Devicor Neoprobe neo2000 Operation Manual

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

Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 USA Tel: 1-877-926-2666 Fax: 1-888-260-6362 e-mail: customerservice@mammotome.com URL: www.mammotome.com

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neoprobeTM GDS Operation Manual

“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.

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.

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Made in U.S.A.

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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

neoprobeTM GDS Operation Manual

TABLE OF CONTENTS

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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.

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neoprobeTM GDS Operation Manual

1. INTRODUCTION

The 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.

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

Step

Start product

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.

Press and release Standby/On button

Console powers on; displays software version; and operates in Dynamic Pitch Mode

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neoprobeTM GDS Operation Manual

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

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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Step

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

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Quick Start BLUETOOTH® Wireless Technology Enabled Probe

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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Step

Prepare

Prepare console for operation as stated above:

If needed, attach external collimator to probe

Using aseptic technique (without sterile surgical drape) connect probe to Model 2024 or Model 2060 probe cable; 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

neoprobeTM system is now ready for use

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 (

99m

TC), 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

99m

TC.

Press and release Radionuclide Selection button [21] until desired radionuclide is lit

Radionuclide Selection Indicator [ 3] is lit

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Quick Start Probe with cable

Procedure for reusable cabled detector probes (Model 1017 or Model 2059).

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.

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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

Count Range

Default Background Count

100

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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.

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Count Range

Default Background Count

1,000

10,000

200

50,000

1000

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

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Operational Notes

Events that may occur during product use:

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

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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.

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AUTORANGE

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]

////

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

99m

Tc, and

radionuclide symbol is lit

Select different

Press and release Radionuclide Selection

Desired radionuclide is lit

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Operational Note

Events that may occur during product use:

4. BINARY PITCH MODE (OPTION)

Binary Pitch Mode sound tells physician when radioactivity is significantly above Background Count of nonradioactive area.

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To……

Perform following……

And this occurs….

radionuclide from

99m

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

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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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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

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Operational Note

Events that may occur during product use:

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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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)

///

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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:

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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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

Step

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

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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 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:

System Shutdown

Shut down system and prepare for reuse.

5. TERMINOLOGY AND SYMBOLS

Terms, symbols and graphics used in this manual.

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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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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.

Radionuclide

Principal

Photo peak Energy

(keV)

Physical Half-Life

Select this Radionuclide

Indicator

 Iodine-125

27-35, Te X-rays

60 days

125

 Cobalt-57

122

270 days

 Technetium-

99m

140

6.02 hrs.

99m

 Indium-111

171/245

2.83 days

111

 Iodine-131

364

8.07 days

131

 Flourine-18

511

110 min.

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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.

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

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

99m

Tc; 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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I or

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Minimally invasive radioguided parathyroidectomy

A preoperative

99m

Tc -Sestamibi scan may be used on patients with primary hyperparathyroidism to localize target parathyroid adenoma and enable limited exploration as an alternative to complete bilateral surgical exploration. Hand-held gamma probes may be useful in assisting surgeons in intraoperative localization of target adenomas. Gamma probes can be used to detect and localize increased uptake of

99m

Tc -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 means of determining if gut is reperfused. Other tracers, such as

99m

Tc labeled DTPA for perfusion or

99m

Tc labeled red blood cells as a

9999mTc

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

99m

Tc 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

99m

Tc 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.

labeled

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

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Cleaning/Sterilization Method

 Cleaning and Disinfection of probes, cables and collimators according to EN ISO 17664:2004

 STERRAD® SYSTEM Reprocessing of probes, cables and collimators according to EN ISO

17664:2004

 Ethylene Oxide (EO) Reprocessing of probes, cables and collimators according to EN ISO

17664:2004

 Autoclave Reprocessing of collimators according to EN ISO 17664:2004

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 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  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 included with product for detailed instructions. See list of documents below:

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.

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

Manufacturer:

Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 USA

Method: Cleaning & Disinfection Symbol:

Model 2300

WARNING:

WARNING: disconnect control unit from power source before cleaning to avoid

electrical shock.

