Reusable SoftFlap Finger Clip Directions for Use V2.2

SPO2 Accuracy 70 - 100%: Arms < 3.0% 0 - 69%: Unspecified Accuracy test methods available from the manufacturer upon request

Instructions for use: Reusable SoftFlap® (Finger Clip) Pulse Oximetry Sensors DIRECTIONS FOR USE Intended Use: Bluepoint Medical Finger Clip oximetry 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.

LED Specifications LED

Wavelength

Radiant Power (typical)

Brand

Red

660 nm

3.5 mW

All below

Infrared

885 nm

3.5 mW

Nellcor, CSI

890 nm

3.5 mW

HP / Phillips

905 nm

3.5 mW

Datex, BCI, Minolta, Bluepoint Medical

910 nm

3.5 mW

Nonin

935 nm

3.5 mW

Nihon-Kohden

940 nm

3.5 mW

Ohmeda, Novametrix

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, intravascular dyes, finger nail polish and long or artificial finger nails 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 1. Connect the sensor cable to the Bluepoint Medical adaptor cable that fits your oximeter or directly to the patient monitor. Then switch on the oximeter and verify proper operation. 2. Insert the patient’s digit into the sensor. The preferred digit to use for adults is the index finger. The digit is correctly inserted when:  The tip of the digit touches the rear guide posts.  The sensor cable extends along the top of the patient’s hand. 3. Visually monitor the sensor site to ensure the integrity of the skin. 4. Secure the lead with medical tape.

Adult / Paediatric Cleaning the Sensor To clean the sensor between uses or between patients, wipe the sensor surfaces with alcohol. 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

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

SF4001

Nellcor

0.90 m

SF4002

Nellcor

2.00 m

SF4006

HP/Philips

2.95 m

SF4007

HP/Philips

2.00 m

SF4008

HP/Philips

2.95 m

SF4011

Datex

0.90 m

SF4012

Datex

2.95 m

SF4013

GE/Datex

2.95 m

SF4016

Ohmeda

2.95 m

SF4017

Ohmeda

1.00 m

SF4021

BCI

1.20 m

SF4026

Nonin

0.90 m

SF4036

CSI

0.90 m

SF4037

CSI

2.95 m

SF4041

Novametrix

2.95 m

SF4046

Nihon-Kohden

2.95 m

SF4047

Nihon-Kohden

1.60 m

SF6500

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

Instructions for Use: Reusable SoftFlap® Pulse Oximetry Sensors V2.2 EN/DE/FR/ES