User Manual PTW-DensiX D148.131.0/3 2005-05 Di/Zi
General Information General Information The product bears the CE-mark "CE-0124" in accordance with the Council Directive 93/42/EEC about Medical Devices and fulfills the essential requirements of Annex 1 of this directive. The product is a class I device with measuring function (MDD). PTW- Freiburg considers itself responsible for safety, reliability and performance of the product only, if assembly, extension, readjustment, modification or repair is carried out by PTW- Freiburg or by persons authorized by PTW- Freiburg, and if the product is used in compliance with the technical documentation. The instruction manual is an integral part of the product. It should always be kept near the product. Observance of the manual is a prerequisite for proper product performance and correct operation. Operator safety, specified measuring accuracy and interference-free operation can be guaranteed only if original products and parts are used. Furthermore only the accessories listed in this manual are approved by PTW-Freiburg and may be used in conjunction with the product, or else accessories whose use has been expressly permitted by PTW-Freiburg. Safe operation and proper product performance are not guaranteed if accessories or consumables from other manufacturers are used. PTW-Freiburg cannot be held liable for damages resulting from the use of accessories, consumables from other manufacturers or when the user ignores the instructions and information given in this manual. The warranty period is 1 (one) year and begins on the day of delivery. It is unaffected by repairs covered by the warranty regulations. Devices on which moisture has developed as a result of temperature changes may not be switched on unless completely dry. This technical documentation is in conformity with the product specifications and all applicable safety standards valid at printing date. All rights are reserved for devices, circuits, techniques and names appearing in the manual. No part of the technical documentation may be reproduced without written permission from PTW-Freiburg. The PTW quality management system complies with the international standards DIN EN ISO 9001 and EN 46001. PTW-FREIBURG Physikalisch Technische Werkstätten Dr. Pychlau GmbH Lörracher Str. 7 79115 FREIBURG GERMANY Phone: +49 761 49055-0 Fax: +49 761 49055-70 info@ptw.de www.ptw.de 2 D148.131.0/3
1 INTENDED USE 4 2 FOR YOUR SAFETY 4 OPERATING CONTROLS AND INDICATORS 6 4 FIRST TIME OPERATION 7 4.1 Power Supply 7 4.2 Adjusting the Dialog Language 7 5 PERFORMING A MEASUREMENT 8 5.1 Switching on and Zero Adjustment 8 5.2 Single Point Measurement 8 6 CALIBRATION OF PTW-DENSIX 9 7 CLEANING, PREVENTIVE MAINTENANCE AND DISPOSAL 10 7.1 Cleaning 10 7.2 Preventive Maintenance 10 7.3 Disposal of the Product 10 8 TECHNICAL SPECIFICATIONS 11 9 ORDER INFORMATION 12 INDEX 13 D148.131.0/3 3
Intended Use 1 Intended Use 2 For your safety The densitometer PTW-DensiX is a modern, universal compact and easy-to-use single point densitometer for quality control of the film processing in diagnostic radiology and all other densitometric tasks, for example in radiotherapy. The PTW-DensiX complies with the actual regulations of: IEC 61223 Evaluation and routing testing in medical imaging departments -2-1 (1993-07) Constancy tests - Film processors -2-2 (1993-07) Constancy tests - Radiographic cassettes and film changers - Film-screen contact and relative sensitivity of the screencassette assembly -2-3 (1993-07) Constancy tests - Darkroom safelight conditions -2-4 (1994-03) Constancy tests - Hard copy cameras -2-10 (1999-09) Constancy tests - X-ray equipment for mammography -2-11 (1999-09) Constancy tests - Equipment for general direct radiography -3-1 (1999-03) Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems -3-2 (1996-11) Acceptance tests - Imaging performance of mammographic X-ray equipment -3-3 (1996-11) Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA) -3-4 (2000-03) Acceptance tests - Imaging performance of dental X-ray equipment The following safety statements are divided into DANGER, WARNING, and CAUTION. Definitions DANGER Indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury. WARNING Indicates a hazard. If not avoided, the hazard can result death or serious injury. CAUTION Indicates a potential hazard. If not avoided, the hazard could result in minor injury or product / property damage. Features well legible digital display adjustable dialog language (German, English, French) easy operation safe film positioning through measuring area with crosshairs can be calibrated by the user (menu prompted) 4 D148.131.0/3
Safety Information WARNING DANGER Explosion Hazard The product is not suitable for operation in areas of risk where an explosion hazard may occur. Explosion hazards may be caused by the use of combustible anaesthetics, skin-cleansing agents and disinfectants. Furthermore the product is not suitable for application in oxygen-enriched atmospheres. The atmosphere is considered to be oxygen-enriched when more than 25 % of oxygen or nitrous oxide is added to the ambient air. WARNING Shock Hazard Strictly observe the following warnings. Failure to do so may endanger the lives of the patient, the user and other persons involved. Suffocation Hazard Dispose of the packaging material, observing the applicable waste-control regulations. Keep the packaging material out of children's reach. Patient Hazard The product is a medical electrical device and must only be handled by persons who are trained in the use of such equipment and are capable of applying it properly. The operator