neoprobe®®

Gamma Detection System (GDS)

Operation Manual

Bluetooth®®
Wireless Technology
 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.

Rx Only

Neoprobe Corporation AR-MED, Ltd.

www.neoprobe.com Runnymede Malthouse
425 Metro Place North, Suite 300 Egham TW20 9BD, United Kingdom
Dublin, Ohio 43015-1367 U.S.A. Tel: + 44 (0) 1344 601204
Tel: +1-614-793-7500 (English only) Fax: + 44 (0) 1344 601202
Toll Free: 1-800-793-0079 (U.S. Only)
Fax: +1-614-793-7520
URL: www.neoprobe.com

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. A Page 2 of 34

 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 .................................................................................................................................................... 33

DIN: 00-1393, Rev. A Page 3 of 34

 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 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
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 REAR

DIN: 00-1393, Rev. A Page 4 of 34

 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 Start product

Connect Model 2009 power cord to console and into AC power source. DO NOT USE EXTENSION
1
CORD
2 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. A Page 5 of 34

 neoprobe® GDS Operation Manual

Quick Start BLUETOOTH Wireless Technology Enabled Probe

Model 1100/1101 Probe, with BLUETOOTH Wireless Technology

Step Prepare probe equipped with BLUETOOTH wireless technology
1 Prepare for operation as stated above
2 Install battery in probe
3 Press button on probe; probe blue light is on steady
Press and hold Target Count Button [11] on console; displays “disc”; release Target Count
4
button
5 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. A Page 6 of 34

 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:
1 If needed, attach external collimator to probe
2 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
3 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…. Perform following….. And this occurs……
Turn system on See Equipment Assembly “Dynamic Pitch” indicator [4] is lit
above
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
Select Dynamic Pitch Press and release Indicator for desired Count Range is lit [18];
count range different Dynamic Pitch Count Background Count Readout [ 8] changes to default
from 0-100 Range selection buttons for selected Count Range
[18].
Select a radionuclide Press and release Radionuclide Selection Indicator [ 3] is lit
different from 99mTC. Radionuclide Selection
button [21] until desired
radionuclide is lit

DIN: 00-1393, Rev. A Page 7 of 34

 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; when
on or off. Button [16]. 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 Default Background Count
100 2

DIN: 00-1393, Rev. A Page 8 of 34

 neoprobe® GDS Operation Manual

Count Range Default Background Count

1,000 20
10,000 200
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 Example: 20 is displayed for 1,000 Count Range
maximum value of selected Count Range
Background Count button [14] is pressed during Ratio is not calculated during Target Count. A Start
background count Beep sounds and Background Count restarts
Background Count button 14] is pressed while A new Background Count starts
Background Count value is displayed
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. A Page 9 of 34

 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

Acquire a Target Count Ratio

DIN: 00-1393, Rev. A Page 10 of 34

 neoprobe® GDS Operation Manual

• 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
Note: Value displayed is not counts per second. Value is total counts obtained in 10 seconds.

DIN: 00-1393, Rev. A Page 11 of 34

 neoprobe® GDS Operation Manual

• 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…. Then this occurs…..
Target Count Button [11] is pressed while
Target Count restarts
Target Count is calculated

DIN: 00-1393, Rev. A Page 12 of 34

 neoprobe® GDS Operation Manual

If…. Then this occurs…..

Target Count is too high Overflow Symbols”///// ” displayed on
Target Count Readout [7] and varying beep /////
is heard
Target Count Button [11] is pressed while
Target Count function returns to Dynamic
Target Count or 10 Second Count is
Pitch Mode and displays Count Rate data
displayed
Calculated Ratio is greater than 99.9 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 15 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 See instructions below
performance
check

Select Binary Press and release Binary Pitch/Dynamic Binary Pitch Symbol is lit
Pitch Mode Pitch Button [4]
Background Count changes to 7 counts per
second
Radionuclide automatically set 99mTc, and
radionuclide symbol is lit
Select different Press and release Radionuclide Selection Desired radionuclide is lit
radionuclide from Button [21] to select radionuclide
99m
Tc
Adjust Binary Turn Volume Adjustment Sound is lowest
Pitch sound counterclockwise

DIN: 00-1393, Rev. A Page 13 of 34

 neoprobe® GDS Operation Manual

To…… Perform following…… And this occurs….

