Further Information - Brainlab 53151 Bedienungsanleitung

EN
Immunity IEC 60601 Compliance
Test Test Level Level
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the Disposable Clip-on Remote Control
is used exceeds the applicable RF compliance level above, the Disposable Clip-on Remote
Control should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Disposable Clip-
on Remote Control.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
RFID Specifications
RFID Specification Frequency
ISO 14223 134.2 kHz
ISO/IEC 14443-3 (Type A) 13.56 MHz
ISO/IEC 14443-4 (Type B) 13.56 MHz
ISO/IEC 15693 (ISO 18000-3
13.56 MHz
Mode 1)
ISO 18000-3 Mode 3 13.56 MHz
ISO/IEC 18000-7 433 MHz
ISO/IEC 18000-63 Type Ca 860 - 960 MHz
ISO/IEC 18000-4 Mode 1 2.45 GHz
[1] For power frequency magnetic fields setup: The frequencies of 134.2 kHz and 13.56 MHz are
tested with very special Helmholtz-coils or magnetic field coils. The one which is used according to
IEC 61000-4-8 does not work for these higher frequencies but the setup is similar.
[2] For proximity fields from RF wireless communications equipment: The frequency range above
100 MHz is similar to the proximity fields in IEC 60601-1-2, with the main difference of special
RFID-modulations instead of the ones defined in IEC 60601-1-2.
RF Communications Equipment - Electromagnetic Environment
The Disposable Clip-on Remote Control system is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled.
The Disposable Clip-on Remote Control system user can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Disposable Clip-on Remote Control system as recommended
below.
RF Communications Equipment - Separation Distances
Portable RF communications equipment (including peripherals like antenna cables and
external antennas) should not be used closer than 30 cm from any part of the Disposable
Clip-on Remote Control including cables specified by Brainlab. Otherwise, degradation of
the performance could result.

Further Information

This product may be covered by one or more patents or pending patent applications. For details,
see:
https://www.brainlab.com/patent/
For further information see the Brainlab user guides or contact Brainlab support.
Brainlab AG Customer Support:
Olof-Palme-Str. 9 support@brainlab.com
81829 Munich North/ South America: +1 800 597 5911
Germany Europe & Rest of the world: +49 89 99 15 68 1044
Electromagnetic Environment - Guidance
Test Level (RMS)
65 A/m
7.5 A/m
7.5 A/m
5 A/m
12 A/m
3 V/m
54 V/m
54 V/m
Page 3/86
Symbols
Warning
Unique device identifier
Do not use if package is
damaged
Reference/article number
Follow instructions for use
Use by date
NOTE: The date is expressed as
in ISO 8601 as YYYY-MM-DD.
Manufacturer
Keep away from sunlight
Do not re-sterilize
Single use (do not reuse)
Temperature limit
NOTE: Indicates the
temperature limits to which the
medical device can be safely
exposed.
Humidity limitation
NOTE: Indicates the range of
humidity to which the medical
device can be safely exposed.
Ingress protection rating
• Protection against foreign
solids (numbers 0 to 6, or
letter X).
• Protection against foreign
IPXX
liquids (numbers 0 to 9, or
letter X).
NOTE: The letter X is listed if
insufficient data has been
gathered to assign a protection
level.
https://userguides.brainlab.com/
Caution
Lot number
Quantity of included items
U.S. federal law restricts this
device to sale by or on the order
of a physician
Consult operating instructions
Medical device
Manufacturing date
Keep dry
Sterile (using ethylene oxide)
Double sterile barrier system
Atmospheric pressure limitation
NOTE: Indicates the range of
atmospheric pressure to which
the medical device can be safely
exposed.
Indicates that the equipment is
suitable for direct current only
Only dispose of electrical and
electronic equipment in
accordance with statutory
regulations. For information
regarding the WEEE (Waste
Electrical and Electronic
Equipment) directive or relevant
substances that could be
present in the medical
equipment, visit:
www.brainlab.com/weee/
53153ML Rev. 9.0
*53153ML*
Date of issue: 2022-08-03 (ISO 8601)