COVIDIEN Nellcor Flexible SpO2 Reusable Sensor Instructions

Nellcor™
Flexible SpO² Sensor, Reusable
FLEXMAX
FLEXMAX-P
Oximax™ Technology

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Directions for Use

Note: This Instruction for Use is intended for the medical professional. When prescribing to lay users, ensure that they have been trained regarding all covered warnings, cautions, and instructions for use and have a home user guide. For home use, a lay operator instruction for use with P/N PT00030916 is available.

Indications for Use

The Nellcor?” Flexible Sp02 Sensors, models FLEXMAX and FLEXMAX-P, are intended for use with monitoring systems that use OxiMax TM and NellcorTm compatible pulse oximeters.

The Nellcor Flexible Sp02 sensors are intended for use in non-invasive continuous or spot-check monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate. The sensor size range includes large and small sensors. The sensors are intended for use on adult and pediatric (excluding infant and neonatal) patients weighing greater than 20kg.

The use environment may include hospitals, hospital-type facilities, intra- hospital transport, mobile emergency medical applications including both ground and air transport, and home use. Transport environments include intra- hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The use environment is dependent upon the use environments specified for the monitoring system utilized in conjunction with the sensor.

The Nellcor Flexible Sp02 Sensors are for prescription use only.

Disposal
Do not dispose of domestic waste. Follow local regulations when disposing or recycling this device and its component parts. A list of component materials is available by contacting Covidien Technical Service Department (see back page).

Instructions for Use

Intended for use with Nellcor™ and OxiMax™ compatible systems. This sensor integrates OxiMax™ technology into its design. When connected to a  compatible OxiMax™ enabled instrument, this sensor uses OxiMax™ technology to provide additional advanced sensor performance features.

To apply the FLEXMAX, FLEXMAX-P model sensors:

1. Insert the patient’s finger into the sensor. The preferred finger to use is the index finger (A).
   Alternative sites may be used depending on finger sizes (B).

2. The finger is correctly inserted when:
   a. The tip of the finger touches the sensor’s the inside end. (C)
   b. The sensor cable extends along the top of the patient’s hand. (A)
   Note: Ensure the sensor is not incorrectly placed upside down (D), backward (E), or with the finger extending (F).

3. Switch on the oximeter and verify proper operation. (Ensure that the oximeter is providing a reading.)

4. Visually monitor the sensor site at least every 6 hours to ensure the integrity of the skin and that no pressure injury is developing. Reposition to an alternate location if skin integrity changes.

To remove the FLEXMAX, FLEXMAX-P model sensors:

1. Open the sensor by pressing on the sides of the sensor. Remove the sensor from the finger and follow the cleaning instructions, if necessary.
2. Disconnect the sensor from the monitor by unplugging the sensor cable.
3. Store the sensor away for its next use.
   The sensor’s expected life is 1 year.

WARNINGS
WARNING: Pulse oximeter probes are designed for use with specific monitoring systems.
Incompatible components can result in degraded performance and electromagnetic incompatibility, or patient injury. The operator is responsible for checking compatibility prior to use.
WARNING: A functional tester cannot be used to assess the accuracy of pulse oximeter probes.
WARNING: Check the patient skin condition at least every 6 hours and reposition to an alternate location if skin integrity changes.
WARNING: Misapplication of a pulse oximeter probe with excessive pressure and for prolonged periods can cause pressure injury.
WARNING: Avoid the application of the sensors to areas with poor skin integrity.
WARNING: Do not sterilize by irradiation, steam, or ethylene oxide – refer to cleaning and disinfection instructions. Use of agents other than specified may damage the sensor.
WARNING: Do not use the sensor if it is damaged. Use of a damaged sensor could cause patient injury or equipment failure.
WARNING: Excessive patient motion, excessive ambient light, electromagnetic interference (e.g., stacking and location to other medical equipment),  dysfunctional hemoglobin, intravascular dyes, fingernail polish, and long or artificial fingernails may affect the sensor performance and the accuracy of the measurement.
WARNING: Route all cables carefully to reduce the possibility of patient entanglement or strangulation.
WARNING: Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
WARNING: Do not use the Nellcor™ sensor or other oximetry sensors during MRI scanning.
Conducted current may cause burns.

CAUTIONS
CAUTION: Avoid possible interference from sources of electromagnetic interference such as, but not limited to Cellular phones, radio transmitters, motors, telephones, lamps, electrosurgical units, defibrillators, and other devices. Interference may cause inaccurate measurements. If you are unsure if your device is working properly, contact your clinician.
CAUTION: Sensors may work with different monitors. Refer to the specific monitor IFU for essential performance, accessories, compliance information (EMC), and electrosurgical applications.

Cleaning

It is necessary to clean and disinfect the sensor before attaching it to a new patient. Routine cleaning or low-level disinfection is recommended when using the sensor on the same patient.

To clean the sensor:

1. Disconnect the sensor from the monitor before cleaning or disinfecting.

2. Rinse the sensor and cable with distilled water for at least 2 minutes.
   CAUTION: Do not immerse the connector of the sensor cable in liquid.

3. Clean the surface of the cable by wiping it with a cotton pad soaked in 70% Isopropyl alcohol.

4. Immerse the sensor in 70% Isopropyl alcohol for 5 minutes and let it air dry for at least 10 minutes.

5. Visually inspect the sensor for cleanliness. If visible soil is present, repeat the cleaning process.

To disinfect (low-level):

1. Disconnect the sensor from the monitor before cleaning or disinfecting.

2. Rinse the sensor and cable with distilled water for at least 2 minutes.
   CAUTION: Do not immerse the connector at the sensor cable in liquid.

