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Summary of Contents for Orantech SpO2
- Page 1 The difference you can sense Single-patient-use SpO2 Sensors User Manual...
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Page 2: Intended Use & Indications For Use
(SpO2) and pulse rate (PR). These compatible replacement sensors are intended for use with major pulse oximeter brands. The SpO2 sensors are designed to match the specifications of the original equipment manufacturer, therefore confirm that the appropriate sensor model numbers are being used with the correct pulse oximeter technology. -
Page 3: Installation
Installation • Connect the SpO2 sensor to the oximeter’s adapter cable. • Turn the oximeter on and verify proper operation. • Select the sensor site on the patient. The preferred sensor sites are the index finger for adult and children, the great toe for infants, and on the foot below the toes for neonate. - Page 4 • Ensure the fingernail is located under the finger stop on the SpO2 sensor clamp. • The sensor must not be located on the same arm as the blood pressure cuff, arterial catheter or intravascular line.
- Page 5 frequently moved. Assess site as frequently as every (1) hour with poorly perfused, patients and move the sensor if there are signs of tissue ischemia. • Circulation distal to the sensor site should be checked routinely • During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure necrosis.
- Page 6 Performance, Reliability, Safety, Compatibility & Mechanical Integrity • Performance/Reliability This SpO2 sensor with its compatible pulse oximeter has been validated and tested for compliance with ISO 80601-2-61. Comparative value measurement in % saturation: SpO2 range (70%-100%) -Accuracy ±3% SpO2 range (<70%) -No specified...
- Page 7 Degree of protection against the Ingress of Water: IPX2 • Compatibility In order to ensure compatibility and claimed accuracy of the devices, the SpO2 sensor should only be used with the specified equipment for which they have been designed and labeled for use.
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Page 8: Operating Conditions
demanding hospital environment. The solid connectors are fitted with flexible sleeves to minimize the risk of cable breakage. They have no accessible metallic parts. Operating Conditions • Ambient temperature: 0°C to +40°C • Relative humidity: 15% to 85% • Atmospheric pressure: 86 kpa ~ 106 kpa Storage &... - Page 9 Warning The sensors should not be fixed in the tissue injury site, not for hyperactivity of blood oxygen monitoring. • The sensors are designed for use with specific monitors. • The operator is responsible for checking the compatibility of the monitor, sensor and cable before its use.
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Page 10: Waste Disposal
MR scanner. Caution Federal (U.S.) Law restricts this device to sale by or on the order of a physician. Waste Disposal Please refer to your local laws and regulations for information on how to dispose of SpO2 sensors. - Page 11 Title of Symbol Manufacturer Caution Date of manufacture Catalogue number Crossed out wheelie Batch code bin indicates separate Serial number treatment from general waste at Not made with end of life. Waste natural rubber latex of Electrical and Electronic Equipment Consult electronic Directive (WEEE) instructions for use...
- Page 12 Support To get the support, please contact the representative of manufacturer or local distributor. The categories shown below are available for sale through the local distributors or e-commerce. SpO2 NIBP TEMP EtCO2 FETAL Orantech Inc. Zone#A, 4F, 1st Bld, 7th Industrial Zone, Yulv Community, GongMing, Guangming New District, Shenzhen, China 518106 www.orantech.com...
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