Schiller AT4 User Guide Issue c Aug 1999

AT-4 User Guide - English AT-4 Gebrauchsanweisung -Deutsch

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ArticleNumber2. 510 173c Iss. 1 Sept. 1995; Iss. 2 Dec. 97, Iss. c Aug 1999 Associated Documents

Guide to the SCHILLER Interpretation and Measurement Program E i D/ F Article Number 2. 510 179 AT-4 User Guide - French / Italian ArticleNumber 2. 510 174 AT-4 User Guide - Spanish / Portuguese Article Number 2. 5 10 183

SCHlLLERAG Altgasse 68 6340 Baar, Switzerland Phone: i+ 41 41 766 42 42 Fax: ++ 41 41 761 08 80 Home Page: http://nww. schiller-ag.ch

Copyright 0 ‘96, ‘97 and ‘99 by SCHILLER AG

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DECLARATION OF CONFOWZTY Electrocardiograph:

AT4

Serial numbers starting with

010.

Yearof manufacture:

1995 Onwards

We, the undersigned,hereby declare that the medical device (classe I1 a) specified above conforms with the Essential Require ments listed in Annex I, of EC Directive 93/42/EEC This declaration is supported by: Certificate of approval No: 11425-02 IS0 9001 / EN 46001 by SQS valid date 17. January 2001 45 1 12-60-0 1 IS0 9001/ 07.94, EN 46001 / 08.96 by D E W valid date 3~0.04.2003 and 451 12-16-01 Annex 11, Section 3 of the Directive93/42/EEC,valid date 30.04.2003

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Baar (Switzerland) 06.05.1998

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J. J. Scmid Research & Development Manager

Markus Butler Quality Assurance Manager

where to Obtain Service and Sales Advice Kundendienst und Verkaufs-/Beratungsstellen Coordonnbes de nos services d 'assistance technique et commerciale America

WELCH ALLYN SCHILLER Inc., 7420 Carroll Road, San Diego, CA 92121. Telephone: (800) 854-2904 www.welchallyn.com

Fax:

(619) 621-6611

Asia Pacific

SCHILLER Asia Pacific, IOA Jalan SS 3/33, Taman University, 47300 Petaling Jaya, Malaysia

Austria

SCHILLER Handelsgesellschafi GmbH Medizintechnik Kampmiillenveg 24, A-4044 Linz, Austria.

Canada

SCHILLER Canada Inc., 100-10 Camelot Drive, Nepean, ON K2G 5x8,Canada.

France

SCHILLER France S.A, Zac des Luats 58, Route de Champigny, F-94350 Villiers Sur Marne, France.

Telephone: Telephone: Telephone: Telephone:

+60 3 777 5336 +43 732 709 90 613 228 0941 +33 I 49 41 24 40

Fax: Fax: Fax: Fax:

+60 3 777 5744 +43 732 757 000 613 723 7687 +33 I 49 41 24 49

Germany

SCHILLER Medizintechnik GmbH, Rudolf Diesel Strasse 14, 0-85521 Ottobrunn, Germany.

(EU-Bevollmachtiger)

Telephone: Hotline:

India

SCHILLER Healthcare India Pvt. Ltd. Kalpatarn Chambers, Nanik Motwane Lane, Ground Floor, Fort, Mumbai 400 023 Telephone:

Italy

+91 22 263 4381

Fax:

Fax:

+49 89 609 509 0

+91 22 263 4384

ESAOTE SPA (SCHILLER), Via di Caciolle 15, I-50125 Firenze, Italy. Telephone:

Switzerland

+49 89 629 981 0 0190 / 87 10 82

+39 / 55 42 291

Fax:

+39 / 55 42 29 208

SCHILLER Reomed AG, Riedstrasse 14, CH-8953 Dietikon, Switzerland. Telephone:

+41 I 741 02 09

Fax:

+41 I 740 37 I0

All other

SCHILLER AG, Altgasse 68, CH-6340 Boar, Switzerland.

Countries

Telephone:

+ 41 41 760 87 87

Home Page:

http://www.schiller-ag.ch/

Fax:

+ 41 41 761 08 80

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 CommunicationsCommision)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 causeharmful interference in which case the user will be required to correct the interference at his own expense.

