b-intense MED, Инструкция по эксплуатации

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EN
Scope of application of b-intense
®
MED
Intended use
The b-intense
®
MED consisting of cabin shell, infrared back and front heater and accessories (speakers, ambient light) is intended for the
local, contact free heat application in order to release muscular tensions and assist in the treatment of pain and tension conditions.
Application time:
Depending on medical advice daily between 30 and 50 minutes.
Intended application
› The b-intense ® MED is intended for infrared therapy according to the specified purpose.
› The product is exclusively intended for professional use under supervision of trained personnel and not for private use.
› Intended application also includes fully reading and understanding the associated documentation and in particular these “safety
instructions”.
Not intended application
› Every use that doesn’t comply with the intended application is not intended and therefore prohibited.
› Application without supervision enables undesired operating conditions during application and can harm the device or the user.
› The use of not licensed components is prohibited.
b-intense
®
is not liable for any damage occuring through unintended use. The risks
of unintended use lies within the user.
Application specification
Operating conditions
Ambient Temperature: 18-35 °C
Realtive humidity: 10-60 %
Atmospheric pressure: 70-106 kPa
Intended medical indication: Release muscular tensions and assist in the treatment of pain and tension conditions
Intended user population: Intended user population are adult humans with an undisturbed sensitivity to heat.
The intended user population do not have any contraindications mentioned in this IFU
which excludes them from the heat treatment.
Intended part of the body or type of
tissue applied to or interacted with: Intended to interact with the back of the user
Intended user profile: Physicians, registrated (RNs) nurses, Licensed practical (LPNs) Nurses, physical therapists
Intended conditions of use:
Stationary installation in a clinical or therapeutic environment.
Operating principle: Local, contact free heat application with an electrical heater device on the back
of the user