NONIN 8004CB-NA Regional Oximetry Sensors Instructions

: June 4, 2024
: NONiN

Table of Contents

Instructions for Use
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Instructions for Use

Model 8004CB-NA Non-Adhesive, Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology

Indications for Use

The 8004CB-NA non-adhesive, single-patient use, non-sterile, disposable regional oximetry sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation (rSO2) of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing ≤ 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8004CB-NA sensor without baseline re-establishment.

Refer to the oximetry system’s operator’s manual for all use environments.

Warnings:

Do not use the device in an MR environment, in an explosive atmosphere, or in the presence of flammable anesthetic compounds.
This device is only defibrillation proof per IEC 60601-1 when used with the X-100SP signal processor or 7600PA oximetry pod.
Inspect the sensor application site(s) 15 minutes after sensor application. Every 2 to 4 hours, lift the sensor to check skin integrity underneath the sensor optics and sensor. If skin is intact, reapply the sensor.
Avoid excessive pressure to the sensor application site(s) as this may cause damage to the skin beneath the sensor.
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.
The 8004CB-NA sensor is only compatible with systems using EQUANOX technology. Refer to the Parts and Accessories List on the system operator’s manual CD for a complete listing of Nonin-branded sensors, parts, and accessories. Patient injury can result from the use of non-compatible combinations.
The sensor is designed for external use only.
Do not apply sensor over open wound, incision, compromised skin, or pre-existing skin condition (e.g., eczema or dermatitis).
This device is intended only as an adjunct device in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with other methods of assessing clinical signs and symptoms.

Front view

Back view

Sensor Front and Back Views

Cautions:

Do not use a damaged sensor. If the sensor is damaged, discontinue use immediately.
Ensure all pulse oximeter sensors are kept a minimum of 6 cm (2.7 in.) away from all regional oximeter sensors.
As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement or strangulation.
The Model 8004CB-NA is designed for single-patient use and should not be reused. Reuse may cause unreliable readings and, if a disposable sensor is used on two patients, there is a risk of cross-contamination.
When using a wrap to secure the sensor, ensure adequate blood flow to the site.
Do not sterilize, autoclave, or immerse in liquid of any kind.
Do not clean the sensor. Cleaning the sensor will damage it.
EQUANOX interrogates a small volume of tissue in areas such as the frontal cerebral cortex and is not necessarily reflective of simultaneous saturation values in other tissue areas.
In order to avoid erroneous readings, ensure all cable connections are correct and secure.
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 the 8004CB-NA sensor.
Refer to the system operator’s manual for additional warnings and cautions.
This device is designed to determine regional hemoglobin oxygen saturation of blood underneath the sensor. Factors that may degrade performance or affect the accuracy of the measurement include the following:
– excessive ambient light or direct sunlight
– excessive motion
– electrosurgical interference
– metal plate or other foreign object in sensor path
– moisture on skin
– improperly applied sensor
– placement over bony prominence
– incorrect sensor type
– skin barriers used between sensor and patient
– anemia or low hemoglobin concentrations
– cardiogreen or other intravascular or tissue dyes
– carboxyhemoglobin and other dyshemoglobins
– hemoglobinopathies
– billirubinemia and/or icterus (jaundice)
– non-normocapnic conditions or other conditions that affect blood volume
When using this device in an operating room, it must remain outside the sterile field.
The value of data from the system has not been demonstrated in specific disease states.
Avoid adjacent placement of non-Nonin branded NIRS sensors to prevent loss of monitoring or erroneous readings.

Symbols:

Symbol	Definition of Symbol
	Follow Instructions for Use
CAUTION!

Sensor Site Examples

A

NONIN 8004CB-NA Regional Oximetry Sensors 01 A

B

Applying the Regional Sensor(s)

Signal Processor or Pod Site(s) and Cable Pathways. Select an appropriate site to locate the signal processor or oximetry pod. The ideal site avoids the patient’s body resting on the signal processor or pod or the signal processor or pod pulling unnecessarily on the sensor. Ensure all cable pathways are clear and unencumbered.
Removal from Packaging and Pre-check. Carefully remove the sensor from the plastic pouch and uncoil the sensor cable. Check the sensor for any sign of damage in transport. If signs of damage are found, replace the sensor.
Cerebral Site. Select the site(s) on the patient’s forehead lateral to the midline, superior to the eyebrow and inferior to the hairline (see example in figure A). The area(s) should be free of hair or surface blemishes such as moles, port-wine stains, or freckles. Avoid placing the sensor(s) over nevi, sinus cavities, hematomas, or arteriovenous malformations.
Somatic Site(s). Select the site(s) that provide optimal access to desired tissue (see example in figure B). The area(s) should be free of hair or surface blemishes such as moles or freckles.
Skin Preparation. Gently cleanse the patient’s skin with isopropyl alcohol to remove oils or soil that might block light. Ensure the skin is thoroughly dried.
Sensor Placement. Gently place the sensor(s) on the desired site(s) (see examples at left). Use a headband, bonnet, or a wrap, such as pre-wrap, to secure the sensor to the desired site(s). Ensure the sensor surface completely contacts the skin to prevent light from traveling between emitting or receiving elements or ambient light from entering. Note: An improperly placed sensor may result in inaccurate readings.
Note: Avoid kinking or twisting the sensor cable during the application process.
Sensor Connections. Firmly insert the sensor connector into the signal processor or pod. If applicable, engage the sensor lock on the signal processor. Note: Consult the system operator’s manual for signal processor connection to the hub and monitor or pod connection to the trunk cable and monitor.
Verify proper operation as described in the system operator’s manual. Verify the sensors are connected as needed for the desired system configuration and that the displayed data correctly correlates with the sensor application site.

Note: rSO2 values and trend lines should begin within seconds. If these clearly identified or alarm conditions are generated, consult the Troubleshooting section of the system operator’s manual.

Specifications

Range	95% Limits of Agreement (rSO 2)
45-95%	(-12.6, 10.9)

*Absolute rSO 2 Accuracy (Arms):** 45% to 95% rSO2 ±5.9%

Accuracy specifications are based on the measured regional hemoglobin saturation value (rSO2) of cerebral sensors calibrated to arterial / venous hemoglobin oxygen (SavO2) value, determined from venous and arterial blood samples from 44 subjects ranging in age from 4 days to 10 years. The model used for blood in the brain was 70% venous and 30% arterial. The venous blood was drawn from the right jugular bulb. The accuracy of the sensors in comparison to the blood gas analyzer samples measured over the rSO2 range of 45-95%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61:2011, Medical Electrical Equipment–Particular requirements for the basic safety and essential performance of pulse oximeter equipment.

Inter/Intra Sensor Repeatability Accuracy: ±2 digits (Arms*)

Temperature:
Operating: -5 °C to 40 °C (23 °F to 104 °F)
Storage/Transportation: -30 °C to 70 °C (-22 °F to 158 °F)

Humidity:
Operating: 10 % to 90 % non-condensing
Storage/Transportation: 10 % to 95 % non-condensing

±1 Arms encompasses 68% of the population.

Measurement Wavelengths and Output Power**

730 nanometers @ 3.0 mW maximum average power
760 nanometers @ 4.5 mW maximum average power
810 nanometers @ 3.2 mW maximum average power
880 nanometers @ 4.5 mW maximum average power
** This information is especially useful for clinicians performing photodynamic therapy.

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.