WORLD OF MEDICINE Gamma Finder User manual

Separate collection for electrical and electronic
equipment
Direct current
"ON" for a part of equipment
Do not use if the package is damaged
Storage conditions
Transport conditions
Humidity limitation
Atmospheric pressure limitation
Temperature limit
Keep away from sunlight
Protect from heat and radioactive sources
Symbols used

Symbols used
3 / 63
Use by date (YYYY-MM-DD)
Date of manufacture (YYYY-MM-DD)
Quantity
Batch code
Catalogue number
Serial number
Authorized for Sale or use by Physician only
Top-Bottom
Fragile
Keep dry

Complies to IEC 60601-1 including US and Cana-
dian deviations in their respective valid version
Do not immerse device in fluids
Do not spray fluids directly into the device
Wipe with damp cloth
MR Unsafe
For indoor use only
Class II equipment
Non sterile
Use the Gamma Finder® III with sterile sleeve
Symbols used

Important Operator/User Notes
5 / 63
1 Important Operator/User Notes
Read the manual carefully and become familiar with the oper-
ation and function of the GAMMA FINDER® III and its accessor-
ies before using the GAMMA FINDER® III in the operating
room. Non-observance of the instructions listed in this manual
can lead to
• injuries of the patient,
• injuries of the surgical and nursing team or service per-
sonnel or
• damages or failure of the GAMMA FINDER® III and ac-
cessories.
The manufacturer reserves the right to modify the appear-
ance, graphics, and technical data of the product through
continued development of its products.
The words WARNING, CAUTION and NOTE carry special
meanings.
Read these paragraphs with special attention.
WARNING!
The safety and/or health of the patient, user, or a third party
are at risk. Comply with this warning to avoid injury to the
patient, user, or third party.
CAUTION!
These paragraphs include information provided to the oper-
ator concerning the intended and proper use of the GAMMA
FINDER® III or accessories.
NOTE!
These paragraphs contain information to clarify the instruc-
tions or provide additional useful information.

Safety Information
6 / 63
2 Safety Information
The applicable regulations regarding the handling of radio-
active substances must be observed.
Federal Law (only for U.S. market)
CAUTION!
U.S. law stipulates that the GAMMA FINDER® III is to be
used only by a physician or under supervision of a physician.
WARNING!
Condensation / Water penetration
Protect device GAMMA FINDER® III from moisture. Do not
use if moisture has penetrated the device.
WARNING!
Condensation / Water penetration
Protect the case from moisture. Do not use if moisture has
penetrated the device.
WARNING!
Replacement device and accessories
In case the device or any of the accessories fail during sur-
gery, a replacement device and replacement accessories
should be kept within close proximity to be able to finish
the operation with the replacement components.

Safety Information
7 / 63
WARNING!
Contamination
Do not use device and/or accessories if signs of contamina-
tion are detected. Make sure the device or/and accessories
can no longer be operated until a qualified service techni-
cian conducts the appropriate tests and repairs.
WARNING!
Obvious defects
Never use the device if it has suspected or confirmed de-
fects, especially if these involve the power plugs or the
mains power supply connection cables. In this case have the
device repaired by authorized service personnel.
NOTE!
Regular charging
Regular charging of the GAMMA FINDER® III to ensure that
it is always ready for use.
NOTE!
Professional qualification
The operation of the device GAMMA FINDER® III is reserved
for persons with the relevant professional qualifications and
trained to use the device.
Exclusion of liability
The manufacturer is not liable for direct or consequential
damages, and the warranty becomes null and void if:
• the GAMMA FINDER® III and/or the accessories are im-
properly used, prepared, or maintained;
• the instructions and rules in the instructions for use
are not adhered to;
• unauthorized persons perform repairs, adjustments, or
alterations on the GAMMA FINDER® III or accessories;

