Schiller AT-10 User Manual Issue f July 2003

SCHILLER

AT-10 User Guide Contents

Safety Notes Important Notes Major Sales and Service Centres

Chapter 1

Introduction and System Settings

Chapter 2

Electrode Attachment and Prerecording Preparations

Chapter 3

Recording of Resting ECGs

Chapter 4

Recording of Exercise ECGs

Chapter 5

Data Storage and transmission

Chapter 6

Recording of external DC signals

Chapter 7

Maintenance andTroubleshooting

Chapter 8

Technical Data

iii

SCHILLER Safety Notices Operational Precautions • Before using the unit, ensure that an introduction regarding the unit functions and the safety precautions has been provided by a product representative. • The guidelines for patient electrode placement are provided as an overview only. They are not a substitute for medical expertise. • It must be ensured that neither the patient nor the electrodes (including the neutral electrode) come into contact with other persons or conducting objects (even if these are earthed). • There is no danger when using the unit for a pacemaker patient or with simultaneous use of other electrical stimulation equipment. However, the stimulation units should only be used at a sufficient distance from the electrodes. In case of doubt, the patient should be disconnected from the recorder. • Do not operate the unit if the earth connection is suspect or if the mains lead is damaged or suspected of being damaged. • Do not use this unit in areas where there is any danger of explosion or in the presence of flammable gases such as anaesthetic agents. • Do not, under any circumstances, immerse the unit or cable assemblies in liquid. • This unit is CF classified and defibrillation protected. Where possible, remove electrodes before defibrillation. • Do not touch the casing during defibrillation. • If the patient cable is defective after defibrillation, ”Lead-off“ is displayed and an acoustic alarm is given. • This product is not designed for sterile use. • This product is not designed for outdoor use. • Surface temperature of applied parts does not exceed 41°C. • Power supply cord is hospital grade.

iv

SCHILLER Safety Notices Precautions for Operation with Other Devices • If several units are coupled there is a danger of summation of leakage currents. • When non-medical devices are connected to the RS-232 interface, ensure that both units are securely connected to the same earth potential. • External devices must only be connected using an original SCHILLER interface cable assembly. • Only use accessories and other parts recommended or supplied by SCHILLER AG. Use of parts other than those recommended or supplied may result in injury, inaccurate information and/or damage to the unit.

Maintenance Precautions • To prevent electric shock do not disassemble the unit. No serviceable parts inside. Refer servicing to qualified personnel only. • Switch the unit off before cleaning and disconnect from the mains. • Do not use high temperature sterilization processes (such as autoclaving). Do not use Ebeam or gamma radiation sterilization. • Do not use solvent cleaners. • Do not attempt to recharge the battery - danger of explosion. • Double pole / neutral fusing for continued protection against risk of fire, replace only with the same type and rating of fuses.

v

SCHILLER Important Notes Interference • This equipment has been tested and found to comply with the limits for a class A digital device, pursuant to both Part 15 of the FCC (Federal Communications Commission) Rules and the radio interference regulations of the Canadian Department of Communications. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. • This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with this instruction manual, may cause harmful interference to radio communications. • The unit complies with EMC regulations for medical products which affords protection against emissions and electrical interference. However, special care must be exercised when the unit is used with high frequency equipment. • Operation of this equipment in a residential area is likely to cause harmful interference in which case, the user will be required to correct the interference at his own expense.

Equipment Classification • Mode of operation: Continuous. • This unit is CF classified according to IEC EN 60601-1. This means that the patient connection is fully isolated and defibrillation protected. However, SCHILLER AG can only guarantee protection against defibrillation voltage when the original SCHILLER patient cable is used. 0123

93/42/EEC Medical Devices 0123 'Notified Body‘ TÜV P.S.

vi

SCHILLER Important Notes Disposal Instructions Units no longer required can be returned to SCHILLER AG for disposal. Alternatively, dispose of the unit in municipally approved recycling centres. Only dispose of batteries in official recycling centres or municipally approved areas. Alternatively, used batteries can be returned to SCHILLER AG for disposal. • The applicable local refuse disposal regulations must be observed. • Do not dispose of the battery by means of fire or incineration - danger of explosion!

