Welch Allyn Schiller SP-1 User manual

Cardio Menu
Service Manual
SP-1
Spirometer
WelclyUlyir
Schiller

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SP-1 User Guide
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Article Number2.510 271a
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WeldyUlyn
Schiller
Welch Allyn Inc*
7420 Carroll load
San Diego, CA 92121
Phone: {800) 854-2904
Pax: [phone]
www.welchallyn.com
Untied Kingdom:
Welch Allyn UK Ltd
Cisbblirsgton Road
Aston Abbotts HP22 4ND
United Kingdom
Tel: [phone]*140
Fax: [phone]
ii
Canada:
Welch Allyn Canada Ltd
160 Matheson Blvd* East, Unit #2
Mississauga, Ontario L42 I V4
Canada
Tel: (S00) 561-8797
Fax: [phone]
Copyright ©' 97 & ’ 98 by Welch Allyn Schiller

DECLARATION OF CONFORMITY
Spirometer: SP-1
Serial numbers starting with: 540.
Year of manufacture: 1995 Onwards
We, the undersigned, hereby declare that the medical device (class Ila) 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: 11425-01 ISO 9001 (Rev. 1994) EN 46001 by SQS
45112-60-00 ISO 9001/08.94, EN 46001 / 12.93 by DEKRA
and 45112-16-00 Annex II, Section 3 of the Directive 93/42/
EEC (30.04.1995)
0124
Baar (Switzerland) 03.07.1996
Martin Sprang Markus Butler
Research & Development Manager Quality Assurance Manager

Desrfakn&
The Information In this guide has been carefully checked for reliability; however no guarantee is given as to the correctness
of the contents and WELCH ALLYN SCHILLER makes no representations or warranties regarding; the contents of this
manual. We reserve the right to revise this document and make changes In the specification of the product described
within at any time without obligation to notify any person of such revision or change ,
Ti&d&mrfts
WELCH ALLYN SCHILLER and SP-1 are registered trademarks of WELCH ALLYN SCHILLER* All trademarks are the
property of their owners.
Copyright Notice
Q Copyright 1996 and 1998 by WELCH ALLYN SCHILLER. All rights reserved, You may not reproduce, transmit, transcribe,
store in a retrieval system or translate Into any language, in any form or by any means, electronic, mechanical, magnetic,
optical, chemical, manual or otherwise, any part of this publication without express written permission of WELCH ALLYN
SCHILLER,
Termsof Warranty
WELCH ALLYN SCHILLER warrants the SP-1 Spirometer, when new, to be free of defects In material and workmanship
and to perform; In accordance with manufacturer's specifications for the period of three {3} years from the date of purchase
from Welch Allyn or it's authori zed distributors or agents. Accessory items such as electrodes, batteries and cables are
limited to a warranty of 90 days from the date of purchase from Welch Allyn or Its authorized distributors or agents, Welch
Allyn will repair or replace any components fou nd to be defective or at variance horn manufacturer's specifications within
this time at no cost to the customer. It shall be the purchasers responsibility to return the Instrument to Welch Allyn or an
authorized distributer, agent or service representative. This warra nty does not include breakage or failure du e to tampering,
misuse, neglect, accidents, modifications or shipping. This warranty Is also void If the instrument is not used In accordance
with manufacturer’s recommendations or If repaired by other than Welch Ally or an authorized agent. Purchase date
determines warranty requirements, No other egress warranty fe given.
J

