Crystal Probe -automatic- (SG04)

1. Description

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SG04 with a Crystal Wireless Probe

Crystal Photonics has 15 years of expertise in developing and manufacturing surgical gamma probe systems, which are especially designed for the intra-operative detection and localization of radioactive enrichments in the body or tissue.

Succeeding the worldwide popular Crystal Probe System [SG03], our new, gamma probe system Crystal Probe -automatic- [SG04] sets standards in capability, versatility and user-friendliness.

Our various gamma probes, which are considered to be the most effective instruments of detection compared to other surgical gamma probes on the market, allow an optimal usage for current and future applications of the sentinel lymph node excision (SLNE). Constructed and manufactured under the strictest quality control measures, all probes are characterized by an excellent side-shielding and outstanding sensitivity, which make it easy to localize even the weakest radioactive enrichments. Different angular resolutions of the changeable collimator sleeves achieve different fields of view and different sensitivities.

Crystal Probe -automatic- is constructed and manufactured in special consideration of user-friendliness. Features like the automated probe recognition, nuclide selection and system check minimize the risk of operating errors and allow a quick setup prior to operation. The clearly acoustical sound enables the surgeon to work visually focused. Additionally, the large 5.5” back-lit display shows all important information.

Crystal Probe -automatic- can be connected via USB to any personal computer or laptop. Our sophisticated measuring and analysis software “Visual Count” (offered optionally) displays the intensity data visually either digital, as bar a chart or as a histogram on the PC monitor.

The automation of the control unit SG04 provides a straightforward operation in combination with the highest reliability. And last but not least, Crystal Probe -automatic- is maintenance-free and can be operated both on mains and on the integrated rechargeable battery.

2. The control unit SG04

2.1 Abstract

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SG04 Front

The portable control device serves the optical and acoustic indication of the detected activity as well as the electricity supply of the probes.

Thanks to the comfortable automation of the control unit SG04 the application of the system can occur in the operating theatre, as soon as one of our gamma probes is connected to the control device SG04. Just turning it on is enough.

The system recognizes the probe immediately, calls the optimum operation-settings („automatic probe recognition“) and selects the suitable standard nuclide ("automatic nuclide choice").

Besides the most frequently used 99mTc (140 keV) there is a huge number of other nuclides which can be detected by Crystal Probe -automatic-.

SG04 can be operated both on mains and on the integrated rechargeable battery, maintaining an uninterrupted operation for more than 13 hours on a fully charged battery, without any connection to mains.

Quality assurance: All important operation-settings are supervised by the system independently ("self-diagnosis"). A detailed diagnosis is begun by the button "system check". In connection with a 57Co testing scource (optionally available), stability tests easily can be performed by pushing the button "Test" on the back panel of the SG04.

2.2 Display features

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SG04 LC-Display

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SG04 Back

The large 5.5 " back-lit display shows all important information to the surgeon such as:

  • count rate (detected radioactivity in cps - counts per second) by five large digits and as bar-graph
  • count rate max (maximum count rate for previous 30 sec.)
  • connected probe
  • automatically set or manually chosen nuclide
  • power source
  • power management of battery
  • sample time (1 sec or 10 sec)
  • setting of acoustic signal (Melody)
  • "pitch"-setting of audible count rate

The countrate which is displayed in "cps" by 5 large digits got a reaction time of < 0.5 sec.

As a matter of course the measured activity is also given acoustically. The optimum correlation between the three eligible acoustic signals and the count rate enables the surgeon to locate the signal maximum without having to avert the gaze from the tissue to be measured.

The volume of the acoustic signal is adjustable and can be adapted to the acoustic relations in the operating room.

Sample time can be switched between 1 sec and 10 sec. The SG04 provides two interfaces: The analogue output signal can be measured at the BNC plug interface. Connecting an oscilloscope, single pulses can be displayed. Additional this signal provides the possibility to measure the energy spectrum of the detected nuclide by a spectrometre (MCA).

The USB interface provides potential seperated transmission of digital information from the probe to a personal computer. Using the optionally available software "Visual Count" the data can be comfortably displayed and processed.

3. PC-Use

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VisualCount 2.x

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VisualCount 2.x

for visual representation and recording of the process of measuring the activity with probes of the system "Crystal Probe"

The PC-supported analysis of the whole measurement process is possible with the Windows-compatible software "Visual Count".

  • visualisation of the measured activity during the recording as line and bar chart
  • Recording and subsequent processing of the data
  • Export of recorded charts in graphics files, MS Word, MS Excel and text files
  • Annotation of measured values while measuring. Overview of all comments after the measurement
  • Add results and comments to every examination
  • Print all examinations with all of its data
  • Create independent password protected accounts for every doctor
  • Create as many patients per doctor (account) as you like. Patient data and examinations are protected from unauthorized access.
  • Record as many examinations as you like
  • High data integrity by fully automated database management (automatic storing, organizing, encrypting)
  • High reliability through hot-plug-ability: at every time the control unit can get connected or disconnected from the PC - even while measuring
  • The connection is done by an USB-port. The retrofitting of the USB-port is easily possible

3.1 Output of the measured data

If the optional PC-supported data processing over the USB-port is used, the following additional features are provided:

The measured values will be shown on the screen of the PC:

  • digitally in counts per second (cps)
  • visually by a cps-related bar
  • by a histogram that shows the progression of the measurings

Through keyboard or mouse the following parameter can be modified or added:

  • Patient- and examination data
  • Scaling factor
  • Gate time
  • Marking of values that can be commented afterwards

3.2. Recording of the measured values

The data collected during the measuring process and the entered patient information / comments are saved along with the current date and time of the system as a file.

A subsequent viewing and editing is possible with all standard office application programs.

4. Technical Data

4.1 Classification of the system

Class IIa according to Directive 93/42/EEC (2007) Annex IX and §13 German Medical Devices Act (2009).

EC Verification Certificate according to Annex II, IV, and VII Directive 93/42/EEC (2007).

4.2 Power supply of the control unit SG04

Maintenance-free lead storage batteries: 1x12V / 5Ah
Operation time with maximum charge: >10 hours at maximum load
>13 hours at normal load
Charging with the delivered battery charger: 110....240V / 300mA
Charging period for maximum charge: < 12 hours
Operation voltages: ± 5V / max. 400 mA
Classification of the control unit CXS-SG03: IP20
Protection degree of the application part against electric shock: Type B
Fuses: 3x1AT on power supply board

4.3 Energy discrimination

Nuclide Energy window
  Lower energy treshold (keV) high energy treshold (keV)
125I 20 60
201Tl, 67Ga 60 100
99mTc 120 160
111In 170 245
131I 310 380
PET-Nuclides 430 600
for tests with 57Co 100 140
All <60 >511
Additional nuclides on request    

4.4 Visual and acoustic signals

5-digit LCD and bargraph Count rate in counts per second (cps) analog visualization
Sound: 3 different acoustic signals, variable according to the radiation intensity, volume adjustable, one signal ca be set to different measuring ranges

4.5 Signal output

Analog: Analog voltage signal; output voltage max. 3,5V, output impedance = 5kOhm; measurement of the spectral data with a multichannel analyser (MCA)
Optional: Digital USB-connector; galvanic separation; positive TTL signals

4.6 Weight

Control unit SG04: 5,5 kg
Probes See individual descriptions; < 0,2 kg

4.7 Size

Control unit SG04 (W x H x D): 295 x 150 x 310 mm
Probes See individual descriptions