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EM Pointer and EM Short Pointer
ENGLISH
General Information
Ensure patient safety by following these instructions for using EM Pointers (18099-
02C, 18099-27):
1.
EM Pointers are used to:
Register the patient
Verify registration accuracy
Navigate
Calibrate additional instruments
2.
EM Pointers are precalibrated and can be used without further calibration.
3.
EM Pointers are not intended for use in an MR environment. Do not expose them
to a highly magnetic field, such as an MRI scanner or magnets (e.g., as
contained in magnetic drapes/maps for instrument fixation), as they may become
magnetized. Tracking with a magnetized device may result in incorrect
navigation and possible injury to the patient and/or medical personnel.
4.
The surface of the pointers must be sterilized prior to use.
EM Pointer Components (Fig. 1, 18099-02C and Fig. 2, 18099-
27):
No.
Component
Function/Usage
Calibration
Calibration of additional instruments using an EM
①
Point
Instrument Reference
Control
Activates various functions, as described in the relevant
②
Button
Software User Guide
③
Cable
Data transfer
④
Connects to the EM Tracking Add-On using an
Plug
instrument port on the EM Base Station
NOTE: For further information, see the Brainlab Instrument User Guide.
Using the EM Pointers
How to Switch on EM Pointer/EM Short Pointer
Attach the EM Pointer/EM Short Pointer plug to an instrument port on the EM Base
Station. After the corresponding LED on the EM Base Station turns green, EM
Pointer/EM Short Pointer is ready for use.
NOTE: It may take a few moments for the LED to turn green.
How to Switch off EM Pointer/EM Short Pointer
Disconnect EM Pointer/EM Short Pointer from the EM Base Station by pulling gently
on the textured area of the plug until the spring mechanism releases.
Point Acquisition Procedure
Place the tip of the EM Pointer/EM Short Pointer on the point of interest and press the
control button to acquire the point. When the device acquires a point, the exact
pointer tip position is transmitted to the EM Tracking Add-On.
NOTE: For further information, see the Brainlab Software User Guide.
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
y
18099-02C, 18099-27
Reprocessing
1.
Remove coarse impurities from EM Pointers directly after use (within 2 hours)
using running water (20-30 °C) or a cleaning/disinfectant solution.
2.
Using a brush, apply detergent solution to all surfaces, ensuring that all parts are
cleaned.
To manually remove impurities, use a soft brush or a clean soft tissue
Do not use metal brushes or steel wool
3.
Cut off the next number from the sterilization counter tag (Fig. 3).
4.
Automatic cleaning and disinfection (see table below "Cleaning Validation
Parameters").
5.
Steam sterilization:
Prevac procedure, 132-134 °C (270-273 °F), 5-18 minutes holding time,
drying time at least 10 min
Prevac procedure, 137 °C (279 °F), 3.5 minutes holding time, drying time at
least 10 min
Sterilization Tray
EM Pointer Sterilization Tray (18099-
08)
EM Basic Instruments Sterilization
Tray (18099-08A)
EM Basic Instruments Sterilization
Tray (18099-08B)
The sterilization temperature must not drop below the specified minimum
temperature. The stated sterilization time is the minimum validated sterilization time
required to achieve a 10
-6
attention to the instructions on pretreatment, cleaning and disinfection, as well as
post-drying and check of the instruments.
Cleaning Validation Parameters
Brainlab has tested the compatibility of the EM Pointers with the following detergents:
Cleaning
Manufacturer
Detergents
neodisher
MediClean forte
Dr. Weigert
neodisher
SeptoClean
Dismoclean 28
Bode
alka med
NOTE: For further information, see the Brainlab Cleaning, Disinfection and Sterilization
Guide.
Symbols
Warning
Not made with natural rubber
latex
The product complies with the
essential requirements of the
4
Medical Device Directive.
Customer Support:
support@brainlab.com
North/South America: +1 800 597 5911
Europe & rest of the world: +49 89 991568 1044
EM Pointer
EM Short Pointer
(18099-02C)
(18099-27)
✓
X
✓
X
✓
✓
sterility assurance level (SAL), and requires complete
Parameters
Disinfection
Thermal at 90 °C
According to
(194 °F) for 5 mins.
manufacturer's
Thermal at 93 °C
specifications
(199.4 °F) for 10
mins.
Caution
x
Manufacturer
Reference / article number
a
Page 2/9
Warnings and Cautions
Warning
Use EM Pointers only as described and only in combination with devices that are
specified in the Software User Guide.
Only use EM Pointers after verifying accuracy. Use the verification point on a
sterile EM Instrument Reference for verification. Do not use the verification point
on the EM Patient Reference, as the EM Patient Reference may not be sterile.
If verification is unsuccessful, do not use it for surgery and contact Brainlab
support.
Do not use EM Pointers on the patient's eyes.
Be aware that pressing the control button may cause the pointer tip to change
position. Hold the pointer steady to avoid movement.
Do not route the cable over the patient's throat as this could lead to patient
injury.
Handle EM Pointers with care, placing the cable in a way that prevents tangling
or tripping over it.
Do not wind the cable around the EM Field Generator as this can cause the
device to malfunction.
Do not bend or kink cables and do not use EM Pointers if cables are damaged.
Using devices with damaged cables could result in personal injury.
Do not drape EM Pointers, otherwise navigation might not work or accuracy
could be affected.
EM Pointers are highly accurate and sensitive medical instruments. To maintain
calibration precision, handle them with extreme care. If one is dropped or
otherwise mishandled (even when inside the sterilization tray), verify the
calibration accuracy as described in the Software User Guide or return it to
Brainlab for testing, replacement or repair.
EM Pointers were not designed or tested for use during or following cardiac
defibrillation. Cardiac defibrillation may affect navigation accuracy or may
damage the navigation system.
Any deviation from the validated parameters could result in patient infection or
injury.
Dispose of pointers when they have been reprocessed 20 times (i.e., all numbers
from the sterilization counter tag are cut off).
Caution
Do not attempt to modify EM Pointers.
Do not expose EM Pointers to X-rays, as this could damage the device.
Do not expose EM Pointers to excessive UV light such as direct sunlight, as this
may affect the plastic housing.
Always store EM Pointers in the sterilization tray provided.
Only dispose of electrical and electronic equipment in accordance with statutory
regulations. For information regarding the WEEE (Waste Electrical and Electronic
Equipment) directive, visit: http://www.brainlab.com/weee
For further information, see the respective Software User Guide or consult
Brainlab customer support.
BL-IL-18099-27_ML Rev. 2.0
*18099-27_ML*
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