ED01_REV01-2021 IFU OB500_ENG
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Test phase
Test result
Recommended action with negative outcome
Checking pump operation
Uniform engine noise, no rpm
drops, no abnormal vibration
Uneven noise indicates a fault in the pump operation. A drop in
speed indicates insufficient current to operate the motor
correctly.
Check for maximum
suction by occluding the
tubing from the filter or
disposable bag to the
device with your fingers
The maximum vacuum value
readable on the vacuum gauge
should be around 800 mbar (±10
%).
If this value is not reached, close the vacuum regulator
completely by turning the knob clockwise. Check that the
occlusion exerted on the tube is complete. If this is not the case,
do not use the device and contact the authorised service centre.
Setting the maximum
vacuum value
Value between approximately 0
and maximum by turning the knob
If the vacuum value cannot be adjusted, contact the authorised
service centre. Remove the device from use
If one or more tests fail, even after carrying out the recommended actions, request the intervention of
an authorised technician or contact the manufacturer for a full field check.
6.5.2.
Periodic six-monthly/annual test of OB500 suction unit (valid for all variants)
This test is used to check whether the device conforms to the original manufacturing characteristics and is therefore
suitable for use in the field. The checks and controls should be carried out by persons and/or companies specialised in
this type of operation on medical devices and must have been instructed/authorised by the manufacturer. Following
the inspection, an electrical safety test in accordance with IEC 60601-1 should be performed and a test summary
document made available to the user.
SIX-
MONTHLY
OR
ANNUAL
TEST
•
Replace the SERRES® disposable bag or antibacterial filter before performing these operations.
•
Check the connection of the electrical cables to the motor block.
•
Check the operation of the internal pump by operating the vacuum. The maximum vacuum value
must be between a minimum of 730 mbar and 880 mbar. Use a precision vacuum gauge to
measure this value (tolerance ±2.5 % or less). There should be no operational anomalies such as
unusual noise, rpm fluctuations, excessive gauge hand movement, and operation of the vacuum
regulator knob should be linear and unobstructed.
•
Check the vacuum regulator which should operate from minimum to maximum. Turn the knob
clockwise and anticlockwise. When the regulator is fully open, it is normal to measure a small
vacuum value (introduced by the antibacterial filter).
•
Check the control and suction unit for structural damage (ask the installer for the location of access
to this unit or consult the technical documentation of the vehicle). All plastic containers must be
intact and not deformed.
•
Check that all labels and screen prints are present and legible.
•
Never open the suction unit for any reason. For technical assistance, contact only one of the
authorised service centres listed available by the manufacturer.
•
Check the function of the vacuum gauge. When the vacuum unit is switched off, the needle should
be at "0".
•
Check that the suction jar is intact and that there are no cracks or breaks that could impair suction.
Penetration of liquids or solids may damage the unit and make it unsafe for operators and patients
(running mechanical parts).
•
Check that the jar holder is fixed to the wall and in a vertical position. If the jar is tilted more than
20° from the vertical, the overflow valve may be triggered.
•
Before declaring the suction unit compliant with the manufacturer's data plate, carry out an
electrical safety test according to IEC60601-1 with a specific safety analyser. Contact the
manufacturer or the authorised service centre for information on how to carry out this test.
