GE Healthcare EasyOne-CS Service Manual

ndd Medizintechnik AG

Technoparkstrasse 1

CH-8005 Zürich, Schweiz

www.ndd.ch

EasyOne-CS

Field Service Manual

EasyOne-CS Spirometer

Manufactured for GE Medical Systems Information Technologies

2030434-006 Rev. D

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 1

Contents

1 Manual Purpose .............................................................................................................................. 2

2 Intended Audience .......................................................................................................................... 3

3 Introduction ................................................................................................................................... 3

4 Operation Principle ......................................................................................................................... 3

5 Technical Details ............................................................................................................................ 4

5.1 EasyOne-CS Spirometer Handheld Unit ........................................................................................... 4

5.2 Screen-Connector ........................................................................................................................... 5

5.3 Block Diagram ................................................................................................................................ 6

5.4 Printed Circuit board....................................................................................................................... 6

6 Specifications ................................................................................................................................. 7

6.1 EasyOne-CS Model 2001 Spirometer .............................................................................................. 7

6.2 EasyOne-CS Model 2010 Screen-Connector ................................................................................... 8

7 Replacement Parts List .................................................................................................................... 8

7.1 Manuals ......................................................................................................................................... 8

7.2 Accessories .................................................................................................................................... 9

7.3 Spare Parts .................................................................................................................................. 10

7.4 Exchange Unit .............................................................................................................................. 12

8 Checkout Procedure ...................................................................................................................... 12

9 Hidden Keys ................................................................................................................................. 13

10 Device Error Codes ........................................................................................................................ 14

11 EasyOne-CS Device Software Update .............................................................................................. 15

11.1 Introduction ................................................................................................................................. 15

11.2 Validated Upgrade Steps .............................................................................................................. 15

11.3 Preparation .................................................................................................................................. 15

11.4 Unpacking of Upgrade Package .................................................................................................... 15

11.5 Installation of EasyFlash PC Software ............................................................................................ 15

11.6 EasyOne-CS Device Software Update Procedure ............................................................................ 17

12 EasyWare PC Software Installation ................................................................................................. 18

13 EasyOne-CS Lithium Battery Replacement ...................................................................................... 20

13.1 Background .................................................................................................................................. 20

13.2 Environment ................................................................................................................................. 21

13.3 Preparation (save database) ......................................................................................................... 21

13.4 Battery exchange procedure ......................................................................................................... 22

13.5 Restart EasyOne-CS ...................................................................................................................... 23

13.6 Restore database ......................................................................................................................... 23

14 EasyOne-CS board with sensor and housing parts Replacement ....................................................... 23

14.1 Background .................................................................................................................................. 23

15 Appendix ...................................................................................................................................... 25

15.1 Schematic Diagrams ..................................................................................................................... 25

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 2

Version

Description

Datum

2030434-006 Rev. A

First Release

August 8, 2006

2030434-006 Rev. D

2030434-006 Rev. C

Chapter 7.1 with new content
Chapter 7.2 with V2.9.5
Chapter 9 with additional comment for 1-2-5
Chapter 11.2 with Windows 2000, XP or Vista
Chapter 11.3 update: added resource update
Chapter 8 updated and renamed as ‘Checkout Procedure’
Chapter 12 EasyWare PC Software Installation - new
This page with additional addresses

August 31, 2009

Octobre 27, 2009

2030434-006 Rev. D

Header info modified to “EasyOne-CS Field Service Manual”
Chapter 7.2 Accessories – CD pictures adapted to V2.9.5
Chapter 11 modified to document update FW v4.1 to v4.3

November 6, 2009

Document History

Europe:

ndd Medizintechnik AG
Technoparkstrasse 1, CH-8005 Zurich, Switzerland
Tel.: [phone]
Fax: [phone]
Web: www.ndd.ch

USA:

ndd Medical Technologies
Two Dundee Park
Andover, MA 01810
Tel: [phone]
Fax: [phone]
Web: www.nddmed.com

Asia - Please contact GE Healthcare:

Asia Headquarters
GE China Co., Ltd.
No1 Huatuo Road,
Zhangjiang Hi-Tech Park Pudong,
Shanghai, P.R.China 201203
Tel: [phone]
Fax: [phone]

Distributed by: GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue, Milwaukee, WI 53223 USA
Tel.: [phone]
[phone] (USA only)
Fax: [phone]

1 Manual Purpose

This manual supplies technical information for service representative and technical personnel so they
can maintain the equipment to the assembly level. Use it as a guide for maintenance and electrical
repairs considered field repairable. Where necessary the manual identifies additional sources of
relevant information and or technical assistance.

