NONIN 6000CP Oximeter Sensor Instruction Manual

6000CP Oximeter Sensor
Instruction Manual

6000CP Oximeter Sensor

Model 6000CP/7000P
Pediatric Disposable Single-Patient Use
Pulse Oximeter Sensor

Cautions:
Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
Indications for Use (from USA FDA Website):
Nonin’s Models 6000xx and 7000xx Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non- invasive spot-checking and/or continuous monitoring of adult and/or pediatric patients who are well or poorly perfused, weighing greater than 66 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergen cy room, long­term care, home use, and mobile environments.

Intended Use (for USA FDA):
Nonin’s Models 6000xx and 7000xx Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non- invasive spot-checking and/or continuous monitoring of adult and/or pediatric patients who are well or poorly perfused, weighing greater than 66 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long­term care, home use, and mobile environments.

Intended Purpose (for Outside USA):
GMDN 31658 – Probe, pulse oximeter, single use -A device applied to a body site, e.g. finger, ear, bridge of nose or foot, of paediatric or adult patients in order to transmit light through the skin to be absorbed by the oxyhaemoglobin and deoxyhaemoglobin, in arterial tissue blood. Signals are received by the parent device which displays the results. It is disposable.

Contraindications:

• Do not use the device in an MR environment or in an explosive
• 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
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.

• blood flow restrictors (arteriacatheters, blood pressure cuffs, infusion lines, etc.)| • fingernail polish

| Emitter| | Detector
---|---|---|---

Center Line

Symbols

| CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices
| Do Not Reuse
| Lot Number
IP32| 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.
| Type BF Applied Part
| Defibrillation Proof Type BF Applied Part (patient isolation from electrical shock when connected to a signal processor or pod)
| Medical Device
| Unique Device Identifier
| Distributor
| Importer
| Humidity Limitation
| RoHS Compliant (China)
| Non-sterile
| Authorized Representative in the European Community.
 | Serial number
 | Catalogue number
| Quantity
| Indicates separate collection for waste electrical and electronic equipment (WEEE)
| Storage/shipping temperature range
 | Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
 | Manufacturer
| Country of Manufacturer
| Date of Manufacturing
 | Handle With Care
| Keep Dry

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 of the 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 %.
  Accuracy specifications based on testing with Models 2500/2500A and 9600.
  Additional accuracy and performance information can be found in the pulse oximeter operator’s manual.

Measurement Wavelengths and Output Power**

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 establishedif 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)
Fax: +1 763-553-7807
Nonin Medical B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands
Email: infointl@nonin.com (Europe)
+31 (0)13 – 45 87 130 (Europe)

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