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P-Welc Altynm
Schiller
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SP-1 User GuideArtide Number2.510 271a
SchillerWelch Allyn Inc.7420 Carroll RoadSan Diego, CA 92121
Phone: 800) 854-2904Fax: 858) 621-6611www.welchal lyn.com
United Kingdom:Welch Allyn UK LtdCubblington RoadAston Abbotts HP22 4NDUnited KingdomTel: 01296-682-140Fax: 01296-682-104
Copyright0 97& 98by WelchA l p schiller
Canada:Welch Allyn Canada Ltd160 Matheson Blvd. East, Unit 2Mississauga, Ontario L4Z 1V4CanadaTel: 800) 561-8797Fax: (905) 890-0008
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DECLA RAT I 0N 0F CONFORM WSpirometer: SP- 1Serial numbers start ing with: 540.Year of manufacture: 1995 OnwardsWe, the undersigned, hereby declare that the medical device (class I Ia ) specified above conformswith the essential requirement listed in Annex 1 of EC Directive 93/42/EEC.This declaration is supported by:Certificate of approval No:and 45112-16-00 Annex 11, Section 3 o f the Directive 93/42/
11425-01 IS0 9001 (Rev.1994) EN 46001 by SQS45112-60-00 IS 0 9001/08.94, EN 46001 / 12.93 by DEKRA
EEC (30.04.1995)c 0124b a r Switzerland) 03.07.1996Martin SprengResearchtiDevelopment Manager
Markus ButlerQuality Assurance Manager
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LXdlimerTheInforma tionin thisguide hasbeencarefullych~edforreliabliity;howevernoguarantee isg ivenas tothewmxtnessof the con tents and WELCH AUYN SCHILLER makes no rep resentationsor warranties regarding he contents of thismanual. We resewe the righ tto revise his document and m ake changes n he specificationof the p rcduct describedwithin at any time without ob ligation o notify any person ofwch revisionor change.TrademaksWELCH ALLYN SCHILLER and SP-1 are registered trademarks of WELCH AUYN SCHILLER. All tra de ma rk are thepropertyofthe ir owners.C o P y n i g M ~
opyright1996 nd 1998by WELCH AUYN SCHIUER. All rights resewed. You ma y not repmduce, hansmit, hansaibe,store in a retrievalsystem orhanslate into any language, in any form or by any means, elebmn ic, mechanical, magnetic,optical, chemical, man ual or otherwise, any partof this oublicationwithout ~XDRSSwritten Dermissionof WELCH AUTSCHILLER.TWlllSOfwdnanlyWELCH AUYN SU-IILLER warrants the SP-1 Spirometer,when new, to be freeof defects In material and w orkmanshipand to perform naccordancewithmanufaburw'sspedficationsfortheperiodofthree(3)yearsfromthedateofpurchasefromWelch Allyn or it' s authorized distributors or agents. Accessoly items such as electrodes, b atteries and cables arelimited to a wanantyof 90d ays mm thed ateof purchasefmm Welch Allyn or tsauthorizeddistributorsoragents. WelchAllyn will repairorreplaceany m p o n e n sfoun dto bedefectiveoratvariancefrom manufacturer 'sspedf icat ionswithinthis time a t no wst to the customer. I tshall be the purchasers esponsibility to return he nsbument to Welch Allyn or anauthorizeddimibuter, agentor~cerep-sentative.Thiswarrantydoesnot indudebreakage orfailu redu eto ampering,misuse, neglect, accidents, modif ication sorshipping.This warranty is alsovoid fth e nstrument s notused inaccordancewith manufacturer's recommendations or if repaired by othe rthan Welch Ally or an authorized agent. Purchase datedeterminesw arranty equirements. No otherexpress warranty sgiven.
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SchillerPHYSICIANS R ESPONSIBILITY
THE SP-1 SPIROMETER I S PROVIDED FOR THE EXC LUSIVE USE OF QUALIFIEDPHYSICIANS OR PERSONNEL UNDER THEIR DIRECT SUPERVISION. THENUMERICAL AND GRAPHICAL RESULTS FROM A RECORDING MUST BEEXAMINED WITH RESPECTTOTHE PATIENTS OVERALL CLINICAL CON DITION.THE RECORDING PREPARATION QUALITY AND THE GENERAL RECORDED DATAQUALITY, WH ICH C OULD EFFECTTHE REPORT DATA ACCURACY, MUST ALSOBE TAKEN INT O ACCOUNT.IT S THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAG NOS IS OR TOOBTAIN EXPERT OPINIO N ON THE RESULTS, AND T O INSTITUT E CORRECTTREATMENT I F NDICATED.FEDERAL LAW I N THE USA RESTRICTS TH IS DEVICE TO SALE BY OR ON THEORDER OF A PHYSICIAN
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Safety NoticesTHIS UNIT I S BF CLASSIFIED ACCORDING TO IEC 601 1.SERVICING TO QU ALIF IED PERSONNEL ONLY.FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS.THIS PRO DUCT IS NOTD ESIGNE D FOR STERILE USE.
DO NOT, UNDER ANY CIRCUMSTANCES, MMERSE THE UN ITO R CABLE ASSEMBLIES IN LI QU ID.THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER IF THE EARTH CON NEC TION S SUSPECTOR I FTHE MA INS LEAD I S DAMAGED OR SUSPECTED OF BEING DAMAGED.OR GAMMA R4DIATlO N STER IUSAIION.DO NOT USE SOLVENT CLEANERSUSE ONLYACC ESSOR IESAND OTHER PARTS RECOMMENDED OR SUPPLIED BY WELCH ALLYN SC HILLER. USE OFOTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESU LTIN INJURY INACCURATE INFORM ATIO NAN D/ ORDAMAGE TO THE UNn .EMISSIO NS AND ELECTRICAL INTERFERENCE. HOWEVER SPECIAL CARE MUST BE EXERCISED W HEN THE UN ITI S USED WIT H HIGH FREQUENCY EQUIPMENT.
Z M
THESP-1 COMPLIES WITH EMC REGULATIONS FOR MEDICAL PRODUCTS WHICH AFFORDS PROTECTION AGAINST
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(
S P - I User 's G uideThis User's Guide gives instructionson how to operate the unit and provides an overviewof all the basic functions n aneasy and simple to use format. The proceduresare presented n a logical, step-by step way to enable the user to quicklyand easily familiarisethemselves with unit operation. Detailed medical information sexcluded rom this guide except wherenecessary to operate the unitor understand the results.