Turn Volume Adjustment Sound is highest
clockwise
Turn Binary Pitch Press and release Mute Button [16] Sound is off, Mute Symbol flashes
sound on/off 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

Operational Note
Events that may occur during product use:

If….. Then this occurs……

DIN: 00-1393, Rev. A Page 14 of 34

 neoprobe® GDS Operation Manual

If….. Then this occurs……

Background Count is too high Overflow Symbols “/ //// ”on
Background Count Readout (7) and beep /////
sounds
Background Count Button (14) is A Start Beep sounds; starts new
pressed while a count is in progress Background Count calculation
Background Count Button (14) is Starts new Background Count
pressed after Background Count Readout calculation
data (7) is displayed

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.
• After 5 seconds, system returns to Binary Pitch Mode displaying last calculated Background Count Data (8)
and current Target Count Readout data (7).

DIN: 00-1393, Rev. A Page 15 of 34

 neoprobe® GDS Operation Manual

TARGET COUNT; 6 SECOND OPTION

Operation Note
Events that may occur during product use:
If….. Then this occurs…..
Target Count Button [11] is activated
Start Beep sounds and starts new Target
(press and hold) while a Target Count is
Count
calculated
Target Count [7] is too high Overflow symbol “///// ” is displayed
in Target Count Readout (7) and beep /////
sounds
Target Count button [11] is pressed twice
while Target Count Readout data is Starts new Target Count
displayed
Calculated Ratio Readout data is greater Overflow symbol “/// ”appears in Ratio
than 99.9 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.
Target Check Display

DIN: 00-1393, Rev. A Page 16 of 34

 neoprobe® GDS Operation Manual

• 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 [8] and
current Target Count [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 Target Count Readout [7] changes to
while Target Count is displayed 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 Disconnect power cord
3 Clean console and power cord; wrap power cord around posts on rear panel of console
4 Separate and clean external collimator and probe
5 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. A Page 17 of 34

 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 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.
Scan/Scanning 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. A Page 18 of 34

 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.
Principal
Photo peak Energy Select this Radionuclide
Radionuclide (keV) Physical Half-Life Indicator
125
• Iodine-125 27-35, Te X-rays 60 days I
57
• Cobalt-57 122 270 days Co
• Technetium- 99m
140 6.02 hrs. Tc
99m
111
• Indium-111 171/245 2.83 days In
131
• Iodine-131 364 8.07 days I
18
• Flourine-18** 511 110 min. F
**Not yet available - contact Neoprobe Corporation for Flourine-18 capable probe.
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. A Page 19 of 34

 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. A Page 20 of 34

 neoprobe® GDS Operation Manual

• Isopropyl Alcohol 70% (rubbing alcohol) – all products

The accessories are compatible with the cleansers listed above and the sterilizers listed below:
• STERRAD – (Sterilization - ASPUS (Johnson & Johnson) - probes, cables, connectors, & collimators
• STERIS (Sterilization - Steris Corp.) - probes, cables, connectors, & collimators
• EO (Sterilization) - probes, cables, connectors, & collimators
• Flash Autoclave (Sterilization) – Collimators Only
NOTE: cleaning agents not listed above are sole responsibility of user to adequately assess and validate.

CAUTION: When using radioactive materials, use safe and proper handling techniques. See your
institution’s radiation safety officer about nuclear regulation commission and other requirements.
Radioactive decontamination procedures
An increase in counts without a known radioactive source may indicate radioactive contamination of environment,
probe or accessories. If high count is detected in absence of a radioactive source, then probe and collimator should be
cleaned with a radioactive decontaminant solution (e.g., Radiacwash®).
Follow standard nuclear medicine decontamination techniques. Wash probe with a decontaminant solution (e.g.
Radiacwash®) using a soft gauze pad. Pay particular attention to cleaning recesses, crevices and mating surfaces
with a soft brush. Do not scratch or abrade surfaces. Treat spent cleaning solution as radioactive waste and do not
allow it to contaminate other surfaces. Dispose of pads and cleaning solution in approved containers.

