Model 2300 Gamma Detection System (with Bluetooth) Operation Manual Rev C

neoprobe® GDS Operation Manual

“neo2000®” and “neoprobe®” word marks and logos are registered trademarks of Neoprobe Corporation. “TÜV” word mark and logos are registered trademarks of TÜV. "Bluetooth®" word mark and logos are owned by Bluetooth SIG, Inc. and any use by Neoprobe or its representatives is under license - - do not translate word marks.

Neoprobe Corporation www.neoprobe.com 425 Metro Place North, Suite 300 Dublin, Ohio 43015-1367 U.S.A. Tel: +1-614-793-7500 (English only) Toll Free: 1-800-793-0079 (U.S. Only) Fax: +1-614-793-7520 URL: www.neoprobe.com

AR-MED, Ltd. Runnymede Malthouse Egham TW20 9BD, United Kingdom Tel: + 44 (0) 1344 601204 Fax: + 44 (0) 1344 601202

Made in U.S.A. This document is sole property of Neoprobe Corporation. Any duplication, reproduction, or transmission of document or any of its content to unauthorized parties without prior written permission of Neoprobe Corporation is prohibited. © 2008 NEOPROBE CORPORATION. ALL RIGHTS RESERVED.

DIN: 00-1393, Rev. C

Page 2 of 36

neoprobe® GDS Operation Manual

TABLE OF CONTENTS 1.

INTRODUCTION... 4

2.

EQUIPMENT ASSEMBLY ... 5

3.

DYNAMIC PITCH MODE (DEFAULT)... 7

4.

BINARY PITCH MODE (OPTION) ... 13

5.

TERMINOLOGY AND SYMBOLS ... 17

6.

POTENTIAL APPLICATIONS... 19

7.

CLEANING & DISINFECTION ... 20

8.

MAINTENANCE ... 24

9.

SYSTEM SPECIFICATIONS ... 30

10.

WARNINGS, CAUTIONS AND NOTES ... 34

DIN: 00-1393, Rev. C

Page 3 of 36

neoprobe® GDS Operation Manual

1. INTRODUCTION neoprobe® 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 Indications

Electronic medical device for detecting and quantifying gamma radiation Used externally and intraoperatively to detect radioactive emissions from body tissues or organs where radiopharmaceuticals are administered

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 Neoprobe Corporation 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 linc ” “on LED screen.

FRONT

DIN: 00-1393, Rev. C

REAR

Page 4 of 36

neoprobe® GDS Operation Manual Number

Name

Number

Name

[1]

Standby/On Switch and Indicator Light

[15]

Volume Adjustment

[2]

“No Probe Connected” Symbol

[16]

Mute Button

[3]

Radionuclide Selection Indicators

[17]

Mute Symbol

[4]

Binary/Dynamic Pitch mode buttons and indicators

[18]

Dynamic Pitch Range Buttons And Indicator Lights

[5]

Probe Input Connector

[19]

EC Authorized Representative Tag

[6]

Count Bar

[20]

Manufacturers’ Tag

[7]

Target Count Readout

[21]

Radionuclide Selector Button

[8]

Background Count Readout

[22]

Serial Port Connector

[9]

Ratio Readout

[23]

BLUETOOTH indicator light

[10]

Target Count Symbol

[24]

Serial Number Tag

[11]

Target Count Button*

[25]

AC Power Inlet Connector

[12]

Ratio Symbol

[26]

Power Rating Tag

[13]

Background Count Symbol

[27]

Equipotential Contact Point

[14]

Background Count Button

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 manual. 2. EQUIPMENT ASSEMBLY

Step 1 2

Start product Connect Model 2009 power cord to console and into AC power source. DO NOT USE EXTENSION CORD Press and release Standby/On button Console powers on; displays software version; and operates in Dynamic Pitch Mode

NOTE: Console is equipped with BLUETOOTH wireless technology and is compatible with both BLUETOOTH wireless technology enabled probes and cabled probes. User can select either probe type to use with console. A wireless probe cannot be operated at the same time a cabled probe is in use.

