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3. The BM-02 medical device is not intended for direct contact or transferred contact with
the patient's body.
4. Minimum specifi ed user profi le
o
Age: 12 years + , with the ability to judge appropriate to his or her age.
o
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.
o
Language aptitude: average ability to read and understand a text in the native language.
o
Experience: basic experience with installing and operating simple electronic devices with the aid
of a manual.
o
Other abilities: hearing and sighted individual, mentally competent to care for a child.
5. Intended environment and conditions of use
o
It is intended for use in healthcare provider and home healthcare environments.
o
It is designed to be used under a mattress with an insulating pad to protect against permeation.
o
Not intended for use in transport means, unlockable cradles, prams, hammocks, hanging baskets,
in environments that easily transmit shocks and vibrations.
o
Not intended to be overloaded beyond the weight limit specifi ed in the manual which can lead to
unreliable operation.
a. User conditions
o
Observation angle: 45°.
o
Observation distance 10 cm to 5 m depending on light conditions
o
Ambient light conditions: 50 lx to 2500 lx.
o
Emitted sound pressure: 80 dBa 1 m from the device.
o
The device is portable when keeping to the specifi ed environmental and usage conditions.
o
Frequency of use: several times a day for 1 year in the home environment to almost continu-
ously for the duration of use by healthcare providers.
o
It is necessary to respect the shelf life for the sensing pad, which is 2 years, and the control
unit, which is 10 years.
b. Ambient conditions - see Technical data above
Package contents:
sensor pad, control unit, 5 m long extension cable, plastic wall attachment, splitting connector,
2 antibacterial tissues, 2 alkaline batteries type AA LR6 1.5 V. Product service life: 2 years (from the date of purchase).
Certifi cation was carried out by the following notifi ed body: EZÚ Prague, No. 1014.
The product underwent clinical testing and was registered by the Health Ministry of the Czech
Republic as a medical device class IIb.
JABLOTRON ALARMS a.s. hereby declares that the BM-02 is in a compliance with the essential
requirements and other respective provisions of Directives MDD 93/42/EEC and 2007/47/
EC and 2011/65/EU (RoHS). The original of the Declaration of Conformity can be found at
www.jablotron.com.
Note: Disposing of this product correctly will help save valuable resources and prevent any
potential negative effects on human health and the environment, which could otherwise arise
from inappropriate waste handling. Please return the product to the dealer or contact your local
authority for further details of your nearest designated collection point.
Please check the website
Date of issue: 2024-07-01 (ver. 24)
MANUFACTURER AND SERVICE PROVIDER:
JABLOTRON ALARMS a.s.
Pod Skalkou 4567/33, 466 01 Jablonec nad Nisou, CZECH REPUBLIC
+420 483 559 811 | e-mail: support@monitornanny.com
www.monitornanny.com
for your local support or contact.
11
MFV52124
(859405253BM02ES)
EN
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