3. Prepare 1:10 bleach dilution in distilled water. Wipe the cable with a cotton pad soaked with the solution of diluted bleach.

4. Immerse the sensor housing in the solution of diluted bleach for 5 minutes.

5. Rinse the sensor and cable by immersing them in distilled water for 5 minutes.

6. Allow 10 minutes for the sensor, cable, and connector to dry after rinsing.

7. Visually inspect the sensor and repeat the cleaning as needed until a visually clean condition has been reached.

To disinfect (high-level):

1. Rinse sensor to remove surface dirt – the sensor housing may be fully immersed in liquid.
   CAUTION: Do not immerse the connector at the sensor cable in liquid.

2. Clean the sensor and patient contact surfaces. Prolystica™* is recommended as a cleaning agent. Follow the manufacturer’s instructions for use.  Immerse the sensor housing in the solution and wipe the inner and outer surfaces with a soft brush or cloth to remove any visible soil. Rinse sensor with water following cleaning and wipe dry prior to disinfection. Visually inspect the sensor and repeat the cleaning as needed until a visually clean condition has been reached.

3. CIDEX OPA™* is recommended for high-level disinfection. Follow the manufacturer’s instructions for use. Immerse the sensor housing in the solution for 12 minutes and remove.

4. Thoroughly rinse the sensor with water following disinfection (5 minutes minimum distilled water rinse/soak).

5. Manually dry the sensor and verify the sensor, cable, and connector are dry prior to use.

Environmental Specification

at -20°C and +50°C temperature conditions.
Storage, and transport temperature range:| -40°C to +70°C (-40°F to 158°F)
Relative humidity range:| 15 – 95% non-condensing
Atmospheric pressure range:| 620 hPa to 1060 hPa
Stabilization Time (from storage to operational conditions):| Up to 20 minutes

Biocompatibility
The materials that come into contact with the patient have undergone extensive biocompatibility testing. Further information is available on request.

IP33 Protected from water spray less than 60 degrees from vertical.

(refer to monitor’s operating manual for more information)
<70%: unspecified

Note: These environmental specifications are specific to the sensor. For information on the environmental specification of the compatible monitoring systems, please see the Operator’s Manual for that system.
Note: Because pulse oximeter measurements are statistically distributed, only about two-thirds of measurements can be expected to fall within ± ARMS of the measured values by a co-oximeter. To verify the function of pulse oximeter probes, a functional tester (Index 2 or equivalent) can be used.

Warranty

To obtain information about a warranty, if any, for this product, contact Covidien’s Technical Services Department, or your local Covidien representative (see back page).

Clinical Studies

Bland-Altman plots or SaO² vs error (SpO² – SaO²) are included to highlight the sampled data points that were collected as part of the clinical evidence used to support the performance specifications (SpO² accuracy) of this device.

1. This information can be especially useful to clinicians.
2. SpO² accuracy is validated by clinical tests, where the measured values of the sensors were compared with those of the arterial co-oximetry in healthy adult subjects over the specified functional oxygen saturation range. These values were validated on the following monitors: Nellcor™ PM1000N, N- 600x, N-560, N-395. A functional tester may not be used to validate SpO² accuracy.
3. Pulse rate accuracy was verified by simulated bench tests to ensure the entire range was verified. These values were verified on the following monitors:  Nellcor™ PM1000N, N-600x, N-560, N-395.

Refer to the Bland-Altman plots at the end of this booklet.

Figure 1 Bland-Altman Plot: Nellcor™ N-600x/FLEXMAX⁴
Call out:

1. Y-axis N-600x FLEXMAX – Ref CO-Oximeter (SpO2 – SaO2)
2. X-axis Reference CO-Oximeter (SaO2)
3. Upper 95% Limit of Agreement
4. Mean
5. Lower 95% Limit of Agreement
6. Clinically Obtained Accuracy (ARMS for each stated SaO2 Range)

Figure 2 Bland-Altman Plot: Nellcor™ N-395/FLEXMAX⁴
Call out:

1. Y-axis N-395 FLEXMAX – Ref CO-Oximeter (SpO2 – SaO2)
2. X-axis Reference CO-Oximeter (SaO2)
3. Upper 95% Limit of Agreement
4. Mean
5. Lower 95% Limit of Agreement
6. Clinically Obtained Accuracy (ARMS for each stated SaO2 Range)

Figure 3 Bland-Altman Plot: Covidien Nellcor™ PM1000N Platform/FLEXMAX⁴
Call out:

1. Y-axis PM1000N FLEXMAX – Ref CO-Oximeter (SpO² – SaO²)
2. X-axis Reference CO-Oximeter (SaO²)
3. Upper 95% Limit of Agreement
4. Mean
5. Lower 95% Limit of Agreement
6. Clinically Obtained Accuracy (ARMS for each stated SaO² Range)

Figure 4 Bland-Altman Plot: Covidien Nellcor™ N-560/FLEXMAX⁴
Call out:

1. Y-axis N-560 FLEXMAX – Ref CO-Oximeter (SpO2 – SaO2)
2. X-axis Reference CO-Oximeter (SaO2)
3. Upper 95% Limit of Agreement
4. Mean
5. Lower 95% Limit of Agreement
6. Clinically Obtained Accuracy (ARMS for each stated SaO2 Range)

Clinical accuracy study, 11 test subjects

Covidien Technical Service Department:
For technical information and assistance, contact Covidien or a local Covidien representative.
Global Technical Assistance 15 Hampshire Street
Mansfield, MA 02048 USA
1.800.635.5267, 1.925.463.4635 (toll)
Local service contact information can be found at www.covidien.com or contact your local Covidien representative.

Part No. PT00017330 Rev E 2018-02
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