Pm1111E Fast Oxygen Transducer Instruction Manual Order manual as Part No. 01111001E/7

*This product meets the material restrictions of the EU RoHS directive 2011/65/EU

*From Serial number 2000000 onwards

8 Servomex Group. 1999. All rights reserved

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WARNINGS, CAUTIONS AND NOTES:

This publication includes WARNINGS, CAUTIONS and NOTES which provide, where appropriate, information relating to the following:

WARNINGS: Hazards that result in personal injury or death. CAUTIONS: Hazards that will result in equipment or property damage. NOTES: Alerts the user to pertinent facts and conditions

WARNING - (SAFETY) This equipment must not be used in areas classified as hazardous or areas which, although not classified as hazardous, could contain potentially explosive or flammable vapours or dusts.

CAUTION - (USE)

As the final conditions of use are outside Servomex's control, it is the responsibility of the equipment designer or manufacturer to ensure that this

transducer is safely installed and suitable for the intended application.

NOTE:

For safety reasons any transducer returned to Servomex must be accompanied by the Decontamination Clearance Certificate (see reverse). Unless the cell is

accompanied by this certificate, Servomex reserves the right to refuse to undertake any examination of the product.

Apply appropriate anti-static handling procedures. Transducer returns must be

packed in the original packing material to prevent damage in transit.

NOTE:

The information in this document is subject to change without notice.

This document contains proprietary information which is protected by copyright. All rights are reserved. No part of this document may be copied, reproduced or

translated to another language without the prior written consent of Servomex Group Ltd.

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DECONTAMINATION CLEARANCE CERTIFICATE

1. It is hereby certified that the product returned and described below has either

never been exposed to biological hazards or has been decontaminated according to the methodology stated in the Servomex Operating Procedure 06-202 and should be free from hazardous biological agents.

2. It is hereby certified that the product returned and described below has not been

exposed to chemical substances hazardous to health or to radioactive hazards.

Product Serial No. Treatment Date/Comments Note: Failure to complete this certificate and attach it to the outside of returned goods packaging will result in handling delays and may incur costs. Form No: 06-202/1 Issue 1 Signed: Print

Name: Position:

Company: Date:

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LIST OF CONTENTS SECTION PAGE 1 Introduction to Pm1111E ........................................................................................ 1

1.1 Mechanical Specification ................................................................................ 1 1.2 External Power Supply Specification .............................................................. 2 1.3 Environmental Specification ........................................................................... 2 1.4 Performance Specification ............................................................................. 3 1.5 Servomex Paramagnetic Measurement Principles ......................................... 5 1.6 Functional Components of the Pm1111E ...................................................... 6

2 Guidelines for Evaluation of Pm1111E and System Design ................................. 7

2.1 Handling of the Pm1111E .............................................................................. 7 2.1.1 Special Packaging .................................................................. 7 2.1.2 How to Handle the Pm1111E .................................................. 7

2.2 How to Minimise Exposure of Pneumatic System to Contaminants ................ 8

2.3 Mechanical Arrangement ............................................................................... 8

2.3.1 Mounting Arrangement ........................................................... 8 2.3.2 Fitting into OEM products designed for Pm1111D .................. 8 2.3.3 Location of Transducer ........................................................... 9 2.3.4 Orientation of Transducer ....................................................... 9

2.4 Pneumatic Arrangement ................................................................................ 9

2.4.1 Sampling Configuration ........................................................... 9 2.4.2 Conditioning of the Sample ................................................... 11 2.4.3 Typical Sample System ........................................................ 12 2.4.4 How to apply Pressure Compensation to the Signal Output . 12

2.5 Electrical Arrangement ................................................................................. 13

2.5.1 Power Supply ....................................................................... 13 2.5.2 Optional Power Supply for LED Source ................................ 13 2.5.3 Electrical Connections ......................................................... 13 2.5.4 Earthing Arrangements ........................................................ 13 2.5.5 Remote Zero and Span Adjustment ..................................... 14

2.6 Operation and Calibration ............................................................................ 16

2.6.1 Start- Up Checks .................................................................. 16 2.6.2 Calibration Equipment ........................................................... 16 2.6.3 Calibration Using Optional Remote Potentiometers .............. 16 2.6.4 Calibration Procedure at Sea Level ....................................... 16 2.6.5 Calibration at High Altitudes .................................................. 17

IV

LIST OF CONTENTS (Cont=d)

SECTION PAGE 3 Trouble Shooting Guide ........................................................................................ 19

Test 1: Power up the Transducer and Test with Gas ............................................... 19

Test 2: Visual Examination ...................................................................................... 21

Test 3: Re-calibration Procedure ............................................................................. 23

4 Warranty ................................................................................................................. 25

4.1 Tests on Suspected Faulty Transducer ....................................................... 25

4.2 Product Failure during Warranty ................................................................. 25

4.3 Product Failure out of Warranty ................................................................. 26

4.4 Maintenance .............................................................................................. 26

4.5 Spares ....................................................................................................... 26

4.6 Decontamination of the Pm1111E ................................................................ 26

5 Appendices ........................................................................................................... 27

5.1 Outline Dimensions of Pm1111E (Dwg 01111/823) ..................................... 29 5.2 List of Relevant Clauses of International Standards ..................................... 31 5.3 Mechanical Vibration and Shock Resistance ............................................... 32 5.4 Decontamination Protocol ............................................................................ 33 5.5 Removal of Sample Cell .............................................................................. 37

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SECTION 1 INTRODUCTION TO Pm1111E

Section 1 includes a description of the Pm1111E and its specification, and a description of the Servomex paramagnetic measurement principle.

