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Electromagnetic Compatibility

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Electromagnetic Compatibility

Precautionary measures

Medical devices are subject to special safety and protective

measures concerning electromagnetic compatibility (here-

after abbreviated as EMC).

This device is to be used only for the purposes described in

the manual and has to be installed, set up, and operated in

compliance with the EMC notes and instructions.

CAUTION!

Accessories
To ensure compliance with the requirements of IEC

60601-1-2 in the current version, the GAMMA FINDER® III

must be used only with the accessories listed in Chapter
"Accessory List" [

}

49].

To ensure the basic safety and essential functionality in re-

lation to electromagnetic interference over the life of the

device, the device must be restarted after 24 hours so that a

diagnostic self-test can be performed. The maintenance in-

tervals indicated in Chapter Care and Maintenance must

also be observed.

CAUTION!

Improper operation due to interferences
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.

12.1

Electrical Connections

ESD (Electrostatic Discharge) precautionary measures

The following are ESD precautionary measures:

• Apply potential equalization (PE), if available on your

equipment, to all devices to be connected.

Содержание Gamma Finder

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Страница 3: ...ct 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...

Страница 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...

Страница 5: ...tions 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 U...

Страница 6: ......

Страница 7: ...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 mea...

Страница 8: ...densation 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...

Страница 9: ...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...

Страница 10: ...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...

Страница 11: ...rical 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...

Страница 12: ...ormance 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 In...

Страница 13: ...he 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 thes...

Страница 14: ...nt 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 t...

Страница 15: ...ve 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 th...

Страница 16: ...NDER 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 th...

Страница 17: ...Initial Startup 15 63 Photo 1 Photo 2 Photo 3 Photo 4 Photo 5 Photo 6...

Страница 18: ...y 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...

Страница 19: ...he 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...

Страница 20: ...Initial Startup 18 63 NOTE Hygiene regulations Observe applicable hygiene regulations when disposing of the sleeve...

Страница 21: ...aker B Display for depicting all relevant information C Scroll button to navigate through the menu up D Back button E Scroll button to navigate through the menu down F Power on button ON for a part of...

Страница 22: ...k 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 III 2 After 45 minutes in Sleeping mode the GAMMA FINDER III s...

Страница 23: ...is detected it automatically switches to Sleeping mode When switching to Sleeping mode the display will show GOING INTO SLEEPING MODE for about 3 seconds During this time an acoustic signal is emitted...

Страница 24: ...OR Screen A Battery level indicator of the GAMMA FINDER III B Set nuclide C Current count rate in counts per second cps D Maximum count rate in counts per second cps of the last 30 seconds A B C D Ba...

Страница 25: ...ain menu Use the or buttons to navigate through the menu 5 5 1 Stability Test The stability test serves to control the quality of the GAMMA FINDER III The sensitivity of the GAMMA FINDER III and the b...

Страница 26: ...th the OK button Scroll to the Finished item and confirm with the OK button if the name is entered correctly Then enter the reference date as found in the source certificate and confirm with the OK bu...

Страница 27: ...III 25 63 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 t...

Страница 28: ...lar stability test with the GAMMA FIND ER III switched on press the OK button in the main menu Select the item STABILITY TEST using the arrow buttons and confirm with the OK button Then select PERFORM...

Страница 29: ...nt Otherwise the res ult can be distorted After the time has expired the result of the test will be displayed It is recommended to document the results of the tests in a continuous table After you hav...

Страница 30: ...est by selecting 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 GA...

Страница 31: ...ORY to view the last 10 stability tests performed Use the or button to scroll through the various tests To select details of a test press the OK button on the corresponding test The details include th...

Страница 32: ...t 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 The nulleffect test fails...

Страница 33: ...rgy 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 selection option Confirm...

Страница 34: ...l 20 512 Use the or button to select the nuclide you want to use and confirm with the OK button A confirmation screen will show you that the corresponding nuclide is now selected After a approximately...

Страница 35: ...e the mode by confirming with the OK but ton The OR screen changes its display and depicts both counting rates The acoustic playback of the count rate in this mode always refers to the count rate in t...

Страница 36: ...nt events in those ten seconds or the av erage of the count events from those ten seconds To activate the mode use the OK button to open the main menu Then select the 10 S COUNTING item and activate w...

Страница 37: ...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 Press the OK button to select whether you want to repeat the measurement...