Disposal Instructions and Battery Care

Battery Care and Disposal Instructions O

O

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 recyclingcentres or municipally approved areas. Alternativelyused batteries can be returned to Schiller AGfor 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 220-240V (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. 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 ll0V.

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.

Disclaimer

The Information in this guidehas bem carefully checked for reliability;however no guarantee is given as to the corr&ncss of the contentsand SCHILLER makes no rcprcsCntatiomor wnrrautiiesregarding the contents of this manual. We resave the right to revise this document and make changes in the spxificationof the product described within at any time without obligationto notity any pasonof such revision or change. Trademarks

SCHILLER and A T 4 ere regktaed eadanarks of SCHILLER AG. AU trademarks arc the p r o m of their ownas. PHYSICIAN'S RESPONSIBILITY ComrfghfNoriec

THE A T 4 ELECTROCARDIOGRAPHIS PROVIDED FOR THE EXCLUSIVE USE O F QUALIFIED PHYSICIANS OR PERSONNEL UNDER THEIR DIRECT SUPERVISION. THE NUMERICAL AND GRAPHICAL RESULTS FROM A RECORDING MUST BE EXAMINED WITH RESPECT TO THE PATIENIS OVERALLCLINICALCONDITION. THE RECORDING PREPARATIONQUALITY AND TIE GENERAL RECORDED DATA OUALITY. WHICH

Ocowright 1996hySCHILLERAG.Allrightsrcpnved. Youmaynotrcproduce,~it,~bc, store in a retrieval system or traasIate into any language, in any form or by any means, elstronic, rnechaaical, magnetic, optical, chemical, manual or othenvise, any part of this publication without express written pamission of SCHILLER AG.

Termsof W m n r y m e SCHILLER A T 4 is wnrrautedagainst defmin mataial and manufacturefor the duration of one year (as from date of purchase). Excluded from this guarantee is damage c a d by an accident or as a result of impropa handling. The warranty entitles bee replacement of the defective part. Any liability for subsequent damage is excluded. The warranty is void if unauthorized or unqualified pasons attempt to make rcpairs. In case of a defect contact your dealer or the manufacturer. me manufacturer CPQ only be held respoosible for the safety, reliability, and performance of tbe npparata i t

n

arsembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by him, and

a

the A T 4 and approved attached equipment are used in'acsordancc with the manufacturem illSbllCfiOns. ~

