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

 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.

I
 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

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:

II
 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

III
 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

IV
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).

1
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

2
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

3
 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.

4
 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

5
 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.

6
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.

7
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.

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.

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.

8
 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

9
 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

10
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 10C above
the gas sample, (but below the specified maximum operating
temperature of 50C) 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.

11
 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

Corrected Oxygen Value = Oxygen Reading x Pcal

Pr

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

12
 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

13
 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.

14
 P1 Description
Pin No.

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

15
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.

CAUTION:
Care must be taken not to exceed the maximum specified purge
flow rate during the calibration procedure.

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.

16
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.

17
 NOTES

18
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.

19
 Figure 3.1 Trouble Shooting Flow Chart

20
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-

21
 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

22
 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.

23
 NOTES

24
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.

25
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.

26
SECTION 5 APPENDICES

27
 Appendix 5.1 Outline Dimensions of Pm1111E (Dwg 01111/823)

28
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

29
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

30
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.

31
 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.

32
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 45C 5C
>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.

33
 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 121C and 15psi for 30
minutes.

2.10 Remove the transducer from the autoclave and place in a drying oven
at 45C - 50C 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.

34
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.

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.

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.

35
 NOTES

Revision History Sheet

Manual: 01111001E

Ref No. Page(s)

Summary of Change Changed by Date
Affected

First issue of manual + subsequent

01111001E/0-3 All CRE -----
ECN, see ECN register for changes

Note added regarding flow error and

01111001E/0-4 Page 4 weight of gas. CRE 04/04/12
Processed on ECN 12-050
Outline dimension drawing 01111/823
01111001E/0-5 26 and 28 shows new label configuration CRE 16/07/13
Processed on Change note 00013

Front page and Updated to reflect RoHS II status

01111001E_6 CRE 19/09/13
page 2 Processed on Change Note 00022
Update Outline Drawing from Revision
01111001E_7 Page 28 KLD 18/02/14
2 to Revision 3

Printed:

36