DIN: 00-1393, Rev. C

Page 5 of 36

neoprobe® GDS Operation Manual

Quick Start BLUETOOTH Wireless Technology Enabled Probe

Model 1100/1101 Probe, with BLUETOOTH Wireless Technology Step 1 2 3 4 5

Prepare probe equipped with BLUETOOTH wireless technology Prepare for operation as stated above Install battery in probe Press button on probe; probe blue light is on steady Press and hold Target Count Button [11] on console; displays “disc”; release Target Count button Probe connects; blue light on probe flashes and starts normal operation See manual provided with probe for complete instructions

When base Binary or Dynamic Pitch Mode (not performing a 10-second count, etc), user can press and hold Background Count Button. After five seconds, a Start Beep sounds and wireless 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 radionuclide indicators will go out. This signifies an Open Window setting. Exit Open Window by pressing and releasing Radionuclide button (last radionuclide selected is restored). When in base Binary or Dynamic Pitch Mode (not performing a 10-second count, etc) and a wireless probe battery is low, Ratio Indicator will show “Lo” and Background Count will show “batt” for two seconds. A low battery chime is sounded and No Probe Connected Icon turns on for two seconds, then turns off. Previous values are restored. Message is seen every 20 seconds.

DIN: 00-1393, Rev. C

Page 6 of 36

neoprobe® GDS Operation Manual

Quick Start Probe with cable Procedure for reusable cabled detector probes (Model 1017 or Model 2059).

Step 1 2 3

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; align red dot on probe to red dot on cable connector; gently insert cable into Probe Input Connector; if using a sterile surgical drape - place probe in drape now Align arrow on cable connector and groove in Probe Input Connector [5] on console; gently insert cable connector neoprobe® system is now ready for use

NOTE: Model 1013 collimator is compatible with Model 1100, 1101, and 1017 probes. NOTE: Model 1017 14mm probe connector has four pins; Model 2059 11mm probe connector has six pins. NOTE: You hear audible click as you insert cable connector into Probe Input Connector. Connector is push/pull component - DO NOT TWIST/TURN CABLE CONNECTOR, damage to connectors and connector pins may occur. 3. DYNAMIC PITCH MODE (DEFAULT) Radioactive isotopes are traced in Dynamic Pitch Mode from injection site to other areas of concentration. To…. Turn system on

Select Dynamic Pitch count range different from 0-100 Select a radionuclide different from 99mTC.

DIN: 00-1393, Rev. C

Perform following….. See Equipment Assembly above

Press and release Dynamic Pitch Count Range selection buttons [18]. Press and release Radionuclide Selection button [21] until desired radionuclide is lit

Page 7 of 36

And this occurs…… “Dynamic Pitch” indicator [4] is lit Dynamic Pitch Range automatically set to 0-100 count range, and default background count is 2 cps Radionuclide automatically set to Technetium 99m (99mTC), and indicator [3] is lit Indicator for desired Count Range is lit [18]; Background Count Readout [ 8] changes to default for selected Count Range Radionuclide Selection Indicator [ 3] is lit

neoprobe® GDS Operation Manual

To…. Set Dynamic Pitch audible tone.

Perform following….. Turn Volume [15] counterclockwise

And this occurs…… Sound is lowest Sound is highest

Set Dynamic Pitch sound on or off.

Turn Volume [15] clockwise Press and release Mute Button [16].

When sound is off, Mute symbol [17] flashes; when sound is on, Mute symbol [17] is constant

Background Count in Dynamic Pitch Mode Background Count [8] is used as minimum value for selected range. Background Count [8] displays default value for Dynamic Pitch range; Ratio Readout [9] is off; and Target Count [7] displays count rates as probe moves over body tissue.

BACKGROUND COUNT How to acquire Background Count 

Place probe tip on target area.



Press and release Background Count Button [14]; a single 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 dashes.



Count Bar [6] fills from bottom to top as data is collected.



Target Count Readout [7] is blank and is stopped temporarily.

Background Count Value Background Count Readout data [8] will remain until a new Background Count is performed, Count Range [18] is changed, Dynamic/Binary Pitch button is pressed, or system is switched off. Set Dynamic Pitch range Physician generally sets Dynamic Pitch Range [18] based on maximum count rates expected in order to achieve highest result for a given Dynamic Pitch Range. Default Background Count values are displayed in table below. Count Range 100 DIN: 00-1393, Rev. C

Page 8 of 36

Default Background Count 2

neoprobe® GDS Operation Manual

Count Range 1,000 10,000 50,000

Default Background Count 20 200 1000

Operational Notes Events that may occur during product use: If…… Background Count is greater than or equal to 80% of maximum value of selected Count Range Background Count is less than or equal to 2% of maximum value of selected Count Range Background Count button [14] is pressed during background count Background Count button 14] is pressed while Background Count value is displayed