Physicians Responsibility • This electrocardiograph is provided for the exclusive use of qualified physicians or personnel under their direct supervision. The numerical and graphical results and any interpretation given must not be considered in isolation but must be examined with respect to the patient‘s overall clinical condition. Preparation for the recording as well as the general quality of the recorded data are also factors which must be taken into consideration. • Making the diagnosis or obtaining expert opinion for the evaluation of the results and the initiation of suitable treatment if indicated are the sole responsibility of the physician. • Federal law in the USA restricts this device to sale by or on the order of a physician.

vii

SCHILLER Major Sales and Service Centres The SCHILLER sales and service centre network is worldwide. For the address of your local distributer, please contact your nearest SCHILLER subsidiary. In case of difficulty, a complete list of all distributors and subsidiaries is provided on our internet site www.schiller.ch or can be supplied from our head office.

SCHILLER AG Altgasse 68, CH-6341 Baar, Switzerland Tel: +4141 766 4242 Fax: +4141 761 0880 Email: [email protected]

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CARDIOVIT AT-10 July 2003

Chapter 1 Introduction and System Settings

CHAPTER 1 Introduction and System Settings Introduction ... 1.3 Location ... 1.3 Potential Equalisation ... 1.3

Accessories ... 1.4 Main Parts of the Unit ... 1.5 Liquid Crystal Display (LCD) ... 1.6 Screen Overview ... 1.6 Contrast Adjustment ... 1.7

Keyboard ... 1.8 Alphanumeric Keys ... 1.8 ON/OFF Keys ... 1.8 Replace Paper Key ... 1.8 Direct Function Keys ... 1.8 Control Keys ... 1.9 ECG Function Keys ... 1.10 Exercise ECG Function Keys ... 1.11 Further Function Keys ...1.11

External Connections ... 1.12 Rear Panel ...1.12 Side Panel ... 1.13

Menu Structure ... 1.14 Introduction ... 1.14 FNCT Menu ... 1.15 ECG Menu ...1.16 ECG Menu (Cont.) ...1.17 EXERCISE Menu ... 1.18

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Chapter 1 Introduction and System Settings

NIBP Menu ... 1.19 STORAGE Menu ... 1.20

Basic System Settings ... 1.21 Unit Configuration ... 1.21 Set Date and Time ... 1.22 User Identification ... 1.22 Store Unit Settings ... 1.22 Default Settings ... 1.22

ECG Settings ... 1.23 Programmable Lead Sequence ... 1.25 Filter Settings & Pacemaker Detection ... 1.26 Switching the Myogram Filter ON and OFF ... 1.27 Reset ECG Signal (Baseline Reset) ... 1.27

Macro Function ... 1.28 Store a Macro ... 1.28 Recall a Macro ... 1.29 Macro Example ... 1.30

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CARDIOVIT AT-10 July 2003

CARDIOVIT AT-10 July 2003

Chapter 1 Introduction and System Settings

INTRODUCTION The CARDIOVIT AT-10 is a technologically advanced, compact unit for cardiovascular and lung function diagnosis with the following features: •

Low weight and mains independent operation for portability.

•

Large, clear and bright LCD display for the simultaneous monitoring of up to 8 leads.

•

Simple menu guidance and direct function keys for ease of operation.

•

Intergrated thermal printer combined with several print functions and formats to ensure clear and precise documention of the data.

•

Video interface for the connection of an external video monitor and two DC input connections for on-screen presentation or printout of external signals.

•

Three RS-232 interfaces and one RS-422 interface for -

automatic ergometer control (bicycle or treadmill)

-

the connection of an external blood pressure measuring unit

-

data transmission/reception

•

Resting ECG and exercise ECG as standard software options.

•

Optional software for ECG measurement and interpretation, evaluation of exercise ECGs, pacemaker measurement, heart rate variability, late potential analysis.

•

Optional software for spirometry testing with or without respiratory resistance measurement.

•

Integration with SEMA - SCHILLER's data management system for verification and archiving of recorded data.

Location •

Do not keep or operate the unit in a wet, moist, or dusty environment. Avoid exposure to direct sunlight or heat from other sources.

•

Do not allow the unit to come into contact with acid vapours or liquids.

•

The AT-10 should not be placed in the vicinity of X-ray or diathermy units, large transformers or electric motors. It must also be positioned at least one meter from the mains supply.

Potential Equalisation The potential equalisation connector (provided at the rear of the unit) is marked with the symbol

. The yellow/green ground cable supplied as an

option (Art. No. 2.310005) fits to the connector. Using this connector, the ECG unit may be linked to the potential equalization connector of other mains powered equipment to ensure that all instruments are at the same earth potential.

