n eop r ob e®®
G a m m a Det ect ion Syst em (G DS)
O p er a t ion M a n u a l
Blu et oot h ®®
W ir eless T ech n ology
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.
© 2011 NEOPROBE CORPORATION. ALL RIGHTS RESERVED.
DIN: 00-1393, Rev. D
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. D
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. D
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. D
Page 5 of 36
neoprobe® GDS Operation Manual
Quick Start BLUETOOTH Wireless Technology Enabled Probe
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. D
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. D
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. D
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. D
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. D
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. D
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. D
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. D
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. D
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. D
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. D
/////
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. D
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. D
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. D
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. D
Page 20 of 36
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. Refer to individual
Cleaning and Sterilization Instruction for Use Documents on Manual CD (00-1432 or 00-1414) for detailed
instructions. See list of documents below:
Cleaning/Sterilization Method
Document #
•
Cleaning and Disinfection - probes, cables, connectors, & collimators
00-1548
•
STERRAD – (Sterilization - ASPUS (Johnson & Johnson) - probes, cables,
connectors, & collimators
00-1296
•
EO (Sterilization) - probes, cables, connectors, & collimators
00-1294
•
Flash Autoclave (Sterilization) – Collimators Only
00-1293
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. D
Page 21 of 36
neoprobe® GDS Operation Manual
Reprocessing of Console according to EN ISO 17664:2004
Manufacturer:
Method: Cleaning & Disinfection
Neoprobe Corporation
425 Metro Place North
Suite 300
Dublin, Ohio 43017-1367 US
Symbol:
Model 2300
Devices(s): Reusable control units comprising fixed assemblies (no moving parts); sold nonsterile.
WARNING:
Limitations on
reprocessing:
INSTRUCTIONS:
Point of use:
Containment &
Transportation:
Preparation for
cleaning:
Cleaning - Automated:
Cleaning: Manual
Disinfection:
Drying:
Maintenance:
Inspection & Function
Testing:
Packaging:
Sterilization:
Storage:
Additional Information:
Manufacturer Contact:
WARNING: disconnect control unit from power source before cleaning to avoid
electrical shock.
Repeated processing has little effect on instrument. End of life is normally determined by
abrasion, wear and damage. DAMP WIPE ONLY.
Remove excess soil and surface contamination with disposable cloth/paper wipe.
No particular requirements. Recommend reprocessing instrument soon after surgical use.
WARNING: disconnect control unit from power source before cleaning to avoid
electrical shock.
Do not use automated cleaning. Clean by hand; cleaning instructions below.
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
No requirement
Air dry at room temperature
Do not use damaged instruments
All instruments: Visually inspect for damage or wear. Where instruments form part of a
larger assembly, check assembly with mating components.
No requirement
Console does not require sterilization
No requirement
Remove debris near power button and probe input connector. Do not allow moisture to
enter through display or other openings.
See troubleshooting section for telephone and address of local representative or telephone
(+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. D
Page 22 of 36
neoprobe® GDS Operation Manual
Reprocessing of Power Cord according to EN ISO 17664:2004
Manufacturer:
Method: Cleaning & Disinfection
Neoprobe Corporation
425 Metro Place North
Suite 300
Dublin, Ohio 43017-1367 US
Symbol:
Model 2009
Devices(s): Reusable power cords comprising fixed assemblies (no moving parts); sold nonsterile.
WARNING:
Limitations on
reprocessing:
INSTRUCTIONS:
Point of use:
Containment &
Transportation:
Preparation for
cleaning:
Cleaning - Automated:
Cleaning: Manual
Disinfection:
Drying:
Maintenance:
Inspection & Function
Testing:
Packaging:
Sterilization:
Storage:
Additional Information:
Manufacturer Contact:
WARNING: disconnect power cord from power source before cleaning to avoid
electrical shock.
Repeated processing has little effect on cable. End of life is normally determined by
abrasion, wear and damage due to use.
Remove excess soil and surface contamination with disposable cloth/paper wipe.
No particular requirements. Recommend reprocessing instrument soon after surgical use.
WARNING: disconnect power cord from power source before cleaning to avoid
electrical shock
Do not use automated cleaning. Clean by hand; cleaning instructions below.
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
No requirement
Air dry at room temperature
Do not use worn, cracked or damaged cable
All instruments: Visually inspect for damage or wear. Where cable forms part of a larger
assembly, check assembly with mating components.
No requirement
Power cord does not require sterilization
No requirement
Periodically perform safety test with equipment system to assure continued integrity of
power cord.
See troubleshooting section for telephone and address of local representative or telephone
(+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. D
Page 23 of 36
neoprobe® GDS Operation Manual
8. MAINTENANCE
Product must be serviced by competent service technicians or engineers. Preventative maintenance is limited to
external cleaning of console, fuse replacement and functional diagnostics. Probes, collimators and cables are sealed or
do not contain serviceable components and cannot be repaired.
