Welch Allyn AT-2Plus User Manual

AT-2plus
6-Channel Electrocardiograph
i
AT-2plus User Guide
Article Number 2. 510 274e
Physician`s Guide to the Interpretation and Measurement Program
Article Number 2. 510 179
Welch Allyn Inc.
7420 Carroll Road
San Diego, CA 92121
Phone: (800) 854-2904
Fax: (858) 621-6611
www.welchallyn.com
United Kingdom: Canada: Welch Allyn UK Ltd Welch Allyn Canada Ltd
Cubblington Road 160 Matheson Blvd. East, Unit #2 Aston Abbotts HP22 4ND Mississauga, Ontario L4Z 1V4 United Kingdom Canada
Tel: 01296-682-140 Tel: (800) 561-8797 Fax: 01296-682-104 Fax: (905) 890-0008
Copyright © `97 & `98 by Welch Allyn Schiller
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DECLARATION OF CONFORMITY

Electrocardiograph: Cardiovit AT - 2 Plus Serial numbers starting with: 025. Years of manufacturing: 1996 onwards
We, the undersigned,hereby declare that the medical device (classe II a) specified above conforms with the Essential Require­ments listed in Annex I, of EC Directive 93/42/EEC
This declaration is supported by: Certificate of approval No: 11425-02 ISO 9001 / EN 46001 by SQS valid date 17. January 2001 45112-60-01 ISO 9001/ 07.94, EN 46001 / 08.96 by DEKRA valid date 30.04.2003 and 45112-16-01 Annex II, Section 3 of the Directive 93/42/EEC, valid date 30.01.2003
Baar (Switzerland) 12.03.1998
JJ Schmid Markus Bütler Research & Development Manager Quality Assurance Manager
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Disclaimer
The Information in this guide has been carefully checked for reliability; however no guarantee is given as to the correctness of the contents and WELCH ALLYN SCHILLER makes no representations or warranties regarding the contents of this manual. We reserve the right to revise this document and make changes in the specification of the product described within at any time without obligation to notify any person of such revision or change.
Trademarks
WELCH ALLYN SCHILLER and AT-2plus are registered trademarks of WELCH ALLYN SCHILLER. All trademarks are the property of their owners.
Copyright Notice
© Copyright 1996 and 1998 by WELCH ALLYN SCHILLER. All rights reserved. You may not reproduce, transmit, 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.

Terms of Warranty

WELCH ALLYN SCHILLER warrants the AT-2plus Electrocardiograph, when new, to be free of defects in material and workmanship and to perform in accordance with manufacturer`s specifications for the period of three (3) years from the date of purchase from Welch Allyn or it`s authorized distributors or agents. Accessory items such as electrodes, batteries and cables are limited to a warranty of 90 days from the date of purchase from Welch Allyn or its authorized distributors or agents. Welch Allyn will repair or replace any 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 responsibility to return the instrument to Welch Allyn or an authorized distributer, agent or service representative. This warranty does not include breakage or failure due to tampering, misuse, neglect, accidents, modifications or shipping. This warranty 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 authorized agent. Purchase date determines warranty requirements. No other express warranty is given.
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PHYSICIAN‘S RESPONSIBILITY
THE AT-2PLUS ELECTROCARDIOGRAPH IS PROVIDED FOR THE EXCLUSIVE USE OF QUALIFIED PHYSICIANS OR PERSONNEL UNDER THEIR DIRECT SUPERVISION. THE NUMERICAL AND GRAPHICAL RESUL TS 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.
IT IS THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAGNOSIS OR TO OBTAIN EXPERT OPINION ON THE RESULTS, AND TO INSTITUTE CORRECT TREATMENT IF INDICATED.
FEDERAL LAW IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
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Safety Notices