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Chapter 1 Introduction and System Settings

ACCESSORIES The SCHILLER representatives in your country keep all parts and accessories for the AT-10 available in their stock. In case of a problem or if you require the address of your local representative, contact the SCHILLERheadquarters in Switzerland. The staff there will be happy to process your order and to supply you with information regarding all SCHILLER products. When ordering, please specify that the required item is for the AT-10 and advise the following details:

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•

Article Description

•

Article No.

•

Your Name, Address and Phone Number

ACCESSORIES

PART NO.

10-LEAD PATIENT CABLE WITH DETACHABLE LEADS PATIENT CABLE FOR RESTING ECG, BANANA TYPE PATIENT CABLE FOR STRESS TEST CLIP TYPE GROUND CABLE MAINS CABLE RECORDING PAPER SUCTION ELECTRODE EXTREMITY ELECTRODE RUBBER STRAPS ELECTRODE GEL (100ML) CARRYING CASE PROTECTIVE COVER

2.400034 2.400048 2.310005 2.300002 2.157012 2.155000 2.155003 2.155006 2.158005 2.156018 2.160008

SET COMPLETE WITH ELECTRODES AND GEL COMPRISING: 6 SUCTION ELECTRODES 4 EXTREMITY ELECTRODES 4 RUBBER STRAPS ELECTRODE GEL (100ML)

2.000011 (2.155000) (2.155003) (2.155006) (2.158005)

FOOTSWITCH

2.171005

CARDIOVIT AT-10 July 2003

Chapter 1 Introduction and System Settings

MAIN PARTS OF THE UNIT 2

1

3

4

5 6

1

Integrated thermal printer with paper tray Paper tray extends and retracts automatically at the press of a button.

2

Large, clear, tilt-up LCD screen

3

Back panel with -

mains connector and power switch

-

potential equalisation stud

-

interface for external video monitor

-

exercise testing interface

-

Data I/O socket ( QRS-trigger output, footswitch)

-

optional LAN connector (Local Area Network)

4

LCD contrast control

5

Side panel with

6

-

4 serial interfaces (3x RS-232, 1x RS-422)

-

2 DC inputs 0,5 V/cm

-

optional connector for flow sensor (for lung function testing)

-

patient cable input

Waterproof keypads

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Chapter 1 Introduction and System Settings

LIQUID CRYSTAL DISPLAY (LCD) Screen Overview The "resting ECG" mode is automatically selected each time the unit is switched on. The ECG signals are acquired, processed and displayed on the screen as shown in the example below. With no patient cable connected, the same display appears, however, without the ECG traces.

HR:

90

Mo

BPM

0.05 - 150 Hz

16.SEP.96

RESTING ECG

25 mm/s

10 mm/mV

CHANN.: 7

aVL -

V1

Top Part of Screen Status and operating information are permanently displayed in the top section of the screen. The left side displays the heart rate (HR) and specific measurement data (when recording an ECG in automatic mode). The right side is divided into the following fields (from top to bottom): •

date and time

•

mode of operation and, next right, remaining battery capacity as % of full battery capacity

•

message field (this displays any status or error messages)

•

status of capital letter lock ("CAPS" indicates capital letter lock on)

•

lead status (if a "LEAD OFF" status is detected, an audible alarm will be given and the electrode indication flashes)

NOTE: When this happens, reapply the electrode (see Chapter 2).

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08:45:07 99%

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Chapter 1 Introduction and System Settings

LIQUID CRYSTAL DISPLAY (LCD) Central Section The central section of the screen is taken up with the measured ECG traces. The lead identifications are given on the left-hand side. In the left-hand corner is the 1 mV reference mark. The time reference is given below the bottom lead indicated by "1 s" and a series of points; the time difference from point to point is 1 second.

Bottom Section The bottom line of the LCD gives, from left to right •

selected baseline and myogram filter settings

•

speed in "mm/s" for printing in manual mode

•

sensitivity in "mm/mV" for printing in manual mode

•

number of channels and selected leads for printing in manual mode

Contrast Adjustment The contrast can be adjusted by means of the LCD knob located on the righthand side of the unit.

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Chapter 1 Introduction and System Settings

KEYBOARD Alphanumeric Keys KEYBOARD KEYS KEY

FUNCTION

DELETE

Delete character to the left of the cursor.

ENTER

Confirm entry or selection.

SPACE

Enter blank space into the text.

SHIFT

When pressed simultaneously with a letter key it activates the upper case letter. When pressed simultaneously with a number key it activates an alternative symbol set.

