Enbrel AutoTouch Connect, Руководство пользователя

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Electromagnetic Immunity
The autoinjector is intended for use in the electromagnetic
environment specified below. The user of this autoinjector should
ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level Electromagnetic
Environment-
Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2 ±8 kV
Contact
±15 kV Air ±15 kV
Contact
±20 kV Air Floors should be
wood, concrete or
ceramic tile. If
floors are
synthetic, the
relative humidity
should be at least
30%.
Power Frequency
50/60 Hz
Magnetic
Fields
IEC 61000-4-8 30 A/m 30 A/m at
60 Hz Power frequency
magnetic fields
should be that of
typical commercial
or hospital
environment.
RF
Electro-
magnetic Field
IEC 61000-4-3 10 V/m
80 MHz
–
2.5 GHz
(E1) =
10 V/m
26 MHz
–
2.7 GHz
Portable and
mobile RF
communications
equipment should
be separated from
the device by no
less than the
distances of 30
cm.
Electrical characteristics
The AutoTouch Connect TM reusable
autoinjector uses a
non-replaceable, non-rechargeable
DL123 Lithium battery. The
battery has a nominal voltage of
3.0 V with a capacity of
1400 mAh.
The autoinjector enclosure is a
Type BF applied part: The skin
sensor and other electronics are
isolated from the skin.
Dimensions and weight
AutoTouch Connect weighs
0.4 pounds (180 grams), and is
9 inches (228 mm) tall by
1.5 inches (38 mm) wide by
1.8 inches (45 mm) deep.