TO PREVENT ELECTRIC SHOCK DO NOT DISASSEMBLE THE UNIT. NO SERVICEABLE PARTS INSIDE. REFER SERVICING TO QUALIFIED PERSONNEL ONLY.
DO NOT USE THIS UNIT IN AREAS WHERE THERE IS ANY DANGER OF EXPLOSION OR THE PRESENCE OF FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS.
THIS PRODUCT IS NOT DESIGNED FOR STERILE USE. THIS PRODUCT IS NOT DESIGNED FOR OUTDOOR USE. SWITCH THE UNIT OFF BEFORE CLEANING AND DISCONNECT FROM THE MAINS. DO NOT, UNDER ANY CIRCUMSTANCES, IMMERSE THE UNIT OR CABLE ASSEMBLIES IN LIQUID. THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER IF THE EARTH CONNECTION IS SUSPECT OR IF THE
MAINS LEAD IS DAMAGED OR SUSPECTED OF BEING DAMAGED. DO NOT USE HIGH TEMPERATURE STERILISA TION PROCESSES (SUCH AS AUTOCLAVING). DO NOT USE E-BEAM OR GAMMA
RADIATION STERILISATION. DO NOT USE SOLVENT CLEANERS USE ONLY ACCESSORIES AND OTHER PARTS RECOMMENDED OR SUPPLIED BY WELCH ALLYN SCHILLER. USE OF OTHER
THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULT IN INJURY INACCURATE INFORMATION AND/ OR DAMAGE TO THE UNIT.
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THE AT-2PLUS 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.
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 ECG 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.
THIS UNIT IS CF CLASSIFIED ACCORDING TO IEC 601-1. THIS MEANS THAT THE PATIENT CONNECTION IS FULLY ISOLATED AND DEFIBRILLATION PROTECTED. WELCH ALLYN SCHILLER CAN ONLY GUARANTEE PROTECTION AGAINST DEFIBRILLATION VOLTAGE HOWEVER, WHEN THE ORIGINAL WELCH ALLYN SCHILLER PATIENT CABLE IS USED.
IF SEVERAL UNITS ARE COUPLED THERE IS A DANGER OF SUMMATION OF LEAKAGE CURRENT DO NOT TOUCH THE CASING DURING DEFIBRILLATION IF THE PATIENT CABLE SHOULD BECOME DEFECTIVE AFTER DEFIBRILLATION, LEAD OFF WILL BE DISPLAYED AND
AN ACOUSTIC ALARM GIVEN
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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 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. 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.

Disposal Instructions and Battery Care

ÆÊ ÇÃ
° 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 Welch Allyn Schiller for disposal.
Unit Disposal Instructions
Units no longer required can be returned to Welch Allyn Schiller for disposal. Alternatively, dispose of the unit in municipally approved recycling centres.
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Power Supply
The mains connection is on the rear of the unit.
The power supply voltage is set by the factory for100-115V(nom. 110V) or 220-240V (nom. 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 2x315mAT for 110V .
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.
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AT-2plus User`s Guide
This User`s Guide gives instructions on how to operate the unit and provides an overview of all the basic functions in an easy and simple to use format. The procedures are presented in a logical, step-by step way to enable the user to quickly and easily familiarise themselves with unit operation. Detailed medical information is excluded from this guide except where necessary to operate the unit or understand the results.
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AT-2plus 6-Channel ECG Unit - USER GUIDE
AT-2plus - User Guide

Short Form Instructions

Automatic ECG Recording
Prepare skin, hook up patient.
Switch unit on, press ON ON .
Press
Press
least 10 seconds until a clear and stable trace is displayed.
Press AUTO AUTO PRINT to record and print.
Press COPY
PATIENT
and enter patient data.
DATA
PATIENT
again and wait for at
DATA
for additional copies.
COPY
Manual ECG Recording (Rhythm Strip)
Prepare skin, hook up patient.
Switch unit on, press ON ON .
Press MAN START
Change lead group with
Press STOP
STOP
to stop the printout.
MAN
PRINT
1
.
and
.
2
Electrode hook-up check
1mV
AUTO
Press
Best results are obtained when the electrode voltage readings (right column) are between ±50mV.
ALT
0
AUTO
3
for electrode check.
3
Filter On/Off
Press
FILTER
to switch the (Myogram) filter On / Off.
System Configuration
Press
ALT
1mV
0
1
to print system settings.
1
1

