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Placement of a sensor on an extremity with a blood pressure
cuff, arterial catheter or intravascular line;
Low perfusion;
Electrosurgical units.
The monitor can be used during defibrillation, but the readings may
be inaccurate for a short time.
5.2.7 Riester / Biolight SpO2 Sensors and Extension cables
a) Sensors
Model: 15-100-0013, 15-100-0015
Intended use:
Intended use of the non-invasive pulse oximeter probe is during
continuous non-invasive arterial oxygen or hemoglobin saturation
measurement or during pulse rate monitoring. The probes may be
used in co-ordination with a variety of other equipment of the non-
invasive pulse oximeter.
Contraindications:
The probe may be used on the same location for a maximum of 4
hours, provided the location is inspected routinely to ensure skin
integrity and correct positioning. Because individual skin condition
affects the ability of the skin to tolerate probe placement, it may be
necessary to change the probe location more frequently with some
patients.
Instruction:
a) Select a suitable location for the probe. The patient's index finger
is the preferred location, alternative recommended locations are
middle or ring finger.
b) As shown on figure 2 , place the index finger over the sensor
window into the probe with the fingertip against the stop. The probe
should be positioned with the cable showing above the finger and
hand.
Note:
If the probe doesn't track the pulse reliably, it may be po-
sitioned incorrectly. It is possible that the diameter of the
finger might be too thick, too thin, or deeply pigmented.
Otherwise it might also be too deeply coloured (for exam-
ple, as a result of externally applied coloring such as nail
polish, dye, or pigmented cream) to permit appropriated
light transmission . . If any of these situations occurs, re-
position the probe or choose an alternate probe to be used
at a different location.
Warning:
The operator or user is responsible for checking compa-
tibility of monitor, probe and cable before use. Otherwise,
incompatible components can result in patient injury or
inferior performance.
Failure to apply the probe properly may cause incorrect
measurements.
Using in the presence of bright light may result in inaccu-
rate measurements. In such cases, cover the probe loca-
tion with an opaque material.
Intravascular dyes or externally applied coloring such as
nail polish, dye, or pigmented cream, may lead to inaccu-
rate measurements.
Heavily moving fingers of active patients affect and/or may
compromise the performance of the probe. The use of the
probe is not recommended for such patients.
Do not use any tape to secure positioning of the probe or
on any fingers directly. Strong venous pulsations may re-
sult in inaccurate saturation measurements.
As with other medical devices likewise, do carefully position cables
in order to reduce possible patient entanglement or strangulation.
Do not use the probe during MRI scanning. Conducted current may
cause burns. The probe may as well affect the MRI image, , and the
MRI unit may affect the accuracy of oximeter measurement.
Do not assess the probe's accuracy only by testing it on a oximetry
simulation device.
Do not do NIBP measurement or use other instruments on the
same arm as the SpO2 probe. Interruption of flow of blood by an
NIBP cuff or special circulatory condition of the patient may result
in no pulse found or a loss of pulse.
Do not reprocess or modify the probes. Performance or accuracy of
probes may otherwise be affected. .
Do not disassemble or repair probes, as it may result in product
damage of operator injury. Such wrongdoings will be regarded as
severe product misuse and a breach of warranty and thus result in
a complete loss of all warranty claims thereafter.
Disposal of the pulse oximeter probe and extension cable shall
comply with laws of the local government. Please contact your local
government authorities regarding such relative local rules. .
Specifications:
Peak wavelength: Red 660-666nm, IR 895-920nm
Maximum optical output power: 2mW
Measurement Range: SpO2 0% ~ 100%
Arms: 70% ~ 100% SpO2: ±2%
0 ~ 69% SpO2: unspecified
Notes:
The accuracy can be reached only in normal working con-
ditions.
Required working conditions:
Range of temperature: 10°C ~ 40°C
Relative humidity: 30% ~ 75%
Required transport and storage conditions:
Range of temperature: -40°C ~ +70°C
Relative humidity:
93%
Cleaning and disinfection:
Use a clean, soft cloth to wipe the probe with 70% isopropyl alco-
hol. Do not use undiluted bleach (5%~5.25% sodium hypochlorite) or
any cleaning solution other than those recommended here because
permanent damage to the probe may occur.
Clean and disinfect the probe after use.
Saturate a clean, soft cloth with 70% isopropyl alcohol. Wring out
excess isopropyl alcohol and wipe all surfaces of the probe and ca-
ble.
Dry all surfaces of the probe and cable with a clean, soft cloth.
Caution: Do not sterilize by irradiation, steam, or ethylene
oxide. These sterilization methods may damage the probe.
b) Extension cables
1. Introduction
Description of function
The SpO2 extension cable is a type of cable connecting the pulse
oximeter sensor cable with the SpO2 main board thus prolonging
the signal transmission distance. .
2. Required working and storage conditions:
Range of working temperature 1°C ~ +40°C
Range of storage temperature -20°C ~ +60°C (inside box),
-20°C ~ +50°C (outside of box)
Humidity: 30% – 75%
c) Transportation
The packaged product may be transported by any means of trans-
port. However, during transport collision, severe vibrations or any
exposure to severe weather conditions such as rain, snow, flooding,
etc. must be avoided by any means.
Storing goods in any kind of open-air warehouse may severely da-
mage the product and may lead to loss of performance.
d) Storage
The product shall be stored in a dry and ventilated environment,
free of any acid, alkali or other corrosive gases. The temperature
and humidity conditions in such warehouse shall be within -20°C -
+60°C, and in between of 30% -70% relative humidity.
e) Cleaning and disinfection
Please use the following materials for cleaning and disinfection:
green soap, green soap (USP) or non-alcoholic hand soap;
• 2% Glutaraldehyde solution (such as Cidex)
• 10% Aqueous sodium hypochlorite solution (Bleach).
f) Life requirements
If the product is used in normal environment conditions, correctly
operated, cleaned and disinfected, the working life is minimum two
years. Maximum shelf life: 4 years
g) Using Steps:
1) Check the product in order to make sure it is not damaged.
2) Clean the product.
3) Connect the 12P plug to the appropriate connector on the instru-
ment.
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