3
1
1
.
.
C
C
L
L
A
A
S
S
S
S
I
I
F
F
I
I
C
C
A
A
T
T
I
I
O
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N
N
Medical device class IIa
Medical device class 2
(electrical safety)
Type BF
Level of protection IP 30:
- protected against ingress of solid foreign objects larger than 2.5 mm;
- not protected against vertical water drops falls.
Device not to be used in presence of a mixture of inflammable anesthetic with air or oxygen or nitrous
oxide.
Expected shelf life of accessories: 1 year.
Expected shelf life of the device: 5 years.
Operating conditions:
TRANSPORT and STORAGE
OPERATING
Room temperature
+ 70 °C
- 25 °C
+ 40 °C
+ 5 °C
Relative humidity
93 %
15 %
93 %
15 %
Atmospheric pressure
1060 hPa
700 hPa
1060 hPa
700 hPa
Essential performances:
Provide sufficient suction for mothers to express milk,
Control the pumping rhythm to better respect the baby's sucking rhythm.
Applied part: Expression Kit Kolor®
Note
: the CE declaration is available on request.
ELECTROMAGNETIC COMPATIBILITY
Electro medical devices require special precautions against EMC and must be installed and set to operate
in accordance with the EMC information provided in this manual.
WARNING: Avoid using this unit near or stacked onto other equipment as this may cause a malfunction. If
this is necessary, this appliance and the other appliances should be monitored for normal operation.
WARNING: Use of accessories, transducers and cables other than those specified or supplied by the
manufacturer of this device may cause an increase in electromagnetic emissions or a decrease in the
immunity of this device and cause improper operation.
WARNING: Portable RF communication devices (including peripherals such as antenna cables and
external antennas) should not be used closer than 12 inches (30 cm) to any part of the FISIO breast
pump, including cables specified by the manufacturer. Otherwise, performance may be impaired.
WARNING: If the device malfunctions due to electromagnetic disturbances, the performance of the
device may be impaired and result in delayed patient care.
Wireless communication devices such as wireless home networking devices, mobile phones, cordless
phones and their bases, walkie-talkies can affect the device, and it is recommended to keep them at a
distance of at least 0.5 m from the device.
