Precautionary Measures; Restrictions On Use; Information For The User - L&R Suprasorb CNP P3 Mode D'emploi

1.4.3 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 and 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
Suprasorb CNP therapy is applicable or whether it may be necessary to implement other
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therapy measures (e.g., revascularisation) first

1.4.4 Restrictions on use

• medical facilities where potential equalisation is required (e.g., cardiac surgery)
• potentially explosive atmospheres
• aircraft
• areas with electromagnetic radiation, e.g., MRI suites

1.5 Information for the user

• Use the Suprasorb
• Use the Suprasorb
• The Suprasorb
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and a functional check prior to use.
• Do not allow unauthorised persons to open the Suprasorb
• Assembly, setup, add-ons, maintenance and repairs must be performed by authorised
personnel.
• The Suprasorb
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performed by L&R or an L&R authorised service partner every 18 months (see Section 7.2).
• The healthcare professionals are trained in the use of the device by L&R or an
authorised L&R sales partner. The training sessions are performed once with reference
to the instructions for use – Sections 2, 3, 4, 6 and 11 for the qualified healthcare
professionals and Sections 2, 3, 5, 6 and 11 for the patient – and documented in
the medical devices book.
• The Suprasorb
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CNP P3 in accordance with its intended purpose.
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CNP P3 in accordance with its instructions for use.
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CNP P3 and its components should always undergo a visual inspection
CNP P3 must undergo a check in accordance with DIN EN 62353
CNP P3 has a product service life of 3 years.
CNP P3 therapy unit.
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