SpiroSoft Ver 1.0 Rev E Operators Manual

SpiroSoft™

Firmware Version 1.0

Operator's Manual 2014847-001 ENG

Revision E

Note The information in this manual only applies to SpiroSoft, firmware version 1.0. It does not apply to earlier firmware versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

CardioSoft, CardioSys, CASE and SpiroSoft are trademarks owned by GE Medical Systems Information Technologies GmbH, a General Electric Company going to market as GE Healthcare. © 2003 - 2008 General Electric Company. All rights reserved.

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Contents

1 Introduction to SpiroSoft, Safety Information

6

2 Controls and Indicators

9

3 In Service

10

4 Replacing the Pneumotach

12

5 Cleaning, Maintenance, Disposal

13

6 Technical Specifications

14

7 Order Information

14

8 Appendix - Electromagnetic Compatibility (EMC)

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General Information

General Information y The product SpiroSoft bears the CE marking CE-

y This manual reflects the equipment specifications and

0123 (notified body TÜV Product Services GmbH

applicable safety standards valid at the time of

Bayern) indicating its compliance with the provisions

printing. All rights are reserved for devices, circuits,

of the Council Directive 93/42/EEC about medical

techniques, software programs, and names appearing

devices and fulfills the essential requirements of

in this manual.

Annex I of this directive. It is an MDD class IIa

y On request GE Medical Systems Information

product.

Technologies will provide a detailed Service Manual.

y The applied part of the device is a type BF

y The safety information given in this manual is

component.

classified as follows:

y The device fulfills the requirements of standard EN 60601-1 "Medical Electrical Equipment, Part 1:

Danger

General Requirements for Safety" as well as the

indicates an imminent hazard. If not avoided, the

interference protection requirements of standard EN

hazard will result in death or serious injury.

60601-1-2 "Electromagnetic Compatibility – Medical Electrical Devices".

Warning

y The device is in radio-interference protection class B in accordance with CISPR11/EN 55011. y

indicates a hazard. If not avoided, the hazard can result in death or serious injury.

The device is classified by ITS/ETL and thus Caution

fulfills the CSA and UL safety requirements. y The CE marking covers only the accessories listed in the "Order Information" chapter.

indicates a potential hazard. If not avoided, this hazard may result in minor personal injury or product/property damage.

y This manual is an integral part of the equipment. It should be available to the equipment operator at all times. Close observance of the information given in

y To ensure patient safety and interference-free

the manual is a prerequisite for proper equipment

operation and to guarantee the specified measuring accuracy, we recommend only original equipment

performance and correct operation and ensures

accessories as available through GE Medical Systems

patient and operator safety. Please note that information pertinent to several chapters is given only once. Therefore, carefully read the manual

distribution. The user is responsible for using accessories from other manufacturers.

once in its entirety.

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General Information

Manufacturer: VIASYS Healthcare GmbH Leibnizstraße 7 D-97204 Höchberg, Germany Tel.

+49 931 4972-0

FAX +49 931 4972-423 Distributor: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel:

+1.414.355.5000 800.558.5120 (USA only)

Fax:

+1.414.355.3790

The country of manufacture appears on the device label.

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Introduction to SpiroSoft, Safety Information

1

Introduction to SpiroSoft, Safety Information

1.1 Application Intended Use

Measuring Principle

SpiroSoft is a respiration flow transducer which, in

The patient breathes through a reference screen (2, Figure

conjunction with CASE / CardioSys / CardioSoft allows

1-2) with a known resistance to air flow. In parallel with

flow-volume loops and parameters to be recorded and

the reference screen, the differential pressure which

analyzed.

varies with the respiratory flow is measured. A pressure transducer (3, Figure 1-2) converts the differential

The pneumotach which is easy to replace ensures the highest level of patient protection and provides accurate results.

pressure into an electrical analog signal which, in turn, is evaluated by the analyzer module (4, Figure 1-2) in SpiroSoft.