Then this occurs…… Example: 800 is displayed for 1,000 Count Range Example: 20 is displayed for 1,000 Count Range Ratio is not calculated during Target Count. A Start Beep sounds and Background Count restarts A new Background Count starts

Scanning to Locate Concentrated Areas of Radioactivity Physician scans target areas to locate radioactivity after setting Background Count and Dynamic Pitch Ranges. System status 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 settings. Scanning procedure Physician slowly scans by moving probe over target tissue at a rate of 1-2 centimeters per second (cm/s). Sound rises in pitch as Count Rate increases from Background Count Value to Dynamic Pitch maximum value.

SCAN OVER TARGET AREA NOTE: Count is too high to be displayed when Count Bar [6] fills to top and flashes with varying audio. To correct, press and release Dynamic Pitch Range Button [18] for next higher Dynamic Count Range, and perform a new Background Count if necessary. Optionally, press, hold and then release any Dynamic Range button (18) to activate “Autorange Function”, see autorange instructions below. Acquiring Target Count in Dynamic Pitch Mode Acquire Target Count to identify intensity of gamma radiation in surrounding area.

DIN: 00-1393, Rev. C

Page 9 of 36

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.



Press and release Target Count Button [11]; keep probe steady over target area for 1 to 6 seconds until Count Bar [6] is full and a double Stop Beep sounds.

Collect Target Count 

Target Count Symbol [10] flashes 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 Symbol (10) flashes green.



Count Bar [6] is off.



After 5 seconds, double Stop Beep sounds and system returns to Dynamic Pitch Mode, displaying last calculated Background Count [8] and current Count Rate [7].

Acquiring Target Count Ratio in Dynamic Pitch Mode

TARGET COUNT RATIO

DIN: 00-1393, Rev. C

Page 10 of 36

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.



Hold probe stationary over target area. Press and release Target Count Button [11] until a beep sounds; hold probe steady over target area for 1 to 6 seconds until Count Bar [6] is full and a double Stop Beep sounds.

Collect a Target Count 

Target Count Symbol [10] flashes amber.



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] and Ratio Readout [9] are displayed 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 Dynamic Pitch Mode displaying last calculated Background Count [8] and current Target Count [7] data.

Acquiring Ten Second Count in Dynamic Pitch Mode

TEN SECOND COUNT Acquire a Ten Second Count 

Hold probe stationary over target area.



Press and hold Target Count Button [11] until beep sounds; then release button.



Hold probe steady for 10 seconds over target area until Count Bar [6] is full and double Stop Beep sounds.

Collect Ten Second Target Count 

Target Count Symbol [10] flashes green.



Target Count Readout [7] displays dashes.



Count Bar [6] fills from bottom to top as data is collected.

Ten Second Target Count Value DIN: 00-1393, Rev. C

Page 11 of 36

neoprobe® GDS Operation Manual

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.



“10” is displayed below amber Target Count Readout, and message “secnd” displayed in green.



Count Bar [6] off.



After 5 seconds, double Stop Beep sounds and system returns to Dynamic Pitch mode, displaying last calculated Background Count [8] and current Target Count Readout data [7].

How to Use Autorange Console has 4 preset ranges: 100; 1000; 10000; and 50000 counts per second. Physician can define a different range with Autorange function. 

Hold probe stationary over target area to achieve highest Target Count Readout data [7] and highest sound.



Press and hold one of four Dynamic 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 [18] to return to default settings for desired range. NOTE: If Target Count Value [7] is greater than maximum value of desired Dynamic Pitch Range [18], then Count Bar [6] is full and flashes with varying beep. Console display 

Target Count Readout data [7] is displayed.



Background Count Data [8] is blank.



Count Bar [6] fills from bottom to top as data is collected; double Stop Beep sounds when completed.

NOTE: Autorange feature sets maximum data point of user defined range to 125% of Target Count [7] acquired during Autorange process. 

Background Count [8] is set to either 2 counts per second or 2% of full scale, whichever is greater.



Selected Dynamic Pitch Range light [18] flashes.

