Orantech SpO2 User manual

The
difference
you can
sense
Veterinary SpO2 Probe
User Manual

2
Intended Use & Indications for Use
T
he
SpO
2
SENSORS
ar
e
in
t
ended
f
or
continuous nonin
v
asive
monit
or
ing
of
func
tional
o
x
y
gen
satura
tion
of
ar
t
er
ial
hemoglobin
(SpO
2
)
and pulse
r
a
t
e
(PR).
These
compa
tible
r
eplacemen
t
sensors
ar
e
in
t
ended
f
or use with major
pulse oximet
er
br
ands
.
T
he
SpO
2
sensors
ar
e
desig
ned
t
o
ma
t
ch
the specifications of the or
ig
inal
equipmen
t
manufac
tur
er
,
ther
ef
ore
c
onfir
m
tha
t
the
appropr
ia
t
e
sensor
model numbers
ar
e
being
used
with the
c
or
r
ec
t
pulse
oximet
er
t
echnology
.
It may be used in the hospital, clinical environment, homecare, and
during emergency land transportation. The SpO2 sensors works with
Compatible device providing SpO2 and pulse rate on horse, rabbit
、
dog and cat.
Principle of Operation
The sensors must be connected to its corresponding monitor.
Blood oxygenation is measured by detecting the infrared and red
light absorption characteristics of deoxygenated hemoglobin and
oxygenated hemoglobin, which consists of a probe attached to
the patient. The sensor is connected to a data acquisition system
which is used to calculate and display oxygen saturation levels and
heart rate conditions.

3
Installation
•
Connect the SpO2 SENSOR to the oximeter’s adapter cable (or
directly into the monitor).
•
Turn the oximeter on and verify proper operation.
•
Select the sensor site on the patient. The preferred sensor sites
are the tongue or anus for animal.
•
Attaching the sensor and clip to the patient’s tongue. Make sure
the light source is the topside of the tongue, just like the figure
as shown in Compatible device.
图1 Attaching the Sensorto the Animal
•
Visually monitor the sensor site to ensure that over time there is
no harm to the patient’s skin.
Caution
•
The sensor and its cable must be cleaned before each patient
use.
•
Do not use the sensor inside or near an MRI.
•
Avoid intense light sources near the sensor.

4
•
For long-term use, the measurement site must be checked and
changed every 2-4 hours in order to guarantee the integrity of
the patient’s skin.
•
Chemicals used in some cleaning agents may cause brittleness
of plastic parts. Follow cleaning instructions in this manual.
•
All user and patient accessible materials are non-toxic.
•
The pins of plug must not be in contact with the cleaning fluid,
otherwise it will cause permanent damage to the SpO2
sensor .
Equipment
•
Connect the sensor adapter cable to the appropriate equipment
(or pulse oximeter).
•
Turn on the equipment and check correct operation by
consulting the monitor’s operation instructions.
•
To ensure proper monitor operations, connect and disconnect
the sensor cable from the monitor cable. The correct, safe use of
the sensor and its connecting cable requires systematic checks
to be carried out at least once or more per month depending on
the frequency of use, as well as disinfecting the cable.
•
Do a visual check (appearance of insulators, connector contact
pins, etc.).
•
Verify the mechanical integrity of the connectors.

5
•
Do not use and discard any sensor that appears to have any
mechanical or electrical flaws.
Performance, Reliability, Safety,
Compatibility & Mechanical Integrity
•
Performance and Reliability
T
his
SpO
2
SENSOR
with its
compa
tible
pulse oximet
er
has
been
v
alida
t
ed and
t
est
ed
f
or
complianc
e with
ISO
80601-2-61.
C
ompar
ative
v
alue measur
emen
t
in
%
satura
tion:
SpO
2
r
ange
(70%
~
100%)
-
Ac
cur
acy
±3%
SpO
2
r
ange
(<70%)
-Not
specified
Pulse rate range: 35
~
240 bpm -Accuracy ±2 bpm
L
o
w perfusion:
SpO
2
r
ange
(70%
~
100%)
-
Ac
cur
acy
±3%
Pulse
r
a
t
e
r
ange: 35~240
bpm
-
Ac
cur
acy
±3
bpm
•
Peak Wavelength and Maximum Output Power:
LED Type
Red Peak
Wavelength
Red Maximum
Output Power
IR Peak
Wavelength
IR Maximum
Output Power
2-Leads
663 nm
1.2 mW
890 nm
1.0 mW
3-Leads
661 nm
1.2 mW
940 nm
1.2 mW
4-Leads
660 nm
1.2 mW
905/940 nm
1.0 mW

6
•
Safety
Degree of protection from electric shocks: type BF
Classification is in accordance with MDD 93/42/EEC: Class IIb
Degree of protection against the ingress of water: IPX2
•
Compatibility
I
n
order
t
o
ensure
compa
tibilit
y and claimed ac
cur
acy
of the
devic
es
,
the
SpO
2
SENSOR should only be used
with the
specified
equipmen
t
f
or
which
they
ha
v
e
been
desig
ned and labeled
f
or
use
.
•
Mechanical Integrity
This sensor is designed to be extremely durable. We use only the
highest quality materials to ensure the sensors stand up to the
demanding hospital environment. The solid connectors are fitted
with flexible sleeves to minimize the risk of cable breakage. They
have no accessible metallic parts.
Cleaning & Disinfecting
Clean the sensor and its connecting cable with warm soapy water
or 70% isopropyl alcohol using a soft, moistened cloth. Carefully
avoid damaging the surface of the visual indicator and the
detector. Allow the sensor and the cable to dry thoroughly before
use. Do not use any abrasive agents or chemical product except
70% isopropyl alcohol.

