LR Suprasorb CNP P3 - Precautionary measures; Restrictions on use

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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

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

CNP P3 in accordance with its intended purpose.

• Use the Suprasorb

CNP P3 in accordance with its instructions for use.

• The Suprasorb

CNP P3 and its components should always undergo avisual inspection

and afunctional check prior to use.

• Do not allow unauthorised persons to open the Suprasorb

CNP P3 therapy unit.

• Assembly, setup, add-ons, maintenance and repairs must be performed by authorised

personnel.

• The Suprasorb

CNP P3 must undergo acheck in accordance with DIN EN 62353

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

CNP P3 has aproduct service life of 3 years.