Safety Information
8 / 63
• unauthorized persons open the GAMMA FINDER® III;
• the prescribed inspection and maintenance schedules
are not adhered to.
The handing over of technical documents does not consti-
tute authorization to make repairs or alterations to the
GAMMA FINDER® III or accessories.
CAUTION!
Modifying the GAMMA FINDER® III and/or its accessories is
not permitted.
Authorized Service Technician
Only authorized service technicians may perform repairs,
adjustments, or alterations to or on the GAMMA FINDER® III
or accessories sand use the service menu. Any violation will
void the manufacturer's warranty. Authorized service tech-
nicians are trained and certified only by the manufacturer.
Care and Maintenance
The service and maintenance of the GAMMA FINDER® III and
its accessories must be carried out as instructed to ensure
the safe operation of the device. Therefore, test function
and completeness before each use to ensure the safety of
the patient and user/surgical team. Maintenance of the
GAMMA FINDER® III may not be performed during its use
and operation.
Contamination
Before shipping, decontaminate GAMMA FINDER® III and ac-
cessories in order to protect the service personnel. Follow
the instructions listed in these instructions for use. If this is
not possible,
• the product must be clearly marked with a contamina-
tion warning and
• must be double-sealed in safety foil.
The manufacturer has the right to reject contaminated
products for repair.

Safety Information
9 / 63
Disposal
This symbol indicates that the waste of electrical and elec-
tronic equipment must not be disposed as unsorted muni-
cipal waste and must be collected separately. For disposal of
the device and its accessories, please consult the manufac-
turer or an authorized disposal company, in compliance
with legal or national regulations.

General Information
10 / 63
3 General Information
3.1 Device Description
The GAMMA FINDER® III is a device used for the pre- and in-
tra-surgical detection of substances labeled radioactively
(gamma emitter). It is exceptionally user-friendly due to its
unique concept as a battery-powered, autonomous, hand-
held device.
The GAMMA FINDER® III displays the detected gamma radi-
ation by means of an acoustic signal and, synchronously,
with a numerical value in cps (counts per second) on the dis-
play, which is proportional to the activity level.
3.2 Essential Performance
The device measures gamma radioactivity in a certain en-
ergy range. Main application is the measurement of Tc-99m
and the dual isotope mode which measures I-125 and
Tc-99m simultaneously.
3.3 Intended Use and Contraindication
3.3.1 Intended Use
The GAMMA FINDER® III is intended for the detection of
gamma radiation in the energy range from 20keV to 512keV.
The GAMMA FINDER® III is indicated for the extra- and intra-
operative detection of radioactively labelled substances
mainly in the fields breast cancer and malignant melanoma.
3.3.2 Contraindication
Dosimetric applications, detection of radiation other than
gamma, and detection of radiopharmaceuticals with radi-
ation energies outside the above listed energy range are
contraindicated.

Initial Startup
11 / 63
4 Initial Startup
NOTE!
Professional qualification
The operation of the device GAMMA FINDER® III is reserved
for persons with the relevant professional qualifications and
trained to use the device.
WARNING!
Not explosion-proof
The GAMMA FINDER® III is not explosion-proof. Do not oper-
ate the GAMMA FINDER® III in the vicinity of explosive anes-
thetic gases or in the vicinity of oxygen-enriched environ-
ments.
WARNING!
Obvious defects
Never use the device if it has suspected or confirmed de-
fects, especially if these involve the power plugs or the
mains power supply connection cables. In this case have the
device repaired by authorized service personnel.
NOTE!
Regular charging
Regular charging of the GAMMA FINDER® III to ensure that
it is always ready for use.
NOTE!
Locations
The GAMMA FINDER® III may be used only in hospitals or
operating rooms.

Initial Startup
12 / 63
4.1 Delivery Scope
2206260 GAMMA FINDER® III including:
Carrying case
Nuclide holder
USB power adapter
USB cable
Instructions for Use
WARNING!
Original accessories
For your own safety and that of your patient, use only ori-
ginal accessories (see Chapter "Accessory List" [}49]).
Delivery Inspection
Always check all parts and optional accessories of the
GAMMA FINDER® III immediately after receiving the ship-
ment. The manufacturer considers only replacement claims
that have been immediately submitted or reported to a
sales representative or an authorized service company.
Initial Installation
Before starting the GAMMAFINDER®III for the first time, re-
move and dispose the insulating bag from the
GAMMAFINDER®III and the insulating badge from the con-
tacts.
WARNING!
Insulating bag
Do not use the insulating bag as a sterile sleeve. The insulat-
ing bag was designed for shipping the GAMMAFINDER®III
and is, in consequence, not sterile.
Returning the GAMMA FINDER®III
Please contact your service point prior to sending the device
back.