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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 Part15 of the FCC Federal Comm unications Comm ision) Rules and the radio interference regulations of the Cana dianDepartment of Comm unications.These imits are designed to provide reasonableprotection against harmful nterferencewhen the equipment is operated in a com mercial environment. This equipm ent generates, uses and can radiate radiofrequency energy and, if not installed and used in accordance with this instruction manual, may cau se harmfulinterference to radio c ommu nications. Operation of this equipm ent in a residential area is likely to cause harm fulinterference n which case the user w ill be required to correct the interference at his own expense.
O DO NOT DISPOSE OF THE BA TTERY BY FIRE OR INCINERATOR -DANGER OF EXPLOSIONisposal Instructionsand Battery Care O DO NOT ATTEMPT TO RECHARGE THE BATTERY - DANGER OFEXPLOSIONO DO NOT OPEN THE BATTERY CASING - DANGER OF ACID BURNOnly dispose of the battery in official recycling centres ormunicipally approvedareas. Alternatively used batteries can be returned to Schiller AG for disposal.
Unit Disposal InstructionsUnits no longe r required can be returned to SchillerAG for disposal. Alternativelydispose of the unit in municipally approved recycling centres.
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SchillerPower SupplyThe mains connection is on the rear of the unit.Th e power supp ly voltage is set by the facto ry for100-115V nom. llOV ) or 220-240Vnom. 230V) working. Th e setting is indicated by the inden ted metal strip on the fusepanel. Co ntact your dealer if the voltage needs to be changed.The mains indicator lampon the keyboard is always lit when the unit is connected o the mainssupply. The unit can either be operated from the mains supply or from the built-in recharge-able battery. The power source is indicted on the top line of the LCD.Changing a M ains FuseIf it is necessary to cha nge a fuse, always replace with t he co rrect ra ting i.e 2x200mA Tfor 230V, or 2x315mAT for l l O V .To change a fuse press the tworetaining lugs on sideof the fuse panel situated below the mainsconnectoron the back panel. Remove the fuse panel and replace the fuse s). Click back the fusepanel.
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Welc AJlp-Schiller
.314ZEEC Medical Devices:
0124 Notif ied Body DEKRA AG
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Contents . ser Guide SP-IPROCEDURE OVERVIEW ................................................ 2INTRODUCTION ................................................................ 4LOCATION.......................................................................... 6POWER SUPPLY ............................................................... 7KEYBOARD ........................................................................ 8MAIN MENU OVERVIEW ................................................... 9SCREEN CO NTRA ST AND ENTERING DATA ............... 12Setting the Contrast ................................................... 12Entering data ina field ............................................... 12SYSTEM SETUP MENU .................................................. 13PATENT DATA .................................................................. 18Race Influences on Norm Values ............................... 19CALIBRATION .................................................................. 20Calibration P rocedure ................................................ 22PULMONARY FUNCTION TEST PROCEDURE .............24Definitionof Best ........................................................ 27Displaying he Results in Tabular Form ..................... 28Obtaining a Printout ................................................... 29Deleting a m easurement ............................................ 31Forced Vital Capacity (FVC) Test ............................... 32Slow Vital Capacity (SVC) Test .................................. 33M W Test .................................................................... 33MV Test ....................................................................... 33POST-MEDICATIQN TESTS ............................................ 34EXPLANATION OF MEASURED VALUES ...................... 35DATA STORAGE .............................................................. 38Automatic Storage...................................................... 38
Manual Storage .......................................................... 38Tagging a Stored File (for Deletion or Sending) ..........41MEMORY MANAGEMENT ............................................... 40Exiting the M emory Option ......................................... 41
SENDING ......................................................................... 42CARE & MAINTENANCE ................................................. 43Self-test ...................................................................... 43Maintenance............................................................... 43REPLACING THE RECORDING PAPER ........................ 44FLOW SENSORS ............................................................. 46Flow Sensor SP-150 .................................................. 46Flow Sensor SP-20 .................................................... 47DIAGNOSIS ...................................................................... 49Diagnos is Setting 'International' ................................ 49Diagnos is Setting 'American' ..................................... 50NORM VALUES ................................................................ 51Norm Values for Coun tries Outside the USA ............. 52ECCS Values .............................................................. 52Quanjer & Tammeling Comparisons .......................... 53Austrian Standard Values (Osterreich) ...................... 54Austrian Standard Values (Oste rreich) ...................... 54Swedish Standards (Berglund) .................................. 55Swedish Standards (Berglund ) .................................. 55Finnish Standards ...................................................... 56Indian Equations......................................................... 57Norm Values for USA and Cana da ............................ 58Morris Norm Values .................................................... 58Crapo Norm Values .................................................... 59Knudson Norm Values ................................................ 59Knudson 76 Norm Values .......................................... 61Composite Norm Values ............................................ 62Polgar Norm Values ................................................... 63TECHNICAL DATA ........................................................... 64
SP-1User's GuidePage 1
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Procedure Overviewr
i_( GeneralSettings I
I Memory, L - -
I
etc.
III
DateTimeDeviceNorm valuesContrastPrintUser I
I for every new patientInsert new filterkc reen
Insert new sensor
1(SP-20)
(SP-150).nter MTA ldent
1
2 OEF 3 GHI 4 JKL 5 MNOIost-medicationtests
Repeat tests (3or more, ortimes)I I
I DISPLAY RESULTS PRINT RESULTS SEND RESULTSPage 2 SP-1User 's Guide
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Procedure Overview123456789101112
Switch ONMake Settings preference if required (remembered when unit switched off)Inse rt new screenAiIter or sensorCalibrate UnitEnter patient dataSelect testPress STARTPatient Makes testPress STOPRepeat as m any times as required (Best, or best two + last printed)Display resultPrint ResultSend result if required
SP-1Users Guide Page 3
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Introduction
PAPER RELEASE CATCH DISPLAY
INS OR CONNECTORMAINS AND POTENTIALEQUALISATION CONNECTORS/
RS-232 CONNECTOR
TEST INDICATORS , IPOWER INDICATORS SYSTEM INDICATORS
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IntroductionThe SCHILLER SP-1 is a stand-alone pulmonary function testing unit that features fourmodes for the measurement of inspiratory and expiratory values. The unit incorporates aliquidcrystal display o instantlyshowthe test results. An integral high quality herm al printe rprovides clear and comprehensive result analysis in a number of differen t formats and anRS-232 interface is provided for transmission of test results to a PC. All tests and settingsare initiated via an easy to use keypad with ded icated test keys. Test indicators show thecurrent test be ing carriedout and function LEDs provide visual indication or func tions suchas power, sensor disconnected, paper tray empty and paper am. Measurementsare madewith a lightweight and hygienic open pneumotacho sensor. Two senso rs are available. TheSP-20 open pneumotacho sensor incorporates a disposable filter and is easily dismantledfor cleaning and sterilisation. The SP-150 sensor has a disposable, single patient senso r/filter assembly eliminating he need o clean the sensor after each use. The SP-1 has thefollowing features:
Direct function keys for measuring the following:FVC Forced Vital CapacitySVC Slow Vital CapacityM W Maximum Voluntary VentilationMV Expired or Minute VentilationLow weight and compact dimensionsBuilt-in rechargeab le battery for mains-independent useSelectab le printing ormats with integrated quality thermal printe rPatient memory for up to approximately 100 single measurements (op tion)Choice of 6 anguages for display and printing
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LocationAs with a ll med ical units, the following general rules are to be noted:
The unit should not be stored or operated in a wet, hum id or dusty env ironment.The unit may not come into con tact with acidic steams or liquids.The unit should not be set up near radiology or diathermic systems, or near largetransformers or electrical motors. Ensure that a minimum distance of 1 meterbetween the unit and the mains supply is maintained
Potential Equalisation
In certain circumstances interference can be caused by external electrical equipment orradio equipm ent. Connect the earth potential equalisationconnection at the bac k of the SP-1 to the hospital common ground or, if acomm on ground s not present, to a metal ramew orke.g. the be d rame. Note that all other electrical equipment in close proximity should also beconnec ted o the same comm on ground. The part number of the po tential equalisationcableis 2. 310 005.
