User Guide
82 Pages
Preview
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Cardio Menu Service Manual
P- I Welc$Altynm Schiller i
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SP-1 User Guide
Artide Number2.510271a
Schiller
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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 Cubblington Road Aston Abbotts HP22 4ND United Kingdom
Welch Allyn Canada Ltd 160 Matheson Blvd. East, Unit #2 Mississauga, Ontario L4Z 1V4 Canada
Tel: 01296-682-140 Fax: 01296-682-104
Tel: (800) 561-8797 Fax: (905) 890-0008
Copyright0 ' 97 & '98 by Welch A l p schiller
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DECLARA T I 0N 0F CONFOR M I W Spirometer:
SP- 1
Serial numbers starting with:
540.
Year of manufacture:
1995 Onwards
We, the undersigned, hereby declare that the medical device (class IIa) 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: and
11425-01 I S 0 9001 (Rev.1994) EN 46001 by SQS I S 0 9001/08.94, EN 46001 / 12.93 by DEKRA 45112-60-00 45112-16-00 Annex 11, Section 3 of the Directive 93/42/ EEC (30.04.1995)
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b a r (Switzerland) 03.07.1996
Martin Spreng Research tiDevelopmentManager
Markus Butler Quality Assurance Manager iii
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TheInformationin thisguide has beencarefullych~edforreliabliity;howevernoguaranteeisgivenastothewmxtness of the contents and WELCH AUYN SCHILLER makes no representationsor warranties regarding the contents of this manual. We resewethe rightto revise this document and make changes in the specificationof the prcduct described within at any time without obligationto notify any person of wch revisionor change. Trademaks WELCH ALLYN SCHILLER and SP-1 are registered trademarks of WELCH AUYN SCHILLER. All trademark are the propertyoftheir owners. C o P y n i g M ~
0Copyright 1996 and 1998 by WELCH AUYN SCHIUER. All rights resewed. You may not repmduce, hansmit, hansaibe, store in a retrievalsystem orhanslate into any language, in any form or by any means, elebmnic, mechanical, magnetic, optical, chemical, manual or otherwise, any part of this oublicationwithout ~XDRSS written Dermissionof WELCH AUT" SCHILLER. TWlllSOfwdnanly
WELCH AUYN SU-IILLER warrants the SP-1 Spirometer,when new, to be free of defects In material and workmanship and to perform inaccordancewithmanufaburw'sspedficationsfortheperiodofthree(3)yearsfromthedateofpurchase from Welch Allyn or it' s authorized distributors or agents. Accessoly items such as electrodes, batteries and cables are limited to a wanantyof 90days fmmthedateof purchasefmm Welch Allyn or itsauthorizeddistributorsoragents. Welch Allyn will repairorreplaceany m p o n e ntsfoundto bedefectiveoratvariancefrom manufacturer'sspedficationswithin this time at no wst to the customer. It shall be the purchasersresponsibility to returnthe insbument to Welch Allyn or an authorizeddimibuter, agentor~cerep-sentative.Thiswarrantydoesnot indudebreakage orfailuredueto tampering, misuse, neglect, accidents, modificationsorshipping.This warranty is alsovoidifthe instrumentis not used in accordance with manufacturer's recommendationsor if repaired by otherthan Welch Ally or an authorized agent. Purchase date determineswarranty requirements. No otherexpresswarranty isgiven.
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Schiller
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PHYSICIAN’S RESPONSIBILITY THE SP-1 SPIROMETER I S PROVIDED FOR THE EXCLUSIVE USE OF QUALIFIED PHYSICIANS OR PERSONNEL UNDER THEIR DIRECT SUPERVISION. THE NUMERICAL AND GRAPHICAL RESULTS FROM A RECORDING MUST BE EXAMINED WITH RESPECTTOTHE PATIENTS OVERALL CLINICAL CONDITION. THE RECORDING PREPARATION QUALITY AND THE GENERAL RECORDED DATA QUALITY, WHICH COULD EFFECTTHE 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 OFA PHYSICIAN
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Safety Notices THIS UNIT I S BF CLASSIFIEDACCORDING TO IEC 601-1.
1 SERVICING TO QUALIFIED PERSONNEL ONLY.
? FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS. THIS PRODUCTIS NOTDESIGNED FOR STERILE USE.
