Brainlab 18099-02C Instruction Manual

EM Pointer
18099-02C
1.
②
①
ENGLISH
General Information
Ensure patient safety by following these instructions for using
EM Pointer:
1. EM Pointer is used to:
•
Verify registration accuracy
• Navigate
• Calibrate additional instruments
EM Pointer is precalibrated and can be used without
2.
further calibration.
3. EM Pointer is not intended for use in an MR
environment. Do not expose the device to a highly
magnetic field, such as an MRI scanner, as it may
become magnetized. Tracking with a magnetized device
may result in incorrect navigation and possible injury to
the patient and/or medical personnel.
The EM Pointer surface must be sterilized prior to use.
4.
EM Pointer Components (fig. 1):
No. Component Function/Usage
Calibration of additional instruments
Calibration

Point
using an EM Instrument Reference
Activates various functions, as
Control

described in the relevant Software
Button
User Guide

Cable Data transfer
Connects to the EM Tracking Add-On

Plug
using an instrument port on the EM
Base Station
How to switch on EM Pointer
Attach the EM Pointer plug to an instrument port on the EM
Base Station.
After the corresponding LED on the EM Base Station turns
green, EM Pointer is ready for use.
NOTE: It may take a few moments for the LED to turn green.
How to switch off EM Pointer
Disconnect EM 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 on the point of interest and
press the control button to acquire the point. When EM
Pointer acquires a point, the exact pointer tip position is
transmitted to the EM Tracking Add-On.
Warning
Use EM Pointer only as described and only in combination
with devices that are specified in the System User Guide.
Warning
Only use EM Pointer after verifying its accuracy. The
verification point on a sterile EM Instrument Reference can
be used for verification. Do not use the verification point on
the EM Patient Reference, as the EM Patient Reference
may not be sterile.
Warning
If EM Pointer verification is unsuccessful, do not use it for
surgery and 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
③
④
Warning
Do not use EM Pointer on the patient's eyes.
Warning
Be aware that pressing the control button may cause the
pointer tip to change position.
Warning
Hold the pointer steady to avoid movement when pressing
control button.
Warning
Do not route the cable over the patient's throat as this
could lead to patient injury.
Warning
Handle the EM Pointer with care, placing the cable in a way
that prevents tangling or tripping over it.
Warning
Do not wind the cable around the EM Field Generator as
this can cause the device to malfunction.
Warning
Do not bend or kink the cable and do not use EM Pointer if
the cable is damaged. Using the device with a damaged
cable could result in personal injury.
Warning
Do not drape EM Pointer, otherwise navigation might not
work or accuracy could be affected.
Warning
EM Pointer is a highly accurate and sensitive medical
instrument. To maintain calibration precision, it must be
handled with extreme care. If it 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.
Warning
EM Pointer was not designed or tested for use during or
following cardiac defibrillation. Cardiac defibrillation may
affect the system accuracy or may damage the system.
Caution
Do not attempt to modify EM Pointer.
Caution
Do not expose EM Pointer to X-rays, as this could damage
the device.
Caution
Do not expose EM Pointer to excessive UV light such as
direct sunlight, as this may affect the plastic housing.
Caution
Always store EM Pointer in the sterilization tray provided.
Caution
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
a
page 1/7
2.
For further information please see the respective Software
User Guide or consult Brainlab customer support.
Reprocessing
1. Remove coarse impurities from EM Pointer 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. 2).
Warning
Dispose of EM Pointer when it has been reprocessed
20 times (i.e., all numbers are cut off).
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
•
Use EM Pointer Sterilization Tray (18099-08) or
EM Basic Instruments Sterilization Tray
(18099-08A)
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
level (SAL), and requires complete attention to the instructions
on pretreatment, cleaning and disinfection, as well as post-
drying and check of the instruments.
Warning
Any deviation from the validated parameters could result in
patient infection or injury.
Cleaning Validation Parameters
Brainlab has tested the compatibility of the EM Pointer with
the following detergents:
Cleaning Manufacturer
Detergents
neodisher
MediClean
forte Dr. Weigert
neodisher
SeptoClean
Dismoclean
28 alka Bode
med
NOTE: For further information, see the Brainlab Cleaning,
Disinfection and Sterilization Guide.
-6 sterility assurance
Parameters Disinfection
Thermal at
90°C (194°F)
for 5 mins.
According to
manufacturer's
Thermal at
specifications
93°C
(199.4°F) for
10 mins.
BL-IL-18099-02C_ML Rev. 2.0
*18099-02C ML*