Use Instructions
16 Safety-related checks
– The Invia Ease pump is a device in protection class II (EN IEC 60601-1), the safety-related
checks are confined to visual inspection of the housing and charger for damage.
This check must be performed prior to each use.
– If any damage or safety defects are observed, contact the Medela Customer Service
or the system provider.
– Devices of protection class II do not have a protective earth conductor therefore there
is no need to check the earth leakage current.
– The Invia Ease pump enclosure is made entirely of insulated material. Tests of the enclosure
leakage current using common measuring instruments will therefore not reveal measurable
values.
– Even when suctioning a conductive fluid until the overflow protection device activates,
measurements of the patient leakage current using common measuring instruments will
not reveal measurable values.
– The Invia Ease pump does not have patient circuits or functional earth connections.
– The Invia Ease pump and charger should be maintained and repaired throughout
its service life in compliance with the Medela service procedures.
– Service work may only be carried out by Medela’s authorized personnel.
– To request maintenance service contact the Medela Customer Service.
17 Maintenance and service
Invia Ease pump, charger, handle, IV pole/bed holder and carrying case cannot
be sterilized.
The following products are sterile and single use only:
Invia Ease canister and tubing
These are single use products that should be disposed of after use.
Do not reuse.
If reused, the performance of the product may deteriorate, cross-contamination may occur.
18 Sterility requirements
Sterile products: Do not use the sterile products if the sterile packaging is damaged,
was opened prior to use or has expired.
WARNING
EN
Safety-related checks/Maintenance and service/Sterility requirements | 49