB

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ECG calibration

automatic recording of a defined voltage step, valid for all channels

* calibration voltage of 1 mV, referred to ECG sig-

nal input

pulse width depending on paper speed 25 mm/s 5mm 50 mm/s 10mm 5 mm/s 1mm

Automatic sensitivity adjustment of ECG signals

automatic adaption of the signal gain in dependence of the incoming signal; highest amplitude of a lead group or of all leads determines gain

* automatic adjustment range 5 to 40 mm/mV

* amplitude range (6 channels) 18 to 31 mm

Blocking

rapid charge reversal of the coupling capacitors in the preamplifiers after electrode application

Electrode monitoring

audible and visual indication on the LCD of disconnected electrodes or line break; each single electrode is monitored

Text input

patient and user data as well as comments can be entered via the panel keyboard and are annotated on the recording strip

Copy function

in the automatic mode, after ECG recording, copies of the ECG can be printed from memory and/or transferred to a connected PC (c)

Baseline

automatic adjustment of the baseline to the optimal recording range, in dependence of the signal amplitude

Anti-Drift System (A.D.S.)

automatic compensation of baseline fluctuations caused by polarization voltage fluctuations at the lead electrodes (recording delay 4.2 s)

ECG storage

* in automatic mode storage of up to 45 ECGs

* stored ECGs can be deleted (individually or all in

one pass), printed, transferred or the patient data can be modified

* when memory is full user is informed of the possi-

ble actions

Test

automatic performance test upon power up, including verification of the signal path starting at the signal input

stored test data for demonstration of the device functions

Power

from the power line or from a built-in rechargeable battery, automatic switchover; automatic battery charging during line-power operation; no recording when battery depleted or missing

Line-power operation

* instrument design in protection class I according

to IEC601-1, internally powered equipment

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Servicing Instructions

rated voltage range 220 to 240 V

* operating voltage range 198 to 264 V;

49 to 65 Hz

* rated current 0.16 A

fuse 2 x T 0.25 A, 5 x 20

rated voltage range 110 to 120 V

* operating voltage range 99 to 132 V;

49 to 65 Hz

* rated current 0.32 A

fuse 2 x D 500 mA, 3 A-G

* power consumption typically:

during battery charging 15 W device turned on 13 W

* max. power consumption 28 W

Battery-power operation

Operational readiness

after successful selftest within 10 s of power-up

Operating position

horizontal

Environment

Operation

* ambient temperature between +10 and +40 °C

* rel. humidity between 25 and 95%

* atmospheric pressure between 700 and 1060 hPa

Storage and transport

* battery type nickel cadmium

* rated battery voltage 18 V

* rated battery capacity 1.4 Ah

* fully charged battery sufficient for up to 50 auto-

matic ECG recordings, if device is switched on only for recording

* battery charging time

approx. 4 hours

* (min. charging time for recording of one automatic

ECG 10 min)

* battery life approx. 2 to 3 years, replacement by

service technician only

* battery for built-in clock: lithium battery, life of

approx. 5 years, replacement by service technician

* ambient temperature between -30 and +60 °C

(also with battery)

* rel. humidity between 25 and 95%

* atmospheric pressure between 500 and 1060 hPa

Case dimensions

* width 370 mm

* height 95 mm

* depth 320 mm (incl. handle)

Weight

CardioSmart with battery and text display approx. 5.3 kg CardioSmart with battery and graphics display approx.

5.6 kg

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Servicing Instructions

CardioSmart ST

For operation of the CardioSmart ST it is neces-

sary to plug in one CardioProm module and one of

the two available displays. The following technical

specifications apply to all CardioSmart ST ver-

sions.

Recording

direct recording of waveforms and alphanumeric characters with rectangular coordinates by means of thermal-array printhead printing on thermosensitive paper.

* recording channels: 6, 12 in automatic mode;

overlapping

* space between baselines6 channels: 31 mm

(manual)

12 channels: 16 mm (auto.)

* writing width 200 mm max.

* annotation of device settings, date, time of day

and patient name, if entered, in margins of recording strip

To prevent debris from collecting on the printhead, use the HELLIGE CONTRAST chart paper only!

Chart transport

* paper speed

5  25  50 mm/s (key-selectable) error limits at 25 and 50 mm/s typically ±1%

at 5 mm/s ±10% max.