The Pm1111E is a small paramagnetic oxygen transducer designed to provide accurate measurement of the oxygen content in the expired breath and in breathing gas mixtures. The transducer gives an analogue output of 1V for a full scale reading of 100% oxygen concentration. The Pm1111E uses the same paramagnetic measurement technology as its predecessor, the Pm1111D. The latter has been integrated into many OEM products where performance, quality and long life are a major consideration. Servomex paramagnetic technology is non-depleting, which means that there are no consumable parts, and ensures a consistent performance over time. The selectivity of the paramagnetic measurement for oxygen means that there

is no interference from other respiratory gases. The Pm1111E=s small

volume chamber allows a rapid gas exchange, giving the capability for fast response oxygen measurement. The Pm1111E offers a stable and inherently linear measurement of oxygen. The excellent linearity of the Pm1111E makes it possible to calibrate the Pm1111E by checking two points only. There is no requirement for a reference gas during operation.

1.1 Mechanical Specification

See Appendix 5.1 for drawing no. 01111/823, AOutline Dimensions

Pm1111E@

Dimensions (H X W XD) 54 x 54 x 56mm (2.12 x 2.12 x 2.2 ins) Weight 420gms (14.8 ozs) Gas Connectors Two inlets, one outlet. 1.4mm nom OD, barbed length 2.3mm. Suitable for 1mm nom ID flexible tubing. Max tubing length over gas connector is 4.5mm. Recommended Orientation Electrical connector at top, gas connectors in a vertical line, port 1 at top. Materials In Contact with Gas Sample 303 and 316 stainless steel, borosilicate glass, polyphenylenesulphide (PPS)

with carbon fibre/PTFE filler, platinum, platinum/iridium alloy, viton (O=ring).

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1.2 External Power Supply Specification

An external power supply is required to provide:

+5V, 0V dc. 65mA maximum, ripple and noise:<0.1V Pk to Pk. A separate power supply may be used to drive the LED Source. The requirement is: 0V, +5V dc. 57mA maximum, ripple and noise:<0.1V Pk to Pk.

A change of 0.25V in the supply voltage results in a change of less than

0.1% in oxygen concentration.

1.3 Environmental Specification

**This product meets the material restrictions of the EU RoHS directive 2011/65/EU. Refer to Appendix 5.3 for a list of the relevant clauses of ISO 7767:1988 and IEC 1207-1:1994.

Sample Gas Condition Dry, non-corrosive, non-flammable gas, free of entrained oil, less than 3 micron particulates. Non-condensing, dew point >10oC below the cell temperature. Pressure With the sample vented to atmosphere, the output voltage is directly proportional to the barometric pressure.

Operating Temperature +5 oC to +50 oC (41oF to 122oF) Storage Temperature -40 oC to +70 oC (-40oF to 158oF) Thermal Time Constant For a step change in ambient temperature, the time taken to reach 63% of the total change in temperature is 11 minutes. Ambient Humidity 0 to 95% RH

Altitude Range (Operating) -250m to +5000m (-770 ft to +15400ft)

** From Serial number 2000000 onwards

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1.4 Performance Specification

(Under constant conditions of pressure, temperature and flow)

Range and Output 0 to 100% O2 gives 0 - 1V dc Linearity

< 0.1% O2 Repeatability

< 0.1% O2 Intrinsic Error

< 0.1% O2 Zero Stability

< 0.01% O2/hr (during first four hours)

< 0.1% O2/week

< 0.2% O2/month

Temperature Coefficient Within a range of 5oC to 50oC (41oF to 122oF):

Zero: < 0.05% O2/oC

Span: < 0.2% of O2 reading /oC Operational Flow Rate

Fast Response Configuration: 50 - 200ml/min Standard Configuration: 10 - 100ml/min

Maximum Purge Flow 300ml/min Response Time for Fast Response Configuration Rise Time (T10 - T90)16% O2 to 21% O2 <200msecs at 150ml/min

<300msecs at 100ml/min Air to 100% O2* <350msecs at 150ml/min

<600msecs at 100ml/min

Fall Time (T10 - T90): 21% O2 to 16% O2 <200msecs at 150ml/min <300msecs at 100ml/min

100% O2 to Air* <350msecs at 150ml/min <600msecs at 100ml/min

*In accordance with the requirements of ISO 7767:1988 Clause 50.8 Response Time for Standard Configuration Rise Time (T10 - T90): N2 to Air <3 secs at 80 ml/min

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Pressure range 34.5 KPag ( 5psig ) Pressure drop across the cell In Fast Response Configuration- 50 ml/min < 2mm H2Og

150ml/min < 6 mm H2Og Flow Error – Based on gases with molecular weights of 28-30g/mol. For more detail see Servomex application note HBAN-PM41. In Fast Response Configuration a change in flow of +10 ml/min produces a change in reading.

Between 90 - 100 ml/min flow < +0.2% O2 Between 100 - 200ml/min flow < +0.25% O2

In Standard Configuration a change of flow from 10 to 100ml/min produces a change in reading < + 0.3% O2. Soft magnetic material Brought within 15mm of the case will result in a change in the reading of <0.1% O2. Pneumatic leakage < 0.02ml/min at -5psig (better than the requirements of Clause 63, ISO 7767:1988) Interference Effects The paramagnetic effect of background gases, at 20OC, in 100% concentration is given in the table below.

Interfering Gas Interference Effect (100% Interferant) (% O2) N2O -0.20 CO2 -0.26 H2O -0.03 Halothane -1.93 Isoflurane -1.97 Enflurane -1.97 Desflurane -2.10 Sevoflurane -2.90 Chloroform -1.37 Helium 0.29 NO 42.56 NO2 5.00

The paramagnetic effect of other gases is given in the Servomex Application Note 7986-0073 (available on request). Tilt In the recommended orientation, a tilt of 15 degrees from the horizontal and with N2 in the cell, will cause a change in reading of less than 0.3% O2.

