Oxford Optronix OxyFlo Pro User manual

OxyFlo Pro User Manual
Revision 1.1 | May 2015 1
User Manual
For models
OxyFlo™ Pro
OxyFlo™ Pro XL
Continuous laser Doppler blood flow
monitoring

OxyFlo Pro User Manual
Revision 1.1 | May 2015
2
Product Documentation
and User Manual
Revision 1.1
For the purposes of this User Manual and unless otherwise stated,
OxyFlo Pro shall also mean OxyFlo Pro XL
Designed and Manufactured by:
Oxford Optronix Ltd.
19-21 East Central
127 Olympic Avenue
Milton Park
Oxford OX14 4SA
United Kingdom
t: +44 (0)1235 821 803
f: +44 (0)1235 821 678
Primary website: www.oxford-optronix.com
Support website: www.oxford-optronix.com/support/supp_oxyflo.htm
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 Laser Safety................................................................................... 6
1.6 OxyFlo Pro Symbols ...................................................................... 6
1.7 Definitions ...................................................................................... 7
1.8 Summary of Warnings for the OxyFlo Pro Monitor......................... 8
1.9 Summary of Cautions for the OxyFlo Pro Monitor.......................... 9
1.10 Summary of Cautions for OxyFlo Pro Probes .............................. 10
1.11 Summary of Cautions for Probe Calibration................................. 11
2. INTRODUCTION 12
2.1 General description...................................................................... 12
2.2 List of Key Features..................................................................... 12
2.3 Laser Doppler flowmetry and the OxyFlo Pro............................... 14
2.4 Measurement parameters generated by the OxyFlo Pro ............. 14
2.5 The OxyFlo Pro Monitor............................................................... 16
2.6 OxyFlo Pro Probes....................................................................... 19
2.7 Accessories.................................................................................. 21
3. MONITOR SETUP AND USE 22
3.1 Unpacking and Inspection............................................................ 22
3.2 List of Standard Components....................................................... 22
3.3 Connecting and Powering Up the Monitor.................................... 22
3.4 Connecting / Disconnecting Probes............................................. 24
3.5 The Touch-Screen Display........................................................... 25
3.6 Probe Calibration ......................................................................... 29
3.7 Placement of Probes.................................................................... 34
3.8 Digital (USB) Data Output............................................................ 35
3.9 Analogue Data Outputs................................................................ 36
4. CARE OF OXYFLO PRO 38
4.1 Use of OxyFlo Pro........................................................................ 38
4.2 Cleaning and Storage of OxyFlo Pro............................................ 38
4.3 Handling and Cleaning of the Touch Screen................................ 38
4.4 Handling and Storage of Probes.................................................. 38
4.5 Cleaning, Disinfection and Sterilization of Probes........................ 39
4.6 Disposal of Probes....................................................................... 40

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5. TROUBLESHOOTING AND MAINTENANCE 41
5.1 Troubleshooting ........................................................................... 41
5.2 Simple Probe Integrity Check....................................................... 45
5.3 Obtaining Technical Assistance................................................... 45
5.4 Maintenance and Servicing.......................................................... 46
5.5 Returning the OxyFlo Pro Monitor................................................ 46
6. TECHNICAL SPECIFICATIONS 48
7. WARRANTY 49
Figures
Figure 1: Front view of the OxyFlo Pro...................................................... 16
Figure 2: Rear view of the OxyFlo Pro ...................................................... 17
Figure 3: Side-view of OxyFlo Pro, showing open probe connector bay... 18
Figure 4: The OxyFlo Pro universal AC adapter........................................ 18
Figure 5: An OxyFlo Pro probe.................................................................. 19
Figure 6: Connecting and disconnecting a probe...................................... 24
Figure 7: The touch screen display with no probes connected.................. 25
Figure 8: Touch screen display with 2 probes connected.......................... 25
Figure 9: The touch screen settings toolbar.............................................. 26
Figure 10: The touch screen probe status dialogue .................................. 28
Tables
Table 1: OxyFlo Pro symbols....................................................................... 7
Table 2: Optional accessories for OxyFlo Pro............................................ 21
Table 3: Touch screen default toolbar icons............................................... 26
Table 4: Touch screen settings toolbar icons............................................. 27
Table 5: Probe status dialogue icons ......................................................... 29
Table 6: Calibration error codes................................................................. 33
Table 7: Parameter identification on analogue output data cable............... 37
Table 8: OxyFlo Pro analogue output unit conversion................................ 37
Table 9: Analogue output voltages during monitor boot and error states... 37
Table 10: OxyFlo Pro technical specifications............................................ 48