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 TREATIvENTIF INDICATED. FEDERAL LAW IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

~~~

THERE ARE NO EXPRESS OR IMPLIED WARRANTIES WHICH EXTEND BEYOND THE WARRANTIES HEREINABOVE SET FORTH. SCHILLER MAKES NO WARRAhTY OF UERCMNTABILITY OR F I m S FOR A PARTICULAR PURPOSE WITH RESPECT TO THE DRODUCTOR PARTS TIBREOF. lboldthis Han&ok rhe philosophy of SCHILLERis one of continuous improvement. Our aim is to provide the USQ with he most up-to-date information and the latest technological developments. (our suggestionsand wmmens are welcome on all SCHILLER documentation. PIeasc contact the CHILLER Techaical Documentation Depmmt.

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. IN THE EVENT OF ACCIDENTAL LCD BREAKAGE AND RESULTANT LEAKAGE OF FLUID3 DO NOT INHALE, INGEST OR MAKE CONTACT WITH THE SKIN. IF CONTACT IS MADE RINSE IMMEDIATELY. THIS PRODUCT IS NOT DESIGNED FOR STERILE USE. THIS PRODUCT IS NOT DESIGNED FOR OUTDOOR USE. SWITCH THE W I T 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 STERILISATION 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 SCHILLER AG. USE OF OTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULT IN INJURY INACCURATE INFORMATION AND/ OR D M G E TO THE UNIT. THE AT-4 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 CONDUCTRVG 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. SCHILLER CAN ONLY GUARANTEE PROTECTION AGAINST DEFIBRILLATION VOLTAGE HOWEVER, WHEN THE ORIGINAL 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

Intended Use The CARDIOVIT A T 4 is a 3-channel ECG recorder with all (12) ECG signals simultaneously processed to provide instant ECG recordings. Two automaticrecording modes can be individually preset to enable one button ECG recording of preferred print formats.

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T H E A R T OF D i A C N d S T t C S

93/42/EEC Medical Devices: 0124 'Notified My'DEKRA AG

ACCESSORIES The SCHILLER representatives in your country keep all parts and accessories for the AT-4 available in their stock. In case of a problem or if you require the address of your local representative, contact the SCHILLER-headquarters 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-4 and advise the following details: Article Description 0

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Article No.

Your Name, Address and Phone Number

ACCESSORIES

PART NO.

ECG UNIT CARDIOVIT AT-4

0.010

ACCESSORY PACK ConteN m y be country specific 10-LEAD PATIENT CABLE 4 EXTREMITY ELECTRODES 6 SUCTION ELECTRODES

2. OOO 039

.. . .

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ELECTRODE CREAM (100 ML) RECORDING PAPER MAINS (POWER) CABLE OPERATING MANUAL

Cardiovit AT- 4 ECG Recorder Decemberl997

THE AT- 4 ECG RECORDER The CARDIOWT AT-4 is a technically advanced and compact 3-channel ECG unit. All important functions are activated directly via the keyboard or via a simple menu structure ensuring quick, easy, and safe use of the unit. The AT-4 has the following features:

. . . . . . . . 0

Mains or battery operation High resolution, high contrast liquid crystal display Immediate, precise display of the ECG and the heart rate User friendly structured menu using the Schiller Select Knob

12 standard lead processing and Nehb lead option StandardCabrera + 2 variations of programmable lead sequences Automatic evaluation of resting ECG with 2 auto mode print formats 3 Channel ECG display on screen and in manual printout Long term rhythm recording Serial interface (RS-232) to sendreceive ECG recordings Internal memory for automatic or manual archiving of up to 50 ECGs

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Comfortable management of archived ECGs Recording of external signals via DC input

Cardiovit A T 4 ECG Recorder December 1997

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MODES OF OPERATION

Base Settinas cm, kg / ins, Ibs Dale and Time LCD Image QRS beeper onloff PaceMaker onloff User Identification StandardCabrera leads Programmable Leads Signal sensitiviy Lead G r o w Myogram Filler cu1 off freq. Automatic saving Automatic transmission Transmission settings

1 Auto Format Settings h 1 ECGformat I Average Format Patient data (Interpretation) (Measurements)

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1. (Auto Mode Format) 2. AUTOSTART

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11

1 -

1. MAN START t o print 2 . Lead group, mmlmV and mmls 3 . Slop printing STOP

-

11

I 1 . Select Lead 2. Select print Format 3 . Start/Stop from menu

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External DC Input

dc signal I 21. Connect Select Lead 3. MANSTAFiT

L

-

-

-

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Cardiovit AT- 4 ECG Recorder December1 997

MODES OF OPERATION There are three methods of ECG recording with the A T 4 as follows: 0

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Manual Automatic Rhythm (long term)

In manual mode, the real-time 12-lead ECG recording is processed. A continuous 3 lead printout can be obtained in various lead configurations and lead size. Automatic mode enables an ECG recording to be performed with predefined information specified by the user, printed at the touch of a button. Two separate auto print formats can be defined. Rhythm mode provides a long term ECG printout of a single lead. The lead is freely defined by the user and a printout can be obtained every 30 seconds, every 2 minutes or every 4 minutes. The lead group, speed and the sensitivity of the displayed ECG can be freely selected. In manual mode the printout is the same as that displayed on the screen (what you see is what you get); in automatic mode the printout format is preprogrammed before commencing the recording and is independent of the displayed ECG. Note that details of the interpretation and measurements options are given in the booklet 'Guide to the Interpretation and Measurement Program' (Article No. 2. 510 179) Cardiovit A T 4 ECG Recorder December I997

