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