Autoclavable SoftCap Pulse Oximetry Sensors Directions for Use V1.2

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

Instructions for use: Autoclavable SoftCap® Pulse Oximetry Sensors DIRECTIONS FOR USE Intended Use: Bluepoint Medical SoftCap® 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. Precautions: For further instructions, warnings and precautions refer to the operating instructions provided with your oximeter. 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.

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, BCI, Bluepoint Medical

910 nm

3.5 mW

Nonin

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 Model - Adult

Bluepoint Model - Paediatric

Oximeter Brand

Cable Length

SCA4001

SCPA4001

Nellcor

0.90 m

SCA4002

SCPA4002

Nellcor

2.00 m

SCA4006

SCPA4006

HP/Philips

2.95 m

SCA4007

SCPA4007

HP/Philips

2.00 m

SCA4008

SCPA4008

HP/Philips

2.95 m

SCA4011

SCPA4011

Datex

0.90 m

SCA4012

SCPA4012

Datex

2.95 m

SCA4013

SCPA4013

GE/Datex

2.95 m

SCA4021

SCPA4021

BCI

1.20 m

SCA4026

SCPA4026

Nonin

0.90 m

SCA4046

SCPA4046

Nihon-Kohden

2.95 m

SCA4047

SCPA4047

Nihon-Kohden

1.60 m

SCA6500

SCPA6500

Bluepoint Medical

1.20 m

Other brands and cable lenghts on request. Adult

CE0482 Bluepoint Medical GmbH & Co. KG

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

An der Trave 15 23923 Selmsdorf Deutschland/Germany Email: [email protected] Homepage: www.bluepoint-medical.com

Autoclaving the Sensor The sensor can be autoclaved at 134°C / 2bar and thereby effectively sterilized. Environmental Requirements  Operating temperature range: 5° - 40° C (41° -104° F)  Storage and transportation temperature range -20° - 70° C (-4° - 158° F)  Relative humidity: 15 - 95% non-condensing Instructions for Use: Autoclavable SoftCap® Pulse Oximetry Sensors V1.2 EN/DE/FR/ES