Y Y J AM
Schiller 1
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PHYSICIAN'S RESPONSIBILITY
THE SP-1 SPIROMETER IS 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 RESPECT TO THE PATIENTS OVERALL CLINICAL CONDITION.
THE RECORDING PREPARATION QUALITY AND THE GENERAL RECORDED DATA
QUALITY, WHICH COULD EFFECT THE REPORT DATA ACCURACY, MUST ALSO
BE TAKEN INTO ACCOUNT.
IT IS THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAGNOSIS OR TO
OBTAIN EXPERT OPINION ON THE RESULTS, AND TO INSTITUTE CORRECT
TREATMENT IF INDICATED.
FEDERAL LAW IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN
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Safety Notices
THIS UNIT IS BFCLASSIFiED ACCORDING TO TEC601 =3.-
io prevent electric shock do not disassemble the unit, no serviceable parts inside, refer
SERVICING TO QUALIFIED PERSONNEL ONLY.
mimrmrTHisimrTfrmE^i/mmFTmwFTS^mTimiGE^FTmjoBioNORTHEPRESENCE^
FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS.
THIS PRODUCT IS NOT DESIGNED TOR STERILE USE. —“.....-
THIS PRODUCT IS NOT DESIGNED FOR OUTDOOR USE. “ ™
SWITCH the UNrr OfF BEFORE CLEANING and DISCONNECT FROM THFMAIns, “ “
DO NO T, UNDER ANY CIRCUMSTANCES, IMMERSE THE UNTT OR CABLE ASSEMBLIES^ LIQUID~
THE DEVICE MUST ONLYBE 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 TmUCDMNCJ. DO NOT USE E-BEAM
OR GAMMA RADIATION STERILISATION.
do mrusE solventcleanehs -
DSEOMYaCCESSORIESAND OTHER PARTS RECOMMENDED OFCSUppUED BY WELCHALLYN SCHILLER. USEOF
OTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULT IN INJURY INACCURATE INFORMATION AND/ OR
DAMAGE TO THE UNIT.
The sP-i compues witHEMc regulations lor 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. _

SP-1 User's Guide
This User's Guide gives instructions on how to operate the unit and provides an overview of all the basic functions in an
easy and simple to use format The procedures are presented in a logical, step-by step way to enable the user to quickly
and easily familiarise themselves with unit operation. Detailed medical informaticn is excluded from this guide except where
necessary to operate the unit or understand the results.

This equipment has been tested and found to comply with the limits for a class A digital device, pursuant to both Fait
15 of the FCC (Federal Communications Commision) Rules and the radio interference regulations of the Canadian
Department of Communications. These limits are designed to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with this instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which ease the user will be required to correct the interference at his own expense.
Disposal Instructions
and Battery Care
° DO NOT DISPOSE OF THE BATTERY BY FIRE OR INCINERATOR -
DANGER OF EXPLOSION
° DO NOT ATTEMPT TO RECHARGE THE BATTERY - DANGER OF
EXPLOSION
* DO NOT OPEN THE BATTERY CASING - DANGER OF ACID BURN
Only dispose of the battery in official recycling centres or municipally approved
areas. Alternatively used batteries can be returned to Schiller AG for disposal.
Unit Disposal Instructions
Units no longer required can be returned to Schiller AG for disposal. Alternatively
dispose of the unit in municipally approved recycling centres.

WelclyVUyn
Schiller'
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Power Supply
The mains connection is on the rear of the unit.
The power supply voltage is set by the factory for 100-115 V(nom. 110V) or 220-240V
(nom. 230V) working. The setting is indicated by the indented metal strip on the fuse
panel. Contact your dealer if the voltage needs to be changed.
The mains indicator lamp on the keyboard is always lit when the unit is connected to the mains
supply. The unit can either be operated from the mains supply or from the built-in recharge¬
able battery. The power source is indicted on the top line of the LCD.
Changing a Mains Fuse
If it is necessary to change a fuse, always replace with the correct rating i.e 2x200mAT
for 230V, or 2x3l5mAT for 110 V .
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
V______

