PTW DIAMENTOR E2 Скачать руководство пользователя

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DIAMENTOR E2

D651.131.00/05 en

Literature

[1] [Council Directive 93/42/EEC concerning medical devices

(Medical Device Directive - MDD)

[2] Council Directive 97/43/EURATOM on health protection of

individuals against the dangers of ionizing radiation in rela-

tion to medical exposure

[3] IEC 60601-1-2

Medical electrical equipment

Part 1-2: General requirements for basic safety and essential

performance -

Collateral Standard: Electromagnetic compatibility - Re-

quirements and tests

[4] IEC/CISPR 11

Industrial, scientific and medical (ISM) radio-frequency

equipment - Radio disturbance characteristics - Limits and

methods of measurement.

[5] IEC 60950-1

Information technology equipment - Safety

Part 1: General requirements

[6] IEC 60601-1 / ANSI/AAMI ES 60601-1/

CAN/CSA-C22.2.No.60601-1

Medical electrical equipment –

Part 1: General requirements for basic safety and essential

performance

[7] IEC 60580

Medical electrical equipment

Dose Area Product Meter

[8] IEC

62353

Medical electrical equipment –

Recurrent test and test after repair of medical electrical

equipment

[9] IEC 61000-3-2

Electromagnetic compatibility (EMC) -

Part 3-2: Limits -

Limits for harmonic current emissions (equipment input cur-

rent

≤

16 A per phase)

[10] IEC 61000-3-3

Electromagnetic compatibility (EMC) -

Part 3-3: Limits -

Limitation of voltage changes, voltage fluctuations and flicker

in public low-voltage supply systems, for equipment with

rated current

≤

16 A per phase and not subject to conditional

connection

[11] IEC 61000-4-2

Electromagnetic compatibility (EMC) -

Part 4-2: Testing and measurement techniques -

Electrostatic discharge immunity test

[12] IEC 61000-4-3

Electromagnetic compatibility (EMC) -

Part 4-3: Testing and measurement techniques -

Radiated, radio-frequency, electromagnetic field immunity

test

[13] IEC 61000-4-4

Electromagnetic compatibility (EMC) -

Part 4-4: Testing and measurement techniques - Electrical

fast transient/burst immunity test

[14] IEC 61000-4-5

Electromagnetic compatibility (EMC) -

Part 4-5: Testing and measurement techniques -

Surge immunity test

[15] IEC 61000-4-6

Electromagnetic compatibility (EMC) -

Part 4-6: Testing and measurement techniques -

Immunity to conducted disturbances, induced by radio-

frequency fields

[16] IEC 61000-4-8

Electromagnetic compatibility (EMC) -

Part 4-8: Testing and measurement techniques -

Power frequency magnetic field immunity test

[17] IEC 61000-4-11

Electromagnetic compatibility (EMC) -

Part 4-11: Testing and measurement techniques -

Voltage dips, short interruptions and voltage variations im-

munity tests

[18] IEC 60522

Determination of the permanent filtration of X-ray tube as-

semblies

Содержание DIAMENTOR E2

Страница 1: ...User Manual DIAMENTOR E2 T11033 from SN 02000 and higher D651 131 00 05 en 2012 11 G Hn Kau...

Страница 2: ...se use has been ex pressly permitted by PTW Freiburg Safe op eration and proper product performance are not guaranteed if accessories or consumables from other manufacturers are used PTW Freiburg cann...

Страница 3: ...ance with a quality management system which is continu ously updated according to national and inter national standards PTW FREIBURG Physikalisch Technische Werkst tten Dr Pychlau GmbH L rracher Str 7...

Страница 4: ...16 5 PERFORMING A MEASUREMENT 17 5 1 Constancy Check 17 5 2 Measurement 17 5 3 Air Density Correction 18 5 4 Print out 18 6 ERROR MESSAGES AND TROUBLESHOOTING 19 7 CALIBRATION 20 8 PERIPHERALS 22 8 1...

Страница 5: ...to connect a label printer or a PC This manual only describes the DIAMENTOR E2 A detailed description of the RS232 interface is supplied on request document number D651 131 1 2 For Your Safety The fol...

Страница 6: ...evice from the power line first remove the connector from the wall outlet Then disconnect the cable from the device Devices on which moisture condensation has developed as a result of temperature chan...

Страница 7: ...1 ANSI AAMI ES 60601 1 CAN CSA C22 2 No 60601 1 WARNING Suffocation Hazard Dispose of the packag ing material observing the applicable waste control regulations Keep the packaging mate rial out of chi...

Страница 8: ...d to the power line or the cable is clamped into the DC supply the system is powered even if the DIAMENTOR E2 is turned off CAUTION Equipment damage Handle the product with care to avoid equipment dam...

