Maico MB 11 Classic, Руководство по эксплуатации

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Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx 4 01/16
2 Important safety instructions
The MAICO MB 11 Classic is designed to be used only by skilled personnel
(Audiologists, Physicians or other trained personnel). No person should
attempt to use this instrument without the necessary knowledge and
training to understand how this equipment is to be properly utilized and
interpreted.
The MAICO MB 11 is intended for use on intact, external skin
around the ears and on the scalp. It should not be used if the
skin is not intact or if the baby has a contagious dermatological
condition.
Electro-medical instruments with strong electromagnetic fields
(e.g. microwaves - radiotherapy devices), can influence the
function of the MB 11 Classic. Therefore the use of these
instruments is not allowed in close proximity to the MB 11
Classic.
The test room must be at normal temperature, usually 15°C /
59°F to 35°C / 95° F. If the device has been cooled down (e.g.
during transport), please wait until it has warmed up to room
temperature.
The MAICO MB 11 classic is specified according to IEC 601-1
safety against electrical hazard. This is only guaranteed, when
the connected notebook computer is powered by batteries or
the computers power supply accords to IEC 601-1 or IEC 950-1
safety regulations and an isolation transformer meeting
requirements of IEC 61558-2-1 or 60601-1 is used. The
complete system must meet the leakage current requirements of
IEC 60601-1-1. This complete system consisting of the MB11
Classic, computer and isolation transformer, is suitable for use in
the patient environment. Equipment not complying with IEC
60601 shall be kept outside the patient environment. Additional
equipment not specified as part of the system shall not be
connected.
Prevent cable breakage: The MB 11 Classic cables must not be
bend or buckled.
Do not use the instrument if the mains cable and/or the outlet is
damaged.
Patient safety: Place the patient at least 1.5 m away from
Notebook or computer. Alternatively work in battery mode, use
a Medical-PC or a special mains adapter according IEC 601-1.