Welch Allyn SP-1 User manual

P-

Cardio Menu

Service Manual

I

Welc$Altynm

i

Sc

hiller

Q

SP-1

User

Artide

Number2.510 271a

Guide

Copyright

0

'

97

&

Schiller

Welch Allyn Inc.

7420

Carroll

San Diego, CA

Phone:

United Kingdom: Welch Allyn

Cubblington Road Aston Abbotts United Kingdom

Tel: Fax:

'

98

by

Welch

Alp

UK

Ltd

HP22 4ND

01296-682-140

01296-682-104

schiller

(800)

Fax:

(858)

www.welchallyn.com

854-2904

621-6611

ii

Road

92121

Canada: Welch Allyn Canada Ltd

160

Matheson Blvd. East, Unit Mississauga, Ontario Canada

Tel:

(800) 561-8797

Fax:

(905)

@

890-0008

L4Z

#2

1V4

DECLA RA

TI0

N

0

F

CO

NFO

R

MIW

Spirometer:

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

This declaration is supported by: Certificate of approval

and 45112-16-00 Annex 11, Section 3

bar (Switzerland) 03.07.1996

Martin Spreng Research

ti

Development Manager

No:

SP-

1

of EC Directive 93/42/EEC.

11425-01 IS0 9001 (Rev.1994) 45112-60-00

(c

IS0 9001/08.94,

EEC

0124

(30.04.1995)

Markus Butler Quality Assurance Manager

EN

46001 by SQS

EN

46001 / 12.93 by DEKRA

of

the Directive 93/42/

iii

LXdlimer

TheInformationin thisguide has

of

the contents and WELCH AUYN SCHILLER makes no representations or warranties regarding the contents of this manual. We resewethe rightto revise within at any time without obligation

Trademaks

WELCH ALLYN SCHILLER and property oftheir owners.

CoPynigM~

0

Copyright

1996

store

in a retrieval optical, chemical, manual or otherwise, any SCHILLER.

TWlllSOfwdnanly

WELCH AUYN SU-IILLER warrants the SP-1 Spirometer, when new, to be and to

perform inaccordancewithmanufaburw'sspedficationsfortheperiodofthree(3)yearsfromthedateofpurchase

from

Welch Allyn or limited to a wanantyof 90days fmmthedateof purchasefmm Welch Allyn or itsauthorized distributors oragents. Welch Allyn will repairorreplaceany mponen tsfoundto bedefectiveoratvariancefrom this time at no authorized dimibuter, misuse, neglect, accidents, modifications orshipping. This warranty is alsovoid ifthe instrument is not with manufacturer's recommendations or if repaired by otherthan Welch Ally or an authorized agent. Purchase date determineswarranty requirements. No otherexpress warranty isgiven.

and

system

it'

wst

to

the customer.

agentor~cerep-sentative.Thiswarrantydoesnot

beencarefullych~edforreliabliity;

this

document and make changes

to

notify any person of

SP-1

are registered trademarks of WELCH AUYN SCHILLER. All trademark are the

1998

by WELCH AUYN SCHIUER.

orhanslate into any language, in any

s

authorized distributors or agents. Accessoly items such as electrodes, batteries and cables are

part

It

shall be the purchasers responsibility to

All

of this oublication without

howevernoguaranteeisgivenastothewmxtness

in

wch

revision or change.

rights resewed. You may not

form

the specification

or by any means, elebmnic, mechanical, magnetic,

~XDRSS

written Dermission of WELCH AUT"

free

of defects

manufacturer'sspedfications

return

indudebreakage orfailuredueto tampering,

of

the prcduct described

repmduce,

hansmit,

In

material and workmanship

the insbument to Welch Allyn or an

used

hansaibe,

within

in

accordance

iv

Schiller

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 RESPECTTO THE 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.

IT

IS THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAGNOSIS OR TO

OBTAIN EXPERT OPINION ON THE RESULTS, AND TO INSTITUTE CORRECT

TREATMENT IF INDICATED.

0

FEDERAL ORDER OFA PHYSICIAN

LAW

IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE

V

Safety Notices

THIS UNIT IS BF CLASSIFIED ACCORDING TO IEC

601

-1.

1

SERVICING TO QUALIFIED PERSONNEL ONLY.

?

FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS. THIS PRODUCTIS NOTDESIGNED FOR STERILE USE.

z

~

DO NOT, UNDER ANY CIRCUMSTANCES, IMMERSE THE UNITOR CABLE ASSEMBLIES IN LIQUID. THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER IF THE EARTH CONNECTION IS SUSPECTOR IF THE MAINS LEAD IS DAMAGED OR SUSPECTED

ZM

OR GAMMA R4DIATlON STERIUSAIION. DO NOT USE SOLVENT CLEANERS USE ONLYACCESSORIES AND OTHER PARTS RECOMMENDED OR SUPPLIED BY WELCH ALLYN SCHILLER. USE OTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULTIN INJURY INACCURATE INFORMATIONAND/ OR

DAMAGE

THE EMISSIONS AND ELECTRICAL INTERFERENCE. HOWEVER SPECIAL CARE MUST BE EXERCISED WHEN THE UNIT IS USED WITH HIGH FREQUENCY EQUIPMENT.

TO

SP-1

THE UNn.

COMPLIES WITH EMC REGULATIONS FOR MEDICAL PRODUCTS WHICH AFFORDS PROTECTION AGAINST

OF

BEING DAMAGED.

vi

OF

(

SP-I

This User's Guide gives instructions on how to operate the unit and provides an overview easy and simple to use format. The procedures are presented in a logical, step-by step way to enable the user and easily familiarisethemselves with unit operation. Detailed medical information

necessary to operate the unit

1

or

understand the results.

User's

vii

Guide

is

excluded from this guide except where

of

all the basic functions in an

to

quickly

This equipment has been tested and found to comply with the limits for a class A digital device, pursuant to both Part

15

of the FCC (Federal Communications Commision) Rules and the radio interference regulations of the Canadian

Department of Communications. These limits are designed to provide reasonable protection against harmful interference

is

when the equipment

operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with this instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

Disposal Instructions and Battery Care

DO NOT DISPOSE DANGER OF EXPLOSION

O

DO NOT ATTEMPT TO RECHARGE THE BATTERY - DANGER EXPLOSION

O

DO NOT OPEN THE BATTERY CASING - DANGER OF ACID BURN

Only dispose of the battery in official recycling centres

OF

THE BATTERY BY

FIRE

OR INCINERATOR

or

municipally approved

-

OF

O

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.

viii

Schiller

Power Supply The mains connection 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

The mains indicator lamp supply. The unit can either be operated able battery. The power source is indicted

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

is

on

the rear of the unit.

to

be changed.

on

the keyboard is always lit when the unit is connected to the mains

from

llOV

.

the mains supply

on

the

top

line

or

from the built-in recharge-

of the LCD.

@

To change a fuse press the

connector

panel.

on

the back panel. Remove the fuse panel and replace the fuse(s). Click back the fuse

two

retaining lugs

on

ix

side

of

the fuse panel (situated below the mains

Welc$AJlp-

Schiller

r

9314ZEEC Medical

0124

‘Notified

X

Devices:

Body’

DEKRA

AG

0

.