Страница 9: ...n Association for Electrical Electronic and Information Tech nologies The product is certified by UL Un derwriters Laboratories for both the U S and Canadian markets to the applicable U S and Canadian...

Страница 10: ...lation Inside the patient Outside the patient Not medical used area environment environment Figure 2 Note for installation in the patient environment PTW DIAMENTOR E2 T11033 Printer PC IEC 60950 1 Pri...

Страница 11: ...em A 4 Connection adapter 5 On Off switch Device switched on Device switched off 6 Display 8 digit seven segment display 7 TEST button to conduct a device test and for cursor control in the menu mode...

Страница 12: ...the supply voltage WARNING The system has no means of isolation from the supply voltage When the mains plug is con nected to the power line or the cable is clamped into the DC supply the system is po...

Страница 13: ...xternal supply voltage CAUTION Make sure that the release of the installation manufacturer is on your hand before you con nect the DIAMENTOR E2 via power limiter T26060 to the installation WARNING The...

Страница 14: ...orities where the equipment is sold The complete system has to be evaluated ac cording to the requirements of IEC 60601 1 ANSI AAMI ES 60601 1 CAN CSA C22 2 No 60601 1 by the end user To achieve the r...

Страница 15: ...itch refer to Figure 3 item 5 The firmware version will be displayed for about 2 seconds followed by a display test After completion of the test the DIAMENTOR E2 is operational 4 4 Mounting the ioniza...

Страница 16: ...amber you should enter the new chamber calibration factor as described below To change the chamber calibration factor confirm the setting for the measuring quantity with RESET The menu item for settin...

Страница 17: ...rsion has been displayed for about 2 seconds and the display test has been completed success fully measured values are displayed according to the selected mode as soon as radiation is detected Auto me...

Страница 18: ...T p T p KD p0 1 013 hPa p current air pressure T0 293 K 20 C T current temperature According to device the correction can perhaps be executed over a correction menu or an used soft ware 5 4 Print out...

Страница 19: ...cation error Turn the device off and on again When the message appears again the device must be repaired Error 54 Memory malfunction Turn the device off and on again When the message appears again the...

Страница 20: ...ions where there is no absorber between chamber and patient is up to 9 In conjunction with undercouch tubes the absorption of the patient couch situated between the patient and the chamber is equivale...

Страница 21: ...e Repeat the measurement 3 times noting down the results Fluoroscopy overcouch tube Place the measurement stand without detector on the patient couch phantom at the top Start the fluoroscopy and deter...

Страница 22: ...IAMENTOR E2 and the measured value 8 2 PC WARNING Please read the printer manual before putting the printer into operation Operate the DIAMENTOR E2 in the patient en vironment only if the connected PC...

Страница 23: ...ctants on a phenol base or peroxide compounds to disinfect the surface First of all disconnect the devices from the power line before attempting to clean or disin fect them Rub the devices down with a...

Страница 24: ...iburg or a qualified calibration laboratory Inspections must also be performed after repairs or after each influence which may have changed the behavior of the product Calibration The exact calibratio...

Страница 25: ...1 Measuring principle detection of irradiation by means of ionization chambers analog and digital signal processing digital readout on LED Operating mode continuous operation Measuring quantities Dos...

Страница 26: ...3 mm x 36 mm x 151 mm Weight 250 g Adapter Power supply T99052 Input 100 240 VDC 0 33 0 18 A 47 63 Hz Output 24 VDC 0 62 A Power limiter T26060 Input 24 VDC 10 Output 24 VDC 10 9 VA Environmental cond...

Страница 27: ...for cursor control to change and confirm settings and to quit a menu Electrical calibration When the Service menu is called up the current setting for the electrical calibration factor CAL will be sho...

Страница 28: ...ic environment specified below The customer or the user of the DIAMENTOR E2 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance Radio Fr...

Страница 29: ...1000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commer cial or hospital environment Voltage dips short in...

Страница 30: ...meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey a are less than the compliance level in each frequency range b Interference may occur in the vicin...

Страница 31: ...out put power of transmit ter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d P V1 5 3 1 2 P 80 MHz to 800 MHz d P E1 5 3 1 2 P 800 MHz to 2 5 GHz d P E1 7 2 3 P 0 0...

Страница 32: ...he toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating conditions so that the use of such electronic information produ...

Страница 33: ...s below the limit requirement in SJ T11363 2006 X Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirem...

Страница 34: ...per phase 10 IEC 61000 3 3 Electromagnetic compatibility EMC Part 3 3 Limits Limitation of voltage changes voltage fluctuations and flicker in public low voltage supply systems for equipment with rate...

Страница 35: ...28 Error Messages 19 F First Time Operation 12 G General Information 2 I Intended Use 5 Ionization chamber mounting 15 L Literature 34 M Maintenance 23 Measurement 17 O Operating Controls and Indicato...

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