NONIN 8000J Adult Flex Pulse Oximeter Sensor User Manual

NONIN 8000J Adult Flex Pulse Oximeter Sensor

Model 8000J, 8000J-WO, and 8000J-WO2 Reusable Adult Flex Pulse Oximeter Sensor. Model 8000JFW FlexiWrap®, Single-Use Sensor Wrap.

Indications for Use

Nonin’s Model 8000J, 8000J-WO, and 8000J-WO2 Adult Flex Sensors are designed for continuous monitoring of adult and pediatric patients (weighing more than 20 kilograms) in which sensor motion might occur. Nonin’s Model 8000JFW Adult FlexiWrap adhesive wrap is designed for applying Nonin’s Model 8000J, 8000J- WO, and 8000J-WO2 Adult Flex Sensors.

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 measurements to meet patients’ medical needs.

Contraindications

• Do not use the device in an MR environment or in an explosive atmosphere.
• This device is not defibrillation proof per IEC 60601-1.

Warnings

• 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 6 to 8 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 on 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, discontinue use immediately and replace the sensor
• 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.
• Do not use caustic or abrasive cleaning agents on the sensors.
• Do not autoclave or immerse in liquid of any kind.
• Follow local governing ordinances and recycling instructions regarding the 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 sensor.
• Refer to the pulse oximeter operator’s manual for additional warnings and cautions.
• 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
  • artificial nails
  • incorrect sensor type
  • poor pulse quality
  • venous pulsations
  • anemia or low hemoglobin concentrations
  • cardiovascular dyes
  • sensor not at heart level
  • dysfunctional hemoglobin
  • fingernail polish
  • residue (e.g., dried blood, dirt, grease, oil) in the light path

Symbols

Choosing the Sensor Application Site
The preferred application site for adults is the index finger. However, other fingers or toes may be used where the tissue thickness is between 5 and 21 millimeters (dimension “A” in Figure 1). Other sites may not give acceptable results because of inadequate light transmission or perfusion.

Attaching the Adult Reusable Flex Sensor and Disposable FlexiWrap

1. Grasp the blue tab on the FlexiWrap, and peel away the paper backing just far enough to apply the Flex Sensor (see Figure A).
2. Place the FlexiWrap, printed side down, onto a table or other hard, smooth surface.
3. Position the Flex Sensor into the cutouts on the adhesive side of the FlexiWrap (see Figure B).
4. Press the sensor firmly onto the adhesive, and fully remove the paper backing.
5. Position the tip of the finger between the notches on the FlexiWrap (see Figure C).
6. Wrap the side flaps of the FlexiWrap around the sides of the finger.
7. Pull the FlexiWrap with the sensor over the tip of the finger, and adhere the wrap to the top and side of the finger (see Figure D).
8. Wrap the long flap of the FlexiWrap around the entire finger. Do not wrap too tightly and restrict blood flow (see Figure E).
9. Optional: For best results, secure the sensor cable independently from the sensor with medical-grade tape, preferably around the base of the finger. Make sure that the tape does not restrict blood flow.
   • Note: If the sensor is not positioned properly, light might bypass the tissue and result in SpO2 inaccuracies. Proper sensor placement is critical for good performance.
   • Note: The 8000J-WO2 sensor is compatible with the WristOx2, Model 3150. It is also compatible with Nonin’s Model 3100 and 4100 oximeters when used with the 3150WI adapter.

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 sensor in liquid of any kind. Do not pour or spray any liquids onto the sensor.
• Do not use caustic or abrasive cleaning agents on the sensor. 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 10% bleach/90% water solution (household bleach [containing less than 10% sodium hypochlorite]).
2. Ensure that all tape residue is removed.
3. Allow the sensor to dry thoroughly before reusing.

Specifications

SpO2 Accuracy (Adults/Peds)1, 2, 3:

Note: To minimize cable deterioration when cleaning the cable, gently wipe away from the plug end towards the sensor end. The 8000JFW FlexiWrap sensor wrap is not reusable and is intended for single use only

Product Information

• SpO2 Low Perfusion Accuracy : 70% to 100% ±2 digits (Arms*)1
• Pulse Rate Accuracy : 18 to 300 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.

1. Additional accuracy and performance information can be found in the sensor accuracy document on the operator’s manual CD.
2. Accuracy testing was performed under no-motion conditions.
3. Accuracy specifications based on Nonin’s PureSAT® SpO2 technology and PureLight® sensor technology.
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 10993-1. Not made from 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

The 8000J, 8000J-WO and 8000J-WO2 Adult Flex Sensors are warranted for 90 days from delivery. The sensor’s expected service life is 90 days. Nonin reserves the right to make changes and improvements to this Instructions for Use and the product it describes at anytime, without notice or obligation. www.nonin.com/warranty.

Nonin Medical, Inc.
13700 1st Avenue North Plymouth, MN 55441, USA www.nonin.com

E-mail: info@nonin.com +1 763-553-9968 800-356-8874 (US and Canada)

Specifications

• Model Numbers : 8000J, 8000J-WO, 8000J-WO2
• Intended Use : Continuous monitoring of adult and pediatric patients (weighing more than 20 kilograms) in situations where sensor motion might occur
• Includes : Adult Flex Sensors and Adult FlexiWrap adhesive wrap
• Regulatory Compliance: CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices

FAQ (Frequently Asked Questions)

Q: Can the Adult Flex Sensors be used on pediatric patients?
A: Yes, the Adult Flex Sensors are designed for use on both adult and pediatric patients weighing more than 20 kilograms.

Q: How often should I calibrate the pulse oximeter device?
A: Calibration frequency may vary, but it is recommended to calibrate the device according to the manufacturer’s guidelines or as needed based on usage.

Q: What should I do if the sensor readings seem inaccurate?
A: Ensure proper placement of the sensor, check for any obstructions, and consider cleaning the sensor to improve accuracy. If issues persist, contact customer support for assistance.

References

• Pulse and Regional Oximeters, Capnographs, Sensors | Nonin
• Warranty - Nonin

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