EasyOne Pro Field Service Manual June 2009

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EasyOne Pro Field Service Manual

Contents 1

MANUAL PURPOSE ... 3

2 3

INTENDED AUDIENCE ... 3 INTRODUCTION ... 3

4

OPERATION PRINCIPLE... 4 4.1 4.2 4.3 4.4 4.5

5

FLOW MEASUREMENT ... 4 HELIUM MEASUREMENT... 4 CO MEASUREMENT ... 4 ENVIRONMENT PRESSURE AND HUMIDITY MEASUREMENT ... 4 DATA PROCESSING SYSTEM ... 4

TECHNICAL DETAILS OF COMPONENTS... 5 5.1 EASYONE PRO MECHANICS AND DESIGN ... 6 51..1 Main Unit Housing Plastic Parts...6 51..2 Main Unit Housing Metal Parts ...6 51..3 DLCO Valve Unit with Motor Bloc...6 5.2 EASYONE PRO SENSORS ... 6 52..1 EasyOne Pro Flow Sensor (spiroson-AS) ...6 52..2 Side Stream Molar Mass Sensor (spiroson-AS) ...7 52..3 CO Sensor...7 52..4 Ambient Temp. and Humidity Sensor...7 5.3 EASYONE PRO EMBEDDED PC AND ACCESSORIES ... 7 53..1 PC ...7 53..2 Hard Disk Drive ...8 53..3 Flash Memory Drive ...8 53..4 TFT Screen with Touch Panel ...8 5.4 EASYONE PRO PNEUMATICS ... 8 54..1 Gas Input ...8 54..2 Pneumatic Bloc ...8 54..3 Demand Valve ...8 54..4 DLCO Hose ...8 54..5 Filter Pack ...9 5.5 EASY ONE PRO SOFTWARE (INTERNAL NAME: EASYWARE PRO)... 9 5.6 BLOCK DIAGRAMS ... 9 56..1 Block Diagram spiroson-x2 board...9 56..2 Block Diagram spiroson AS for EasyOne Pro ...10 56..3 Block Diagram spiroson AS Motor Driver for EasyOne Pro...10 56..4 Block Diagram Embedded PC ...11 56..5 Block Diagram TFT Screen ...11 5.7 PRINTED CIRCUIT BOARDS ... 11 57..1 EasyOne Pro Flow Sensor Electronics Main board...11 57..2 EasyOne Pro Flow Sensor Electronics Motor Driver Board ...12 57..3 EasyOne Pro Power Supply Unit...12 57..4 EasyOne Pro spiroson x2 Board...13 57..5 Embedded PC Board...13

6 7

SPECIFICATIONS... 15 REPLACEMENT PARTS LIST ... 17 7.1 EASYONE PRO MANUAL ... 17 DOWNLOAD CURRENT VERSION FROM NDD WEBSITE ... 17 7.2 ACCESSORIES ... 17 7.3 SERVICE PARTS ... 18

8

SERVICE PROCEDURES ... 20

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8.1 CALIBRATION CHECK ... 27 81..1 EasyOne Pro Flow Sensor...27 81..2 EasyOne Pro DLCO System ...27 8.2 TOUCH SCREEN CALIBRATION ... 27 8.3 EASYONE PRO FLOW SENSOR FIRMWARE UPDATE ... 27 83..1 Preparation ...27 83..2 Firmware Update Procedure ...28 8.4 EASYONE PRO MOLAR MASS SENSOR FIRMWARE UPDATE ... 29 84..1 Preparation ...29 84..2 Firmware Update Procedure ...29 84..3 EasyFlash: Firmware Update Procedure ...29 8.5 EASYONE PRO SPIROSON-X2 FIRMWARE UPDATE ... 29 85..1 Preparation ...29 85..2 Firmware Update Procedure ...29 85..3 EasyFlash: Firmware Update Procedure ...30