1

i

Contents . User Guide

SP-I

PROCEDURE OVERVIEW INTRODUCTION LOCATION POWER SUPPLY KEYBOARD MAIN MENU OVERVIEW

SCREEN CONTRAST AND ENTERING DATA

Setting the Contrast

Entering data SYSTEM SETUP MENU PATENT DATA

Race Influences on Norm Values CALIBRATION

Calibration Procedure PULMONARY FUNCTION TEST PROCEDURE

Definition

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-MEDICATIQN TESTS EXPLANATION OF MEASURED VALUES DATA STORAGE

Automatic Storage

Manual Storage MEMORY MANAGEMENT

Tagging a Stored File (for Deletion or Sending) Exiting the Memory Option

................................................................

..........................................................................

...............................................................

........................................................................

in

..................................................................

of

Best

....................................................................

.......................................................................

..............................................................

................................................

...................................................

a field

...............................................

..................................................

...............................

................................................

........................................................

.....................

...................................................

............................................

...............................

..................................

............................................

......................

......................................................

..........................................................

...............................................

.........................................

...............

.............

..........

SENDING

2

CARE & MAINTENANCE

4 6

7

REPLACING THE RECORDING PAPER

8

FLOW SENSORS

9 12 12

DIAGNOSIS

12 13

18

NORM VALUES

19

20 22 24 27 28 29 31 32 33 33 33 34 35 38 38 38

TECHNICAL DATA

40 41

41

.........................................................................

Self-test Maintenance

......................................................................

...............................................................

.............................................................

Flow Sensor Flow Sensor

SP-150

SP-20

......................................................................

Diagnosis Setting 'International' Diagnosis Setting 'American'

................................................................

Norm Values for Countries Outside the USA ECCS Values Quanjer & Tammeling Comparisons Austrian Standard Values (Osterreich) Austrian Standard Values (Osterreich) Swedish Standards (Berglund) Swedish Standards (Berglund) Finnish Standards Indian Equations

Norm

Morris Norm Values Crapo Norm Values Knudson Norm Values Knudson Composite Norm Values Polgar Norm Values

..............................................................

......................................................

.........................................................

Values for

USA

76

Norm Values

...........................................................

.................................................

........................

..................................................

....................................................

................................

.....................................

.............

..........................

......................

..................................

and Canada

............................

....................................................

................................................

..........................................

............................................

...................................................

42 43 43 43 44 46 46 47 49 49

50

51

52 52 53 54 54

55

56 57

58

59

59 61 62 63 64

SP-1

User's

Guide

Page

1

Procedure Overview

r

I

for

every new patient

Insert new filterkcreen

Insert new sensor

(SP-20)

(SP-150)

-1

\

2

OEF

3

GHI

4

JKL

5

MNO

-_

(

General Settings Date Time Device Norm values Contrast Print

User

I

Memory etc.

,L--

Page

2

-i-

.

I

Enter MTA ldent

1

Repeat tests

or more, or

times)

I

DISPLAY

I

(3

I

RESULTS PRINT RESULTS SEND RESULTS

I

Post-medication

tests

I

User's

1

SP-

Guide

I

!

',

1

i

Procedure Overview

1

Switch

ON

Make Settings preference

2

Insert new screenAiIter or sensor

3

Calibrate Unit

4

Enter patient data

5

Select test

6

Press

7

8

9

10

11

12

START Patient Makes test Press

STOP

Repeat as many times

Display result

Print Result

Send result

if

required

if

required (remembered when unit switched

as

required (Best, or best two + last printed)

off)

SP-1

User’s

Guide

Page

3

Introduction

FNSOR CONNECTOR

PAPER RELEASE CATCH DISPLAY

I

MAINS AND POTENTIAL

EQUALISATION CONNECTORS

/

RS-232

CONNECTOR

Page

TEST

INDICATORS

4

POWER INDICATORS SYSTEM INDICATORS

,I

User's

SP-

Guide

1

Introduction

The SCHILLER

modes for the measurement of inspiratory and expiratory values. The unit incorporates a liquidcrystal display to instantly showthetest results. An integral high quality thermal printer provides clear and comprehensive result analysis in a number of different formats and an

RS-232

are initiated via an easy to use keypad with dedicated test keys. Test indicators show the current test being carried 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

for cleaning and sterilisation. The filter assembly eliminating the need following features:

interface is provided for transmission of test results to a

open pneumotacho sensor incorporates a disposable filter and is easily dismantled

Direct function keys for measuring the following:

FVC Forced Vital Capacity SVC

MW

MV

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 Choice of

SP-1

is a stand-alone pulmonary function testing unit that features four

out

and function

Slow

Vital Capacity Maximum Voluntary Ventilation Expired or Minute Ventilation

6

languages for display and printing

LEDs

SP-150

sensor has a disposable, single patient sensor/

to

clean the sensor after each use. The

PC.

All

tests and settings

provide visual indication for functions such

SP-1

has the

100

single measurements (option)

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

between the unit and the mains supply

Potential Equalisation

In certain circumstances interference can be caused by external electrical equipment or radio equipment. Connect the earth potential equalisation connection at the back

1

to the hospital common ground or, 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.

31

0

005.

if

acommon ground is not present, to a metal framework

is

maintained

of

1

the

meter

SP-

Page

6

User's

SP-1

Guide

Power

Supply

The unit can be operatedfromthe mains orfrom the built-in rechargeable battery. 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. the battery capacity is limited, the indicator flashes. To recharge the battery, connect the apparatus to the mains supply by means battery needs less than

A

battery indicator lamp confirms battery operation. When

of

the supplied power cable. A totally discharged

15

hours to be fully 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 damage to either the battery or the unit.

of

SP-

1

User's

titwhenoperati fromthe

internal

battery.

#Lws

banery

Guide

has

limited

*en

capaaty

Lit

when mains

suppty

CoMected

Switching

The

SP-1

the

ON

and

On

and

Off

is switched on and

OFF

keys.

off

with

Page

7

Keyboard

Indicates the test

currently being carried out

Move Display Cursor

Stop Measurement or Stop Printout

Display Menu options for the indirect functions or

I

Start Measurement Print Measurement

Enter Patient Data

Change Rey to second function

Delete a character/delete last measurment

Enter Lung Function Test Menu as designated (Commence each measurement with START; Switch Switch end each measurement with

I

1

Escape

Dis lay Result of th test

Enter menu option displayed or confirm entry

STOP)

I

Calibibrate unit

Pre and Post medication test

Battery Operation / Mains Connectec

Paper jam or no paper in paper tray

Sensor not connected

Post test being carried out

unit off unit on

Page

8

User's

SP-1

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

Page

10

Save

Memory

MTA ldent

Send

Setup

This option only appears when the memory option is installed. Select this option to save the current measurement in the 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

Enter the name of the person carrying out the test. The MTA name (medical

technical Assistant)

remembered when the unit is switched

is

given on printouts. The users name entered here, is

off;

it

only needs updating when a new

user takes over.

Current recording PC storage program). Note that the

is

sent overthe

RS-232

interface (for example to the

SEMA

protocol settings must be defined

in the setup menu before transmission.

See System Setup Menu following

User's

SP-

1

Guide

,t

!

I

Menu

Overview

SP-1

User's

When a menu is displayed use these keys

to

move the cursor

When an enter field is displayed e.g.

MTA

Ident, use these keys to move

the cursor

Guide

LEFT

/

RIGHT

Use this key to display the main menu as above. When an enter field this key is used the same as the ENTER key to confirm entry and to exit field

UP

/

DOWN.