SpiroSoft has no battery, it is powered either from CASE, CardioSys or from the PC. Note Use SpiroSoft only in conjunction with CASE (version 5.15 and later), CardioSys and CardioSoft (version 5 and later) or with the DFT analysis program CardioSoft supplied with the equipment (refer to the respective Operator Manuals; you will find the CardioSoft DFT manual on the enclosed CD). Figure 1-2

Measuring principle 1

Respiration flow sensor pneumotach

2

Reference screen

3

Pressure transducer

4

Analyzer module

. Biocompatibility The parts of the equipment described in this manual, including all accessories, that come in contact with the patient during the intended use, fulfill the biocompatibility requirements of the applicable standards if used as intended. If you have questions in this matter, please contact GE Medical Systems Information Technologies or its Sales Representatives.

Figure 1-1 SpiroSoft

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Introduction to SpiroSoft, Safety Information

1.2 Safety Information Warning

Danger Risk to persons -

Risk to persons -

– SpiroSoft is not designed for use in areas where

– Inspect the device/system for damage, before

an explosion hazard may occur. Explosion

turning it on. When the display is broken, the

hazards may result from the use of flammable

device requires immediate repair to avoid injury.

anesthetic mixtures with air or with oxygen, nitrous oxide, skin cleansing agents or

– Before cleaning, disconnect SpiroSoft from CASE, CardioSys or from the PC.

disinfectants.

– Dispose of the packaging material, observing the applicable waste-control regulations. Keep

Warning

the packaging material out of children's reach.

Risk to persons - – If SpiroSoft is connected to a PC with CardioSoft, this PC must meet the requirements

Incorrect measurements, risk of infection - – The pneumotach is designed for single use. Use

of the standard IEC 60950.

a fresh pneumotach for each new patient. The

– During the lung-function tests, the PC must be

PT code on the pneumotach must be the same as

located outside the patient environment (1.5 m).

the PT code displayed on the acquisition screen.

– For connection of CardioSys or the PC to a network, a transceiver to IEC 60601-1 or 606011-1 must be provided. – Equipment may be connected to other

Caution Incorrect measurements - – Magnetic and electrical fields are capable of

equipment or to parts of systems only when it

interfering with the proper performance of the

has been made certain that there is no danger to

equipment. For this reason make sure that

the patient, the operators, or the environment as

external equipment operated in the vicinity

a result. In those instances where there is any

complies with the relevant EMC requirements.

element of doubt concerning the safety of

X-ray equipment, MRI devices, radio systems

connected equipment, the user must contact the

etc. are a possible source of interference as they

manufacturers concerned or other informed

may emit higher levels of electromagnetic

experts as to whether there is any possible

radiation.

danger to the patient, the operator, or the environment as a result of the proposed combination of equipment. Compliance with the standard IEC 60601-1-1 must always be

– The operator must be trained in the use of the equipment. – Before using the equipment, the operator must ascertain that it is in correct working order and

ensured.

operating condition. Do not use the equipment if

– Chemicals required for the maintenance of the

you detect a defective cable, damaged

equipment, for instance, must under all

connectors or housing or if covers are missing.

circumstances be stored, prepared, and kept at

Replace defective cables and repair the device

hand in their specific containers. Failure to observe this instruction may have severe consequences for the patient or operator.

before use. – Close the battery compartment before using the equipment.

– Liquids must not enter the equipment. Equipment into which liquids have entered must be inspected by a service technician before use.

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Introduction to SpiroSoft, Safety Information

Caution Incorrect measurements - – Only persons who are trained in the use of medical technical equipment and are capable of applying it properly are authorized to apply such equipment. Interpretation hazard - – A qualified physician must overread computergenerated tracings. Computerized interpretation is only significant when used in conjunction with clinical findings. Equipment damage - – There are no user-replaceable components inside the device. Do not open the housing. For service or repair, please contact your local , authorized dealer (http://gehealthcare.com).

