Operators Manual
164 Pages
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SpiroSoft®
2014847-001 Revision C
SpiroSoft ® Firmware Version 1.0
Operator's Manual 2014847-001 ENG
Revision C
0123
2
SpiroSoft®
2014847-001 Revision C
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
13
6 Technical Specifications
14
7 Order Information
14
Revision History This manual is subject to the change order service of GE Medical Systems Information Technologies. The revision code, a letter that follows the document part number, changes with every update of the manual. P/N / Revision
Date
Comment
2014847-001 Revision A
March 2003
Initial Release
2014847-001 Revision B
December 2003
ECO 075 536
2014847-001 Revision C
August 2004
ECO 077 018
2014847-001 Revision C
SpiroSoft®
3
General Information
y This manual reflects the equipment specifications and
General Information
applicable safety standards valid at the time of
y The product SpiroSoft® bears the CE marking CE-
printing. All rights are reserved for devices, circuits,
0123 (notified body TÜV Product Services GmbH
techniques, software programs, and names appearing
Bayern) indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of
in this manual. y On request GE Medical Systems Information Technologies will provide a detailed Service Manual.
Annex I of this directive. It is an MDD class IIa
y The GE Medical Systems Information Technologies
product.
quality management system complies with the
y The applied part of the device is a type BF
standards DIN EN ISO 9001 and EN 46001.
component. y The device fulfills the requirements of standard EN
y The safety information given in this manual is classified as follows:
60601-1 "Medical Electrical Equipment, Part 1: General Requirements for Safety" as well as the
Danger
interference protection requirements of standard EN 60601-1-2 "Electromagnetic Compatibility – Medical
indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.
Electrical Devices". y The device is in radio-interference protection class B
Warning
in accordance with CISPR11/EN 55011. y
indicates a hazard. If not avoided, the hazard can The device is classified by ITS/ETL and thus
result in death or serious injury.
fulfills the CSA and UL safety requirements. y The CE marking covers only the accessories listed in the "Order Information" chapter.
Caution indicates a potential hazard. If not avoided, this
y The information given in this manual reflects
hazard may result in minor personal injury or product/property damage.
firmware version 1.0. y This manual is an integral part of the equipment. It should be available to the equipment operator at all
y To ensure patient safety and interference-free
times. Close observance of the information given in
operation and to guarantee the specified measuring
the manual is a prerequisite for proper equipment
accuracy, we recommend using only original GE
performance and correct operation and ensures
Medical Systems Information Technologies
patient and operator safety. Please note that
accessories. The user is responsible for using
information pertinent to several chapters is given
accessories from other manufacturers.
only once. Therefore, carefully read the manual once in its entirety. y The symbol
means: Consult accompanying
documents. It indicates points which are of particular importance in the operation of the equipment.
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SpiroSoft®
2014847-001 Revision C
General Information
y The warranty does not cover damage resulting from the use of unsuitable accessories and consumables from other manufacturers. y GE Medical Systems Information Technologies is responsible for the effects on safety, reliability, and performance of the device, only if – assembly operations, extensions, readjustments, modifications, or repairs are carried out by GE Medical Systems Information Technologies or by persons authorized by GE Medical Systems Information Technologies, – the device is used in accordance with the instructions given in this manual. Manufacturer: VIASYS Healthcare GmbH Leibnizstraße 7 D-97204 Höchberg, Germany 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 authorized representative for GE Medical Systems Information Technologies Inc. in Europe is: GE Medical Systems Information Technologies GmbH Munzinger Str. 3 D-79111 Freiburg, Germany Tel:+49.761.45.43.0 Fax: +49.761.45.43.233 The country of manufacture appears on the device label. © 2003 - 2004 General Electric Company. All rights reserved
2014847-001 Revision C
SpiroSoft®
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Introduction to SpiroSoft®, Safety Information
1
Introduction to SpiroSoft®, Safety Information
1.1 Application
Measuring Principle
Intended Use
The patient breathes through a reference screen (2, Figure
SpiroSoft® is a respiration flow transducer which, in
1-2) with a known resistance to air flow. In parallel with
conjunction with CASE®
the reference screen, the differential pressure which
®
®
/ CardioSys / CardioSoft
allows flow-volume loops and parameters to be recorded
varies with the respiratory flow is measured. A pressure
and analyzed.
transducer (3, Figure 1-2) converts the differential pressure into an electrical analog signal which, in turn, is
The pneumotach which is easy to replace ensures the
evaluated by the analyzer module (4, Figure 1-2) in
highest level of patient protection and provides accurate
SpiroSoft®.
results. 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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2014847-001 Revision C
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
– Before cleaning, disconnect SpiroSoft® from CASE®, CardioSys® or from the PC.
an explosion hazard may occur. Explosion hazards may result from the use of flammable
– Dispose of the packaging material, observing
anesthetics, skin cleansing agents and
the applicable waste-control regulations. Keep
disinfectants.
the packaging material out of children's reach. Incorrect measurements, risk of infection - Warning
– The pneumotach is designed for single use. Use
Risk to persons -
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.
