AT10 6-Channel Electrocardiograph User Guide

DECLARATION OF CONFORMIW Electrocardiograph:

AT-1 0

Serial numbers starting with:

171.

Year of manufacture:

1995 Onwards

We, the undersigned, hereby declare that the medicaldevice (class lla)specified above conforms with the essential requirement listed in Annex 1 of EC Directive 93/42/EEC.

This declaration is supported by: Certificate of approval No:

cnd

I S 0 9001 (Rev.1994) EN 46001 by SQS 11425-01 451 12-60-00 I S 0 9001/08.94, EN 46001 / 12.93 by DEKRA

451 12-16-00 Annex II, Section 3 of the Directive 93/42/EEC (30.04.1995)

(c

0124

Baar (Switzerland) 03.07.1 996

/

t d

Martin Spreng Research & Development Manager

Markus Butler Quality Assurance Manager

ii

lXs&im The Information in this guide has been carefully checked for reliability; however no guarantee is given as to the correctnessof the contents and WELCH ALLYN SCHILLER makes no representationsor wananties regarding the contents of this manual. We reserve the right to revise this document and make changes in the specificationof the product described within at any time without obligation to notify any person of such revision or change. Trademarics WELCH ALLYN SCHILLER and AT-10 are registered trademarks of WELCH ALLYN SCHILLER. All trademarks are the property of their owners. ay3ylighthwa3 0 Copyright 1996 and 1998 by WELCH ALLYN SCHILLER. All rights reserved. You may not reproduce, ttansmit, transcribe, store in a retrieval system or translate into any language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual or otherwise, any part of this publication without express written permission of WELCH ALLYN SCHILLER. TennSOfwarranty

WELCH ALLYN SCHILLER wanants the AT-10 Electrocardiograph,when new, to be free of defects in material and workmanship and to perform in accordance with manufacturer' sspecifications forthe periodof three (3) years from the date of purchase from Welch Allyn or it' s authorizeddistributorsor agents. Accessory items such as electrodes, batteries and cables are limitedto a wananty of 90 days from the date of purchasefrom Welch Allyn or its authorized distributors or agents. Welch Allyn will repair or replaceany components found to be defective or at variance from manufacturer's specifications within this time at no cost to the customer. It shall be the purchasers responsibilityto retum the instrument to Welch Allyn or an authorizeddistributer,agent or service representative. This wananty does not indude breakage or failure due to tampering, misuse, neglect, accidents, modifications or shipping. This wananty is also void if the instrument is not used in accordance with manufacturer' s recommendations or if repaired by other than Welch Allyn or an authorizedagent. Purchase date determines warranty requirements. No other express warranty is given.

iii

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 Commision) Rules and the radio interference regulations of the Canadian Department of Communications.These limits are designed to provide reasonableprotection 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. 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.

O

Disposal Instructions and Battery Care

I

DO NOT DISPOSE OF THE BATTERY BY FIRE OR INCINERATOR DANGER OF EXPLOSION DO NOT ATTEMPT TO RECHARGE THE BATTERY - DANGER OF EXPLOSION DO NOT OPEN THE BATTERY CASING - DANGER OF ACID BURN

Only dispose of the battery in official recycling centres or municipally approved areas. Alternatively used batteries can be returned to Schiller AG for disposal.

%@

Unit Disposal Instructions Units no longer required can be returned to Schiller AG for disposal. Alternatively dispose of the unit in municipally approved recycling centres.

Power Supply The mains connection is on the rear of the unit. The power supply voltage is set by the factory for100-115V(nom. llOV) or 220-24OV (norn. 230V) working. The setting is indicated by the indented metal strip on the fuse panel. Contact your dealer if the voltage needs to be changed. The mains indicator lamp on the keyboard is always lit when the unit is connected to the mains supply. The unit can either be operated from the mains supply or from the built-in rechargeable battery. The power source is indicted on the top line of the LCD. Changing a Mains Fuse If it is necessary to change a fuse, always replace with the correct rating i.e 2x200mAT for 230V, or 2x400mAT for llOV.

To change a fuse press the two retaining lugs on side of the fuse panel (situated below the mains connector on the back panel. Remove the fuse panel and replace the fuse(s). Click back the fuse panel.

iv

TvelcI@l€ynG Schiller

0

PHYSICIANS RESPONSIBILITY THE AT-10 ELECTROCARDIOGRAPH I S PROVIDED FORTHE EXCLUSIVE USE OF QUALIFIED PHYSICIANS OR PERSONNEL UNDER THEIR DIRECT SUPERVISION. THE NUMERICAL AND GRAPHICAL RESULTS FROM A RECORDING MUST BE EXAMINED WITH RESPECT TO THE PATIENTS OVERALL CLINICAL CONDITION, THE RECORDING PREPARATION QUALITY AND THE GENERAL RECORDED DATA QUALITY, WHICH COULD EFFECT THE REPORT DATA ACCURACY, MUST ALSO BE TAKEN INTO ACCOUNT. I T I S THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAGNOSIS OR TO OBTAIN EXPERT OPINION ON THE RESULTS, AND TO INSTITUTE CORRECT TREATMENT I F INDICATED. FEDERAL LAW I N THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

