Model 2200 neo2000 Gamma Detection System Operation Manual Rev C

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Table of Contents 1.1 System Warnings, Cautions, and Notes 1.2 Definitions 1.3 System Functions and Features 1.4 New System Installation

1-1 1.1-1 1.2-1 1.3-1 1.4-1

2.1 Setting Up the System for Dynamic Pitch Mode 2.2 Starting the System in Dynamic Pitch Mode 2.3 Acquiring the Background Count in Dynamic Pitch Mode 2.4 Scanning to Locate Concentrated Areas of Radiopharmaceuticals 2.5 Acquiring Target Count in Dynamic Pitch Mode 2.6 System Shutdown

2-1 2.1-1 2.2-1 2.3-1 2.4-1 2.5-1 2.6-1

3.1 Setting Up the System for Binary Pitch Mode 3.2 Starting the System in Binary Pitch Mode 3.3 Acquiring the Background Count in Binary Pitch Mode 3.4 Scanning to Establish Boundaries of Target Tissue in Binary Pitch Mode 3.5 Acquiring Target Count (6-Second Option) 3.6 Performing a Target Check (2-Second Option) 3.7 System Shutdown

3-1 3.1-1 3.2-1 3.3-1 3.4-1 3.5-1 3.6-1 3.7-1

1. Introduction

2. Using the neo2000® in Dynamic Pitch Mode

3. Using the neo2000® in Binary Pitch Mode

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Table of Contents 4. Maintenance

4-1 4.1 System Diagnostics 4.1-1 4.2-1 4.2 Cleaning and Decontamination 4.3 Sterilization Procedures 4.3-1 4.3.1 Ethylene oxide gas sterilization for reusable probes, cables, and accessories 4.3-2 4.3.2 Steris sterilization for reusable probe tips 4.3-5 4.4 Fuse Maintenance 4.4-1 4.5 Service Policy 4.5-1 4.6 Warranty 4.6-1 4.7 System Accuracy Check 4.7-1 4.8 Performance Check 4.8-1

5. Troubleshooting

5-1

6. System Specifications

6-1

7. Hazards

7-1

8. Potential Applications

8-1

9. Equipment Classification and Description

9-1

10. Notices

10-1

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Introduction

Overview Purpose This manual describes how to operate the neo2000® Gamma Detection System (neo2000), which includes a control unit or console and a family of probes for detecting gamma radiation. Intended Use The neo2000 is an electronic device intended to detect and quantify gamma radiation. Indications The neo2000 is indicated for external and intraoperative detection of radioactivity in body tissues or organs, where radiopharmaceuticals are administered.

for the neo2000 as well as routine maintenance, safety, and troubleshooting instructions. It does not provide detailed system repair and technical documentation; it does not discuss how to perform surgery and procedures related to nuclear medicine. In this chapter The rest of this chapter covers the following: • 1.1 System warnings • 1.2 Definitions • 1.3 System functions and features • 1.4 New system installation

Users This manual is intended for physicians and operating room staff who must use the neo2000 and ensure that it is functioning properly. Scope This manual gives operating instructions 1-1

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Introduction

1. Plug in power cord.

2. Push power button.

3. Plug in probe cable.

1-2

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1.1 System Warnings, Cautions and Notes Overview Read this section before operating the neo2000®. Included below are operational warnings, cautions and notes for safe operation of the neo2000. Definitions Warning: Specific information provided to the user to advise of situations where the misuse or unlabeled use of the device could present potential harm to the user or patient and/or could result in irreparable damage to the device or property. Caution: specific information provided to the user to prevent the misuse of the device which may cause it to malfunction or produce erroneous readings. Note: general information provided to the user to further explain or clarify the proper operation of the device and/or its accessories.

Warnings • The reusable detector probe is a delicate surgical instrument. DO NOT DROP. Mechanical shock can result in irreparable damage. • Only properly trained and qualified personnel should use the system. • There are no user serviceable parts in the neo2000 - DO NOT OPEN. • The system is not to be used in the presence of flammable anesthetics or other explosive gases. • The neo2000 should only be cleaned after the power cord is disconnected from the console and the power outlet. • Do not sterilize or immerse the console as permanent damage may result. • Only Neoprobe approved accessory equipment shall be used with this device. Use of this device with unauthorized accessories may void the warranty with the user assuming all liabilities. • When using Model 1017 14mm probes with the neo2000 console, only use probes with serial numbers 1498600 or higher (gain-trimmed). Model 1017 14mm probes with serial numbers less than 1498600 (not gain-trimmed) are designed