9

OPENING UND CLOSING PROCEDURE ... 32

10 11

DEVICE ERROR CODES... 39 APPENDIX ... 40

11.1 SCHEMATIC DIAGRAMS... 40 111..1 Spiroson-AS...40 111..2 Spiroson-X2...43

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EasyOne Pro Field Service Manual

Address: Manufacturer of the EasyOne Pro: ndd Medizintechnik AG Technoparkstrasse 1, CH-8005 Zürich Tel.: +41 44 445 29 70 Fax: +41 44 445 25 31 Web: www.ndd.ch

1 Manual Purpose This manual supplies technical information for service representative and technical personnel so they can maintain the equipment to the assembly level. See the operator manual for the instructions necessary to operate the equipment safely in accordance with its function and intended use.

2 Intended Audience This manual is intended for ndd authorized service personnel that uses, maintains, or troubleshoots this equipment.

3 Introduction The EasyOne Pro uses digital ultrasonic flow measurement technology for fast, accurate, reliable operation. The EasyOne Pro was designed for full range lung function 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 and barriette minimize the risk of cross-infection.

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4 Operation Principle 4.1

Flow Measurement

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

Figure 1: Schematic of EasyOne Pro flow sensor

4.2

Helium Measurement

The same sensor electronics in a different transducer setup is used for the molar mass determination of the gas sample. By measuring the molar mass the helium concentration of the gas can be calculated. 4.3

CO Measurement

A CO sensor based on NDIR technology is implemented in the EasyOne Pro for the CO measurement of the gas sample. 4.4

Environment Pressure and Humidity Measurement

EasyOne Pro has an integrated environment pressure and humidity sensor. 4.5

Data Processing System

An interface board synchronizes the signals of the flow and gas sensors. Industrial PC components are used in the portable EasyOne Pro unit. See more details in the scheme.

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5 Technical Details of Components

Figure 2:EasyOne Pro System Overview

A B C D E F G H I J K1 L M N O P Q R S T

Mains Power Medical Power Supply Compact Flash Card Hard Disk Drive Embedded PC Connectors (USB, Video, LAN) Spiroson-x2 board Ambient Temperature and Humidity Sensor Gas Sample Pump Pneumatic Bloc Demand Valve CO Sensor Molar Mass sidestream Sensor (He) LCD with Touch Panel Filter Pack DLCO Hose DLCO Valve Unit Motor Bloc EasyOne Pro Flow sensor (spiroson-AS) Gas Supply bottle with reduction valve

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5.1

EasyOne Pro Mechanics and Design

51..1

Main Unit Housing Plastic Parts

Consists of 3 main parts: Front cover, left side panel, right side panel. Material: Polyurethan Integral Hard Foam, painted with biocompatible fine structure color. Function: Front cover has handle function and must carry all weight. Side panels have pure design function. 51..2

Main Unit Housing Metal Parts

Consists of the following parts: back panel, display back panel, lower housing, upper housing, U-shape mounting plate Material: Stainless steel, aluminium. Function: electromagnetic shielding, ESD function, main assembling structure 51..3

DLCO Valve Unit with Motor Bloc

Consists of the following parts: motor bloc with DC motor, guide tube with spindle and nut, valve drive with silicone connector and one way valve mounting, connector to DLCO hose and sample line Material: stainless steel, POM (medical grade), silicone (medical grade) Function: motor controlled air tight connection and disconnection between spirette and barriette. 5.2

EasyOne Pro Sensors

52..1

EasyOne Pro Flow Sensor (spiroson-AS)

The following picture shows the EasyOne Pro sensor. It consists of three housing parts, two electronic boards and two ultrasound transducers. It has a connector on top to mount the DLCO valve for DLCO tests. The connector (plug) at the end of the cable is specific to EasyOne Pro. The sensor cannot be connected directly to a PC. Materials: Medical grade plastics, medical grade POM, electronics (ROHS compliant) Function: Flow and molar mass measurement, DLCO valve control by driving the motor.

