46
KOHJ-H-01-EN1-1.7-15112021
10 Technical specifications
Essential performance of the
medical device
Measures, adjusts and maintains the function-specific pressure
values in the mattress system, specified in the software for
each program.
Permissible weight of the patient
7-300 kg (cell width ≥ 80 cm) / 7-200 kg (cell width 70-75 cm)
REF code of the controller
OP7xyz (Optima7080) / OP8xyz (Optima8590), where x=lan
-
guage (F=Finnish, S=Swedish, E=English, D=German, R=French,
P=Spanish, J=Japanese, N=Dutch, O=Norwegian, T=Danish,
G=Portuguese), y=voltage range (E=230 V, S=120 V), z=hanger
type
Controller dimensions (W x L x H)
26 x 26 x 11.5 cm
Mattress dimensions (W x L x H)
70/75/80/85/90 x 200/210/220/230 x 13 cm, with Rehab add-
on for the cover 80-120 x 200/210/220/230 x 13 cm
Weight (controller/mattress)
5 kg/7–8 kg (depending on cell dimensions)
Controller decibel level
26.41 dB LAeq (24-hour operating time, 1 m)
Flammability (mattress)
EN 597-1:2015; EN 597-2:2015; IMO 2010 FTP Code, Annex 1,
Part 9
Operating voltage
230V 50HZ (voltage range E)
or
120V 50/60HZ (voltage range
S)
Nominal input power
max. 35W
Battery type
Lithium-ion, 7.26V, capacity 2,650mAh, manufacturer: Cell-
tech Oy / Varta Storage GmbH
Non-rechargeable battery type
CR2032, lithium-ion, 3.0V, capacity 230mAh, manufacturer:
Varta Microbattery GmbH
Fuses
F1 & F2 – T 2.5A/250V 5X20 mm; F3 – T5A/250V 5X20 mm; F4 –
T 2.0A/250V 5X20 mm; pump/motor fuse – T 1.6A/250V; main
fuse: (voltage range E) – T315mA/250V 5X20 mm, breaking
capacity (BC) 35A or (voltage range S) – T500mA/250V 5X20
mm, breaking capacity (BC) 35A
Separating device
Power cable – EU/UK/AU (voltage range E): C13, 1 mm
2
,
10A/250 VAC; 50 Hz or US (voltage range S): C13, SJT 3x16
AWG, 13 A / 125 VAC; 50/60 Hz
Electromagnetic compatibility
See Appendix 1: Carital Controllers - Guidance and Manufac
-
turer’s Declarations – EMC
Applied part
Applied part type
Mattress (cover and cells)
BF
IP class
IP22 (protected against particles with a diameter of 12.5mm
or greater and from water falling vertically or at an angle not
exceeding 15
◦
)
Protection class
II, insulated
Operating environment
temperature range
+10°C – +35°C
Operating environment
air humidity
15% – 90%
Operating environment
atmospheric pressure
700 hPa – 1,060 hPa
Class 1 medical device under the EU Medical Device Regulation
2017/745 (MDR) (Rule 1 - Non-invasive devices / Rule 13 - All
other active devices).