Limitations on reprocessing:

Repeated processing has little effect on instrument. End of life is normally determined by abrasion, wear and damage. DAMP WIPE ONLY.

INSTRUCTIONS:

Point of use:

Remove excess soil and surface contamination with disposable cloth/paper wipe.

Containment & Transportation:

No particular requirements. Recommend reprocessing instrument soon after surgical use.

Preparation for cleaning:

WARNING: disconnect control unit from power source before cleaning to avoid

electrical shock.

Cleaning - Automated:

Do not use automated cleaning. Clean by hand; cleaning instructions below.

Cleaning: Manual

Equipment: mild detergent, clean gauze pad or lint free cloth, and clean soft brush.

Method:

1. Dampen cloth with mild detergent and wipe excess soil from surface

2. Clean air flow vents with dry brush

3. Visually inspect for cleanliness

4. Repeat steps 1 to 3 until visually clean.

5. Allow to dry in room air

Disinfection:

No requirement

Drying:

Air dry at room temperature

Maintenance:

Do not use damaged instruments

Inspection & Function Testing:

All instruments: Visually inspect for damage or wear. Where instruments form part of a larger assembly, check assembly with mating components.

Packaging:

No requirement

Sterilization:

Console does not require sterilization

Storage:

No requirement

Additional Information:

Remove debris near power button and probe input connector. Do not allow moisture to enter through display or other openings.

Manufacturer Contact:

See troubleshooting section for telephone and address of local representative or telephone

1-877-926-2666.

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Reprocessing of Console according to EN ISO 17664:2004

Devices(s): Reusable control units comprising fixed assemblies (no moving parts); sold nonsterile.

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.

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

Manufacturer:

Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor

Cincinnati, OH 45241-2378 USA

Method: Cleaning & Disinfection Symbol:

Model 2009

WARNING:

WARNING: disconnect power cord from power source before cleaning to avoid

electrical shock.

Limitations on reprocessing:

Repeated processing has little effect on cable. End of life is normally determined by abrasion, wear and damage due to use.

INSTRUCTIONS:

Point of use:

Remove excess soil and surface contamination with disposable cloth/paper wipe.

Containment & Transportation:

No particular requirements. Recommend reprocessing instrument soon after surgical use.

Preparation for cleaning:

WARNING: disconnect power cord from power source before cleaning to avoid

electrical shock

Cleaning - Automated:

Do not use automated cleaning. Clean by hand; cleaning instructions below.

Cleaning: Manual

Equipment: mild detergent and lint free cloth.

Method:

1. Dampen cloth with mild detergent and wipe excess soil from surface

2. Visually inspect for cleanliness

3. Repeat steps 1 to 3 until visually clean.

4. Allow to dry in room air

Disinfection:

No requirement

Drying:

Air dry at room temperature

Maintenance:

Do not use worn, cracked or damaged cable

Inspection & Function Testing:

All instruments: Visually inspect for damage or wear. Where cable forms part of a larger assembly, check assembly with mating components.

Packaging:

No requirement

Sterilization:

Power cord does not require sterilization

Storage:

No requirement

Additional Information:

Periodically perform safety test with equipment system to assure continued integrity of power cord.

Manufacturer Contact:

See troubleshooting section for telephone and address of local representative or telephone

1-877-926-2666.

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Reprocessing of Power Cord according to EN ISO 17664:2004

Devices(s): Reusable power cords comprising fixed assemblies (no moving parts); sold nonsterile.

NOTE: Instructions provided above are validated by medical device manufacturer as being capable of preparing a

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

Step

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.

Step

Procedure

Result

Press and hold Dynamic/Binary Pitch Mode Selection Button [4] press and release Mute Button [16] to enter Diagnostic Mode

Background Count Readout [8]

displays message “diag”.

diag

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).

LED components on top half of LED screen are lit. Note: LED components on bottom half of LED screen are off.

