SP10 User Guide

DECLARATION OF CONFORMITY Spimmeter:

-10

Serial numbers starting with:

531.

Year of manufacture:

1995Onwards

We, the undersigned, hereby declare that the medical device (class IIa) specified above conforms with the essential requirement listed in Annex 1of EC Directive93/42/EEC.

This declaration is supported by: Certificate of approval No:

and

IS0 9001 (Rev.1994) EN 46001 by SQS 11425-01 45112-60-00 IS0 9001/08.94, EN 46001 / 12.93 by DEKRA 45112-16-00 Annex 11, Section 3 of the Directive 93/42/EEC (30.04.1995)

(<

0124

Baar (Switzerland) 03.07.1996

Markus Butler Quality Assurance Manager

Martin Spreng Research& Development Manager

ii

This equipment has been tested and found to coinply 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 Deparhnent of Communications.These limits are designed to provide reasonableprotection 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 case the user will be required to correct the interference at his own expense.

1 Disposal Instructions and Battery Care

O

O

O

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.

.%c9

Unit Disposal Instructions Units no longer required can bereturned to Schiller AG for disposal. Alternatively dispose of the unit in municipally approved recycling centres.

Power Supply The mains connection is on the rear of the unit. The power supply voltage is set by the factory for100-115V(nom. llOV) 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 rechargeable battery. The power source is indicted on the top line of the LCD. Changing a Mains Fuse If it is necessary to change a fuse, always replace with the correct rating i.e 2x200mAT for 230V, or 2x400mAT for llOV . 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(+ Click back the fuse panel.

L

J

iv

PHYSICIAN’S RESPONSIBILITY THE SP-10 SPIROMETER I S PROVIDED FOR THE EXCLUSIVE US€ 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 PREPARATIONQUALITY AND THE GENERAL RECORDED DATA QUALITY, WHICH COULD EFFECT THE REPORT DATA ACCURACY, MUST ALSO BE TAKEN INTO ACCOUNT. I T I S THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAGNOSIS ORTO OBTAIN EXPERT OPINION ON THE RESULTS, AND TO INSTITUTE CORRECT TREATMENTI F INDICATED. FEDERAL LAW I N THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

vercqnuyrs* Schiller

I Safety Notices THIS UNIT I S BF CLASSIFIED ACCORDING TO IEC 601-1. TO PREVENT ELECTRIC SHOCK DO NOT DISASSEMBLE THE UNIT. NO SERVICEABLE PARTS INSIDE. REFER SERVICING TO QUALIFIED PERSONNEL ONLY. DO NOT USE THIS UNIT I N AREAS WHERE THERE IS ANY DANGER OF EXPLOSION OR THE PRESENCE OF FLAMMABLE GASES SUCH AS ANAESTHETICAGENTS. THIS PRODUCTIS NOT DESIGNED FOR STERILE USE. THIS PRODUCT IS NOT DESIGNED FOR OUTDOOR USE. SWITCH THE UNITOFF BEFORE CLEANINGAND DISCONNECT FROM THE MAINS. DO NOT UNDER ANY CIRCUMSTANCES, IMMERSE THE UNITOR CABLE ASSEMBLIES IN LIOUID.

I

THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER I F THE EARTH CONNECTION I S SUSPECTOR I F THE MAINS LEAD IS DAMAGED OR SUSPECTED OF BEING DAMAGED. DO NOT USE HIGH TEMPERATURE STERILISATION PROCESSES (SUCH AS AUTOCLAVING). DO NOTUSE E-BEAM OR GAMMA RADIATIONSTERILISATION. DO NOT USE SOLVENT CLEANERS USE ONLYACCESSORIESAND OTHER PARTS RECOMMENDED OR SUPPLIED BY WELCHALLYN SCHILLER. USE OFOTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULTIN INJURY INACCURATEINFORMATION AND/ OR DAMAGE TO THE UNIT. THE SP-10 COMPLIES WITH EMC REGULATIONS FOR MEDICAL PRODUCTS WHICHAFFORDS PROTECTION AGAINST EMISSIONS AND ELECTRICAL INTERFERENCE. HOWEVER SPECIAL CARE MUSTBE EXERCISED WHEN THE UNITIS USED WITH HIGH FREQUENCY EQUIPMENT.

vi

I

F

SP-I0 User‘s Guide This User’ s Guide gives instructionson how to opemte the unit and providesan 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 userto quickly and easily familiarise themselves with unit opemtion. Detailed medical information is excludedfrom this guide except where necessary to opemte the unit or understand the results.