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Figure 1: Easy on-PC sensor

52..2

Side Stream Molar Mass Sensor (spiroson-AS)

Uses the same sensor technology and electronics used in the EasyOne Pro flow sensor. Consists of a case for the flow path with Piezo transducer mounting, electronics, case temperature sensor. Materials: medical grade POM, electronics (ROHS compliant) Function: molar mass measurement for Helium analysis, side stream flow measurement, internal temperature monitoring. 52..3

CO Sensor

Consists of a gas measurement chamber with mounted IR sender and receiver, electronics Materials: glass (coated), electronics 52..4

Ambient Temp. and Humidity Sensor

External component connected to the back plate of EasyOne Pro. Consists of a connector, cable and the temp/humidity sensor Function: Ambient temperature and humidity measurement

5.3

EasyOne Pro Embedded PC and Accessories

53..1

PC

The used PC is a mid-sized, EPIC-compatible, affordable, high quality single-board system, which contains all the component subsystems of a PC/AT PCI motherboard Copyright ndd, June 2009

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plus the equivalent of several PCI expansion boards. The PC is based on one of the ultra high performance, high-integration Intel Pentium M processors. These processors with the matching chip set give designers a complete integration solution with a high performance embedded processor based on the EPIC form factor. 53..2

Hard Disk Drive

The disk drive is 2.5-inch hard disk drives with built-in disk controllers. These disk drives use the AT-bus hard disk interface protocol and are compact and reliable. 53..3

Flash Memory Drive

The Flash Memory Drive is a high reliable high capacity industrial CompactFlash Memory Card. 53..4

TFT Screen with Touch Panel

The touch panel is a low reflection resistive touch screen with high light transmission and enhanced optical clarity. For the display a 12.1” color TFT-LCD (Thin Film Transistor Liquid Crystal Display) module composed of LCD panel, driver ICs, control circuit, and backlight unit is used. 5.4

EasyOne Pro Pneumatics

54..1

Gas Input

Consists of a pressure hose connector for 5 bar input of test gas. Material: medical grade plastic and stainless steel Function: tight connection 54..2

Pneumatic Bloc

Consists of main bloc, overpressure valve, main inlet valve, gas sample pump, pressure reduction valve, flush valve and other gas sample valves. Material: Aluminium, other medical grade valve materials Function: compact centralized control of gas supply and gas sampling. 54..3

Demand Valve

Consists of various housing parts and membranes with gas connector. Material: medical grade plastic and medical grade silicone Function: provide test gas on demand with low resistance 54..4

DLCO Hose

Consists of 22 mm hose, POM connectors with o-rings and mounting nut, sample line with filter Materials: medical grade plastics, medical grade POM, medical grade PVC, non woven stainless steel Copyright ndd, June 2009

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Function: deliver test gas to patient, transport gas sample from patient to gas sensors. 54..5

Filter Pack

Consists of two housing parts, nafion tube, filter, connectors Materials: medical grade POM, medical grade silicone, nonwoven stainless steel Function: easily exchangeable set for gas humidity adjustment and filter for dust protection. 5.5

Easy One Pro Software (internal name: EasyWare Pro)

ndd developed the EasyWarePro software platform, which is the fundamental basis for different devices designed for lung function testing. The EasyOne Pro software application is a specific configuration derived from the EasyWarePro software. Since EasyOne Pro uses a subset of the functions that are implemented in the EasyWarePro software, documents describing the EasyWarePro software are also applicable for the EasyOne Pro software. The EasyWarePro software is developed for standard Windows based computers. The software controls the functions required for performing lung function tests. In the EasyOne Pro application the patient data is derived from gas analyzers and the flow sensor which are both connected to the spiroson-x2 board which then is connected with the computer. The software calculates the lung function parameters based upon data received from the spiroson-x2 board. Patient related data is stored in a database on the computer. The software also generates reports based upon the patient related data that are presented on the EasyOne Pro display. The EasyOne Pro can be used with touchscreen or optional also with mouse and keyboard.