-

When a menu is displayed to select highlighted menu option. When an enter field this key to confirm entry and to exit field

is

displayed e.g. MTA Ident, use

press this key

is

displayed,

Page

1

I1

Screen Contrast and Entering Data

Change the contrast of the screen to your preference as follows:

Press the ALT key and the MENU key togetherthen change the contrast with the cursor keys UP and DOWN

Page

12

User's Guide

SP-

I

System Setup Menu

t

3-v-

7

User’s

Guide

Press this Option or

key

to select highlighted menu

to

change setting.

to program settings and

Press

exit

the

menu

MENU

Page

13

System Setup Menu

This menu option defines all the general settings. unit is switched

User

ldent

Measurement

off)

until overwritten. The settings are as follows:

Use this to enter the name of the consultant operates the unit.

This is how the FVC graph is displayed and printed. With the

ENTER

following:

key toggle the options to set aflow display of one

Flow = f(vol) Flow = loop

Vol =f(t)

-8-l

Flow

=

f(v0l)

All

entries remain stored (even when the

or

department that

,

11)

Flow = LOOP

:kL

of

Vol

the

=

f(1)

Page

14

User's

SP-

Guide

I

System Setup

Print This defines the format and content of the printout when the

Menu

PRINT key is pressed. The settings are as follows:

SP-

1

User’s Guide

Graph Select

Axis

Time

Flow

Graph Set to ON or

Vol

Graph

111.1

Flow

Diagnosis

PEF

This defines the time axis of the graph - set

1

Omds or 20mm/s

Print the volume graph

Graph

Diagnosis printed NO

Peak Expiratory flow calculation min or litres/second

ALL

or BEST (measurements)

OFF - graph printed or not printed

-

select

YES

Volume

or

not

printed -select

-

to

or

NO

Graph

YES

or

select litred

Page

15

System Setup Menu

Device

STANDARD

Set to 'International' for all countries outside the USA and Canada or to 'American' for USA and Canada

NORMALS

The diagnosis is based on the standard defined here. The Normal value standards are given at the end of this section'Diagnosis and Norm Value Tables'

UNITS DATE

cm I kg IoC, cm I kg /OF,

settheorder ofthedatetomonth-day-year,

inch I Ib. 1°F

day- month-year

Set to

:

or year-month-day

RACE

set to: NONE

(no

race): recommended for Europe,

WIB

(White1 Black) for all countries outside the USA and

Canada CIHIBIA (Caucasian

/

Hispanic I Black I Asian) for USA and

Canada

The standards and Norm Values are detailed at the end of this section (Diagnosis and Norm Values). The individual setting for

race, and the effect of race on results is detailed in the

Patient data (see following page)

LANGUAGE This defines the language on the printout and menu structure.

to

English, German, French, Italian, Spanish, or Portuguese

Set

Page

16

1

Isnr's

SP-

Guide

1

System Setup Menu

Clock

RSlMemory

Press the shows

MENU

key to confirm all settings and exit the setup menu. The following table

typical setup combinations.

BERGLUND / QUANJER

FINNISH

INDIAN

OSTERREICH

KNUDSON

KNUDSON76

/

QUANJER

I

ITS

I

ITS

Set the time and date The Baud rate

for sending over the

(300

to

38400)

RS

and parity setting (No/odd/even)

interface must be set to the same as

the receiving unit. The save options are MAN (manual) or AUTO (automatic).

When the save option is set to AUTO, all measurements are

automatically saved when completed (only when the memory option is installed).

(W/B)

International

or

NONE

cm/kglC

SP-

1

User‘s Guide

Page

17

Patient Data

Each printout is complete with the name and other information concerning the patient. Before beginning a recording, the patient data should be entered. The following parameters have to be entered:

Pat-Name: Pat-No: Age: Sex: Height:

Weight:

Race:

Wrongly typed characters can be deleted by pressing the

Page

18

Patient name Patient number Enter age Select Height in centimetres (or inches

(scaled to unit setup).

Weight in kilogrammes (or pounds,

depending on unit setup). Enter patients race: WIB:

C/H/B/A:

If

this position does not appear,

option <SETUP> <DEVICE> <RACE> see previous page.

of

patient in whole years

"M"

(male) or

1/10

"W

for White, "B" for Black

"C"

"F"

inch), depending on

for Caucasian,

(female).

"H"

for

"NONE"

'

Pat-Name Pat-No

Age

Sex

Height

Weight

Race

was selected in the device setup. (menu

DEL

(delete) key.

:

years

(M/F)

cm

kg

SP-

1

User's Guide

Patient Data

Race Influences

on

Norm

Values

According to the setting of the patients race the predicted values will differ. The differences are (according to

When in the "Settings" menu

ITS

recommendations) as follows:

NONE

was set: All values are calculated according to the given formulas. When in the "Settings" menu

W

(White): values are calculated accordingtothe given formulas

B (Black):

85%

When in the "Settings" menu C (Caucasian): H (Hispanic): B (Black):

A (Asian):

The

85%

race compensation is calculated only when the following normal

values are calculatedaccordingtothe given formulas values are calculated according

85% 85%

values are selected: COMPOSITE;

(WB)

was set:

of the given formulas

(CMIB/A)

was set:

of the given formulas of the given formulas

KNUDSON;

(=

1

OO0/o)

(=

100%)

to

the given formulas

(=

100%)

CRAPO; MORRIS; POLGAR

SP-

1

User's

Guide

Page

19

Calibration

r

I

Page 20

Last calib.

BTPS

Calib.

Temperature Measured Syringe

THE UNIT MUST THE DAY, AFTER EVERY SIGNIFICANT TEMPERATURE CHANGE

CHANGING THE SENSOR.

BE

Factor

Vol.

IMPORTANT

CALIBRATED WITH THE FIRST PULMONARY FUNCTION TESTOF

23.1

1.090

1

.ooo

20

0.00

4.00

1.95

"C

I

OR

AFTER

User's

SP-

Guide

1

Calibration

last Calibration BTPS

Calibration Factor

Temperature

Measured Volume Syringe Volume

date of last calibration

(=>

Factor calculated BTPS

Body Temperature, Ambient

Pressure, Saturated with water vapour) value. This value compensatesforthe diff erence in inhaledand exhaled humidity. The unit is set for measuring exhaled volume

so

Temp 36.8O), and

when inhaled volume is measured this

(1

00%

humidity,

factor is applied. The SP-1 uses ambient temperature to calculate the BTPS factor. This is sufficient for accurate

FlVC

calculation. The formula used is as follow:

5

+

BTPS

=

0.033 + 273.1

273.1

5

+

36.8

T~

Tu is ambient temperature degrees centigrade

0.033 is equivialent to 760mmHg at

degrees

C

22

273.1 5 is degrees absolute

calculated value between measured and effective calibration

air volume

ambient temperature in

"C

(or

OF)

dependent on device setting air volume measured by the system from the calibration pump entered air volume depending on the size of the calibration

pump and times the air was pumped through the sensor; e.g. pumping 2 litres 3 times amounts to

volume with a

2

litre pump is 4 litres; with 3 litre pump, 6 litres)

6

litres (the recommended

SP-

1

User's

Guide

Page

21

Calibration

I

Calibration

To

calibrate the unit proceed as follows:

0

Note: Make

While pumping, the unit records the volume being pumped through the flow sensor and

indicates it on the display.

0

Procedure

Connect the calibration pump to the sensor. Ensure that there are no air leaks

Press the CAL key -the menu is displayed as shown on the previous page

The cursor is positioned at temperature. Enter the ambient temperature

Press ENTER when the correct temperature entered

Wait 1 second.

