11 MAINTENANCE
During normal operation, the LuMon System does not require any internal adjustments or calibrations.
However, to guarantee continuous performance, reliability and safety of the LuMon System, routine checks
and preventive maintenance procedures (including cleaning/disinfection) as well as safety checks should be
performed regularly.
11.1 Routine Checks, Preventive Maintenance and Safety Checks
The following checks and maintenance procedures should be performed regularly (at least as often as stated
below or in accordance with institutional, local or governmental ordinances or regulations):
• Perform the preoperational check (7.4) each time before initiating monitoring for a new patient (8).
• Dispose of the belt (11.4) when the
belt time
has elapsed or after ending monitoring for a patient (10.3).
• Clean and disinfect the belt connector and LuMon Monitor (11.2) after ending monitoring for a
patient (10.3) and before use with a new patient, and regularly according to institutional policy during
use with a single patient.
• Check the LuMon Monitor, its power cord and the belt connector for mechanical or functional
damage at least once a month. Replace any defective parts with Sentec original parts. Refer to 11.3 to
replace the fuses of the LuMon Monitor.
• Check the expiry date of disposables (belts and contact agent/spray) at least once a month. Replace
any expired products.
• Initiate a complete safety and functionality check for the LuMon System regularly (recommended
every 12 months but at least once every 24 months). Respective instructions are provided in the
Service Manual for the LuMon System. Hereto contact a qualified technician (e.g. a biomedical
engineer), your local Sentec EIT representative or Sentec AG.
WARNING
There are no user serviceable parts inside the LuMon Monitor. The cover of the LuMon Monitor should only
be removed by
Sentec Authorized LuMon Technicians
. Service as well as the complete safety and
functionality test should be made by qualified technicians. Failure to do so could lead to injury, inaccurate
measurements and/or damage to the device.
NOTE
To perform a safety and functionality check and for service or repair, contact a qualified technician (e.g. a
biomedical engineer), your local Sentec EIT representative or Sentec AG.
NOTE
Repair and service procedures which require opening the cover of the LuMon Monitor must be performed by
Sentec Authorized LuMon Technicians
.
NOTE
Instructions for disinfection, repackaging and shipping when equipment and accessories are to be returned for
a safety check and/or service/repair are provided in sub-section 11.5.
11.2 Cleaning and disinfection
Due to the nature and seriousness of infectious diseases, it is important that equipment and accessories which
can come into contact with human tissues or fluids should always be regarded as potentially contaminated and
therefore hazardous.
Contaminated equipment and accessories must be decontaminated. Decontamination must be carried out by
a properly trained person. The directions for cleaning and disinfection vary from hospital to hospital. If you are in
any doubt regarding contamination or decontamination, consult your local infection control authority/hygiene
department.
The agents listened below may be used to clean and/or disinfect the surfaces of LuMon Monitors and of belt
connectors after ending monitoring for a patient (10.3), and before use with a new patient, and regularly
according to institutional policy during use with a single patient. However, other cleaning/disinfection
procedures may be applied as often as required per institutional ordinances.
As the number of available cleaning and disinfection agents varies from country to country and from hospital to
hospital, it is not possible to provide a complete list of all suitable cleaning and disinfection agents. The below
listed name brand products may be substituted by other name brand products of equivalent composition.
Refer to the instructions for use of the respective manufacturer for preparation, application and disposal of the
cleaning agents.