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Shock and Vibration Meets the requirements of BS EN 60068-2-6:1996 (IEC 68-2-6) , BS EN 60068-2-27:1993 (IEC 68-2-27), and IEC 68-2-34. Details of these requirements are given in Appendix 5.3.

1.5 Servomex Paramagnetic Measurement Principles

The Pm1111E utilises the paramagnetic susceptibility of oxygen, a physical property which distinguishes oxygen from most other common gases. The Pm1111E incorporates two nitrogen-filled glass spheres mounted on a strong rare metal taut-band suspension. This assembly is suspended in a symmetrical non-uniform magnetic field. When the surrounding gas contains paramagnetic oxygen, the glass spheres are pushed further away from the strongest part of the magnetic field. The strength of the torque acting on the suspension is proportional to the oxygen content of the surrounding gases.

Figure 1.1 The Servomex Measuring System

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Refer to Figure 1.1. The measuring system is "null-balanced". First, the 'zero' position of the suspension assembly, as measured in nitrogen, is sensed by a split photo-sensor that receives light reflected from a mirror attached to the suspension assembly. The output from the photo-sensor is fed back to a coil wound around the suspension assembly. This feedback achieves two objectives. First, when oxygen is introduced to the cell, the torque acting upon the suspension assembly is balanced by a restoring torque due to this feedback current in the coil. The feedback current is directly proportional to the volume magnetic susceptibility of the sample gas and hence, after calibration, to the partial pressure of oxygen in the sample. A voltage output is derived which is proportional to the current.

Second, the electromagnetic feedback "stiffens" the suspension, damping it heavily and increasing its natural frequency, making the suspension resilient to shock.

1.6 Functional components of the Pm1111E

The main components of the Pm1111E are:

The Transducer Body

The Optical Assembly with Integrated Electronics Board

The Transducer Body

The transducer body consists of the sample cell and the magnet frame.

The sample cell is a precision moulded plastic component sealed on one side by the suspension plate, and on the other side by the gas connectors and back plate. The sample cell fits snugly within the magnet frame. A dust cover is fitted over back of the magnet frame to protect the gas connectors from ingress of particulates during shipping and storage.

Optical Assembly with Integrated Electronics Board The optical assembly consists of a precision moulded plastic plate onto which the integrated electronics board and the small photo-sensor board are fitted. The optical assembly is fitted to the magnet frame. The electronics board is a two part flex-rigid construction, utilising a flexible circuit interconnect and surface mount technology. The smaller rigid board contains the LED source and thermistors. The larger rigid board contains the rest of the electronics, a 16-way IDC connector and the multi-turn zero and span potentiometers. The whole flex-rigid component is mounted onto the optical assembly.

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SECTION 2 Guidelines for the Evaluation and Integration of Pm1111E

This section contains information to help achieve the optimum performance from the Pm1111E during its evaluation and when integrating into the host unit. This section will look at: Handling of the Pm1111E How to minimise exposure of the pneumatic system to contaminants Mechanical arrangement Pneumatic arrangement Electrical arrangement

2.1 Handling of the Pm1111E

2.1.1 Special Packaging The Pm1111E is manufactured under clean conditions. A dust cover is snapped over the gas connectors before the product leaves the clean area to be boxed. The Pm1111E is fitted into an anti-static foam insert designed either for a single unit or for 5 units. Shipments are made in single units or in multiple unit packaging for 5, 20 or 50 units. It is recommended that the single unit and 5-unit anti-static foam inserts are used to store the Pm1111E transducer until required for production. 2.1.2 How to Handle the Pm1111E Remove the Pm1111E body carefully from the anti-static foam packaging, using the recesses cut into the foam to access the side of the transducer. Do not lift the body by the light cover or the dust cover. Although the Pm1111E has no exposed sensitive electronic components, we recommend that the normal anti-static handling procedures are applied. The Pm1111E should be fitted into the OEM equipment under clean conditions in order to minimise the likelihood of contaminants entering the Pm1111E or the OEM system. Do not remove the dust cover until the piping is ready to be fitted to the gas connectors.

CAUTION: The backplate is an integral part of the sample cell. Removal of the

backplate will invalidate the warranty on the product.

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2.2 How to Minimise Exposure of Pneumatic System to Contaminants

Keep the components of the pneumatic system, whether in the laboratory or in

the production assembly area, away from the Adirty@ operations, such as

drilling, packaging, filling, cutting, deburring and finishing. Assemble components in a separate positive pressure controlled room. Ensure all the components in the sample line tubing have been cleaned for oxygen service and are bagged immediately after cleaning.

2.3 Mechanical Arrangement

2.3.1 Mounting Arrangement

The Pm1111E body offers a pair of M4 tapped fixing holes on its base and on two faces. The Pm1111E body can be fitted to the OEM chassis using one of the three pairs of fixing holes, provided the body is mounted in the recommended orientation. Refer to Appendix 5.1 for the dimensional drawing. Ensure there is clear access to the connector and the two potentiometers at the top of the body.

2.3.2 Fitting into OEM Products Designed for the Pm1111D The Pm1111D was fitted using the Servomex mounting bracket (part number 01111/407) or a bracket of a similar design. For backward compatibility, the Pm1111E transducer may be fitted using the mounting bracket. Care should be taken to avoid clamping at the point where the optics assembly meets the body.

CAUTION:

When installing the Pm1111D using the M4 tapped holes note that the maximum insertion depth for the fixing screws is 5mm.

