Use Instructions

Instruction for Use

plasma care and plasma care spacer

IFU plasma care© and plasma care© spacer

Version: 0.1

Date: 26.05.2020

Page 14/38

• Wounds without hemostasis

• Wounds with exposed inner organs (e.g., during surgery)

• Wounds at mucous membranes

• Wounds of head and neck area

• Children under the age of 12 years

4 Operator and Patient Profiles

4.1 Operator

The plasma care® is a medical device that is intended for use in a professional environment.

The operators are physicians and other healthcare professionals

• in hospitals (e.g. dermatology, surgery, angiology) and wound centers,

• in medical practices (e.g. GPs, dermatologists, diabetologists, surgeons, angiologists

and podologists),

• in out-patient care,

• in retirement and nursing homes or

• in home care setting (e.g. travelling nurses)

The operators have undergone medical training and are experienced in the treatment of

wounds in compliance with the current therapeutic guidelines.

Prior to use of the plasma care® with the plasma care® spacer, all operators need to study the

manual carefully and need to be instructed in the use of the plasma care®. The instruction can

be given by the manufacturer or an expert.

Before using the plasma care® with the plasma care® spacer the operators

need to read the manual carefully.

4.2 Patient Profile

The patients are people with wounds of varying aetiology. The patients need to be at least 12

years of age. As wounds occur more frequently in elderly patients, a higher average age can

be assumed. The patients often display co-morbidities or limitations such as the following:

• limited mobility

• sensory disorders

• metabolic disorders

• circulatory disorders

• venous insufficiency

• peripheral artery disease

• Diabetes mellitus

• neoplasias

The treated wounds are not gender-specific.