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Power SupplyThe unit can be operated fromthe mains orfrom he built-in rechargeablebattery. The mainsconnection is on the rear of the unit. The mains indicator lamp is always lit when the unit isconne cted o the mains supply. A battery indicator lamp confirm s battery operation. Whenthe batte ry capacity is limited, the indicator flashes. To recha rge the battery, connect theapparatus to the mains supply by means of the supplied power cable. A totally dischargedbattery needs less than 15 hours to be fully recharged (60 in less than 3 hours).
A fully charged battery lasts approxi-mately 2 hours of normal use. Theunit can remain connected to themains supply without any danger ofdamage to either the battery or theunit.
Switching On and OffThe SP-1 is switched on and off withthe ON and OFF keys.
titwhenoperati fromthe Litwhen mainsinternalbattery. Lws enbanery has limited capaaty suppty CoMected
SP-1User's Guide Page 7 Keyboard
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Enter Lung Function Test Menu as designatedIndicates the test (Commence each measurement with START; Switch Switchcurrently being carried out end each measurement with STOP) unit off unit on
Iove Display Cursor ISta rt MeasurementPrint MeasurementStop Measurement or Stop Printout Inter Patient DataDisplay Menu options for the indirect functions orEscape
Dis lay Resu lt of th testChange Rey to second functionCalibibrate unitDelete a character/delete last measurment
Pre and Post medication testEnter menu option displayed or confirm entryBattery Operation / Mains Connectec
Sensor not connectedPaper jam or no paper in paper trayPost test being carried out
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Main Menu Overview
Note that the Sa ve and the Memory menu items only appear when the memory op tion is insta lled
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Menu OverviewMain MenuSave
Memory
MTA ldent
Send
Setup
This option only appears when the memory option is installed. Select thisoption to save the current measurement in the memory.This option only appears when the memory option is installed. Select thememory m enu item to:
Print a stored recording. Delete a recording. Send a recordingEnter the name of the person carrying out the test. The MTA name (m edica ltechnical Assistant) is given on printouts. The users name entered here, isrememberedwhen the unit is switchedoff; itonly needs upda tingwhen a newuser takes over.Current recording s sent overthe RS-232 nterface (for example o the SEMAPC storage program). Note that the RS-232protocol settings must be de finedin the setup menu before transmission.See System Setup Menu following
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Menu Overview
hen a menu is displayed use thesekeys to move the cursor UP / DOWN.When an en ter field is displayed e.g.When a menu is displayed - press this keyto select highlighted men u option. When anenter field is displayed e.g. MTA Ident, useMTA Ident, use these keys to m ovethe cursor LEFT RIGHT this key to confirm entry and to exit field
Use this key to display the main menu as above. When an e nter field is displayed,this key is us ed the same as the ENTER key to confirm entry and to exit field
SP-1User 's Guide Page I Screen Contrast and Entering Data
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Change the con trast of the screen to your preference as follows:Press he ALT key and the MENU key togetherthen change the contrast with the cursor key sUP and DOWN
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Press th is key to select highlighted menukey to program sett ings and exit menuOption or to change sett ing. Press the MENU
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System Setup Menu
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This menu option defines all the general settings. All entries remain stored (even when theunit is switched off) until overwritten. The settings are as follows:User ldent Use his to enter the name of the consultant or department thatopera tes the unit.Measurement This is how the FVC graph is displayed and printed. With theENTER key toggle the options to set aflow display of one of thefollowing:
Flow = (vol)Flow = loopVol =f(t)
-8-l
Flow = (v0l)
, 11
Flow = LOOP :kLol = (1)Page 14 SP-User s Guide
System Setup Menu
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Print This defines the format and content of the printou t when th ePRIN T key is pressed. The settings are as follow s:
Graph Select ALL or BEST (measurements)Time Axis This defines the time axis of the graph - set to1Om ds or 20mm/sFlow Graph Set to ON or OFF - graph printed or not printedVol Graph Print the volume graph - select YES or NO
1111
Flow Graph Volume Graph
DiagnosisPEF
Diagnosis printed or not printed -select YES orNOPeak Expiratory flow calculation - select litredmin or litres/second
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System Setup MenuDevice STANDARD
NORMALS
UNITSDATERACE
Set to 'International' for all countries outside the USA andCanada or to 'American' for USA and Can adaThe diagnosis is based on the standard defined here. T heNorm al value standards are given at the en d of this section-'Diagnos is and Norm Value Tables'Set to : cm I kg IoC, cm I kg /OF,settheorder ofthedatetomonth-day-year, day- month-yearor year-month-dayset to:NONE (no race): recommended for Europe,WIB (White1 Black) for all countries outside the USA andCanadaCIHIBIA (Caucasian / Hispanic I Black I Asian) for USA andCanadaThe standards and Norm Values are deta iled at the end of thissection (Diagnosis and Norm Values). The individual settingfor race, and the effect of race on results is detailed in thePatient data (see following page)
inch I Ib. 1F
LANGU AGE This defines he language on the printout and men u structure.Set to English, German, French, Italian ,Spanish, or Portuguese
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System Setup Menu
BERGLUND / QUANJERFINNISH / QUANJER
INDIANOSTERREICHKNUDSON I ITS
KNUDSON76 I ITS
ClockRSlMemory
Set the time and dateThe Baud rate (300 to 38400)and parity setting (No/odd/even)for sending over the RS nterface must be set to the sam e asthe receiving unit.The save options are MAN (manual) or AUTO (automatic).When the save option is set to AUTO, all mea surem ents areautomatically saved when completed (only when the memoryoption is installed).
