NDD EasyOne-CS Quick start guide

EasyOne-CS
Field Service Manual
EasyOne-CS Spirometer
Manufactured for GE Medical Systems Information Technologies
ndd Medizintechnik AG
Technoparkstrasse 1
CH-8005 Zürich, Schweiz
www.ndd.ch
2030434-006 Rev. E

2030434-006 Rev. E EasyOne-CS Field Service Manual Page 1
Contents
1Manual Purpose..............................................................................................................................3
2Intended Audience .......................................................................................................................... 3
3Introduction ...................................................................................................................................3
4Operation Principle .........................................................................................................................3
5Technical 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
6Specifications.................................................................................................................................7
6.1 EasyOne-CS Model 2001 Spirometer ..............................................................................................7
6.2 EasyOne-CS Model 2010 Screen-Connector ...................................................................................8
7Replacement Parts List....................................................................................................................8
7.1 Manuals.........................................................................................................................................8
7.2 Accessories....................................................................................................................................9
7.3 Spare Parts ..................................................................................................................................11
7.4 Exchange Unit ..............................................................................................................................12
8Checkout Procedure ...................................................................................................................... 13
9Hidden Keys ................................................................................................................................. 14
10 Device Error Codes ........................................................................................................................15
11 EasyOne-CS Device Software Update .............................................................................................. 16
11.1 Introduction .................................................................................................................................16
11.2 Validated Upgrade Steps ..............................................................................................................16
11.3 Preparation ..................................................................................................................................16
11.4 Unpacking of Upgrade Package ....................................................................................................16
11.5 Installation of EasyFlash PC Software............................................................................................16
11.6 EasyOne-CS Device Software Update Procedure............................................................................18
12 EasyWare PC Software Installation................................................................................................. 19
13 EasyOne-CS Lithium Battery Replacement ...................................................................................... 21
13.1 Background..................................................................................................................................21
13.2 Environment.................................................................................................................................22
13.3 Preparation (save database).........................................................................................................22
13.4 Battery exchange procedure .........................................................................................................23
13.5 Restart EasyOne-CS ......................................................................................................................24
13.6 Restore database .........................................................................................................................24
14 EasyOne-CS board with sensor and housing parts Replacement.......................................................24
14.1 Background..................................................................................................................................24
15 Appendix...................................................................................................................................... 26
15.1 Schematic Diagrams.....................................................................................................................26
15.2 WEEE Selective Treatment ............................................................................................................33

2030434-006 Rev. E EasyOne-CS Field Service Manual Page 2
Document History
Version
Description
Datum
2030434-006 Rev. A
First Release
August 8, 2006
2030434-006 Rev. B
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
2030434-006 Rev. E
Telephone number (US) changed
Chapter 7.1: Chinese manual is no longer available
New chapter 15.2 WEEE Selective Treatment
April 1, 2014
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)
[phone] (Canada only)
Fax: [phone]

2030434-006 Rev. E EasyOne-CS Field Service Manual Page 3
1Manual 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.
2Intended Audience
This manual is intended for the person who uses, maintains, or troubleshoots this equipment.
3Introduction
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, pre-
and 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.
4Operation 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

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5Technical 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. E 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.

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5.3 Block Diagram
The following picture shows the functional block diagram of the EasyOne-CS Spirometer.
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)
5.4 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. E EasyOne-CS Field Service Manual Page 7
Figure 8: Top view of EasyOne-CS PCB (without EMI shielding)
6Specifications
6.1 EasyOne-CS Model 2001 Spirometer
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

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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 O2or NO.
Life time:
7 years
6.2 EasyOne-CS Model 2010 Screen-Connector
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.
7Replacement Parts List
The following parts are available for replacement:
7.1 Manuals
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
2030434-023
Operator’s Manual English-US

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7.2 Accessories
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

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Part Number
Short Description
Description
2030431-008
SPLY NOSECLIP #25
25 nose clips
2030431-009
SPLY PAD FOR NOSECLIP #100
100 pads for noseclips
2030431-010
SPLY CALIBRATION SYRINGE EASYONE-CS
Calibration syringe