– If SpiroSoft is connected to a PC with CardioSoft , this PC must meet the requirements of the standard IEC 60950. – During the lung-function tests, the PC must be located outside the patient environment (1.5 m). – For connection of CardioSys® or the PC to a
Caution Incorrect measurements - – Magnetic and electrical fields are capable of
network, a transceiver to IEC 60601-1 or 60601-
interfering with the proper performance of the
1-1 must be provided.
equipment. For this reason make sure that
– Equipment may be connected to other
external equipment operated in the vicinity
equipment or to parts of systems only when it
complies with the relevant EMC requirements.
has been made certain that there is no danger to
X-ray equipment, MRI devices, radio systems
the patient, the operators, or the environment as
etc. are a possible source of interference as they
a result. In those instances where there is any
may emit higher levels of electromagnetic
element of doubt concerning the safety of
radiation.
connected equipment, the user must contact the
– Only the use of accessories approved by GE
manufacturers concerned or other informed
Medical Systems Information Technologies is
experts as to whether there is any possible
permitted. The user is responsible for using
danger to the patient, the operator, or the
accessories from other manufacturers.
environment as a result of the proposed combination of equipment. Compliance with the
– The operator must be trained in the use of the equipment.
standard IEC 60601-1-1 must always be
– Before using the equipment, the operator must
ensured.
ascertain that it is in correct working order and
– Chemicals required for the maintenance of the
operating condition. Do not use the equipment if
equipment, for instance, must under all
you detect a defective connection cable or
circumstances be stored, prepared, and kept at
damaged housing.
hand in their specific containers. Failure to
– Close the battery compartment before using the
observe this instruction may have severe
equipment.
consequences for the patient or operator. – Liquids must not enter the equipment. Equipment into which liquids have entered must be inspected by a service technician before use.
2014847-001 Revision C
SpiroSoft®
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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 (notify Service).
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2014847-001 Revision C
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 Caution, consult accompanying documents
Type BF applied part
Figure 2-1 SpiroSoft® controls and indicators
2014847-001 Revision C
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In Service
3
In Service
Connection
Functional Test
SpiroSoft® is powered from CASE®, CardioSys® or
After power-up, SpiroSoft® runs a self-test. If a problem
from the PC; batteries are not needed.
is identified in the course of the self-test, the message
Connect SpiroSoft® to CASE®, CardioSys® or to the PC,
"ERROR x" appears on the display. One of the error
using the supplied connection cable (see Figure 3-1).
codes 1 to 4 will appear instead of the "x".
Switch off CASE®, CardioSys® or the PC before
– 1
Flash
connecting the sensor.
– 2
RAM
y Connect SpiroSoft® to plug 1 (connector 4, Figure 2-
– 3
EEPROM
– 4
Pressure system
1).
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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2014847-001 Revision C
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.
2014847-001 Revision C
SpiroSoft®
11
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.
y Push the tab upwards. Figure 4-1 Locking tab
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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SpiroSoft®
2014847-001 Revision C
Cleaning, Maintenance
5
Cleaning, Maintenance
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®, CardioSys® or from the PC before
If you detect damages or impaired functions which may
cleaning.
result in a hazard to the patient or the operator, the device must be repaired before it can be used again.
y Wipe the device clean with a moist cloth, then dry it
Technical Safety Inspections
with a cotton cloth. Do not let liquid enter the device. For safety, the equipment requires regular maintenance.
y For disinfection of the device surface, use a 1.5 % 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
To ensure functional and operational safety of SpiroSoft®, Technical Safety Inspections should be carried out on an annual basis.
have been tested, a 3 % solution is needed and the
These checks should be performed by persons with
solution should take effect for 60 minutes.
adequate training and experience. The checks can be carried out by GE Medical Systems
Caution
Information Technologies within the framework of a
Risk to persons, equipment damage - Do not fail
service agreement. Contact GE Medical Systems
to observe the manufacturer's safety information.
Information Technologies Service for details.
Do not let disinfectant enter the device. Equipment The nature and scope of these checks are explained in the
into which liquids have entered must be inspected
corresponding sections of the Service Manual.
by a service technician before use. Also prevent electrical connectors from coming in contact with
The device does not require any other maintenance.
the solution. y Descogen® is biodegradable, therefore it can be
Caution
disposed of by pouring it down the sink!
Disposal of the product - At the end of their
y Clean the nose clip after each patient and attach new
service life, the device described in this manual and
foam pads. If necessary, disinfect the nose clip with a
its accessories must be disposed of in compliance
1.5-% solution of Descogen®.
with the applicable local waste control regulations. If you have questions in this matter, please contact GE Medical Systems Information Technologies or a representative.
2014847-001 Revision C
SpiroSoft®
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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
piece (10 units)
Resolution
< 5 ml
y Nose clip (2 units)
– PEF
5 ml/s
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 Resistance
max. 2 kPa at 15 l/s
Parameters
see CASE®, CardioSys®,
Operator Manual Accessories
CardioSoft® Operator Manuals
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
2014846-008 Nose clip (25 units)
– atmospheric pressure between 600 and 1200 hPa
2014846-002 SpiroSoft® - PC connection cable
Transport and Storage – 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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SpiroSoft®
2014847-001 Revision C
2
SpiroSoft®
2014847-001 Révision C
2
SpiroSoft®
2014847-001 Revision C
SpiroSoft ® 固件版本 1.0
操作手册 2014847-001 CHS
C版
0123
2
SpiroSoft®
2014847-001 C 版
2
SpiroSoft®
2014847-001 改訂 C