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1. SAFETY INFORMATION
This section contains important safety information related to the general use
of the OxyFlo Pro monitor. Other important safety information appears
throughout this manual in the form of warnings and cautions.
1.1 Intended Use
The OxyFlo Pro is a laser Doppler blood flowmetry (LDF) monitor intended
for monitoring microvascular blood flow in tissue.
Most applications are concerned with monitoring the competence of
regional (microvascular) blood supply in specialties such as peripheral
vascular disorders, cerebral perfusion monitoring in models of stroke and
brain injury, tumour perfusion monitoring / angiogenesis, blood flow in free
flaps and pedicle flaps, wound healing, surgery, transplantation and more.
A range of fibre-optic based probes is available in support of these
application areas, including small and lightweight probes for (non-invasive)
skin and tissue surface measurements and needle type probes for direct
(invasive) measurements within tissue, such as muscle and vitals organs.
In common with all LDF devices, quantitative measurements of tissue blood
flow in absolute units (e.g. ml/min/g of tissue) are not possible with the
OxyFlo Pro.
The OxyFlo Pro has been specifically developed for use with the OxyLite
Pro, a fibre optic tissue pO2and temperature monitor. 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 flow monitoring.
1.2 Contra-Indications
The OxyFlo Pro is purely for laboratory, industrial and research use and is
NOT a medical device. The OxyFlo Pro does NOT possess regulatory
approvals 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

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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.
1.4 EMC Compliance – EC Declaration of Conformity
This equipment meets the 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 Laser Safety
WARNING
Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous
radiation exposure.
WARNING
Never apply an OxyFlo Pro probe directly to the eye. The
laser exposure may cause permanent damage to the retina.
OxyFlo Pro is classified as a Class 1 Laser Product in accordance with the
European Standard EN 60825-1:1994 and 21 CFR 1040.10 and 1040.11.
In accordance with the standard, the back panel of the monitor carries the
declaration:
Class 1 Laser Product
OxyFlo Pro incorporates semiconductor laser diode devices operating in
continuous mode and emitting invisible laser radiation at a nominal
operating wavelength of 830nm. The maximum output power at the probe
tip is less than 0.5mW. Laser light emitted from the optical fibre is highly
divergent.
Although the characteristics of the laser radiation place the OxyFlo device
within the Class 1 classification, users should avoid directing the laser
radiation onto the eye.
Applying the probe to any tissue other than the eye is harmless, even over
prolonged time periods.
1.6 OxyFlo Pro Symbols
SN
Serial number
REF
Catalogue number
(product code)

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Date of manufacture
Equipment should not
be disposed of in the
normal waste stream
Attention. See
instructions for use.
Read instructions for
use
Alternating current
Direct current
Digital output
Analogue outputs
Table 1: OxyFlo Pro symbols
1.7 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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1.8 Summary of Warnings for the OxyFlo Pro Monitor
WARNING
Do not attempt to open the OxyFlo Pro. 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 OxyFlo Pro should only be repaired or serviced by
Oxford Optronix Ltd. trained service staff.
WARNING
Use ONLY the NX-PSU universal AC adapter provided by
Oxford Optronix. Failure to do so may result in irreparable
damage to the OxyFlo Pro monitor and may cause harm to
the user.
WARNING
To avoid the risk of electric shock or shorts, do not spray,
pour or spill any liquid in or on the OxyFlo Pro.
WARNING
Never apply an OxyFlo Pro probe directly to the eye. The
laser exposure may cause permanent damage to the retina.

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1.9 Summary of Cautions for the OxyFlo Pro Monitor
CAUTION
To avoid damage, do not use sharp objects to operate the
touch screen display.
CAUTION
To avoid damage, do not spray, pour or spill any liquid on the
touch screen display.
CAUTION
DO NOT attempt to operate the OxyFlo Pro 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. Extended probe lengths are
available that allow the OxyFlo Pro monitor to be operated at
a safe distance from such equipment.
CAUTION
DO NOT attempt to autoclave, pressure sterilise, or expose
to radiation, any part of the monitor.
CAUTION
Connecting the NX-PSU universal AC adapter to the DC
POWER IN inlet at the rear of the OxyFlo Pro, having already
powered it via its On/Off switch MAY trigger the surge
protection circuit within the OxyFlo Pro. If the OxyFlo Pro
does not start up, turn off the AC adapter, wait 2 - 3 minutes,
then turn the AC adapter on once more.
CAUTION
Attempting to disconnect the probe by pulling the cable
sleeving instead of the probe connector may cause
irreparable damage to the probe.
CAUTION
Use only probes, cables and accessories supplied by Oxford
Optronix Ltd., otherwise serious damage may result.

