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WORLD OF MEDICINE Gamma Finder Instructions For Use Manual
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WORLD OF MEDICINE Gamma Finder Instructions For Use Manual

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Summary of Contents for WORLD OF MEDICINE Gamma Finder

  • Page 3 Symbols used 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...
  • Page 4 Symbols used 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...
  • Page 5 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...
  • Page 7 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 •...

  • Page 8: 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®...
  • Page 9 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.
  • Page 10 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.
  • Page 11 Safety Information 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.

  • Page 12: General Information

    General Information General Information 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.

  • Page 13: Initial Startup

    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!
  • Page 14 (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.
  • Page 15 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.
  • Page 16 Initial Startup 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®...
  • Page 17 Initial Startup Photo 1 Photo 2 Photo 3 Photo 4 Photo 5 Photo 6 15 / 63...
  • Page 18 (photo 1). 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).
  • Page 19 FINDER® III to close the sleeve (photo 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.
  • Page 20 Initial Startup NOTE! Hygiene regulations Observe applicable hygiene regulations when disposing of the sleeve. 18 / 63...
  • Page 21 Description of the GAMMA FINDER® III Description of the GAMMA FINDER® III A Loudspeaker B Display for depicting all relevant information C Scroll button to navigate through the menu (up º) D Back button (<) E Scroll button to navigate through the menu (down »)
  • Page 22 Starting phase of 10 seconds Turning the GAMMA FINDER® III off To turn off the GAMMA FINDER® III, there are two options: Click on the OK button and scroll with the arrow but- tons to the "SHUTDOWN" menu item. Then click on the OK button to shut down the GAMMA FINDER®...
  • Page 23 3  seconds. During this time an acoustic signal is emitted. The display turns off to conserve battery. As soon as the GAMMA FINDER® III is moved, the display switches back on and you can continue working. 21 / 63...
  • Page 24 Description of the GAMMA FINDER® III OR Screen Battery level indicator of the GAMMA FINDER® III Set nuclide Current count rate in counts per second (cps) Maximum count rate in counts per second (cps) of the last 30 seconds Battery level indicator of the GAMMA FINDER® III...
  • Page 25 Preparing the stability test (reference measurement) Prior to performing a regular stability test for the first time you need to register a source. • To do this, start the GAMMA FINDER® III as described in Chapter "Starting the GAMMA FINDER® III" [} 20]. 23 / 63...
  • Page 26 • Then place the source in the supplied source holder as depicted in Fig. "Source in source holder" [} 25]. Make sure the writing on the source points to the hole for the GAMMA FINDER® III and screw down the source holder. 24 / 63...
  • Page 27 Fig. 5–1  Source in source holder Fig. 5–2  GAMMA FINDER® III with source • Place the source holder on the GAMMA FINDER® III so that the tip of the GAMMA FINDER® III touches the nuclide. Then press the OK button and wait until the...
  • Page 28 Then select "PERFORM TEST" and confirm with the OK but- ton. Place the source holder on the GAMMA FINDER® III so that the tip of the GAMMA FINDER® III touches the nuclide. Make sure that the nuclide you used for reference measurement is inserted in the source holder.
  • Page 29 If the source holder is correctly placed, the stability test can be started by confirming with the OK button. Be careful not to subject the GAMMA FINDER® III to vibra- tion or impact during the measurement. Otherwise the res- ult can be distorted. After the time has expired, the result of the test will be displayed.
  • Page 30 "YES" with the OK button. Again, make sure once more that there is no radioactivity near the GAMMA FINDER® III and start the test by pressing the OK button. Be careful not to subject the GAMMA FINDER® III to vibra- tion or impact during the measurement.
  • Page 31 It is recommended to document the results of the tests in a continuous table. The test is considered "SUCCESS- FUL" if the nulleffect of the GAMMA FINDER® III does not ex- ceed 20 counts per minute (cpm). Test history In the "STABILITY TEST"...
  • Page 32 Verify that the correct source is in the source holder and that it has been placed correctly on the GAMMA FINDER® III. The tip of the GAMMA FINDER® III must touch the source. Repeat the test. If the test fails two more times, contact ser- vice.
  • Page 33 5.5.2 Isotope Selection The selected isotope (nuclide) determines the energy win- dow used. When the GAMMA FINDER® III is switched on, technetium-99m is always automatically selected as the nuclide. Use the menu (press the OK button) to go to the "ISOTOPE"...
  • Page 34 Description of the GAMMA FINDER® III Table 1 (below) shows the energy windows that are set when the respective nuclide is selected. Select Lower energy Upper energy threshold [keV] threshold [keV] Tc-99m I-125 Co-57 Use the º or » button to select the nuclide you want to use and confirm with the OK button.
