Brainlab Einweg-Clip-On-Remote-Control 53151 Bedienungsanleitung

Disposable Clip-on Remote Control
Fig. 1
ENGLISH
General Information
Intended Use:
The Disposable Clip-on Remote Control (referred to from this
point forward as "Clip"):
• Enables active patient registration and software control in
combination with existing Brainlab pointers
• Is a non-invasive, single-use device and is delivered sterile
in sterile packaging
Supported Pointers:
• Pointer Angled / Square Angled
• Pointer Straight
• Pointer Extended / Extended with Sharp Tip
Components (see Fig. 1):
Infrared Detected by the camera, but invisible to
a
LED the human eye.
Status Indicates the battery status and
s
LED functionality.
Control Activates infrared LED to be tracked by
f
button the navigation camera.
Using the Disposable Clip-on Remote
Control
Attachment:
1. Remove the Clip from the sterile packaging.
• Verify prior to opening the sterile packaging that the
expiration date has not lapsed and the package is not
damaged.
2. Attach the Clip with its center hole d over the distal pin of
the pointer (Fig. 2).
• Choose the preferred handling position (Fig. 3) for a
right-handed g or left-handed h user.
3. Attach Disposable Reflective Marker Spheres to the
pointer.
• Completely screw the marker sphere onto the pin, until
the stop rim is reached.
Use:
1. Press the control button to perform a functionality check. If
the Clip is functioning properly the:
• Status LED should become activated, and the
• Infrared LED should display as a colored flash on the
navigation screen.
2. Throughout the entire use, the camera must have an
unobstructed view of the reflective marker spheres and the
infrared LED.
3. During point acquisition, always make sure the pointer tip
has contact with the patient or bone, when activating the
infrared LED of the Clip.
• It is recommended to hold the pointer between the
thumb and middle finger, pressing the control button
with the index finger.
After Use:
1. Remove the Clip from the pointer.
2. Clean all surfaces with a surface disinfectant.
3. Open the housing at the notch with a small sharp tool.
4. Dispose of the Clip primary lithium battery, according to
your local environmental protection and waste agency
regulations.
Brainlab AG
Olof-Palme-Str. 9
81829 München
Germany
Fig. 2
Technical Specifications
Physical
Height
Length
Width
Weight
Electrical
Power supply
Power consumption
Current
Electrical safety
LEDs
Wavelength
Viewing angle at 50%
intensity
Photobiological safety
Housing
IP class
Materials
Housing
Environmental
Temperature
Humidity
Pressure
Disposal
NOTE: For further information on compatibility and
functionality, see corresponding Brainlab user guides or
consult Brainlab customer support.
Do not press on the housing of the Disposable Clip-on
Remote Control where LEDs are located.
Do not completely immerse the Disposable Clip-on Remote
Control into any liquids.
If any battery leakage is visible inside the sterile package,
do not open and dispose of the device immediately.
No modification of the device is allowed. Do not re-use or
replace the battery and do not autoclave the Disposable
Clip-on Remote Control after use.
Do not look directly into the infrared LED of the Disposable
Clip-on Remote Control when the control button is
activated.
Customer Support
support@brainlab.com
North / South America: +1 800 597 5911
Europe & Rest of the world: +49 89 99 15 68 1044
y
53151, 53153
17.3 mm
53.9 mm
27.0 mm
12 g
3 V, primary lithium cell CR2032
max. 36 mW
12 mA, direct current (DC)
Compliance with IEC 60601-1
Infrared LED Status LED
870 nm 570 nm
120 degree
Compliance with IEC 62471
IP44 according to IEC 60529
(protected against ingress of solid foreign
objects ≥ Ø 1mm and splashing water)
Polyamide 12
Storage Operation
0 - 30 °C 10 - 40 °C
(32 - 86 °F) (50 - 104 °F)
15 - 80 % 20 - 80 %
non-condensing non-condensing
700 hPa - 1060 hPa
According to local environmental
waste regulations.
a
Page 1/7
Fig. 3
Symbols
Caution
Warning
CE label shows that the Brainlab product
complies with the essential requirements of
3
European Medical Device Directive (MDD).
Sterile, using ethylene oxide
t
2 Single use, do not reuse
Q
Do not use if package is damaged
q Do not re-sterilize
R Caution
j Consult instructions for use
y Reference / article number
K Quantity of included items
u Lot number
Unique device identifier
x Manufacturer
X Manufacturing date
b Expiration date, do not use after this date
z Keep away from sunlight
Z Keep dry
p Storage temperature limitation
Storage humidity limitation
Atmospheric pressure limitation
O Direct current
Degree of protection against ingress of solid
IPxx
foreign objects and liquid.
For re-ordering, use the REF
Separate disposal of electronics and battery.
For more information regarding the WEEE
(Waste Electrical and Electronic Equipment)
directive, visit:
https://www.brainlab.com/en/sustainability/
U.S. federal law restricts this device to sale by
or on the order of a physician.
BL-IL-53153ML Rev. 7.0
*53153*