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Controls and Indicators

2

Controls and Indicators 1

Pneumotach with attached mouth piece

2

Locking tab, push upward to replace pneumotach

3

Liquid crystal display (LCD)

4

Connector for CASE, CardioSys or PC connection cable

5

Battery comparment cover (the device does not need batteries; the nameplate is located inside the battery compartment)

Explanation of signs and symbols used on the equipment and on the packaging Caution, consult accompanying documents Type BF applied part This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for

Figure 2-1 SpiroSoft controls and indicators

information concerning the decommissioning of your equipment. REF

Catalogue number

SN

Serial number

0123

CE marked per the Medical Device Directive 93/42/EEC of the European Union. The notified body is TÜV Product Services GmbH Bayern. Gossudarstwenny Standart Russia (GOST) ITS/ETL classification mark

Manufacturer’s identification

Date of manufacture. The number found under this symbol is the date of manufacture in the YYYYMM format. 2014847-001 Revision E

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In Service

3

In Service

Connection

Functional Test

SpiroSoft is powered from CASE, CardioSys or from the

After power-up, SpiroSoft runs a self-test. If a problem is

PC; batteries are not needed.

identified in the course of the self-test, the message "ERROR x" appears on the display. One of the error

Connect SpiroSoft to CASE, CardioSys or to the PC,

codes 1 to 4 will appear instead of the "x".

using the supplied connection cable (see Figure 3-1). Switch off CASE, CardioSys or the PC before connecting

– 1

Flash

the sensor.

– 2

RAM

– 3

EEPROM

– 4

Pressure system

y Connect SpiroSoft to plug 1 (connector 4, Figure 21).

Check that the pneumotach is correctly

y Remove the keyboard connector at the PC and

installed. This error code could be caused by a

connect to socket 3.

strong draft of air flowing through the

y Plug connector 2 (Figure 3-1) into the keyboard port

pneumotach.

at the PC. If you see an error code, disconnect SpiroSoft from

y Plug connector 4 into the serial port of the PC.

CASE, CardioSys or from the PC by disconnecting plug 1 (Figure 3-1). Wait for about 10 seconds, then reconnect. If the problem persists, notify Service to have SpiroSoft inspected, before using it again. Besides, the error code remains displayed and the spirometry test cannot be continued.

Figure 3-1 Connecting SpiroSoft

Turning the Device On SpiroSoft is automatically turned on and off with CASE, CardioSys or with the PC. After power-up, the firmware version will be displayed on the LCD for about 4 seconds.

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In Service

Performing a Measurement During the measurement, the patient should sit straight and hold the SpiroSoft in a horizontal position. For details on performing a spirometry test, please refer to the operator manuals for CASE, CardioSys , CardioSoft or CardioSoft DFT.

Figure 3-2 Performing a measurement with SpiroSoft

When activated, SpiroSoft indicates the equipment status on the display: – "x"

SpiroSoft ready for operation.

– "-"

SpiroSoft in measuring mode.

– "o"

A measurement is in progress, data is sent to CASE, CardioSys or to the PC.

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Replacing the Pneumotach

4

Replacing the Pneumotach

Warning Incorrect measurements, risk of infection - The pneumotach is designed for single use. Use a fresh pneumotach for each new patient. The PT code on the pneumotach must be the same as the PT code displayed on the acquisition screen. For information on entering the PT code in CASE, CardioSys or CardioSoft, please refer to the respective Operator Manuals.

Figure 4-1 Locking tab

y Push the tab upwards.

y Remove the pneumotach. Figure 4-2 Pneumotach removed

y Insert the new pneumotach and lock it with the tab.

Figure 4-3 New pneumotach inserted

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Cleaning, Maintenance, Disposal

5

Cleaning, Maintenance, Disposal

5.1 Cleaning, Disinfection

5.2 Maintenance

Equipment Surface

Checks before each use Before each use visually check the device and the cables

Warning

for signs of mechanical damage.