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1.10 Summary of Cautions for OxyFlo Pro Probes
CAUTION
OxyFlo Pro probes must be HANDLED WITH CARE.
Failure to do so may result in breakage of the internal optical
fibres, scratching the polished probe ends or separation of
the cable from the probe ends or connectors.
CAUTION
OxyFlo Pro probes are NOT approved for use on patients.
CAUTION
DO NOT drop, apply tension or ‘kink’ any part of an OxyFlo
Pro probe. Permanent damage may result.
CAUTION
OxyFlo Pro probes should be stored, with the probe cable
carefully coiled to avoid ‘kinks’, in the dedicated protective
case in which they are supplied.
CAUTION
Do not use a probe if it appears worn or damaged.
CAUTION
Avoid immersing the probe connector in any cleaning
solution.
CAUTION
If the probe connector has been immersed in 70% alcohol
ensure that it is completely free of pockets of non-
evaporated alcohol prior to use.
CAUTION
The effectiveness of ETO gas, radiation or plasma methods
for probe sterilization has not been validated.
CAUTION
It is the responsibility of the user to validate the sterility of
OxyFlo probes after sterilisation.

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1.11 Summary of Cautions for Probe Calibration
CAUTION
It is essential that the calibration procedure is performed on a
stable and vibration-free surface. Any movement or vibration
during the calibration procedure - however slight - is likely to
result in a failed calibration.
CAUTION
The motility standard has a limited life. The expiry date is
indicated on the label. The solution must not be used beyond
this date, as it may produce misleading values due to the
gradual aggregation of the latex spheres.
CAUTION
Do not use the motility standard in ambient temperatures
below 15ºC or above 25ºC.
CAUTION
Store the motility standard within the temperature range 3 –
25ºC. DO NOT FREEZE the solution.
CAUTION
Do not dilute the motility standard.
CAUTION
It is important that all probes to be used with any one OxyFlo
Pro monitor have different probe identification numbers in
order to prevent possible probe calibration errors. Please
contact technical support for advice.

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2. INTRODUCTION
2.1 General description
The OxyFlo Pro is a microvascular blood flow monitor that is capable of
monitoring red blood cell (erythrocyte) perfusion in the microcirculation of a
tissue.
The monitor uses a technique referred to as Laser Doppler Flowmetry
(LDF), an established and reliable method for the measurement of blood
perfusion in microvascular research.
OxyFlo Pro probes plug into the OxyFlo Pro monitor, which contains the
laser source and sensitive photo-detection and signal processing circuitry.
Probes are standardised using a reference motility standard consisting of
latex microspheres undergoing Brownian motion.
Microvascular blood flow is indicated on the touch screen display in relative
units called Blood Perfusion Units (BPU).
The OxyFlo Pro laser Doppler blood flow monitor is available in two
configurations;
OxyFlo Pro
A dual-channel device, capable of monitoring up to two independent tissue
sites simultaneously.
OxyFlo Pro XL
A four-channel device, capable of monitoring up to four independent tissue
sites simultaneously.
2.2 List of Key Features
Continuous tissue blood flow assessment
Uncompromised reliability in continuous tissue blood flow assessment;
ideally suited to measurements of changing tissue blood flow in acute
experimental models.
Versatility
A range of probe types and probe formats provide support for a host of
specialist disciplines and applications requiring either invasive or non-
invasive tissue blood flow assessment.
ART
A proprietary artefact rejection technology that effectively filters out the
presence of motion artefacts in the blood flow signal. Substantially
reduces and in most cases, completely eliminates motion artefacts or