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.
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
1.
2.
3.
Procedure
Remove fuse holder with flat blade screwdriver
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.
Reinstall fuse holder.
System Diagnostics
Visual Indicator Test Mode (VITM)
Verify visual indicators are operating properly:
Step
1
2
3
4
Procedure
Press and hold Dynamic/Binary Pitch
Mode Selection Button [4] press and
release Mute Button [16] to enter
Diagnostic Mode
Press and hold Dynamic/Binary Pitch
Mode Selection Button [4]. Press and
release Dynamic Pitch Range 100
Button to activate visual indicator test
mode (vitm).
Press and release Target Count Button
[11].
Press and release Background Count
Button [14].
DIN: 00-1393, Rev. D
Result
Background Count Readout [8]
displays message “diag ”.
LED components on top half of LED
screen are lit.
Note: LED components on bottom half
of LED screen are off.
Target Count Readout color changes
from green to amber.
LED components on bottom half of
LED screen are lit. Background Count
Readout displays message “vitm”.
Note: LED components on top half of
LED screen are off.
Page 24 of 36
diag
Vitm
Vitm
neoprobe® GDS Operation Manual
Step
5
Procedure
Diagnostic Mode: Press and hold
Dynamic/Binary Pitch Mode Selection
Button [4], press and release
Background Count Button [14].
6
Exit Diagnostic Mode - press and hold
Dynamic/Binary Pitch Mode Selection
Button [4], press and release Mute
Button [16].
Input Controls Test Mode (ICTM)
Result
A double Stop Beep sounds and
Background Count Readout displays
“diag”.
diag
Exits Diagnostic Mode.
Verify input controls are operating properly:
Step
1
2
3
4
5
Procedure
Result
Press and hold down Binary
Pitch/Dynamic Pitch mode selection
button and press Mute button - release all buttons at once
Background count displays “diag”.
Enter Input Controls Test Mode
(ictm) - Press and hold down
Binary Pitch/Dynamic Pitch mode
selection button and press Dynamic
Pitch range 1000 button - - release all
buttons at once
Background count displays “ictm”.
Press and release buttons in order
listed below:
Continuous tone sounds and message
is displayed in Target Count Readout
[7]:
diag
ictm
•
Radionuclide
•
Target count
•
Background count
•
Mute
•
Binary pitch/dynamic pitch
mode
Bu4
•
Count range 100
•
Count range 1,000
•
Count range 10,000
•
Count range 50,000
Bu5
Bu6
Bu7
Bu8
Bu0
Bu1
Bu2
Bu3
To exit ITCM Mode, press and hold
Binary Pitch/Dynamic Pitch selection
button, and while holding it down,
press and release Background Count
button
A double chime tone is heard and
Background Count display displays
“diag”.
Exit Base Diagnostic Mode - press
and hold down Binary Pitch/Dynamic
Pitch mode selection button and press
Exit Diagnostic Mode
DIN: 00-1393, Rev. D
Page 25 of 36
diag
neoprobe® GDS Operation Manual
Step
Procedure
Mute button - release all buttons at
same time
Result
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: Readings will differ between probe types. See battery housing of Wireless Probes for “
” marking.
” or “
1) Wireless Probe with “
” marking, or “
” with software version 5.02 or earlierPhoto 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 (or use P-405 Check Source Fixture). 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, orWireless Probe with“
” and software version 6.01 or later Photo Peak Efficiency
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 (or use P-405 Check Source Fixture). 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. Record this value. 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. D
Page 26 of 36
neoprobe® GDS Operation Manual
5. Press and hold Target Count Button to perform a 10 second count. Record this value. Divide 57Co 10-second
count by open energy window 10-second count. Results should be greater than 50%.
6. 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
needed. 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
DIN: 00-1393, Rev. D
POSSIBLE CAUSE
Page 27 of 36
CORRECTIVE ACTION
neoprobe® GDS Operation Manual
SYMPTOM
Console does not turn on
Probe with BLUETOOTH wireless
technology: Unit displays “no linc”
on power up
Unit displays “Lo Batt”
POSSIBLE CAUSE
Power cord not connected
Power button is damaged
Faulty fuse
BLUETOOTH not active
Battery is too low to operate probe
For cabled probe: Unit displays “error no Probe or cable not connected
probe” on power up.
Damaged cable
Damaged probe
Unit displays “Error 2” through
“error 6”
Internal error codes
Intermittent and unusually high readings
Intermittent electrical interference
(e.g., electrosurgical unit, X-ray,
etc.)
