Devicor Neoprobe neo2000 Operation Manual

Gamma detection system

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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

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Summary of Contents for Devicor Neoprobe neo2000

Page 1 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 ” work mark and the “neoprobe” logo are registered trademarks of Devicor Medical Products, Inc. ® "Bluetooth " word mark and logos are owned by Bluetooth SIG, Inc. and any use by Devicor or its representatives is under license. Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor...
Page 3: Table Of Contents
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual TABLE OF CONTENTS INTRODUCTION ....................................... 4 EQUIPMENT ASSEMBLY ..................................5 DYNAMIC PITCH MODE (DEFAULT) ..............................7 BINARY PITCH MODE (OPTION) ............................... 13 TERMINOLOGY AND SYMBOLS ................................ 17 POTENTIAL APPLICATIONS ................................
Page 4: Introduction
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.
Page 5: Equipment Assembly
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Number Name Number Name Standby/On Switch and Indicator Light [15] Volume Adjustment “No Probe Connected” Symbol [16] Mute Button Radionuclide Selection Indicators [17] Mute Symbol Binary/Dynamic Pitch mode buttons and indicators [18] Dynamic Pitch Range Buttons And Indicator Lights...
Page 6 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual ® Quick Start BLUETOOTH Wireless Technology Enabled Probe ® Step Prepare probe equipped with BLUETOOTH wireless technology Prepare for operation as stated above Install battery in probe Press button on probe;...
Page 7: Dynamic Pitch Mode (Default)
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Quick Start Probe with cable Procedure for reusable cabled detector probes (Model 1017 or Model 2059). Step Prepare Prepare console for operation as stated above: If needed, attach external collimator to probe Using aseptic technique (without sterile surgical drape) connect probe to Model 2024 or Model 2060 probe cable;...
Page 8 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual To…. Perform following….. And this occurs…… Set Dynamic Pitch Turn Volume [15] Sound is lowest audible tone. counterclockwise Turn Volume [15] Sound is highest clockwise Set Dynamic Pitch sound Press and release Mute When sound is off, Mute symbol [17] flashes;...
Page 9 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Count Range Default Background Count 1,000 10,000 50,000 1000 Operational Notes Events that may occur during product use: If…… Then this occurs…… Background Count is greater than or equal to 80% of Example: 800 is displayed for 1,000 Count Range maximum value of selected Count Range Background Count is less than or equal to 2% of...
Page 10 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual TARGET COUNT Acquire Target Count  Hold probe stationary over target area to achieve highest Target Count Readout value [7], highest Count Bar level, and highest sound. ...
Page 11 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Acquire a Target Count Ratio  Hold probe stationary over target area. Press and release Background Count Button [14]. Background Count must be greater than default value (2%) of Count Range selected in order to activate Ratio Calculation function.
Page 12 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Ten Second Target Count Value Note: Value displayed is not counts per second. Value is total counts obtained in 10 seconds.  10 second Target Count [7] displayed for 5 seconds; Target Count Symbol [10] flashes amber. ...
Page 13: Binary Pitch Mode (Option)
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Operational Note Events that may occur during product use: If…. Then this occurs….. Target Count Button [11] is pressed while Target Count restarts Target Count is calculated Overflow Symbols”/////”...
Page 14 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual To…… Perform following…… And this occurs…. radionuclide from Button [21] to select radionuclide Adjust Binary Turn Volume Adjustment Sound is lowest Pitch sound counterclockwise Turn Volume Adjustment Sound is highest clockwise Turn Binary Pitch...
Page 15 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Operational Note Events that may occur during product use: If….. Then this occurs…… Overflow Symbols “/////”on Background Count is too high ///// Background Count Readout (7) and beep sounds Background Count Button (14) is A Start Beep sounds;...
Page 16 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual  Ratio Readout [9] is displayed. Ratio Symbol [12] flashes.  After 5 seconds, system returns to Binary Pitch Mode displaying last calculated Background Count data [8] and current Count Rate data [7].
Page 17: Terminology And Symbols
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual  Count Bar [6] fills from bottom to top as data is collected for 2 seconds. Target Check Display  Target Check data is displayed in Target Count Readout [7] for 5 seconds; Target Count Symbol [10] flashes green.
Page 18 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual ITEM DESCRIPTION Check data when these functions are not active. Background Count In Dynamic Pitch Mode: a baseline value in counts per second stored in console and used as threshold to activate sound In Binary Pitch Mode: baseline value in counts per second stored in console for comparison to Target Count determines if difference in radioactivity between Background Tissue and Target...
Page 19: Potential Applications
DESCRIPTION CAUTION: non-sterile WARNING: hazardous voltage or shock hazard present; follow instructions and warnings Devicor uses recyclable materials wherever possible. There are materials in our product that do contain risk associated with Disposal. If the need arises that components, parts, accessories or devices at end of life need to be disposed of, we recommend that you comply with local, state and/or international laws and regulations for your country or area.
Page 20: Cleaning & Disinfection
