NONIN 6000CI Infant Disposable Single Patient Use Pulse Oximeter Sensor Instruction Manual
- June 4, 2024
- NONiN
Table of Contents
NONIN 6000CI Infant Disposable Single Patient Use Pulse Oximeter Sensor
Contraindications:
- Do not use the device in an MR environment or in an explosive atmosphere.
- This device is not defibrillation proof per IEC 60601-1:1990 clause 17h.
Warnings
- The use of sensor and oximeter combinations other than Non-in-branded products have not been tested for accuracy as a system and may affect performance of the system. Refer to Nonin pulse oximeter operator’s manuals for a complete listing of Nonin-branded 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 to the sensor application site as this may cause damage to the skin beneath the sensor.
Cautions:
- Do not use a damaged sensor. If the sensor is damaged, discontinue use immediately.
- Do not sterilize, autoclave or immerse in liquid of any kind.
- Do not use caustic or abrasive cleaning agents on the sensor.
- 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 sensor.
- As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement or strangulation.
- 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
- moisture in the sensor
- improperly applied sensor
- carboxyhemoglobin
- methemoglobin
- blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.)
- incorrect sensor type
- poor pulse quality
- venous pulsations
- anemia or low hemoglobin concentrations
- cardiovascular dyes
- dysfunctional hemoglobin
- artificial nails
- fingernail polish
Symbols
Choosing the Sensor Application Site
The preferred application site for infants is the large toe. Other sites may
not give acceptable results because of inadequate light transmission or
perfusion.
Attaching the Infant Disposable Sensor
- Carefully peel away and discard the adhesive backing (figure A).
- Place the sensor light detector on the bottom of the large toe as shown in figure B.
- Wrap the tape around the toe (figures C, D, and E). When wrapping the tape, ensure the light detector is centered on the bottom of the toe and the light emitter is on the toe nail, directly opposite the light detector. The center line may be used as an alignment guide and should be on the side of the toe.
- For best results, use medical tape to secure the sensor cable independently from the sensor (figure E). Ensure the tape securing the cable does not restrict blood flow.
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.
Specifications
-
SpO2 Accuracy: 70 % to 100 % ±2 digits (Arms*)1, 2, 3
-
SpO2 Low Perfusion Accuracy: 70 % to 100 % ±2 digits (Arms)3 Pulse Rate Accuracy: 18 to 321 BPM ±2 digits (Arms)3
-
Pulse Rate Low Perfusion Accuracy: 40 to 240 BPM ±2 digits (Arms*)3
-
±1 Arms encompasses 68 % of the population.
1SpO2 accuracy was conducted during induced hypoxia study on healthy subjects over the range of 70 % to 100 %.
2Accuracy specifications based on testing with Models 2500/2500A and 9600. 3Additional accuracy and performance information can be found in the pulse oximeter operator’s manual.
Measurement Wavelengths and Output Power**
- Red: 660 nanometers @ 3 mW nominal
- Infrared: 910 nanometers @ 3 mW nominal
Compliance
This product complies with ISO 10993-1.
Not made with natural rubber latex.