Vitm

Press and release Target Count Button [11].

Target Count Readout color changes from green to amber.

Press and release Background Count Button [14].

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.

Vitm

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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.

System Diagnostics

Visual Indicator Test Mode (VITM)

Verify visual indicators are operating properly:

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Step

Procedure

Result

Diagnostic Mode: Press and hold Dynamic/Binary Pitch Mode Selection Button [4], press and release Background Count Button [14].

A double Stop Beep sounds and Background Count Readout displays

“diag”.

diag

Exit Diagnostic Mode - press and hold Dynamic/Binary Pitch Mode Selection Button [4], press and release Mute Button [16].

Exits Diagnostic Mode.

Step

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”.

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”.

ictm

Press and release buttons in order listed below:

Continuous tone sounds and message is displayed in Target Count Readout [7]:

 Radionuclide

Bu0

 Target count

Bu1

 Background count

Bu2

 Mute

Bu3

 Binary pitch/dynamic pitch

mode

Bu4

 Count range 100

Bu5

 Count range 1,000

Bu6

 Count range 10,000

Bu7

 Count range 50,000

Bu8

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”.

diag

Exit Base Diagnostic Mode - press

Exit Diagnostic Mode

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Input Controls Test Mode (ICTM)

Verify input controls are operating properly:

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Step

Procedure

Result

and hold down Binary Pitch/Dynamic Pitch mode selection button and press Mute button - release all buttons at same time

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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 “ ” or “

” marking.

1) Wireless Probe with “ ” marking, or “ ” with software version 5.02 or earlier Photo Peak Efficiency

Only conduct this test with BLUETOOTH® wireless technology enabled probes.

1. Turn on and link a probe to console.

2. Set to Dynamic Pitch mode with

99m

Tc 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

99m

Tc 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

125

I to perform this procedure.

2) Cabled Probe, or Wireless 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.

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4. Press Radionuclide Selection button on back of unit to select an open energy window (select

125

I 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.)

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 Devicor Medical Products, Inc. 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 Devicor Medical Products, Inc. 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 Devicor Medical Products, Inc. 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.

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

SYMPTOM

POSSIBLE CAUSE

CORRECTIVE ACTION

Console does not turn on

Power cord not connected

Connect power cord

Power button is damaged

Return for service

Faulty fuse

Replace fuse

Probe with BLUETOOTH® wireless technology: Unit displays “no linc” on

power up BLUETOOTH® not active

Activate probe

Replace probe battery and reactivate

Return probe for service

Unit displays “Lo Batt”

Battery is too low to operate probe

Replace battery Return for service if condition persists

For cabled probe: Unit displays “error no probe” on power up.

Probe or cable not connected

Connect probe or cable Damaged cable

Replace cable

Damaged probe

Replace probe

Return for service if condition persists

Unit displays “Error 2” through “error 6”

Internal error codes

Cycle power to unit Return for service if condition persists

Intermittent and unusually high readings

Intermittent electrical interference (e.g., electrosurgical unit, X-ray, etc.)

Track down source of interference Turn off offending sources (if possible)

Damaged probe

Change probe Return for service if condition persists

Unexpected high readings (continuous)

Contaminated probe or collimator

Decontaminate probe and collimator

Background too high

Shield background source

Damaged probe

Change probe

Incorrect Radionuclide selected

Select appropriate radionuclide Return for service if condition persists

Unexpected low readings

Incorrect Radionuclide selected

Select appropriate Radionuclide

Damaged probe

Change probe Return for service if condition persists

Erratic readings or no counts

Damaged probe

Return for service if condition persists

Sound does not vary with count rate

Volume turned down

Turn volume up

Mute button is on

Turn mute off

Wrong count range is active

Lower count range Return for service if condition persists

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Questions

Call Devicor Medical Products, Inc. at 1-877-926-2666.

