PONY FX Service Manual, II Edition Jan 2006

Cosmed does not assume the liability for interpretation mistakes of this documentation or for casual or consequential damages in connection with the provision, representation or use of this documentation. No parts of this manual may be reproduced or transmitted in any form without the express permission of COSMED Srl. COSMED Software can be installed only in one device. Excel is a registered trademark of Microsoft Corporation. DBIII is a registered trademark of Bordland International Inc. Lotus 123 is a registered trademark of Lotus Development Corporation .

Pony FX Service manual, II Edition 1/2006 Copyright © 1998 COSMED Copyright © 2003 COSMED COSMED Srl - Italy http://www.cosmed.it Part No. C02532-02-81

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Table of Contents 1. Introduction... 7 1.1 Introduction ... 8

1.1.1 Organisation of the manual... 8 1.1.2 Reference Documents... 8 1.1.3 Customer Communication... 8 1.2 Material return for repair/maintenance... 9

1.2.1 EU countries ... 9 1.2.2 Non-EU Countries ... 9 1.3 Service Return Number Form... 10 1.4 Technical Specifications... 11

1.4.1 Windows PC Software ... 11 1.4.2 Safety and conformity ... 12

2. Functional Description ... 13 2.1 Functional Description... 14

2.1.1 General Overview... 14

3. Part Description ... 15 3.1 Overview ... 16

3.1.1 Configuration... 16 3.2 Pony FX Unit ... 17

3.2.1 Mother Board (C02310-00-15)... 17 3.2.2 Display Assembly (A 506 005 003) ... 18 3.2.3 Keyboard Assembly (C02320-01-15) ... 19 3.2.4 Printer (A 666 052 001)... 19 3.2.5 Opto Electronic Assembly (C02364-01-05)... 20 3.2.6 Battery Charger (C02383-01-05)... 22

4. System Maintenance ... 23 4.1 System Maintenance ... 24

4.1.1 Overview ... 24 4.1.2 Cleaning and disinfection ... 24

5. Troubleshooting ... 27 5.1 Troubleshooting ... 28

5.1.1 Overview ... 28 5.1.2 The printer doesn't work properly ... 29 5.1.3 The Pony FX is unable to measure properly flow and volume ... 29 5.1.4 Serial Communication error ... 29 5.1.5 The keyboard doesn't work... 29 5.1.6 The LCD Display back-light doesn't work ... 29

Table of Contents - 3

6. Service Procedure ... 31 6.1 Service Procedures... 32

6.1.1 Disassembling the Pony FX... 32 6.1.2 Consumable Replacement ... 34 6.1.3 Display Check... 34 6.1.4 Connecting to External Printer ... 34 6.1.5 Pony FX Internal Program (Firmware) Upgrade ... 36

7. Schematics & Layouts ... 39 7.1 Pony FX unit ... 40

7.1.1 Unit Layout... 40 7.1.2 Disassembling Pony FX Unit ... 41 7.1.3 Flowmeter ... 42 7.1.4 Keyboard PCB ... 43 7.1.5 Battery Charger... 44 7.1.6 Rocc Option ... 45

8. Replaceable Part List ... 47 8.1 Service Parts ... 48

8.1.1 Consumables... 48 8.1.2 Cables ... 48 8.1.3 Miscellaneous1 ... 48 8.1.4 Calibration ... 49 8.1.5 Flowmeter, turbines & accessories ... 49 8.1.6 Boards... 49 8.1.7 PC Software ... 50 8.1.8 Manuals ... 50

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WARNING Do not use the equipment in presence of flammable gases or anesthetic mixtures. Perform the service procedures described in this manual only if you are a trained and authorized COSMED service person. Keep the equipment away from heat, flames, sparks, flammable liquid mixtures and explosive gases. For using this equipment along with other medical ones, contact COSMED. The following symbols are used into the equipment, in accordance of the actual standards: Type B equipment (according to EN60601-1) DANGER: high temperature OFF ON Protective earth AC

Table of Contents - 5

WARNING Perform the service procedures described in this manual only if you are a trained and authorized COSMED service person. You must have a thorough knowledge and experience with medical electronic equipment. Pay attention to the directions in this service manual, along with the warning and cautions that appear throughout this manual. Read through each step in every procedure before beginning the repair. Always use the proper tools, test equipment and the most recent revision of this service manual. Warning If you deviate from the instructions or recommendations in this manual, you may cause the Pony FX to operate improperly or unsafely, and you may damage the unit. The Pony FX User's Manual is an integral companion to this manual. Familiarize yourself with it before operating and repairing the device.

