Reusable Earprobe Pulse Oximetry Sensors Directions for Use V1.4

Instructions for use: Reusable Earprobe Pulse Oximetry Sensors DIRECTIONS FOR USE

Environmental Requirements  Operating temperature range: 10° - 40° C (50° - 104° F)  Storage and transportation temperature range 0° - 50° C (32° - 122° F)  Relative humidity: 0 - 75% non-condensing SPO2 Accuracy 70 - 100%: Arms < 3.0% 0 - 69%: Unspecified Accuracy test methods available from the manufacturer upon request

Intended Use: Bluepoint Medical pulse oximetry ear sensors are indicated for use in continuous non-invasive monitoring of arterial oxygen saturation and pulse rate. They are original or fully compatible replacement sensors intended for use with major brands of pulse oximeters and patient monitors. Select the sensor model number that matches the brand of oximeter or patient monitor that you are using. Precautions: For further instructions, warnings and precautions refer to the operating instructions provided with your oximeter. Do not autoclave or immerse the sensor in liquid. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Warnings: Match the sensor model with your brand of oximeter. A mismatch may cause patient injury, inaccurate measurements or equipment damage. Check the sensor every 8 hours and reposition to an alternate location every 24 hours. Avoid application of the sensors to oedematous or fragile tissue. Do not use the sensor if it is damaged. Use of a damaged sensor could cause patient injury or equipment failure. Excessive patient motion, excessive ambient light, electromagnetic interference, dysfunctional haemoglobin, low perfusion or intravascular dyes may affect the sensor performance and the accuracy of the measurement. Note: The materials used in the manufacture of the sensor contain no natural latex protein. The materials have undergone extensive bio-compatibility testing. Further information is available upon request. Application of the Sensor The use of the ear sensor is contraindicated for patients whose ears are pierced at the indicated site. 1. The preferred site is the patient’s ear lobe, securing the sensor using the cable support. Alternatively, position the ear sensor on the ear pinna and secure using medical tape. 2. Wipe the patient’s ear clean with alcohol solution. 3. If applying the sensor to the earlobe, insert the ear sensor cable into the cable support, leaving enough residual cable to connect the sensor to the fleshy portion of the ear lobe. 4. Hook the cable support over the patient’s ear. 5. Clip the sensor to the fleshy portion of the ear lobe, with the light source on the outside of the ear. 6. If applying the sensor to the pinna, clip the sensor to the pinna with the light source on the outside of the ear, and ensure that the cable runs behind the ear and down the side of the patient’s body. 7. Secure the sensor cable using medical tape. 8. Connect the sensor cable into the patient monitor and verify proper operation as described in the instrument’s user manual.

LED Specifications LED

Wavelength

Radiant Power (typical)

Brand

Red

660 nm

3.5 mW

All below

Infrared

885 nm

3.5 mW

Nellcor

890 nm

3.5 mW

HP/Philips

905 nm

3.5 mW

Datex, Bluepoint Medical

935 nm

3.5 mW

Nihon-Kohden

Disposal Follow local regulations governing disposable recycling plans regarding disposal or recycling of device components. A list of component materials is available by contacting Bluepoint Medical. All registered trademarks recognized. Bluepoint Medical Model

Oximeter Brand

Cable Length

EP4001

Nellcor

0.90 m

EP4007

HP/Philips

2.00 m

EP4008

HP/Philips

2.95 m

EP4011

Datex

0.90 m

EP4012

Datex

2.95 m

EP4013

GE/Datex

2.95 m

EP4047

Nihon-Kohden

1.60 m

EP6500

Bluepoint Medical

1.20 m

CE0482 Bluepoint Medical GmbH & Co. KG An der Trave 15 23923 Selmsdorf Deutschland/Germany Email: [email protected] Homepage: www.bluepoint-medical.com

Sensor attached to the ear lobe

Sensor attached to the pinna

Cleaning the Sensor To clean the sensor between uses or between patients, wipe the sensor surfaces with alcohol. Instructions for Use: Reusable Ear Pulse Oximetry Sensors V1.4 EN/GE/FR/ES