ED01_REV01-2021 IFU OB500_ENG
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DEVICE
COMPLIANCE
Only use consumable or spare parts supplied by the manufacturer. Do not use similar or
apparently identical components. The conformity of the component can only be confirmed by the
manufacturer.
Keep a document confirming that all checks have been carried out and, if possible, a photographic
report on the condition of the device before and after the check. Always also keep a copy of the
safety report carried out with the appropriate calibrated instrument.
If you have any doubts or concerns regarding the conduct of the tests, please always contact the manufacturer of the
device or its authorised service centre. If you fail even a single test, please contact a service centre or the manufacturer.
Do not use the device if you have not passed all tests.
For further information please call +39 0471 932893 or send an e-mail to [email protected].
6.6.
Safety information for the safety of users, patients and third parties
To avoid unwanted effects and risks, always follow the information below:
•
Do not take unnecessary risks: always replace defective parts to ensure that the device is always efficient in case
of use and emergency.
•
We recommend another suction unit in case this one does not work or is defective (e.g. manual suction unit).
•
Always bear in mind what is stated in the initial warnings regarding the risks arising from the effects of magnetic
fields (EMC).
•
Always select the appropriate level of vacuum according to the patient and medical guidelines.
•
Do not alter or modify the medical device. Serious consequences for the patient and the user may occur.
•
OB500 (all variants) is
not a sterile device
and cannot be sterilised with the exception of the suction jar and silicone
tubing.
•
Keep children away from hoses and connecting cables. Also keep them away from small parts.
Risk of infection
•
Improper use of the device can lead to transmission of infections, even fatal ones.
•
Always wear disposable gloves, especially if there is a risk of coming into contact with aspirated secretions.
•
Never use components marked disposable more than once. Disposable parts or medical devices are marked
as in the figure opposite (number 2 crossed out).
•
Never use the device without the bacterial filter.
•
Always use only original accessories and original spare parts.
Attention
Assembly, repairs and modifications to the device are prohibited and may only be carried out by the
manufacturer or authorised personnel.
7.
SUCTION JARS FOR OB500 (all variants)
The device is marketed with two different types of jars with a capacity of 1000 ml:
•
Suction unit with autoclavable suction jar (OB500 FA).
•
Suction unit with suction jar equipped with disposable bag (OB500 FM and OB500 LINER)
