Certification

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Testing and Certification for Oxygen concentrator

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  • KOKILA Oxygen Concentrator is meant to be an experimental device made available for emergency use in medical care settings in the absence of availability of other solutions. 

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The KOKILA Oxygen concentrator is tested at a third-party accredited laboratory for performance, safety & efficacy for following tests.

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Sr. No.TestsStandard & Clause No
1Humidity PreconditioningISO 80601-2-69 (Clause 201.5) IEC 60601-1 (Clause 5.7)
2Leakage Currents and Patient Auxiliary CurrentsISO 80601-2-69 (Clause 201.8) IEC 60601-1 (Clause 8.7, 8.7.1, 8.7.3 & 8.7.4.5)
3Leakage Currents and Patient Auxiliary CurrentsISO 80601-2-69 (Clause 201.8) IEC 60601-1 (Clause 8.7, 8.7.1, 8.7.3 & 8.7.4.6)
4Accuracy of continuous flow rateISO 80601-2-69 (Clause 201.12.1.101)
5Accuracy of concentrationISO 80601-2-69 (Clause 201.12.1.103)

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Test Report