and can be used with the Neoprobe 1500 console, but are not recommended for use with the neo2000 console. •Do not use Model 1002 19mm probes with the neo2000 console. The Model 1002 19mm probe is designed for use with the Neoprobe 1500 console, but is not compatible with the neo2000. • No component, part, or accessory can be autoclaved. Use only recommended cleaning and sterilization methods (see Chapter 4). • No component, part, or accessory can be gamma sterilized. Cautions • The system components should not touch other electrical equipment during use. • Use of this device in the vicinity of X-ray producing devices may cause false counts. • Electrocautery and other electrosurgical devices may interfere with the operation of the neo2000. If interference is observed in the presence of these devices, the user is advised not to operate these devices while the neo2000® is in operation. If this can not be done, move these devices away 1.1-1

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1.1 System Warnings, Cautions and Notes (Continued) from the neo2000 to mitigate the effects of the electromagnetic interference. • If the neo2000 does not operate at all when the power is turned on, the user should check the user-accessible fuses on the back panel. The fuses should only be checked with the power cord disconnected from the neo2000 console. • Use of this device in the vicinity of persons undergoing radiation therapy may cause false counts. • The neo2000 has a radionuclide selection indicator for 18F, which has a photo peak energy of 511 keV. The 18F function is for future product development. For information on availability contact Neoprobe. • Always make sure probe connector pins and contacts are dry before use. Wet contacts may cause erroneous readings or operation.

Notes • Inspect Model 2024 and Model 2060 reusable cable for cracks or cuts before use; do not use if the cable is damaged. If a cable is cut during surgery, it should be replaced immediately. • Assure that reusable probes (Model 1017 and Model 2059, respectively) are securely attached to the reusable cables (Model 2024 and Model 2060) before use. • The system generates no hazardous radiation but is designed to detect various radioactive materials. When using radioactive materials, use safe and proper handling techniques. See your institution’s Radiation Safety Officer about Nuclear Regulation Commission and other requirements.

• Call Neoprobe Corporation immediately at 800-793-0079 or 614-793-7500 to report any incident or injury that occurred during use of the neo2000.

1.1-2

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1.2 Definitions Overview This section defines symbols and key terms used in this manual. Words in bold are defined in this section.

Compton scattering Radioactive “noise” at an energy level lower than the photopeak of the injected radiopharmaceutical.

Count rate A continuous counting rate of gamma radiation measured in counts per second (cps) and updated every half-second. Count rate is shown on the same line of the console display as target count and target check when these functions are not activated.

Dynamic pitch range An operator-selected audible and counting range of radioactivity. If the count rate falls within the selected range, a variable-pitch sound is produced which is proportional to the level of gamma radiation present. Areas of tissue that generate higher pitch are associated with higher levels of radioactivity.

Background count In Binary Pitch mode: baseline value measured in counts per second (cps) that is stored by the system for comparison with the target count to determine if the difference in radioactivity between background tissue and target tissue is statistically significant. In Dynamic Pitch mode: a baseline value measured in cps that is stored by the system, and is used as the threshold at which the sound is activated.

Ratio A value indicating how likely it is that target tissue has been found (target count divided by background count).

Target count A number indicating the level of radioactivity detected by a probe as measured held stationary for 6 seconds over target tissue; more accurate than target check. The target count activates and displays ratio calculation.

Target check A quick check of the 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. The target check function does not display a ratio calculation. 1.2-1

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1.2 Definitions (Continued) Symbol

Definition

In the U.S.A., Caution: Federal Law restricts this device to sale by or on the order of a physician. Use by Storage and Transit Temperature Storage and Transit Pressure Type CF Sterile using Ethylene Oxide

CE Mark, Class I CE Mark, Class II, Class I STERILE

Symbol

Definition

Neoprobe Corporation logo TUV Classified device

Date of manufacture Storage and Transit Humidity Serial Number Catalog Number Batch Code Caution: consult accompanying documents

For additional information on graphic symbols refer to section 1.3

1.2-2

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1.2 Definitions (Continued) Symbol

Definition

Standby / ON

Alternating current

Not for use in the presence of flammable anesthetics For additional information on graphic symbols refer to section 1.3

1.2-3

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1.3 System Functions and Features

Graphic display

6

77 Target count numeric display 8 Background count numeric display 9 Ratio numeric display 10 Target count indicator light 11 Target count selection button

Power standby button

1

and indicator light

X:1

12 Ratio indicator light 13 Background count indicator light

“No Probe Connected” and System

2

14

Radionuclide indicator lights

3

15 Volume control

Binary pitch/dynamic pitch mode

4

function indicator light

selection button

16

Probe input port

5

Dynamic pitch range

18

selection buttons

Figure 1 neo2000 ® console front panel

Background count selection button

Mute button

17 Mute indicator light

1.3-1

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1.3 System Functions and Features (Continued) 19 Radionuclide selection button

Authorized Representative Label

23 c

Product compliance label 23 a

Data port 20

23 b Serial number plate

22 Power cord port and external access to fuse

Remote display port 21

Figure 2 neo2000® console back panel

1.3-2

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1.3 System Functions and Features (Continued) See section 1.1 for compatibility of probes with the neo2000.