DIN: 00-1393, Rev. A Page 21 of 34

 neoprobe® GDS Operation Manual

Reprocessing of Console according to EN ISO 17664:2004

Manufacturer: Method: Cleaning & Disinfection Symbol:

Neoprobe Corporation
425 Metro Place North
Suite 300
Dublin, Ohio 43017-1367 US Model 2300
Devices(s): Reusable control units comprising fixed assemblies (no moving parts); sold nonsterile.

WARNING: WARNING: disconnect control unit from power source before cleaning to avoid
electrical shock.
Limitations on Repeated processing has little effect on instrument. End of life is normally determined by
reprocessing: abrasion, wear and damage. DAMP WIPE ONLY.
INSTRUCTIONS:
Point of use: Remove excess soil and surface contamination with disposable cloth/paper wipe.
Containment &
No particular requirements. Recommend reprocessing instrument soon after surgical use.
Transportation:
Preparation for
WARNING: disconnect control unit from power source before cleaning to avoid
cleaning:
electrical shock.
Cleaning - Automated: Do not use automated cleaning. Clean by hand; cleaning instructions below.
Cleaning: Manual Equipment: mild detergent, clean gauze pad or lint free cloth, and clean soft brush.
Method:
1. Dampen cloth with mild detergent and wipe excess soil from surface
2. Clean air flow vents with dry brush
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 damaged instruments
Inspection & Function All instruments: Visually inspect for damage or wear. Where instruments form part of a
Testing: larger assembly, check assembly with mating components.
Packaging: No requirement
Sterilization: Console does not require sterilization
Storage: No requirement
Remove debris near power button and probe input connector. Do not allow moisture to
Additional Information:
enter through display or other openings.
See troubleshooting section for telephone and address of local representative or telephone
Manufacturer Contact:
(+1) 614-793-7500, extension 167.
NOTE: Instructions provided above are validated by medical device manufacturer as being capable of preparing a
medical device for re-use. It remains responsibility of reprocessor to ensure that reprocessing is actually performed using
equipment, materials, and personnel in processing facility to achieve desired result. This requires validation and routine
monitoring of processes. Likewise any deviation by processor from instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.

DIN: 00-1393, Rev. A Page 22 of 34

 neoprobe® GDS Operation Manual

Reprocessing of Power Cord according to EN ISO 17664:2004

Manufacturer: Method: Cleaning & Disinfection Symbol:

Neoprobe Corporation
425 Metro Place North
Suite 300
Dublin, Ohio 43017-1367 US Model 2009
Devices(s): Reusable power cords comprising fixed assemblies (no moving parts); sold nonsterile.

WARNING: WARNING: disconnect power cord from power source before cleaning to avoid
electrical shock.
Limitations on Repeated processing has little effect on cable. End of life is normally determined by
reprocessing: abrasion, wear and damage due to use.
INSTRUCTIONS:
Point of use: Remove excess soil and surface contamination with disposable cloth/paper wipe.
Containment &
No particular requirements. Recommend reprocessing instrument soon after surgical use.
Transportation:
Preparation for
WARNING: disconnect power cord from power source before cleaning to avoid
cleaning:
electrical shock
Cleaning - Automated: Do not use automated cleaning. Clean by hand; cleaning instructions below.
Cleaning: Manual Equipment: mild detergent and lint free cloth.
Method:
1. Dampen cloth with mild detergent and wipe excess soil from surface
2. Visually inspect for cleanliness
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
Inspection & Function All instruments: Visually inspect for damage or wear. Where cable forms part of a larger
Testing: assembly, check assembly with mating components.
Packaging: No requirement
Sterilization: Power cord does not require sterilization
Storage: No requirement
Periodically perform safety test with equipment system to assure continued integrity of
Additional Information:
power cord.
See troubleshooting section for telephone and address of local representative or telephone
Manufacturer Contact:
(+1) 614-793-7500, extension 167.
NOTE: Instructions provided above are validated by medical device manufacturer as being capable of preparing a
medical device for re-use. It remains responsibility of reprocessor to ensure that reprocessing is actually performed using
equipment, materials, and personnel in processing facility to achieve desired result. This requires validation and routine
monitoring of processes. Likewise any deviation by processor from instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.

DIN: 00-1393, Rev. A Page 23 of 34

 neoprobe® GDS Operation Manual

8. MAINTENANCE
Product must be serviced by competent service technicians or engineers. User 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.

