Covidien Nellcor FLEXMAX, Instructions For Use Manual

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3. CIDEX OPA™* is recommended for high-level disinfection. Follow the manufacturer’s
instructions for use. Immerse the sensor housing in the solution for 12 minutes and
remove.
4. Thoroughly rinse the sensor with water following disinfection (5 minutes minimum
distilled water rinse/soak).
5. Manually dry the sensor and verify the sensor, cable, and connector are dry prior to use.
Environmental Specification
Operational temperature range:
+0°C to +40°C (32°F to 104°F)
Transient operating conditions: Sensor will operate for 20 minutes at -20°C
and +50°C temperature conditions.
Storage, and transport temperature range: -40°C to +70°C (-40°F to 158°F)
Relative humidity range:
15 - 95% non-condensing
Atmospheric pressure range: 620 hPa to 1060 hPa
Stabilization Time (from storage to
operational conditions):
Up to 20 minutes
Biocompatibility
The materials that come into contact with the patient have undergone extensive
biocompatibility testing. Further information is available on request.
IP33 Protected from water spray less than 60 degrees from vertical.
Specifications LED Wavelength Output Power
1
Red: 660nm Peak < 5 mW
Infrared: 885nm Centroid < 5 mW
Accuracy SpO
2
Accuracy:
2
Pulse Rate Accuracy:
3
70 – 100%: A
RMS
≤ 2.5 20 – 250 BPM: ±3 BPM
(refer to monitor’s operating
manual for more information)
<70%: unspecified
Note:
These environmental specifications are specific to the sensor. For information on the
environmental specification of the compatible monitoring systems, please see the Operator’s
Manual for that system.
Note: Because pulse oximeter measurements are statistically distributed, only about two-
thirds of measurements can be expected to fall within ± A
RMS
of the measured values by a
co-oximeter. To verify the function of pulse oximeter probes, a functional tester (Index 2 or
equivalent) can be used.