Important Information - Alert-it Companion Mini Pro Handbook

Important Information

The system complies with 93/42/EEC as a Class 1 Medical Device for use in a Home Healthcare
environment.
The system complies with EN60601 for Class 2 Electrical Safety and does not need a protective earth
and group 1 Class B EMC in a Home Healthcare environment.
1.
Ensure that the senor cable is routed and secured to
avoid the risk of entanglement or strangulation.
2. Ensure the power cable is routed to avoid a trip
hazard.
3. Regularly check the power supplies for damage and
potential shock risks.
4. Ensure, by testing, that the alarm is annunciated at
the carer's location(s).
5.
Clean and disinfect each item regularly in accordance
with information on page 11.
6.
Regularly test sensors as defined herein.
7. Use only the power supply and batteries
recommended.
8. Operate power supply and charge pager away from
direct heat and uncovered.
9.
As with all medical electronic equipment there is
potential for the equipment to interfere with or be
effected by interference from other electrical or
electronic devices. For this reason avoid placing
the monitor, sensor or connecting cable in close
proximity to sensitive electronic devices or devices
which produce strong electromagnetic fields such as
radio transmitters, mobile phones or power cables.
The Alert-it system has been designed with due regard to reliability and integrity. While it offers a highly vigilant
monitoring method, it is always possible that a distress condition can go undetected for a variety of reasons (including
malfunction) and in life threatening situations it is advisable to use the Alert-it system in conjunction with additional
monitoring techniques (e.g. video). Neither the manufacturer nor its agent can accept legal responsibility to provide a
system that is infallible. The carer is responsible for assessing the risks of using this equipment and any settings
pertaining to it.
10.
Only use the monitor with accessories approved for
use with this product and only in accordance with
instructions.
11.
If the equipment is modified in any way, appropriate
inspection and testing must be conducted to ensure
continued safe use of the equipment.
12.
The carer must conduct a risk assessment to
determine if the level of reliability offered by the
monitor is sufficient or if additional monitoring is
needed. Contact the manufacture for assistance
with Risk Evaluation Tools.
13. Additional levels of mechanical protection may be
needed for some patient disorders. Contact the
manufacturers for advice.
14. The pager "Extended User" option should be
disabled if there are concerns that the carer may
turn-off the pager inappropriately and ignore alarms.
15. Some accessories are fitted with small screws and
have plastic bags. Ensure these do not come into
the possession of vulnerable patients who might
choke on them.
16.
Any sensor over the mattress (Bed Vacation or
Incontinence) has the potential to cause pressure
sores. The carer must assess this risk and monitor
the use of these products.
17. Any sensor over the mattress could pose a fire
hazard if in contact with a smouldering cigarette.
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