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‘spikes’ in the blood flow data arising from probe cable movement
and/or regular tissue movement (e.g. due to breathing).
Plug and play
Probes require no calibration procedures or configuration following
one-time probe calibration. Probes supplied at the time of monitor
shipment are supplied factor pre-calibrated.
Touch-screen display and interface
A touch-sensitive, high-contrast, 140º viewing-angle screen displays
real-time data in both digital and graphical (trace) formats, and
provides access to instrument/user settings.
Multi-channel productivity
Available in dual or 4-channel models to suit all needs including the
simultaneous monitoring of blood flow from multiple tissue sites (e.g.
comparison of pathological versus control tissue sites).
Upgradeable
The OxyFlo Pro dual-channel model can be factory upgraded to the 4-
channel OxyFlo Pro XL device.
Multi-parameter monitoring
Our OxyFlo Pro blood flow monitors are designed specifically to be
used in tandem with our OxyLite Pro range of oxygen monitors,
providing support for simultaneous measurements of tissue
oxygenation, blood flow and temperature from each combined sensor.
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 data 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.
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
2-year product warranty
Our comprehensive manufacturer’s warranty covers defects in
material, function or in workmanship for a period of 2 years following
delivery.

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2.3 Laser Doppler flowmetry and the OxyFlo Pro
Laser Doppler Flowmetry (‘LDF’) is an established and reliable method for
the measurement of blood perfusion in microvascular research that in no
way harms or disturbs the normal physiological state of the microcirculation.
The OxyFlo Pro blood flow monitor implements this method by illuminating
tissue with low power laser light using a probe containing optical fibre light
guides. Laser light from one fibre is scattered within the tissue and some is
scattered back to the probe. A second optical fibre collects the
backscattered light from the tissue and returns it to the monitor. Most of the
light is scattered by tissue that is not moving but a small percentage of the
returned light is scattered by moving red blood cells. The light returned to
the monitor undergoes signal processing to extract the signal related to the
moving red blood cells.
Laser Doppler signals from the tissue are recorded in BPU (Blood Perfusion
Units) which is a relative units scale defined relative to a carefully controlled
motility standard comprising a suspension of latex spheres undergoing
Brownian motion.
Perfusion is also referred to as tissue blood flow, microvascular blood flow
or red blood cell flux.
In common with all LDF devices the OxyFlo Pro generates arbitrary, non-
absolute units of tissue blood flow since the tissue sampling volume cannot
be reliably established. Thus, LDF is best suited to observations of
continuous, acute changes in blood flow relative to a baseline (control)
obtained within the same experiment.
In other words, measurements obtained by LDF are intrinsically of a relative
nature; although such measurements are proportional to perfusion, the
factor of proportionality will be different for different tissues.
2.4 Measurement parameters generated by the OxyFlo Pro
The blood flow (BPU) parameter
The primary function of the OxyFlo Pro is to produce a tissue blood flow
output signal that is proportional to the red blood cell perfusion (or flux) in
the area of tissue being investigated. This represents the transport of blood
cells through the microvasculature and is defined as,
Tissue blood flow
=
Number of blood cells moving in
the tissue sampling volume
x
Mean
velocity of
these cells
Tissue blood flow therefore, is the product of mean blood cell velocity and
mean blood cell number (concentration) present in the measuring volume of
tissue under illumination from the probe.

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For the OxyFlo Pro, tissue blood flow is indicated in relative units called
Blood Perfusion Units (BPU). All OxyFlo Pro monitors have been calibrated
with a constant, known motility standard so that, for a given blood flow
situation, all OxyFlo Pro probes will read the same value of blood flow
expressed in BPU.
The standard BPU output has been optimally filtered with a time constant of
200ms to give a clean and smooth looking signal whilst able to respond to
dynamic changes and pulsatile blood flow changes.
The ‘ART’ parameter
ART is a processed version of the standard blood flow output, also
measured in arbitrary ‘BPU’ units, in which a proprietary artefact rejection
algorithm effectively filters out the presence of motion artefacts in the blood
flow signal. This substantially reduces motion artefacts or ‘spikes’ in the
blood flow data arising from regular probe cable movement and/or regular
tissue movement (e.g. due to breathing), as well as unwanted spikes e.g.,
from accidental cable movement. The ART parameter can be output on the
secondary data channel for each probe, via the touch screen (see table 4).
The ‘RAW’ parameter
The optional ‘RAW’ output is a version of the standard blood flow output
that is subject to reduced filtering. This provides faster response times to
rapid blood flow changes, at the expense of a degree more noise. The RAW
parameter can be output on the secondary data channel for each probe, via
the touch screen (see table 4).
The ‘Backscatter’ parameter
The OxyFlo Pro also generates a signal which is proportional to the total
light remitted or backscattered from the tissue. This is called the
Backscatter Signal (BS).
Backscatter is expressed as a percentage (%) fraction of the laser light
remitted from the tissue relative to the total amount of laser light incident on
the tissue.
For example, in highly perfused tissues the BS will be low due to increased
photon absorption. Situations where the BS signal is close to zero may
indicate that the probe has come into contact with whole blood, this could
cause the BPU reading to saturate since the system is no longer monitoring
microvascular blood flow.
The backscatter parameter too can be output on the secondary data
channel for each probe, via the touch screen (see table 4).

