NONIN 6000CP Pediatric Disposable Single Patient Use Pulse Oximeter Sensor Instructions

NONIN 6000CP Pediatric Disposable Single Patient Use Pulse Oximeter

Sensor

Product Information

Specifications

• Model: 6000CP/7000P Pediatric Disposable Single-Patient Use Pulse Oximeter Sensor
• Weight Capacity: >22 pounds (>10 kilograms)
• Intended Use: Non-invasive spot-checking and/or continuous monitoring of pediatric patients
• Environment of Use: Operating room, surgical recovery, critical care, emergency room, long-term care, home use, and mobile environments
• Compliance: CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices
• IP Rating: IP32 (Protected against vertically falling water drops when the 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)

Product Usage Instructions

Indications for Use
The Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are designed for non-invasive spot-checking and continuous monitoring of pediatric patients weighing more than 22 pounds (>10 kilograms). They can be used in various environments such as operating rooms, surgical recovery areas, critical care units, emergency rooms, long-term care facilities, homes, and mobile settings.

Contraindications
Avoid using pulse oximeter sensors in patients with contraindications such as arterial catheters, blood pressure cuffs, infusion lines, etc.

Symbols
Follow the instructions for use provided with the product. The CE Marking indicates compliance with the EC Directive No. 93/42/EEC for medical devices. The symbol “Do Not Reuse” signifies that the sensors are for single-patient use only.

Use By
Ensure to use the sensors before the expiration date mentioned on the packaging.

Lot Number
The lot number is IP32. The product is RoHS compliant for China.

FAQs

• Q: Can the pulse oximeter sensors be reused?
  A: No, the pulse oximeter sensors are designed for single-patient use only and should not be reused.

• Q: What is the weight capacity for pediatric patients?
  A: The sensors are suitable for pediatric patients weighing more than 22 pounds (>10 kilograms).

• Q: In which environments can the sensors be used?
  A: The sensors can be used in various settings including operating rooms, surgical recovery areas, critical care units, emergency rooms, long-term care facilities, homes, and mobile environments.

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

Indications for Use

Nonin’s Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use, and mobile environments.

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 Noninbranded 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 Noninbranded 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 pediatric patients is the index finger. However, other fingers or toes may be used where the tissue thickness is between 5 and 17 millimeters (see figure at left). Other sites may not give acceptable results because of inadequate light transmission or perfusion.

Attaching the Pediatric Disposable Sensor

1. Partially peel away the adhesive backing from the sensor, as shown in figure A.
2. Place the patient’s fingernail against the sensor. Center the tip ofthe digit against the center line marked on the sensor (indicated by the solid black arrow in figure B). This ensures alignment between the light emitter and light detector.
3. Wrap the sensor around the sides of the digit (figure B).
4. Finish removing the adhesive backing and discard (figure B).
5. Fold the tab under the bottom of the digit. Ensure the light emitter and light detector are aligned (as illustrated by the vertical dotted line in figure C).
6. Wrap the tape around the digit (figure D).
7. 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.

1. SpO2 accuracy was conducted during induced hypoxia study on healthy subjects over the range of 70 % to 100 %.
2. Accuracy specifications based on testing with Models 2500/2500A and 9600.
3. Additional 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

**This information is especially useful for clinicians.

Compliance
This product complies with ISO 10993-1. 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.

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)

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

References

• Pulse and Regional Oximeters, Capnographs, Sensors | Nonin

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