Welc9AUyrr Schiller

9314UEEC Medical Devices: 0124 ‘Notified Body’ DEKRA AG

vii

viii

Chapter 1 Introduction and System Settings

Introduction and System Settings

INTRODUCTION ... Getting Started ... Location ... Potential Equalisation (Grounding) ... Switch the Unit On/Off ... Overview of the SCHILLER SP-10...

1.2 1.3 1.3 1.3 1.3 1.4

DISPLAY ... Liquid Crystal Display (LCD) ... Adjusting the Contrast ...

1.5 1.5

KEYBOARD ... Alpha Numeric Keyboard ... General Purpose Keys ... Control and Function Keys ... Menu Control Keys ...

1.6 1.7 1.8 1.9 1.10

PANELS ... Right-handSide Panel ... Rear Panel ... Mains Module ...

1.11 1-11 1.12 1.12

SYSTEM SElTlNGS ... General ... Adjusting Date and 'Time ... User Identification... Printout Settings ... Device Settings ... Device Setup Combinations ...

1.13 1.13 1.13 1.14 1.14 1.15 1 .16

SCHILLER SP-10 Spirometer .User Guide

1.5

1.I

Chapter 1 lntroduction and System Settings

INTRODUCTION The SCHILLER SP-10 is a sophisticated, compact workstation for pulmonarydiagnosis with the following characteristics: Multiple operation possibilities, thanks to low weight and battery power. 0

LCD display. Menu guidance provided for ease of operation. The SP-10 is capable of working in four measurement modes as follows:

Forced Vital Capacity (FVC-Test) Vital Capacity (VC-Test) Expired or Minute Ventilation (MV-Test) Maximum Voluntary Ventilation (MVV-Test) Additional options enable resistance testing and blood oximetry diagnosis to be carried out. The test results are displayedon the integralLCD and recorded on the built-inthermal printer. The open pneumotacho transducer SP-110, with disposable mouthpiece, is usedfor respiratory measurement. As options, WELCH ALLYN offers instead of the SP-110, either the SP-150 with disposable measurement unit integrated inside the mouthpiece or the SP-20. As further option in combination with resistance tests the SP-11O/R flow sensor is necessary. This sensor can also be used for normal pulmonary function tests. RS-232 and RS-422 interfaces are provided for data transmission and for the connection to the SCHILLER PC-based data management program (SEMA) for validation and archiving of recorded data.

The unit also has a facility for the connection of an external video monitor.

1.2

Chapter 1 Introduction and System Settings

INTRODUCTION

Getting Started Location

Do not keep or operate the apparatus in a wet, moist, or dusty environment. Also, avoid exposure to direct sunlight or heat from other sources. Do not allowthe unit to come into contact with acidic vapours or liquids, as such contact may cause irreparable damage.

The unit should not be placed near X-ray or diathermy units, large transformers or motors of any kind.

WARNING: THIS APPARATUS SHOULD NOT BE OPERATED IN AREAS WHERE THERE IS ANY DANGER OF EXPLOSION. Potential Equalisation (Grounding)

Attach the yellow/greenground lead (supplied with the unit) betweenthe potential equalisation stud of the SP-10 (situatedon the rear panel) and the hospital/buildingcommon ground. The connection for the potential equalisation is marked with the+ symbol.

Switch the Unit OnlOff

The SCHILLER SP-10 can be operated either from the mains supply or from the built-in batteries. To operate the unit from the mains, connect the power cable to the mains supply and plug it into the connection on the rear of the unit.

TheSCHILLERSP-1Oisswitchedonoroff withtheVOpowerswitch locatedabovethe mains connection on the rear of the unit (green lamp is lighted when on). If the unit is switched on and the ON key is not pressed, the battery is charged if necessary (yellow lamp is lighted). The SP-10 can remain connected to the mains supply without damage. To start the functionsthe ON key has to be pressed. If that is done without switchingthe unit on with the I/O switch, the SP-10 runs on battery power (yellow lamp is lighted). A self-test of the unit is automatically initiated every time the unit is switched on.

