Oxford Optronix OxyLite User manual

OxyLite User Manual
Revision 1.1 | May 2015
1
User Manual
OxyLite™
Continuous in vivo and in vitro combined
pO2and temperature monitoring

OxyLite User Manual
Revision 1.1 | May 2015
2
Product Documentation
and User Manual
Revision 1.1
Designed and Manufactured by:
Oxford Optronix Ltd.
19-21 East Central
127 Olympic Avenue
Milton Park
Oxford OX14 4SA
United Kingdom
t: [phone]
f: [phone]
Primary website: www.oxford-optronix.com
Sales email: [email protected]
Support website: www.oxford-optronix.com/support/supp_oxylite.htm
Support email: [e-mail]
OxyLite™ and OxyFlo™ are registered trademarks of Oxford Optronix Ltd.
© Oxford Optronix Ltd. 2015. All rights reserved.

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Table of Contents
1. SAFETY INFORMATION 5
1.1 Intended Use.................................................................................. 5
1.2 Contra-Indications.......................................................................... 5
1.3 FCC Compliance............................................................................ 5
1.4 EMC Compliance – EC Declaration of Conformity......................... 6
1.5 OxyLite Symbols............................................................................ 6
1.6 Definitions ...................................................................................... 6
1.7 Summary of Warnings for the OxyLite Monitor............................... 7
1.8 Summary of Cautions for the OxyLite Monitor................................ 7
1.9 Summary of Cautions for OxyLite Sensors .................................... 7
2. INTRODUCTION 9
2.1 General Description ....................................................................... 9
2.2 List of Key Features..................................................................... 10
2.3 The OxyLite Monitor..................................................................... 12
2.4 OxyLite Sensors........................................................................... 13
2.5 Accessories.................................................................................. 16
3. MONITOR SETUP AND USE 17
3.1 Unpacking and Inspection............................................................ 17
3.2 List of Standard Components....................................................... 17
3.3 Connecting and Powering-up the Monitor.................................... 17
3.4 Connecting / Disconnecting Sensors ........................................... 18
3.5 Display Messages........................................................................ 19
3.6 The SET button............................................................................ 21
3.7 Sensor Shelf Life and Accumulated Longevity............................. 21
3.8 Placement of Sensors in Vivo or in Vitro...................................... 23
3.9 Temperature Compensation......................................................... 23
3.10 Digital (USB) Data Output............................................................ 25
3.11 Analogue Data Outputs................................................................ 25
4. CARE OF OXYLITE 27
4.1 Use of OxyLite.............................................................................. 27
4.2 Cleaning and Storage of OxyLite ................................................. 27
4.3 Handling and Storage of Sensors ................................................ 27
4.4 Cleaning, Disinfection and Sterilization of Sensors...................... 28
4.5 Disposal of Sensors..................................................................... 29
5. TROUBLESHOOTING AND MAINTENANCE 30
5.1 Troubleshooting ........................................................................... 30

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5.2 Simple Sensor Functionality / Calibration Check.......................... 33
5.3 Obtaining Technical Assistance................................................... 34
5.4 Maintenance and Servicing.......................................................... 34
5.5 Returning the OxyLite Monitor...................................................... 35
6. TECHNICAL SPECIFICATIONS 36
7. WARRANTIES 38
7.1 Sensor Warranty.......................................................................... 38
7.2 Monitor Warranty.......................................................................... 38
Figures
Figure 1: Front view of the OxyLite ........................................................... 12
Figure 2: Rear view of the OxyLite............................................................ 12
Figure 3: An OxyLite sensor...................................................................... 14
Figure 4: Connecting and disconnecting a sensor .................................... 18
Tables
Table 1: OxyLite symbols............................................................................. 6
Table 2: Optional accessories for OxyLite.................................................. 16
Table 3: OxyLite display messages............................................................ 20
Table 4: OxyLite analogue output unit conversion ..................................... 26
Table 5: Diagnostic analogue output voltages............................................ 26
Table 6: Common sensor fault codes......................................................... 31
Table 7: OxyLite technical specifications.................................................... 37