Damaged probe
Unexpected high readings (continuous)
Contaminated probe or collimator
Background too high
Damaged probe
Incorrect Radionuclide selected
Unexpected low readings
Incorrect Radionuclide selected
Damaged probe
Erratic readings or no counts
Damaged probe
Sound does not vary with count rate
Volume turned down
Mute button is on
Wrong count range is active
DIN: 00-1393, Rev. D
Page 28 of 36
CORRECTIVE ACTION
Connect power cord
Return for service
Replace fuse
Activate probe
Replace probe battery and
reactivate
Return probe for service
Replace battery
Return for service if condition persists
Connect probe or cable
Replace cable
Replace probe
Return for service if condition persists
Cycle power to unit
Return for service if condition
persists
Track down source of interference
Turn off offending sources (if
possible)
Change probe
Return for service if condition
persists
Decontaminate probe and
collimator
Shield background source
Change probe
Select appropriate radionuclide
Return for service if condition
persists
Select appropriate Radionuclide
Change probe
Return for service if condition
persists
Return for service if condition
persists
Turn volume up
Turn mute off
Lower count range
Return for service if condition
persists
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, nocharge 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. D
Page 29 of 36
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
Operating power
Heat output
Audio
Energy Range
Maximum count range
Length
Width
Height
Weight (approximate)
Operating temperature range
SPECIFICATIONS
AC Line Power 100-240 VAC (50-60Hz)
26 watts, nominal
38 watts, maximum (at high volume)
Negligible (10 watts, nominal)
70 dB Sound Pressure Level at 1 meter
12-600 keV internal windowing resolution
99,999 cps
25.4 cm (10 in.)
30.5 cm (12 in.)
22.9 cm (9 in.)
2.5 kg (5.6 lb.)
10° to 40° C (50° to 104° F)
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)
Power consumption
+60°C
-20°C
Operational Displays and Software
Displayed parameters:
Additional display:
Hardware
System Controls:
Interconnects:
Display:
Radioactive counts
Threshold value
Function Selector, Buttons
Custom cables
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
125VAC, 60 Hz
250VAC, 50 Hz
DENTORI, SVT
CSA, UL, SJT
ASTA, CEBEC, CCEE, DEMKO, FMKO, IMQ, KEMA, LCIE,
NEMKO, OVE, SECV, SEMKO, SEV, VDE
IEC Classifications [EN 60601-1]
Electrical shock protection - Classification
Electrical shock protection - Degree
DIN: 00-1393, Rev. D
Class I
Type CF Applied Part
Page 30 of 36
neoprobe® GDS Operation Manual
Flammable Anesthetics
Operating mode
Ingress of fluids - probes
Ingress of fluids - console
DIN: 00-1393, Rev. D
Equipment not suitable for use in presence of
FLAMMABLE ANESTHETIC MIXTURE WITH
AIR OR WITH OXYGEN OR NITROUS OXIDE
Continuous
IPX8, see individual probe instructions for use
Ordinary equipment
Page 31 of 36
neoprobe® GDS Operation Manual
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
The Model 2300 Gamma Detection System must emit electromagnetic energy in
RF Emissions
Group 2
order to perform its intended function. All emissions comply with EN 61000-4-3,
CISPR 11
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
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Class B
Not applicable
The Model 2300 Gamma Detection System is suitable for use in all establishments,
including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
Complies
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
(>95 % dip in UT for 5
(>95 % dip in UT for 5
input lines
Detection System be powered from an uninterruptible
IEC 60001-4-11
cycles)
cycles)
power supply or a battery.
DIN: 00-1393, Rev. D
<70 % UT
(>30 % dip in UT for 25
cycles)
<70 % UT
(>30 % dip in UT for 25
cycles)
<5 % UT
(>95 % dip in UT for 5
sec)
<5 % UT
(>95 % dip in UT for 5
sec)
Page 32 of 36
NOTE: UT is the AC mains voltage prior to
application of the test level.
neoprobe® GDS Operation Manual
Power frequency
(50/60 Hz)
magnetic field
IEC61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
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
level
Compliance level
Electromagnetic environment – guidance
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
IEC 61000-4-6
3 Vrms
3 Vrms
Recommended separation distance
d = 1.17 * √ P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
80 MHz to 2.5 GHz
Recommended separation distance
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,
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 .
DIN: 00-1393, Rev. D
Page 33 of 36
neoprobe® GDS Operation Manual
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
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150KHz to 80MHz
d = 1.17 * √ P
80MHz to 800 MHz
d = 1.17 * √ P
800 MHz to 2.5 GHz
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.
Declaration of Conformance:
Hereby, Neoprobe Corporation declares that this “Wireless Probe” is in compliance with the essential requirements and other relevant
provisions of Directive 1999/5/EC.
Česky
[Czech]
Neoprobe Corporation tímto prohlašuje, že tento “Wireless Probe” je ve shodě se základními požadavky a dalšími
příslušnými ustanoveními směrnice 1999/5/ES.