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DO NOT, UNDER ANY CIRCUMSTANCES, IMMERSE THE UNITOR CABLE ASSEMBLIES I N LIQUID. THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER I F THE EARTH CONNECTIONI S SUSPECTOR I F THE MAINS LEAD I S DAMAGED OR SUSPECTED OF BEING DAMAGED. Z M OR GAMMA R4DIATlON STERIUSAIION. DO NOT USE SOLVENT CLEANERS USE ONLYACCESSORIESAND OTHER PARTS RECOMMENDED OR SUPPLIED BY WELCHALLYN SCHILLER. USE OF OTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULTIN INJURY INACCURATE INFORMATIONAND/ OR DAMAGE TO THE UNn. THE SP-1 COMPLIES WITH EMC REGULATIONS FOR MEDICAL PRODUCTS WHICH AFFORDS PROTECTIONAGAINST EMISSIONS AND ELECTRICAL INTERFERENCE. HOWEVER SPECIAL CARE MUST BE EXERCISED WHEN THE UNIT I S USED WITH HIGH FREQUENCY EQUIPMENT.
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S P - I User's Guide This User's Guide gives instructionson how to operate the 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 enable the user to quickly and easily familiarisethemselves with unit operation. Detailed medical information is excluded from this guide exceptwhere necessary to operate the unit or understand the results.
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This equipmenthas 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 providereasonableprotection 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 interferencein which case the user will be required to correct the interference at his own expense.
Disposal Instructions and Battery Care
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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 SchillerAG for disposal. Alternatively dispose of the unit in municipally approved recycling centres.
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Schiller 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) o r 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 connectedto 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, o r 2x315mAT for llOV
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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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Contents
.User Guide SP-I
PROCEDURE OVERVIEW ... 2 INTRODUCTION ... 4 LOCATION 6 POWER SUPPLY ... 7 KEYBOARD ... 8 MAIN MENU OVERVIEW ... 9 SCREEN CONTRAST AND ENTERING DATA ... 12 Setting the Contrast ... 12 Entering data in a field ... 12 SYSTEM SETUP MENU ... 13 PATENT DATA ... 18 Race Influences on Norm Values ... 19 CALIBRATION ... 20 Calibration Procedure ... 22 PULMONARY FUNCTION TEST PROCEDURE ... 24 Definitionof Best ... 27 Displayingthe Results in Tabular Form ... 28 Obtaining a Printout ... 29 Deletinga measurement ... 31 Forced Vital Capacity (FVC) Test ... 32 Slow Vital Capacity (SVC) Test ... 33 M W Test ... 33 MV Test ... 33 POST-MEDICATIQN TESTS ... 34 EXPLANATION OF MEASURED VALUES ... 35 DATA STORAGE ... 38 Automatic Storage ... 38 Manual Storage ... 38 MEMORY MANAGEMENT ... 40 Tagging a Stored File (for Deletion or Sending) ...41 Exiting the Memory Option ... 41
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SP-1 User's Guide
SENDING ... 42 CARE & MAINTENANCE ... 43 Self-test ... 43 Maintenance... 43 REPLACINGTHE RECORDING PAPER ... 44 FLOW SENSORS ... 46 Flow Sensor SP-150 ... 46 Flow Sensor SP-20 ... 47 DIAGNOSIS ... 49 Diagnosis Setting 'International' ... 49 Diagnosis Setting 'American' ... 50 NORM VALUES ... 51 Norm Values for Countries Outside the USA ... 52 ECCS Values ... 52 Quanjer & Tammeling Comparisons ... 53 Austrian Standard Values (Osterreich) ... 54 Austrian Standard Values (Osterreich) ... 54 Swedish Standards (Berglund) ... 55 Swedish Standards (Berglund) ... 55 Finnish Standards ... 56 Indian Equations... 57 Norm Values for USA and Canada ... 58 Morris Norm Values ... 58 Crapo Norm Values ... 59 Knudson Norm Values ... 59 Knudson 76 Norm Values ... 61 Composite Norm Values ... 62 Polgar Norm Values ... 63 TECHNICAL DATA ... 64
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Procedure Overview
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Insert new filterkcreen (SP-20) Insert new sensor (SP-150)
- _ ( General
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OEF
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JKL
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MNO
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Settings I Date Time Device Norm values I Contrast Print User I I Memory I etc.