* when supply of chart paper is depleted, recorder

switches off and sounds an alarm; the last pages of the pad bear a red stripe in the margin

Membrane keypad

membrane keys with tactile feedback

* function keys for all important routine operations

* alphanumeric keypad for entry of texts

Display

graphics display for 24 x 40 characters, contrast adjustable

* with appropriate software module documentation

of analysis results and report in each mode on separate pages

* resolution of the recording:

vertically 8 dots/mm horizontally 25 µm at 25 mm/s

Chart paper

HELLIGE CONTRAST® Z-fold pad, 150 pages per pad, equivalent to a chart length of 45 m

paper width 210 mm or 8.5 in. (US format) sheet length 300 mm or 11 in. (US format)

resolution of 320 x 240 pixels, backlit

Indicators (LEDs)

for mains supply, battery condition and start/stop function

Lead selection

manual selection of individual lead groups or automatic sequencing of lead groups

* lead programs (c):

EINTHOVEN, GOLDBERGER, WILSON, NEHB, CABRERA lead sequence and custom lead programs in manual and stress test mode

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Automatic functions

assisting and facilitating device operation:

* automatic amplifier blocking

* automatic lead sequencing, paper feed, calibra-

tion (c)

* report formatting (c)

* automatic baseline adjustment

* anti-drift system compensating for polarization

voltage fluctuations (c)

Detection of pacing pulses

* pulse duration between 0.1 and 2.5 ms

* marks irrespective of pulse polarity

* pulse amplitude between ±5 mV and ±700 mV

* input impedance for differential signals applied

between any two electrode connections >10 MΩ for 10 Hz

* input impedance for common-mode signals re-

ferred to N >50 MΩ for up to 60 Hz

* dynamic range for differential signals between any

two electrode connections for AC voltage ±10 mV, for superimposed DC voltage (polarization voltage) ±600mV

* dynamic range for common-mode signals referred

to N±1V, referred to chassis 263 V AC voltage (rms)

* quiescent input current via any electrode connec-

tion for 1-kΩ termination referred to N <50 nA

* patient leakage current (rms values) according to

IEC class CF: under normal conditions <10 µA, in single-fault condition (e.g., patient in contact with line voltage) <20 µA

Heart-rate display

derivation of the heart rate from all ECG signals

* display range 30 to 300 BPM

* display update with every heart beat, max.

every 2 s

Signal inputs

isolated patient signal input, type CF according to IEC, high-voltage protection for all lead connections and N-electrode connection, interference compensation via neutral electrode (N), monitoring for detection of open leads

* electrode connections for R, L, F, N, C1 to C6,

Nax, Nst and Nap (=C4)

* non-destructive range for lead-electrode connec-

tions and the N-connection referred to N ±50 V, referred to chassis ±1500 V

* pulse voltage resistance of all lead-electrode

connections and of the N-connection referred to chassis (e.g., defibrillation) 5000 V

* monitoring of each electrode for disconnection: R,

L, F, N, C1, C2, C3, C4, C5, C6, Nap, Nax, Nst audible alarm signal upon program start

Data interface

one serial RS 232 interface for exchange of data with adapted peripherals and software handshake

RS 232 interface (standard V.24 interface):

* input voltage range ±15 V max.

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* output voltage range ±5 V min.

* ESD interface protection for up to ±10 kV

Remote start (hardware)

remote start connection for paper feed (depending on selected operating mode), external make contact referred to chassis via circuit reference:

* source impedance R

* dwell of contact >100 ms

* non-destructive load ±10 V

* ESD interface protection up to ±10 kV max.

Pin assignment of data port

<300 Ω

2 RXDE 3 TXDE 5 circuit reference 8 remote start

* high cut-off frequency (-3-dB limits)

in Auto and manual modes: 150 Hz (IEC/AHA) in stress test mode: 75 Hz (IEC)

* signal sampling rate 1000/s

* resolution, referred to the input, 5 µV

* output rate to recorder 2000/s

* for all leads adjustment of sensitivity in four steps:

40-20-10-5 mm/mV

* with muscle filter (low-pass characteristic)

switched on, 3-dB drop of the amplitude frequency response at approx. 35 Hz or 20 Hz

* with AC filter switched on, identification and com-

pensation of periodic 50 or 60-Hz frequency components (depending on recorder model: attenuation > 40 dB)

* non-linear distortion below values specified in IEC

and AHA recommendations

Signal transmission

Patient signal input to recording

* low cut-off frequency (-3-dB limits) 0.08 Hz,

equivalent to a time constant of 2.04 s

* coincidence error limits between any two channels

±0.5mm

* identification of pacing pulses in C2 or other C-

leads and marking in all channels for signals referred to patient input: duration + 0.1 ms, amplitude > 5 mV

* noise in the signal-transmission path below values

specified in IEC and AHA recommendations: ≤ 2.5 µV rms

* common-mode rejection for 50 or 60-Hz signals

(depending on CardioSmart ST model) with AC filter switched on > 140 dB

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ECG calibration

automatic recording of a defined voltage step, valid for all channels

* calibration voltage of 1 mV, referred to ECG sig-

nal input

pulse width depending on paper speed 25 mm/s 5 mm 50 mm/s 10 mm 5 mm/s 1 mm

Automatic sensitivity adjustment of ECG signals

automatic adaption of the signal gain in dependence of the incoming signal; highest amplitude of a lead group or of all leads determines gain