CAUTION: Perform safety testing of current leakage and ground continuity tests with power cable
attached as part of routine maintenance of product. This will ensure that power cord continues to be suitable
and safe for use.
User Calibration and Repair
Do not open console. Console is set to factory specifications. Console design is optimized for digital operation and
does not contain any analog adjustments. User cannot calibrate or repair any components.
Fuse Maintenance
Fuses can be accessed and replaced in AC Power Inlet Connector [25] located at rear of console. Table below
describes how to replace fuses (2 each).

CAUTION: disconnect power cord from console before checking fuses.

NOTE: Both fuses are required for proper operation.
Step Procedure
1. Remove fuse holder 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
damage, and void warranty.
3. Reinstall fuse holder.
System Diagnostics
Visual Indicator Test Mode (VITM)
Verify visual indicators are operating properly:
Step Procedure Result
1 Press and hold Dynamic/Binary Pitch Background Count Readout [8]
Mode Selection Button [4] press and displays message “diag ”.
release Mute Button [16] to enter diag
Diagnostic Mode
2 Press and hold Dynamic/Binary Pitch LED components on top half of LED
Mode Selection Button [4]. Press and screen are lit.
release Dynamic Pitch Range 100 Note: LED components on bottom half Vitm
Button to activate visual indicator test of LED screen are off.
mode (vitm).
3 Press and release Target Count Button Target Count Readout color changes
[11]. from green to amber.
4 Press and release Background Count LED components on bottom half of
Button [14]. LED screen are lit. Background Count
Readout displays message “vitm”. Vitm
Note: LED components on top half of
LED screen are off.

DIN: 00-1393, Rev. A Page 24 of 34

 neoprobe® GDS Operation Manual

Step Procedure Result

5 Diagnostic Mode: Press and hold A double Stop Beep sounds and
Dynamic/Binary Pitch Mode Selection Background Count Readout displays
Button [4], press and release “diag”. diag
Background Count Button [14].
6 Exit Diagnostic Mode - press and hold Exits Diagnostic Mode.
Dynamic/Binary Pitch Mode Selection
Button [4], press and release Mute
Button [16].
Input Controls Test Mode (ICTM)
Verify input controls are operating properly:

Step Procedure Result

1 Press and hold down Binary Background count displays “diag”.
Pitch/Dynamic Pitch mode selection
button and press Mute button - - diag
release all buttons at once
2 Enter Input Controls Test Mode Background count displays “ictm”.
(ictm) - Press and hold down
Binary Pitch/Dynamic Pitch mode
selection button and press Dynamic ictm
Pitch range 1000 button - - release all
buttons at once
3 Press and release buttons in order Continuous tone sounds and message
listed below: is displayed in Target Count Readout
[7]:
• Radionuclide Bu0
• Target count Bu1
• Background count Bu2
• Mute Bu3
• Binary pitch/dynamic pitch
mode Bu4
• Count range 100 Bu5
• Count range 1,000 Bu6
• Count range 10,000 Bu7
• Count range 50,000 Bu8
4 To exit ITCM Mode, press and hold A double chime tone is heard and
Binary Pitch/Dynamic Pitch selection Background Count display displays
button, and while holding it down, “diag”. diag
press and release Background Count
button
5 Exit Base Diagnostic Mode - press Exit Diagnostic Mode
and hold down Binary Pitch/Dynamic
Pitch mode selection button and press