Service Policy

New Product Warranty Service

 Call 1-877-926-2666 for authorization to return products to Devicor. Provide model, serial or lot numbers of

defective product, technical description of defect or malfunction, no-charge purchase order number, and your shipping and billing address. Also obtain return merchandise authorization (RMA) number from Devicor.

Out-of-Warranty Service

 Call 1-877-926-2666 for authorization to return product to Devicor. Provide model, serial or lot number of

defective product, technical description of defect or malfunction, billable purchase order number to cover Devicor’s estimate of repair cost, and shipping and billing address for Buyer. Also obtain return merchandise authorization (RMA) number from Devicor.

Return product in original packing and Label packaging with RMA number. Shipment to Devicor is at Buyer’s expense. Repaired or replacement equipment is shipped C.I.P. from Devicor’s plant. Reported problems or defects not verified by Devicor 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.

Devicor 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 Devicor at 1-877-926-2666 if you cannot find a convenient means of disposal.

New Product Warranty

New products manufactured by Devicor are warranted against defects in workmanship and material for period of one year (period) from date of shipment by Devicor to Buyer, subject to limitations hereinafter set forth. Should any defects be found and reported during period, Devicor, at its option, will repair or replace such defective product provided Buyer ships defective product to Devicor, transportation charges prepaid, with notice of defect and certification that product was properly installed, maintained, and operated within limits of rated and normal usage. Repaired or replacement product is shipped C.I.P. from Devicor’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. DEVICOR’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.

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

PARAMETER

SPECIFICATIONS

Operating power

AC Line Power 100-240 VAC (50-60Hz)

Power consumption

52 VA, nominal 76 VA, maximum (at high volume)

Heat output

Negligible (10 watts, nominal)

Audio

70 dB Sound Pressure Level at 1 meter

Energy Range

12-600 keV internal windowing resolution

Maximum count range

99,999 cps

Length

25.4 cm (10 in.)

Width

30.5 cm (12 in.)

Height

22.9 cm (9 in.)

Weight (approximate)

2.5 kg (5.6 lb.)

Operating temperature range

10° to 40° C (50° to 104° F)

Operating atmospheric pressure

810hPa to 1060hPa (11.7 psia to 15.4 psia)

+60°C

-20°C

Storage and transit temperature

-20° to 60° C (-40° to 104° F)

Storage and transit humidity

10 percent to 95 percent

Storage and transit atmospheric pressure

500hPa to 1060 hPa (7.3 psia to 15.4 psia)

Operational Displays and Software

Displayed parameters:

Radioactive counts

Additional display:

Threshold value

Hardware

System Controls:

Function Selector, Buttons

Interconnects:

Custom cables

Display:

LED elements

100VAC, 50- 60 Hz

DENTORI, SVT

125VAC, 60 Hz

CSA, UL, SJT

250VAC, 50 Hz

ASTA, CEBEC, CCEE, DEMKO, FMKO, IMQ, KEMA, LCIE, NEMKO, OVE, SECV, SEMKO, SEV, VDE

IEC Classifications [EN 60601-1]

Electrical shock protection - Classification

Class I

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THIS WARRANTY CONTAINS THE ENTIRE OBLIGATION OF DEVICOR AND NO OTHER WARRANTIES INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTIES EXPRESSED, IMPLIED, OR STATUTORY ARE GIVEN.

9. SYSTEM SPECIFICATIONS

Model 2300 Console

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:

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

Electrical shock protection - Degree

Type CF Applied Part

Flammable Anesthetics

Equipment not suitable for use in presence of FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE

Operating mode

Continuous

Ingress of fluids - probes

IPX8, see individual probe instructions for use

Ingress of fluids - console

Ordinary equipment

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Model 2300 Gamma Detection System is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 2300 Gamma Detection System should assure that it is used in such an environment.

Emission test

Compliance

Electromagnetic environment - guidance

RF Emissions

CISPR 11

Group 2

The Model 2300 Gamma Detection System must emit electromagnetic energy in order to perform its intended function. All emissions comply with EN 61000-4-3, FCC and IC regulations. Nearby electronic equipment may be affected if the Model 2300 is operated within 11.7 cm or 4.6" of equipment marked with the following symbol:

RF emissions

CISPR 11

Class B

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.