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1. SAFETY INFORMATION
This section contains important safety information related to the general use
of the OxyLite monitor. Other important safety information appears
throughout this manual in the form of warnings and cautions.
1.1 Intended Use
The OxyLite monitor is intended for the continuous measurement of pO2
and temperature in tissue (i.e. in vivo), physiological fluids, cell cultures or
other samples (i.e. in vitro).
OxyLite is suited to the determination of tissue or cell culture hypoxia as the
measurement technique is particularly sensitive at low tissue pO2.
OxyLite may be used in conjunction with OxyFlo, a laser Doppler blood flow
monitor that is intended for monitoring microvascular blood perfusion in
tissue. The combination of these two fibre optic measurement systems
provides simultaneous tissue blood flow and oxygenation data. Combined
sensors are available that support simultaneous pO2and blood perfusion
monitoring.
OxyLite is not suited to the measurement of pO2values in excess of
200mmHg or in non-aqueous environments.
1.2 Contra-Indications
OxyLite is purely for laboratory, industrial and research use and is NOT a
medical device. OxyLite does NOT possess requisite regulatory approval(s)
for use with human subjects or patients.
1.3 FCC Compliance
This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause interference, in which case
the user will be required to correct the interference at his/her own expense.

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1.4 EMC Compliance – EC Declaration of Conformity
This equipment meets intent of Directive 2004/108/EC for Electromagnetic
Compatibility. Compliance was demonstrated to the following specifications
as listed in the Official Journal of the European Communities.
EN 61326-1:2006
EN 61326-2-1:2006
1.5 OxyLite Symbols
SN
Serial number
REF
Catalogue number
(product code)
Date of manufacture
Equipment should not
be disposed of in the
normal waste stream
Attention. See
instructions for use.
Read instructions for
use
USB output
Analogue outputs
Table 1: OxyLite symbols
1.6 Definitions
WARNING
A warning indicates the possibility of injury to the operator.
CAUTION
A caution indicates a condition that may lead to equipment
damage and/or malfunction.

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1.7 Summary of Warnings for the OxyLite Monitor
WARNING
Do not attempt to open the OxyLite. There are no user-
serviceable parts inside. There is a risk of electrical shock or
other injury or permanent damage to the monitor.
WARNING
The OxyLite should only be repaired or serviced by Oxford
Optronix Ltd. trained service staff.
WARNING
To avoid the risk of electric shock or shorts, do not spray,
pour or spill any liquid in or on the OxyLite.
1.8 Summary of Cautions for the OxyLite Monitor
CAUTION
DO NOT attempt to operate the OxyLite in the vicinity of
imaging or therapeutic equipment that emits ionising radiation
or produces a strong magnetic field as the performance of
the monitor may be affected.
CAUTION
DO NOT attempt to autoclave, pressure sterilise, or expose
to radiation, any part of the monitor.
CAUTION
Use only sensors, cables and accessories supplied by Oxford
Optronix Ltd.
CAUTION
Failure to pack the OxyLite monitor appropriately for repair or
service may result in potentially costly damage to the monitor
during transit.
1.9 Summary of Cautions for OxyLite Sensors
CAUTION
OxyLite sensors should be HANDLED WITH CARE.
Failure to do so may result in breakage of the internal optical
fibre, loss of the oxygen sensing tip or separation of the cable
from the sensor connector.
REFER TO WARRANTY STATEMENTS PROVIDED AT
THE END OF THIS DOCUMENT.
CAUTION
OxyLite sensors are NOT approved for use on patients.