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LOCATION As with all medical units, the following general rules are to be noted: The unit should not be stored or operated in a wet, humid or dusty environment. The unit may not come into contact with acidic steams or liquids. The unit should not be set up near radiology or diathermic systems, or near large transformers or electrical motors. Ensure that a minimum distance of 1meter between the unit and the mains supply is maintained

Potential Ftqualiiation

In certain circumstances interference on the ECG recording can be caused by external electrical equipment or radio equipment. Connect the earth potential equalisation connection at the back of the AT- 4 to the hospital common ground or, if a common ground is not present, to a metal framework e.g. the bed frame. Note that all other electrical equipment in close proximity should also be connected to the same common ground. The part number of the potential equalisation cable is 2.310 005.

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Cardiovit AT- 4 ECG Recorder December1 997

POWER SUPPLY The AT-4 can be operated either by using mains power, or from the built-in battery. When mains is connected, the green lamp on the upper casing of the unit (Symbol -) is lit. With mains connected the battery is autonomically recharged. Recharging of a completely discharged battery takes approximately 3 hours. When operating from the battery (mains notconnected), a battery symbol is displayed in the top right hand corner. When the battery capacity is almost empty the battery symbol flashes - mains should be connected to recharge the battery. The AT-4 will operate for approximately 2 hours (without printing) with a fully charged battery.

A power save feature automatically switches the unit off after approximately 5 minutes when the patient is not connected EATERY OPERATION INDICATOR (FLASHES WHEN APPROXIMATELY 5 MINUTES OfERAllNG TIME LEFT)

I MAINS INMCATOR

Cardiovit A T 4 ECG Recorder December 1997

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KEYBOARD

Switches the unit odoff *

In addition to number entry the number keys have the following additional functions: Key

Starts automatic ECG recording and

prints the results according to print format l.(for print format 2 press ALT followed by AUTO START)

1

Step back by 1 lead group

2

Step forward by 1 lead group

3

Starts continuous printout of ECG displayed

Stops printout

Enables input of the patient data

Allows additional functions in combination with other keys. Deletes last character or number when an input field is displayed

Switch Myogram filter ON/OFF

The cut oflfrequency of the Myogram filter (25'35 Hz)is set in Base Settings. 4

ECG signal sensitivity 5 mm/mV

5

Signal sensitivity 10 d m V

6

Signal sensitivity 20 mm/mV

7

Recording speed 5 d

8

Recording speed 25 mm/s

9

Recording speed 50 mm

0

1 mV calibration signal for screen + Printer

s

The above speed and sellsitivity keys are f o r manual mode only. In automatic mode the speed and sensitiviry is defined by the auto mode format.

*The unit also automatieally switches offafer approximately 5 minutes when no patient is connected (or a n electrode is loose or disconnected). Page 10

Cardiovit AT- 4 ECG Recorder December1997

SCHILLER SELECT KNOB AND MENU STRUCTURE Operation of the AT-4 is via a cursor (lighvdark inverted text field), which is moved through the menu options using a Select Knob. Two simple operations are required: 1

Rotate the Select Knob to move the highlight bar up and down the list.

2

Press the Select Knob to select the highlighted option. When the Select Knob is pressed its function is dependent on the selection made: Further menu items are displayed or a data field is displayed.

When afirrther menu options or datapelds are mailable in a menu option, this is indicated on the menu by a rightfacing arrow 7'. A setting made. For example switching the QRS beeper ON or OFF. A function performed. For example quitting the current menu.

In all menus to return to the previous menu display the return option is selected '< ' :to return to the main display directly the quit option is selected ' <<I.

Throughout this guide the following symbol is used

1,@ZI

This indicates that to select the requiredfinction, operdwn or setting, the item is selected and set with the Select Knob as described above.

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Cardiovit AT- 4 ECG Recorder December1997

SCHILLER SELECT KNOB AND MENU STRUCTURE

Auto Format1 interpret. view Storage manag. >

Sensitivity : ON

interpretat.

>

User identif.

>

QRS-Beep : ON Test function ECG electr. test >

v4 D v7

V5 A

vO

V6 J v9

Cardiovit A T 4 ECG Recorder December 1997

10 mm/mV

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SYSTEM S E l T N G S Screen Contrast Select the required contrast setting by rotating the Select Knob. When the desired setting is displayed push the knob to program the setting. The contrast setting is remembered when the unit is switched Off

Select-Knob (tJ)

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I+

Date and Time The AT-4 contains a calendar clock for which the number of days per month and the leap years are already preprogrammed. The weekday is automatically calculated. The time and data appears on the LCD and on printouts. Select the date menu with the Select Knob (working through the menus by turning the Select Knob and choosing the next menu by ‘clicking’ i.e. pressing and releasing the Select Knob. Enter the date using the rubber numeric keyboard on the bottom of the unit.

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Cardiovit AT- 4 ECG Recorder December1997