Skytrofa Auto-Injector, Инструкция по эксплуатации

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Product Informa
tion
61 60
SKYTROFA Auto-Injector
Lifetime Expiration date
b
page 56.
Serial Number
(SN)
Please refer to the bottom side
of your auto-injector, marked
after .
Size 7.09 x 1.46 x 1.06 in (180 x 37 x 27
mm).
Weight 5.29 oz (150 g).
Display Light-emitting diodes (LED).
Power source Mains charger: 100 to 240 V AC.
Power supply 1 rechargeable internal Li-ion
battery.
Full capacity
charging time
2 hours and 30 minutes. Charging
time for 1 injection: 15 minutes.
Full capacity 4 weeks with 1 injection per week.
Electromagnetic
compatibility
SKYTROFA Auto-Injector meets the
requirements of IEC / EN 60601-1-
2, 4-th Edition. Like most electronic
devices, using SKYTROFA Auto-
Injector in the immediate vicinity
of mobile phones or microwave
appliances may result in impaired
functioning. Use and store
SKYTROFA Auto-Injector outside
such an environment.
Protection
against electric
shock
Type BF.
Dose accuracy According to ISO11608-1:2015.
Ingress
protection
IP22:
IP2X: Ingress protection of solid
foreign objects, ≥ 12.5mm
diameter. IPX2: Ingress protection
of water with harmful effects,
dripping (15% tilted). Both put
together called IP22.
Cable USB to Micro-USB cable, 1m.
Charger
Model ASSA54a-050100.
Input 100-240V – 50-60Hz.
Output 5.0V
d
1.0A.
Technical Specification
Use Conditions for
SKYTROFA Auto-Injector
Operation
temperature (with
medicine)
59°F to 86°F (15°C to 30°C)
(marking on device bottom).
Storage &
Transportation
temperature
14°F to 104°F (-10°C to 40°C)
(marking on device cover).
Charging
temperature
59°F to 86°F (15°C to 30°C).
Operation humidity 15 to 90% relative humidity,
non-condensing.
Storage &
Transportation
relative humidity
Up to 93% relative humidity,
non-condensing.
Atmospheric
pressure
10.15 psi to 15.37 psi
(700 hPa to 1060 hPa).
Use Conditions for Cartridge with Medicine and
Needles
The use conditions provided here are for the
SKYTROFA Auto-Injector device. The use conditions for
SKYTROFA cartridges with medicine and needles may
be different. To see the use conditions for cartridges
with medicine and needles, please see the information
provided with your medicine.
Side Effects
For information on side effects, please see the
information provided with your medicine.
Waste
Regular waste: Packaging material (not including
cartridges) may be thrown away with your household
waste.
Electronic waste: The auto-injector, including battery,
must be returned to the manufacturer. Contact
Ascendis Pharma Customer Support for instructions
on how to return properly
b
back cover.
Charger and USB cable must be disposed of following
local regulations for disposal of electronic waste.