Dansk
[Danish]
Undertegnede Neoprobe Corporation erklærer herved, at følgende udstyr “Wireless Probe” overholder de væsentlige
krav og øvrige relevante krav i direktiv 1999/5/EF.
Deutsch
[German]
Hiermit erklärt Neoprobe Corporation, dass sich das Gerät “Wireless Probe” in Übereinstimmung mit den
grundlegenden Anforderungen und den übrigen einschlägigen Bestimmungen der Richtlinie 1999/5/EG befindet.
Eesti
[Estonian]
Käesolevaga kinnitab Neoprobe Corporation seadme “Wireless Probe” vastavust direktiivi 1999/5/EÜ põhinõuetele
ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele.
Español
[Spanish]
Por medio de la presente Neoprobe Corporation declara que el “Wireless Probe” cumple con los requisitos esenciales
y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 1999/5/CE.
Ελληνική
[Greek]
ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Neoprobe Corporation ΔΗΛΩΝΕΙ ΟΤΙ “Wireless Probe” ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ
ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999/5/ΕΚ.
DIN: 00-1393, Rev. D
Page 34 of 36
neoprobe® GDS Operation Manual
Français
[French]
Par la présente Neoprobe Corporation déclare que l'appareil “Wireless Probe” est conforme aux exigences essentielles
et aux autres dispositions pertinentes de la directive 1999/5/CE.
Italiano
[Italian]
Con la presente Neoprobe Corporation dichiara che questo “Wireless Probe” è conforme ai requisiti essenziali ed alle
altre disposizioni pertinenti stabilite dalla direttiva 1999/5/CE.
Latviski
[Latvian]
Ar šo Neoprobe Corporation deklarē, ka “Wireless Probe” atbilst Direktīvas 1999/5/EK būtiskajām prasībām un
citiem ar to saistītajiem noteikumiem.
Lietuvių
[Lithuanian]
Šiuo Neoprobe Corporation deklaruoja, kad šis “Wireless Probe” atitinka esminius reikalavimus ir kitas 1999/5/EB
Direktyvos nuostatas.
Hierbij verklaart Neoprobe Corporation dat het toestel “Wireless Probe” in overeenstemming is met de essentiële
eisen en de andere relevante bepalingen van richtlijn 1999/5/EG.
Nederlands
[Dutch]
Malti
[Maltese]
Hawnhekk, Neoprobe Corporation, jiddikjara li dan “Wireless Probe” jikkonforma mal-ħtiġijiet essenzjali u ma
provvedimenti oħrajn relevanti li hemm fid-Dirrettiva 1999/5/EC.
Magyar
[Hungarian]
Alulírott, Neoprobe Corporation nyilatkozom, hogy a “Wireless Probe” megfelel a vonatkozó alapvetõ
követelményeknek és az 1999/5/EC irányelv egyéb elõírásainak.
Polski
[Polish]
Niniejszym Neoprobe Corporation oświadcza, że “Wireless Probe” jest zgodny z zasadniczymi wymogami oraz
pozostałymi stosownymi postanowieniami Dyrektywy 1999/5/EC.
Português
[Portuguese]
Neoprobe Corporation declara que este “Wireless Probe” está conforme com os requisitos essenciais e outras
disposições da Directiva 1999/5/CE.
Slovensko
[Slovenian]
Neoprobe Corporation izjavlja, da je ta “Wireless Probe” v skladu z bistvenimi zahtevami in ostalimi relevantnimi
določili direktive 1999/5/ES.
Slovensky
[Slovak]
Neoprobe Corporation týmto vyhlasuje, že “Wireless Probe” spĺňa základné požiadavky a všetky príslušné
ustanovenia Smernice 1999/5/ES.
Suomi
[Finnish]
Neoprobe Corporation vakuuttaa täten että “Wireless Probe” tyyppinen laite on direktiivin 1999/5/EY oleellisten
vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen.
Svenska
[Swedish]
Härmed intygar Neoprobe Corporation att denna “Wireless Probe” står I överensstämmelse med de väsentliga
egenskapskrav och övriga relevanta bestämmelser som framgår av direktiv 1999/5/EG.
Íslenska
[Icelandic]
Hér með lýsir Neoprobe Corporation yfir því að “Wireless Probe” er í samræmi við grunnkröfur og aðrar kröfur, sem
gerðar eru í tilskipun 1999/5/EC.
Norsk
[Norwegian]
Neoprobe Corporation erklærer herved at utstyret “Wireless Probe” er i samsvar med de grunnleggende krav og
øvrige relevante krav i direktiv 1999/5/EF.
10. WARNINGS, CAUTIONS AND NOTES
Read this section before operating product.
DEFINITIONS:
or
DIN: 00-1393, Rev. D
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.
Page 35 of 36
neoprobe® GDS Operation Manual
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.
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. D
Page 36 of 36