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1. Introduction

1.1 Introduction This manual provides the basic procedures for the maintenance and the technical support of the Pony FX. Perform the service procedures described in this manual only if you are a trained and authorized COSMED service person. You must have a through knowledge and experience with medical electronic equipment.Pay attention to the directions in this service manual, along with the warning and cautions that appear throughout this manual. Read through each step in every procedure before beginning the repair. Always use the proper tools, test equipment and the most recent revision of this service manual. The Pony FX User’s Manual is an integral companion to this manual. Familiarize yourself with it before operating and repairing the equipment.

1.1.1 Organisation of the manual This manual is organized as follows: Functional Description

Provides a general description of the device, the theory of operation and the main usage modes. This chapter is useful to use the device in the most complete and proper mode. Part Description:

Provides a detailed description of the device and the theory of operation of the modules. This chapter is useful to identify cause for problems and to operate properly. Maintenance

Provides general specifications for maintenance and calibration. Trouble-shooting

Trouble-shooting guidelines for detecting problems and their respective solutions Service Procedures:

Description of the adjustments and checks to carry out for a problem Schematics & Layouts

A collection for drawing for disassembling of the parts, electric and pneumatic schematics, mounting planes and PCB Layouts Appendix A

Contains Technical information, replaceable part list, and customer communication.

1.1.2 Reference Documents The following document contains information that you may find useful for further reference as you read this manual: Pony FX: User’s Manual P/N: C02361-02-91.

1.1.3 Customer Communication COSMED would like to receive your comments and suggestions on its products and manuals. We are interested in your application with our products, and we would like to help you if you have problems with them. To make it easier for you to contact us, this manual contains our address and a Technical Support Form in the Appendix Our contact Address

COSMED S.r.l, Via Dei Piani di Monte Savello, 37, , Pavona di Albano, ROMA 00040 ITALY. Voice +39 (6) 931 5492 Fax +39 (6) 931 4580 Internet Web site: http://www.cosmed.it 8 –K4b2 Service Manual

1.2 Material return for repair/maintenance 1.2.1 EU countries 1.

2. 3. 4. 5.

Fill in the top part of the SRN form and fax it to the Customer Support at COSMED (fax nr. +39 06 9314580); in return, COSMED will fax you the TSR document. Pack the unit in a very good and safe box. COSMED is not responsible for loss or damage caused by the courier. 3. Put a copy of the TSR document and the packing list in an adhesive envelop outside the package. 4. Ship the unit to COSMED Srl – Via dei Piani di Monte Savello, 37 – 00040 Pavona di Albano, Rome - Italy. 5. For any problem, please contact [email protected].

1.2.2 Non-EU Countries 1. 2. 3. 4. a. b. c.

Fill in the top part of the SRN form and fax it to the Customer Support at COSMED (fax nr. +39 06 9314580); in return, COSMED will fax you the TSR document. Pack the unit in a very good and safe box. COSMED is not responsible for loss or damage caused by the courier. Put a copy of the TSR document and the packing list in an adhesive envelop outside the package. Prepare the Temporary Export. Make sure whether or not the request of assistance is made under warranty period The equipment has to be temporary exported from your Country (follow the procedures requested by your customs office). The equipment has to be accompanied with a document (shipping note, pro-forma invoice, etc.) mentioning the following details:

Description and s/n (if any) of the goods shipped

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Reference of the purchase invoice (if possible)

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The document must clearly bear the description: “Items being temporary returned to the manufacturer forcalibration and ordinary maintenance or assistance during warranty period”. Please delete”during warranty period” if not applicable.

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Quote a value as close as possible to the real value of the equipment.

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For confirming the shipment the document (point c.) has to be faxed to the Customer Support at (+39 06 9314580) before the shipment,. 5. Ship the unit to COSMED Srl – Via dei Piani di Monte Savello, 37 00040 Pavona di Albano, Rome - Italy. 6. Fax the AWB#______________ and the name of the forwarding agency performing the shipment and related shipping details. For any assistance, please contact : [email protected]

Chapter 1 – Introduction- 9

1.3 Service Return Number Form

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1.4 Technical Specifications Pony FX Unit

Graphic display Display Printer Keyboard Serial cable Serial cable Dimensions Dimensions Weight Flow meter Flow meter: Flow range Volume range Accuracy F/V Dynamic res. at 12 l/s Mouthpieces

