4 Specification of application
ASTOFLO PLUS ECO Instructions for Use
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4.3 Contraindications
There are no known contraindications for warming blood, intravenous fluids and
irrigation fluids.
4.4 Possible adverse effects
When the ASTOFLO PLUS ECO is used as a warmer for return blood flow in a
haemofiltration, haemodialysis or haemodiafiltration device, it must be ensured
that the entire system meets the following:
The highest set temperature (43°C) must be used with care when operating at
low effluent flow rates (below 500 ml/h) for patients who weigh less than 30 kg.
Global positive heat balance and net patient warming may occur. If necessary,
operate the warmer at a reduced temperature setting.
Do not allow the heating profile or the power supply cord to interfere with the
scales, fluid bags or scale hooks.
4.5 Intended patient population
There are no restrictions for the intended patient group.
4.6 Intended user profile
The ASTOFLO PLUS ECO 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).
During application the heating profile has skin contact.