ASTOTHERM PLUS Instructions for Use
4 Specification of application
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4 Specification of application
4.1 Intended use
ASTOTHERM PLUS is a warmer for Blood, Intravenous Fluids and Irrigation
Fluids. The application areas include blood transfusions, intravenous fluids,
dialysis, hemofiltration and apheresis.
4.2 Intended medical indication
The warming of medical fluids with ASTOTHERM PLUS supports the prevention
and therapy of hypothermia.
4.3 Contraindications
There are no known contraindications for warming blood, intravenous fluids and
irrigation fluids.
4.4 Possible adverse effects
There are no known side effects, which are causally attributed to the warming of
blood, intravenous fluids or irrigation fluids.
4.5 Intended patient population
There are no restrictions for the intended patient group.
4.6 Intended user profile
The ASTOTHERM PLUS Warmer is to be operated only by medically qualified
and trained healthcare professionals.
4.7 Intended use/operation environment
The warmer may only be used in professional healthcare facilities (e.g. hospital,
emergency care, dialysis, including HF surgical equipment, etc.).
The warmer is not intended for home healthcare environment.
The warmer is reusable, but requires cleaning / disinfection between the
applications.
Appropriate medical hygienic factors must be applied for the use of the warmer.
The warmer must not be used in an environment at risk of explosion or in the
present of flammable anesthetics.
4.8 Intended part of the body/type of tissue
The warmer is used to warm blood or other medical fluids supplied to the body.
The fluids are physically separated from the warmer by disposable parts (tubes).