DIN: 00-1393, Rev. A Page 25 of 34

 neoprobe® GDS Operation Manual

Step Procedure Result

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.
NOTE: Individuals from Nuclear Medicine department familiar with radioactive emissions and measuring equipment
should perform System Accuracy Check below. Ensure that source strength, distance from probe to source, and stray
radiation from other sources do not adversely affect measurements taken. Ensure distance between probe and
radiation source does not change during System Accuracy Check.
Product design includes solid-state sensor and digital electronics technology that does not require periodic
adjustments to compensate for gain “drift” commonly associated with analog photomultiplier electron tube designs.
Use and maintain product as described in this manual. Product is not expected to exhibit any performance drift over
prescribed lifecycle.
Before performing quality checks, make sure probe with BLUETOOTH wireless technology is clean and free from
sources of radioactive contamination. All other sources of radiation emission must be removed from proximity of
probe during procedure. Shielding materials should be positioned to minimize effects of scatter and fluorescence
peaks from radioactive source. Use a 57Co radioactive source with known strength between 5 and 25 micro Curies
(185 to 925 kBq) during these procedures. Results will differ if you use another radionuclide, source strength, or
source location.
NOTE: BLUETOOTH wireless technology enabled probes have a larger crystal, are more sensitive (≥ 50%) than
cabled probes. Readings will differ between probe types.
1) Probe with BLUETOOTH Wireless Technology 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 mode with 99mTc radionuclide selected.
3. Place 57Co radioactive source 20mm in front of probe. Place probe and source in air above a table or other
surface to minimize effects of scattered radiation on measurement.
4. On console, press and hold Target Count Button to perform a 10 second count. Make sure probe does not
move during this process. Record this value.
5. Press and hold Radionuclide Selection button on back of console to select Open Window (v5.01 and later)*.
6. On console, press and hold Target Count Button to perform a 10 second count. Make sure probe does not
move during this process. Record this value.
7. Divide 99mTc count from step 4 by open window count from step 6. Result should be greater than 40%.
8. Count-rate ratio determined by this procedure should be stable and consistent over time within expected +/-
10% statistical variation of radioactive emissions during recommended counting intervals.
*NOTE: v4.01 or earlier software does not have Open Window feature, select 125I to perform this procedure.
2) Cabled Probe Photo Peak Efficiency
NOTE: Only conduct this test with cabled probes (without BLUETOOTH wireless technology).
1. Set unit to Dynamic Pitch mode and press Radionuclide selection button on back of unit to select 57Co
radionuclide.
2. Place 57Co radioactive source 20mm in front of probe. Place probe and source in air above a table or other
surface to minimize effects of scattered radiation on measurement.
3. Press and hold Target Count Button to perform a 10 second count. Make sure probe does not move during this
count.
4. Press Radionuclide Selection button on back of unit to select an open energy window (select 125I Radionuclide
for units with v2.01 or earlier software or press and hold Radionuclide button for an open energy window in
units with v2.02 or later software.)

DIN: 00-1393, Rev. A Page 26 of 34

 neoprobe® GDS Operation Manual

5. Press and hold Target Count Button to perform a 10 second count. Make sure probe does not move during this
count.
6. Divide 57Co 10-second count by open energy window 10-second count. Results should be greater than 50%.
7. Count-rate ratio determined by this procedure should be stable and consistent over time within expected
+10% statistical variations of radioactive emissions during recommended counting intervals.
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 Neoprobe Corporation for technical assistance.
Performance Check
Perform periodic performance checks to assure proper performance of product. No calibration or adjustments are
provided. Regardless of probe type or radioisotope in use, this performance check is a simplified procedure that will
check proper performance of system with either probe type.
Performance check procedure
This performance check should be performed before each use.
1. Place 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 registered count level decreases from
source count level.
If performance check does not meet conditions of Steps #1 and #2 above, consider following:
• If probe fails to detect measureable levels of gamma emissions when positioned over source of radioactivity,
check that power is on and that correct radionuclide is selected. For low counts, run system diagnostic checks to
test all visual indicators are functioning properly. Contact Neoprobe Corporation for technical assistance if
problem continues.
• If console displays error codes “error 2 ” through “error 6” when powered on, or anytime during
operation, cycle power to console. Contact Neoprobe Corporation if error codes continue.
• If console indicates high level of gamma emissions when probe is pointed away from radioactive source, and no
other source of radiation is known, move to another room and repeat low count performance check.
o If counts go down, there must be another source of radioactivity in room or patient source is too high.
o If counts do not go down, probe may be contaminated and should be cleaned with a radioactive
decontaminant solution (e.g., Radiacwash®), or probe has internal mechanical damage.
Troubleshooting
Use this table to identify and correct problems. Additional information is provided in service manual.

