Conformity; Emc Test Record; Transport And Storage; Service Life And Disposal - Ardo CARUM Instrucciones De Uso

Stimulation mode
Start value
Setting values
Expression mode
Start value
Setting values
"Sensitive Programme"
Start value
Setting values
* The expression mode uses the setting value last selected by the user in the stimulation mode and increases the vacuum by 30 mbar / 3 kPa /
22 mmHg
The vacuum values are independent of the actual atmospheric pressure.
1)

11.2. Conformity

As per the Medical Device Directive 93/42 EEC, EN 60601-1,
EN 60601-1-2, EN ISO 10079-1, EN 60601-1-6, EN 60601-1-11,
2011/65/EU (RoHS)
MEDICAL – GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005, C1:09, A2:10),
CAN/CSA C22.2 No.60601.1 (2008, R:2011)
E358823

12. Transport and Storage

The original packaging must be used to transport and store the Carum and the Carum Battery. We
recommend storing the Carum protected against UV light (e.g., sunlight, halogen lamps), heat, and dust.
Carum Battery: Please obtain information from the particular airline about transport requirements when flying.
Temperature
Relative air humidity
Air pressure

13. Service life and disposal

The service life of the device with proper use is 10 years excluding wear parts. This device contains
electronic components and a rechargeable lithium ion battery unit.
At the end of the service life of the device, the device and its accessories must be disposed of in
accordance with the locally applicable regulations.
Used reachargeable battery units must not be disposed of in household trash but
instead returned to the point of purchase or disposed of in accordance with locally
applicable regulations.
The device is subject to the requirements of the WEEE Directive.
Vacuum (± 5%
60 mbar | 6 kPa | 45 mmHg
30–150 mbar | 3–15 kPa | 22–113 mmHg
*
30–330 mbar | 3–33 kPa | 22–248 mmHg
30 mbar | 3 kPa | 22 mmHg
30–330 mbar | 3–33 kPa | 22–248 mmHg
0123
–20°C to +70°C (–4°F to 158°F)
10–93% RH, not condensing
700–1060 hPa
)
1)

11.3. EMC test record

See page 213
en
Cycle (± 3)
90 / min
72–120 / min
45 / min
30–60 / min
30 / min
30–60 / min
17