AUTORANGE Operational Note Events that may occur during product use: If…. Target Count Button [11] is pressed while DIN: 00-1393, Rev. C

Then this occurs….. Target Count restarts Page 12 of 36

neoprobe® GDS Operation Manual

If…. Target Count is calculated Target Count is too high

Then this occurs….. Overflow Symbols”///// ” displayed on Target Count Readout [7] and varying beep is heard

Target Count Button [11] is pressed while Target Count or 10 Second Count is displayed Calculated Ratio is greater than 99.9

/////

Target Count function returns to Dynamic Pitch Mode and displays Count Rate data Overflow symbol “/// ” is displayed [9]

////

4. BINARY PITCH MODE (OPTION) Binary Pitch Mode sound tells physician when radioactivity is significantly above Background Count of nonradioactive area. To……

Perform following……

And this occurs….

Turn system on

Press and release power standby button [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. See troubleshooting instructions below. For a cabled probe: If there is no probe or cable attached message “error no Probe” is displayed. See troubleshooting instructions below. System function indicator lights and “error 2” through “error 6 ” are displayed. See troubleshooting instructions below.

Conduct performance check

See instructions below

Select Binary Pitch Mode

Press and release Binary Pitch/Dynamic Pitch Button [4]

Binary Pitch Symbol is lit Background Count changes to 7 counts per second Radionuclide automatically set 99mTc, and radionuclide symbol is lit

Select different radionuclide from 99m Tc

DIN: 00-1393, Rev. C

Press and release Radionuclide Selection Button [21] to select radionuclide

Page 13 of 36

Desired radionuclide is lit

neoprobe® GDS Operation Manual

To……

Perform following……

Adjust Binary Pitch sound

Turn Volume Adjustment counterclockwise

Sound is lowest

Turn Volume Adjustment clockwise

Sound is highest

Turn Binary Pitch sound on/off

And this occurs….

Press and release Mute Button [16]

Sound is off, Mute Symbol flashes Sound is on, Mute Symbol is steady

Background Count in Binary Pitch Mode Background Count establishes baseline data for radioactivity level of normal tissue. System compares background data to radioactivity level of Target Tissue when a Target Count is performed. System status before background count Background Count Readout [8] displays number “7” as a default 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 (e.g., normal adjacent tissue, etc.)



Press and release Background Count Button [14]; single beep sounds. Hold probe steady for 6 seconds; beep stops.

Console display 

Background Count Symbol [13] flashes



Background Count Readout [8] displays dashes



Count Rate [7] is temporarily blank



Count Bar [6] fills from bottom to top as data is collected for 6 seconds.

Background count display 

After 6 seconds, Background Count Data [8] is constant until a new Background Count is taken; Binary Pitch Mode [18] is changed; or system is shut off.



Count Rate [7] data is displayed.

BACKGROUND COUNT - BINARY PITCH MODE

DIN: 00-1393, Rev. C

Page 14 of 36

neoprobe® GDS Operation Manual

Operational Note Events that may occur during product use: If…..

Then this occurs……

Background Count is too high

Overflow Symbols “/ //// ”on Background Count Readout (7) and beep sounds

Background Count Button (14) is pressed while a count is in progress

A Start Beep sounds; starts new Background Count calculation

Background Count Button (14) is pressed after Background Count Readout data (7) is displayed

Starts new Background Count calculation

/////

Scanning to Establish Boundaries of Target Tissue in Binary Pitch Mode Scan target tissue to locate area of localized radioactivity after Background Count Calculation is completed. Scanning procedure Scan for radioactivity by moving probe slowly over tissue at a rate of 1 or 2 centimeters per second (cm/s). When radioactivity exceeds Background Count Data by a statistically significant amount, beep sounds to indicate target tissue 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 Target Count (6-Second Option) System status before Target Count Background Count Readout [8] displays Background Count Data. Ratio Readout [9] is off. Target Count Readout [8] displays count rates as probe is moved over tissue. How to Acquire Target Count 

Hold probe stationary over Target Tissue.



Press and hold Target Count Button [11] until Start Beep sounds. Release button.



Hold probe steady 6 seconds until Stop Beep sounds.

Console Display 

Target Count Symbol [10] changes from green to amber and flashes.



Target Count Readout [7] displays dashes.



Count Bar [6] fills from bottom to top as data is collected for 6 seconds.

Target Count and Ratio Display 

Target Count Readout data [7] and Ratio Count Data [9] are displayed for 5 seconds. Target Count Symbol [10] flashes amber.



Ratio Readout [9] is displayed. Ratio Symbol [12] flashes.

DIN: 00-1393, Rev. C

Page 15 of 36

neoprobe® GDS Operation Manual



After 5 seconds, system returns to Binary Pitch Mode displaying last calculated Background Count data [8] and current Count Rate data [7].

