rnal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby equipment.
CISPR B
Emissions Classification Class B
Electromagnetic Immunity
The On-body Injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of this equipment should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment –
Guidance
ESD
IEC 610000-4-2 ±6kV Contact
±8kV Air 6kV Contact
±8kV Air Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%.
Power Frequency
50/60 Hz
Magnetic Field IEC
61000-4-8 3A/m 3A/m Power frequency magnetic fields should be that of typical commercial or hospital environment.
Radiated RF Fields
61000-4-3 3 V/m
80 MHz to 2.5 GHz (E1)=3V/m Portable and mobile
communications
equipment should be
separated from the
On-body Injector for Neulasta by no less
than the distances
calculated/listed
below:
D=(3.5/V1)(√P)150
kHz to 80 MHz
D=(3.5/E1)(√P)80 to
800 MHz
D=(7/E1)(√P)800 MHz
to 2.5 GHz
Where P is the max
power in watts and D
is the recommended
separation distance
in meters. Field
strengths from fixed
transmitters, as
determined by an
electromagnetic site
survey, should be less
than the compliance
levels (V1 and E1).
Interference may
occur in the vicinity of
equipment containing
a transmitter.
Recommended separation distances between portable and mobile RF communications equipment and the On-body Injector for Neulasta
You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the On-body Injector for Neulasta, as recommended below, according to the maximum power of the communication equipment.
Rated maximum
output power of
transmitter, in watts Separation distance according to frequency of transmitter, in meters
150 kHz to 80 MHz
D=(3.5/V1)( √P) 80 to 800 MHz
D=(3.5/E1)( √P) 800 MHz to 2.5 GHz
D=(7/E1)(√P)
0.01 0.11667 0.11667 0.23333
0.1 0.36894 0.36894 0.73785
1 1.1667 1.1667 2.3333
10 3.6894 3.6894 7.3785
100 11.667 11.667 23.333
INSTRUCTIONS FOR USE
{SIDE 1 Information}
Patient Instructions for Use
On-body Injector for Neulasta Description
The On-body Injector for Neulasta is intended for delivery of Neulasta. The On-body Injector is small, for one-time use, lightweight, battery-powered, and waterproof up to 8 feet for 1 hour. Your healthcare provider will use a prefilled syringe with Neulasta to fill the On-body Injector prior to applying it. The prefilled syringe with Neulasta and the On-body Injector are provided to your healthcare provider as part of Neulasta OnproTM kit. The On-body Injector is applied directly to your skin using a self-adhesive backing. The On-body Injector informs you of its status with sounds and lights.
The On-body Injector contains electronic components as well as: a plastic housing, acrylic adhesive, batteries, a cannula introducer (needle) and a cannula. The On-body Injector is approximately: 2.4 in long, 1.6 in wide, 0.7 in height (62 mm long, 41 mm wide, 17 mm height).
Warnings
Before y
