Crystal Probe -automatic- (SG04)

1. Description

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.

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

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

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
• 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).

3. Technical Data

3.1 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).

3.2 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

3.3 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

3.4 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

3.5 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

3.6 Weight

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

3.7 Size

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