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage

fluctuations/flicker

emissions

IEC 61000-3-3

Complies

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) 61000-4-2

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrostatic fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 60001-4-5

±1 kV differential mode ±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 60001-4-11

<5 % UT (>95 % dip in UT for 0.5 cycle)

<40 % UT (>95 % dip in UT for 5 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 0.5 cycle)

<40 % UT (>95 % dip in UT for 5 cycles)

<70 % UT (>30 % dip in UT for 25 cycles)

<5 % UT (>95 % dip in UT for 5 sec)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Model 2300 Gamma Detection System requires continued operation during power mains interruptions, it is recommended that the Model 2300 Gamma Detection System be powered from an uninterruptible power supply or a battery.

NOTE: UT is the AC mains voltage prior to application of the test level.

Power frequency (50/60 Hz) magnetic field

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Electromagnetic Compatibility Declaration

EMC Requirements in Accordance with EN 60601-1-2:2007

Table 201

Table 202

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IEC61000-4-8

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

Recommended separation distance d = 1.17 * √ P

Radiated RF IEC 61000-4-3

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.

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.

Over the frequency range 150 KHZ to 80 MHz, field strength should be less than 3 V .

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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

Separation distance according to frequency of transmitter

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

0.23m

0.1

0.37m

0.74m

3.7m

7.4m

100

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.

Česky

[Czech]

Devicor Medical Products, Inc. tímto prohlašuje, že tento “Wireless Probe” je ve shodě se základními požadavky a dalšími příslušnými ustanoveními směrnice 1999/5/ES.

Dansk

[Danish]

Undertegnede Devicor Medical Products, Inc. erklærer herved, at følgende udstyr “Wireless Probe” overholder de væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF.

Deutsch

[German]

Hiermit erklärt Devicor Medical Products, Inc., 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 Devicor Medical Products, Inc. seadme “Wireless Probe” vastavust direktiivi 1999/5/EÜ põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele.

Español

[Spanish]

Por medio de la presente Devicor Medical Products, Inc. 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 Devicor Medical Products, Inc. ΔΗΛΩΝΕΙ ΟΤΙ “Wireless Probe” ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ

Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork

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EMC Requirements in Accordance with EN 60601-1-2:2007

Table 206

Declaration of Conformance:

Hereby, Devicor Medical Products, Inc. declares that this “Wireless Probe” is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.

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1999/5/ΕΚ.

Français

[French]

Par la présente Devicor Medical Products, Inc. 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 Devicor Medical Products, Inc. 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 Devicor Medical Products, Inc. deklarē, ka “Wireless Probe” atbilst Direktīvas 1999/5/EK būtiskajām prasībām un citiem ar to saistītajiem noteikumiem.

Lietuvių

[Lithuanian]

Šiuo Devicor Medical Products, Inc. deklaruoja, kad šis “Wireless Probe” atitinka esminius reikalavimus ir kitas 1999/5/EB Direktyvos nuostatas.

Nederlands [Dutch]

Hierbij verklaart Devicor Medical Products, Inc. dat het toestel “Wireless Probe” in overeenstemming is met de essentiële eisen en de andere relevante bepalingen van richtlijn 1999/5/EG.

Malti

[Maltese]

Hawnhekk, Devicor Medical Products, Inc., jiddikjara li dan “Wireless Probe” jikkonforma mal-ħtiġijiet essenzjali u ma provvedimenti oħrajn relevanti li hemm fid-Dirrettiva 1999/5/EC.

Magyar

[Hungarian]

Alulírott, Devicor Medical Products, Inc. nyilatkozom, hogy a “Wireless Probe” megfelel a vonatkozó alapvetõ követelményeknek és az 1999/5/EC irányelv egyéb elõírásainak.