TARGET COUNT; 6-SECOND OPTION Operation Note Events that may occur during product use: If….. Target Count Button [11] is activated (press and hold) while a Target Count is calculated Target Count [7] is too high Target Count button [11] is pressed twice while Target Count Readout data is displayed Calculated Ratio Readout data is greater than 99.9

Then this occurs….. Start Beep sounds and starts new Target Count Overflow symbol “///// ” is displayed in Target Count Readout (7) and beep sounds Starts new Target Count Overflow symbol “/// ”appears in Ratio Readout (9)

Performing a Target Check (2-Second Option) Perform a 2-second Target Check to obtain a quick reading of radioactivity level of target tissue. System status before Target Check Background Count Readout [8] displays Background Count Data. Ratio Readout [9] is off. Target Count [7] displays count rate as probe is moved over tissue. How to perform Target Check 

Hold probe stationary over target tissue.



Press and release Target Count Button [11]; Start Beep sounds.



Hold probe steady for 2 seconds until Stop Beep sounds.

Console Display 

Target Count Symbol [10] flashes.



Target Count Readout [7] displays dashes.



Count Bar [6] fills from bottom to top as data is collected for 2 seconds.

DIN: 00-1393, Rev. C

/////

Page 16 of 36

///

neoprobe® GDS Operation Manual

Target Check Display 

Target Check data is displayed in Target Count Readout [7] for 5 seconds; Target Count Symbol [10] flashes green.



After 5 seconds, system returns to Binary Pitch mode displaying last calculated Background Count data [8] and current Count Rate data [7].

TARGET CHECK; 2-SECOND OPTION Operation Note Events that may occur during product use: If…..

Then this occurs……

Target Check data is too high

Overflow Symbol “///// ” is displayed in Target Count Readout [7] and beep sounds

Target Count Button [11] is pressed while Target Count is displayed

/////

Target Count Readout [7] changes to Binary Pitch Mode and displays Target Count data

System Shutdown Shut down system and prepare for reuse. Step 1 2 3 4 5

System shutdown and reuse Press and release Standby/On button [1] Disconnect power cord Clean console and power cord; wrap power cord around posts on rear panel of console Separate and clean external collimator and probe Sterilize external collimator and probe if no sterile surgical drape is used

5. TERMINOLOGY AND SYMBOLS Terms, symbols and graphics used in this manual. ITEM

DESCRIPTION

Count Rate

A continuous rate of gamma radiation measured in counts per second and updated every one-half second. Count Rate is displayed on same line of LED screen as Target Count data and Target Check data when these functions are not active.

DIN: 00-1393, Rev. C

Page 17 of 36

neoprobe® GDS Operation Manual ITEM

DESCRIPTION

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 Tissue is statistically significant.

Compton Scattering

Radioactive noise at an energy level lower than photo peak of radioactive material.

Ratio Readout

A value indicating how likely it is that Target Tissue is identified (Target Count divided by Background Count).

Dynamic Pitch

Default mode of operation: baseline value measured in counts per second that is stored in console, and used as threshold at which sound is activated.

Binary Pitch Scan/Scanning

Optional mode of operation: baseline value measured in counts per second that is stored in console for comparison to Target Count determines if difference in radioactivity between Background Tissue and Target Tissue is statistically significant. Moving probe across Target Area to locate highest radiation reading.

Target Area

Area of interest selected by physician during a procedure

Target Check

Binary Pitch Mode Only: quick check of level of radioactivity measured in counts per second detected by a probe held stationary for 2 seconds over target tissue; more accurate than Count Rate. Target Check function does not display a calculated Ratio Readout.

Target Count

Number indicating level of radioactivity detected by probe when held stationary for 6 seconds over Target Tissue; more accurate than Target Check. Target Count activates and displays a calculated Ratio Readout; 6 seconds in Binary Pitch mode; 1 to 6 seconds in Dynamic Pitch mode. Caution: United States Federal Law restricts this device to sale by or on order of a physician. +60°C

Storage and Transit Temperature

-20°C

Storage and Transit Pressure

Storage and Transit Humidity

Type CF CAUTION: consult accompanying documents Standby/ON CAUTION: non-sterile

DIN: 00-1393, Rev. C

Page 18 of 36

neoprobe® GDS Operation Manual ITEM

DESCRIPTION WARNING: hazardous voltage or shock hazard present; follow instructions and warnings

6. POTENTIAL APPLICATIONS Product is used transcutaneously and intracutaneously to detect radioactive emissions from body tissues or organs where radiopharmaceuticals are administered. Most commonly administered isotopes are listed in following table, all are detected by this product.

