General Electric SPIROSOFT SVC MNL_SM_2014847-009_C UniCel DxC Synchron Access Clinical System Integrated Workstations For In Vitro Diagnostic Use

SpiroSoft

Service Manual

2014847-009 Revision C

NOTE: The information in this manual only applies to the SpiroSoft. Due to continuing product innovation, specifications in
this manual are subject to change without notice.

Caution:

During repairs/service interventions, observe the protective measures against damage due to ESD.

GE Medical Systems Information Technologies considers itself responsible for the effects on safety, reliability, and
performance of the equipment, only if:

- assembly operations, extensions, readjustments, modifications, or repairs are carried out by GE Medical Systems
Information Technologi or by persons authorized by GE Medical Systems Information Technologies,

- the electrical installation of the relevant room complies with the applicable national and local requirements, and

- the instrument is used in accordance with the instructions for use.
This manual contains service information; operating instructions are provided in the operator’s manual of the instrument.
This manual is in conformity with the instrument at printing date.
All rights are reserved for instruments, circuits, techniques, and names appearing in the manual.

CardioSoft, CardioSys and CASE are trademarks owned by GE Medical Systems Information Technologies, a General
Electric Company going to market as GE Healthcare. All other marks are owned by their respective owners.

© 2005 General Electric Company. All rights reserved.

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SpiroSoft: Contents

Contents

1 Block Diagram ............................................................................................................................3

2 Functional Description ................................................................................................................3

3 Names of Signals ........................................................................................................................3

4 Pin Connections ..........................................................................................................................4

5 Instrument Options ......................................................................................................................4

6 Instrument Version ......................................................................................................................4

7 Pictures ........................................................................................................................................4

7.1 Serial Number ....................................................................................................................4

8 Firmware Loading Procedure .....................................................................................................5

8.1 Standard Update .................................................................................................................5

8.2 Update of a Device Without Functioning Firmware .........................................................6

9 Diagnosis Codes / Error Codes ...................................................................................................7

10 Adjustment Instructions ..............................................................................................................8

10.1 Interior View ......................................................................................................................8

11 Jumper Table ...............................................................................................................................8

12 Technical Specifications .............................................................................................................9

13 Technical Inspections ..................................................................................................................9

14 Spare Parts ............................................ ....................................................................................10

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SpiroSoft: Revision History

Revision History

This manual is subject to the GE Medical Systems Information Technologies (GEMS IT) change order service. The revision
code, a letter that follows the document part number, changes with every update of the manual. The initial version of the man
ual has the letter A.

Table 1. Revision History

Part No./Revision Code Date Comment

2014847-009 A 2003-07 Initial version
2014847-009 B 2003-12 ECO 075536
2014847-009 C 2005-05 ECO 080514

-

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1 Block Diagram

SpiroSoft: Block Diagram

2 Functional Description

The SpiroSoft System consists of a 16-bit microcontroller with an integrated Flash program memory.
The peripheral components are a real-time clock backed up by GoldCap, which, when the device is turned off, retains the time

for a minimum of 5 days, an EEPROM which stores the data of the pressure sensor used and the SpiroSoft settings, as well as
a Flash memory which stores the texts, the bitmaps and the database.

SpiroSoft has a reset generator which resets SpiroSoft, if the voltage drops below the 2.5-Volt threshold. The voltage is supplied
from a 3.0 Volt low-dropout regulator; a 6.1-Volt Transil diode provides transient overvoltage and reverse polarity protection.

A piezoresistive pressure sensor sampled by a serial 16-bit A/D converter with integrated measuring bridge determines the mea­suring value by acquiring the pressure drop across the PT.

3 Names of Signals

none

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SpiroSoft: Pin Connections

4 Pin Connections

Both the communication and the voltage supply take place via the 6-pin connector of SpiroSoft.
The pin assignment is as follows.

6 5 4 3 2 1

1 VCC supply (3.6 Volt to 5 Volt)
2 RXD V24 data line
3 TXD V24 data line
4 GND ground
5 IO/1 IO line TTL
6 IO/2 IO line TTL

5 Instrument Options

None

6 Instrument Version

The current hardware is version HW1.0.
The current software is version FW1.0.1.

7Pictures

7.1 Serial Number

The serial number of the device is located under the lid of the battery compartment.

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SpiroSoft: Firmware Loading Procedure

8 Firmware Loading Procedure

8.1 Standard Update

The firmware updated is supplied in the form of a zipped file named “SW FIRMWARE SPIROSOFT FW102.zip” (2014848-

002).
To begin with, unpack the zipped file.
Connect SpiroSoft to the PC, using the connection cable.
Then start the update procedure with the program SW FIRMWARE SPIROSOFT FW102.exe.

Select the COM port where SpiroSoft is connected and click the Start button to initiate the update.
If the firmware version of the SpiroSoft is newer than the update version, the following window appears.

Pressing “OK” starts the update, pressing “Abbrechen” stopps the update.
The update procedure is fully automatic, no further user interventions are required.

ATTENTION!!!

During the update, do not disconnect SpiroSoft
from the PC and do not shut down the PC.

During the update, the following message appears on the display of SpiroSoft: “Download Microcontroller Program”.
After the update, you will see the message “Download OK! Please remove the PS/2 conector for at least

3 Seconds”.

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SpiroSoft: Firmware Loading Procedure

Press “OK” and click “End” to terminate the update program.
Remove the PS/2 connector for at least 3 seconds
Then reconnect: SpiroSoft will start up with the new firmware version.

8.2 Update of a Device Without Functioning Firmware

If SpiroSoft has been disconnected from the PC while an update was in progress or the update has been interrupted for one rea­son or another, the SpiroSoft memory may be without a functioning firmware.