Press the START key Pump 4 to 6 litres of air through the sensor

sure

that the flow sensor is kept still during the pumping operation.

Press the STOP key when finished pumping. Enter the pumped air volume at syringe volume prompt (depending on the size of the

calibration pump and times of pumping; i.e. a Press ENTER.

The message "Calibration complete " appears on the display, press the PRINT key

to

obtain a printout of the calibration report with the following information:

2

litre pump pumped3 times

=

6

litres).

Page

22

SP-

1

User's Guide

Calibration

SP-1 User's Guide

If the message 'EXCESSIVE DEVIATION!' appears on the screen after a calibration, indicates that the difference between the measured volume and the entered volume great

(>25%).

volume. If these are all correct change the screen/filter and recalibrate

Check the temperature setting, the syringe volume and the entered syringe

is

too

it

Page

23

Pulmonary Function Test Procedure

The test method for the FVC, SVC, MW and MV test

1.

Calibrate the unit

THE

UNIT

MUST

BE CALIBRATED

is

the same. Proceed as follows:

At the beginning of each day

If

the sensor is changed

When a significant temperature or pressure difference occurs

Press the function test key

2.

0

FVC

0

svc

MW

0

MV

The relevant keyboard lamp lights and the corresponding coordinate presentation appears on the display as shown in this example for

FVC

The coordinates represent the graph on which the curve will be drawn with the respiratory volume in litres being represented on the vertical axis and the time in seconds

horizontal

axis.

on

the

Page

24

User's

SP-

Guide

1

Pulmonary Function Test Procedure

SP-

1

User's

Guide

Page

d

25

Pulmonary Function Test Procedure

r

Press the START k eY

3.

The flow sensor must be heldquite stillandno air shouldbe breathedinto the device for at least one

second before and after the

The message "READY counter graph for the value. begins to record the expiratory flow. The corresponding curve is represented on the display. The break-off point forthe expiration measurement is reached automatically (orthe Stop key is pressed).

4.

Press the STOP key on completion

5.

Repeat steps 3 and 4 until three measurements have been taken.

Note: If the Start key is again pressed (a

stored.

When American standards are stipulated, the message "ATS criteria met" appears on the printout

if

the deviation (as stipulated by the American Thorasic Society) between the best and second best

measurements is not greater than 200ml.

START

FOR

As

key

is

pressed.

MEASUREMENT' appears on the display together with a volume

soon as the patient starts to breathe into the flow sensor, the unit

of

the test.

fourth

or more times),

only

the best three measurements are

Page

26

SP-7

User's Guide

Pulmonary Function Test Procedure

Following a series of patient measurements the best two results are recorded and stored

along with the last test made (which may

results can then (from these three results). The table

screen.

~__

Definition

of

be

printed graphical along with a table of the best individual measurements

~~

Best

or

may not be one of the best three). These three

of

the best measurements can also be displayed on the

SP-

1

Uses’s

In accordance with the ATS Spirometry Standard (1 1 November

1994),

the best recordings

are defined as the highest value from the calculation:

The measurement table

measurements (e.g. FVC, FEVl

(on

the printout and on the display) gives the highest individual

,

SVC,

MW

etc.) from the two best recordings as defined above, and the last recording made. This is true for all parameters except the following which are based solely on the highest

Guide

FVC

+

FEVl value:

Page

27

Pulmonary Function Test Procedure

FVC

svc

MV

Displaying

Press the

A

measurement table is displayedforthetest mode (as indicated bythetest lamp) asfollows:

the

Results in Tabular

RESULT

Key after a measurement, or series of measurements have been made.

Form

Page

28

User’s

SP-1

Guide

Pulmonary Function Test Procedure

Obtaining a Printout

...............

Press after taking all measurements.

.............

SP-

I

User's

Guide

Page

29

Pulmonary Function Test Procedure

The following is given:

The patient data The selected norm values The date of last calibration The number of tests stored.

brackets indicates the total number of tests carried out. The number stored, and the total number of post tests made are given in the same manner after the slash. In the example given opposite, atotal of of

6

post tests.

The

FVC

and

FEW

variation in ml between the best and second best measurements.

If

this value

The diagnostic statement (if enabled in Settings menu)

MTA

The The user identification The date and time of the printout The software version and the installed options

bottom of this page.

is

within 200ml the message

identification

If

more than three tests are made the figure given in

of

post tests

5

tests were carried out and atotal

'ATS

criteria met' is printed.

(M

=

memory) are also indicz

3d at th

I

,

Page

30

User's

SP-

I

Guide

1

Pulmonary Function Test Procedure

r

The second section of the printout comprises:

the test results presented as atable giving the best values, the predictedvalues and the best values as a percentage*

*

The predicted values

would be obtained predicted values on the printout are rounded to two decimalplaces, the processor however,

%

exists, the values given on the printout are always the more accurate.

Deleting a measurement

The last measurement made can be deleted by pressing

uses

of

predicted value. This can account for a possible variation. Where a difference

(%)

given on the printout may differ slightly from the values that

if

manually calculated. The reason is that the measured and

the actual values -measured to three decimalplaces - to calculate the

of

the predicted.

DEL

3

SP-

1

User's Guide

Page

37

Pulmonary Function

Test

Procedure

Forced

For this test the patient must exhale as quickly as possible from the time

Note:

To

coordinate presentation appears on the display

The patient must exhale as quickly as possible from the time of starting the test that he understands what is required of him.

exhalation can be immediatelyfollowed by a maximum inhalation. The inspiration results will be given on the printout.

Before initiating a printout of the FVC Test, ensure that the settings are correct as detailed

previously. Press the PRINT key to obtain a printout as defined.

Vital

Capacity (FVC)

NC

The volume is too large display

carry out the test for Forced Vital Capacity (FVC), press key "FVC and the corresponding

Test

of

starting the test.

test employs the "Back extrapolation" method. If the extrapolated

(>O.

15 litres or5%

of

FVC),

then a warning appears on the

so

be sure

If

inspiratory measurements are required, the

Page

32

SP-1

User's Guide

Pulmonary Function Test Procedure

Slow

Vital Capacity (SVC) Test

The patient should breathe normally 3 times and then inhale maximally to total lung capacity

and then expire maximally. Make sure that the patient understands what is required of him.

MW

Test

SP-

1

User’s

The patient should breathe as deeply and as rapidly as possible over a period seconds

so

make sure that he understands what is required of him.

WARNING

EXTREME CARE SHOULD BE EXERCISED WHEN PERFORMING THIS TEST AS THERE IS A DANGER OF HYPERVENTILATION. ENSURE THAT THE PATIENT SITTING DOWN.

MV

Test

The patient should breathe as normally as possiblefor up to seconds. Make sure that the patient understands what is required

Guide

60

seconds, but for at least

of

him.

of

6

to

12

IS

20

Page

33

Post-Medication Tests

I

In order to carry out post-medication tests for comparison, press the PRVPOST key and "POST" Lamp lights

The post-medication tests are carried out in the same way as the premedication tests (three measurements stored). The printout following post-medication tests will give the curves of both pre and post-medication tests (the premedication curve is bold). The measurement results 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 postmedication results.

Page

34

The diagnosis resulting from the premedication test is also given on this printout.

User's

SP-

1

Guide

I

Explanation

FVC Forced (expiratory) Vital Capacity. Volume achieved by the

of

Measured Values

quickest possible exhalation after a maximal inhalation.