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7.3 Spare Parts
Part Number
Short Description
Description
2033231-001
SPARE EASYONE-CS FRONTHALF
Case front half
2033231-002
SPARE EASYONE-CS REARHALF
Case rear half
2033231-003
SPARE EASYONE-CS BATTERY DOOR
Battery door
2033231-004
SPARE EASYONE-CS KEYPAD
Keypad

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Part Number
Short Description
Description
2033231-005
SPARE EASYONE-CS SCREW SET
Screw set, consisting of:
-#1 Spring lock ring 12mm
-#2 Torx screw K30x6, WN1452
-#2 Washer
-#2 Allen screw M3x25
-#2 Hook-sleeve 5.6x6.5
2033231-006
SPARE EASYONE-CS BOARD WITH SENSOR
-PCB board with sensor and
programmed serial number
-Serial number label (Silver label)
2033231-007
SPARE EASYONE-CS LITHIUM BATTERY
BR1225 Lithium battery coin
7.4 Exchange Unit
Part Number
Short Description
Description
2030431-002
RCDR EASYONE-CS
EasyOne-CS unit for exchange

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8Checkout Procedure
After repair or maintenance of the EasyOne-CS the following procedure is recommended in order to
check correct operations of EasyOne-CS:
Optional step: If all data in EasyOne-CS must be deleted, perform the ‘hidden key’ sequence 1-
2-5 described in the following chapter in order to perform a factory reset. Please be aware that
this step clears all customer data and resets the device to factory default settings.
Get a calibration adapter and a calibration syringe (2030431-010)
Ensure that the correct syringe volume is entered in the instrument’s configuration setting.
Choose item “Check calibration” in the main menu of EasyOne.
Connect the spirometer as shown below using the calibration adapter and the syringe. Ensure
that the piston is fully inserted and at the stop position.
Now press ENTER.
Wait until the baseline has been set and you hear an audible signal.
Now execute one full inspiratory pump stroke followed by one full expiratory pump stroke at
moderate speed.
After you perform the maneuver, you will see the text "Accuracy confirmed" at the top of the
display and, beneath it, the percentage deviation and the average flow velocity of the pump
stroke.
If desired, make a printout of the calibration report.

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9Hidden Keys
The “hidden key” sequences access special features that are not available in the standard menu
structure of EasyOne-CS. The following table shows what key sequences are available. The column
labeled ‘Location’ indicates in what menu / screen the described key sequence has to be used.
Caution: The key sequences should not be used in conjunction with patient testing.
Location
Key
sequence
Description
Main Menu
1-3-5
Factory defaults (same as in Configuration Menu).
Device self test error
screen
1-3-5
Ignore error and go on. Use only for troubleshooting! Do not
perform a patient test, because the results could be errorneous
Device info screen (from
Configuration Menu).
1-2-4
Show additional device information.
Device info screen
1-2-5
Hard factory reset (configuration settings are reset and database is
deleted (In case of synchronisation with EasyWare, please do not
forget to synchronize EasyOne with new database.)
Device info screen
1-2-6
FVC filter disable temporarily (until next power cycle).
Device info screen
1-2-7
Switch off BTPS correction temporarily (until next power cycle).
Device info screen
1-2-8
Switch off flow linearity correction temporarily (until next power
cycle).
Device info screen
1-3-9
Restore corrupt database: Caution use only for inconsistent
databases