See the operator manual for the instructions necessary to operate the equipment safely in accordance
with its function and intended use.

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 3

2 Intended Audience

This manual is intended for the person who uses, maintains, or troubleshoots this equipment.

3 Introduction

The EasyOne-CS Spirometer uses digital ultrasonic flow measurement technology for fast, accurate,
reliable operation. The EasyOne-CS was designed for full range testing in primary care, specialty
physician, industrial and hospital settings. It offers automated comparison to predicted values, pre­and post Broncho Dilator comparisons, interpretation of results and test quality control that
automatically assesses patient effort offering helpful suggestions to obtain optimum results. Optional
easy to read and interpret color printout with graphic display for instant test review is available. The
single-patient-use spirette minimizes risk of cross-infection.

4 Operation Principle

This EasyOne-CS flow sensor is equipped with two ultrasonic transducers, mounted at different sides of
the flow channel. In order to determine gas flow (and molar mass), ultrasonic pulses are transmitted in
up- and downstream direction. Precisely measured transit-times are the basis for determining flow and
molar mass. The following figure shows a diagram of the flow sensor including its internal sound
transmission path.

Figure 1: Schematic of EasyOne-CS flow sensor

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 4

5 Technical Details

5.1 EasyOne-CS Spirometer Handheld Unit

The following pictures show the top, rear and bottom views of the EasyOne-CS.

Figure 2: Top view of EasyOne-CS

Figure 3: Rear view with empty battery compartment

The two screws on the back side are used to open EasyOne-CS. With the exception of the lithium
battery there are no serviceable parts inside the unit. Therefore do not open the unit!

Figure 4: Bottom view of EasyOne-CS

The bottom view shows the name plate, the serial number and the EasyOne-CS-to-Screen-Connector.

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 5

5.2 Screen-Connector

The following pictures show the top and bottom views of the EasyOne-CS Screen-Connector.

Figure 5: Screen-Connector top view

Figure 6: Screen-Connector bottom view

The Screen-Connector uses a standard USB connection to the PC.

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 6

Microcontroller

M16C62

Real Time

Clock (RTC)

Serial Data

Flash

Graphic LC

Display

Flow Sensor

ASIC

Power

Management

Buzzer

Keypad

ON/OFF

EZ1-BlockDiagram.sdr

Screen

Connector

PC (USB)

5.3 Block Diagram

The following picture shows the functional block diagram of the EasyOne-CS Spirometer.

5.4 Printed Circuit board

All electrical components of EasyOne-CS are mounted on a single PCB.

With the exception of the lithium battery no components can be serviced.

The following two pictures show a top and bottom view of the PCB.

Figure 7: Bottom view of EasyOne-CS PCB

The lithium battery located on the top right of the PCB has an approximate life time of 5 to 10 years. In
early revisions of the hardware the lithium battery is soldered on the board.

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 7

Size:

83 x 158 x 43 mm (3.3 x 6.2 x 1.7 inches)

Weight:

242 grams (8,6 ounces), with batteries

Measuring accuracy

Volume: ±2% or 0.050 l
Flow: ±2% or 0.020 l/s, (except PEF)
PEF: ±5% or 0.200 l/s
MVV: ±5% or 5 l/min.