Exceeding this depth may damage the sample cell body.

NOTE:

Do not separate the magnet frame and optics assembly. This will affect the zero setting.

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2.3.3 Location of Transducer

The Pm1111E body should be fixed rigidly to the OEM assembly, away from vibrating components. If the OEM equipment is subjected to extensive mechanical shocks and vibration during use, it may be necessary to mount it on shock absorbers to dampen the impact on the output of the Pm1111E. The Pm1111E should be mounted away from soft magnetic materials. If a soft magnetic material is permanently fitted within 15mm of the Pm1111E, the small error introduced will be nulled out during calibration. Protect the Pm1111E from violent temperature variations, such as from cooling fans, as this can affect both the zero and span calibrations. Fitting the transducer into a temperature controlled environment will overcome varying environmental conditions and optimise its performance.

2.3.4 Orientation of Transducer

The recommended orientation is shown in the drawing given in Appendix 5.1. Namely, with the electrical connector at the top, and the three gas connectors in a vertical line. Orientation other than this may affect the tilt specification.

2.4 Pneumatic Arrangement

2.4.1 Sampling Configuration of Pm1111E

There are two configurations for connecting piping to the Pm1111E, as shown in Figure 2.1.

Fast Response Configuration

The Fast Response Configuration is suitable for providing both oxygen concentration and expired breath measurements.

The Fast Response Configuration uses a AY-connector@ (supplied by OEM) to

split the sample line and feed the two outer gas connectors (numbered 1 and 3 on the body). The central gas connector (number 2 on the body) is used as the outlet. Standard Configuration The Standard Configuration is suitable for the measurement of oxygen concentration in applications where a small flow error is required and a fast response is not necessary. In the Standard Configuration, the sample gas is fed into the top gas connector 1 and vented from the bottom connector 3. The central gas

10

connector 2 is sealed off permanently. Use a short length of 1mm ID tubing, pushed over the end of the gas connector at one end and plugged at the other. Refer to Figure 2.2.

Fast Response Standard Response

Figure 2.1 Sampling Configuration

Figure 2.2 Plug arrangement for Standard Sampling Configuration

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2.4.2 Conditioning of the Sample

The purpose of the sampling system is to convey clean sample gas to the gas transducers, including the Pm1111E, with minimal effect on response time. Particulates and fluids must not enter the sample gas tubing and oxygen transducer, as this may cause blockages and so affect system performance. Field experience has demonstrated that when there is effective filtering of contaminants before the pneumatic system, many years of reliable and maintenance free operation are achievable from Servomex paramagnetic transducers. Attention must be paid to the following areas when designing a pneumatic system:

Particulates: Filtering must remove particles of greater than 3 micron size. Fluids and water: Use of a water separator or catch-pot will prevent inflow into the system.

Humidity: Use a humidity balancing tube such as Nafion, of an appropriate length in the sample line, to reduce the water vapour level prior to entering the transducer. Sample temperature:

By maintaining the transducer at a temperature of around 10C above the gas sample, (but below the specified maximum operating

temperature of 50C) condensation within the sample cell may be avoided. Pump fluctuations: Fluctuations in flow will affect the transducer response time and oxygen output signal. Good flow control is essential for a high performance system. It is recommended that the sample is drawn through the transducer, fitting the pump downstream of the transducer. Depending on the type of sample pump used, it is may be of benefit to install a damping volume of between 5 to 50ml between the transducer and pump to reduce the variation in output due to the pump pulsations. Back Pressure Effects: Restrictions in the exhaust tube will cause the back pressure to vary with changes in flow rate. As the transducer is a partial pressure device, this will result in a change in observed oxygen output. Where the sample is not vented to the atmosphere, such as in a closed loop system, the pressure must be precisely controlled or compensated for.

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Occlusion: A sudden release of an accidental occlusion of the exhaust tube will produce a short term reverse flow in the transducer. Under certain conditions, the magnitude of this reverse flow may be great enough to cause permanent damage to the suspension assembly in the transducer. Under these conditions, it may be necessary to use a one-way check valve to prevent the reverse flow through the transducer cell. Further information is available from the Servomex OEM Customer Applications Engineer. Sample line: The barbed connectors should be fitted with sample tubing with an inner diameter of 1mm. Use consistent inner bore tubing for the sample line in order to avoid sample degradation.

2.4.3 Typical Sample System

The sample system shown in Figure 2.3 may be used to validate the performance parameters of the Pm1111E. It incorporates the elements that help optimise the performance of the Pm1111E in a typical OEM sample system. The final selection of the elements will depend on the application and the performance specification required of the system. Note: The flow through controller 1 should be set around 50ml/min greater than the flow through controller 2 (sample flow rate). Ensure that the flow through controller 2 does not exceed the rated specification of the transducer. The pneumatic components, including pipework, should be cleaned for oxygen service. 2.4.4 How to apply Pressure Compensation to the Signal Output Complete the zero and span calibration procedures described in Section 2.6. Store the pressure output at P1/10 wrt P1/9 as Pcal , the pressure reading taken at calibration. To correct the oxygen output for changes in barometric pressure, apply the

following formula: where: Pcal is the pressure reading taken at calibration. PR is the barometric pressure measured at the time of the oxygen reading.

P

P x Reading Oxygen = Value Oxygen Corrected

r

cal

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Figure 2.3 Typical Sample System

2.5 Electrical Arrangement

2.5.1 Power Supply (to be fitted by OEM)

An external 5V dc power supply is required to drive the electronics, including the LED Source. See Section 1.2 for the specification.