V

Safety Notices TO PREVENT ELECTRICSHOCK DO NOT DISASSEMBLE THE UNIT. NO SERVICEABLE PARTS INSIDE. REFER SERVICING TO QUALIFIED PERSONNEL ONLY. DO NOT USE THIS U N I T I N AREAS WHERE THERE IS ANY DANGER OF EXPLOSION OR THE PRESENCE OF FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS. THIS PRODUCTIS NOTDESIGNED FOR STERILE USE. THIS PRODUCT IS NOT DESIGNED FOR OUTDOOR USE. SWITCH THE UNITOFF BEFORE CLEANINGAND DISCONNECTFROM THE MAINS. DO NOT, UNDER ANYCIRCUMSTANCES, IMMERSE THE UNITOR CABLEASSEMBLIESI N LIQUID. THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER I F THE EARTH CONNECnON I S SUSPECT OR I F THE MAINS LEAD I S DAMAGED OR SUSPECTED OF BEING DAMAGED. DO NOT USE HIGH TEMPERATURE STERILISATION PROCESSES (SUCH AS AUTOCLAVING). DO NOT USE EBEAM OR GAMMA RADIATION STERIUSATION. DO NOT USE SOLVENT CLEANERS USE ONLYACCESSORIES AND OTHER PARTS RECOMMENDED OR SUPPLIED BY WELCHALLYN SCHILLER. USE OF OTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULT I N INJURY INACCURATE INFORMATIONAND/OR DAMAGE TO THE UNIT THEAT-1 0 COMPLIES WITH EMC REGULATIONS FOR MEDICAL PRODUCTS WHICHAFFORDS PROTECTION AGAINST EMISSIONS AND ELECTRICAL INTERFERENCE. HOWEVER SPECIAL CARE MUST BE EXERCISED WHEN THE UNIT I S USED WITH HIGH FREQUENCY EQUIPMENT. I T 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). THEREI S NO DANGER WHEN USING THE ECG UNIT FOR A PACEMAKER PATIENT OR WlTH SIMULTANEOUS USE OF OTHER ELECTRICALSTIMULATION EQUIPMENT. HOWEVER, THE STTMULATION UNITS SHOULD ONLY BE USED A T A SUFFICIENT DISTANCE FROM THE ELECTRODES. I N CASE OF DOUBT, THE PATIENTSHOULD BE DISCONNECTED FROM THE RECORDER. THIS UNIT IS CF CLASSIFIED ACCORDING TO IEC 601-1. THIS MEANS THAT THE PATIENT CONNECTION I S FULLY ISOLATED AND DEFIBRILLATION PROTECTED. WELCH ALLYN SCHILLER CAN ONLY GUARANTEE PROTECTION AGAINST DEFIBRILLATION VOLTAGE HOWEVER, WHEN THE ORIGINAL WELCH ALLYN SCHILLER PATIENT CABLE I S USED. I F SEVERAL UNITS ARE COUPLED THERE I S A DANGER OF SUMMATION OF LEAKAGE CURRENT DO NOT TOUCH THE CASING DURING DEFIBRILLATION I F THE PATIENT CABLE SHOULD BECOME DEFECTIVE AFTER DEFIBRILLATION, LEAD OFF WILL BE DISPLAYED AND AN ACOUSTIC ALARM GIVEN

vi

This User's Guide gives instructionson how to operatethe unit and provides an overview of all the basic functions in an easy and simple to use format. The proceduresare presented in a logical, step-by step way to enablethe user to quickly and easily familiarise themselves with unit operation. Detailedmedicalinformation is excluded from this guide except where necessary to opemte the unit or understandthe results.

Welcl@WynSchiller

9314UEEC Medical Devices: 0124 'Notified Body' DEKRA AG

vii

8

viii

Chapter 1 Introduction and System Settings

Introduction and System Settings ...

Introduction

.

i3

Location...

1.3

Potential Equalisation ...

1.3

... Main Parts of the Unit ... Liquid Crystal Display (LCD) ...

1.5

Screen Overview ...

1.6

Contrast Adjustment ...

1.7

Accessories

Keyboard

...

1.4

1.6

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

...

1.12

Rear Panel ...

1.12

Side Panel ...

1.13

...

1.14

External Connections

Menu Structure

Introduction ...

1.14

FNCT Menu ...

1.15

ECG Menu ...

1.16

ECG Menu (Cont.) ...

1.17

EXERCISE Menu ...

1.18

Page 1.1

Chapter 1 Introduction and System Settings

.