X:1

26

25 Reusable Detector probe cable (Model 2024)

28 Reusable Detector probe cable (Model 2060)

Figure 3

14mm Detector probe collimator (snap on). (Model 1013)

24 14mm Reusable Probe (Model 1017)

24

27 11mm Reusable Detector Probe (Model 2059)

Refer to 00-0280 supplied with Model 2059 probe.

1.3-3

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1.3 System Functions and Features (Continued) The following probes are no lobnger in production but may exsist with older neo2000 systems. Refer to DOC0780 for use, cleaning and sterilization of older Neoprobe probes.

Alternate probe configurations

Disposable handle (Model 2025) X:1

19mm uncollimated BlueTip™ (Model 2003)

12mm uncollimated BlueTip™ (Model 2001)

12mm collimated BlueTip™ (Model 2002)

19mm Reusable probe (Model 1002)

Figure 4

Do not use with neo2000.

1.3-4

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1.3 System Functions and Features (Continued) Features 1

Power standby button and indicator light. Press and release to turn console on; press and release again to place in standby. Light is on when power is active.

2 “No Probe Connected” and system function indicator light. Lights up when no probe is attached or there is a problem with the console. 3

Radionuclide indicator lights. Lights up to indicate radionuclide selected.

4

Binary pitch/dynamic pitch mode selection button. Press and release to toggle between modes (binary pitch/dynamic pitch). Corresponding indicator lights up.

5

Probe input port. Attachment point on console for probe cables.

1.3-5

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1.3 System Functions and Features (Continued) 6

Graphic display. Accumulates light bars starting from bottom as data is collected or time elapses during a count. Displays count rate in dynamic pitch mode.

7 Target count numeric display. Shows the radioactivity count detected by the probe either while scanning (count rate) or after taking a target count or target check. 8

Background count numeric display. Shows default values or actual values of radioactivity counts detected after taking a background count.

9

Ratio numeric display. Lights up to show ratio calculated

10 Target count indicator light. Flashes when target count or target check is calculated and displayed.

11 Target count selection button. In Binary Pitch mode press and release to take a target check; press, hold, and release to take a target count. In Dynamic Pitch mode press and release to take a target count; press, hold and release to take a 10 second count.

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1.3 System Functions & Features (Continued) 12 Ratio indicator light. Lights up to indicate ratio is being calculated and displayed.

13 Background count indicator light. Flashes to indicate background count is in process.

14 Background count selection button. Press and release to take background count.

15 Volume control. Adjusts volume of system’s audible signals.

16 Mute button. Press and release to turn binary pitch alarm and dynamic pitch sound on and off.

17 Mute indicator light. Flashes to indicate mute is enabled. Remains lit continuously when mute is not enabled.

1.3-7

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1.3 System Functions & Features (Continued) 18 Dynamic pitch range selection buttons. Press and release to select dynamic pitch range and corresponding indicator lights up.

19 Radionuclide selection button. Press and release to cycle to next radionuclide.

Nuclide Selection

20 Data port. For use in software upgrades.

21 Remote display port. Provided for future expansion; not used on neo2000®.

22 Power cord port and fuse access. Attachment point on console for power cord. This receptacle also houses the user accessible fuses. 23a Product compliance label. Identifies regulatory compliance to standards and statutes.

1.3-8

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1.3 System Functions & Features (Continued) 23b Serial number plate. Identifies equipment by serial number.

23c European Union (EU) Authorized Representative Label

1.3-9

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1.3 System Functions & Features (Continued) System Components 24 Model 1017 - 14 mm Reusable probe. Detects gamma radiatio

25 Model 2024 - Reusable Detector probe cable. For use with 14 mm reusable probe. The cable is reusable. end view (enlarged), connects to probe

side view

end view (enlarged), connects to neo2000

26 Model 1013 - 14mm Detector probe collimator (snap on). For use with 14mm reusable probe. The collimator is reusable.

27 Model 2059 - 11mm Reusable Detector probe. Detects gamma radiation.

28 Model 2060 - 11mm Reusable probe cable.

side view

end view (enlarged), connects to probe end view (enlarged), connects to neo2000

1.3-10