SYMPTOM POSSIBLE CAUSE CORRECTIVE ACTION

DIN: 00-1393, Rev. A Page 27 of 34

 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
Probe with BLUETOOTH wireless BLUETOOTH not active Activate probe
technology: Unit displays “no linc” Replace probe battery and
on power up reactivate
Return probe for service
Unit displays “Lo Batt” Battery is too low to operate probe Replace battery
Return for service if condition persists
For cabled probe: Unit displays “error no Probe or cable not connected Connect probe or cable
probe” on power up.
Damaged cable Replace cable
Damaged probe Replace probe
Return for service if condition persists
Unit displays “Error 2” through Internal error codes Cycle power to unit
“error 6” Return for service if condition
persists
Intermittent and unusually high readings Intermittent electrical interference Track down source of interference
(e.g., electrosurgical unit, X-ray, Turn off offending sources (if
etc.) possible)
Damaged probe Change probe
Return for service if condition
persists
Unexpected high readings (continuous) Contaminated probe or collimator Decontaminate probe and
collimator
Background too high Shield background source
Damaged probe Change probe
Incorrect Radionuclide selected Select appropriate radionuclide
Return for service if condition
persists
Unexpected low readings Incorrect Radionuclide selected Select appropriate Radionuclide
Damaged probe Change probe
Return for service if condition
persists
Erratic readings or no counts Damaged probe Return for service if condition
persists
Sound does not vary with count rate Volume turned down Turn volume up
Mute button is on Turn mute off
Wrong count range is active Lower count range
Return for service if condition
persists

DIN: 00-1393, Rev. A Page 28 of 34

 neoprobe® GDS Operation Manual

Questions
Call Neoprobe Corporation at 800-793-0079 US or +1 614-793-7500.
Service Policy
New Product Warranty Service
• Call Neoprobe Corporation at 614-793-7500 or 800-793-0079 for authorization to return products to Company.
Provide model, serial or lot numbers of defective product, technical description of defect or malfunction, no-
charge purchase order number, and your shipping and billing address. Also obtain return merchandise
authorization (RMA) number from Neoprobe.
Out-of-Warranty Service
• Call Neoprobe Corporation +1 614-793-7500 or 800-793-0079 (US only) for authorization to return product to
Company. Provide model, serial or lot number of defective product, technical description of defect or
malfunction, billable purchase order number to cover Company’s estimate of repair cost, and shipping and billing
address for Buyer. Also obtain return merchandise authorization (RMA) number from Neoprobe.
Return product in original packing and Label packaging with RMA number. Shipment to Company is at Buyer’s
expense. Repaired or replacement equipment is shipped C.I.P. from Company’s plant. Reported problems or defects
not verified by Neoprobe are subject to additional charge(s).
Repair of product is warranted for 90 days from date of shipment to Buyer. Limited warranty applies only to repaired
defective product and does not apply to product when no defect was found.
Neoprobe Corporation uses recyclable products and materials when possible. Follow all local, state and/or
international laws and regulations for proper disposal of components, parts or accessories. Contact Neoprobe
Corporation +1-614-793-7500 if you cannot find a convenient means of disposal.

New Product Warranty

New products manufactured by Company are warranted against defects in workmanship and material for period of
one year (period) from date of shipment by Company to Buyer, subject to limitations hereinafter set forth. Should
any defects be found and reported during period, Company, at its option, will repair or replace such defective product
provided Buyer ships defective product to Company, transportation charges prepaid, with notice of defect and
certification that product was properly installed, maintained, and operated within limits of rated and normal usage.
Repaired or replacement product is shipped C.I.P. from Company’s plant to Buyer. Terms of product warranty do not
extend to product or part which, under normal usage, has expected useful life of less than one year.
Warranty shall not apply to product where installation or servicing of product is improper, or where product is
operated outside rated load capacity, or included in accident, tampering, alteration, or abuse. THE COMPANY’S
LIABILITY UNDER THIS WARRANTY OR ANY OTHER WARRANTY WHETHER EXPRESS OR IMPLIED
IN LAW OR FACT IS LIMITED TO REPAIR OR REPLACEMENT OF DEFECTIVE MATERIAL AND
WORKMANSHIP, AND IN NO EVENT SHALL COMPANY BE LIABLE FOR CONSEQUENTIAL OR
INDIRECT DAMAGES.