SP-1 User‘s

FE”o.5/I.o/3.0

FEF

FEF,,,

FEF,,S,

FEF,,

FEFSO,

FEF.2-1.2

PEF Peak Expiratory Flow

MEF Maximal Expiratory Flow

Guide

Forced expiratory volume. Lung volume in litres, measured after

0.5,

1

.O

Forced Expiratory Flow Respiratory. Flow in terms of differing lung volumes measured in litres per second.

flow speed of the expired air by 25 to capacity (FVC)

flow speed of the expired air by capacity (FVC)

flowspeed of the expired air by25% of the forced vital capacity

(FVC)

flow speed of the expired air by

(FVC)

flow speed of the expired air by

(FVC)

averaged flow between vital capacity

or 3 seconds forced expiration.

75%

of the forced vital

75

to

85%

of the forced vital

50%

of the forced vital capacity

75%

of the forced vital capacity

0.2

and

1.2

litres of the forced expired

Page

35

Explanation

of

Measured Values

flow speed of the expired air by25% of the forced vital capacity

(FVC)

Page

36

flow speed of the expired air by

(FW

flow speed

~

of

the expired air by

50%

of

the forced vital capacity

75%

of the forced vital capacity

(FW MEF=,= MEF,,

FEFZ5,

=

FEF=,

MEF,,,= FEF,,

ERV

Expiratory Reserve Volume. Possible further expiration

starting from the normal expiration level

lnspiratory Reserve Volume. Possible further inspiration

starting from the normal inspiration level

TV Tidal Volume. Expirational and inspirational volumes during

normal respiration

Slow

Vital Capacity. Lung volume measured from a complete

expiration following a deep inspiration

Expired

or

Minute Ventilation. Volume of expired air in litres

per minute measured over a minimum of one minute

I

Icer’c

SP-

Criida

1

Explanation

MW Maximum Voluntary Ventilation. Maximum volume of air

of

Measured Values

~~ ~ ~

~~~

which can be moved on expiration while breathing as deeply

and as rapidly as possible

SP-1

User's

RR

Respiration Rate

FMFT Forced Mid-expiratory Flow Time. Time difference between

the

25%

and

75%

points of the

FVC

FlVC Forced lnspiratory Vital Capacity. Inspiration volume

achieved between a maximal expiration and a maximal

inspiration

FI"

1.0

forced inspiratory air volume in litres measured in the first second

FIV

,.o

/

FlVC

forced inspiratory air volume measured in the first second as a percentage of forced inspiratory vital capacity

FIV

l.o

/

FVC

forced inspiratory air volume measured in the first second as a percentage of forced expiratory vital capacity

PIF

Peak lnspiratory Flow. Maximum inspiratory flow speed in litres

/

second

MIF Maximum lnspiratory Flow. Maximum inspiratory flow in

litres

MIF

uM6

flow speed by

50

%

of the forced inspiratory vital capacity

Guide

Page

37

Data

f

Storage

This section is only applicable when the memory option is installed.

Automatic Storage

To store a measurement automatically the save option in the setting menu must be set to

AUTO

-

See

page

19.

When this is set, the patients measurements are stored automatically

at the end of the test (when

Manual Storage

To

store a measurement manually press the

press enter. The message

a

new patient is entered).

MENU

FILE

IS

STORED

is displayed. Press

key, highlight the

ENTER

SAVE

to

111'"")

option, and

exit.

Page

38

User's

SP-

1

Guide

Data Storage

SP-

1

User's

The message be deleted (see next section) appear when a new patient must be made available before entering new patient details.

Guide

MEMORY

FULL

appears when all memory space is used. Old records must

to

store the current recording. In auto mode this message will

is

entered.

If

you wish to store the current measurement, space

Page

39

Memory Management

f

This section is only applicable when the memory option is installed.

Enter the memory screen press the MENU key, highlight the enter. A list of the stored recordings is displayed. At the bottom of the screen the number of

files stored is displayed along with the percentage of free memory available. Six files are displayed on each page. Use the up and down cursor keys to select or top file is highlighted the nedpreceding page, is automatically displayed when the down or up cursor key is again pressed.

MEMORY

option, and press

a

file. When the bottom

Page

40

User's

SP-I

Guide

Memory Management

With a file highlighted, press the MENU key to display the following options:

SP-

1

User's

Read

Delete

Send

To cancel any operation in the above option press the MENU key.

Tagging a

Highlight the File (with the READIDELETOSEND menu NOT displayed displayed, exit by pressing the MENU key) and press ENTER. An asterisk appears by the side

of

Exiting the Memory Option

Press any of the Function keys (FVC, SVC, MW, or MV) to return to the measurement screen. Note that it is notpossible to exit the memory screen when the Delete or Sendmenu options are selected (TaggedAll displayed); press the function key.

Guide

Highlight this option and press ENTER to display the patient data of the selected file. Obtain a printout of the selected file by pressing the PRINT key. Display results by pressing the RESULT key.

Highlight this option and press ENTERto delete all or selectedfiles. When this option is selected you are prompted by the message TAGGED or ALL. Select

the option you require to delete only the tagged files or all stored files.

Highlight this option and press ENTERto send all or selectedfiles overthe

232

interface. When this option

TAGGED

or all stored files. See the following page for sending procedure.

Stored

File

or

ALL. Select the option you require to send only the tagged files

(for

Deletion

or

Sending)

is

selectedyou are prompted bythe message

-

the file. Cancel the tag by pressing ENTER again.

MENU

key first then and then the

if

RS-

the menu is

Page

41

Sending

r

Measurements can besent to the SEMAdata management system. To send a measurement

proceed as follows:

Connect the PC to the

Carry out the measurement(s) as described previously

Press the

When the transmission is complete a message is displayed showing that successful transmission has been completed. check settings in the PC and on the unit. Check the cable connection. Ensure that the Baud rate and the parity settings are the same in both the PC and the unit (SETUP menu).

MENU

RS-232

key and select

If

an error message is displayed e.g. 'serial link time-out'

connector on the right hand side of the unit

SEND

Page

42

Stored files can also be sent - see previous page.

SP-

User's Guide

1

I

Care & Maintenance

The casing of the

the

unit before cleaning.

DO

NOT, UNDER ANY CIRCUMSTANCES, IMMERSE THE APPARATUS INTO A

CLEANING LIQUID

Self-test

At the time of print his function was not fully defined

A table giving information for the service staff is printed out.

Maintenance

At

12

monthly intervals, the unit should undergo a technical safety check. The extent of this

check should include the following:

Visual inspection of the unit, sensor and cables. Electrical safety tests according Functional tests according to the Service Handbook.

The test results must be documented.

SP-1

should be cleaned with a

WARNING

OR

STERILIZE WITH HOT WATER, STEAM,

to

IEC

soft

601

-1.

cloth on the surface only.

OR

AIR.

Disconnect

SP-1

User's Guide

Page

43

Replacing the Recording Paper

The recording paper must be replaced as soon as the end stripe on the lower edge. After the indication first appears, there are about However, we recommend that the paper be replaced immediately.

If

no paper is

blink.

left,

the printing process

is

interrupted and the paper warning lamp starts

of

the paper is indicated by a red

8

pages

left.

to

Page

44

User's

SP-1

Guide

Replacing the Recording Paper

Push paper compartment release and lift up cover. Remove the remaining paper. Place a new paper pack into the drawer.

Check that the printed (grid) side is facing upwards, and place the beginning of the paper over the guide roller.

Close lid and press firmly until release catches.

Press

STOP

to transport the paper to the start position.

SP-

1

User’s

Guide

NOTE:

WELCH ALLYN SCHILLER can only guarantee an excellent printout if WELCHALLYN SCHILLER originalchartpaper or a chart paper

quality

is

used.

of

the same

Page

45

Flow

c

I

Sensors

Flow

1.

2.

3.

Sensor

SP-150

Remove disposable mouthpiece handle

(2).

Discard the complete assembly.

Position new disposable mouthpiece

it

in position.

(1)

by gently but firmly pulling it away from the

(Part

No.

2.100077)

and gently but firmly click

L

Page

46

NOTE:

The disposable mouthpiece can only be positioned in one direction and no

force is necessaty

to

insert it on the handle.

SP-

1

User's Guide

I

Flow

Sensors

Flow

1.

2.

Sensor

SP-20

Slide out the combined filter/mouthpiece assembly direction.

Unscrew the assembly.

(1).

This

is

only possible in one

SP-

1

User's Guide

Page

47

Flow

Sensors

3.

4.

5.

6.

Remove and discard filter Clean and disinfect the assembly after every patient. Insert a new filter Carefully screw the two halves of the assembly together again.

