Med Accessories Technology Dongguan Co., Ltd.
Med Accessories Technology Dongguan Co., Ltd. integrity creates quality, quality wins the market.
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| Manufacturer | Model |
|---|---|
| Nihon Kohden | AL-800PA Module, BSM-1101 Life Scope EC, BSM-2101/2 Life Scope L, BSM-3101 Life Scope LC, BSM-7100/7200 Life Scope 8, BSM-8200/1 Life Scope 12, BSM-8301/2 Life Scope 9, NT3B, OLV-1100A, SM-8800 Life Scope 14 |
Performance/Realiability
The performance and reliability of our SpO2 finger sensor, along with its compatible pulse oximeter, have been thoroughly validated and tested for compliance with EN ISO9919:2005 standards. The following accuracy specifications apply to the comparative value measurement in percentage saturation (SpO2) and pulse rate:
SpO2 Range (90%-100%):
Accuracy: ±2%
SpO2 Range (70%-90%):
Accuracy: ±3%
SpO2 Range (<69%):
No specified accuracy range provided
Pulse Rate Range: 20-250 bpm:
Accuracy: ±2 bpm
These accuracy specifications indicate the level of precision you can expect when using our SpO2 finger sensor and pulse oximeter combination. The accuracy values reflect the deviation from the true measurement, providing confidence in the reliability of the readings within the specified ranges.
We have conducted comprehensive testing to ensure that our SpO2 finger sensor and pulse oximeter meet these accuracy standards, enabling healthcare professionals to monitor oxygen saturation and pulse rate with confidence.
Safety
As mentioned before, Med Accessories SpO2 sensors are designed with safety in mind. Here are some additional details about the security features:
Degree of protection against electric shock: Our sensors are type BF (Body Floating) according to international standards for medical electrical equipment. This classification indicates a higher level of protection against electric shock when the sensor is in contact with the patient's body.
Classification according to MDD 93/42/EEC: The Med Accessories SpO2 sensor is classified as a Class IIb medical device according to the Medical Device Directive 93/42/EEC. This classification represents a higher level of risk and requires more stringent controls to ensure safety and performance.
These safety designations and classifications demonstrate our commitment to meeting strict safety standards and regulations. We prioritize the well-being of patients and healthcare professionals by providing SpO2 sensors that comply with necessary safety guidelines.