NONIN 6500MA Single Patient Disposable Pulse Oximeter Sensor Instruction Manual

NONIN 6500MA Single Patient Disposable Pulse Oximeter Sensor Instruction Manual

Instructions

Indications for Use
Nonin’s Model 6500MA Single-Patient Use, Disposable Pulse Oximeter Sensor is
indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients, who are well or poorly perfused, weighing more than 60 pounds (27 kilograms). Refer to the oximetry system’s operator’s manual for all use environments.

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 measurement in order to meet patients’  medical needs.

Warnings

• Do not use the device in an MR environment, in an explosive atmosphere, or on infant or neonatal patients.
• This device is not defibrillation proof per IEC 60601-1.
• The use of sensor and oximeter combinations other than Nonin-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 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

• 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.
• 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
  • incorrect sensor type
  • poor pulse quality
  • venous pulsations
  • anemia or low hemoglobinconcentrations
  • cardiovascular dyes
  • dysfunctional hemoglobin
  • fingernail polish or artificial nails
  • residue (e.g., dried blood, dirt, grease, oil) in the light path

Symbols

| Follow Instructions for Use
| CAUTION!
| Do Not Reuse
| CE Marking indicatingconformance toEC Directive No. 93/42/ EEC concerning medical devices
**** 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.
**EC  REP| Authorized representativein the European Community
**| Importer
| ** Distributor
MD| ** Medical Device
**UDI| ** Unique Device Identifier
Symbol| Definition
---|---
**LOT| Lot Number
****REF| Catalogue number
****QTY| Quantity
**| Date of manufacture
| Manufacturer
| Country of manufacture
| Storage/shipping temperature range
| Indicates separatecollection for waste electrical and electronic equipment (WEEE)
| Medical prescription required
| Handle with Care
| Keep Dry
| Humidity Limitation
| **** Use By

Applying the Single-Patient Use Sensor

Notes:

• 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.
• The fingertip should not be inserted through the center fold opening.
• The sensor cable may be secured with medical tape.

Application by a Healthcare Professional

1. Place the patient’s fingertip at the center fold, so the cable is on top of the hand and the black foam touches the skin.

2. Bend sensor around the finger to conform to finger.

3. Gently pinch just the sides of the sensor to secure comfortably. Do not squeeze the sensor as it may interfere with its performance.

Self-Application

1. Place the finger at the center fold so the sensor cable is  directed away from the finger and the black foam touches the skin.

2. Bend sensor around the fingertip to conform to the finger.

3. Gently pinch just the sides of the sensor to secure comfortably. Do not squeeze the sensor as it may interfere with its performance.

Sensor Removal

1. Partially open the sensor.
2. Remove from finger.

Specifications

SpO2 Accuracy1, 2, 3:

SpO2
Low Perfusion Accuracy: 70 % to 100 % ±2 digits (Arms)1
Pulse Rate Accuracy: 18 BPM to 300 BPM ±3 digits (Arms)1
Pulse Rate Low Perfusion Accuracy: 40 BPM to 240 BPM ±3 digits (Arms*)1

Temperature

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 at zero bias.

  1. Additional accuracy and performance information can be found in the pulse oximeter operator’s manual.
  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 @ 0.8 mW nominal
Infrared: 910 nanometers @ 1.2 mW nominal
** This information is especially useful for clinicians performing photodynamic therapy

Compliance

This product complies with ISO 10993-1. Not made from natural rubber latex. Nonin reserves the right to make changes and improvements to these instructions and the product it describes at anytime, without notice or obligation.

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)

References

• Pulse and Regional Oximeters, Capnographs, Sensors | Nonin

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