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Instructions for use D-Vapor/D-Vapor 3000
95
Service
Inspection
Regular inspections must be carried out and logged
in accordance with the following requirements and
at the stated intervals.
The inspections and safety checks are identical for
D-Vapor and D-Vapor 3000.
Safety checks
The safety checks do not replace the manufacturer-
specified maintenance and its preventive
replacement of wear parts.
1
Check accompanying documents:
– Associated instructions for use for the
medical device present.
2
Check the medical device to see that the ready-
to-use product is complete in accordance with
the instructions for use.
3
Check the equipment combination for perfect
condition:
– Markings are complete and legible
– No damage
4
Check function and safety:
– Checking operational readiness (see
chapter "Operation" on page 54).
– Check of electrical safety according to
IEC 62353 (device leakage current <50
A)
or IEC 60601 (normal condition NC*
<50
A,
SFC** <100
A)
– Check emergency power operation
Battery charged for 1 hour; the vaporizer
must dose for 5 minutes in battery operation
at a flow rate of 4 L/min and control dial
position 6 Vol%
– Check of leak tightness with vaporizer
switched off and control dial positions
0
and
18 Vol%
Test pressure: 350 hPa (357 cmH
2
O),
Test value: Leakage rate <3 mL/min relative
to an ambient pressure of 1013 hPa
(14.69 psi)
– Check of pneumatic resistance in control
dial position
0
and
2
Vol%
carrier gas: Air, flow: 10.0 L/min.
Checks
Interval
Personnel responsible
Inspection and safety checks
Every 12 months
Service personnel
WARNING
Risk of patient injury
Perform safety checks at the indicated inter-
vals. Otherwise, the correct functioning of the
medical device may be compromised.
*
NC: Normal Condition
** SFC: Single Fault Condition
Control dial
position
Test value
0
10 to 28 hPa
(10.2 to 28.6 cmH
2
O)
2
Pressure increase relative
to control dial position
0
by
53 to 79 hPa
(54 to 80.1 cmH
2
O)
Summary of Contents for D-Vapor
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