TIM SmartVap D, Инструкция по эксплуатации

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1 Introduction
SmartVap Vaporizer SW 1.n, Instructions for use (en-US) 9
1 Introduction
1.1 Intended purpose
SmartVap is a heated, calibrated anaesthetic vaporizer for the enrichment of dry, medicinal
fresh gases from an anaesthesia workstation with the vapor of the anaesthetic agent Des-
flurane, in a concentration range of 2 to 18 Vol %.
1.2 Product description
SmartVap is an electronic vaporizer for Desflurane for integration in an anaesthesia work-
station in accordance with ISO 80601-2-13. The vaporizer is equipped with integrated flow-
rate measurement of the fresh gas flow, and a dosing unit for enriching the fresh gas with
Desflurane vapor according to the set concentration.
The fresh gas from the anaesthesia workstation can be enriched with gaseous Desflurane
in concentrations of 2 to 18 Vol %, at gas flows of 0.2 to 15 liters/minute.
1.3 Operator and user qualification
1.3.1 Medical personnel
The vaporizer may only be operated by trained medical personnel under the supervision of
a physician.
Training is conducted by a medical device consultant contracted by the manufacturer.
For later use, instruction videos can
be viewed on the manufacturer’s website.
1.3.2 Processing personnel
Hygienic processing of the vaporizer must always be performed by personnel with exper-
tise in the processing of medical devices.