Radionuclide  Iodine-125  Cobalt-57  Technetium99m  Indium-111  Iodine-131  Flourine-18

Principal Photo peak Energy (keV) 27-35, Te X-rays 122

Physical Half-Life 60 days 270 days

140

6.02 hrs.

99m

171/245 364 511

2.83 days 8.07 days 110 min.

111

Select this Radionuclide Indicator 125 I 57 Co Tc

In I 18 F

131

NOTE: A variety of radiopharmaceuticals 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 probe intracutaneously. External application External gamma detection of administered isotope provides noninvasive means of gathering important physiological and/or anatomical information. Some examples are: detection and localization of blood clot formulation using 125I or 111 In labeled platelets: evaluation of thyroid function by measuring radioactive iodine uptake; evaluation of skin or skeletal muscle blood flow; diagnosis of testicular torsion using 99mTc; intracutaneous scanning for localization of lymphatic tissue. Intraoperative localization of lymphatic tissue Lymphoscintigraphy is a common medical procedure employed to define lymphatic flow from a site of injection through lymphatic tissue. Hand-held gamma probes may be useful in assisting a surgeon in localization of regional lymph node basins draining a lesion site. This allows surgeons to identify areas within lymphatics where a biopsy of tissue may be taken to determine histological status of lymph tissue. Minimally invasive radioguided parathyroidectomy A preoperative 99mTc -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. Gamma probes can be used to detect and localize increased uptake of 99mTc -99m-Sestabibi by hyperparathyroid gland. Evaluation of ischemic bowel Strangulation of gut may cause ischemic bowel. Surgeon must revascularize it and determine its viability as part of surgical protocol. Gamma probes can be used to detect intra-arterial distribution of 99mTc labeled red blood cells as a means of determining if gut is reperfused. Other tracers, such as 99mTc labeled DTPA for perfusion or 9999mTc labeled pyrophosphate for muscle infarction, may require investigational drug status for this application. Perfusion of anastomosis-assessment of compromised blood flow DIN: 00-1393, Rev. C

Page 19 of 36

neoprobe® GDS Operation Manual

When a surgeon creates an anastomosis, it must be determined that each side of anastomosis has adequate perfusion; otherwise, anastomosis may fail, and leakage may occur. A high degree of morbidity is associated with this failure. Gamma probes provide opportunity to assess perfusion before and after creating anastomosis. Intravenous administration of stannous pyrophosphate followed by 99mTc automatically labels red blood cells in vivo. Blood flow to anastomotic ends and across anastomotic juncture can be 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 curative. Modern radiographic techniques externally image lesion with 99mTc labeled pyrophosphate. However, because of their size (rarely greater than 1 centimeter) and location within cortical bone, it may be difficult for surgeon to localize lesion intraoperatively. A gamma probe may be useful in localizing a lesion site intraoperatively. Additionally, checking high concentration of radioactive isotope in removed bone fragments provides evidence that nidus is being excised. 7. Cleaning & Disinfection Follow precautions established in your facility when handling any medical device that has been in contact with body fluids, tissues, or blood (intraoperative). All medical devices used intraoperatively must be cleaned, decontaminated or sterilized before reuse. WARNING: Do not clean console or accessories when energized. Disconnect power cord from console and from power outlet before cleaning. Do not sterilize console or immerse it in fluids. Attempting to do so will cause permanent damage. Damp wipe only. CAUTION: Following general warnings apply to sterilization of system components: 

Do not sterilize console



Use only approved sterilization procedures described with each probe or accessory.



Do not touch patient or operator with product when electrosurgical device is in use or energized. CAUTION: Prior to sterilization, probe and collimator should be inspected to ensure:



Cleanliness



Power cable is free of cracks or cuts



Connectors are completely dry



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



Metrizyme (Metrex Research Corporation) – probes cables, collimators & connectors



Mild Soap and Water Solution – all products



Tor-II (Huntington Laboratories) – all products



Ammonia and 97% water – all products



Clorox and 90 to 95% water – all products



MediClean Forte – all products



MediZym – all products

DIN: 00-1393, Rev. C

Page 20 of 36