  • Page 35 Description of the GAMMA FINDER® III Use the menu (press the OK button) to go to the "DUAL ISO- TOPE" selection option. Confirm your selection with OK. You can activate the mode by confirming with the OK but- ton. The OR screen changes its display and depicts both counting rates.
  • Page 36 Description of the GAMMA FINDER® III 5.5.4 10-Second Count The 10-second count is used to adjust the measurement time from one second to ten seconds and to display either the sum of the count events in those ten seconds or the av- erage of the count events from those ten seconds.
  • Page 37 Description of the GAMMA FINDER® III To start the measurement, press the OK button. During the measurement, the ten seconds are counted down. The result of the measurement is displayed in the lower part of the screen. The upper part of the screen continues to dis- play the normal count rate in counts per second.
  • Page 38 Description of the GAMMA FINDER® III 5.5.5 Background Suppression This function facilitates the finding of "99m-Tc enriched" tis- sue areas, with simultaneously existing relatively high, non- specific background activity. To activate the mode, use the OK button to open the main menu.
  • Page 39 Description of the GAMMA FINDER® III Position the switched on GAMMA FINDER® III onto an area where non-specific background activity exists and scan the procedure area and start the measurement with the OK button. Wait until the countdown has counted down. Make sure that nuclide accumulations do not get into the direct field of view of the GAMMA FINDER®...
  • Page 40 To enter the settings, press the OK button to access the main menu. Use the º or » button and select the "SET- TINGS" item. Language Here you can choose between different languages for the GAMMA FINDER® III. The selected language is confirmed by a screen. 38 / 63...
  • Page 41 This menu allows you to set the current date and time on the device. It is important that the correct date and time are stored in the GAMMA FINDER® III or there may be deviations in the stability test, for example. Hygiene Please refer to Chapter "Use of Sterile Sleeves/Drapes"...
  • Page 42 Description of the GAMMA FINDER® III Cleaning and disinfecting the GAMMA FINDER® III The Gamma Finder® III must be wipe cleaned and wipe dis- infected after each use. The entire Gamma Finder® III must be wipe cleaned with a damp cloth in combination with an alcohol-based cleaning agent.
  • Page 43 Care and Maintenance Care and Maintenance The GAMMA FINDER® III is not a medical device with a measuring function within the meaning of the products lis- ted in Appendix 2 of the Medical Device Operator Ordinance (MPBetreibV). The GAMMA FINDER® III is not a therapy and/ or diagnostic dosimeter.
  • Page 44 Fax: +1 407 859-2425 Email: info.orlando@wom.group To do this, please also complete the "Return Material Au- thorization" form and enclose it with the device. This form is available at W.O.M. WORLD OF MEDICINE GmbH Service Point or https://www.wom.group/en/product-services/technical-service/ 42 / 63...
  • Page 45 Carrying Case Carrying Case The GAMMA FINDER® III comes in a carrying case. CAUTION! Radioactive substances regulation The applicable regulations regarding the handling of radio- active substances must be observed. 43 / 63...
  • Page 46 (3) Charging cradle (4) Instructions for Use Charging • To charge the GAMMA FINDER® III, place it in the char- ging cradle of the carrying case and close the carrying case. Insert the USB cable into the USB power adapter and on the other side into the USB port on the carrying case.
  • Page 47 Make sure the GAMMA FINDER® III has been placed cor- rectly in the charging cradle. The charging contacts of the cradle and the GAMMA FINDER® III must be in contact with each other. To ensure that the charging process is active, check the charging status via the LEDs on the carrying case (see Fig.
  • Page 48 Contact customer service. Deep Discharge Procedure If not used for a long time, the GAMMA FINDER® III may dis- charge to such an extent that the red carrying case LED in- dicator "Battery low" goes off and the GAMMA FINDER® III does not turn on.
  • Page 49 The site-dependent maximum counting rate serves to local- ize the center of activity. This counting rate, however, also depends on the angle of the GAMMA FINDER® III to the cen- ter of activity. Superimposition of both dependencies may lead to the incorrect localization of the maximum activity.
  • Page 50 Purpose Counting Rates Logging The acoustic counting value output serves for the qualitat- ive general orientation. The numerical signal displayed should be used for quantitative statements. 48 / 63...
  • Page 51 Accessory List Accessory List 2206427 Carrying case 2206419 Nuclide holder 2206426 USB power adapter 2206256 USB cable 1201635 Sterile sleeve (purchased separately) 49 / 63...
  • Page 52 Nulleffect test does Please contact the not work service department Please check the source data and re- Reference set failed peat the measure- ment GAMMA FINDER® III Please contact the must be serviced service department 50 / 63...
  • Page 53 Technical Data Technical Data Type designation GAMMA FINDER® III Manufacturer Information W.O.M. WORLD OF MEDICINE GmbH Salzufer 8, 10587 Berlin The device measures gamma ra- dioactivity in a certain energy range. Main application is the Essential performance measurement of Tc-99m and the...
  • Page 54 Technical Data Dimensions (mm) (Width x Height x Depth) 270 x 62 x 52 GAMMA FINDER® III 41 x 71 x 31.5 USB power supply 352 x 262 x 152 Carrying case (empty) Weight (g) GAMMA FINDER® III USB power supply...
  • Page 55 Technical Data Port: Optional Bluetooth (Core Spe- Signal output (display external cification sv2.1) remote display) 53 / 63...

