PONY FX Service Manual , II Edition Jan 2006

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P/N. C02532-02-81 /IIEdition/ Date of Issue: Jan 2006

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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

2–

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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

4–

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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

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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

Page 8

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

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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 customersupport@cosmed.it.

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

•

Reference of the purchase invoice (if possible)

•

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.

•

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

•

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 : customersupport@cosmed.it

Chapter 1 – Introduction- 9

Page 10

1.3 Service Return Number Form

10 –K4b2 Service Manual

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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.

Page 12

• 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)

12 – Pony FX Service Manual

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2. Functional

Description

Page 14

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

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3. Part Description

Page 16

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

16 – PonyFX Service Manual

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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

•

Display:

P/N: A 506 005 003

•

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.

•

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

•

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

B)).

•

Battery voltage level detection.

•

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

Page 18

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

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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

•

Display failure

•

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

Page 20

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

•

Printing Failure

•

Paper jam during Printing

•

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).

20 – PonyFX Service Manual

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Description

The Optoelectronic transducer contains 2 couples of Infrared Emitter/Receiver diodes to

detect the position of the rotor. The air passing through the helical conveyors, takes a

spiral motion which causes the rotation of the turbine rotor. The rolling blade interrupts

the infrared light beamed by the diodes of the optoelectronic reader, each interruption

represents half turn of the rotor, this is used to measure the number of turn in the time.

There is a constant ratio due to software linearization between air passing through the

turbine and number of turns. This allows for an accurate measurement of volume and

flows. Refer to the electrical diagram and layout of the output signals from the infrared

receivers D4 (Rx1) and D3 (Rx2) as shown following figure.

The flow and volume measurement is carried out as follows:

Volume: It is proportional to the number of pulses detected by the receiver diode during

expiration (expired volume) or inspiration (inspiratory volume);

Flow: The absolute value of the flow (positive for both expiration and inspiration) is

proportional to the inverse of the pulse width detected by the receiver diode;

IN/EX: The flow direction is detected by verifying which pulse (rx1, rx2) is received

first. The turbine doesn't need to be calibrated daily as it is not affected by pressure,

humidity and temperature. The turbine should be maintained with regular ordinary

sterilization to move freely without friction, free of dust.

Adjustment & checks

There are no adjustments to be performed on this assembly.

Assembly Drawing (Refer to Section: Schematics & Layouts)

Warnings & Indications in Event of Failure

Chapter 3 – Part Description - 21

Page 22

•

Flow and Volume errors

3.2.6 Battery Charger (C02383-01-05)

Function

The Battery charger of the Pony FX supplies power to the Battery charging circuit (see

Mother Board).

Pony FX AC/DC adapter 12V 1A

P/N: C02383-01-05

Description

The battery charger is a classified Class II equipment according to "IEC 601-1: 1990:

Safety of medical electrical equipment “General requirements"

The diagram in assembly drawing shows the polarity of the connections between the

Pony FX Unit and the AC/DC adapter.

Adjustments & checks

There is no adjustment to be performed on this assembly

Assembly Drawing

Warnings & Indications in Event of Failure

•

•

22 – PonyFX Service Manual

Power failure

Battery

charging

failure.

Page 23

4. System

Maintenance

Page 24

4.1 System Maintenance

4.1.1 Overview

All service operations which are specified in this manual should be performed by

qualified personnel. All materials used in the construction of the Pony FX are non toxic

and pose no safety risk to the patient or operator. Prior to the device cleaning,

disinfection and inspection it is necessary to switch off the device and to disconnect

adapters from the supply mains. In order to guarantee the highest accuracy of

measurements we recommend you to disinfect the turbine periodically. Use disposable

anti-bacterial filters or disinfect each part in contact with the patient before each test.