List of Symbols

applications. Note: The paddles indicate
that the equipment is defibrillator proof
Mains connected
Battery operation (Flashes when battery capacity limited.
93/42/EEC Medical Devices: 0124 `Notified Body` DEKRA AG
2
Potential Equalisation (common ground)
Attention - General warning sign ­see accompanying documentation
Type CF equipment - safe for internal
AT-2plus 6-Channel ECG Unit - USER GUIDE
Modes of Operation................................................. 4
Automatic Mode.................................................................. 4
Manual Mode .....................................................................4
Automatic Mode ...................................................... 5
Manual Mode .......................................................... 6
Patient Cable Connections ...................................... 8
Standard Leads ..................................................................9
Location & Power ................................................... 10
Location ............................................................................. 10
Power Supply .....................................................................10
Switching On and Off .............................................. 11
Potential Equalisation .........................................................11
Keyboard ................................................................. 12
LCD Screen.............................................................. 14
Settings .................................................................... 15
Default Settings................................................................... 17
Language - American and Standard English ...................... 18
User Identification .............................................................. 18
Filters ................................................................................. 19
Baseline Filter ....................................................................19
Mains Filter ........................................................................19
Myogram Filter ..................................................................20
Defining Lead Sequence & Printout ....................................21
Acoustic QRS Indication .....................................................22
Time / Date ......................................................................... 22
Automatic Mode (ECG) Settings..............................23
Average Cycles ................................................................... 24
Measurements and Markings (i version only) .................... 25
Interpretation (i version only)............................................. 26
Interpretation Settings (i version only)................................ 26
Selecting Rhythm Leads ......................................................27
Memory and Data Transmission Option ..................28
Safety Notices .....................................................................28
Auto Storage and Auto Erase.............................................. 28
Manual Storage .................................................................. 29
Displaying Memory Files ................................................... 29
Reading and Printing a Stored File ..................................... 29
Erasing Memory Files ........................................................ 29
Memory and Data Transmission Option ..................30
Transmitting Stored Files ................................................... 30
Transmission Settings......................................................... 30
Line Transmission .............................................................. 31
Modem Transmission ......................................................... 31
Care & Maintenance ................................................33
Self-test ............................................................................... 33
12 Monthly Check............................................................... 33
Cleaning the Casing ........................................................... 33
Cleaning the Patient Cable.................................................. 34
Cleaning the Thermal Print Head .......................................34
Replacing the Recording Paper ...............................35
Thermal Paper Handling ................................................... 36
Fault Diagnosis ........................................................37
Technical Data .........................................................39
Available Configurations ....................................................41
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Modes of Operation

Automatic Mode

Automatic Mode provides a printout giving 10 seconds of ECG recording of all 12 leads with a choice of 2 different formats.
The following can be programmed freely for each of the 2 formats before recording:
Lead Format
Chart Speed
With the optional interpretation program installed it is also possible to select the measurement table, average cycles with optional markings and interpretation statements for the printout.
For further information see paragraph `Settings for Automatic Mode`.

Manual Mode

Manual Mode provides a real time printout of 6 leads that are selected and indicated on the screen.
The following can be freely selected before or during recording:
Lead Group
Chart Speed
Sensitivity
Myogram Filter For further information see paragraph `ECG Recording in Manual
Mode` following.
4

Automatic Mode

AT-2plus 6-Channel ECG Unit - USER GUIDE
In automatic mode , a full 12-lead ECG is printed in one of two predefined formats with a sensitivity of 10 mm/mV. These two formats are selected by the user to suit his specific needs and requirements.
AUTO
When the AUTO SENSITIVITY key recording in automatic mode, the unit detects very large waveform amplitudes and sets the sensitivity for the extremity and/or precordial leads to 5 mm/mV to reduce the overlapping of traces. An `A` on the bottom line of the LCD indicates that Auto sensitivity is set.
3
is pressed before
To start the automatic ECG recording in Format 1, press the AUTO key:
AUTO PRINT
To start the automatic recording in the second format, press the ALT key followed by the AUTO key:
ALT
+
AUTO PRINT
The printout gives the following:
ECG recording of all leads in either Standard or Cabrera
format according to selection
Sensitivity
Heart Rate
Speed
Filter Settings
Time and Date
Interpretation statements
Average Cycles
Intervals
Axis
Sokolow Index (ECG index for hypertrophy)
Detailed Measurement Table
To obtain an extra printout of the ECG recording in Format 1, simply press the COPY key
To obtain an extra printout of the second format, press the ALT key
followed by the COPY key
The Auto mode settings for the two formats are detailed in the paragraph entitled `Settings for Automatic Mode` later in this book
ALT
+
COPY
COPY
5

Manual Mode

Manual mode provides a direct printout of the real-time ECG with full control of parameter selection.
To start the manual recording of a real-time ECG, press the MANUAL Printout key
MAN
PRINT
To stop the manual recording (printout) press the STOP key
STOP
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The printout provides you with the following:
Six (selected) leads with lead identification.
On the lower edge, the chart speed, user identification and
filter settings (if on).
At the top, the heart rate as current average of 4 beats, trace
sensitivity, and the time and date
The following can be freely chosen during or before the recording: Lead Group by means of the LEAD FORWARD and LEAD
BACKWARD key
1
The following lead groups are selectable:
• I, II, III aVR, aVL, aVF (Cabrera: aVL, I, -aVR / II, aVF, III)
• V1, V2, V3 / V4, V5, V6
• II, aVF, III / V2, V4, V5
• V4, V5, V6 / V7, V8, V9
Note: The LCD only displays three leads at one time. When the
lead forward or lead backward key is pressed, the following /preceding three lead group is displayed
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