Devicor Neoprobe neo2000 User manual

TM
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“neo2000®”work mark and the “neoprobe”logo are registered trademarks of Devicor Medical Products,
Inc.
"Bluetooth®" word mark and logos are owned by Bluetooth SIG, Inc. and any use by Devicor or its
representatives is under license.
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati, OH 45241 USA
Tel: [phone]
Fax: [phone]
e-mail: [email protected]
URL: www.mammotome.com
Made in U.S.A.
This document is sole property of Devicor Medical Products, Inc.. Any duplication, reproduction, or
transmission of document or any of its content to unauthorized parties without prior written permission of
Devicor Medical Products, Inc. is prohibited.
© 2012 DEVICOR MEDICAL PRODUCTS, INC. ALL RIGHTS RESERVED.
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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. AUTHORIZED ACCESSORIES.............................................................................................................................................................36
11. WARNINGS, CAUTIONS AND NOTES................................................................................................................................................37
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1. INTRODUCTION
The neoprobeTM Gamma Detection System console, with BLUETOOTH®wireless technology, detects presence of
gamma rays emitted from radioactive isotopes in body organs or tissue. System provides an increasing or decreasing
sound and visual indicator (Count Bar) that vary in pitch as level of gamma radioactivity increases or decreases.
Intended use
Electronic medical device for detecting and quantifying gamma radiation
Indications
Used externally and intraoperatively to detect radioactive emissions from body tissues
or organs where radiopharmaceuticals are administered. There are no known
contraindications in the application or use of the device.
Detecting gamma radiation with a hand-held probe is based on inverse square law of physics which allows detection
of radiation emitted from a small source. Placing probe close to radioactive site increases number of counts detected
and localization occurs. Excision of lesion is then performed using standard surgical technique.
Gamma detection protocols that control use of large, highly collimated scintillation detectors may require
modifications when used in conjunction with hand-held gamma probe.
NOTE: User is responsible to determine suitability of product for use in any surgical procedure. Contact Devicor
regarding questions for intended use of product.
CAUTION: United States Federal law restricts this device to sale by or on order of a physician.
CAUTION: Read Warnings, Cautions and Notes section before operating product.
CAUTION: Clean and sterilize probe and collimator before use; use sterile surgical probe cover if not
sterilized.
NOTE: Save packing material to return product for service.
NOTE: Accessories packaged separately from control unit (console) during shipment. Verify you have received all
items ordered.
Visual Indicators and Controls
Visual information and data viewed on LED screen. Visual information displayed in Liquid Crystal fonts and
translated in this manual; example - “No Linc” is displayed as “no linc”“on LED screen.
FRONT REAR
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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
1
Connect Model 2009 power cord to console and into AC power source. DO NOT USE EXTENSION
CORD. Maintain proper clearance for access to AC Power Inlet Connector for disconnection from
mains power.
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.
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Quick Start BLUETOOTH®Wireless Technology Enabled Probe
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
4
Press and hold Target Count Button [11] on console; displays “disc”; release Target Count
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.
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Quick Start Probe with cable
Procedureforreusablecableddetector probes(Model1017orModel 2059).
Step
Prepare
Prepareconsoleforoperationas statedabove:
1
Ifneeded,attach external collimatortoprobe
2
Usingaseptictechnique(withoutsterilesurgicaldrape)connectprobe toModel2024orModel2060probecable;
alignreddotonprobetoreddotoncableconnector; gentlyinsertcableinto ProbeInputConnector;ifusingasterile
surgicaldrape -placeprobe indrapenow
3
Alignarrowoncableconnectorand grooveinProbeInputConnector[5]onconsole; gentlyinsertcableconnector
neoprobeTM systemisnowreadyforuse
NOTE: Model 1013collimatoriscompatiblewithModel 1100,1101,and 1017probes.
NOTE: Model101714mmprobeconnector hasfourpins; Model205911mmprobeconnectorhassixpins.
NOTE: Youhearaudibleclickas youinsertcableconnectorintoProbeInputConnector.Connectorispush/pullcomponent-DO
NOTTWIST/TURNCABLECONNECTOR, damagetoconnectors andconnectorpinsmay 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
above
“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
Select Dynamic Pitch
count range different
from 0-100
Press and release
Dynamic Pitch Count
Range selection buttons
[18].
Indicator for desired Count Range is lit [18];
Background Count Readout [ 8] changes to default
for selected Count Range
Select a radionuclide
different from 99mTC.
Press and release
Radionuclide Selection
button [21] until desired
radionuclide is lit
Radionuclide Selection Indicator [ 3] is lit
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To….