7
Do not irradiate, autoclave, soak or immerse the sensor in any kind
of solution. Keep the sensor clean and dry.
T
he
a
v
er
age
lif
e e
xpectancy
of a
SpO
2
SENSOR
is more
than
a
y
ear
under
the
conditions
of use
defined in
these opera
ting
instructions
.
Storage & Handling
When not in use, sensors should be loosely coiled and stored at
room temperature. Don’t wrap sensors around equipment cases to
avoid damaging internal wires.
Operating Conditions
•
Ambient temperature: 0°C to +40°C
•
Relative humidity: 15% to 85%
•
Atmospheric pressure: 86 kpa ~ 106 kpa
Storage & Packaging
Each sensor is individually packaged.
The sensor must be stored in its original packaging and within the
storage conditions to maximize the storage life.
Storage conditions are as follows:
•
Ambient temperature: -10°C to +40°C
•
Relative humidity: 15% to 85%
•
Atmospheric pressure: 86 kpa ~106 kpa

8
Shelf Life
5 years.
Warranty & Liability
Orantech offers 12 months warranty against defects in material or
workmanship from the date of purchase. But does not include the
damage or breakage due to the abusive use or negligent care of
the sensors.
Orantech reserves the right to perform warranty service at its
own facility. We guarantee that the products conform to the
specifications of the safety and performance standards
currently in force and applicable to it.
Warning
The sensors should not be fixed to an exposed tissue injury site. Do
not use for hyperactivity blood oxygen monitoring.
•
The sensors are designed for use with specific monitors.
•
The operator is responsible for checking the compatibility of the
monitor, sensor and cable before its use.
•
Incompatible components can result in degraded accuracy and
performance.
•
Consult the operation instructions for the equipment and the
related accessories before operating equipment to ensure their

9
compatibility.
•
Portable and mobile RF communications equipment can affect
the equipment.
•
Do not immerse connector ends in cleaning solution(s).
•
Do not allow service or maintenance on the sensor while being
used on a patient.
•
No modification of this sensor is allowed.
•
The sensors are tested for biocompatibility, there is no risk to the
human body.
•
Do not use this device in the presence of flammable anesthetics
•
or other flammable substance in combination with air, oxygen-
enriched environments, or nitrous oxide.
•
This device is intended for use by persons trained in professional
health care. The operator must be thoroughly familiar with the
information in this manual before using the device.
•
Prolonged use or the patient’s condition may require changing the
sensor site periodically. Change sensor site and check skin integrity,
circulatory status, and correct alignment at least every 2 hours.
•
Significant levels of dysfunctional hemoglobins, such as
carboxyhemoglobin or methemoglobin, will affect the accuracy of
the SpO2 measurement.
•
Any condition that restricts blood flow, such as use of a blood
pressure cuff or extremes in systemic vascular resistance, may

10
cause an inability to determine accurate pulse rate and SpO2
readings.
•
Significant levels of dysfunctional hemoglobins, such as
carboxyhemoglobin or methemoglobin, will affect the accuracy of
the SpO2 measurement.
•
Optical cross-talk can occur when two or more sensors are placed
in close proximity. It can be eliminated by covering each site with
an opaque material.
•
Tissue damage may result from overexposure to sensor light
during photodynamic therapy with agents such as verteporphin,
porfimer sodium, and metatetrahydroxyphenylchlorin (mTHPC).
•
Change the sensor site at least every hour and observe for signs of
tissue damage. More frequent sensor site changes/inspections
may be indicated depending upon the photodynamic agent used,
agent dose, skin condition, total exposure time or other factors.
•
Use multiple sensor sites.
Under certain clinical conditions, pulse oximeters may display dashes if
unable to display SpO2 and/or pulse rate values. Under these conditions,
pulse oximeters may also display erroneous values. These conditions
include, but are not limited to: patient motion, low perfusion, cardiac
arrhythmias, high or low pulse rates or a combination of the above
conditions. Failure of the clinician to recognize the effects of these
conditions on pulse oximeter readings may result in patient injury.

11
Warning: MR Unsafe!
Do not expose the device to a magnetic resonance (MR)
environment.
•
The device may present a risk of projectile injury due to the
presence of ferromagnetic materials that can be attracted by
the MR magnet core.
•
Thermal injury and burns may occur due to the metal
components of the device that can heat during MR scanning.
•
The device may generate artifacts in the MR image.
•
The device may not function properly due to the strong
magnetic and radiofrequency fields generated by the MR
scanner.
Caution
Federal (U.S.) Law restricts this device to sale by or on the order of
a physician.
Waste Disposal
Please
r
ef
er
t
o y
our
local
laws
and
r
egula
tions
f
or informa
tion on
ho
w
t
o dispose
of
SpO
2
SENSORS
.

12
Definition of Symbols

13
Support
To get the support, please contact the representative of manufacturer or local distributor.
The categories shown beloware available forsale through the local distributors ore-commerce.
SpO
2
ECG
NIBP
IBP
TEMP
E
t
CO
2
FETAL
EEG
Orantech Inc.
Zone#A, 4F,1st Bld, 7th Industrial Zone, Yulv Community, GongMing,
Guangming New District, Shenzhen, China 518106
www.orantech.com
(+86) 755 2369 9939
info@orantech.com
REF: M20-M006-01
Cables and Sensors B.V.
Zekeringstraat 21B 1014 BM Amsterdam, Netherlands
Rev: A1
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2
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