Press the MENU key to confirm all settings and exit the setup menu. The following tableshows typical setup combinations.
cm/kglCW/B) orInternational NONE
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Patient Data
Patient namePatient numberEnter age of patient in whole yea rsSelect M (male) or F (female).Height in centimetres (or inches(scaled to 1/10 inch), depending onunit setup).Weight in kilogrammes (or pounds,depen ding on unit setup).Enter patients race:WIB: W or White, B for BlackC/H/B/A: C or Caucasian, H for
Each printout is com plete with the name and other information concerning the patient. Beforebeginning a recording, the patient data should be entered. The following parameters have to beentered:Pat-Name:Pat-No:Age:Sex:Height:
Weight:Race:
a t - N a m e :Pat-NoAgeSexHeight cmWeight kgRace
years(M/F)
If this position does not appear, "NONE" was selected in the device setup. (menuoption see previous page.Wrongly typed cha racters can be deleted by pressing he DEL (delete) key.
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Patient Data
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Race Inf luences o n Norm ValuesAccording o the setting of the patients race the predicted values will differ. The differencesare (according o ITS recommendations) as follows:
When in the Settings menu NONE was set:All values are calculated acco rding to the given formulas.When in the Settings m enu WB)was set:W (White): values are calculatedaccordingto the given orm ulas (=1OO0/o)B (Black): 85% of the given formulasWhen in the Settings menu (CMIB/A) was set:C (Caucasian):H (Hispanic):B (Black):A (Asian):The 85 race comp ensation is calculated only when the follow ing nor malvalues are selected: COMPOSITE; KNUDSON; CRAPO; MORRIS; POLGA R
values are calculatedaccordingto thegiven ormulas (=100 )values are calculatedaccording o the given formu las (=100 )85% of the given formulas85% of the given formulas
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Calibration
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r
Last calib. 23.11.95BTPS Factor 1.090Calib. Factor 1 oooTemperature 20 CMeasured Vol. 0.00Syringe Vol. 4.00
IMPORTANTTHE U NIT MUST B E CALIBRATED WITH THE FIRST PULMONARY FUNC TIONTESTOFTHE DAY, AFTER EVERY SIGNIFICANT TEMPERATURE CHANGE OR AFTERCHANGING THE SENSOR.
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Calibration
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l a s t Cal ib rat i onBTPS
date of last calibrationFactor calculated BTPS (=> Body Temperature, AmbientPressure, Saturated with water vapour) value. This valuecompensatesforthediff erence in nhaledandexhaled humidity.The unit s set for measuring exhaled volume (100 humidity,Temp 36.8O), and so when inhaled volume is measured thisfactor is applied. The SP-1 uses ambient temperature tocalculate he BTPS factor. This is sufficient for accurate FlVCcalculation. The formula used is as follow:
273.1 5 + 36.8BTPS = 0.033 + 273.15 T~Tu is ambient temperature degrees centigrade0.033 is equivialent to 760mmHg at 22 degrees C273.15 is degrees absolute
Calibration Factor calculated value between measured and effective calibrationair volumeambient temperature in "C (or OF) dependent on device settingair volume measured by the system rom the calibration pumpentered air volume depending on the size of the calibrationpump and times the air was pumped through the sensor; e.g.pumping 2 litres 3 times amounts to 6 litres (the recommendedvolume with a 2 litre pump is 4 litres; with 3 litre pump, 6 itres)
TemperatureMeasured VolumeSyringe Volume
SP-1User's Guide Page21 Calibration
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CalibrationProcedureTo calibra te the unit proceed as follows:
Wait 1 second.Press the START key
Note: Make sure that the flow sensor is kept still during the pumping operation.While pumping, the unit records the volume being pumped through the flow sensor andindicates it on the display.
Connect the calibration pump to the sensor. Ensure that there are no air leaksPress the CAL key - th e m enu is displayed as shown on the previous pageThe cursor is positioned at temperature. Enter the ambient temperaturePress ENTER when the correct temperature entered
I Pump 4 to 6 itres of air through the sensor
Press the STOP key when finished pumping.Enter the pumped air volume at syringe volume prompt (depending on the size of thecalibra tion pump and times of pumping; i.e. a 2 litre pump pumped3 times = 6 litres).Press ENTER.The m essage Calibration complete appears on the display, press the PRINT keyto obta in a printou t of the calibra tion report with the follow ing information :
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Calibration
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If the message 'EXCESSIVE DEVIATION ' appears on the screen after a calibration, itindica tes that the difference between the measured volume and the en tered volume s toogreat (>25 ).Check the temperature setting, the syringe volume and the entered syringevolume. If these are a ll correct change the screen/filter and recalibrate
SP-1User's Guide Page 23
Pulmonary Function Test Procedure
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The test method or the FVC, SVC, M W and MV test is the same. Proceed as follows:1. Calibrate he unit
THE UNIT MUST BE CAL IBRATEDAt the beginn ing of each dayIf the sensor is chang edWhen a s ignificant temperature or pressure difference occurs
2. Press the function test keyFVCsvcM WMV
The relevant keyboard amp lights and the correspondingcoordinate presentation appearson the display as shown in this ex ample for FVCThe coo rdinates represent the gra ph on which the curve will be drawn with the respiratoryvolume in litres being represented on the vertical axis and the time in seconds on thehorizontal axis.
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Pulmonary Function Test Procedure
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SP-1 Page 25User's Guide
Pulmonary Function Test Procedure
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r 3. Press the START keY
The low sensor must be heldqu ite stillandn o air shouldbe breathedin to the device for at least onesecond before an d after the START key is pressed.The message READY FOR MEASUREM ENT' appears on the display together with a volumecounter graph for the value. As soon as the patient starts to breathe into the flow sensor, the unitbegins to record the expiratory flow. The corresponding curve is represented on the display. Thebreak-off point orthe expiration measurement s reached automatically (orthe S top key s pressed).
4. Press the STOP key on com pletion of the test.5. Repeat s teps 3 and 4 un til three m easurements h ave been taken.Note: If the Start key is again pr essed (a fourth or more times), only the best th ree measurements arestored.
When Am erican standards are stipulated, the message ATS criteria met appears on the printoutif the deviation (as stipulated by the American Thorasic Society) between he best and second bestmeasu remen ts s not greater than 200ml.