NlBP Menu ...

1.19

STORAGE Menu...

1.20

Basic System Settings

...

Unit Configuration ...

1.21

Set Date and Time ...

1.22

User Identification ...

1-22

Store Unit Settings ...

1.22

Default Settings ...

1.22

...

1.23

ECG Settings

Programmable Lead Sequence ...

Reset ECG Signal (Baseline Reset) ...

.25 .26 .27 .27

...

1.28

Filter Settings &. Pacemaker Detection... Switching the Myogram Filter ON and OFF ...

Macro Function

Page 1.2

1.21

Store a Macro ...

1.28

Recall a Macro ...

1.29

Chapter 1 Introduction and System Settings

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

Low weight and mains independent operation for portability.

m

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

a

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

a

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

0

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

a

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

- automatic ergometer control (bicycle or treadmill) 0

the connection of an external blood pressure measuring unit data transmissionheception

Resting ECG and exercise ECG as standard software options.

a

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

a

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

a

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

6.

The yellow/green ground cable supplied as an marked with the symbol 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.

Page 1.3

Chapter 1 Introduction and System Settings

MAIN PARTS OF THE UNIT 2

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

-

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

- 2 DC inputs 0,5 V/cm -

optional connector for flow sensor (for lung function testing) patient cable input

6 Waterproof keypads

Page 1.4

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.

-iR:

90

BPM

RESTING ECG

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 YOof 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).

Page 1.5

Chapter 7 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 so'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 " m d s " for printing in manual mode sensitivity in "mdmV" 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.

Page 1.6

Chapter 1 Introduction and System Settings

KEYBOARD Alphanumeric Keys

Printout Speed Selection

2-55,10, 12.5, 25,510or 100 mmls Macro Function Keys (1-6)

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.

Printout Sensitivity Selection 2.5,5,10, or 20 mm/mV

'8 ' to '-'

ON/OFF Keys

(dNi

switch unit on

@:

switch unit off

CAPS

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.

Replace Paper Key

0. REPLACE i PAPER j

extend or retract the paper tray for paper replacement

Direct Function Keys input of patient data

initiate data transmission to another unit

I ] . STORE f DATA j

0 RECEIVE i DATA i

...

initiate data storage to internal memory

initiate data reception from another unit

display menu for data storage and transmission toggle display

print the displayed screen

initiate copy of last ECG recording

select second function Page 1.7

Chapter 1 Introduction and System Settings

KEYBOARD Control Keys ...

start automatic recording and printing

@!d

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

I L i return to previous menu

("-")

change setting / disable function

change setting / enable function

la)

move cursor to the left

...

move cursor to the right

(n)

move cursor or menu bar up

...

a

Page 1.8

move cursor or menu bar down

Chapter 1 Introduction and System Settings

KEYBOARD ECG Function Keys

I ECG 1 ...

rn m

...

select resting ECG menu

select previous lead group (for display and printout)

select next lead group (for display and printout)

select display speed

select signal level for display

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

reset ECG signal to baseline

[R... LTERJ

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

Page 7.9

Chapter 7 Introduction and System Settings

KEYBOARD Exercise ECG Function Keys

[EXERCl SEj ...

select menu for exercise ECG

display/select exercise protocol

manual input of symptoms

0 BEGIN TEST

j

start exercise test (beginning of warm-up

j

...

phase) stop exercise test (start of recovery phase)

print final report (end of recovery phase)

...

print rhythm strip

hold current load stage

0 NEXT i STAGE i

switch to next load stage

...

increase or decrease treadmill elevation in combination with the

a

and

keys increase or decrease speed (treadmill) or load (bicycle) in combination with the and

keys

Further Function Keys

(NIBP,

select menu for non-invasive blood pressure measurements

[

Page 1.10

SPlRO

1

select spirometry menu (if installed)

Chapter 1 Introduction and System Settings

EXTERNAL CONNECTIONS Rear Panel 7

I

6

5

4

I

I

I

1

2

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 I10 socket for connection of footswitch (option), QRS trigger, treadmill elevation control

6

Potential equalisation stud

7

Optional LAN connector (Local Area Network)

Page 1 . 1 1

Chapter 7 Introduction and System Settings

EXTERNAL CONNECTIONS Side Panel 1

10

9

8

7

3

5

2 4

6

1

RS-232C interface (port 1) for connection of a blood pressure device

2

RS-232C interface (port 2) for connection of an ergometer (bicycle or treadmill)

3

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

4

RS-422 interface for data transfer

5

LCD contrast control

6

DC input DClN 1, 0.5 V/cm

7

DC input DClN 2, 0.5 V/cm

8

Connector for pneumotach sensor SP-110, SP-11O/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 PROTECTEDONLY IF USED WITH ORIGINAL WELCH ALLYN SCHILLER PATIENT CABLE !

Page 7.12