Polski

[Polish]

Niniejszym Devicor Medical Products, Inc. oświadcza, że “Wireless Probe” jest zgodny z zasadniczymi wymogami oraz pozostałymi stosownymi postanowieniami Dyrektywy 1999/5/EC.

Português

[Portuguese]

Devicor Medical Products, Inc. declara que este “Wireless Probe” está conforme com os requisitos

essenciais e outras disposições da Directiva 1999/5/CE.

Slovensko

[Slovenian]

Devicor Medical Products, Inc. izjavlja, da je ta “Wireless Probe” v skladu z bistvenimi zahtevami in ostalimi relevantnimi določili direktive 1999/5/ES.

Slovensky

[Slovak]

Devicor Medical Products, Inc. týmto vyhlasuje, že “Wireless Probe” spĺňa základné požiadavky a všetky príslušné ustanovenia Smernice 1999/5/ES.

Suomi

[Finnish]

Devicor Medical Products, Inc. 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 Devicor Medical Products, Inc. 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 Devicor Medical Products, Inc. yfir því að “Wireless Probe” er í samræmi við grunnkröfur og aðrar kröfur, sem gerðar eru í tilskipun 1999/5/EC.

Norsk

[Norwegian]

Devicor Medical Products, Inc. erklærer herved at utstyret “Wireless Probe” er i samsvar med de grunnleggende krav og øvrige relevante krav i direktiv 1999/5/EF.

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Item Description

Product Code

Model 1017, 14mm Corded Probe

NPR14

Model 1100, 14mm Wireless Straight Probe

NPB14S

Model 1101, 14mm Wireless Angled Probe

NPB14A

Model 1102, 11mm Wireless Laparoscopic Probe

NPR11L

Model 1103, High Energy Detector Probe

NPRF18

Model 1104, 9mm Wireless Probe

NPB09S

Item Description

Product Code

Model 2009, North American Medical Grade AC Power Cord

NPA75

Model 2024, Probe Cable for 1017 Probe

NPA76

Model 2060, Probe Cable for 1103 Probe

NPAF18

Item Description

Product Code

Model 1013, 14mm Probe Collimator (fits 1017, 1100, 1101)

NPE14

Item Description

Product Code

Model 1131, Wireless Serial Port Adapter (for 2200 only)

NPBAK

Model 2010, Accessory Case

NPA71

Model 2046, v6.01 Software & Utilities Kit

NPSW601

Probe Sensitivity Check Source Fixture

P-405

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neoprobeTM GDS Operation Manual

10. AUTHORIZED ACCESSORIES

The following is a list of authorized accessories for use with the neoprobeTM GDS console:

Probes:

Cables:

Collimator:

Additional Accessories:

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neoprobeTM GDS Operation Manual

11. WARNINGS, CAUTIONS AND NOTES

Read this section before operating product.

DEFINITIONS:

, or WARNING: Specific information identifies events when misuse or improper use of

device may cause harm to user or patient or could result in irreparable damage to device or property.

CAUTION: Specific information identifies when misuse of equipment may cause malfunction or

produce incorrect readings.

NOTE: General information to explain or clarify proper operation of product.

Injury

Report injuries immediately to Devicor at 1-877-926-2666 and leave product undisturbed until authorized Devicor 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.  To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.  Maintain proper clearance for access to AC Power Inlet Connector for disconnection from mains power.

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.

 No modification of this equipment is allowed. 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.

Do not connect unauthorized equipment or accessories to external serial port connector during clinical use. Any person who connects additional equipment to the signal input or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the systems requirements of IEC 60601-1.

CAUTIONS:

 System components should not touch other electrical equipment during use.

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neoprobeTM GDS Operation Manual

 Do not position or use product near sources of extreme magnetism such as MRI equipment.  Operation of product in vicinity of X-ray equipment may cause incorrect counts.  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 -

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PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012

Devicor Neoprobe neo2000 Operation Manual

Specifications and Main Features

Frequently Asked Questions

User Manual