65
EN
MXA51006
(85956141BM03SJ)
2. Designated patient population
• Age: from birth to typically 12 months (depending on the child’s maximum
recommended weight corresponding to the physiological age up to 2 years, in
exceptional cases, for non-physiological cases, even above 2 years, but always taking
into account the recommended maximum weight).
• Recommended patient weight from 1 to 15 kg.
• State of health: according to the specifi ed medical indication.
• Ethnicity: multiple.
• The patient is not a device user (does not control device).
3. The BM-03 medical device is not intended for direct contact or transferred contact
with the patient’s body.
4. Minimum specifi ed user profi le
• Age: 12 years + , with the ability to judge appropriate to his or her age.
• Knowledge: ability to distinguish the colours and meanings of the signal lights, ability
to change batteries in the device and install the device according to the instructions
in the manual.
• Language aptitude: average ability to read and understand a text in the native
language.
• Experience: basic experience with installing and operating simple electronic devices
with the aid of a manual.
• Other abilities: hearing and sighted individual, mentally competent to care for a child.
5. Intended environment and conditions of use
• It is intended for use in healthcare provider and home environments.
• It is designed to be used under a mattress with an insulating pad to protect against
permeation.
• Not intended for use in transport means, unlockable cradles, prams, hammocks,
hanging baskets, in environments that easily transmit shocks and vibrations.
• Not intended to be overloaded beyond the weight limit specifi ed in the manual which
can lead to unreliable operation.
a. User conditions
•
Observation angle: 45°.
• Observation distance 1 to 5 m depending on light conditions
• Ambient light conditions: 50 lx to 2500 lx.
• Emitted sound pressure: 80 dBa 1 m from the device.
• The device is portable when keeping to the specifi ed environmental and usage
conditions.
• The frequency of use of the device is not limited by the manufacturer.
• It is necessary to respect the life span for the sensing pad, which is 2 years or
14600 hours, and the control unit, which is 10 years.
b. Ambient conditions - see Technical data below
Summary of Contents for BM-03
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