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CAUTION
The tips of oxygen sensors are fragile and can be damaged
by attempts to clean them without due care and attention.
CAUTION
For safe storage of OxyLite sensors always refit the
protective black cover when a sensor is not in use.
CAUTION
DO NOT drop, stretch or ‘kink’ any part of an OxyLite sensor.
Permanent damage may result.
CAUTION
Attempting to disconnect the sensor by pulling the cable
sleeving instead of the front of the sensor connector may
cause irreparable damage to the sensor.
CAUTION
DO NOT soak or immerse OxyLite sensors in corrosive
solution. Permanent damage may result.
CAUTION
DO NOT store OxyLite sensors in bright sunlight.
CAUTION
AVOID using OxyLite sensors under strong (e.g. surgical)
lights.
CAUTION
The oxygen-sensitive tip of sensors must be isolated from
atmospheric oxygen to ensure reliable in situ oxygen
measurements.
CAUTION
Oxygen sensor calibration accuracy is warranted for a period
of 6 months from factory calibration.
CAUTION
If the sensor connector has been immersed in 70% alcohol
ensure that it is completely free of pockets of non-evaporated
alcohol prior to use.
CAUTION
The effect of exposure to heat, radiation, glutaraldehyde,
ETO gas or plasma on the performance and measurement
accuracy of OxyLite sensors has not been validated.

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2. INTRODUCTION
2.1 General Description
The OxyLite is an instrument capable of continuous, quantitative
measurement of the partial pressure of oxygen (pO2) and temperature in
tissues, physiological fluids, cell cultures and other in vitro applications. pO2
is also variously referred to as an ‘oxygen tension’ or as ‘dissolved oxygen’.
OxyLite is an optical device based upon the principle that the presence of
molecular dissolved oxygen in tissues or fluids can terminate (quench) light
emitted by a fluorescent compound (dye). The quenching of the fluorescent
light is proportional to the pO2in the vicinity of the dye.
The OxyLite system consists of a portable monitor and detachable, re-
usable sensors. The monitor houses a green LED light source, sensitive
photo-detector, a PC module and proprietary signal processing electronics.
All OxyLite sensors comprise a single optical fibre that conducts light from
the monitor to the sensing tip. The sensing tip contains a platinum-based
fluorescent dye held within a polymer matrix.
When the dye is illuminated/excited with light from the monitor, it fluoresces.
The fluorescent light is returned to the monitor using the same optical fibre
and the signal processor determines the fluorescent decay time. From this,
the corresponding pO2is derived. As pO2in the vicinity of the sensing tip
decreases, the extent of quenching decreases and the fluorescence decay
time increases. The quenching process is a purely collisional dynamic where
the energy from the excited fluorescent dye is transferred to the oxygen
molecule during a collision, hence, reducing the emission intensity as well
as the fluorescent lifetime of the dye. Thus, the oxygen content of the tissue
or fluid under investigation is not changed by the measurement process.
Measured pO2is displayed on the monitor’s display in units of either
millimetres of mercury (mmHg) or kilo Pascal (kPa).
Measured pO2is dependent on the local temperature at the sensing tip. In
general it is therefore important that pO2measurements are compensated
for temperature. To this end, the OxyLite monitor incorporates a calibrated
temperature measurement system. The OxyLite monitor performs automatic
temperature compensation and will generate a continuous readout of
temperature when a combined oxygen/temperature sensor is in use.
In order to display an accurate pO2value the OxyLite requires calibration
data. The calibration data is sensor-specific and for maximum ease of use
each sensor is supplied pre-calibrated. The calibration data, as well as setup
information are contained in a miniature ‘EEPROM’ electronic chip integral

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to the sensor connector; these data are automatically read by and
transferred to the OxyLite monitor upon connection.
Available OxyLite functionality is controlled via a functions button at the rear
of the monitor.
Continuous pO2and temperature data from the OxyLite can be acquired for
recording, playback and analysis using a suitable data acquisition system
connected via a choice of interfaces at the rear of the monitor.
2.2 List of Key Features
Absolute units of dissolved oxygen
The fluorescence-based technique employed by the OxyLite type
monitors provides an absolute measurement of dissolved oxygen in
mmHg or kPa. For in vivo applications, this provides a direct readout
of oxygen availability to cells and tissue, in contrast to blood oxygen
saturation assessment (pulse oximetry), which merely describes the
haemoglobin oxygenation status of blood.
Sensitivity and accuracy
Third-generation opto-electronics provide unmatched sensitivity,
stability and accuracy in the physiologically relevant pO2range (0 -
200mmHg) and under conditions of hypoxia (0 – 15mmHg).
No oxygen consumption
Zero oxygen consumption at the point of measurement, thus innately
suitable for continuous and absolute oxygen sensing, even under
conditions of extreme hypoxia.
Microchip sensors
‘EEPROM’ technology embedded within our purpose-designed
connectors provides unsurpassed ease of use and user convenience
by completely eliminating all calibration procedures. Simply ‘plug-in
and go’.
OLED display
High-contrast, 40-character, 140º viewing-angle OLED display.
Built-in temperature compensation
Automatic temperature compensation of the pO2measurement
through optional, integrated temperature sensors.
Versatility
Full support for both in vivo (tissue) pO2applications AND
measurement of dissolved oxygen in vitro (e.g. hypoxic cell culture,
tissue constructs, bioreactors and more).