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Pulmonary Function Test Procedure
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Following a series of patient measurements the best two results are recorded and storedalong with the last test made (which may or may not be one of the best three). The se threeresults can then be printed graphical along with a table of the best individua l mea surem ents(from hese three results). The table of the best m easurements can also be displayed on thescreen.~ _ _ ~
Definitionof BestIn accordance with the ATS Spirometry S tandard (11 N ovember 1994 , the best recordingsare defined as the highest value from the calculation:
The measurem ent table (on the printout and on the display) gives the highest individualmea surem ents (e.g. FVC, FE Vl ,SVC, M W etc.) f rom the two bes t recordings as definedabove, and he last recording made. This is true for all parametersexcept the following whichare ba sed solely on the highest FVC + FE Vl value:
SP-1Usess Guide Page 27
Pulmonary Function Test Procedure
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Displaying the Results in Tabular FormPress the RESULT Key after a m easurement, or series of measurements have been m ade.A measurement table is disp layedfort hetest mode (as indicated byt hetest amp) asfollows:
FVC
svc
MV
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Pulmonary Function Test Procedure
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Obtaining a Printout
Press after taking all measurements.............................
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Pulmonary Function Test Procedure
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The following is given:The pa tient dataThe se lected norm valuesThe date of last calibrationThe number of tests stored. If more than three tests are made the figure given inbrack ets indicates the total number of tests carried out. The number of post testsstored, and the total number of post tests made are given in the sam e manner afterthe slash. In he example given opposite, atotal of 5 tests were carried out and at ota lof 6 post tests.The FVC and FEW variation n ml between he best and second best measuremen ts.If this value is within 200m l the message 'ATS criteria met' is printed.The diagnostic statement (if enabled in Settings menu)The MTA identificationThe user identificationThe date and time of the printoutThe software version and he installedoptions (M= memory) are also indiczbottom of this page. 3d at th
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Pulmonary Function Test Procedure
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r The second section of the printout comprises:the test results presented as atable giving the best values, the predictedvalues andthe best values as a percentage* of the predicted.
* The predicted values (%)given on the printout may differ slightly from the values thatwould be obtained if manually calculated. The reason is that the measured a ndpredicted values on the printout are rounded to two decim alplaces, the processorhowever,uses the actual values -measured o three decimalplaces - to calculate heof predic ted value. This can account for a possible variation. Where a d ifferenceexists , the values given on the printout are always the more accu rate.
Deleting a measurement
The last measurement made can be deleted by pressing DEL
SP-1User's Guide Page 37
Pulmonary Function Test Procedure
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Forced Vital Capacity FVC) TestFor this test the patient must exhale as quickly as possible rom the time of starting he test.Note: The N C est employs the "Back extrapolation" method. If the extrapolatedvolume s too large (>O. 15 itres or5% of FVC), thena warning appears on the
displayTo carry out the test for ForcedVital Capacity (FVC), press key F V C and he correspondingcoordinate presentation appears on the displayThe patient must exhale as quickly as possible rom the time of starting the test so be surethat he understan ds what is required of him. If inspiratory measurements are required, theexhalation can be imme diatelyfollowedby a maximum nhalation.The inspiration results willbe g iven on th e printout.Before initiating a printout of the FVC Test, ensure that the s ettings are correct as detailedpreviously. Press the PRINT key to obtain a printout as defined.
Page 32 SP-1User's Guide
Pulmonary Function Test Procedure
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Slow Vital Capacity (SVC) TestThe patient should breathe normally3 times and then inha le maximally to total lung capac ityand then expire maximally. Make sure that the patient understands what i s required of him.M W TestThe patient should breathe as deeply and as rapidly as possible over a period of 6 to 12seconds so make sure that he understands what is required of h im.
WARNINGEXTREME CARE SHOULD BE EXERCISED WHEN PERFORMING THIS TEST ASTHERE IS A DANGER OF HYPERVENTILATION. ENSURE THAT THE PATIENT ISSITTING DOWN.MV TestThe pa tient should breathe as normally as possib lefor up to 60 seconds, but for at least 20seconds. M ake sure that the patient understands what is required of him.
SPUser s Guide Page 33
Post-Medication TestsI
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In order to carry out post-medication tests for comparison, press the PR VPOS T key andPOST Lamp lights
The post-medication ests are carried out in the same way as the premedica tion ests (threemeasurements stored). The printou t following post-medication ests will give the curves ofboth pre and post-medication tests (the premedication curve is bold). The measurementresults are shown as the best results (pre/post), results as a percentage of those predicted,(both pre and post) and the percentage change (i.e. difference) between pre and post-med ication results.The diagnosis resulting rom the premedication est is also given on this printout.
Page 34 SP-1User s Guide
Explanation of Measured Values
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FVC Forced (expiratory) Vital Capacity. Volume achieved by thequickest possible exhalation after a maxima l inhalation .FEo.5/I.o/3.0
FEF
Forced expiratory volume. Lung volume in litres, measuredafter 0.5, 1 O or 3 seconds forced e xpiration.Forc ed Expiratory Flo w Resp iratory. Flow n erms of differinglung volumes measured in litres per second.flow speed of the expired air by 25 to 75 of the forced vitalcapacity (FVC)flow speed of the expired air by 75 to 85 of the forced vitalcapacity (FVC)flowspe ed of the expired air by25% of the forced vital capacityflow speed of the expired air by 50 of the forced vital capacity
FEFEFSFEFFEFSO,
(FVC)(FVC)flow speed of the expired air by 75 of the forced vital capacity(FVC)
FEF.2-1.2 averaged flow between 0.2 and 1.2 litres of the fo rced exp iredvital capacityPEF Peak Expiratory FlowMEF Maximal Expiratory Flow
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Explanation of Measured Values
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flow speed of the expired air by25 % of the forced vital capacity(FVC)flow speed of the expired air by 50 of the forced vital capacity( F W
~
flow speed of the expired air by 75 of the forced vital capacity( F WMEF=,= FEFZ5,MEF = FEF=,MEF= FEFERV Expiratory Reserve Volume. Possible further expirationstarting from the normal expiration level
lnsp iratory Reserve Volume. Possible further inspirationstarting from the normal inspiration levelTV Tid al Volume. Expirational and inspirational volumes duringnormal respiration
Slow Vit al Capacity.Lungvolume measured rom a completeexpiration following a deep inspirationExpiredo r Minute Ventilation. Volume of expired air in litresper minute measured over a minimum of one minu te
Page 36 SP-1I Icerc Cri ida
Explanation of Measured Values~~~~ ~ ~
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M W Maximum Voluntary Ventilation. Maximum volume of airwhich can be m oved on expiration while b reathing as deeplyand as rapidly as possibleR R Respiration RateFMFT Forced Mid-expiratory Flow Time. Time difference betweenthe 25 and 75% points of the FVCFlVC Forc ed lnspira tory Vital Capacity. Inspiration volumeachieved between a maximal expiration and a maximalinspiration
forced inspiratory air volume in litres measured in the firstsecondFI 1.0FIV ,.o / FlVC forced inspiratory air volume measured n the first se cond as apercentage of forced inspiratory vital capac ityFIV .o / FVCPIF
forced inspiratory air volume measured n the first se cond as apercentage of forced expiratory vita l capa cityPeak lnspiratory Flow. Maximum inspiratory flow speed inlitres / second
MIF Maxim um lnspiratory Flow. Maximum inspiratory flow inlitresMIF uM6 flow speed by 50 of th e forced insp iratory vital capa city
SP-1User's Guide Page 37
Data Storagef
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This section is only ap plicable when the memory option is ins talled.Automatic StorageTo store a measurem ent automatically the save option in the se tting menu must be set toAUTO - Seepage 19. When this is set, the patients measurementsare stored automaticallyat the end of the tes t (when a new patient is entered).Manual StorageTo store a measuremen t manually press the MENU key, highlight the SAVE option, andpress enter. The m essage FILE IS STORED is displayed. Press ENTER to exit.