Measuring range:

Volume: ±12 l
Flow: ±16 l/s

Resistance:

below 0.3 cm H2O/L/s

Display:

64 x 160 graphic display

Data entry:

14-key keyboard

Data memory:

For up to 700 tests, stored in EasyOne CS

Test modes:

FVC, FVL, Slow VC, MVV, Pre/Post

Parameters:

FVC, MVV, FEV6, FEV1, FEV1/FVC, FEV1/VC , FEV1/FEV6, MEF25 (FEF75),
MEF50 (FEF50), MEF75 (FEF25), MEF25%-75%, PEF, FET, FIVC, PIF, IVC, ERV,
IRV, pre-post % variation, Lung Age

Respiratory tube:

Disposable spirette respiratory tube

Measurement principle:

Ultrasound transit-time measurement

Adult predicted:

NHANES-III, Knudson_83, Knudson_76, Crapo, Morris, ERS (ECCS/EGKS),
Forche (Austria), Sapaldia (Switzerland), Roca (Spain), Berglund, Gulsvik,
Hedenström, Gore, Cherniak (only for MVV)

Pediatric predicted:

Dockery (Harvard), Hsu, Zapletal, Polgar, Hibbert

Power supply
Power consumption:

2 alkaline batteries, Type AA, 1.5V
Typical 0.6 W

Report:

A4

Storage:

Temperature: -20 to 50 °C
Relative humidity: 5% to95%
Ambient pressure: 500 to 1060 hPa

Figure 8: Top view of EasyOne-CS PCB (without EMI shielding)

6 Specifications

6.1 EasyOne-CS Model 2001 Spirometer

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 8

Operating conditions:

Temperature: 0 to 40 °C
Relative humidity: 0% to 95%
Ambient pressure: 500 to 1060 hPa

Certifications and standards:

CE Declaration of Conformity
C CSA US approval, CAN/CSA-C22.2 No. 601.1-M90, S1-94, CSA 601.1
Amendment 2:1998, UL Std No. 2601.1
FDA 510 (k) approval, K993921
EasyOne-CS meets or exceeds the published targets of the European
Respiratory Society (ERS), the American Thoracic Society (ATS) and the
National Lung Health Education Program (NLHEP).

Instrument classification:

Type BF applied part (when used with a PC, protection class 2

according to IEC 60601-1)

Instrument not suitable for use in flammable anesthetic gases in mixtures
with O2 or NO.

Life time:

7 years

Size:

64 x 44 x 25 mm (2.5 x 1.7 x 1.0 inches)

Weight:

82 grams (3 ounces)

Power supply:

From USB port

Power consumption:

Type 0.15W

Function:

Connects the EasyOne-CS spirometer to a PC

Interface:

Standard USB type A connector for connection to PC

Pins: 1 = VBus, 2 = D–, 3 = D+, 4 = GND

Storage:

Temperature: -20 to 50 °C
Relative humidity: 5% to 95%
Ambient pressure: 500 to 1060 hPa

Operating conditions:

Temperature: 0 to 40 °C
Relative humidity: 0% to 95%
Ambient pressure: 500 to 1060 hPa

PC:

The PC must comply with corresponding IEC standard (ex. IEC 60950-1. The
user is responsible that requirements of IEC 60601-1-1 for safety of medical
electrical systems are met.

Part Number
Short Description

Description

2030434-006 MNL SVCE EASYONE-CS

Field Service Manual (this document)

2030434-013

Operator’s Manual German

2030434-014

Operator’s Manual English

2030434-015

Operator’s Manual French

2030434-016

Operator’s Manual Italian

2030434-017

Operator’s Manual Spanish

2030434-018

Operator’s Manual Portuguese

2030434-019

Operator’s Manual Danish

2030434-020

Operator’s Manual Dutch

2030434-021

Operator’s Manual Chinese

2030434-023

Operator’s Manual English-US

6.2 EasyOne-CS Model 2010 Screen-Connector

7 Replacement Parts List

The following parts are available for replacement:

7.1 Manuals

2030434-006 Rev. D EasyOne-CS Field Service Manual Page 9

Part Number
Short Description

Description

2030431-003
CABLE EASYONE-CS - PC

Screen-Connector, connects EasyOne-CS with
the PC via USB connection

2030431-005
CD EASYWARE V2.9.5

CD with EasyWare V2.9.5 software

2030431-006
SPLY SPIRETTES #50

50 spirettes

2030431-007
SPLY SPIRETTES #200

200 spirettes

2030431-008
SPLY NOSECLIP #25

25 nose clips

7.2 Accessories