2.5.2 Optional Power Supply for LED Source (to be fitted by OEM)

A separate 5V dc power supply may be used to drive the LED Source. See Section 1.2 for the specification. To implement the external power supplies option: Remove the solder links at LK1 and LK2 on the track side of the PCB. (The PCB is normally supplied with these links shorted). Connect the positive supply to P1/16 and OV to P1/15. Note: Maximum current drawn by the Pm1111E excluding the LED Source is 8mA.

2.5.3 Electrical Connections

All electrical connections to the Pm1111E are made through the 16-way IDC polarised low profile header P1. Refer to Figure 2.4. Note: the Pm1111E may be fitted into an electrical system designed for the Pm1111D.

2.5.4 Earthing Arrangement

The carbon filled body provides a discharge path for any static electricity. The earth terminal on the body must be connected to a star point on the analyser

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chassis.

2.5.5 Remote Zero and Span Adjustment

Optional remote potentiometers for the Zero and Span adjustment may be fitted by the OEM.

Remote zero: The remote potentiometer should be a high resolution multi-turn 10k ohm potentiometer. To use the remote zero adjustment: Adjust the remote Zero potentiometer to its mid-position. Connect the remote potentiometer terminals to P1/1 (CCW), P1/2 (CW) and P1/3 (WIPER). Apply power to the transducer. Select the nitrogen Zero gas. Set Zero gas flow to the sample flow level as seen in the OEM host unit. Adjust the transducer Zero potentiometer so that the output voltage on P1/10

wrt P1/9 reads 0V 0.2mV. Set Zero gas flow to zero using flow control valve on gas supply line. Calibrate as described is Section 2.6. NB: This arrangement sets the transducer zero potentiometer as a coarse

zero adjustment and the remote zero potentiometer as a fine zero adjustment.

Remote span: The remote potentiometer should be a high resolution multi-turn 10kOhm potentiometer.

To use the remote span adjustment:

Adjust the transducer Span potentiometer RV1(shown on drawing in Appendix 5.1) to its fully clockwise position.

Connect the remote potentiometer terminals to P1/7 (WIPER), P1/8 (CW) and P1/11 (CCW). Calibrate as described in Section 2.6.

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P1

Pin No.

Description

1

Remote Zero pot (CCW) (Optional)

2

Remote Zero pot (CW) (Optional)

3

Remote Zero pot (WIPER) (Optional)

4

Not connected

5

Supply 0V

6

Supply +5V

7

Remote Span pot (WIPER) (Optional)

8

Remote Span pot(CW) (Optional)

9

O2 output common

10

O2 output signal

11

Remote Span pot (CCW) (Optional)

12

Not connected

13

Do not connect (Test only)

14

Not connected

15

Optional LED Source Supply 0V

16

Optional LED Source Supply +5V

Figure 2.4 Electrical Connections to Plug P1

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2.6 Operation and Calibration

This section describes how to set up the Pm1111E for the initial evaluation and for calibration under different operating conditions.

2.6.1 Start- up Checks Following installation, it is recommended that the transducer is powered for half an hour at normal operating conditions before calibration.

The transducer should be calibrated at the zero and span points, as follows.

2.6.2 Calibration Equipment

Test gas: Nitrogen Zero gas; Span gas >20% Oxygen concentration. Gas flow controller: 50 to 200 ml/min. Digital Voltmeter (0.1mV resolution) Suitable adaptor to provide access to P1/9 and P1/10.

2.6.3 Calibration Procedure Using Optional Remote Potentiometers

Follow the procedures described in this Section 2.6 replacing references to

AZero@ and ASpan@ potentiometers with ARemote Zero@ and ARemote

Span@ potentiometers.

2.6.4 Calibration Procedure at Sea Level Set flow to zero using flow control valve on gas supply line. Select either Fast Response Configuration or Standard Configuration, as appropriate. Ensure outlet gas connector vents freely to atmosphere to eliminate back-pressure effects. Apply power to the transducer. Select the nitrogen Zero gas.

CAUTION: Care must be taken not to exceed the maximum specified purge

flow rate during the calibration procedure.

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Set Zero gas flow to the sample flow level as seen in the OEM host unit. Adjust the Zero potentiometer so that the output voltage on P1/10 wrt P1/9

reads 0V 0.2mV. Set Zero gas flow to zero using flow control valve on gas supply line. Select the Span gas. Set Span gas flow to the sample flow level as seen in the OEM host unit. Monitor the output voltage on P1/10 wrt P1/9, and set to the required level by adjusting the Span potentiometer. For example, 25% oxygen span gas should be set to produce an output of 250mV. 2.6.5 Calibration at High Altitudes The Pm1111E may be used at any altitude between 250m (770 ft) below sea-level and 5000m (15400 ft) above sea level, after the transducer has been calibrated at the altitude of operation. Apply the calibration procedure described in Sections 2.6.1 - 2.6.4 at the altitude of operation.

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NOTES

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Section 3 TROUBLE SHOOTING GUIDE

The generation of an Aoxygen error@ message by the OEM equipment may be

due to the failure of one or more components of the system. The Trouble Shooting Guide may be used to help eliminate the Pm1111E as the root

cause of the Aoxygen error@ message.

This guide describes the step-by-step tests that may be applied to a Pm1111E to determine whether it is functional, and if it is appropriate to return it to Servomex for further analysis. Follow the flow chart described in Figure 3.1 and perform the appropriate tests as described below. Test 1: Powered Gas Test

Equipment Required:

Power supply for Pm1111E Adapter to access pins on Pm1111E connector P1 1off digital voltmeter (0.1mV resolution). Suitable flow control device (50 =>200/min). Clean dry nitrogen. Clean dry instrument grade air. Clean dry 100% oxygen.

