General Safety - BORCAD Medical AVE2 Instruction Manual

5 General safety

Birthing Bed is not primarily intended for newborns. For this case there is a special cot which
comes as a separate medical device. It is assumed that the position of the baby during
breast-feeding is under the constant control of the mother and thus any uncontrollable
movement of a newborn on the bed is improbable. After breastfeeding the newborn baby is
moved into the cot intended for this purpose. The caregivers are informed about potential
risks in the instruction manual.
Do not operate the bed in rooms with inflammable gases/vapours. Danger of injury/damage
of the equipment.
Use only ventilation or nasal-type oxygen supply units. Do not use the bed in oxygen tents
(risk of injury or damage of the equiment).
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established!
Only authorised and trained person using the tool is allowed to change fuses and power
supplies!
This medical device is not intended for oxygen enriched environment!
This medical device is not intended for use with flammable substances!
This medical device is not portable medical electrical equipment!
Make sure the duty cycle (2 min ON/18 min OFF) is not exceeded during bed positioning!
Patient is allowed to use selected control elements only if hospital personnel had assessed
that the patient´s physical and psychological state is in accordance with use of them and
only if the hospital personnel had trained the patient in accordance with the instructions for
use!
•
Leave the bed in the low position when the patient is unattended. This can reduce
the possibility of patient falls and the severity of any resultant injuries.
•
Make sure to fix and set the accessories properly (tightening of handles etc.)
•
Do not dismantle or execute unqualified repairs of motors, control unit, etc.
•
The birthing bedAVE2 must not be used in medical facilities with fire or
explosion risks caused by air or in combination with nitrous oxide and anesthetics or
cleaning agents.
•
Construction modifications reserved!
•
The bed must be equipotentially connected with other medical devices to prevent fire in
combination with flammable substances and anesthetics during minor surgical
procedures using high-frequency (HF) instruments.
•
Never use other than original accessories. All original accessories are marked with an
original label containing the name and brand of the manufacturer, designation of the
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: +420 558 640 631
Warning:
Caution
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