In this case, a bridge has to be closed inside SpiroSoft to allow SpiroSoft to start up in the firmware update mode.
For this purpose, disconnect the PS/2 connector of SpiroSoft from the PC.

Then take off the lid from the battery compartment and open SpiroSoft by removing the four screws.

Next, remove the enclosure and connect the two contacts to the left of the Western connector (marking), using a metal object
(tweezers, or similar object).

Then reconnect the PS/2 connector to the PC and start the update procedure by starting the program SW FIRMWARE
SPIROSOFT FW102.exe

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SpiroSoft: Diagnosis Codes / Error Codes

Select the COM port where SpiroSoft is connected, select the “ROM Update” option and click the Start button to initiate the
update.
The update procedure is fully automatic, no further user interventions are required.

After the update, you will see the message “Download OK! Please remove the PS/2 conector for at least 3 Seconds”.
Press “OK” and click “End” to terminate the update program.
Remove the PS/2 connector for at least 3 seconds.

Then reconnect: SpiroSoft will start up with the new firmware version.

9 Diagnosis Codes / Error Codes

The following diagnosis/error codes can be displayed on the PC (CardioSoft).

Message Cause

Error in spirometer setup!
Please check the settings!

Zeroing of the spirometer was not
successful, probably you inhaled
prematurely.
Please repeat the test!

Data obtained cannot be analyzed.
Please repeat the test!

The ambient conditions entered are incorrect; therefore the correction
factor is out of range.

The system could not be zeroed before a measurement.
This may be due to one of the following reasons

– The patient breathed into the sensor while the system was zeroed.
– The tubing to the pressure transducer was squeezed between the

parts of the enclosure after a repair.

The test was aborted; therefore the system is unable to find data that can
be analyzed.

In forced tests, this will be the case when no expiration with a volume
greater than 100 ml has been found.

In slow spirometry tests, this will be the case when
– less than 5 respiratory cycles have been recorded

– the max. VC is found in the first 5 respiratory cycles (before the

beep)
– the measured VC is less than 0.5 l
– the maneuver took less than 8 seconds.

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Other possible problems:

Problem Cause

SpiroSoft: Adjustment Instructions

No information displayed on
SpiroSoft

No values are displayed during the
measurement, or the displayed values
are only inspiratory or only
expiratory values.

SpiroSoft does not respond – If SpiroSoft does not respond any more, disconnect the PS/2 cable

– PC not turned on­– SpiroSoft not correctly connected to the PC
– No functioning firmware in SpiroSoft (see 8.2)

– The PT is not properly locked in SpiroSoft
– The silicone tubing to the pressure transducer was squeezed between

the parts of the enclosure after a repair
– The seals of the tubing inside SpiroSoft are damaged.

of SpiroSoft from the PC for about 3 seconds. Afterwards, SpiroSoft

will restart the firmware.

10 Adjustment Instructions

SpiroSoft does not contain components that require maintenance or can be repaired.
Defective devices should be returned to GEMS IT Repair Center for repair.

10.1 Interior View

11 Jumper Table

None

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SpiroSoft: Technical Specifications

12 Technical Specifications

Dimensions: 150 x 94 x 40 mm (h x w x d)
Weight: 150 g
Operating voltage: 3.0 V to 5.0 V
Power consumption: 60 mA max.
Measuring principle: JAEGER “High-Quality” pneumotach
Interface: serial (RS 232)
Measuring range:

PEF 0.1 to 16 l/s
FEV1 and FVC 0.1 … 8 l

Resolution:

PEF 5 ml/s
FEV1 and FVC 1 ml

Accuracy:

PEF +/-3 % / 0.4 l/s
FEV1 and FVC +/-3 % / 0.05 l

Resistance: 2 kPa max. at 15 l/s
Environment:

Operation

temperature +10 to +40 °C
humidity 10 to 90 %, no condensation
atmospheric pressure 600 to 1200 hPa

Transport and Storage

temperature -20 to +50 °C
humidity 10 to 95 %, no condensation
atmospheric pressure 500 to 1200 hPa

Medical device: CE0123

13 Technical Inspections

None

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SpiroSoft: Spare Parts

14 Spare Parts

The following spare parts and accessories can be ordered for SpiroSoft.

Item Description Item Number

SPARE SPIROSOFT BATTERY COVER 2014846-009
CABLE SPIROSOFT - PC 2014846-002
SPLY PNEUMATACH W MOUTHPIECE #10 2014846-003
SPLY NOSECLIP #25 2014846-008
SPLY MOUTHPIECE #25 2014846-006
SPLY PAD FOR NOSECLIP #100 2014846-007
MNL OPR SPIROSOFT 2014847-001
RCDR SPIROSOFT 2014846-001
RCDR SPIROSOFT EXCHANGE 2014846-010
PACKAGING BOX SPIROSOFT 2014846-005

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gemedical.com

0123

World Headquarters
GE Medical Systems
Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223 USA

Tel. [phone]

1 800 558 5120 (US only)

Fax [phone]

European Representative
GE Medical Systems
Information Technologies GmbH
Munzinger Straße 3
D-79111 Freiburg
Germany
Tel. [phone] - 0
Fax [phone] - 233

Asia Headquarters
GE Medical Systems

Information Technologies Asia;

24th Floor Shanghai MAXDO Centre,
8 Xing Yi Road, Hong Qiao Development Zone
Shanghai 200336, P.R. China
Tel: [phone]
Fax: [phone]

GE (China)Co., Ltd.

2019524-001 Rev B