filter is not displaced.

(Part

(2).

No.

2.100123).

Make

sure

that the

Page

48

7.

Push the combined filtedmouthpiece assembly gently but firmly into the outer tube until

it

makes contact

go

in

one direction.

on

the outside edge of the outer tube. The assembly can only

SP-

User's Guide

1

Diagnosis

The diagnostic interpretation is dependent upon the country. The factors used in the

evaluation for diagnosis are automatically included in the respective language software and described in the following chapters.

Diagnosis Setting 'International'

SP-1

User's

'International

Note:

Possible respiratory problems are diagnosed on evaluation

The measurement

Guide

When

(if

taken).

%VC

100

FEV%

100

If

=

100

*

NC/FVC predicted

=

100

*

FEVl/NC

I

Obstructive

FEVIIFVC

'is set, diagnosticnorms arepredictedusing the VCvalue

VC values are not recorded, FVC

*

VCNC predicted (when VC measurement taken), otherwise

FEVlNC (when VC measurement taken), otherwise

I

or

FEVl

NC

will adapted on the screen and on the printout.

-

is

used. That is:

of

the following factors:

I

<70%

I

Page

49

Diagnosis

Diagnosis Setting 'American'

calculations apply to patients between the calculated as follows:

Adolescent Child

Using this LLN value, the diagnostic statements and their criteria are as follows:

For the USA and Canada, diagnosis of possible respiratory problems is based on the

ITS

interpretation standard which uses the LLN (Lower Limits of Normal) calculations. These

ages

I

19 to

I

el8 yrs:

25

I

yrs: I Predicted FEV1% x 0.848

I

Predicted FEV1%

Diagnosis

1

Normal

limits

Borderline Obstruction I FEVl/FVC% is 80

]Mild Obstruction

Moderate Obstruction Severe Obstruction

Mild Restriction

I

Moderate Restriction 1 %FVCpredicted is Severe Restriction

x

0.826

I

Criteria

I

FEVl/FVC% predicted is >80%

I

1

I

FEVl/FVC% is FEVl/FVC% is

FEVl/FVC% is ~40%

"/FVCpredicted is

%FVCpredicted is

of 5 and

1

19

to

I

el8 yrs:

to

60

to

40

to

60

50

40%

85.

The LLN

20

vrs: I Predicted FEV1% x 0.805

100%

of

80%

of

LLN

60%

of

LLN

of

LLN

to

80%

to

60%

FEV1%

I

Predicted FEV1% x 0.791

1

I

LLN

value

I

is

Page

50

User's

SP-

1

Guide

Norm

Values

The norm values used for the calculation of predicted values are dependent upon the country.

For Great Britain, Italy, Spain and Switzerland, the ECCS andQuanjer standards are used.

For Sweden, the Swedish (Berglund) and Quanjer standards are used. In Finland the Finnish and Quanjer.standards are used.

0

In Austria the Austrian standards are used. In India the Indian norm values are used.

0

In America and Canada the norm values that are used are Knudson, Knudson76, Crapo, Morris, Composite and Polgar. The American normvalues are extended with

values taken from the ITS (Intermountain Thoracic Society) recommendations.

The factors used in the evaluation for diagnosis and the specific norm values are included in the software and are described in the following pages.

IMPORTANT

SP-

I

User’s

Guide

DUE ARE

TO

GREAT DIFFERENCES IN THE

NO

STANDARD VALUES FOR CHILDREN UNDER 6 YEARS

SIZE

OF

THE LUNGS

OF

CHILDREN, THERE

OF

AGE.

Page

51

Norm

Values

Norm Values for Countries Outside the

ECCS

Values

The safety standards valid for adults of at least calculated on the basis of a

FEVlISVC

MEF PEF MER5

I

MEF50

I

MEF25 12.605xH -0.026xA-1.336 I1.050xH -0.025xA+1.107

H: Height in meters

of

the European Coal and Steel Community Standards (ECCS) are

25

years

25

year old. The calculation equations are as follows:

-0.179 x A e7.21

1.944

x

H

-0.043 x A +2.699

6.146xH-0.043xA+0.154 5.50xH -0.030XA-1.106

5.459

x

H

-0.029 x A -0.470 3.218 x H -0.025 x A +1.596

I

3.794 x H -0.031 x A -0.352

A:

Age

USA

of

age. Patients between the ages of

-0.192 x A +89.10

1.252 x H -0.034

1

2.450 x H

-0.025

18

x

A

+2.924

x A +1.156

and

25

I

are

Page

52

User’s

SP-1

Guide

Norm

Values

Quanjer & Tammeling Comparisons

The Quanjer and Tammeling comparison as follows:

MEF50

5.6

x

H

-4.4

H: Height in meters

is

valid for children between the ages of 6 and

6.6

x

H

-5.3

4.6

X

H

-3.3

17

SP-1

User's

Guide

Page

53

Norm Values

Austrian Standard Values (Osterreich)

Page

54

ln(FEV1)=-1.178+ 1.221H+0.003841AW In(PEF)

=

-0.214

+

O.921H

+

..

ln(PEF75) = -0.077 + O.77OH + 0.0373A + 0.0025W

=

In(PEF50)

H

-0.522

=

Height in meters,

0.0467A + 0.002OW

+

0.843H + 0.03ooA

+

0.0035W

A

=

Age in years, W = Weight in kg, Fi = Body fat index = H/dW

I

1

FVC1

=

-8.125 + 6.212H

I

JPEF = 1.798

I

JPEF75

=

1.581

I

JPEFW = 1.490 + 1.2901nfHI + 0.0125A - 0.00021M(mwer 2)

-

0.03OOA x

H + 0.97701n(A)

+

231

Iln(H) + 0.0159A - 0.000248Abower

..

+

1.8541n(H) + 0.0213A - 0.000283A(power 2)

..

2)

User’s

SP-1

Guide

Norm

Values

Swedish

The

Standards

(Berglund)

Swedish (Berglund) standard

follows:

A:

FEV%

SVC

FEV

Age

91.79 -(0.373

1.09 [ (4.81

1.01.09

H: Height in

[

(3.44

x

H)

A)

40.020

x

H)

meters

is

valid for adults between the ages

92.1 1 -(0.261

x

A)

-(0.033

-2.811

x

A)

-1

.OO]

1.09 [ (4.04

1.09

[

(2.67

x

A)

x

H)

-(0.022 x A)

x

H)

-(0.027

of

18

and

75

years as

-2.351

x

A)

-0.541

SP-

1

User's

Guide

Page

55

Norm

Values

Finnish

The Finnish standard is valid for adults from the age of

A

Standards

18

years as follows:

exp

svc

(I)

FEVl

(I)

FVC

(I)

FEVl ISVC FEVl / FVC PEF

svc

FEVl

~~

FVC FEVl I SVC

FEVl I FVC (%) PEF

(“10)

(“h)

(l/s)

(I)

(“A)

Ills)

exp exp

exp

1

exp

1

exp exp exp

exp

8XD

[(-0.00833 [(-0.00567

[(-0.00827 [(0.00246

[(0.00240 1(-0.00211

[(-0.01016 [(-0.00920

[(-0.00982 [(0.00096

[(0.00062 [(-0.00677

x

A)

+

x

A)

+

x

A)

+

x

A)

+

x

A)

+

x

A)

+

x

A)

+

x

A)

+

x

A)

+

x

A)

+

x

A)

+

X

A)

+

(0.6309

x

log

(0.2756

x

log

(0.5860

x

log

(-0.3553 (-0.3104

(-0.2223 x log

(-0.1586

(0.1049

(0.6995 (0.4772

(0.6358

(0.4017

x

log

x

log

x

log

x

log

x

log

x

log

x

log

X

log

A)

A) A)

A)

A) A)

A)

+

+ +

+

+ +

Age H: Height in meters log: Logarithm to base

(-1.4750 (-1.1655

(-1.4468 (0.3095

(0.2813 (-0.6774

(-1.4518 (-1.3284

(-1.4137 (0.1233

(0.0853 (-0.7422

I

I I

/

10

I

H)

I

/ I

H) H)

H)

+

H)

+

H)

+

H)

+

H)

+0.7763]

H)

+

H)

+

+ +

H)

+

0.90471

1.0980]

0.94611

2.19331

2.15191

1.32551

0.92961.

0.83201

2.15331

2.09751

0.966ll

Page

56

User’s

SP-

1

Guide

Norm

FVC FEVl

FVC

Values

Indian Equations

The Indian equations are valid for patients from the age of 7 years as follows:

c30

years

old:

0.055 x H + 0.019 x A -6.058

0.039

x

>30

years

0.054

H - 0.010

x

H

old:

-

0.01

x

A

-3.266

8

x

A -4.832 10.043 x H - 0.010 x A - 3.755

0.030 x H + 0.006 x A - 2.284

0.025

x

H - 0.01 1 x A - 1.424

FEVlIFVC

svc

FEV3

FEF25-75% PEF FEF50 FER5

MW

SP-1

User’s

Guide

-0.1756 x H - 0.2457 x A -1 19.346

0.0522

0.0485

0.0173xH -0.0407xA-1.6108

0.0850

0.0195

0.0088

1.3056

A

Age, H: Height in meters

x

H

-

0.01 14

X

H

-

0.0183

x

H

-

0.0187

x

H

-

0.0365 x A -1.7383

x

H

-

0.0301 x A -1.0402

x

H

-

0.5228

x

A

-4.859

X

A -4.138

x

A

-6.2083

x

A -93.2102

-0.0334 X H - 0.21 46 X A - 94.8867

0.0587

x

H

-

0.0296 x A - 5.927

0.0533

x

H - 0.0105 x A - 5.660

0.0245

x

H - 0.0336 x A - 0.1399

x

0.0497

0.0272 x H - 0.0279 x A - 0.2704

0.0113

0.7149

H - 0.0018 x A - 2.7154

x

H

-

0.0288 x A - 0.5012

x

H - 0.3624 x A - 25.0208

Page

57

Norm

Values

Norm

Morris

Values

Norm

for

USA

Values

and Canada

Page

58

The Morris equations are valid for women between

range of

of

FVC FEW

FEVl/FVC FEF0.2- 1.2

FEF25 - 75

FEF75

20

to

-

85

20

to

90

years, and for men between

90

years

as

follows:

0.1480

x

H

-0.0250

x

A

-4.241

0.0920

x

H

-0.0320

x

A

I

-0.31 18

x

H

-0.2422

0.1090~H-0.0470~A+2.010 0.1450

0.0470

x

H

-0.0450 x A +2.513

x

H

0.0130

-0.0230

-1.260

x

A

+107.120 14.0679

x

A

+1.210

58

and

The Morris normals are extended with the following:

FEV0.5 FEV3.0

1

FEV3.0FVC -0.1 593

MW

(0.0831

3.4040

x

H

-0.0152xA-1.914

x

H

-0.1450

X

H

-1.2600

x

A

-3.512

x

A

+112.090

x

A

-21.400 2.0500

56

and

72

inches tall and within the age

80

inches tall and within the age range

0.1 150

x

H

-0.0240

x

A

-2.852

0.0890

x

H

-0.0250

x

A

-1.932

x

H

-0.1815 xA +88.700

x

H

-0.0360

x

A

-2.532

0.0600

x

H

-0.0300

x

A

+0.551

0.0250

x

H

-0.0210

x

A

+0.321

10.0605

x

H

-0.01 85

x

A

-0.809

1-0.1 123

x

H

-0.0257 x A -2.745 1-0.1359~ H -0.0271

-0.2380~H-0.1630~A+118.160

x

H

-0.5700

x

A

-5.500

I

SP-1

User's

Guide

J,

Norm

Values

Crapo Norm

Values

The Crapo equations are valid for men between 61 and 77 inches tall and within the age

range

of

18 to 89 years, and for women between

57

and 71 inches tall and within the age

range of 18 to 89 years as follows:

FVC

FEV1 FEV3 FEVlFVC

-

FEF25

MW

VOl.