111 )
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Data Storage
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The message MEMORY FULL appears when all memory space is used. O ld records mustbe deleted (see next section) o store the current recording. In auto mode this message willappea r when a new patient is entered. Ifyou wish to store the current measurement, spacemust be made availab le before entering new patient details.
SP-1User 's Guide Page 39
Memory Managementf
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This section is only applicable when the memory option is installed.Enter the memory screen press the M ENU key, highlight the MEMORY option, and pressenter. A list of the stored recordings s displayed. At the bottom of the screen the number offiles stored is displayed along with the percentage of free mem ory available. Six files a redisplayed on each page. Use the up and down cursor keys o select a file. When the bottomor top file is highlighted he nedp rec ed ing page, is automatically displayed when the downor up cursor key is again pressed.
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Memory Management
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With a file highlighted, press the MENU key to display the following options:Read Highlight this option and press ENTER to display the patient data of theselec ted ile. Obtain a printout of the selected ile by pressing he PRINT key.Display resu lts by pressing the RESULT key.
Highlight his option and press ENTERto delete all or selec tedfiles. When thisoption is selected you are prompted by the message TAGGED or ALL. Selectthe option you require to delete only the tagged files or a ll stored files.Highlight his option and press ENTERto send all or selected files overthe RS-232 interface. When this option is selectedyou are prom ptedbythe m essageTAGGED or ALL. Select the option you require to send only the tagged filesor all stored files. See the following page for sending procedure.
Delete
Send
To cancel any operation in the above option press the M ENU key.Tagging a Stored File (for Deletionor Sending)Highlight the File (with the READIDELETOSEND menu N OT displayed - if the menu isdisplayed, exit by pressing he MENU key) and press ENTER. An asterisk appears by theside of the file. Cancel the tag by pressing ENTER again.Exiting the Memory OptionPress any of the Function keys (FVC, SVC, M W , or MV) to return to the m easurem entscreen. Note that it s notpossible to exit the memory screen when the Delete or Sen dmenuoptions are selected (TaggedA ll displayed); press the MENUkey first then an d hen thefunction key.
SP- 1User's Guide Page 41
Sendingr
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Measurementscan besen t to the SEMA data management system. To se nd a me asurementproceed as follows:Connect the PC to the RS-232connector on the right hand side of the un itCarry out the measurem ent(s) as described previouslyPress the MENU key and select SEND
When the transmission is complete a message is displayed showing that successfultransm ission has b een completed. If an error message is displaye d e.g. 'seria l link time-ou t'check se ttings in the PC and on the unit. Check the cable connection. Ensure hat the B audrate and the parity settings are the same in both the PC and the unit (SETUP menu).Stored files c an also be sent - see previous page.
Page 42 SP-User's Guide
Care & Maintenance
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The casing of the SP-1 should be cleaned with a soft cloth on the surface only. Disconnectthe unit before cleaning.WARNING
DO NOT, UNDER ANY CIRCUMSTANCES, IMMERSE THE APPARATUS INTO ACLEANING LIQUID OR STERILIZE WITH HOT WATER, STEAM, OR AIR.Self-testAt the time of print his function was not fully definedA table giving inform ation or the service staff is printed out.MaintenanceAt 12 monthly intervals, he unit should undergo a technica l safety check. The extent of thischeck should include the following:
Visu al inspection of the unit, sensor and cables.
The tes t results must be documented.
Electrical safety tests according o IEC 601 1.Functiona l ests according o the Service Handbook.
SP-1User's Guide Page 43
Replacing the Recording PaperThe recording paper must be replaced as soon as the endof the paper is indicated by a red
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stripe on the lower edge. After the indication first appears, there are about 8 pages left.However, we recommend hat the paper be replaced m mediately.Ifno paper is left, the p rinting process is interrupted and the paper warning lam p starts toblink.
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Replacing the Recording Paper
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Remove the remaining paper.Push paper compartment release and lift up cover.
Place a new paper pack into the drawer.Check that the p rinted (grid) side is facing upwards, an d place the beginning of thepaper ove r the guide roller.Close lid and pres s firmly until release catches.Press STOP to transpo rt the paper to the start position.
NOTE: WELCH ALLYN SCHILLER can only guarantee an excellent printout ifWELCHA LLYN SCHILLER originalchartpaper or a chart paper of the samequality is used.
SP-1Users Guide Page 45
Flow Sensors
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Flow Sensor SP-150
1. Remove disposable mouthpiece (1) by gently but firmly pulling it away from thehandle (2).2. Discar d the com plete assembly.I3. Position new dispos able mouthpiece (Part No. 2.100077)and gently but firmly clickit in position.NOTE: The disposable mouthpiece can only be positioned in one d irection and noforce is necessaty to insert it on the handle.
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Flow Sensors
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Flow Sensor SP-20
1. Slide out the co mbined filter/mouthpiece assembly (1). This is only possible in onedirection.2. Unsc rew the assembly.
SP-1 Page 47User's Guide
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Diagnosis
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The diagnostic interpretation is dependent upon the country. The factors used in theevaluation or diagnosis are automatically included in the respective language softw are anddescribed in the following chapters.Diagnosis Setting InternationalNote: When International i sset, diagnosticnormsarepredictedusing the VCvalue(if taken). If VC values are not recorded, FVC is used. T hat is:
%VC100 * NC /F VC predicted= 100 * VC NC predicted (when VC measurement taken ), otherwise
FEV% = 100 F E V lN C (when VC measurement taken), otherwise100 * F E V l / N C
Poss ible respiratory problems are diagnosed on evaluation of the following factors:
IObstructive I - I
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Moderate ObstructionSevere ObstructionMild Restriction
Diagnosis Setting AmericanFor the USA and Canada, diagnosis of possible respiratory problems is bas ed on the ITSinterpretation standard which uses the LLN (Lower Limits of Normal) calculations . Thesecalculations apply to patients between the ages of 5 and 85. The LLN FEV1% value iscalculated as follows:
FEVl/FVC% s40 to 60% of LLNFEVl/FVC% s ~ 4 0 %f LLN/FVCpredicted is 60 to 80%
I IAdolescent I 19 to 25 yrs: IPredicted FEV1%x 0.848 19to 20vrs: IPredicted FEV1%x 0.805
Severe Restriction
I IChild Ie l8 yrs: I Predicted FEV1%x 0.826 I el 8 yrs: IPredicted FEV1%x 0.791
%FVCpredicted is 4 0
Using this LLN value , the diagnostic statements and their criteria are as follows:Diagnosis I CriteriaNormal limits I FEVl/FVC% predicted is >80% I
IBorderlineObstruction I FEVl/FVC% s 80 to 100%of LLN1]Mild Obstruction IFEVl/FVC% s60 o 80% of LLN
I Moderate Restriction %FVCpredicted s 50 to60% IPage 50 SP-1User s Guide
Norm Values
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The norm values used for the calculation of predicted values are dependent upon thecountry.For Great Britain, Italy, Spain and Switzerland, he ECCS andQ uanjer standards areused.For Sweden, the Swedish (Berglund) and Quanjer standards are used.In Finland the Finnish and Quanjer.standardsare used.In Aus tria the Aus trian standards are used.In India the Indian norm values are used.In Am erica and Canada the norm values that are used are Knudson, Kn udson76,Crapo , Morris, Composite and Polgar. The American norm values are extendedwithvalues taken from the ITS (Intermountain Thoracic Society) recomm endation s.
The factors used in the evaluation or diagnosis and the specific norm values are includedin the software an d are described in the following pages.IMPORTANT
DUE TO GREA T DIFFERENCES IN THE SIZE OFTHE LUNGS OF CHILDREN, THER EARE NO STANDARD VALUES FOR CHILDREN UNDER 6 YEARS OF AGE.
SP-Users Guide Page 51
Norm ValuesNorm Values for Countries Outside the USA
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FEVlISVCMEFPEFMER5
-0.179 x A e7.211.944 x H -0.043 x A +2.699
-0.192 x A +89.101.252 x H -0.034 x A +2.924
6.146xH-0.043xA+0.154 5.50xH -0.030XA-1.1065.459x H 0.029 x A -0.470 3.218 x H -0.025 x A +1.596
ECCS ValuesThe safety standards of the European Coal and Steel Community Standards (ECCS) arevalid for adults of at least 25 years of age. Patients between the ages of 18 and 25 arecalculated on the basis of a 25 year old. The calculation equations are as follows:
I MEF50 I 3.794 x H -0.031 x A -0.352 2.450 x H -0.025x A +1.156 IIMEF25 12.605xH -0.026xA-1.336 I1.050xH -0.025xA+1.107 IH: Height in meters A: Age
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Norm Values
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Quanjer & Tammeling ComparisonsThe Quanjer and Tammeling comparison s valid for children between he ages of 6 and 17as follows:
6.6 x H -5.3MEF 5 5.6 x H -4.4 4.6 X H -3.3
H: Height in mete rs
SP-1 Page 53User's Guide
Norm ValuesAus trian Stand ard Values (Osterreich)
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I . .ln(FEV1)=-1.178+ 1.221H+0.003841AWIn(PEF)= -0.214 + O.921H+ 0.0467A + 0.002OW
FVC1 = -8.125 + 6.212H - 0.03OOAx H+ 0.97701n(A)I JPEF= 1.798 + 231 ln(H)+ 0.0159A - 0.000248Abower 2)I . ..
ln(PEF75)= -0.077 + O.77OH + 0.0373A + 0.0025WIn(PEF50)=-0.522 0.843H + 0.03ooA +0.0035W I JPEF75 = 1.581 + 1.8541n(H) + 0.0213A - 0.000283A(power 2)I JPEFW= 1.490 + 1.2901nfHI + 0.0125A - 0.00021M(mwer 2)
H = Height in m eters, A = Age in years, W = Weight in kg, Fi = Body fat index = H / d W
Page 54 SP-1Users Guide
Norm ValuesSwedish Standards (Berglund)
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FEV%SVCFEV
SP-1User's Guide
91.79 -(0.373 x A)1.09 [ (4.81 x H) 40.020 x A) -2.8111.01.09 [ (3.44 x H) -(0.033x A) -1OO]
92.11 -(0.261 x A)1.09 [ (4.04x H) -(0.022 A) -2.3511.09 [ (2.67 x H) -(0.027 x A) -0.541
The Swedi sh (Berglund) standard is valid for adults between he ages of 18and 75 years asfollows:
A: Age H: Height in meters
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Norm ValuesNorm Values for USA and Canada
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FVCFEW
0.1480x H 0.0250 x A -4.2410.0920 H -0.0320 x A -1.260
0.1 150x H -0.0240 x A -2.8520.0890 x H -0.0250 x A -1.932
Morris Norm ValuesThe M orris equations are valid for women between 56 and 72 inches tall and within the agerange of 20 to 90years, and for men between 58 and 80 inches tall and within the age rangeof 20 to 90 years as follows:
FEF0.2- 1.2FEF25 - 75FEF75 - 85
0.1090~H-0.0470~A+2.010 0.1450 x H -0.0360 x A -2.5320.0470 x H -0.0450 x A +2.5130.0130 x H -0.0230 x A +1.210
0.0600 x H -0.0300 x A +0.5510.0250 x H -0.0210 x A +0.321
IFEVl/FVC I -0.31 18x H -0.2422 x A +107.120 14.0679 x H -0.1815 xA +88.700
FEV3.0FVC -0.1 593x H -0.1450 x A +112.090 -0.2380~H-0.1630~A+118.160M W 3.4040 X H -1.2600 x A -21.400 2.0500 x H -0.5700 x A -5.500
The Morris normals are extended with the following:
FEV0.5 (0.0831x H -0.0152xA-1.914FEV3.0
10.0605x H -0.01 85 x A -0.8091-0.1 123 x H -0.0257 x A -2.745-0.1359~ -0.0271 x A -3.512
Page 58 SP 1User's Guide
Norm ValuesCrapo Norm Values
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FVCFEV1FEV3FEVlFVCFEF25 - 75M W VOl.
