Dräger D-Vapor

Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
D-23542 Lübeck
is certified as a manufacturer of medical devices according to Annex II of Directive 93/42/EEC and
maintains a Quality Management System conforming to the requirements of ISO 13485:2016 and
ISO 9001:2015.
We hereby confirm to our client
(to be completed by the Drägerwerk AG & Co. KGaA distribution partner)
that the product D-Vapor/D-Vapor 3000
with the Serial No.
(See rear of these Instructions for Use.
to be completed by the Drägerwerk AG & Co. KGaA distribution partner)
was manufactured and tested in Germany and conforms to the technical specifications.
The D-Vapor and D-Vapor 3000 anesthetic vaporizers are adjusted in the factory to within the tolerances
specified in the following table under calibration conditions (temperature 22 °C (71.6 °F), atmospheric
pressure 1013 hPa (14.69 psi), continuous flow 2.5 L/min Air without ventilation pressure, without
pressure fluctuations and without back pressure). Precise measuring instruments are used for the
individual adjustment to the desflurane anesthetic agent.
The control dial positions are set from low to high.
D-Vapor and D-Vapor 3000 anesthetic agent vaporizers bearing the CE mark fulfill the requirements of
Annex I of Directive 93/42/EEC (medical products).
Drägerwerk AG & Co. KGaA
Vaporizer Production – Final Inspection
Control dial position [Vol%] 3.0 5.0 8.0 10.0 14.0 18.0
Tolerance [Vol%] 2.5
to
3.5
4.25
to
5.75
6.8
to
9.2
8.5
to
11.5
11.9
to
16.1
15.3
to
20.7
Quality Inspection Certificate
(Do not remove. Photocopy if necessary.)