ndd Medical Technologies
EasyOne Pro Field Service Manual June 2009
Field Service Manual
47 Pages
Preview
Page 1
EasyOne Pro Field Service Manual
EasyOne Pro Lung Function Instrument Please Note: This manual is for ndd authorized service personnel only!
ndd Medizintechnik AG Technoparkstrasse 1 CH-8005 Zürich, Switzerland www.ndd.ch
Page 1
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
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 2
EasyOne Pro Field Service Manual
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
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 3
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.
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 4
EasyOne Pro Field Service Manual
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.
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 5
EasyOne Pro Field Service Manual
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
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 6
EasyOne Pro Field Service Manual
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.
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 7
EasyOne Pro Field Service Manual
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
EasyOne Pro-Field Service Manual V1.1.doc
Page 8
EasyOne Pro Field Service Manual
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
EasyOne Pro-Field Service Manual V1.1.doc
Page 9
EasyOne Pro Field Service Manual
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
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 10
EasyOne Pro Field Service Manual
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
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 11
EasyOne Pro Field Service Manual
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
EasyOne Pro-Field Service Manual V1.1.doc
Page 12
EasyOne Pro Field Service Manual
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.
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 13
EasyOne Pro Field Service Manual
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.
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 14
EasyOne Pro Field Service Manual
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 15
EasyOne Pro Field Service Manual
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:
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 16
EasyOne Pro Field Service Manual
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
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc
Page 17
EasyOne Pro Field Service Manual
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
Copyright ndd, June 2009
50 spirettes
EasyOne Pro-Field Service Manual V1.1.doc
Page 18
EasyOne Pro Field Service Manual
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
Copyright ndd, June 2009
To be replaced in case of defect only
EasyOne Pro-Field Service Manual V1.1.doc
Page 19
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
Copyright ndd, June 2009
EasyOne Pro-Field Service Manual V1.1.doc