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Minimally invasive for in vivo applications
Oxygen sensor diameters range from approximately 230µm - 750µm
to suit a host of tissue monitoring applications and cause minimal
tissue disruption in use.
MRI compatible sensors
Dedicated 8m sensors provide support and compatibility for magnetic
resonance imaging.
Single-sensor multi-parameter monitoring
Our OxyLite oxygen and temperature monitor is designed specifically
to be used in tandem with our OxyFlo blood flow monitor, providing
support for simultaneous measurements of tissue oxygenation, blood
flow and temperature using dedicated combined sensors.
USB digital output
A dedicated USB output supports direct streaming of recordings to a
PC running the popular LabChart® Pro charting software. Features
automatic identification of the monitor and pre-loading of configuration
and channel settings for ‘plug and play’ convenience.
Analogue outputs
Continuous data recording to PC or Mac platforms is also supported
via standard analogue data outputs offering compatibility with third
party data recording solutions.
2-year product warranty
OxyLite is supplied with a comprehensive 2-year manufacturer’s
warranty, covering defects in material or in workmanship.

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2.3 The OxyLite Monitor
Figure 1: Front view of the OxyLite
1. Power-on indicator light
2. Alphanumeric OLED display
3. Sensor connector
Figure 2: Rear view of the OxyLite
1. SET button (see section 3.6)
2. BNC analogue output connectors. A = ‘Oxygen (pO2)’; B = ‘Temperature’
3. USB serial output for optional direct data streaming to LabChart® Pro
4. IEC mains inlet (containing fuses) and on/off switch
1
2
3
1
2
3
4

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2.4 OxyLite Sensors
Introduction
A range of pO2sensors are available for use with the OxyLite monitor. In
addition, there are sensors available for the simultaneous measurement of
microvascular blood perfusion when OxyLite is used in conjunction with its
counterpart, the OxyFlo.
All OxyLite sensors comprise a 230µm diameter bare optical fibre, which is
used to direct light to and from the sensing tip. The fibres terminate at one
end of the sensor in the sensing tip (protected beneath a removable black
tubular protective cover) and at the other end in a connector plug that
attaches to the OxyLite. The connector plug is colour-coded with a blue
band.
A durable white polyurethane sleeving serves to protect the optical fibre(s)
along the 2.5m length of the sensor.
The oxygen sensing tip comprises a platinum-based dye held within a
matrix of silicone. A polymer layer encapsulates the tip and the fibre, giving
an overall tip diameter of approximately 250µm (bare-fibre sensors only).
Since measured pO2is dependent on the local tissue temperature, some
OxyLite oxygen sensors are available with integrated temperature sensors.
These monitor temperature from the site of oxygen measurement and
provide automatic temperature compensation of the oxygen measurement.
The temperature sensors are polyurethane-coated T-type thermocouples
that have a diameter of approx. 100µm.
A comprehensive list and detailed description of available sensor types can
be found on our website (www.oxford-optronix.com).
The number of plugs on a sensor is dependent on the number of
parameters being measured. Oxygen and dual-parameter
oxygen/temperature sensors feature a single plug, while triple-parameter
sensors, also incorporating laser Doppler blood flow support feature two
connector plugs. The optional temperature parameter is supported by
additional pins integral to the oxygen connector plug, i.e. no additional
connector plug is required.
In the case of combined sensors the connector plug carrying the laser
Doppler signal is colour-coded with a red band.