Initial Startup
13 / 63
Use the original packaging material if a GAMMA FINDER®III
has to be returned. The manufacturer is not responsible for
transport damages due to insufficient or unsuitable ship-
ping packaging. Please make sure that all required informa-
tion has been supplied:
• Name of owner
• Address of owner
• Device type and model
• Serial number of the equipment (see identification
plate)
• Detailed description of defect
Use the return shipping form included in Chapter "Return
Form" [}62].
4.2 Function Test before Use
Before use, the GAMMAFINDER®III must be checked with a
radioactive source (e.g. Co-57, I-125 or Tc-99m). This re-
quires positioning the sensor of the GAMMA FINDER® III
over a radioactive source with the acoustic signal enabled. If
the device works correctly, an activity dependent acoustic
signal is emitted and the GAMMAFINDER®III shows the cor-
responding numerical value.
Make sure that the GAMMAFINDER®III does not show the
service symbol (see Chapter "Care and Mainten-
ance" [}41]). If the GAMMA FINDER® III shows the service
symbol, please refer to "Care and Maintenance" [}41].
4.3 Use of Sterile Sleeves/Drapes
The GAMMA FINDER® III should be gently inserted into the
sterile sleeve. Use the adhesive strips to secure the sterile
sleeve. The display and pushbuttons must remain visible.
The sterile sleeve allows the device to safely contact to the
skin, tissue and blood of the patient.
Please handle with care. To prevent accidental damage to
the sleeve, do not force the GAMMA FINDER® III into the
sterile sleeve and avoid contact with sharp objects, and con-
stant friction on hard objects.

Initial Startup
14 / 63
CAUTION!
Sterilization
The GAMMA FINDER® III itself may not be sterilized. The
sterilization of the GAMMA FINDER® III can have a negative
impact on its function and safety. W.O.M. WORLD OF MEDI-
CINE GmbH rejects any and all responsibility for any dam-
age or undesired events resulting from failure to observe
this warning and when sterilizing the GAMMA FINDER® III.
WARNING!
Use of sterile sleeve
Do not use the device without sterile sleeve.

Initial Startup
15 / 63
Photo 1 Photo 2
Photo 3 Photo 4
Photo 5 Photo 6

Initial Startup
16 / 63
Photo 7 Photo 8
Photo 9 Photo 10
Photo 11 Photo 12
1. The sterile sleeve should be removed from the pack-
aging by sterile personnel (photo 1).
2. Preparing the GAMMA FINDER® III: the sterile sleeve
only fits the GAMMA FINDER®III. Its conical shape fits
on the GAMMA FINDER® III and already has pre-cut
strips of tape to attach the sleeve to the GAMMA FIND-
ER®III (photos2 and 3).
3. Insert the GAMMA FINDER® III gently into the sterile
sleeve (photos4 and 5).

Initial Startup
17 / 63
4. Fold the sterile sleeve to ensure the entire
GAMMA FINDER® III is covered (photo 6). Make sure
that display and buttons of the GAMMAFINDER®III are
easily to read.
5. Remove protective strip from the adhesive tape
(photo7).
6. Press the folded part of the sterile sleeve onto the dis-
play (photo8).
7. Tighten the folded part to keep the display clearly vis-
ible.
8. Press down the folded part on the back of the GAMMA
FINDER®III to close the sleeve (photo 9).
9. Remove the protective cover from the adhesive tape
and fold over the pre-cut tape and press it down (pho-
tos10 and 11).
10. The GAMMA FINDER®III with sterile sleeve is ready for
use (photo12).
WARNING!
Sterile sleeve
The sterile sleeve may not be reused nor sterilized twice.
WARNING!
Packaging
Check the sterile sleeve before removing from the pack-
aging to ensure that the packaging is intact and that the ex-
piration date is still valid.
NOTE!
Storage
The sterile sleeves must be stored at room temperature. The
shelf life for sterile sleeves is 3 years.

Initial Startup
18 / 63
NOTE!
Hygiene regulations
Observe applicable hygiene regulations when disposing of
the sleeve.