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Minimally invasive radioguided parathyroidectomy A preoperative Tc -Sestamibi scan may be used on patients with primary hyperparathyroidism to localize target parathyroid adenoma and enable limited exploration as an alternative to complete bilateral surgical exploration. Hand-held gamma probes may be useful in assisting surgeons in intraoperative localization of target adenomas.
Page 21 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual  External collimator is removed from probe. Approved Cleansers/Sterilizers The console is compatible with following cleaning and disinfection agents/processes:  Control III (Maril Products, Inc.) – probes cables, collimators & connectors ...
Page 22 Reprocessing of Console according to EN ISO 17664:2004 Manufacturer: Method: Cleaning & Disinfection Symbol: Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 USA Model 2300 Devices(s): Reusable control units comprising fixed assemblies (no moving parts); sold nonsterile.
Page 23 Reprocessing of Power Cord according to EN ISO 17664:2004 Manufacturer: Method: Cleaning & Disinfection Symbol: Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241-2378 USA Model 2009 Devices(s): Reusable power cords comprising fixed assemblies (no moving parts); sold nonsterile.
Page 24: Maintenance
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual 8. MAINTENANCE Product must be serviced by competent service technicians or engineers. Preventative maintenance is limited to external cleaning of console, fuse replacement and functional diagnostics. Probes, collimators and cables are sealed or do not contain serviceable components and cannot be repaired.
Page 25 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Result Step Procedure A double Stop Beep sounds and Diagnostic Mode: Press and hold Background Count Readout displays Dynamic/Binary Pitch Mode Selection diag “diag”. Button [4], press and release Background Count Button [14].
Page 26 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Step Procedure Result and hold down Binary Pitch/Dynamic Pitch mode selection button and press Mute button - release all buttons at same time System Accuracy Check Following procedure is used to confirm performance of system components is stable and consistent.
Page 27 If result indicates variation from specified amount, and indicates performance has changed or is not stable, check for proper setup with desired Radionuclide selected, and that all external factors (source, strength, source distance, stray radiation, etc.) have been determined and controlled. Contact Devicor Medical Products, Inc. for technical assistance. Performance Check Perform periodic performance checks to assure proper performance of product.
Page 28 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual SYMPTOM POSSIBLE CAUSE CORRECTIVE ACTION Console does not turn on Power cord not connected Connect power cord Power button is damaged Return for service Faulty fuse Replace fuse ®...
Page 29 New products manufactured by Devicor are warranted against defects in workmanship and material for period of one year (period) from date of shipment by Devicor to Buyer, subject to limitations hereinafter set forth. Should any defects be found and reported during period, Devicor, at its option, will repair or replace such defective product provided Buyer ships defective product to Devicor, transportation charges prepaid, with notice of defect and certification that product was properly installed, maintained, and operated within limits of rated and normal usage.
Page 30: System Specifications
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual THIS WARRANTY CONTAINS THE ENTIRE OBLIGATION OF DEVICOR AND NO OTHER WARRANTIES INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTIES EXPRESSED, IMPLIED, OR STATUTORY ARE GIVEN.
Page 31 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Electrical shock protection - Degree Type CF Applied Part Equipment not suitable for use in presence of Flammable Anesthetics FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE Operating mode Continuous Ingress of fluids - probes...
Page 32 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual Electromagnetic Compatibility Declaration EMC Requirements in Accordance with EN 60601-1-2:2007 Table 201 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Model 2300 Gamma Detection System is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 2300 Gamma Detection System should assure that it is used in such an environment.
Page 33 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual IEC61000-4-8 Table 204 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Model 2300 Gamma Detection System equipment is intended for use in the electromagnetic environment specified below. The customer or user of the Model 2300 Gamma Detection System equipment should assure that it is used in such an environment.
Page 34 Declaration of Conformance: Hereby, Devicor Medical Products, Inc. declares that this “Wireless Probe” is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Devicor Medical Products, Inc. tímto prohlašuje, že tento “Wireless Probe” je ve shodě se základními požadavky a Česky...
Page 35 övriga relevanta bestämmelser som framgår av direktiv 1999/5/EG. [Swedish] Íslenska Hér með lýsir Devicor Medical Products, Inc. yfir því að “Wireless Probe” er í samræmi við grunnkröfur og aðrar [Icelandic] kröfur, sem gerðar eru í tilskipun 1999/5/EC.
Page 36: Authorized Accessories
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual 10. AUTHORIZED ACCESSORIES The following is a list of authorized accessories for use with the neoprobe GDS console: Probes: Item Description Product Code Model 1017, 14mm Corded Probe NPR14 Model 1100, 14mm Wireless Straight Probe NPB14S...
Page 37: Warnings, Cautions And Notes
NOTE: General information to explain or clarify proper operation of product. Injury 1-877-926-2666 Report injuries immediately to Devicor at and leave product undisturbed until authorized Devicor representative can inspect it. ELECTRICAL:  Verify power cable is secure before each use.
Page 38 Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork neoprobe GDS Operation Manual  Do not position or use product near sources of extreme magnetism such as MRI equipment.  Operation of product in vicinity of X-ray equipment may cause incorrect counts. ...