DIN: 00-1393, Rev. A Page 29 of 34

 neoprobe® GDS Operation Manual

WARRANTY CONTAINS ENTIRE OBLIGATION OF NEOPROBE CORPORATION AND NOT OTHER

WARRANTIES INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTIES EXPRESSED, IMPLIED, OR
STATUTORY ARE GIVEN.

9. SYSTEM SPECIFICATIONS
Model 2300 Console
PARAMETER SPECIFICATIONS
Operating power AC Line Power 100-240 VAC (50-60Hz)
26 watts, nominal
Power consumption
38 watts, maximum (at high volume)
Heat output Negligible (10 watts, nominal)
Audio 70 dB Sound Pressure Level at 1 meter
Energy Range 12-600 keV internal windowing resolution
Maximum count range 99,999 cps
Length 25.4 cm (10 in.)
Width 30.5 cm (12 in.)
Height 22.9 cm (9 in.)
Weight (approximate) 2.5 kg (5.6 lb.)
Operating temperature range 10° to 40° C (50° to 104° F)
+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 1060 hPa (7.3 psia to 15.4 psia)

Operational Displays and Software

Displayed parameters: Radioactive counts
Additional display: Threshold value
Hardware
System Controls: Function Selector, Buttons
Interconnects: Custom cables
Display: LED elements
NOTE: Disconnect from power source and store product in a clean environmentally controlled area.
NOTE: Use only power cords of 18 gauge wire and hospital grade plugs in compliance to one or more of these
agency approvals:
100VAC, 50- 60 Hz DENTORI, SVT
125VAC, 60 Hz CSA, UL, SJT
ASTA, CEBEC, CCEE, DEMKO, FMKO, IMQ, KEMA, LCIE,
250VAC, 50 Hz
NEMKO, OVE, SECV, SEMKO, SEV, VDE

IEC Classifications
Electrical shock protection - Classification Class I
Electrical shock protection - Degree Type CF Applied Part

DIN: 00-1393, Rev. A Page 30 of 34

 neoprobe® GDS Operation Manual

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 IPX8, see individual probe instructions for use
Ingress of fluids - console Ordinary equipment

Electromagnetic Compatibility Declaration

EMC Requirements in Accordance with EN 60601-1-2:2003
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.
Emission test Compliance Electromagnetic environment - guidance
RF Emissions Group 2 The Model 2300 Gamma Detection System must emit electromagnetic energy in
CISPR 11 order to perform its intended function. All emissions comply with EN 61000-4-3,
FCC and IC regulations. Nearby electronic equipment may be affected if the
Model 2300 is operated within 11.7 cm or 4.6" of equipment marked with the
following symbol:

RF emissions Class B The Model 2300 Gamma Detection System is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly connected to the public low-
Harmonic emissions Not applicable voltage power supply network that supplies buildings used for domestic purposes.
IEC 61000-3-2
Voltage Complies
fluctuations/flicker
emissions
IEC 61000-3-3
Table 202
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
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.
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile. If
discharge (ESD) ±8 kV air ±8 kV air floors are covered with synthetic material, the relative
61000-4-2 humidity should be at least 30%.
Electrostatic fast ±2 kV for power supply ±2 kV for power supply Mains power quality should be that of a typical
transient/burst lines lines commercial or hospital environment.
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output
lines lines
Surge ±1 kV differential mode ±1 kV differential mode Mains power quality should be that of a typical
IEC 60001-4-5 ±2 kV common mode ±2 kV common mode commercial or hospital environment.
Voltage dips, <5 % UT <5 % UT Mains power quality should be that of a typical
short interruptions (>95 % dip in UT for 0.5 (>95 % dip in UT for 0.5 commercial or hospital environment. If the user of the
and voltage cycle) cycle) Model 2300 Gamma Detection System requires
variations on continued operation during power mains interruptions,
power supply <40 % UT <40 % UT it is recommended that the Model 2300 Gamma
input lines (>95 % dip in UT for 5 (>95 % dip in UT for 5 Detection System be powered from an uninterruptible
IEC 60001-4-11 cycles) cycles) power supply or a battery.

DIN: 00-1393, Rev. A Page 31 of 34

 neoprobe® GDS Operation Manual

<70 % UT <70 % UT
(>30 % dip in UT for 25 (>30 % dip in UT for 25 NOTE: UT is the AC mains voltage prior to
cycles) cycles) application of the test level.

