Classifications; Intended Purpose And Scope Of Use - I-Tech I-Press User Manual

Classifications

The I-PRESS device assumes the following classifications:
class IIa device (Directive 93/42/EEC, annex IX, rule 9 and subsequent
•
amendments/additions);
• Class II with type BF applied part (Classif. EN 60601-1);
IP21 protection degree device in relation to the penetration of liquids
•
and dust.
• device and applicators not subject to sterilisation;
device not suitable for use in the presence of a flammable anaesthetic
•
mixture with air or with oxygen or with nitrous oxide;
• device intended for continuous operation;
device not suitable for external use.
•

Intended purpose and scope of use

Clinical purpose:
Scope of use:
The I-PRESS device for pressotherapy is ideal for the treatment of diseases
affecting the circulatory system, in order to improve peripheral blood
circulation. This type of device is designed for the following applications:
- Oedema
- Lymphedema
- Venous ulcers
- Venous insufficiency
- Muscle recovery
The device can be used by patients themselves. In this case they will also
assume the role of operator during therapy.
The minimum age for patients to use the device is 18 years.
IACER Srl
Therapeutic
OutpatientClinic/Hospital and home
4 MNPG338-00