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every new patient
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Enter MTA ldent
Repeat tests (3 or more, or times)
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Post-medication tests
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DISPLAY RESULTS
PRINT RESULTS
SEND RESULTS
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SP- 1 User's Guide
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Procedure Overview 1
Switch ON
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Make Settings preference if required (remembered when unit switched off)
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Insert new screenAiIter or sensor
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Calibrate Unit
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Enter patient data
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Select test
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Press START
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Patient Makes test
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Press STOP
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Repeat as many times as required (Best, or best two + last printed)
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Display result
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Print Result Send result if required
SP-1
User’s Guide
Page 3
Introduction
PAPER RELEASE CATCH
DISPLAY
MAINS AND POTENTIAL EQUALISATIONCONNECTORS
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FNSOR CONNECTOR
/
RS-232 CONNECTOR
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TEST INDICATORS
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POWER INDICATORS
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SYSTEM INDICATORS
SP- 1 User's Guide
Introduction The SCHILLER SP-1 is a stand-alone pulmonary function testing unit that features four modes for the measurement of inspiratory and expiratory values. The unit incorporates a liquidcrystal display to instantlyshowthetest results. An integral high quality thermal printer provides clear and comprehensive result analysis in a number of different formats and an RS-232 interface is provided for transmission of test results to a PC. All tests and settings are initiated via an easy to use keypad with dedicated test keys. Test indicators show the current test being carried out and function LEDs provide visual indication for functions such as power, sensor disconnected, paper tray empty and paperjam. Measurementsare made with a lightweight and hygienic open pneumotacho sensor. Two sensors are available. The SP-20 open pneumotacho sensor incorporates a disposable filter and is easily dismantled for cleaning and sterilisation. The SP-150 sensor has a disposable, single patient sensor/ filter assembly eliminatingthe need to clean the sensor after each use. The SP-1 has the following features: Direct function keys for measuring the following: FVC Forced Vital Capacity SVC Slow Vital Capacity
M W Maximum Voluntary Ventilation MV Expired or Minute Ventilation Low weight and compact dimensions Built-in rechargeablebattery for mains-independent use Selectable printing formats with integrated quality thermal printer Patient memory for up to approximately 100 single measurements (option) Choice of 6 languages for display and printing SP- 1
User's Guide
Page 5
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 1 meter between the unit and the mains supply is maintained Potential Equalisation
In certain circumstances interference can be caused by external electrical equipment or radio equipment. Connect the earth potential equalisationconnection at the back of the SP1 to the hospital common ground or, if acommon ground is not present, to a metalframework e.g. the bed frame. Note that all other electrical equipment in close proximity should also be connectedto the same common ground. The part number of the potentialequalisationcable is 2. 310 005.
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SP-1 User's Guide
Power Supply The unit can be operatedfromthe mains orfrom the built-in rechargeablebattery. The mains connection is on the rear of the unit. The mains indicator lamp is always lit when the unit is connected to the mains supply. A battery indicator lamp confirms battery operation. When the battery capacity is limited, the indicator flashes. To recharge the battery, connect the apparatus to the mains supply by means of the supplied power cable. A totally discharged battery needs less than 15 hours to be fully recharged (60% in less than 3 hours). A fully charged battery lasts approximately 2 hours of normal use. The unit can remain connected to the mains supply without any danger of damage to either the battery or the unit.
Switching On and Off The SP-1 is switched on and off with the ON and OFF keys.
titwhenoperati fromthe
internalbattery. #Lws *en banery has limited capaaty
SP-1 User's Guide
Lit when mains suppty CoMected
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Keyboard Enter Lung Function Test Menu as designated (Commence each measurement with START; end each measurement with STOP)
Indicates the test currently being carried out
Move Display Cursor
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Start Measurement Print Measurement Stop Measurement or Stop Printout
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Switch unit off
Switch unit on
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Enter Patient Data Display Menu options for the indirect functions or Escape Dis lay Result of th test Change Rey to second function Calibibrate unit Delete a character/delete last measurment Pre and Post medication test Enter menu option displayed or confirm entry Battery Operation / Mains Connectec Sensor not connected Paper jam or no paper in paper tray Post test being carried out
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SP-1 User's Guide
Main Menu Overview
Note that the Save and the Memory menu items only appear when the memory option is installed
SP-1 User's Guide
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Menu Overview Main Menu Save
This option only appears when the memory option is installed. Select this option to save the current measurement in the memory.
Memory
This option only appears when the memory option is installed. Select the memory menu item to: Print a stored recording
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Delete a recording Send a recording
MTA ldent
Enter the name of the person carrying out the test. The MTA name (medical technical Assistant) is given on printouts. The users name entered here, is rememberedwhen the unit is switched off; it only needs updatingwhen a new user takes over.
Send
Current recordingis sent overthe RS-232 interface (for example to the SEMA PC storage program). Note that the RS-232 protocol settings must be defined in the setup menu before transmission. ,
Setup
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See System Setup Menu following I
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SP- 1 User's Guide
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