BEFORE SWITCHING THE UNIT ON, ENSURE THAT THE FLOW SENSOR IS PLUGGED IN. IF THE SENSOR IS NOT CONNECTED, A MESSAGE APPEARS TO CONNECT THE SENSOR. THE UNIT MUST FIRST BE SWITCHED OF5 THE SENSOR CONNECTED AND THE UNIT SWITCHED ON AGAIN. THE FLOW SENSOR CAN ONLY BE CONNECTED WHEN THE UNIT IS SWITCHED OFF. IF ANY KEY IS PRESSED WITH THE SENSOR NOT CONNECTED THE UNIT AUTOMATICALLY SWITCHES OFF.

SCHILLER SP-10 Spirometer - User Guide

1.3

Chapter 1 Introduction and System Settings

INTRODUCTION

Overview of the SCHILLER SP-10

The main operating and connection modules of the SCHILLER SP-10 are as follows:

1.4

Keyboard

The keyboardcomprises the generalfunction and control keys, and the alphanumeric keys for data entry.

LCD Screen

The LCD screen displays the pulmonary traces and certain operating and status information. Under operator control the display also gives menu options and displays operator entered data. The display is folded down when not in use.

Thermal Printer

The printer provides the hard copy of test results.

Right-hand Side Panel

The side panel contains the Spirometry connector and the RS serial connectors.

Left-hand Side Panel

This panel contains the paper tray and (below the paper tray) the program pack.

Back Panel

The back panel contains the video monitor connector and the mains connector with on/off switch, voltage selector and mains fuse.

Chapter 1 Introduction and System Settings

DISPLAY

Liquid Crystal Display (LCD) The liquidcrystal display (LCD) performsboth as a real-timemonitor and as an alphanumeric display for menu selection, data input and the provision of important information. Depending on the function, the displayed information will vary but the screen is normally divided into three main parts: Top of the screen

status and operating information are permanently displayed.

Right side

test results are displayed.

Left side

the display is divided into the following five fields from the top: 0

Date and Time Function / Battery capacity in % Status of CAPS key Alert field

Central Part of Display

In the central part of the display the test curve of the selected test is displayed.

Lower Part of Display

The very bottom line gives the function key for the next step.

Adjusting the Contrast The contrast can be adjusted by means of the LCD knob located on the right-hand side of the unit. Visibility is best when the display is fully illuminated.

SCHILLER SP-10 Spirometer - User Guide

1.5

Chapter 1 Introduction and System Settings

KEYBOARD The keyboard is divided into the following functional sections: alphanumeric keypad menu control keys control and function keys test function keys general purpose keys

1.6

Chapter 1 Introduction and System Settings

KEYBOARD

Alpha Numeric Keyboard The alphanumeric keyboard serves as a normal keyboard for data input and is arranged as follows:

Special keys of the alphanumeric keyboard:

!QaL

Function

I+-

Delete character to the left of the cursor.

(-IENTER

Confirm entry or selection.

OEL

SPACE

It

Enter blank space into the text.

When pressed simultaneously with a letter key it activates the uppercaseletter. When pressedsimultaneouslywith a number key it activates an alternative symbol set.

Ir

Toggle key to set lower case or upper case letters. The Caps Lock key status is indicated on status information field on the right-hand side of the screen.

SCHILLER SP-10 Spirometer - User Guide

1.7

Chapter 1 Introduction and System Settings

KEYBOARD

General Purpose Keys

The general purpose keys are:

p T c J

...

call up main menu I return to monitor mode

return to previous menu

1.8

("p) ...

change setting I disable command

...

change setting I enable command

am

move the cursor up I down

(a ... -]p-J

move cursor to left I right

Chapter 1 Introduction and System Settings

KEYBOARD

Control and Function Keys

The control and function keys are:

switch unit on

J p -

...

switch unit off

extend I retract paper tray

enter patient data

(STARTJ

start selected test

stop test / move paper to start position

print best test result

print all test results

select test result for printout

I . SEND i DATA i

...

mi

initiate data transmission

STORE :

...