Shock hazard - Disconnect SpiroSoft from CASE,

If you detect damages or impaired functions which may

CardioSys or from the PC before cleaning.

result in a hazard to the patient or the operator, the device y Wipe the device clean with a moist cloth, then dry it with a cotton cloth. Do not let liquid enter the device. y For disinfection of the device surface, use a 1.5 %

must be repaired before it can be used again.

Technical Safety Inspections For safety, the equipment requires regular maintenance.

solution of Descogen® (15 g dissolved in 1 liter of water). Let the solution take effect for 15 minutes. If patients suspected to be suffering from tuberculosis have been tested, a 3 % solution is needed and the

To ensure functional and operational safety of SpiroSoft, Technical Safety Inspections should be carried out on an annual basis. These checks should be performed by persons with

solution should take effect for 60 minutes.

adequate training and experience. Caution

The checks can be carried out by GE Medical Systems

Risk to persons, equipment damage - Do not fail

Information Technologies within the framework of a

to observe the manufacturer's safety information.

service agreement. Please contact your local, authorized

Do not let disinfectant enter the device. Equipment

dealer for details.

into which liquids have entered must be inspected

The nature and scope of these checks are explained in the

by a service technician before use. Also prevent electrical connectors from coming in contact with

corresponding sections of the Service Manual.

the solution.

The device does not require any other maintenance.

5.3 Disposal of the Product

y Descogen® is biodegradable, therefore it can be disposed of by pouring it down the sink!

The product described in this operator manual

y Clean the nose clip after each patient and attach new

must not be disposed as unsorted municipal

foam pads. If necessary, disinfect the nose clip with a

waste and must be collected separately. Please

1.5-% solution of Descogen®.

contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

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Technical Specifications / Order Information

6

Technical Specifications

7

Interface

Subject to change. Always refer to latest list of accessories.

– serial (RS-232) Measuring Range – PEF

Order Information

2014845-001 SpiroSoft acquisition system y SpiroSoft device

0.1 to 16 l/s

y Pneumotach with attached mouth

– FEV1 and FVC 0.1 to 8 l Resolution

< 5 ml

– PEF

5 ml/s

piece (10 units) y Nose clip (2 units) y Foam pads for nose clip (100 units)

– FEV1 and FVC 1 ml

y SpiroSoft - PC connection cable

Accuracy

y SpiroSoft Operator's Manual

– PEF

y CardioSoft DFT data analysis

+3 % / 0.4 l/s

program, including CardioSoft

– FEV1 and FVC +3 % / 0.05 l

Operator Manual

Resistance

max. 2 kPa at 15 l/s

Parameters

see CASE, CardioSys, CardioSoft Operator Manuals

Accessories 2014847-001 SpiroSoft Operator's Manual

Environment

2014846-003 Pneumotach with attached mouth piece (10 units)

Operation – temperature between +10 and + 40 °C (50 and 104 °F)

2014846-006 Mouth piece (25 units)

– relative humidity between 10 and 90 %, no

2014846-007 Foam pads for nose clip (100 units)

condensation – atmospheric pressure between 600 and 1200 hPa Transport and Storage

2014846-008 Nose clip (25 units) 2014846-002 SpiroSoft - PC connection cable, length 2m

– temperature between -20 and + 50 °C (-4 and +122 °F) – relative humidity between 10 and 95 %, no condensation – atmospheric pressure between 500 and 1200 hPa Dimensions and Weight – height 150 mm – width 94 mm – depth 40 mm – weight approx. 150 g SpiroSoft complies with ATS 1994 ATS Literature Crapo, O et al., "Standardization of Spirometry, 1994 Update", A. J. Respir. Crit. Care. Med., 154, 1995, p. 1107-1136

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Electromagnetic Compatibility (EMC)

8

Appendix - Electromagnetic Compatibility (EMC)

Changes or modification to this system not expressly approved by GE Medical Systems could cause EMC Warning

issues with this or other equipment This system is designed and tested to comply with applicable regulation

Use of portable phones or other radio frequency

regarding EMC. It needs to be installed and put into

(RF) emitting equipment near the system may cause

service according to the EMC information stated as

unexpected or adverse operation.

follows.

