Brainlab 53151 Bedienungsanleitung Seite 2

EN
Dimensions and Weight
Dimension Value
Height / Length / Width 17.3 mm / 53.9 mm / 27.0 mm
Weight 12 g
Electrical Specifications
Specification Description
Power Supply 3 V primary lithium cell CR2032
Power Consumption Maximum 36 mW
Current 12 mA, direct current (DC)
Electrical Safety Compliance with IEC 60601-1
The Disposable Clip-on Remote Control provides no
essential performance on its own, only basic safety.
Essential Performance
Device is free of physical hazards with special regards to
Characteristics and Basic
electrical risks. Based on the Certification Body Reports
Safety
according to IEC 60601-1 Ed. 3.1, it is concluded that the
device provides an adequate degree of protection against
electric shock under all reasonable foreseeable circumstances.
LED Specifications
Specification Infrared LED
Wavelength 850 nm
Photobiological Safety Compliance with IEC 62471
Housing Specifications
Specification Description
IP Classification IP44 (according to IEC 60529)
Housing Material Polyamide 12
Sterility and Usability
Specification Description
Sterility Status Sterile
Method Ethylene-oxide
Shelf Life Five years
Usability Single use
Electromagnetic Emissions - Declaration
Guidance and manufacturer's declaration regarding electromagnetic emissions:
Emissions Test Standard
Conducted and radiated RF
CISPR 11
emissions
Harmonic distortion IEC 61000-3-2
Voltage fluctuations flicker IEC 61000-3-3
Use of accessories, transducers and cables other than those specified or provided by
Brainlab could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
The emissions characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B
is normally required) this equipment might not offer adequate protection to radiofrequency
communication services. The user might need to take mitigation measures, such as relocating or
re-orienting the equipment.
The system produces electromagnetic fields that may interfere with other sensitive equipment, and
can itself be disturbed by other electromagnetic fields.
HF Surgery Equipment
Disposable Clip-on Remote Control is not tested in combination with HF Surgery Equipment
(e.g., diathermy and electrocautery).
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
Electromagnetic Immunity - IEC 60601-1-2
The following lists all applicable immunity tests and standards, as well as the used compliance
levels:
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
Supplemental information for IEC 61000-4-3 (test specifications for enclosure port immunity to RF
wireless communications equipment):
Status LED
570 nm
Compliance Level
Group 1
Class A
Electromagnetic Immunity - IEC 61000-4-3
n/a
n/a
Page 2/86
Immunity Test Standard
Electrostatic Discharge -
Contact
IEC 61000-4-2
Electrostatic Discharge -
Air
Radiated RF EM Fields IEC 61000-4-3
Power Frequency
IEC 61000-4-8
Magnetic Field
Test Fre- Band Service
quency
(MHz)
(MHz)
385 380 - 390 TETRA 400
GMRS 460,
450 430 - 470
FRS 460
710
LTE Band 13,
745 704 - 787
17
780
810 GSM
800/900,
870
TETRA 800,
800 - 960
iDEN 820,
CDMA 850,
930
LTE Band 5
1720 GSM 1800;
CDMA 1900;
1845
GSM 1900;
1700 -
DECT;
1990
LTE Band 1,
1970
3, 4, 25;
UMTS
Bluetooth,
WLAN,
2400 -
802.11 b/g/n,
2450
2570
RFID 2450,
LTE Band 7
5240
5100 - WLAN 802.11
5500
5800 a/n
5785
Immunity IEC 60601 Compliance
Test Test Level Level
Radiated RF 3 V/m
IEC 80 MHz to 3 V/m
61000-4-3 2.7 GHz
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
https://userguides.brainlab.com/
IEC 60601-1-2 Test Compliance Level
Level
±8 kV ±8 kV
±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV,
±15 kV ±15 kV
3 V/m 3 V/m
80 MHz to 2.7 GHz 80 MHz to 2.7 GHz
80% AM at 1 kHz 80% AM at 1 kHz
30 A/m 30 A/m
50 Hz or 60 Hz 50 Hz or 60 Hz
Modulation Maxi- Distance Immunity
mum Compli-
(m)
ance Level
(W)
(V/m)
Pulse
modulation
1.8 0.3 27
18 Hz
FM
± 5 deviation 2 0.3 28
1 kHz sine
Pulse
modulation
0.2 0.3 9
217 Hz
Pulse
modulation
2 0.3 28
18 Hz
Pulse
modulation
2 0.3 28
217 Hz
Pulse
modulation
2 0.3 28
217 Hz
Pulse
modulation
0.2 0.3 9
217 Hz
Electromagnetic Environment - Guidance
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a
should be less than the compliance level b in
each frequency range.
Interference may occur in the vicinity of
equipment marked with this symbol:
53153ML Rev. 9.0
*53153ML*
Date of issue: 2022-08-03 (ISO 8601)