Precautionary Measures; Restrictions On Use; Information For The User - Lohmann & Rauscher Suprasorb Cnp P3 Gebrauchsanweisung

1.4.4 Precautionary measures

Precautionary measures need to be taken for:
• patients under anticoagulation therapy
and/or with active bleeding
• patients with difficult wound haemostasis
• application of the system in the immediate
vicinity of blood vessels, organs, muscles,
fascias and bradytrophic tissue (tendons,
ligaments or cartilage)
• irradiated vessels and tissues
• bone fragments with sharp edges
• uncooperative patients
• wound cavities and pockets with hidden
areas
• patients with ischaemia and/or circulatory
disorders; the attending doctor must check
whether negative pressure therapy is
applicable or whether it may be necessary

1.5 Information for the user

• Use the Suprasorb
• The Suprasorb
®
newborns. The attending doctor is responsible for selecting eligible patients.
• Use the Suprasorb
• The Suprasorb
®
inspection and functional testing prior to use.
• The device may only be opened and repaired by L&R or an authorised specialist in
accordance with the service documentation provided by the manufacturer and taking
appropriate technical and hygiene safety precautions.
• The Suprasorb
®
authorised by L&R (see Section 8.1) every 18 months or after 1,000 hours filter runtime
(see Section 4.11).
• The target group for the Suprasorb
professionals and laypersons who have been trained in its use. The healthcare professionals
are primarily nurses, doctors and surgeons who use the Suprasorb
wound care field. Trained healthcare professionals can train other medical staff.
• Healthcare professionals are trained in the use of the device by L&R or an authorised L&R
sales partner. The training sessions are carried out once with reference to the instructions
for use. Laypersons must be trained by a healthcare professional.
CNP P3 therapy unit in accordance with its intended purpose.
®
CNP P3 therapy unit is intended for use on adults, children and infants/
CNP P3 in accordance with its instructions for use.
®
CNP P3 therapy unit and its accessories should always undergo a visual
CNP P3 must undergo servicing performed by L&R or a service partner
CNP P3 system is restricted to trained healthcare
®
to implement other therapy measures
(e.g. revascularisation) first
• pressure settings for paediatric patients
(in particular infants and newborns),
because at present no documented
clinical experience with the device is
available

1.4.5 Restrictions on use

• In medical facilities where
potential equalisation is required
(e.g. cardiac surgery)
• in potentially explosive
atmospheres
• in aircraft
• in areas with electromagnetic
radiation, e.g. MRI suites
CNP P3 system in the
®
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