Objectives of Test 1

To confirm that:

The gas ports and sample cell are free of contamination The suspension assembly in the sample cell has not been damaged

Procedure: 1: Connect the transducer under test to the P1 adapter and apply power. 2: Connect the digital voltmeter to P1/10 wrt P1/9, switch on and select

the 2V range. 3: Set the nitrogen test gas flow rate to zero. 4: Connect the transducer to the nitrogen test gas in the fast response

configuration. 5: Set the nitrogen test gas at the host system sample gas flow rate, and

allow the transducer output to settle prior to noting the reading on the voltmeter.

6: Reduce the nitrogen test gas flow rate to zero.

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Figure 3.1 Trouble Shooting Flow Chart

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7: Select the air test gas, ensuring that the sample flow rate is set to zero. 8: Adjust the air test gas to the host system sample gas flow rate, and

allow the transducer output to settle prior to noting the reading on the voltmeter.

9: Reduce the air test gas flow rate to zero. 10: Select the oxygen test gas, ensuring that the sample flow rate is set to

zero. 11: Adjust the oxygen test gas to the host system sample gas flow rate,

and allow the transducer output to settle prior to noting the reading on the voltmeter.

12: Calculate and note the difference in mV between the nitrogen and air

test gas readings. This should be 209mV 30mV. 13: Calculate and note the difference in mV between the air and oxygen

test gas readings. This should be 790mV 120mV. If the transducer fails to fall within either of the stated limits in the air and oxygen tests (Items 12 and 13 respectively) it has failed the Powered Gas Test 1. If the transducer meets the stated figures, it has passed Test 1. Test 2: Visual Examination

Equipment Required:

Philips super drive No1 instrument screw driver. Calibrated torque driver fitted with Philips super drive No1 bit. (Set to 0.4Nm). Stereo microscope. (Magnification range variable 15X => 30X). Anti-static work surface and earthed wrist strap

Objectives of Test 2

To confirm:

The presence of contaminants in the sample cell. The integrity of the optical components and the solder joints.

Procedure: 1: Fit the earthed wrist strap. Holding the transducer securely over the

work bench remove the optics assembly cover. Release the large board on the flexi-rigid PCB by carefully removing the central self-

22

tapping Phillips headed screw holding the board to the optics housing assembly. Take care not to stress the short flexible interconnection to the small board.

2: Release the optics assembly, first by removing the four Phillips headed

screws that hold it to the magnet frame, and then by carefully easing the optics assembly from the transducer body. Make sure that stress is not placed on the solder joints to the black and yellow wires, or the sleeved thermistor leads, as these links the optics assembly to the sample cell.

3: Using the microscope examine the following components and junctions

comprising the optics assembly.

a: Soldered cell feedback connections, yellow & black wires.

b: Soldered photo-cell connections, red & green wires.

c: Photo-cell assembly, checking for damage to or lifting of the photo-cell chips.

d: The LED soldered connections.

4: Using the microscope examine the following features comprising the

sample cell assembly.

a: General sample cell contamination, this could be in the form of particulates or evidence that liquids have been present.

b: The pole piece area should be free from any magnetic particles.

c: The general form of the suspension.

d: Suspension mirror should be clean and not show signs of

corrosion.

e: A gentle movement of the transducer should induce a rotation and then oscillation of the suspension assembly. This would imply that the suspension welds are sound.

If the examination described in Sections 3 and 4 above identifies evidence of contamination or damage, then the transducer has failed the Visual Examination, Test 2. 5: After the visual examination, re-assemble the transducer in the

following sequence.

Fit the optics assembly onto the magnet frame, taking care not to pinch

23

the black and yellow wires connecting this assembly to the sensor cell. Use the torque screwdriver to tighten the four Phillips headed screws in turn, in a diagonally opposite fashion. Place the flexi-rigid board onto its seat on the optics assembly, aligning the board over the two raised lugs. Carefully screw the self-tapping Phillips headed screw into the central hole. Fit the cover onto the optics assembly, by sliding the cover over the board connector at a slight angle and swinging the cover into place at the opposite end in order to clear the board.

Test 3: Re-calibration Procedure

Equipment Required:

Power supply for Pm1111E Adapter to access pins on Pm1111E connector P1 1off digital voltmeter (0.1mV resolution). Suitable flow control device (50 =>200/min). Clean dry nitrogen. Clean dry 100% oxygen.

Procedure: 1: Connect the transducer to the P1 adapter and apply power. 2: Connect and switch on the digital voltmeter, set to the 2V range. 3: Set the nitrogen test gas flow rate to zero, and connect to the

transducer in the fast response configuration. 4: Set the nitrogen test gas to the host system sample gas flow rate, and

allow the transducer output to settle. 7: Monitor the output voltage at P1/10 wrt P1/9 and adjust the zero

potentiometer to give 0V 0.2mV. 8: Select the oxygen test gas, ensuring that the sample flow rate is set to

zero. 9: Adjust the oxygen test gas to the host system sample gas flow rate,

and allow the transducer output to settle. 10: Monitor the transducer output at P1/10 wrt P1/9 and adjust the span

potentiometer to give 1V 2mV.

If the transducer cannot calibrated as above, it has failed Test 3.

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NOTES

25

SECTION 4 Maintenance, Warranty and Product Return 4.1 Tests on Suspected Faulty Transducer

In the event of a suspected product failure, test the transducer by following the instructions given in the Trouble Shooting Guide, Section 3. The Trouble Shooting Guide will provide useful information on whether: .... the transducer is functional (therefore the host system needs examination, and the transducer may be re-used). .... the transducer has been contaminated (and therefore the host system needs examination, and the transducer needs to be fitted with a new cell). .... the transducer is faulty (and therefore should be returned to Servomex for root cause analysis and possible warranty credit). If the transducer has to be returned to Servomex for examination, use the original packing material to prevent damage in transit. All product returns must conform to the requirements of the Decontamination Protocol, described in Appendix 5.5.

