Directions for Use
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SPO2 Accuracy 70 - 100%: Arms < 3.0% 0 - 69%: Unspecified Accuracy test methods available from the manufacturer upon request LED Specifications
Instructions for use: Reusable 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.
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 / Philips
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. 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: 5° - 40° C (41° -104° F) Storage and transportation temperature range -20° - 70° C (-4° -158° F) Relative humidity: 15 - 95% 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 Model - Adult
Bluepoint Model - Paediatric
Oximeter Brand
Cable Length
SC4001
SCP4001
Nellcor
0.90 m
SC4002
SCP4002
Nellcor
2.00 m
SC4006
SCP4006
HP/Philips
2.95 m
SC4007
SCP4007
HP/Philips
2.00 m
SC4011
SCP4011
Datex
0.90 m
SC4012
SCP4012
Datex
2.95 m
SC4016
SCP4016
Ohmeda
2.95 m
SC4017
SCP4017
Ohmeda
1.00 m
SC4021
SCP4021
BCI
1.20 m
SC4026
SCP4026
Nonin
0.90 m
SC4031
SCP4031
Minolta
0.33 m
SC4036
SCP4036
CSI
0.90 m
SC4037
SCP4037
CSI
2.95 m
SC4041
SCP4041
Novametrix
2.95 m
SC4046
SCP4046
Nihon-Kohden
2.95 m
SC4047
SCP4047
Nihon-Kohden
1.60 m
SC6500
SCP6500
Bluepoint Medical
1.20 m
SC6501
SCP6501
Bluepoint Medical
0.30 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 SoftCap® Pulse Oximetry Sensors V2.3 ENG/DE/F/ESP