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Sensor presentation
OxyLite sensors consist of an optical fibre
used to direct light to and from the sensing
tip.
The fibres terminate at one end in the
sensing tip (protected beneath a black
protective cover) and at the other end in a
connector plug that attaches to the OxyLite.
A durable white polyurethane sleeving
serves to protect the optical fibre(s) along
the 2.5m length of the sensor.
The removable protective cover is push-
fitted into the Tuohy Borst / Luer adapter.
The protective cover serves to protect the
delicate optical fibres and should be refitted
following sensor use and for sensor storage.
The Tuohy Borst / Luer adapter is intended
to accommodate the protective cover
(above) and can also serve to accept a
catheter or needle introducer (refer to
section 3.8 below).
The adapter grips the white sensor sleeving
internally but can itself be removed by
twisting the threaded rear section of the
adapter (arrow) in an anticlockwise
direction.
NOTE: When replacing the adapter and in
order to achieve a secure ‘grip’ on the
sleeving, ensure that the threaded rear
section is twisted tightly.
Figure 3: An OxyLite sensor (‘NX-BF/OT’ type depicted)

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Sensor calibration
All OxyLite sensors are individually factory pre-calibrated prior to dispatch.
Sensor calibration data is stored within integrated ‘EEPROM’ electronic
chips to provide true ‘plug and play’ convenience. The electronic chip
contains detailed, sensor-specific calibration information which is read and
loaded automatically by the monitor upon connection.
Each sensor is uniquely identified with an alphanumeric code of the
following general format ‘XXnnnX’, for example ‘MR007S’.
The sensor ID is printed at the connector (plug) end of each sensor and is
also found on the sensor packaging.
It is not possible for the user to calibrate OxyLite sensors.
CAUTION
OxyLite sensors should be HANDLED WITH CARE.
Failure to do so may result in breakage of the internal optical
fibre, loss of the oxygen sensing tip or separation of the cable
from the sensor connector.
REFER TO WARRANTY STATEMENTS PROVIDED AT
THE END OF THIS DOCUMENT.
CAUTION
OxyLite sensors are NOT approved for use on patients.
CAUTION
DO NOT drop, stretch or ‘kink’ any part of an OxyLite sensor.
Permanent damage may result.
CAUTION
Attempting to disconnect the sensor by pulling the cable
sleeving instead of the front of the sensor connector may
cause irreparable damage to the sensor.
CAUTION
DO NOT soak or immerse OxyLite sensors in any corrosive
solution. Permanent damage may result.
CAUTION
DO NOT store OxyLite sensors in bright sunlight.
CAUTION
AVOID using OxyLite sensors under strong (e.g. surgical)
lights.

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CAUTION
For safe storage of OxyLite sensors always refit the
protective black cover when a sensor is not in use.
2.5 Accessories
The following, non sensor-related accessories are available from Oxford
Optronix Ltd. for use with the OxyLite:
Product Code
Product Description
OLO-BNC
BNC data cables for OxyLite or OxyFlo.
Pack of 2 (1 m)
LABCHART_PRO
LabChart® Pro software (PC/Windows® only), incl. 1
user license and 5 years free updates
VALUE ADC
12 channel analogue output data recorder and PC
software, by Dataq Inc.
POWERLAB
A range of analogue output data recorders and
associated PC or Mac software, by AD Instruments
Table 2: Optional accessories for OxyLite