J-Fp

...

initiate data storage

initiate reception mode

enter details of medical assistant

display general settings menu

delete stored measurement

SCHlLLER SP- 10 Spirometer - User Guide

,

1.9

Chapter 7 Introduction and System Settings

KEYBOARD

Menu Control Keys The menu control keys are:

display test results

IFm]

inhalation / exhalation flow (Vs) vs. Volume (I)

...

volume (I) vs. Time (s)

FVC E

1

I F V C E-l 1

(svc) ...

Forced Vital Capacity test (Exhalation only)

Forced Vital Capacity test (Exhalation and Inhalation)

Slow Vital Capacity test

Minute Volume (volume in one minute)

p , v v ,)

Minute Volume (forced volume in one minute)

[RESIS.) ...

ResistanceTest (Option)

...

(PRUPOST)

FALIBRATIO3 ...

1.10

pre / post medication test

calibration of the unit to environmental conditions

Chapter 1 Introduction and System Settings

PANELS The SCHILLER SP-10 has two connector panels. One is located on the back and the other on the right-hand side of the unit. Right-hand Side Panel 3

7

1

5

2

4

6

1

RS-232C interface (Port 1) (not used)

2

RS-232C interface (Port 2) (not used)

3

RS-232C interface (Port 3) (for data transmission (as.to SEMA)

4

RS-422 interface (Port 4)

5

LCD contrast control

6

Connection for: SP-110

for pulmonary function measurements with disposable mouthpiece

SP-150

for pulmonary function measurements for single use with disposable f low-sensor

SP-20

for pulmonary function measurements with disposable filter

SP-11O/R

for resistance measurements (Option) with disposable mouthpiece

N0TE:The resistance sensor SP-lIO/R can also be used for pulmonary function (i.e. FVC, VC, MV, MVV) tests. 7

Connection for optional Sp02 sensor

SCHILLER SP-10 Spirometer - User Guide

1.11

Chapter 1

Introduction and System Settings

SYSTEM SE77INGS

User Identification This function enables entry of the name of the physician, clinic or departmentwhich will then be given on each printout.The input is stored until overwritten by the user. It is not lost when the unit is switched off. To reach that menu, proceed as follows:

m y - User < id. > ...

user identification:

(memorized when power off)

I (confirm id with 'ENTER')

The maximum number of characters is 23.

0

Confirm with (,ENTER.

Press ... ESC

f to return to the settings menu.

Printout Settings There are five settings which may need to be made before startingthe test, namely the time axis for a printout of the FVC graph, the norm values that are to be used, including of diagnosis on the printout, including of a flow graph on the printout and the sensor that is connected and used for the tests. These settings stay stored until they are selected new. To reach the menu proceed as follows:

B r -Print <settings >

FVC-Graph Diagnosis Flow-Graph PEF [Vmin]

Selections in the menu: By pressing key 1, the time axis for the printout of an FVC graph can be set to: 10 m d s 0

20 m d s

By pressing key2 and settingto ON the diagnosis is given as indicationon the printout (for explanations, check in the chapter "Value Information" under paragraph "Diagnosis"). By pressing key 3 and setting to ON the flow graphics is printed. By pressing key 4 and setting to ON the PEF values are printed.

1.14

Chapter 1 Introduction and System Settings I

I

SYSTEM SETTINGS

Device Settings

There are seven settings which need to be made before starting the test, namely: the sensor that is connected and used for the tests calculation basis for norm values norm values that are to be used race of the patient calculation units for weight and size of the patient order of date measurement units for temperature. All these settings stay stored until they are selected new. To reach the menu proceed as follows:

. -.

r-7-<

Device Settings >

SrnlNGS

LJnits in. - . .. Order of date Temperature

...

(61; F;&;yy

Selection possibilities: By pressing key 1, the flow sensor that is to be used can be selected. The available settings are: SP-110 (also used for SP-I 1 O/R resistance sensor)

SP-150 SP-20

CAUTION:

ENSURE THAT THE CORRECT SENSOR IS SELECTED. MEASURED VALUES CAN BE INACCURRATEWHEN THE INCORRECT SENSOR TYPE IS SET. By pressing key (see Chapter 3). 0

2,

the

diagnosis

standard

can

be

selected

International; for all countries outside the USA and Canada American;

for USA and Canada

By pressing key 3, the standards used for the various measurement calculationscan be selected (see Chapter 3).

SCHILLER SP- 10 Spirometer - User Guide

1.15