<5 % UT <5 % UT
(>95 % dip in UT for 5 (>95 % dip in UT for 5
sec) sec)
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at levels
(50/60 Hz) characteristic of a typical location in a typical
magnetic field commercial or hospital environment.
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.
Immunity Test IEC 60601-1 test Compliance level Electromagnetic environment – guidance
level
Portable and mobile RF communications equipment should
be used no closer to any part of the Model 2300 Gamma
Detection System equipment, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Conducted RF 3 Vrms 3 Vrms Recommended separation distance
IEC 61000-4-6 d = 1.17 * √ P
Radiated RF 3 V/m 3 V/m Recommended separation distance
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz d = 1.17 * √ P (for 80 MHz to 800 GHz)
d = 2.33 * √ P (for 800 MHz to 2.5 GHz)
Where (P) is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and (d) is the recommended separation distance
in meters (m).
Field strength from fixed RF transmitters, as determined by
an electromagnetic survey, a should be less than the
compliance level in each frequency range b.
Interference may occur if the Model 2300 is operated within
11.7 cm or 4.6" of equipment marked with the following
symbol:

Note 1: at 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Model 2300 Gamma Detection System equipment is used exceeds the applicable RF
compliance level above, the Model 2300 Gamma Detection System equipment should be observed to verify normal operation. If abnormal performance is observed,

DIN: 00-1393, Rev. A Page 32 of 34

 neoprobe® GDS Operation Manual

additional measures may be necessary, such as reorienting or relocating the Model 2300 Gamma Detection System equipment.
b
Over the frequency range 150 KHZ to 80 MHz, field strength should be less than 3 V .

EMC Requirements in Accordance with EN 60601-1-2:2003

Table 206

Recommended separation distance between portable and mobile RF communications equipment and the Model 2300
Gamma Detection System equipment
The Model 2300 Gamma Detection System equipment is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Model 2300 Gamma Detection System equipment can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile communications equipment
(transmitters) and the Model 2300 Gamma Detection System equipment as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter
W 150KHz to 80MHz 80MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.17 * √ P d = 1.17 * √ P d = 2.33 * √ P
0.01 0.12m 0.12m 0.23m
0.1 0.37m 0.37m 0.74m
10 3.7m 3.7m 7.4m
100 12m 12m 23m
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where (P) is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800 MHz, the separation distance 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.

10. WARNINGS, CAUTIONS AND NOTES

Read this section before operating product.
DEFINITIONS:

or WARNING: Specific information identifies events when misuse or improper use of device
may cause harm to user or patient or could result in irreparable damage to device or
property.

CAUTION: Specific information identifies when misuse of equipment may cause malfunction or
produce incorrect readings.
NOTE: General information to explain or clarify proper operation of product.

Injury
Report injuries immediately to Neoprobe Corporation at 800-793-0079 or +1 614-793-793-7500 and leave product
undisturbed until authorized Neoprobe representative can inspect it.

DIN: 00-1393, Rev. A Page 33 of 34

 neoprobe® GDS Operation Manual

ELECTRICAL:
• Verify power cable is secure before each use.
• Inspect cables for damage before each use. Use of damaged cables may present an electrical shock hazard.
• Disconnect power cord from console to verify fuses. Only use specified rated fuses.
• Disconnect power cord from source and disconnect power cord from console before cleaning product.
Risk of Fire/Explosion
DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS OR EXPLOSIVE GASES.

WARNINGS:
• DO NOT GAMMA OR STEAM (AUTOCLAVE) STERILIZE ANY COMPONENT, PART, OR
ACCESSORY.
• Opening or tampering with product may cause damage; void warranty.
• Only properly trained personnel should operate product.
• Do not sterilize or immerse in liquid as permanent damage may result.
• Use of unauthorized accessories will void warranty; user assumes all liability.

CAUTIONS:
• System components should not touch other electrical equipment during use.
• 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.
• Electrocautery and electrosurgical devices can interfere with system operation. Isolate system away from
electrocautery 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 radiation emissions; is not a ‘measuring device’; and does not
generate hazardous radiation.
• Contact your radiation safety officer for regulatory compliance and other requirements.

- END -

DIN: 00-1393, Rev. A Page 34 of 34