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10 Device Error Codes
Internal errors are reported using the following screen:
ERROR
Device Selftest
Failure #xx
Please contact
service
The number xx indicates the type of error that is detected. The following list shows all error numbers
and a description of the internal error.
No.
Description
1
internal software error (wrong argument)
2
internal software error (unsupported)
3
internal software error (timeout)
4
internal software error (data inconsistent)
5
internal software error (write error)
6
internal software error (read error)
7
internal software error (not found error)
13
internal software error (WD timeout)
14
the ultrasonic receive amplitude is too low (check spirette insertion)
15
the ultrasonic receive amplitude is too high (check spirette insertion)
16
Bootloader software inconsistent (CRC failure)
17
User software inconsistent (CRC failure). Update EasyOne-CS device software.
18
Calibration data inconsistent.
19
Failure of flash memory.
20
Flow sensor transit time range check error. Possible reasons: a) Blocked sound path, e.g. caused by
wrongly inserted spirette, b) almost empty batteries.
21
ndd ASIC serial transmission error (STX expected)
22
ndd ASIC serial transmission error (sequence error)
23
ndd ASIC serial transmission error (unknown character)
24
Real time clock RAM error
25
Configuration data inconsistent (lithium battery failure possible)
49
internal software error (overrun error)
50
internal software error (timeout error)
51
internal software error (storage error)
52
internal software error (record structure error)
53
internal software error (address error)
54
Serial data flash or serial communication data inconsistent (CRC failure)
55
internal software error. Writing to the internal Flash failed (flash command sequence error)
56
internal software error. Erasing the internal Flash failed (flash block erase error)
57
internal software error. Writing to the internal Flash failed (flash program error)
65
internal software error. Writing to the internal Flash failed (flash block program error)
66
internal software error. Accessing the internal Flash failed (flash busy)
67
First record of database reached. Go beyond this record failed (FIRST_RECORD)
68
Last record of database reached. Go beyond this record failed (LAST_RECORD)
69
No valid record in the database found (NO_VALID_RECORD)
70
internal software error (UNKNOWN_ERROR)
144
Sensor serial communication error

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11 EasyOne-CS Device Software Update
11.1 Introduction
The internal software of EasyOne-CS is stored in a Flash EPROM. It is therefore possible to update the
internal software. The following procedure describes how this update is executed.
11.2 Validated Upgrade Steps
The following upgrade steps are validated:
Old Version
New Version
Item Number
EasyOne-CS device software
CRC
V04.01.00.00
V04.03.00.00
2033231-008
GE-EOV04030000-P-EU_Resources.hex
with EU language package
0xF3D7
11.3 Preparation
The following items are required:
2033231-008.zip (upgrade package with EasyFlash and EasyOne-CS device software V4.3)
ndd Screen-Connector cable 2030431-003.
PC program EasyFlash, V2.4.12 or higher.
EasyOne-CS device software for the download (*.hex).
PC with Windows 2000, XP or Vista (all 32 Bit).
The following installation description presumes that you have basic knowledge of your PC operating
system.
11.4 Unpacking of Upgrade Package
After getting upgrade package 2033231-008.zip the zip archive can be extracted to a folder of your
choice, e.g. to C:\nddmed\2033231-008.
11.5 Installation of EasyFlash PC Software
The PC software EasyFlash is needed to update EasyOne-CS device software:
1. Start “C:\nddmed\2033231-008\EasyFlash\Setup.exe” to install the EasyFlash software.

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2. Click “Next >”
3. Select target installation folder if you prefer another one. Click “Next >”.
4. Click “Next >”
5. The EasyFlash software is now installed on your PC. Click “Close” to terminate the setup
program.
6. To start EasyFlash you find an appropriate short cut in the start menu of your PC.

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11.6 EasyOne-CS Device Software Update Procedure
In order to update the EasyOne-CS device software follow this procedure:
1. Connect the EasyOne-CS Screen-Connector with an unused USB port of your PC.
2. Turn the power of EasyOne-CS on and connect it with the ScreenConnector. The EasyOne-CS
display shows: „EasyOne“.
3. Start the PC software “EasyFlash”.
4. Set “Device Selection” to “EasyOne” and communication port to “Screen Connector”.
5. Press the “Update Device Info”button. The window on the right side shows the Model and the
version information of the EasyOne-CS.
6. The device software can be selected through selecting the “Open”icon or with menu command
“File/Open”C:\nddmed\2033231-008\ EasyOne-CS V4.3 Firmware EU\GE-EOV04030000-P-
EU_Resources.hex”).
7. The programming is started by pressing the “Download” button. You are requested to enter
your company and user name.
8. Under certain circumstances the following message can appear.
In order to procede perform the following steps.
a. Click “OK”.
b. Disconnect EasyOne-CS from the ScreenConnector. The display of EasyOne-CS shows
“Receive Idle mode, Setting 19200 Baud”.
c. Reconnect EasyOne-CS with the ScreenConnector
d. Click “Update Device Info” and press the “Download” button again.
9. During the programming of EasyOne-CS a progress bar is shown. The programming takes
approx. 3 to 5 minutes. Please do not interrupt the programming process. After successful
programming the following message is shown:
10. The EasyOne-CS device has to be restarted using the ON/OFF key.