4.2 Product Failure during Warranty

Servomex will replace a unit free of charge if it has failed whilst under warranty, providing that any failure is not due to misuse. For example, failures due to excessive flow, excessive pressure, contamination or condensate in the cell is considered as misuse. Under these conditions Servomex reserves the right to charge for replacement.

Removal of the back plate without prior written consent of Servomex will invalidate the warranty. This plate lies inside the magnet frame, and fits over the gas connectors. A pictorial view of this is given in Appendix 5.1.

CAUTION:

For Health & Safety reasons, Servomex reserves the right to refuse to examine product returned without a completed

Decontamination Clearance Certificate.

Apply appropriate anti-static handling procedures. Transducer returns must be packed in the original packing material to

prevent damage in transit.

26

4.3 Product failure out of warranty Servomex will examine transducer returns on request in order to determine the reason for a reported product failure.

4.4 Maintenance

There is No Requirement for Regular Maintenance The Pm1111E offers the Servomex non-depleting paramagnetic technology, which means that the Pm1111E has an unlimited shelf life. The result is, that provided there is adequate control of flow and pressure, with no cell contamination by fluids or particulates, there are no components that will require regular maintenance. Replacement of Sample Cell If the sample cell becomes contaminated, it must be replaced. The new cell must be fitted and the transducer tested and calibrated by Servomex before its re-use. The contaminated cell must be removed by the OEM, following the instructions given in Appendix 5.5, before shipping the transducer to Servomex. Note: Contaminated cells should be disposed of in accordance with local Environmental and Health & Safety regulations. It must not be shipped with the returned product.

4.5 Spares

The available spares are: Transducer Part No 01111E000

Instruction Manual Part No 01111001E/5 4.6 Decontamination of the Pm1111E

In order to meet the requirements of UK Health & Safety legislation, all transducer returns must be accompanied by a completed Decontamination Clearance Certificate. If the transducer has not been exposed to expired breath, it will be sufficient to declare on the certificate that the device is free from biological hazards. If the transducer has been exposed to expired breath during the examination or treatment of a patient, then it will be necessary to decontaminate according to the Servomex Operating Procedure 06-202( given in Appendix 5.4). Decontamination as per SOP 06-202 should not affect the short term functional performance of the transducer. However, Servomex will not warranty the performance of the transducer after decontamination due to the possible impact on long term performance.

27

SECTION 5 APPENDICES

28

Appendix 5.1 Outline Dimensions of Pm1111E (Dwg 01111/823)

29

Appendix 5.2 List of Relevant Clauses of International Standards The clauses below are taken from two International Standards, and have been identified as relevant to the Pm1111E when used in a medical oxygen analyser. The Pm1111E has been tested against the requirements of these clauses, and meets those requirements. Further information on these tests is available from Servomex OEM Customer Applications department.

IEC 1207-1:1994

5.6.1 Intrinsic Error 5.6.2 Linearity Error 5.6.3 Repeatability 5.6.4 Output Fluctuation 5.6.5 Drift: short, medium & long term 5.6.7 Warm up time

ISO 7767:1988

21 Mechanical Strength 44.5 Humidity and condensation effects 50.3 Measurement accuracy 50.6 Stability of measurement accuracy 50.8 Response time 60 Interfering gas and vapour effects 61 Environmental temperature limitations 62 Cyclic pressure 63 Gas leakage and sampling loss 64 Replacement of Oxygen sensor

30

Appendix 5.3 Mechanical Vibration and Shock Resistance The Pm1111E will meet the requirements of the following clauses of the International Standard IEC 68-2 Basic Environmental Testing Procedures.

BS EN 60068-2-27:1993 (IEC 68-2-27) Shock Peak acceleration: 100g (980 m/s2) Duration: 6 msecs Pulse shape: half sine

BS EN 60068-2-6:1996 (IEC 68-2-6) Sinusoidal Vibration

Frequency range: 10Hz to 500 Hz Acceleration amplitude: 1g (9.8 m/s2) Type and duration of endurance: 10 sweep cycles in each axis

IEC 68-2-34 Random Vibration, Wide Band

Frequency Range: 20Hz to 500Hz Acceleration spectral density: 0.02 g2/Hz Duration: 9 mins

31

Appendix 5.4 Decontamination Protocol for Medical OEMs

1.0 PURPOSE.

To ensure that every transducer product return from a Medical OEM customer is rendered free of viable and potentially infectious agents prior to being shipped to Servomex Companies.

2.0 DEFINITIONS

2.1 Biological Hazard:

A product that may contain a viable and potentially infectious agent, putting the person who handles the returned product at risk of infection.

2.2 Biological Decontamination:

A process that renders the returned product free of viable and potentially infectious agents. The end result is a product that may be handled safely.

2.3 Class 6.2

Infectious substances are defined in Class 6.2 of the dangerous goods classification of the United Nations recommendations and ICAO instructions (see Section 5).

3.0 RESPONSIBILITY

3.1 OEM Customer

The Medical OEM customer must treat all transducer returns from its users as a biological hazard.

The Medical OEM customer must ensure that all biological hazards are decontaminated prior to shipment to Servomex. Failure to comply will cause delays and may incur charges.

After decontamination treatment, the OEM customer must complete a Decontamination Clearance Certificate, Form 06-202/1, which must accompany each transducer return.

Note: Decontamination Clearance Certificate is supplied with

every transducer to Medical OEM Customers.