WelclyVllyn ™
Schiller

Contents - User Guide SP-1
f
PROCEDURE OVERVIEW......2
INTRODUCTION .«.............,4
LOCATION......*.-..6
POWER SUPPLY.......T
KEYBOARD..........
MAIN MENU OVERVIEW... 9
SCREEN CONTRAST AND ENTERING DATA ... 12
i Selling the Contest......12
Entering data in afield ..... 12
SYSTEM SETUP MENU........ 13
PATENT DATA ..............10
Race Influences on Norm Values..... 19
CALIBRATION........, 20
Calibration Procedure .. 22
PULMONARY FUNCTION TEST PROCEDURE
Definition of Best.......
Displaying the Results in Tabular Form.
Obtaining a Printout......
Deleting a measurement.....
Forced Vital Capacity (FVC) Test...
Slow Vital Capacity (SVC) Test...
MW Test.....
MV Test.......
POST-MEDICATION TESTS...
EXPLANATION OF MEASURED VALUES.........
DATASTORAGE ......
Automatic Storage......
Manual Storage..
MEMORY MANAGEMENT.
Tagging a Stored File (tor Deletion or Sending}....41
Exiting the Memory Option..... 41
SP-1
User's Guide
SENDING ........... 42
CARE & MAINTENANCE........ 43
Self-test....... 43
Maintenance...........43
REFUGING THE RECORDING PAPER . . 44
FLOW SENSORS....,.... 46
Flow Sensor SP*150.........46
Flow Sensor SP*20 ..... 47
DIAGNOSIS...................... . . . 4 9
Diagnosis Setting 'international'.... 49
Diagnosis Setting 'American'.. 50
NORM VALUES........ 51
Norm Values for Countries Outside the USA ..52
ECCS Values.. 6 2
Guanjer & Tammefing Comparisons.... S3
Austrian Standard Values (Osterreich)... 54
Austrian Standard Values (Osterreich)...54
Swedish Standards (Berglund).................. 55
Swedish Standards (Berglund) .................. 55
Finnish Standards.......................... 56
Indian Equations..................... 67
Norm Values for USA and Canada...... 58
Morris Norm Values.........56
Cnapo Norm Values...... 59
Knudson Norm Values...... 59
Knudson 76 Norm Values................. 61
Composite Norm Values . . . 6 2
Polgar Norm Values . 0 3
TECHNICAL DATA ........64
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Page 1

f General
Settings
Date
Time
Device
Norm values
Contrast
Print
User
| Memory
etc.
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Page 2
DISPLAY RESULTS PRINT RESULTS
SEND RESULTS
SP-1
User's Guide

Procedure Overview
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1
Switch ON
2
Make Settings preference if required (remembered when unit switched off)
3
Insert new screen/filter or sensor
4
Calibrate Unit
5
Enter patient data
6
Select test
7
Press START
8
Patient Makes test
9
Press STOP
10
Repeat as many times as required {Best, or best two + last printed)
11 Display result
12 Print Result
Send result if required
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Page 3
SP~1
User's Guide

Introduction
Page 4
SP-1
Users 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
liquid crystal display to instantly showthe test results. An integral high quality thermal printer
provides clear and comprehensive result analysis in a number of different formats and an
RS-232 interf ace 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 paper jam. Measurements are 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 eliminating the 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
MW Maximum Voluntary Ventilation
MV Expired or Minute Ventilation
Low weight and compact dimensions
Built-in rechargeable battery 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
Page 6
—
As with ati 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
v
In certain circumstances interference can be caused by external electrical equipment or
radio equipment. Connect the earth potential equalisation connection at the back of the SP-
1 to the hospital common ground or, if a common g round is not prese nt, to a metal f ramework
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.
SP-1
User's Guide

Power Supply
/-—-———... .. s
I The unit can be ope rated from the mains or from the built-in rechargeable battery. The mains
connection is on the rear of the unit. The mains indicator [amp 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 fulfy recharged (60% in less than 3 hours),
A fully charged battery lasts approxi¬
mately 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, i
Switching On and Off
The SP-1 is switched on and off with
the ON and OFF keys.
Lit when operating from the Lit when mains
internal battery. Flashes when supply connected
battery has limited capacity
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Page 7
SP-1
User's Guide

Keyboard
Indicates the test
currently being carried out
Enter Lung Function Test Menu as designated
(Commence each measurement with START; Switch Switch
end each measurement with STOP)
uni off unit
on
;'Sk
"
0
t
N j
Move Display Cursor
Start Measurement
Print Measurement
Stop Measurement or Stop Printout
Enter Patient Data
Display Menu options for the indirect functions or <
Escape
Display Result of the test
Change key to second function
Calibibrate unit
Delete a character/delete last measurment
Pre and Post medication test
Enter menu option displayed or confirm entry 1
Battery Operation / Mains Connected
Sensor not connected
Paper jam or no paper in paper tray
Post test being carried out
Page 8
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
Page 9

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
Delete a recording
. Send a recording
MTA Ident
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
remembered when the unit is switched off: it only needs updating when a new
user takes over.
Send
Current recording is sent over the 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
See System Setup Menu following
Page 10
SP-1
User 's Guide