TM
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork
PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012
Page 1: ...TM Artwork No AW 000639 Revision A Artwork Status Released Lifecycle Name Artwork PCO No N A ECN No ECN 000214 Release Date 10 09 2012 Effective Date 10 09 2012...
Page 2: ...1 877 926 2666 Fax 1 888 260 6362 e mail customerservice mammotome com URL www mammotome com Made in U S A This document is sole property of Devicor Medical Products Inc Any duplication reproduction...
Page 3: ...DE OPTION 13 5 TERMINOLOGY AND SYMBOLS 17 6 POTENTIAL APPLICATIONS 19 7 CLEANING DISINFECTION 20 8 MAINTENANCE 24 9 SYSTEM SPECIFICATIONS 30 10 AUTHORIZED ACCESSORIES 36 11 WARNINGS CAUTIONS AND NOTES...
Page 4: ...ng standard surgical technique Gamma detection protocols that control use of large highly collimated scintillation detectors may require modifications when used in conjunction with hand held gamma pro...
Page 5: ...ton NOTE Numbers are repeated in following text to identify indicator or control Functionality of button 11 same as button on probe with BLUETOOTH wireless technology See wireless probe operation manu...
Page 6: ...ess probe will turn off Note It takes an additional five seconds before system displays no Linc If Radionuclide Button is pressed and held for more than one second user will hear a start beep and all...
Page 7: ...put Connector Connector is push pull component DO NOT TWIST TURN CABLECONNECTOR damage to connectors and connector pins may occur 3 DYNAMIC PITCH MODE DEFAULT Radioactive isotopes are traced in Dynami...
Page 8: ...Start Beep will sound hold probe steady 2 to 6 seconds until Count Bar 6 is full and a double Stop Beep sounds Console display Background Count Symbol 13 flashes Background Count Readout 8 displays d...
Page 9: ...us Target Count Readout 7 displays Count Rate value Count Bar 6 is on and displays Count Rate activity Audible signal may be heard depending on Count Rate Dynamic Pitch Range selection and Volume sett...
Page 10: ...shes green Target Count Readout 7 displays dashes Count Bar 6 fills from bottom to top as data is collected Target Count Value Target Count Readout data 7 is displayed for 5 seconds Target Count Symbo...
Page 11: ...isplayed for 5 seconds Target Count Symbol 10 flashes amber Amber Ratio Symbol 12 displayed below Target Count Symbol 10 Count Bar 6 off After 5 seconds a double Stop Beep sounds and system returns to...
Page 12: ...c Pitch Range Buttons 18 until beep sounds release button Hold probe steady over target area until Count Bar 6 is full and double Stop Beep sounds NOTE Press and release any Dynamic Pitch Range Button...
Page 13: ...n 1 Power indicator is lit All LEDs are lit System should begin normal operation within 20 seconds Operation of BLUETOOTH message no linc indicates problem with probe console or serial port adapter Se...
Page 14: ...fault value Ratio Readout 9 is off and Target Count Readout data 7 updates count rates every one half second as probe moves over tissue How to acquire background count Place probe tip on normal tissue...
Page 15: ...e with localized radioactivity Mark perimeter of Target Tissue Count display Count Rate is displayed in Target Count Readout 7 No Target Count or Ratio is displayed during scanning procedure Acquiring...
Page 16: ...tarts new Target Count Calculated Ratio Readout data is greater than 99 9 Overflow symbol appears in Ratio Readout 9 Performing a Target Check 2 Second Option Perform a 2 second Target Check to obtain...
Page 17: ...eadout 7 changes to Binary Pitch Mode and displays Target Count data System Shutdown Shut down system and prepare for reuse Step System shutdown and reuse 1 Press and release Standby On button 1 2 Dis...
Page 18: ...activity between Background Tissue and Target Tissue is statistically significant Scan Scanning Moving probe across Target Area to locate highest radiation reading Target Area Area of interest selecte...