4.1.2 Cleaning and disinfection

Cleaning and disinfecting instructions are of fundamental importance to control

infections and assure patient safety. In fact aspiration of residue, particles and

contaminated agents are life – threatening. In this handbook we strongly recommend

you to follow the rules worked out by ATS and ERS (see:”Lung Volume Equipment

and Infection Control” – ERS/ATS WORKSHOP REPORT SERIES, European

Respiratory Journal 1997; 10: 1928 – 1932), which are summarised as follows: ·

Accessible internal as well as external surfaces of equipment exposed to expired gas

should be washed and disinfected prior to testing of subsequent patients. · Liquid

disinfection can be used if the equipment is well cleaned first (no droplets of

saliva/sputum remain). Disposable gloves should be worn when handling mouthpieces,

when cleaning equipment exposed to saliva or sputum and especially when drawing

blood. Laboratory staff should wash hands prior to testing of each patient.

Adopt particular precautions when testing patients with recognised high - risk

communicable diseases (e.g. tuberculosis, multidrug - resistant staphylococcus). In

these cases, the clinical need for such testing should justify the risks.

4.1.2.1 During the disinfection:

Do not use alcohol or other liquids containing gluteraldehyde on the exterior surfaces of

the equipment. Actually they can damage polycarbonates plastics and may produce

unhealthy substances.

Do not use abrasive powders or glass cleaners containing alcohol or ammonia on the

plexiglas components of the equipment

Do not steam autoclave any parts of the equipment unless it is clearly specified.

Do not immerse the optoelectronic reader.

4.1.2.2 Preparing the disinfecting solution

The following recommendations are retrieved from:

APIC (Association for Professionals in Infection Control and Epidemiology, Inc.):

APIC Guidelines for Selection and Use of Disinfectants; William A. Rutala, PhD,

MPH, CIC. AmericanJournal of Infection Control, vol.24, N.4, pp. 313-342, August

1996 - http://www.apic.org/pdf/gddisinf.pdf

As disinfecting solution it is suggested:

Sodium hypochlorite 0.5% (5000 ppm) prepared fresh for use within 24 hours.

Sodium hypochlorite 1% (10000 ppm) prepared fresh for use within 30 days.

The first solution can be easily prepared by adding 1 part household bleach (sodium

hypochlorite 5.25%) to 9 parts water, the second one by adding 1 part household bleach

to 4 parts water.

24 – Pony FX Service Manual

Page 25

4.1.2.3 Cleaning the turbine flowmeter

It is necessary to disinfect periodically the turbine for sanitary measures or/and for the

correct device function.

1. Take out the turbine.

2. Dip it in a disinfectant solution (non alcoholic based) for about 20 minutes.

3. Rinse the turbine in a vessel, filled of clean water, shaking gently to remove the

disinfectant (do not clean the turbine by putting it under running water!).

4.

Let it dry to air.

Warning: Do not use alcoholic solutions for the turbine; otherwise there can be

damages to the plastic material.

5.

6.

After cleaning the turbine, check if the turbine propeller rotates freely even with a

low speed air flow.

Connect the turbine to the reader.

4.1.2.4 Precautions during the cleaning of the turbine

•

Do not expose the turbine to high heat and do not put it under running water.

•

Do not ever dip the optoelectronic reader in any kind of solution; the liquid

infiltration would damage the internal circuit.

•

Do not use alcoholic solutions to clean the turbine.

4.1.2.5 Suggested disinfection solutions

Helipur H Plus Braun Melsungen AG

Gigasept FF Schulke & Mayr GmbH

Dismozon pur Bode Chemie GmbH

TETA-S Fresenius AG

CIDEX Johnson & Johnson

4.1.2.6 Inspections

The equipment requires easy inspections to be carried out in order to assure a proper

electrical and mechanical safety level in the years. These inspections are highly

recommended after a rough use of the equipment or after a period of storage in

unfavourable environmental conditions. Referring to the electrical safety, it is important

to check the conditions of insulation materials of cables, plugs and any other visible part

by means of simple inspection, when the equipment is switched off and adapters (or

electrical feeders) are disconnected from the supply mains.Extract the turbine from the

unit and verify, by inspection, that the turbine axis fits correctly its seats and the blade is

strongly fastened on the axis itself (it can be useful to shake slightly the turbine in order

to note any anomalous movement). Check if there are any torn or broken components in

the breathing circuits: remember that they can create safety risk to patients during tests.

Charter 4 – System Maintenance 25