~~~

~

75

0.1524

0.1052

0.1359

-0.3302

0.0518

3.4040

x x

x

x x

H

-0.0214

H

-0.0244

H

-0.0271

H

-0.0380

H

-1.2600

-0.1520

x

A

x

A

x

A

x

A

x

A

-4.650

-2.190

-3.512

A

+110.490

+2.133

-21.400

0.1247X H -0.0216xA -3.590

0.0869

x

H

-0.0255

x

A

-1 578

x

H

-0.0257

x

A

x x

xA

A A

-2.745 +126.580

+2.683

-5.500

0.1 123

-0.5131

0.0391

2.0500

x

x x

H

-0.2520

H

-0.0460

H

-0.5700

The Crapo normals are extended with the following ITS equations:

0.0605

x

H

-0.0185

x

A

x

A

-0.809

+118.160

FEV0.5

FEV3.0lFVC

A: Age

Knudson

0.0831

-0.1593

H:

Norm

x

H

-0.0152

x

H

-0.1450

Height in inches

Values

x

A

x

-1.914

A

+112.090

-0.2380

x

H

-0.1630

The Knudson equations are valid for both children and adults in specific groups according

to age and height as shown following:

SP-1 User’s

Guide

Page

59

Norm

Values

I

0.0434

I

3.0300~

x

H

+

H.

0.8160~

0.0~

A

-

A

1.015

-

37.900

[

0.0277~

H

+

0.0

XA

~

12.7600xH+3.4000xA-

I

H=52

lo

72

hches.