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2.5 The OxyFlo Pro Monitor
Figure 1: Front view of the OxyFlo Pro
1. Power-on indicator light.
2. Sensor connector bay (one on each side for OxyFlo Pro XL).
3. Touch-screen display (with adjustable viewing angle).
1
2
3

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Figure 2: Rear view of the OxyFlo Pro
1. On/Off switch
2. Low voltage power inlet (use ‘NX-PSU’ universal AC Adapter only)
3. Analogue output connectors:
Ch 1 / Ch 2 (common to all OxyFlo Pro models)
Ch 3 / Ch 4 (OxyFlo Pro XL model only)
4. USB serial output for optional direct data streaming to LabChart® Pro
5. Symbols applicable to OxyFlo Pro
1
2
3
4
5

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Figure 3: Side-view of OxyFlo Pro, showing open probe connector bay
1. Channel 1 probe connector
2. Channel 2 probe connector
3. Push-release latch opens side panel to reveal probe connector bay
Channel 3 and Channel 4 probe connectors (OxyFlo Pro XL model only) are
located inside the connector bay on the right-hand side of the monitor.
Figure 4: The OxyFlo Pro universal AC adapter
NOTE: Use ONLY the universal AC adapter provided by Oxford Optronix.
Failure to do so may result in irreparable damage to the OxyFlo Pro monitor.
1
2
3

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2.6 OxyFlo Pro Probes
Introduction
A comprehensive range of Laser Doppler probes is available for use with
the OxyFlo Pro monitor, a description of which can be found on our website
(www.oxford-optronix.com).
All probes are comprised of a pair of 125 μm optical fibres, which are used
to direct low power laser light to and from the tissue. The fibres terminate at
one end of the probe in the probe head (of variable design, depending on
probe type) and at the other end in a connector plug that attaches to the
OxyFlo Pro. The connector plug is colour-coded with a red band.
OxyFlo Pro probes are either referred to as ‘dedicated blood flow probes’,
for the exclusive measurement of tissue blood flow, or as ‘combined
sensors’ for the simultaneous measurement of tissue blood flow and tissue
pO2/temperature, where the OxyFlo Pro is used in conjunction with its
optional counterpart, the OxyLite Pro.
The number of plugs on a sensor is dependent on the number of
parameters being measured. Dedicated blood flow probes feature a single
plug, while combined sensors featuring support for tissue pO2/temperature
measurements (and requiring the counterpart OxyLite Pro monitor), feature
two connector plugs.
In the case of combined sensors, the connector plug carrying the
oxygen/temperature signal is colour coded with a blue band.
Probe Presentation
OxyFlo Pro probes consist of a pair of
optical fibres used to direct weak laser light
to and from the probe head.
The fibres terminate at one end in the probe
head (MSP300NX surface probe type
depicted here) and, at the other end, in a
connector plug that attaches to the OxyFlo
Pro (colour-coded with a red band).
A durable white silicone sleeving serves to
protect the optical fibres along the 3 m
length of the probe.
Figure 5: An OxyFlo Pro probe (‘MSP300NX’ type depicted)

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PROBE-RELATED CAUTIONS:
CAUTION
OxyFlo Pro probes must be HANDLED WITH CARE.
Failure to do so may result in breakage of the internal optical
fibres, scratching the polished probe ends or separation of
the cable from the probe ends or connectors.
CAUTION
The optical fibres used in OxyFlo Pro probes consist of glass
with a diameter of 125 µm. The fibres are flexible and can be
bent, however it is recommended that they are not subjected
to bends with a radius of less than 30mm.
CAUTION
DO NOT drop, apply tension or ‘kink’ any part of an OxyFlo
Pro probe. Permanent damage may result.
CAUTION
OxyFlo Pro probes are NOT approved for use on patients.
CAUTION
Do not use a worn or damaged probe.
CAUTION
OxyFlo Pro probes should be stored, with the probe cable
carefully coiled to avoid ‘kinks’, in the dedicated protective
case in which they are supplied.
CAUTION
Avoid using OxyFlo Pro probes under strong (e.g. surgical)
lights.
This manual suits for next models
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