Warning The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions SpiroSoft is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that SpiroSoft is used in such an environment. Emissions Test RF emissions

Compliance Group 1

Electromagnetic Environment - Guidance SpiroSoft uses RF energy only for its internal

CISPR 11

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

Class B

SpiroSoft is suitable for use in all establishments,

CISPR 11 Harmonic emissions

including domestic and those directly connected to the public low-voltage power supply network that

Class A

supplies buildings used for domestic purposes.

IEC 61000-3-2 Voltage fluctuations/flicker

Complies

emissions IEC 61000-3-3

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Electromagnetic Compatibility (EMC)

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity SpiroSoft is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that SpiroSoft is used in such an environment. Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2

IEC 60601 Test Level

Compliance

Electromagnetic Environment -

Level

Guidance

± 6 kV contact

± 6 kV

± 8 kV air

± 8 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/

± 2 kV for AC power supply

not

Mains power should be that of a typical

burst

lines

applicable

commercial or hospital environment.

IEC 61000-4-4

± 2 kV for DC power supply ± 2 kV lines

SpiroSoft has no input or output lines that require testing.

± 1 kV for input/output lines not applicable Surge IEC 61000-4-5

± 1 kV differential mode

± 1 kV

± 2 kV common mode

± 2 kV

Mains power should be that of a typical commercial or hospital environment.

Voltage dips, short

< 5 % UT (> 95 % dip in UT) < 5 % UT

Mains power should be that of a typical

interruptions and voltage

for 0.5 cycles

commercial or hospital environment. If

variations on power supply input lines IEC61000-4-11

40 % UT (60 % dip in UT) for 40 % UT 5 cycles

the user of SpiroSoft requires continued operation during power mains interruptions, it is recommended that

70 % UT (30 % dip in UT) for 70 % UT

SpiroSoft be powered from an

25 cycles

uninterruptible power supply or a battery.

< 5 % UT (> 95 % dip in UT) < 5 % UT for 5 s Power frequency (50/

3 A/m

3 A/m

Power frequency magnetic fields should

60 Hz) magnetic field

be at levels characteristic of a typical

IEC 61000-4-8

location in a typical commercial or hospital environment.

NOTE

16

UT is the AC mains voltage prior to application of the test level.

SpiroSoft

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Electromagnetic Compatibility (EMC)

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity SpiroSoft is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that SpiroSoft is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance

Electromagnetic Environment -

Level

Guidance Portable and mobile RF communications equipment should be used no closer to any part of SpiroSoft, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

3 Vrms

3 V/m

Recommended separation distance: d = 1.17

P

d = 1.17

P 80 MHz to 800 MHz

d = 2.33

P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which SpiroSoft is used exceeds the applicable RF compliance level above, SpiroSoft should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 2014847-001 Revision E

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Electromagnetic Compatibility (EMC)

Recommended separation distances between portable and mobile RF communication equipment and SpiroSoft SpiroSoft is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of SpiroSoft can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and SpiroSoft as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output

Separation Distance According to Frequency of Transmitter

Power of Transmitter [W]

[m] 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 P

d = 1.2 P

d = 2.3 P

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.334

10

3.7

3.7

7.37

100

11.7

11.7

23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all instances. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Electromagnetic Compatibility (EMC)

Compliant Cables and Accessories Warning The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system. The list below shows the accessories that have been tested and found EMC compliant for use with SpiroSoft. Note Any supplied accessories that would not affect electromagnetic compatibility (EMC) are not included.

2014846-002 SpiroSoft-PC connection cable, length 2m

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