Sentec LuMon System - 13.5 Belts; 13.6 Contact Agent; 13.7 Device Classification

Technical specifications
82 of 93
for the LuMon System
13.5 Belts
Table 13-13: Physical characteristics belts
Sizes
See Table 13-14.
See Table 13-14.
See Table 13-14.
Width (cm)
Approx. 4.0
Approx. 4.0
Approx. 2.8
Compatibility
LuMon Monitor - Adult
SensorBeltConnector
LuMon Monitor - Adult
LuMon Connector
LuMon Monitor - Neo
LuMon Connector
Table 13-14: Belt sizes
Size
Full underbust girth in cm
80
78-88
92
88-100
104
100-114
116
114-130
Size
Full underbust girth in cm
19
17.0-20.5
22
20.5-24.0
26
24.0-28.0
30
28.0-32.5
35
32.5-37.5
40
37.5-43.5
47
43.5-52.0
Biological evaluation has been conducted in compliance with ISO 10993-1 on the SensorBelts and LuMon
Belts.
13.6 Contact agent
Table 13-15: Characteristics of contact agent
Properties
ContactAgent
LuMon Contact Spray
NeoContactAgent
Content spray
can/bottle
100 ml
94 ml
25 ml
Ingredients
(INCI)
Aqua, Dimethyl ether, Alcohol
denat., Panthenol, Helianthus
annus seed oil, Urea, Glycerin,
Cyclopentasiloxane, Cetearyl
alcohol, Cetearyl glucoside,
Laureth-9, Cyclohexasiloxane,
Phenoxyethanol, Butane,
Hexyldecanol, Hexyldecyl laurate,
Disodium laureth sulfosuccinate,
Propane, Isobutane,
Ethylhexylgycerin, Lactic acid,
Tocopherol.
Water (Aqua), Glycerin, Butane,
Sodium chloride, Isobutane
Aqua, Glycerol and Sodium
chloride
Biological evaluation has been conducted in compliance with ISO 10993-1 on the ContactAgent/LuMon
Contact Spray and the NeoContactAgent.
13.7 Device classification
According to the European directive 93/42/EEC and the European Regulation 2017/745
• LuMon Monitor, SensorBeltConnector and LuMon Connector are classified as Class IIa devices.
• SensorBelt, LuMon Belts, ContactAgent/LuMon Contact Spray and NeoContactAgent are
classified as Class I devices.
Properties
SensorBelt
LuMon Belt Adult
LuMon Belt Neo
SensorBelt/LuMon Belt Adult
LuMon Belt Neo