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Devicor Neoprobe neo2000, Руководство по эксплуатации

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neoprobe

TM

 GDS Operation Manual 

 

AW-000639 

 

 

 

 

 

Page 

4 of 38

 

1.

 

INTRODUCTION 

The

 neoprobe

TM

 

 Gamma Detection System console, with BLUETOOTH

®

 wireless technology, detects presence of 

gamma rays emitted from radioactive isotopes in body organs or tissue. System provides an increasing or decreasing 
sound and visual indicator (Count Bar) that vary in pitch as level of gamma radioactivity increases or decreases. 

Intended use 

Electronic medical device for detecting and quantifying gamma radiation 
 

Indications 

Used externally and intraoperatively to detect radioactive emissions from body tissues 
or organs where radiopharmaceuticals are administered.  There are no known 
contraindications in the application or use of the device. 

Detecting gamma radiation with a hand-held probe is based on inverse square law of physics which allows detection 
of radiation emitted from a small source. Placing probe close to radioactive site increases number of counts detected 
and localization occurs. Excision of lesion is then performed using 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 probe.  

NOTE

: User is responsible to determine suitability of product for use in any surgical procedure. Contact Devicor 

regarding questions for intended use of product. 

 CAUTION: United States Federal law restricts this device to sale by or on order of a physician. 

 CAUTION: Read Warnings, Cautions and Notes section before operating product.  

 CAUTION: Clean and sterilize probe and collimator before use; use sterile surgical probe cover if not 

sterilized. 

NOTE

: Save packing material to return product for service. 

NOTE

: Accessories packaged separately from control unit (console) during shipment. Verify you have received all 

items ordered. 

Visual Indicators and Controls  

Visual information and data viewed on LED screen. Visual information displayed in Liquid Crystal fonts and 
translated in this manual; example - “No Linc” is displayed as “

no l i nc

” “on LED screen.

  

  

 

 

 

 

FRONT 

 

 

 

 

 

REAR 

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

Содержание Neoprobe neo2000

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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