Страница 38: ...to open the main menu Then select the BACKGROUND item and activate it with the OK button After the function has been triggered the device calculates an average of the previous measurements of the non...

Страница 39: ...d 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 III during this t...

Страница 40: ...cps To exit the background measurement mode press the OK button and select NO You will then return to the main menu 5 5 6 Settings To enter the settings press the OK button to access the main menu Us...

Страница 41: ...n about your GAMMA FINDER III This includes the built in accumulator capacity in percent the version of the GAMMA FINDER III the device number the next maintenance date and the current time stored in...

Страница 42: ...n with an alcohol based cleaning agent After cleaning visually inspect the Gamma Finder III to verify that it is free of soil debris or stain If there are still visual residuals repeat the cleaning pr...

Страница 43: ...detector Visual inspection and cleaning of device housing Two year maintenance interval An authorized service technician must inspect and service the device at appropriate intervals to ensure the safe...

Страница 44: ...o FL 32811 6527 USA Phone 1 407 438 8810 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 for...

Страница 45: ...Case 43 63 7 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...

Страница 46: ...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 carryi...

Страница 47: ...s on the carrying case see Fig LED Charging indicators 45 7 3 LED Charging Indicators Fig 7 3 LED Charging indicators 1 USB charging port 2 LEDs for the charging status 1 2 The LEDs indicate the curre...

Страница 48: ...ntact customer service 7 4 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...

Страница 49: ...the maximum activity Therefore it is recommended within a series of measure ments to change the position with a constant angle or the angle with a constant position It is recommended to train this te...

Страница 50: ...Purpose 48 63 8 5 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...

Страница 51: ...Accessory List 49 63 9 Accessory List 2206427 Carrying case 2206419 Nuclide holder 2206426 USB power adapter 2206256 USB cable 1201635 Sterile sleeve purchased separately...

Страница 52: ...Charge the battery now E04 Critical error 42 Please contact the service department E05 Stability test does not work Please contact the service department E06 Nulleffect test does not work Please conta...

Страница 53: ...er supply Carrying case DC battery 100 240 V 50 60 Hz DC USB Power consumption Current mA 80 Power consump tion VA 0 40 Battery charging time fully discharged GAMMA FINDER III 2 h Protection class GAM...

Страница 54: ...o 70 Air pressure kPa 70 to 106 Max usage height above sea level m 3000 Transport conditions Temperature C F 20 to 60 C 4 to 140 F Relative humidity 5 to 90 Air pressure kPa 70 to 106 Storage conditio...

Страница 55: ...Technical Data 53 63 Port Signal output display external remote display Optional Bluetooth Core Spe cification sv2 1...

Страница 56: ...and essential functionality in re lation to electromagnetic interference over the life of the device the device must be restarted after 24 hours so that a diagnostic self test can be performed The ma...

Страница 57: ...ons Therefore its HF emission is very low and it is un likely that devices in close proximity will experience interfer ence HF emission accord ing to CISPR 11 Class B The GAMMA FIND ER III is suitable...

Страница 58: ...least 30 Electrical fast transients bursts accord ing to IEC 61000 4 4 2 kV for power lines 1 kV for input and output lines Repetition fre quency 100 kHz 2 kV for power lines 1 kV for input and output...

Страница 59: ...it is re commended to supply the device with power from an uninterruptible power supply 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 U...

Страница 60: ...commended 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 80 MHz to 800 MHz d 2 3 P f...

Страница 61: ...s objects and people a The field strength of stationary transmitters such as base stations of wireless phones and cell phones ham radio oper ators AM and FM radio and TV stations theoretically cannot...

Страница 62: ...odula tion 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz devi ation 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modula tion 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 90 0 TETRA 800 IDEN 820...

Страница 63: ...2 0 3 28 5240 5100 58 00 WLAN 802 11 a n Pulse modula tion 217 Hz 0 2 0 3 9 5500 5785 Table 1 Transients HF IEC 61000 4 3 WARNING Portable HF communication equipment Portable HF communication equipmen...

Страница 64: ...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 i...

Страница 65: ...Return Form 63 63 Description of defect Contact Signature Date...

Страница 66: ...on about this or any of our other products Some of the parts and equipment referred to in this instructions for use bear registered trademarks but are not identified as such It should therefore not be...

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