5.6

Block Diagrams

56..1

Block Diagram spiroson-x2 board

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56..2

Block Diagram spiroson AS for EasyOne Pro

56..3

Block Diagram spiroson AS Motor Driver for EasyOne Pro Input Connector

Current Protection

Current Regulator

Power Capacitors

H-Bridge

Motor

Current Measurement

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56..4

Block Diagram Embedded PC

56..5

Block Diagram TFT Screen

5.7

Printed Circuit boards

57..1

EasyOne Pro Flow Sensor Electronics Main board

See also Easy on-PC Service field manual for details. Copyright ndd, June 2009

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All electrical components are mounted on a single PCB. No components can be serviced.

Figure 4: EasyOne Pro sensor electronics main board

57..2

EasyOne Pro Flow Sensor Electronics Motor Driver Board

All electrical components are mounted on a single PCB. No components can be serviced.

57..3

EasyOne Pro Power Supply Unit

All electrical components are mounted on a single PCB. No components can be serviced.

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57..4

EasyOne Pro spiroson x2 Board

All electrical components are mounted on a single PCB. No components can be serviced.

57..5

Embedded PC Board

All electrical components are mounted on a single PCB. No components can be serviced.

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6 Specifications Dimensions/Weight Dimension: Weight:

20H x 24W x 20D cm < 8 kg

Flow/Volume Measurement Accuracy: volume: flow: Resolution volume: Resolution flow: Range volume: Range flow: Resistance:

± 2 % or 0.050 l ± 2 % or 0.020 l / s > 1ml 4 ml / s ± 12 l ± 16 l / s < 1.5 cm H2O / l / s @ 12 l / s

Helium Analyzer Type: Range: Accuracy: Resolution:

molar mass 0 – 50 % He < 0.1 % He 0.02 % He

Carbon Monoxide Analyzer Type: Range: Accuracy:

NDIR 0 – 0.35 % ± 0.002 %

Mouth Pressure Transducer Range: Accuracy:

± 300 cmH2O ±1%

Electrical Voltage: Frequency: Power: max.

100 VAC to 240 VAC 50 / 60 Hz 50 W

System Features Languages:

Display:

English, Spanish, German others on request direct USB to printer printer, modem, memory stick, email, ethernet / LAN color touch-screen

Environmental Conditions Operating Temperature:

5 – 40 °C

Printout: Data Transfer:

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Operating Humidity: Storage Temperature: Storage Humidity:

15 – 95 % non-condensing -20 – 50 °C 5 – 95 % non-condensing

Standards (Pending) Quality System: FDA: MDD 93/42/EEC: Electrical Safety: EMC:

ISO 9001 / ISO 13485 510(k) market clearance CE marked EN 60601-1 EN 60601-1-2

Barometric Pressure Transducer Range: Accuracy:

300 – 800 mmHg ± 3 mmHg

Temperature Sensor Range: Accuracy:

0 – 40 °C ± 1°C

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7 Replacement Parts List 7.1

EasyOne Pro Manual

Download current version from ndd website 7.2

Accessories

Part Number Short Description 2050-1 Spirettes box of 50

Description

2050-5 Spirettes box of 200

200 spirettes

2030-2C Calibration Syringe with calibration adapter

Calibration syringe and adapter

3000-60.1 Stand

Stand for holding the flow sensor with or without DLCO valve during spirometry or DLCO test

3050-1 barriette box of 50

Single patient use hygiene shield for DLCO valve

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50 spirettes

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7.3

Service Parts

Part Number Short Description 3000-50.5SP EasyOne Pro Flow Sensor

Description

3000-50.8SP Gas Supply Tube

To be replaced once per year

3000-50.9SP One way valve

To be replaced once per year

3000-50.3SP DLCO Valve

To be replaced in case of defect only

3000-50.2SP Motor Bloc

To be replaced in case of defect only

3000-50.1SP Filter Pack

To be replaced every 3 years

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To be replaced in case of defect only

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EasyOne Pro Field Service Manual Part Number Short Description

Description

3000-50.4 Pressure Tube

To be replaced in case of defect only

3000-50.7SP Temperature/Humidity Sensor

To be replaced in case of defect only

30000-50.6SP Touch Stylus

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