Backlight LCD 70x80 mm LCD 2 lines x 16 characters Graphic,24 char/lin,2,5 lines/s 12 multifunction keys RS 232, RJ 45 –9 pin D Type( bi-directional, 4800 baud) USB Type A & Type B 198 x 238x 76mm 1.2 kg Digital bi-directional turbine 0.03 -20 l/s 12 l ± 3%%or ± 50 ml <0.7 cm H2O/l/s Ø 31 and 22 mm

Power supply:

Ni-Cd Batteries Battery Autonomy Battery charger Power supply input

5V, 1.2 AH, Rechargeable. 200 tests including prints out 120V - 240 V

1.4.1 Windows PC Software The PC software runs on Windows operating systems, allows the user to carry out real time tests, manage data stored in the Pony FX Unit and transmitting tests to PC. The main features of the software are as follows, • Carrying out real time tests • Test data management. • Viewing data in table and graphic form • Spirometry (FVC, VC, IVC, MVV. Pre-Post bronco-challenge test). • Automatic BTPS correction by means of inbuilt temperature sensor. • Adding parameters and predicted equations trough the "Formula Editor" tool-kit. • New NHANES III predicated equations included. • DDE with Microsoft Excel. • FV6 parameter and related calculation now measured. • Customizing software environments (colours, printed parameters...). • Automatic interpretation according to latest ATS recommendations. • Quality control messages as per ATS guidelines during the test • Trend analysis on multiple Parameters • on line Help. PC configuration required

• Pentium 133 MHz. Or higher • Windows 95, 98, NT. • 16 MB RAM . • 3.5 drive.

• VGA, SVGA monitor. • Serial Port RS 232 available ( two serial ports or USB port) • Any Mouse and Printer compatible with the MS Windows™ operating system. • PC confirm to European Directive 89/336 EMC

1.4.2 Safety and conformity SAFETY

IEC 601-1 (1988)/EN 60 601-1 (1990) Below is reported the complete classification of the device: • Class B "internally powered equipment" device • IP00, ordinary equipment unprotected against water penetration; • Non sterile device • Device not suitable in the presence of flammable aesthetics; • Continuous functioning equipment; EMC

The system meets the EMC Directive 89/336 EN 60601-1-2,EN 55011 Class B (emission) IEC 1000-4-2 (immunity ESD): 4KV CD, 8KV AD IEC 1000-4-3 (immunity EM): 3 V/m IEC 1000-4-4 (immunity Bursts): 1 KV QUALITY ASSURANCE

UNI ISO EN 9001 (Reg 387 Cermet)

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2. Functional Description

2.1 Functional Description 2.1.1 General Overview Pony FX is a portable spirometer designed for carrying out the typical test of the screening spirometry: Forced Vital Capacity (Pre and Post), Slow Vital Capacity (Inspiratory and Expiratory) and Maximum Voluntary Ventilation

The system is mainly composed of following parts Pony FX Unit

It is the core of the system; contains the microcontroller and the electronics necessary to operate the peripherals and to manage the different measurements. It can be operated either in stand alone mode using the internal rechargeable NiMH batteries or connected to the AC/DC adapter(optional: Battery Charger Pony FX , Medical grade, C02383-0105). It is connected to the Turbine flow meter during the measurement. It can be connected to a PC compatible using a standard RS 232 cable or a USB cable for real time data acquisition, he measured data can then be printed directly from the Pony FX unit to an external USB printer for direct printing. Flowmeter

It is composed by the turbine and the Opto electronic transducer; the air passing through the helical conveyors makes a spiral motion which causes the rotation of the turbine rotor. The rolling blade interrupts the infrared light sources beamed by the diodes of the opto electronic transducer. Every interruption represents half turn of the rotor, this allows to measure the number of turn in the time. There is a constant ratio between air passing trough the turbine and number of turns. This allows to calculate an accurate measurement of volume and flow. Battery Charger (AC /DC Adapter)

The battery charger (AC /DC Adapter) can charge NiMH batteries of the Pony FX unit and at the same time also supply power to the unit. It can operate at both, 110 or 220V AC inputs.The battery under charge status is indicates by a illuminated green LED and completely charged one with Orange color. Red color indicates some mal function in the unit. RS232 cables

It allows to visualize test data in real time or can be used to download the data of the test to a PC or to print the result with an external Printer There are three types of serial cable, one is with standard 9 pin D-Type Female connector and other two are is USB type A and B. 14 – Pony FX Service Manual

3. Part Description

3.1 Overview 3.1.1 Configuration This section deals with the electronic circuits and their functions; it gives an overview regarding the general aspect of the PCB assembly, its electronic description and the possible errors and faults, which can occur due to malfunction in the component from that assembly. It provides the complete reference for the service personnel for diagnosis. The section consists of the following. Pony FX Unit

1. 2. 3. 4.