0.166

A

=

11

108.120

lo20

vrs

I

Page

60

tF

FEF50

I

0.1080~

I

0.1379~

H

+0.1660xA

H

+

0.1150

-

8.061

x

A

-

6.385

10.1240~

10.0732~

H H+

+

0.1570~

0.1111

x

A A

-

3.920

-

2.304

User’s

SP-

1

Guide

I

Norm

Values

Knudson

The Knudson

follows:

76

Norm

Values

76

equations are valid for

both

males and females in specific age groups as

SP-1

User's Guide

A

Age

H:

Height in inches

Page

61

Norm

Values

Composite

Selection of the Composite normals provides selected equations taken from other tables as follows:

Norm

Values

FVC FEVl

FEV3 FEF25 FER5-85 FEF0.2

MW

svc

-

75

-

1.2

Knudson Knudson

crape

Knudson

MOMS

Morns

CmPo

Knudson

(same

as

FVC)

I

1

Norm

r

Values

Polgar

The Polgar equations are valid for both children and adults in specific groups according to age as

Norm

Values

follows:

1

SP-

User's

Guide

A

Age

Height in inches, The remaining values are taken from the

H:

ITS

equations.

Page

63

Technical Data

Technical data subject to change without notice.

Safety standard:

BF

according to

RL

93/42/EEC

60601

EN IEC 601-1

pr

EN

1441:1994

~

-1

:1990

IEC

and complying with the following:

Page

64

~~ ~

Protection class:

Dimensions (IMh): Weight: Mains

Supply:

LCD

IEC 513:1994

I

according to

Ila according

290 x 21

2.9

kg:

100

to

IEC, VDE, SEV

to

0 x 69

6.31bs

1 15 I 220

RL

93/42/EEC

mm:

1 1.4 x 8.3 x 2.7

to

240 VAC, 50/60

Liquid crystal, display representat ion

Resolution

-

192 x 64

dots variable contrast

ins

Hz

for

graphic and alpha numeric

SP-1

User's Guide

Technical

Data

Battery:

Built-in

12

V

lead-acid battery (rechargeable).

Power Consumption:

~___

~ ~

Control Panel:

Storage:

Paper Speed:

Chart Paper:

Printing Process:

Normal working time Charging time

(<6

28

hours to

VA

90%)

max.

-

5

hours

-

15

hours for a completely discharged battery

Splashproof Rubber keys Memory for approximately

25

mds

Thermoreactive Z-folded,

(3.54

ins)

50

measurements

90

mm wide, perforation 90mm

High-resolution thermal print head

SP-1

User's

Guide

Page

65

Technical Data

Method

Measurement Ranges:

Measurement Accuracy:

Flow

Measured Values:

of

Measurement: Pneumotachometer

Flow:

0

f2%

Impedance:

Less than FVC, ERV, IRV,

to

f14

0.2

Vs;

mbar

TV,

FEV,.$FVC, FEV,,flC, FEF

,,PEF, MEF,%, MEF,,, MEF25,, MV, MW, FIVC, FIV,,,,

FIV,JFIVC, FIV,,$NC, PIF, MIFw

Comparison pre/post medication possible.

Extrapolated predicted values

Prediction Equation:

Adults: ECCS

I

Austria I Berglund I Finnish I Indian I Morris

Crapo I Knudson I Knudson Children: Quanjer & Tammeling / Austria / Indian / Knudson

Knudson

76

/

Polgar

Standards Compliance: ATS, OSHA, NIOSH

Volume: 0 to

s/l

at

12

Vs

kl

1

litres

FVC, FEVo,5, FEV,,, FEV,,, FEVo,,ISVC,

,,,.

1,2

(litres), FEF,,,,, FEF,.

76

I

Polgar / Composite

I

Page

66

SP-1

User's Guide

Technical Data

Environmental Conditions:

RS-232

Pin Connections:

(V24)

Interface

Temperature, Operating: Temperature, Storage:

Relative humidity:

Atmospheric pressure:

Protocol: Baud Rate: Byte Format:

or

-),

1

Transfer Control:

Connection Socket:

300

stop bit

Asynchronous

to

38400

1

start bit, 8 data bits 0 or 1 parity bit

10'

-1

0"

25

to

95%

700

Baud

By means

3

x

D subminiature

to

40'

C

to

55"

C

(non condensing)

to

1060

hPa

of

CTS,

RTS

(9

pole

female), wired as DTE (Data Terminal Equipment).

3

TXDl

0

(output data)

2

RXDl

I

(input data)

7

RTS1

0 Pin Pin

8

5

CTSl

GND

I

(request (ready (ground)

for

output)

(+

SP-1

User's

Guide

Page

67

Page

68

User's

I

SP-1

Guide

INDEX

A

Austrian Standard Values (Osterreich)

54

B

Berglund Standards Best 27

BTPS 21

55

C

Calibration 20 Calibration Factor 21 Calibration Procedure 22

Changing the filter SP-20 Flow Sensor 47 Changing the Flow Sensor SP-150 46 Clock 17 Composite Norm Values 62 Crapo Norm Values 59

D

Data Storage 38

Definition of Best 27 Deleting a Memory file 40 Device Diagnosis Diagnosis for Countries Outside the USA 49 Diagnosis for USA and Canada Diagnostic statements Displaying the results in tabular form

16

50

28

E

ECCS Values 52 Environmental Conditions 67 Exiting the memory option 41 Exiting the the memory option Explanation of Measured Values

41

35

F

Features Finnish Standards 56 Flow Sensor SP-150 46 Flow Sensor SP-20 47 Forced Vial Capacity (FVC) Test 32 FVC 35

5

I

Indian Equitations

K

Keyboard Knudson 76 Norm Values 61

8

57

L

LLNvalue Location 6

50

M

P

Main Menu 10 Maintenance 43 Measured Values 35 Measured Volume 21 Memory 10, 38 Memory Management Menu Overview and Setup Morris Norm Values 58

Morris normals 58

MTA ldent 10

40

N

Norm Values 51 Berglund Crapo

ECCS

Finnish 56 Indian Knudson76 61 Morris 58 Osterreich Outside the Polgar Quanjer & Tammeling 53

’

Race Influences 18 Swedish

USA

Norm Values for Countries Outside the Norm Values for

55

59

52

57

54

USA

52

63

55

and Canada 58

USA

and Canada

Patent Data 18 Polgar Norm Values 63 Post-Medication Tests Potential Equalisation 6 Power Supply 7 Print

15

9

Protection class 64 Pulmonary Function Test Procedure 24

34

Q

Quanjer & Tammeling Comparisons 53

R

Race 16

18

58

USA

52

Race Influences on Norm Values

Reading from the Memory 40 Replacing the Recording Paper 44 RS-232

17

S

Safety standards 64 Self-test

Sending a Memory Sensor Sensor Storage Swedish Standards Swedish Standards (Berglund) Switching On and

43

SP-150 SP-20

38

46

47

Off

File

55

40

7

T

55

Tagging a Stored File (for Deletion ing) 41 Temperature

21

U

User ldent 14

or

Send-

Welch Allyn SP-1 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Procedure Overview

Introduction

Location

Keyboard

Main Menu Overview

Screen Contrast and Entering Data

System Setup Menu

Patient Data

Calibration

Pulmonary Function Test Procedure

Memory Management

Sending

Replacing the Recording Paper

Diagnosis

Technical Data

INDEX