Page 19: ...ceuticals are available It is responsibility of user to determine suitability and clinical utility of chosen radiopharmaceutical or radiolabeled compound and protocol for administering drug and using...
Page 20: ...verified with radiolabeled labeled blood cells detected by gamma probe Intraoperative localization of osteoid osteomas Osteoid osteoma is a small but painful benign bone lesion Surgical excision is c...
Page 21: ...bles and collimators according to EN ISO 17664 2004 Autoclave Reprocessing of collimators according to EN ISO 17664 2004 NOTE cleaning agents not listed above are sole responsibility of user to adequa...
Page 22: ...rush 3 Visually inspect for cleanliness 4 Repeat steps 1 to 3 until visually clean 5 Allow to dry in room air Disinfection No requirement Drying Air dry at room temperature Maintenance Do not use dama...
Page 23: ...liness 3 Repeat steps 1 to 3 until visually clean 4 Allow to dry in room air Disinfection No requirement Drying Air dry at room temperature Maintenance Do not use worn cracked or damaged cable Inspect...
Page 24: ...lder with flat blade screwdriver 2 Replace new 1 6 AMP 250V slow blow low breaking capacity T1 6AL 250V fuses Replacing fuse with incorrect rating will compromise safe operation may cause permanent da...
Page 25: ...hold down Binary Pitch Dynamic Pitch mode selection button and press Dynamic Pitch range 1000 button release all buttons at once Background count displays ictm ictm 3 Press and release buttons in ord...
Page 26: ...ing or with software version 5 02 or earlier Photo Peak Efficiency Only conduct this test with BLUETOOTH wireless technology enabled probes 1 Turn on and link a probe to console 2 Set to Dynamic Pitch...
Page 27: ...probe near source of radioactivity i e injection site on patient Verify that registered counts are greater than zero 2 Position probe several feet away from source of radioactivity Verify that registe...
Page 28: ...ngs Intermittent electrical interference e g electrosurgical unit X ray etc Track down source of interference Turn off offending sources if possible Damaged probe Change probe Return for service if co...
Page 29: ...l state and or international laws and regulations for proper disposal of components parts or accessories Contact Devicor at 1 877 926 2666 if you cannot find a convenient means of disposal New Product...
Page 30: ...0hPa 11 7 psia to 15 4 psia 60 C 20 C Storage and transit temperature 20 to 60 C 40 to 104 F Storage and transit humidity 10 percent to 95 percent Storage and transit atmospheric pressure 500hPa to 10...
Page 31: ...e of FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE Operating mode Continuous Ingress of fluids probes IPX8 see individual probe instructions for use Ingress of fluids console O...
Page 32: ...ompliance level Electromagnetic environment guidance Electrostatic discharge ESD 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are cove...
Page 33: ...ectromagnetic survey a should be less than the compliance level in each frequency rangeb Interference may occur if the Model 2300 is operated within 11 7 cm or 4 6 of equipment marked with the followi...
Page 34: ...ance for the higher frequency applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people De...
Page 35: ...olski Polish Niniejszym Devicor Medical Products Inc o wiadcza e Wireless Probe jest zgodny z zasadniczymi wymogami oraz pozosta ymi stosownymi postanowieniami Dyrektywy 1999 5 EC Portugu s Portuguese...
Page 36: ...Item Description Product Code Model 2009 North American Medical Grade AC Power Cord NPA75 Model 2024 Probe Cable for 1017 Probe NPA76 Model 2060 Probe Cable for 1103 Probe NPAF18 Collimator Item Desc...
Page 37: ...his equipment must only be connected to a supply mains with protective earth Maintain proper clearance for access to AC Power Inlet Connector for disconnection from mains power Risk of Fire Explosion...
Page 38: ...utery and electrosurgical devices to reduce electromagnetic interference Incorrect counts can occur in vicinity of persons exposed to radiation therapy NOTES Product is designed only to detect gamma r...
