NONIN 8000AP Pediatric Finger Clip Pulse Oximeter Sensor Instruction Manual

: June 16, 2024
: NONiN

Table of Contents

NONIN 8000AP Pediatric Finger Clip Pulse Oximeter Sensor
Product Information
Product Usage Instructions
Frequently Asked Questions
Indications for Use
Choosing the Appropriate Sensor
Attaching the Pediatric Finger Clip Sensor
Cleaning the Reusable Sensor
Specifications
Contact
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

NONIN 8000AP Pediatric Finger Clip Pulse Oximeter Sensor

Product Information

Specifications:

Product Name: Model 8000AP Pediatric Finger Clip Sensor
Intended Use: Spotchecking or short-term continuous monitoring of pediatric patients
Compatibility: Pediatric patients
Model Number: 8000AP
Manufacturer: Nonin

Product Usage Instructions

Directions for Use:

The Model 8000AP Pediatric Finger Clip Sensor is designed for spot-checking or short-term continuous monitoring of pediatric patients where little sensor motion is expected.

Warnings:

Do not use the sensor if damaged.
Avoid contact with high-humidity environments.
Keep the sensor dry.

Symbols:

Follow Instructions For Use: !
CAUTION: IP32
CE Marking: Indicates conformance to EC Directive No. 93/42/EEC concerning medical devices.
LOT: Lot number
EC REP: Authorized representative in the European Community
CH REP: Authorized Representative in Switzerland

Frequently Asked Questions

*  **Q: What is the intended use of the Model 8000AP Pediatric Finger Clip Sensor?**

A: The sensor is designed for spot-checking or short-term continuous monitoring of pediatric patients where little sensor motion is expected.
Q: Can the sensor be reused?
- A: The sensor is not meant to be reused. Discard after use according to regulations.
Q: How should I store the sensor?
- A: Store the sensor in a dry place away from high-humidity environments to prevent damage.

Indications for Use

The Nonin Model 8000AP Pediatric Finger Clip Sensor is designed for spot checking or short-term continuous monitoring of pediatric patients where little sensor motion is expected.

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

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.
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.
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.
Factors that may degrade pulse oximeter performance include the following
- 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 Appropriate Sensor

The 8000AP sensor is designed for use on the fingers of patients weighing between 8 and 30 kilograms, where the finger tissue thickness is between 5 and 13 millimeters (dimension “H” in Figure A). If excessive sensor motion isoccurring, use the Model 8008J Infant Flex Sensor.

Attaching the Pediatric Finger Clip Sensor

Insert a finger (preferably the index, middle, or ring finger) into the Pediatric Finger Clip Sensor (Figure B) until the end of the finger reaches the finger stop. Keep the finger nail facing the sensor top (as shown in Figure B). Ensure that long fingernails do not interfere with proper finger position.
For the best results when using the sensor for short-term continuous monitoring, secure the sensor cable independently from the sensor with medical tape, preferably around the base of the finger. Make sure that the tape securing the cable does not restrict the blood flow. The thumb is not recommended for use with the Pediatric Finger Clip 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 notspray 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 or isopropyl alcohol.

To aid in cleaning the sensor, remove the spring from the slot on the bottom of the sensor (Figure C), and then rotate the spring forward as shown in Figure D.
Note: The spring must be disengaged from the bottom slot before opening the sensor 90°, or the spring will be damaged.
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]). Ensure that all tape residue is removed.
Allow the sensor to dry thoroughly before reusing.
Reverse the steps shown in Figures C and D to reattach the sensor spring.

Note: To minimize cable deterioration when cleaning the cable, gently wipe awayfrom the plug end towards the sensor end.

Specifications

SpO2 Accuracy1, 2:

SpO2 Low Perfusion Accuracy: 70% to 100% ±2 digits (Arms*)1
Pulse Rate Accuracy: 40 to 240 BPM ±3 digits (Arms*)1
Pulse Rate Motion Accuracy: 40 to 250 BPM ±5 digits (Arms*)1
Pulse Rate Low Perfusion Accuracy: 40 to 240 BPM ±3 digits (Arms*)1
Temperature: 3, 4
Operating: -20 °C to 50 °C (-4 °F to 122 °F)
Storage/Transportation: -40 °C to 70 °C (-40 °F to 158 °F)
Humidity: 3, 4
Operating: 10% to 95% non-condensing Storage/Transportation: 10% to 95% non-condensing * ±1 Arms encompasses 68% of the population at zero bias.

Additional accuracy and performance information can be found in the sensor accuracy document on the operator’s manual CD.
Accuracy specifications based on Nonin’s PureSAT® SpO2 technology and PureLight® sensor technology.
For combined oximeter/sensor specifications, refer to the applicable oximetry system’s operator’s manual.
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

1 year from the date of delivery. The device’s expected service life is 1 year. Nonin reserves the right to make changes and improvements to these instructions and the product it describes at anytime, without notice or obligation.