Tandem t:slim X2, Руководство пользователя

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Chapter 20 – Technical Specifications
20.5 Electromagnetic Compatibility
The information contained in this section is specific to the t:slim X2 Pump. This information provides reasonable assurance of
normal operation, but does not guarantee such under all conditions. If the t:slim X2 Pump must be used in close proximity with
other electrical equipment, the pump should be observed in this environment to verify normal operation. Special precautions for
electromagnetic compatibility must be taken when using medical electrical equipment. The Pump shall be placed into service with
adherence to the EMC information provided here. Using cables and accessories not specified in this User Guide may adversely
impact safety, performance, and electromagnetic compatibility, including increased emissions and/or decreased immunity.
For IEC 60601-1 testing, Essential Performance for the t:slim X2 Pump is defined as follows:
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The Pump will not over deliver a clinically significant amount of insulin.
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The Pump will not under deliver a clinically significant amount of insulin without notification to the user.
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The Pump will not deliver a clinically significant amount of insulin after occlusion release.
This section contains the following tables of information:
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Electromagnetic Emissions
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Electromagnetic Immunity
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Distances Between the t:slim X2 Pump and RF Equipment