  • Page 56: Electromagnetic Compatibility

    Avoid using the GAMMA  FINDER®  III adjacent to other devices or stacked with other devices. This may lead to im- proper operation of the GAMMA FINDER®  III. If you cannot avoid such use, observe the GAMMA FINDER®  III and the other devices to verify that they are operating normally.
  • Page 57 12.2 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions The GAMMA FINDER® III is intended for use in an environ- ment as described below. The user/operator of the GAMMA FINDER® III should make sure the device is operated within such an environment.
  • Page 58 Electromagnetic Compatibility Electromagnetic IEC 60601-1-2 Compliance Electromagnetic interference im- test level levels environment/ munity tests guidelines Floors should be made from wood or con- crete or Discharge of covered with static electricity ceramic tiles. If ± 8 kV contact ± 8 kV contact (ESD) according the floor cover- ± 15 kV air ± 15 kV air...
  • Page 59 Electromagnetic Compatibility Electromagnetic IEC 60601-1-2 Compliance Electromagnetic interference im- test level levels environment/ munity tests guidelines Blackouts, 0 % UT; 0 % UT; 0.5 The quality of brownouts, and 0.5 cycle cycle the supply fluctuations of At 0°, 45°, 90°, At 0°, 45°, 90°, voltage should the power sup- 135°,180°,...
  • Page 60 Electromagnetic Compatibility Electromagnetic IEC 60601-1-2 Compliance Electromagnetic interference im- test level levels environment/ munity tests guidelines lines) than the recommended safety distance calculated based on the transmitting frequency and the applicable formula. Re- commended safety dis- tances: d = 1.2√P for 150 KHz to 80 MHz d = 1.2√P for...
  • Page 61 GAMMA FINDER® III exceeds the compliance levels listed above, the device GAMMA FINDER® III should be monitored for proper function. If unusual performance characteristics are observed, additional measures may be required such as changing orientation or the location of the device GAMMA FINDER®...

  • Page 62: Immunity Tests

    Electromagnetic Compatibility IMMUNITY TESTS Test fre- Band Service Modula- Max. Distance quency (MHz) tion power MUNITY (MHz) TEST LEVEL (V/m) Pulse 380-390 TETRA modula- tion 18 Hz 430-470 GMRS 460, FRS ±5 kHz devi- ation Pulse modula- 704-787 Band tion 13, 17 217 Hz 800-960 800/90...
  • Page 63 WARNING! Portable HF communication equipment Portable HF communication equipment can affect the per- formance characteristics of the GAMMA FINDER® III. Such equipment must therefore comply with a minimum dis- tance of 30  cm (regardless of all calculations) from the GAMMA FINDER® III, its components and cables.
  • Page 64 Return Form Return Form Please fill out this form when returning the device: Name of owner: Sales Partner: Address of person returning unit: Street: House number: ZIP/Postal code: City: Country: IMPORTANT! Serial number (SN, see type identification plate): Device type: 62 / 63...
  • Page 65 Return Form Description of defect: Contact Signature Date 63 / 63...
  • Page 66 This instructions for use should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the approval of W.O.M. WORLD OF MEDICINE GmbH. We reserve the right to technical changes without prior notification due to the continuous further development of our products.