Mother board Assembly Display Assembly Keyboard Assembly Printer unit Assembly

(C02310-00-15) (A 506 005 003) (C02320-01-15) (A 666 052 001)

Opto electronic Reader

5.

Opto electronic Assembly (C02364-01-05)

Battery Charger Unit

6. Battery Charger (C02383-01-05) The circuit diagrams and PCB Layouts are attached for ready referenceDescrizione

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3.2 Pony FX Unit The Pony FX Unit is made of 4 different PCBs: •

Mother Board P/N: C02310-00-15

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Display:

P/N: A 506 005 003

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Keyboard:

P/N: C02320-01-15

• Printer: P/N: A 666 052 001 The physical structure of the Pony FX Unit is described in the following block diagram:The Unit contains most of the parts constituting the spirometer and can be interfaced to the, the turbine flow meter. It can be used with a personal computer or external printer via USB Cable. The Battery charger powers and charges the unit.

3.2.1 Mother Board (C02310-00-15) Function

The Mother Board consists of the components shown in the diagram, all the connection between them perform the following functions: •

Control of the all peripherals (display, internal printer, keyboard.) through the micro controller.

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Data Acquisition and amplification of the signal coming from the flowmeter.

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Serial communication management (RS232 (DB9 Type) /and USB Type A and B)).

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Battery voltage level detection.

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Battery charging management through Power Supply section on the motherboard PCB.

• External Printer Control. The mother Board layout is enclosed in the Appendix. Description

This is the main board and controls all peripherals connected to it, it has a connector board mounted on it with different connectors for input and output functions, includes also control of external USB port based printer, Adjustments & checks

Chapter 3 – Part Description - 17

There are no adjustments to be performed on the motherboard. Assembly Drawing

Warnings & Indications in Event of Failure

The system does not operate when switched on (refer to Troubleshooting section) No Print out on External Printer.

3.2.2 Display Assembly (A 506 005 003) Function

The display of Pony FX is the main interface for user to enter the patient details, to view the results and to print a particular test performed by the patient and for all the control functions to be performed. Description

The LCD display is controlled by U17 which is a color / monochrome LCD graphics controller with an embedded 40K Byte SRAM display buffer. The Display is connected to the motherboard through connector J4 (see the Display layout in Schematics and Layouts section): Adjustments & checks

It is automatically compensated for temperature variations. (1) Test Points Pin 5 of J13 Digital Logic supply LCD supply (Only for Black and white Display) Pin 4 of J13 3.3V 18 – PonyFX Service Manual

Pin 3 of J13 LCD supply (VCC 5V) (2) For Backlight Pin 4 of Q14 Logic high for backlight ON Assembly Drawing

Warnings & Indications in Event of Failure

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Display failure

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Backlight failure

3.2.3 Keyboard Assembly (C02320-01-15) Function

The keyboard is the primary input device for the patient data and for executing the test. It is passive device connected directly to the CPU. Description

The keyboard is directly interfaced with the I/O ports of the U16 (CPU) through the connector J14 on the motherboard. Adjustments & Checks There are no adjustments to be performed on this assembly. Assembly Drawing

Warnings & Indications in Event of Failure •

Key failure

3.2.4 Printer (A 666 052 001) Function

The Printer in Pony FX is a thermal line printer. It is a Very compact printer (height is only 27 mm) with a High-resolution of printing at 8 dots/mm and 60 mm/s printing speed. Description

Chapter 3 – Part Description - 19

Pony FX printer is connected to the motherboard with the connectors J7 and from Printer to the connectors J12 and J11 on the motherboard, please refer to the diagram below or to schem-atics and diagrams chapter in this manual for more detailed information, Pony FX has an end of paper sensor achieved by a phototransistor. Please do not print without paper, since this could damage both roller and head. Adjustment & checks

There is no adjustment on this assembly. Assembly Drawing

Warnings & Indications in Event of Failure

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Printing Failure

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Paper jam during Printing

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No Printout

3.2.5 Opto Electronic Assembly (C02364-01-05) Function

The flow meter is composed by a Bi-directional turbine and an Optoelectronic transducer. The Turbine is made of (see figure) a transparent tube with two helical conveyors to which is fixed (rotating free) a very lightweight rotor (blade).

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