Huntleigh Sonicaid FM800 Series, Instructions For Use Manual, Page: 123 / 130

Sonicaid FM800 Encore Series Instructions for Use
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19.8
136B
Safety
i) FM800E is designed to comply with:
EN60601-1 (2006)
ii) FM800E is Class 1 equipment, with protective earth via the AC mains input. FM800E
must be connected to an earth supply complying with local safety standards. The
installation engineer must check that the supply voltage falls within the permitted
range as specified on the supply voltage label.
iii) This equipment is not explosion-proof and must not be used in the presence of
flammable anaesthetics. It is ordinary equipment (not drip-proof or splash-proof),
designed for continuous operation.
iv) The equipment must be serviced only by authorised and qualified personnel.
Huntleigh Healthcare Ltd cannot accept responsibility for safety compliance, reliability
and performance if modifications or repairs are carried out by unauthorised
personnel. Identical replacement parts must be used.
v) If there is doubt whether FM800E is operating correctly, when being used on a
patient, fetal condition must be checked by an alternative diagnostic method without
delay.
vi) The protective category against electric shock of all patient-applied parts is
Type CF.
vii) Installation is the responsibility of the vendor via a competent person, approved by
Huntleigh Healthcare Ltd.
viii) This equipment is not protected against:
a) the effects of defibrillator shocks or discharge.
b) the effects of high-frequency currents.
c) the effects of ‘bistoury’ - either TENS (Transcutaneous Electrical Nerve Stimulation), or
electro-surgery.
ix) The nature of the parts in direct or indirect contact with the patient is:
Ultrasound transducers ABS plastic
External Toco transducer ABS plastic with Thermoplastic Elastomeric Over
moulding
Sonicaid FECG electrode Stainless steel
Sonicaid FECG electrode lead Stainless steel, rubber
Safelinc™ FECG electrode Stainless steel
Intran IUP catheter Polyurethane plastic
MSpO
2
probe Biocompatible plastics
Transducer belts Latex-free fabric
ECG leg plate belt Fabric
All patient contact parts are biocompatible and comply with EN30993-1.