* automatic adjustment range 5 to 40 mm/mV

* amplitude range (6 channels) 18 to 31 mm

Baseline

automatic adjustment of the baseline to the optimal recording range, in dependence of the signal amplitude

Anti-Drift System (A.D.S.)

automatic compensation of baseline fluctuations caused by polarization voltage fluctuations at the lead electrodes (delay in recording: 4.2s)

* when memory is full user is informed of the possi-

ble actions

Blocking

rapid charge reversal of the coupling capacitors in the preamplifiers after electrode application

Electrode monitoring

audible and visual indication on the LCD of disconnected electrodes or line break; each single electrode is monitored

Text input

patient and user data as well as comments can be entered via the panel keyboard and are annotated on the recording strip

Copy function

in the automatic mode, after ECG recording, copies of the ECG can be printed from memory and/or transferred to a connected PC (c)

Test

automatic performance test upon power up, including verification of the signal path starting at the signal input

stored test data for demonstration of the device functions

ECG storage

* in automatic mode storage of up to 45 ECGs

* stored ECGs can be deleted (individually or all in

one pass), printed, transferred or the patient data can be modified

Power

from the power line or from a built-in rechargeable battery, automatic switchover; automatic battery charging during line-power operation; no recording when battery depleted or missing

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Line-power operation

* instrument design in protection class I according

to IEC601-1

* rated voltage range 220 to 240 V * operating voltage range 198 to 264 V;

49 to 65 Hz

* rated current 0.16 A

fuse 2x slow-blow 0.25A, 5 x 20

* rated voltage range 110 to 120 V * operating voltage range 99 to 132 V;

49 to 65 Hz

* rated current 0.32 A

fuse 2 x D500mA, 3AG

* power consumption typically:

during battery charging 15 W device turned on 13 W

* max. power consumption 28 W

Battery-power operation

* rated battery voltage 18 V

* battery for built-in clock: lithium battery, life of

approx. 5 years, replacement by service technician

Operational readiness

after successful selftest within 10 s of power-up

Operating position

horizontal

Environment

Operation

* ambient temperature between +10 and +40 °C

* rel. humidity between 25 and 95%

* atmospheric pressure between 700 and 1060 hPa

Storage and transport

* ambient temperature between -30 and +60 °C

(also with battery)

* rated battery capacity 1.4 Ah

* fully charged battery sufficient for up to 50 auto-

matic ECG recordings, if device is switched on only for recording

* battery charging timeapprox. 4 hours

* (min. charging time for recording of one automatic

ECG 10 min)

* battery life approx. 2 to 3 years, replacement by

service technician only

* rel. humidity between 25 and 95%

* atmospheric pressure between 500 and 1060 hPa

Case dimensions

* width 370 mm

* height 95 mm

* depth 320 mm (incl. handle)

Weight

CardioSmart ST with battery and graphics display approx. 5.6kg

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10. Device Documents

The following documents are enclosed:

- Entire instrument mechanical specifications:

- Assembly drawing: 101 116 01...19

- Entire instrument wiring specifications: 101 116 01...07/10...19 S Sheet 1

- Master Record Index: MRI V1.0 101 116 01...03 S Sh. 2 MRI V1.1 101 116 01...05 S Sh. 3 MRI V1.2 101 116 01...05/10...13 S Sheet 4 MRI V1.3 101 116 01...07/10...19 S Sheet 5,6

- PCB Control CS: 388 028 12 P Sh. 1/8 and Sheet 8/8

388 028 12 R Sh. 1/2 and Sheet 2/2

- PCB Control CS_S: 388 032 13 P Sh. 1/8 and Sheet 8/8

388 032 13 R Sh. 1/2 and Sheet 2/2

- PCB Power Supply CS: 388 028 14 P

388 028 14 R

Note on Master Record Index (MRI)

MRI modified/new functions PCB Control used

MRI V1.0 CardioSmart w/o remote start input 388 028 12, PCB Control CS

Device types 101 116 01...03 Device status V1.0

MRI V.1.1 CardioSmart with remote start input 388 032 12, PCB Control CS_S

and optional suction pump Device types 101 116 01...05 Device status V1.1

MRI V.1.1 CardioSmart with remote start input 388 032 13, PCB Control CS_S

and optional suction pump Device types 101 116 01...05 Device status V1.1

MRI V.1.2 CardioSmart ST with remote start input 388 032 13, PCB Control CS_S

and optional suction pump Device types 101 116 10...13 Device status V1.2

MRI V.1.3 CardioSmart with remote start input 388 032 13, PCB Control CS_S

and optional suction pump, additional Regional models Device types 101 116 10...13 Device status V1.2

and

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MRI V.1.3 CardioSmart ST with remote start input 388 032 13, PCB Control CS_S

and optional suction pump, additional Regional models Device types 101 116 10...13 Device status V1.2

For reference numbers, compatibilities and correspondence with the respective versions of the device, please refer to the appropriate Master Record Index.

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