CAPS LOCK

Toggle key to set lower case or upper case letters. The Caps Lock key status is indicated on status information field on the right-hand side of the screen.

ON/OFF Keys ON

switch unit on

OFF

switch unit off

Replace Paper Key

REPLACE PAPER

extend or retract the paper tray for paper replacement

Direct Function Keys PATIENT DATA

TX DATA

STORE DATA

RECALL DATA

STORAGE

input of patient data

initiate data transmission to another unit

initiate data storage to internal memory

initiate data reception from another unit

display menu for data storage and transmission

CHANGE SCREEN

PRINT SCREEN

COPY

2ND

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toggle display

print the displayed screen

initiate copy of last ECG recording

select second function

CARDIOVIT AT-10 July 2003

Chapter 1 Introduction and System Settings

KEYBOARD Control Keys AUTO START

MAN START

STOP

FNCT

ESC

NO –

YES +

start automatic recording and printing

start manual recording and printing

stop manual recording and printing / advance paper to beginning of new page

display menu for system settings / return to monitor mode

return to previous menu

change setting / disable function

change setting / enable function

move cursor to the left

move cursor to the right

move cursor or menu bar up

move cursor or menu bar down

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Chapter 1 Introduction and System Settings

KEYBOARD ECG Function Keys ECG

select resting ECG menu

LEAD

select previous lead group (for display and printout) LEAD

select next lead group (for display and printout) MONITOR mm/s

MONITOR mm/mV

MONITOR CHANNEL

select display speed

select signal level for display

select number of channels (3, 6, 8) for the display

reset ECG signal to baseline FILTER

1 mV

PRINTER CHANNEL

switch myogram filter on or off

insert calibration signal on the screen or on the printout

select number of channels (3, 6 and programmable number) for printout

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Chapter 1 Introduction and System Settings

KEYBOARD Exercise ECG Function Keys EXERCISE

PROTOCOL

SYMPTOMS

BEGIN

select menu for exercise ECG

display/select exercise protocol

manual input of symptoms

start exercise test (beginning of warm-up phase)

END

PRINT REPORT

PRINT RHYTHM

HOLD STAGE

NEXT STAGE

GRADE

stop exercise test (start of recovery phase)

print final report (end of recovery phase)

print rhythm strip

hold current load stage

switch to next load stage

increase or decrease treadmill elevation in

combination with the

YES +

and

NO –

keys SPEED LOAD

increase or decrease speed (treadmill) or load (bicycle) in combination with the YES +

and

NO –

keys

Further Function Keys NIBP

select menu for non-invasive blood pressure measurements

SPIRO

select spirometry menu (if installed)

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Chapter 1 Introduction and System Settings

EXTERNAL CONNECTIONS Rear Panel 7

1

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6

5

2

4

3

1

Unit identification plate

2

Mains connector with power switch and mains fuse box (fuses: 2 x T 200 mA / 250 V)

3

Connector for external video monitor

4

Exercise test connection for analogue ergometer (bicycle or treadmill)

5

Data I/O socket for connection of footswitch (option), QRS trigger, treadmill elevation control

6

Potential equalisation stud

7

Optional LAN connector (Local Area Network)

CARDIOVIT AT-10 July 2003

Chapter 1 Introduction and System Settings

EXTERNAL CONNECTIONS Side Panel 13

31

5

2 4

EKG/ECG

TEST

10

1

9

8

7

6

RS-232C interface (port 1) for connection of a ergometer with intergral blood pressure measurement.

e.g Ergoline 900/911/911SL or Variobike 550/560 2

RS-232C interface (port 2) for connection of an ergometer (treadmill) e.g MTM 1500/TM400s/schiller R9/Powerjog M10-S/ Woodway

3

RS-232C interface (port 3) for data transfer

4

RS-422 interface for data transfer

5

LCD contrast control

6

DC input DCIN 1, 0.5 V/cm

7

DC input DCIN 2, 0.5 V/cm

8

Connector for pneumotach sensor SP-110, SP-110/R, SP-150 or SP-20 for pulmonary function testing

9

TEST = test socket for patient cable with control light

10

EKG/ECG = patient cable input socket -> CF rated The socket is CF rated, that is fully floating and isolated, defibrillation protected, suitable for intra-cardiac application.

CAUTION! DEFIBRILLATION PROTECTED ONLY IF USED WITH ORIGINAL SCHILLER PATIENT CABLE !

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