VBM Medizintechnik Tourniquet 2500 Manual Del Usuario página 26

1 DEVICE CHECK
Maintenance
The medical device may only be serviced by persons
who have the technical knowledge, qualification and the
required means to properly carry out the service.
After servicing the medical device, the structural and func-
tional characteristics essential for safety and functionality
must be checked, insofar as they can be influenced by the
service procedure.
All guarantee or warranty claims are null and void if the
user or an unauthorised body tries to remedy a defect
themselves, which is not described in these instructions
for use.
For a fast repair process, it is required that the medical
device be returned with the most precise a fault descrip-
tion as possible.
To protect employees, every medical device must be
thoroughly cleaned and disinfected before returning (cf.
"Instructions for use, 9 Cleaning Instructions"). The manu-
facturer can refuse to repair soiled or contaminated medi-
cal devices for reasons of safety.
Manufacturer inspection
It is recommended to return the device to the manufac-
turer for inspection after an operating period of 5 years.
Metrological check
The accuracy ±10 mmHg must be checked every
12 months.
If there is an indication that the tourniquet cannot keep
the accuracy of measurement within the 12 months, or
the metrological characteristics of the tourniquet have
been affected, a metrological check has to be carried out
immediately. This must only be carried out by a person
who meets the requirements for metrological checks. The
results of the check, as well as a minimum of the meas-
ured values and measurement procedures, have to be
documented.
After successful check, the tourniquet has to be marked
with a sign that indicates (clearly and traceable) the year
of the next inspection and the person who carried out the
metrological check.
In order to check the values, the female positive locking
connector of the tourniquet has to be connected to a
calibrated pressure gauge (measurement inaccuracy max.
±2 mmHg).
Inflate the manometer with pressure range 600 mmHg to
100, 200, 300, 400, 500, 600 mmHg and note the values.
The values must be within the tolerance. If this is not the
case, the device must be returned to the manufacturer for
repair. If the values are within the tolerance, the device
can still be used.
If required measuring equipment is not available, the met-
rological check can be carried out by the manufacturer.
In this case the tourniquet has to be sent to the manu-
facturer.
Note for conversion of mmHg to SI unit Pascal:
100 mmHg corresponds approximately to 13.33 kPa
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