Perform following…..
And this occurs……
Set Dynamic Pitch
audible tone.
Turn Volume [15]
counterclockwise
Sound is lowest
Turn Volume [15]
clockwise
Sound is highest
Set Dynamic Pitch sound
on or off.
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
Default Background Count
100
2
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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
maximum value of selected Count Range
Example: 800 is displayed for 1,000 Count Range
Background Count is less than or equal to 2% of
maximum value of selected Count Range
Example: 20 is displayed for 1,000 Count Range
Background Count button [14] is pressed during
background count
Ratio is not calculated during Target Count. A Start
Beep sounds and Background Count restarts
Background Count button 14] is pressed while
Background Count value is displayed
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.
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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
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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.
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Ten Second Target Count Value
Note: Value displayed is not counts per second. Value is total counts obtained in 10 seconds.
10 second Target Count [7] displayed for 5 seconds; Target Count Symbol [10] flashes amber.
“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
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Operational Note
Events that may occur during product use:
If….
Then this occurs…..
Target Count Button [11] is pressed while
Target Count is calculated
Target Count restarts
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 or 10 Second Count is
displayed
Target Count function returns to Dynamic
Pitch Mode and displays Count Rate data
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 20 seconds
Operation of BLUETOOTH®: message
“no linc” indicates problem with probe,
console or serial port adapter. See
troubleshooting instructions below.
Foracabledprobe:Ifthereisnoprobeor
cable attached message “errornoProbe” is
displayed.Seetroubleshootinginstructions
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
Press and release Radionuclide Selection
Desired radionuclide is lit
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To……
Perform following……
And this occurs….
radionuclide from
99mTc
Button [21] to select radionuclide
Adjust Binary
Pitch sound
Turn Volume Adjustment
counterclockwise
Sound is lowest
Turn Volume Adjustment
clockwise
Sound is highest
Turn Binary Pitch
sound on/off
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
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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.
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Ratio Readout [9] is displayed. Ratio Symbol [12] flashes.
After 5 seconds, system returns to Binary Pitch Mode displaying last calculated Background Count data [8]
and current Count Rate data [7].
TARGET COUNT; 6-SECOND OPTION
Operation Note
Events that may occur during product use:
If…..
Then this occurs…..
Target Count Button [11] is activated
(press and hold) while a Target Count is
calculated
Start Beep sounds and starts new Target
Count
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
displayed
Starts new Target Count
Calculated Ratio Readout data is greater
than 99.9
Overflow symbol “///”appears in Ratio
Readout (9)
///
Performing a Target Check (2-Second Option)
Perform a 2-second Target Check to obtain 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.
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Count Bar [6] fills from bottom to top as data is collected for 2 seconds.
Target Check Display
Target Check data is displayed in Target Count Readout [7] for 5 seconds; Target Count Symbol [10] flashes
green.
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
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
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ITEM
DESCRIPTION
Check data when these functions are not active.
Background Count
In Dynamic Pitch Mode: a baseline value in counts per second stored in console and used as
threshold to activate sound
In Binary Pitch Mode: baseline value in counts per second stored in console for comparison to
Target Count determines if difference in radioactivity between Background Tissue and Target
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
-20°C
Storage and Transit Temperature
Storage and Transit Pressure
Storage and Transit Humidity
Type CF
Warning: Follow instructions for use
CAUTION: consult accompanying documents
Standby/ON
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neoprobeTM GDS Operation Manual
AW-000639 Page 19 of 38
ITEM
DESCRIPTION
CAUTION: non-sterile
WARNING: hazardous voltage or shock hazard present; follow instructions and warnings
Devicor uses recyclable materials wherever possible. There are materials in our
product that do contain risk associated with Disposal. If the need arises that
components, parts, accessories or devices at end of life need to be disposed of, we
recommend that you comply with local, state and/or international laws and
regulations for your country or area.
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
Principal
Photo peak Energy
(keV)
Physical Half-Life
Select this Radionuclide
Indicator
Iodine-125
27-35, Te X-rays
60 days
125I
Cobalt-57
122
270 days
57Co
Technetium-
99m
140
6.02 hrs.
99mTc
Indium-111
171/245
2.83 days
111In
Iodine-131
364
8.07 days
131I
Flourine-18
511
110 min.
18F
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
111In 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.
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neoprobeTM GDS Operation Manual
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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 9999mTclabeled
pyrophosphate for muscle infarction, may require investigational drug status for this application.
Perfusion of anastomosis-assessment of compromised blood flow
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
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork
PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012