The Crapo equations are valid for men between 61 and 77 inches tall and within the agerange of 18 to 89 years, and for women between 57 and 71 inches tall and within the ag erange of 18 to 89 years as follows:
0.1524 x H -0.0214 x A -4.6500.1052 x H -0.0244 x A -2.1900.1359 x H -0.0271 x A -3.512-0.3302 x H -0.1520 x A +110.4900.0518 x H -0.0380 x A +2.1333.4040 x H -1.2600 x A -21.400
0.1247X H -0.0216xA -3.5900.0869 x H -0.0255 x A -15780.1 123x H -0.0257 x A -2.745-0.5131 x H -0.2520 xA +126.5800.0391 x H -0.0460x A +2.6832.0500 x H -0.5700 x A -5.500
FEV0.5FEV3.0lFVC
~ ~~~
The Crapo normals are extended with the following ITS equations:
0.0831 x H -0.0152 x A -1.914-0.1593 x H -0.1450 x A +112.090
0.0605 H -0.0185 x A -0.809-0.2380 x H -0.1630 x A +118.160
A: Age H: Height in inchesKnudson Norm ValuesThe Knuds on equations are valid for both children and adults in specific groups accordingto age and height as shown following:
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Norm Values
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I 0.0434 H+ 0 . 0 ~ - 1.015I 3.0300~ . 0.8160~ - 37.900 [ 0.0277~ + 0.0X A 0.16612.7600xH+3.4000xA-108.120IH = 5 2 lo 72 hches. A = lo20 rs
tFFEF50 I0.1080~ + 0 . 1 6 6 0 x A - 8.061 10.1240~ + 0.1570~ 3.920I 0.1379~ + 0.1150 x A - 6.385 10.0732~H+ 0.1111 x A - 2.304
Page 60 SP-1Users Guide
Norm ValuesKnudson 76 Norm Values
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The Knudson 76 equations are valid for both males and females in specific ag e group s asfollows:
A Age H: Height in inchesSP-1User's Guide Page 61
Norm Values
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I
Composite Norm ValuesSelection of the Com pos ite norm als provid es selected equations taken from other tables asfollows:
FVCFEVlFEV3FEF25 - 75FEF0.2 - 1.2M Wsvc
F E R 5 - 8 5
KnudsonKnudsoncrapeKnudsonMOMSMornsCmPoKnudson (same as FVC)
Norm ValuesrPolgar Norm Values
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The Polgar equations are valid for both children and adults in specific groups according toage as follows:
A Age H: Height in inches, The remaining values are taken from the ITS equations.SP-1User 's Guide Page 63
Technical DataTech nical data subject to change without notice.
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Safety standard: BF according o IEC and com plying with the following:~
RL 93/42/EECEN 60601-1 1990IEC 601-1pr EN1441:1994IEC 513:1994
~~ ~
Protection class: according to IEC, VDE, SEVIla according o RL 93/42/EEC
Dimensions (IMh): 290 x 210 x 69 mm: 11.4 x 8.3 x 2.7 insWeight: 2.9 kg: 6.31bsMains Supply: 100 to 115I 220 to 240 VAC, 50/60 HzLCD Liquid crystal, display fo r graphic and alpha numericrepresentat on
Resolution - 192x 64 dots variable contrast
Page 64 SP-1User's Guide
TechnicalDataBattery: Built-in 12V lead-acid ba ttery (rechargeable).
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Norm al working time - 5 hoursCharging time - 15 hours for a com pletely discharged battery(
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Flow: to f14 s;Volume: 0 to litresMeasuremen t Accuracy: f2Flow Impedance: Less than 0.2 mbar s/l at 12 VsMeasured Values: FVC, ERV, IRV, TV, FVC, FEVo,5,FEV,,, FEV FEVo,,ISVC,FEV,.$FVC, FEV,,flC, FEF ,,,. 1,2 (litres), FEF FEF,PEF MEF,%, MEF MEF25,, MV, M W , FIVC, FIV,,,,FIV,JFIVC, FIV,,$NC, PIF, MIFw
Com parison pre/post medication possible.Extrapolated predicted valuesAdults: ECCS I Austria I Berglund I FinnishI Indian I Morris ICrapo I Knudson I Knudson 76 I Polgar / Composite
Prediction Equation:
Children: Quanjer & Tammeling / Austria / Indian / Knudson IKnudson 76 / PolgarStandards Comp liance: ATS, OSHA, NIOSH
Page 66 SP-1User's Guide
Technical DataEnvironm ental Condit ions: Temperature, Operating: 10' to 40 C
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Temperature, Storage:Relative humidity:Atmospheric pressure:
-10 o 55 C25 to 95 (non condensing)
700 to 1060 hPaRS-232 V24) Interface Protocol: Asynchronous
Baud Rate: 300 o 38400BaudByte Format: 1 start bit, 8 ata bits 0 r 1 parity bit (+or -), 1 stop bitTransfer Control:Connection Socket: 3 x D subminiature (9 polefemale), wired as D TE (Data Termina l Equipmen t).
By means of CTS, RTS
Pin Connections: Pin 3 TXDl 0 (output data)Pin 2 RXDl I (input data)Pin 7 RTS1 0 (request for output)Pin 8 CTSl I (ready for output)Pin 5 GND (ground)
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INDEX
AAustrian Standa rd Values (Osterreich) 54BBerglund Standards 55
EECCS Values 52Environmental Cond itions 67Exiting he memory option 41Exiting he the memory option 41
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Best 27BTPS 21CCalibration 20Calibration Factor 21Calibration Procedure 22Changing he filter SP-20 Flow Sensor 47Changing he Flow Sensor SP-150 46Clock 17Composite Norm Values 62Crapo Norm Values 59DData Storage 38Definition of Bes t 27Deleting a Mem ory file 40Device 16Diagnosis 50Diagnosis for Countries Outside the USA 49Diagnosis for USA and Canada 50Diagnostic statements 50Displaying he results in tabular form 28
Explanation of Measured Values 35FFeatures 5Finnish Standards 56Flow Sensor SP-150 46Flow Sensor SP-20 47Forced V ia l Capacity (FVC) Test 32FVC 35I
KIndian Equitations 57
Keyboard 8Knudson 76 Norm Values 61LLLNvalue 50Location 6
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SSafety standards 64Self-test 43Sending a Memo ry File 40
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Sensor SP-150 46Sensor SP-20 47Storage 38Swedish Standards 55Swedish Standards (Berglund) 55Switching On and Off 7TTagging a Stored File (for Deletion or Send-ing) 41Temperature 21UUser ldent 14