Serious Incident; End Of Life Disposal - arjo Flowtron DVT5 Mode D'emploi

EN
To be used only under the direction of a physician • Only for use with Flowtron® DVT pre-
vention pumps manufactured by Arjo • Not made with natural rubber latex • Non-Sterile
Indications
To help prevent Deep Vein Thrombosis (DVT).
Contraindications
IPC should not be used in the following
conditions
• Severe arteriosclerosis or other ischaemic
vascular diseases.
• Known or suspected acute Deep Vein
Thrombosis (DVT) or phlebitis.
• Severe congestive cardiac failure or any
condition where an increase of uid to the
heart may be detrimental.
• Pulmonary Embolism.
• Any local condition in which the garments
would interfere, including gangrene, recent
skin graft, dermatitis or untreated, infected
leg wounds.
• If you are unsure of any contraindications
refer to the patient's physician before using
the device.

Serious Incident

If a serious incident occurs in relation to this
medicl device, a ecting the user, or the patient
then the user or patient should report the serious
incident to the medcial device manufacturer or
the distributor.
In the European Union, the user should also
report the serious incident to the Competent
Authority in the member state where they are
located.
Recommendations
• Continuous intermittent pneumatic compres-
sion is recommended until the patient is fully
ambulatory. Uninterrupted use of the system
is recommended.
• In the non-surgical patient, the system
should be initiated immediately once the risk
of DVT formation is identi ed.
• Garments should be removed regularly
to inspect the skin for signs of redness or
pressure points.
6
Cautions
• Garments should be removed immediately
if patient experiences tingling, numbness or
pain.
• When used for DVT prophylaxis, continuous
use is recommended and any interruption
of therapy for a substantial length of time
should be at the discretion of physician.
• Lower limb positioning in relation to the gar-
ment and tubing should also be considered
particularly when a patient is unconscious,
or has reduced sensation / ability to move
their legs.
• Additional care should be taken when plac-
ing the garments on any deformed leg or
foot, or on legs with signi cant oedema.
• This product cannot be adequately cleaned
and / or sterilized by the user in order
to facilitate safe reuse and is therefore
intended for single patient use. Attempts to
clean or sterilize these devices may result in
a biocompatibility, infection or product failure
risk to the patient.

End of Life Disposal

Garment material or any other textiles, polymers
or plastic materials etc. should be sorted as
combustible waste.
CE marking indicating conformity with
European Community harmonised
legislation
Single patient use
Read the Instruction for Use
before use
Indicates the product is a Medical
Device according to EU Medical Device
Regulation 2017/745