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3. MONITOR SETUP AND USE
3.1 Unpacking and Inspection
Immediately notify Oxford Optronix Ltd. or your local distributor if the outer
packaging or carton is wet or damaged in any way. Unpack the OxyLite
and its components, ensuring that all items listed on the enclosed packing
list / dispatch note are present. If anything is missing or damaged please
contact Oxford Optronix Ltd. or your local distributor.
NOTE: We recommend that the original shipping carton and shock-
absorbing inserts be stored in a safe place rather than discarded, since
these will be required for any warranty returns and/or for shipping the
OxyLite safely for scheduled servicing.
3.2 List of Standard Components
OxyLite monitor
Country-specific IEC power cable
User Manual (this document)
3.3 Connecting and Powering-up the Monitor
1. Position the unit on a flat and stable surface. Note that the standard
sensor cable length is 2.5 metres (approx. 8 feet).
2. Ensure that the power On/Off switch at the rear of the OxyLite is in
the OFF (0) position.
3. Plug the IEC power cable into the IEC mains inlet at the rear of the
OxyLite and the plug end of the IEC power cable into a wall mains
supply.
4. Power up the monitor via the power On/Off switch at the rear of the
OxyLite. The monitor will automatically detect the mains voltage
(110 - 240V supported). The power-on indicator LED will illuminate
and the monitor will run its internal boot sequence and start-up
checks (approx. 20 seconds in total).
During this time there will be several audible ‘beeps’ and the display
will show a number of messages (see section 3.5) including
confirmation of internal software version and the date/time.
5. Once the display shows ‘No Sensor’ the monitor is ready for sensor
connection and use (see section 3.4).

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3.4 Connecting / Disconnecting Sensors
The OxyLite supports pre-calibrated sensors featuring integrated ‘EEPROM’
electronic chips to provide true plug and play convenience. The electronic
chip contains sensor-specific calibration information which is read and
loaded by the monitor upon connection.
Figure 4: Connecting and disconnecting a sensor
Align the sensor connector such that the arrow is aligned with the black dot
on the instrument connector surround and simply push. The connector will
snap into position and calibration and other sensor information will be read
automatically by the monitor.
Disconnect by twisting the front portion of the sensor connector anti-
clockwise in the direction of the ‘Release’ arrow printed on the connector.
CAUTION
Attempting to disconnect the sensor by pulling the cable
sleeving instead of the front of the sensor connector may
cause irreparable damage to the sensor.

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3.5 Display Messages
The OxyLite front panel displays the pO2and temperature measurements
when a sensor is connected and in use. Other messages, including error
messages are also displayed to the user. A list of messages and their
meaning is provided below:
Message
Description
First message that is displayed during
the OxyLite boot sequence. Analogue
output during this time is 2.5V (50%
scale).
Second message displayed during the
boot sequence. Confirms instrument
model and internal software version.
Analogue output during this time is
2.5V (50% scale).
Third message of the boot sequence.
Displays (factory set) date and time
(GMT). Analogue output during this
time is 0V (0% scale).
There is no sensor connected to the
OxyLite but the monitor has completed
its boot sequence and is ready for use.
Analogue output during this time is
-2.5V (-50% scale).
First message displayed after a sensor
is connected. Confirms the sensor 6-
digit ID in the format XXnnnX, where X
is a letter and n is a number.
Second message after a sensor is
connected. Confirms hours of
accumulated longevity remaining and
the calibration period expiry date (see
section 3.7). If either limit has been
exceeded, press the SET button to
clear (see section 3.6).
Use Left nn hrs
Cal.Expiry dd/mm/yy
Loading
SensorID XXnnnX
No Sensor
Date dd/mm/yy
Time hh:mm
OxyLite
pO2_Soft 2.04
Oxford
Optronix

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Normal display with a sensor
connected, showing real-time pO2and
temperature measurements.
Pressing the SET button when no
sensor is connected allows the user to
choose between mmHg and kPa units
for pO2. The selection is remembered
when the monitor is powered down.
Pressing the SET button when an
oxygen-only sensor is connected
allows the user to select the desired
manual compensation temperature.
Press and hold to scroll. The chosen
temperature is lost when the monitor is
powered down.
Error message displayed when a
sensor reaches the end of its
Accumulated Longevity grace period
(see section 3.7).
Error message displayed when a
sensor reaches the end of its Shelf Life
(see section 3.7).
Indicates a recognized error condition.
Refer to section 5.1 and table 6.
Indicates a potential sensor hardware
condition.
Indicates a potential device hardware
condition.
Table 3: OxyLite display messages
Device Fault (nnn)
XXnnnX
Sensor Fault (nnn)
XXnnnX
Sensor Error (nnn)
XXnnnX
Sensor Expired (1)
XXnnnX
Sensor Expired (3)
Select Setting
Set Temp. nn ºC
Select Setting
Units mmHg
nnn.nmmHg nn.nºC