32

3.2 Servomex Companies

It is the responsibility of the Servomex Operating companies to treat all transducer product returns from Medical OEM customers as a biological hazard unless accompanied by a completed Decontamination Clearance Certificate.

In the event that a Decontamination Clearance Certificate does not accompany a product return, then the transducer product return is to be shipped back to the customer in packaging suitable for infectious substances under Class 6.2.

Costs incurred in dealing with such a product return will be chargeable to the OEM customer.

4.0 REQUIREMENTS

4.1 Medical OEM Customers

The part of the transducer normally subject to decontamination treatment depends on the transducer model, as follows:

Pm1111E, Fast Response Oxygen

The whole transducer should be subjected to decontamination treatment. There is no requirement to remove the electronics board.

4.2 Decontamination Treatment

Subject the appropriate part of the transducer to the decontamination treatment as described in Annex C.

4.3 Decontamination Clearance Certificate

After decontamination treatment, the treated part must be re-united with the rest of the original transducer before shipping to Servomex. The Clearance Certificate must be completed and a copy attached to the outside of the return packaging so that it may be inspected prior to unpacking.

5.0 REFERENCES

Infectious substances are defined in Class 6.2 of the dangerous goods classification in:

ARecommendations of the United Nations Committee of Experts on the

Transport of Dangerous Goods by Air@.

ATechnical Instructions for the Safe Transport of Dangerous Goods by Air@,

International Civil Aviation Organisation.

33

6.0 RECORDS

Customers should maintain suitable records for traceability purposes. 7.0 ATTACHMENTS

Decontamination Treatment for Pm1111E Transducer Annex C Decontamination Clearance Certificate Form No: 06-202/1 (To be found at front of the Instruction Manual)

ANNEX C Decontamination Treatment for Pm1111E Transducer

1. Equipment

Clean-Air Workstation Vacuum-assisted Steam Autoclave

Drying Oven at 45C 5C

>Sterilin= Disposal Bag

2 Forceps & Scissors in 70% IMS (Industrial Methylated Spirits) Labels Disposable Gloves & Face Mask Decontamination Log Book & Certificates

2. Procedures

2.1 Don gloves and face mask.

2.2 Remove the transducer from the analyser, or from its packaging, inside the Clean-air workstation.

2.3 Place all packaging into a ASterilin@ disposal bag. Place tools used to

remove packaging in 70% IMS. 2.4 When handling the body, avoid contact with the gas connectors. 2.5 Place tools used to unpack the transducer in 70% IMS.

2.6 Place the transducer into the vacuum assisted autoclave.

34

2.7 Discard the gloves and face mask, in this order, into ASterilin@ disposal

bag.

2.8 Enter serial number of transducer and date in the Decontamination Log Book.

2.9 Treat the devices with saturated steam at 121C and 15psi for 30 minutes.

2.10 Remove the transducer from the autoclave and place in a drying oven

at 45C - 50C for a time necessary to achieve thorough dryness.

2.11 Remove the body from the drying oven and pack with optical assembly for return to Servomex.

2.12 Despatch documentation must include a completed Decontamination

Clearance Certificate. 2.13 Dispose of the disposal bag and contents in the microbiologically

approved manner by prior autoclaving of the bag and contents at 15psi for at least 30 minutes.

Note: The bag must allow for free access of steam to the contents

during the autoclaving process.

35

Appendix 5.5 Removal of Sample Cell Equipment Required:

Philips super drive No1 instrument screw driver. 2mm AF, Allen key. Soldering iron. Anti-static work surface and earthed wrist strap

Procedure: 1: Fit the earthed wrist strap and hold the transducer securely over the

work bench. Carefully remove the optics cover, and then remove the central self-tapping Phillips headed screw. Remove the main control PCB, taking care not to stress the short flexible interconnection to the smaller interconnect PCB.

2: Release the optical assembly by removing the four remaining Phillips

headed screws and carefully ease the optical housing assembly from the transducer body. De-solder the cell feedback connections (black and yellow wires) adjacent to the cell window, and carefully cut the sleeved thermistor leads. Re-fit the control PCB to the optical assembly, taking care not to damage or over tighten the preformed thread in the optical assembly.

3: Remove the security seal from the base of the transducer body to

expose 3 recessed grub screws. Loosen these grub screws such the heads are flush with the transducer body.

4: Holding the transducer firmly against a flat surface, carefully remove

the sample cell from the magnet frame by applying pressure from the gas connector side.

5: Remove the magnets from their recesses in the sample cell, and place

them inside the magnet frame to prevent damage during transport.

6: Place the optical assembly and magnet frame into the original

transducer packaging, and return to Servomex. 7: The sample cell assembly should be disposed of in accordance with

the requirements of local regulations.

CAUTION The magnets used in the transducer have a very strong magnetic field, and extreme care is advised during handling. Their removal from the sample cell is best achieved using the magnet frame or a

piece of soft iron as an extraction tool.

36

NOTES

Revision History Sheet

Manual: 01111001E

Ref No. Page(s) Affected

Summary of Change Changed by Date

01111001E/0-3 All First issue of manual + subsequent ECN, see ECN register for changes

CRE -----

01111001E/0-4 Page 4

Note added regarding flow error and weight of gas.

Processed on ECN 12-050

CRE 04/04/12

01111001E/0-5 26 and 28

Outline dimension drawing 01111/823 shows new label configuration

Processed on Change note 00013

CRE 16/07/13

01111001E_6 Front page and page 2

Updated to reflect RoHS II status

Processed on Change Note 00022 CRE 19/09/13

01111001E_7 Page 28 Update Outline Drawing from Revision 2 to Revision 3

KLD 18/02/14

Printed: