NONIN 8000R Reflectance Pulse Oximeter Sensor Instruction Manual

NONIN 8000R Reflectance Pulse Oximeter Sensor

Indications for Use

The Nonin Model 8000R Reflectance Sensor (Figure 3) is designed for use on well-vascularized skin surfaces of patients weighing greater than 30 kilograms.
The application site will usually be the forehead.
The Model 8000H Reflectance Sensor Holder (Figure 1) and the double-back tape (Figure 2) provide the precise pressure against the skin needed for this sensor. C

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.

Clinical Benefits

Nonin pulse oximeters allow for the management of patients’ medical conditions by providing fast, accurate, real-time, noninvasive oxygen measurement in order to meet patients’ medical needs.

Warnings:

• Do not use the device in an MR environment.
• Use only with Nonin pulse oximeters. These pulse oximeters are manufactured to meet the accuracy specifications for Nonin sensors. Using other pulse oximeters may cause improper sensor performance. Refer to Nonin pulse oximeter operator’s manuals for a complete listing of compatible oximeters, sensors, and accessories.
• Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary due to medical status or skin condition.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.

Cautions:

• To prevent improper performance and/or patient injury, verify sensor and pulse oximeter compatibility before use.
• Do not use a damaged sensor. If the sensor is damaged in any way, do not use, or discontinue use immediately.
• Reflectance sensors are not recommended for pediatric or neonatal use. Sensor accuracy has not been established for pediatric or neonatal use.
• Do not sterilize, autoclave, or immerse in liquid of any kind. Do not spray any liquids into the sensor. Do not sterilize with EtO.
• Do not use caustic or abrasive cleaning agents on the sensors. Do not use cleaning agents containing ammonium chloride.
• Follow local governing ordinances and recycling instructions regarding disposal or recycling of the sensor and any components.
• A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or probe.
• Refer to the pulse oximeter operator’s manual for additional warnings and cautions.
• Discontinue use if the patient exhibits allergic reactions to the adhesive material.
• Do not stretch the adhesive tape while applying the sensor. This may cause inaccurate readings or skin blisters.
• Factors that may degrade pulse oximeter performance include the following:
• excessive ambient light
• excessive motion
• electrosurgical interference
• arterial catheters, blood pressure cuffs, infusion lines, etc.
• moisture in the sensor
• improperly applied sensor
• carboxyhemoglobin
• methemoglobin
• incorrect sensor type
• poor pulse quality
• venous pulsations
• anemia or low hemoglobin concentrations
• cardiovascular dyes
• sensor not at heart level
• dysfunctional hemoglobin
• residue (e.g., dried blood, dirt, grease, oil) in the light path

Symbols:

Symbol

| Definition
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| Follow Instructions for Use
| CAUTION!
| CE Marking indicating conformance to EC Directive No. 93/42/ EEC concerning medical devices
| Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and ingress of solid foreign objects greater than or equal to 2.5 mm in diameter per IEC 60529.
| Lot number
| Use by (applies to 8000H reflectance tape only)
| Importer
| Distributor
| Medical Device
| Quantity
| Unique Device Identifier
| Indicates separate collection for waste electrical and electronic equipment ! (WEEE)
| Storage/shipping temperature range
| Authorized representative in the European Community
| Authorized representative in Switzerland
| Country of manufacture
| Manufacturer
| Catalogue number
| RoHS compliant (China)
| Medical prescription required
| Date of Manufacture
| Handle With Care
| Keep Dry
| Humidity Limitation
| Do Not Reuse

Attaching the Reflectance Sensor

1. Clean the patient’s skin with an alcohol wipe before applying the Reflectance Sensor. Allow the skin to dry before attaching the sensor.
2. Remove the backing from one side of the double-back tape, and apply it to the flange of the Reflectance Sensor Holder (Figure 4).
3. Remove the backing from the other side of the tape.
4. Press the Reflectance Sensor into the foam with the sensor window facing out (Figure 5).
5. Attach the sensor and sensor holder to the patient. Use additional medical tape to secure the sensor and cable to the patient to avoid pulling or tipping the sensor.

Note: Proper sensor placement is critical for good performance. If the sensor is not positioned properly, light may bypass the tissue and result in SpO2 inaccuracies

Cleaning the Reusable Sensor

Cautions:

• Clean the sensor before applying it to a new patient.
• Unplug the sensor from the pulse oximeter before cleaning.
• Do not sterilize, autoclave or immerse the sensors in liquid of any kind. Do not spray any liquids in the sensor. Do not sterilize with EtO.
• Do not use caustic or abrasive cleaning agents on the sensors. Do not use cleaning agents containing ammonium chloride.

1. To clean the sensor, wipe all patient contact surfaces with a soft cloth dampened with a mild detergent or a 10% bleach/90% water solution (household bleach [containing less than 10% sodium hypochlorite]).
2. Allow the sensor to dry thoroughly before reusing.
   Note: To minimize cable deterioration when cleaning the cable, gently wipe away from the plug end towards the sensor end.

Specifications

SpO2 Accuracy1, 2, 3:

• SpO2 Low Perfusion Accuracy: 70% to 100% ±2 digits (Arms*)1

• Pulse Rate Accuracy: 40 to 240 BPM ±3 digits (Arms*)1

• Pulse Rate Low Perfusion Accuracy: 40 to 240 BPM ±3 digits (Arms*)1

• Temperature: 4, 5

• Operating: -20 °C to 50 °C (-4 °F to 122 °F)

• Storage/Transportation: -40 °C to 70 °C (-40 °F to 158 °F

• Humidity: 4, 5

• Operating: 10% to 95% non-condensing

• Storage/Transportation: 10% to 95% non-condensing

• ±1 Arms encompasses 68% of the population at zero bias.

1. SpO2 accuracy was conducted during induced hypoxia study on healthy subjects over the range of 70 % to 100 %.
2. Accuracy specifications based on Nonin’s PureSAT® SpO2 technology and PureLight® sensor technology.
3. Additional accuracy and performance information can be found in the sensor accuracy document on the operator’s manual CD.
4. For combined oximeter/sensor specifications, refer to the applicable oximetry system’s operator’s manual.
5. Range as tested with Nonin’s PureSAT SpO2 technology.

Measurement Wavelengths and Output Power**

Red: 660 nanometers @ 3 mW nominal
Infrared: 910 nanometers @ 3 mW nominal
** This information is especially useful for clinicians.

Compliance

This product complies with ISO 10993.
Not made with natural rubber latex.

Users and/or patients should report adverse events involving their Nonin device to
Nonin Medical, Inc. and the competent authority of the EU Member State in which the user and/or patient is established, if applicable.

Warranty

90 days from the date of delivery.
The sensor’s expected service life is 90 days.
Nonin reserves the right to make changes and improvements to these instructions and the product it describes at anytime, without notice or obligation.

Customer Support

Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
www.nonin.com
E-mail:info@nonin.com
+1763-553-9968
800-356-8874 (US and Canada)

Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email:infointl@nonin.com (Europe)
+31 (0)13 – 45 87 130 (Europe)
MPS, Medical Product Service GmbH
Bomgasse 20
D-35619 Braunfels, Gemany
MedEnvoy Switzerland
Gotthardstrasse 28, 6302 Zug
Switzerland

Documents / Resources

| NONIN 8000R Reflectance Pulse Oximeter Sensor [pdf] Instruction Manual
8000R Reflectance Pulse Oximeter Sensor, 8000R, Reflectance Pulse Oximeter Sensor, Pulse Oximeter Sensor, Oximeter Sensor
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References

• Pulse and Regional Oximeters, Capnographs, Sensors | Nonin

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