must be trained in the use of the device. Risk of Poisoning Chemicals required for application or maintenance of the device, for instance, must under all circumstances be stored, prepared, and kept at hand in their specific containers. Failure to observe this instruction may result in severe consequences for the patient. Before using the product, the operator must ascertain that it is in correct working order and operating condition. Before putting the device into operation, visually inspect all connection cables for signs of damage. Damaged cables and connectors must be replaced immediately. Devices on which moisture condensation has developed as a result of temperature changes must not be switched on unless completely dry. Liquids must not enter the device. If liquids have entered the device, it must be thoroughly inspected before being used again. CAUTION Equipment damage - Before connecting the device to the power line, make sure that line voltage and frequency are equivalent to the ratings indicated on the nameplate of the device. Equipment damage - Always observe the ambient conditions as indicated in the `Technical Specifications`. D148.131.0/3 5
Operating Controls and Indicators 3 Operating Controls and Indicators Figure 1: Display- and Control Panel of PTW-DensiX 1 Measuring arm 2 LC display 3 Press the button On/Next to switch on the PTW-DensiX or to get to the next measurement / numerical values / functions. 4 Press the button Zero for zero adjustment 5 Press the button Off to switch off the PTW- DensiX (device switches off automatically about 1.5 min after the last action. 6 Measuring area 7 Type plate (bottom) 8 Connection for power supply (device back) 6 D148.131.0/3
4 First Time Operation 4.1 Power Supply Connect the power supply to the PTW-DensiX. Connect the power supply to mains. HINT The power supply can be operated in the voltage range of 100... 240 V. 4.2 Adjusting the Dialog Language The dialog text can be displayed in English, German or French. To adjust the dialog language, push the button ON/NEXT, keep it pressed and then push the button OFF. The display indicates for example LANGUAGE: English Adjust the language using the buttons ON/NEXT ( ) or the button ZERO ( ). The adjusting mode is quit by pushing the button OFF. D148.131.0/3 7
Performing a Measurement 5 Performing a Measurement 5.1 Switching on and Zero Adjustment Density: 0.00 The PTW-DensiX switches on automatically when the measuring arm will be pressed down. When the device is switched on the measuring area is illuminated. To switch off the device you have to press the Off button. NOTE The device switches off automatically after about 1.5 min after the last action. Press down the measuring arm until the measuring area is brightly illuminated. 5.2 Single Point Measurement Put the part of the film to be measured onto the measuring area (within the crosshairs) and press down the measuring arm until the result is displayed. For example: Density: 3.36 The measuring value will be displayed until: a new measurement will be carried out the device will be switched off with the Off button the device switches off automatically approximately after 1.5 min. The display indicates the firmware version: and then DENSITOMETER VERSION: x.xx Density: x.xx The DensiX should be zeroed before each measurement: push the button ZERO The display indicates DENSITOMETER Zero processing Press down the measuring arm and keep it pressed until the display indicates Density: 0.00 8 D148.131.0/3
6 Calibration of PTW-DensiX General Calibrating a densitometer means to provide exact reference values for densitometric measurements by establishing defined optical densities and related density values. The calibration of the DensiX is performed with help of the supplied calibration film at optical density values of D = 0 and D 2.0. The calibration has already been done in the factory and usually will remain stable. However, the calibration may change if Calibration CAUTION Erroneous calibration Before calibration the device has to be switched off. Switch on the PTW-DensiX (hold down the measuring arm). Perform the zero processing. Now press the button ON/NEXT, hold it down and press the button Zero. the calibration was not done with the supplied calibration film the calibration was not properly done The display now shows SPOT Calibration: 2.32 a software reset was performed (for example change of EEPROM) It is recommended to check the calibration in regular intervals (weekly), particularly after repairs. CAUTION Erroneous calibration Calibration checks and recalibration must only be executed using the original calibration film! The device number on the film has to be the same as the number on the typeplate. Checking the Calibration This calibration value must be the same value as the specified value near the black dot on the calibration film. If it is not, use the buttons ON/NEXT ( ) or the button ZERO ( ) to adjust the spot calibration value to the one specified on the calibration film. Then put the black dot of the calibration film on the measuring area within the cross-hairs and press down the measuring arm until the display shows: DENSITOMETER Ready The calibration is now finished. Perform the zero processing. Measure the density of the black dot on the calibration film. The measuring value must be the same as the one specified on the calibration film. Otherwise you have to recalibrate the device as follows. D148.131.0/3 9
Cleaning, Preventive Maintenance and Disposal 7 Cleaning, Preventive Maintenance and Disposal 7.1 Cleaning CAUTION Equipment damage Clean the sensitive optical parts regularly with alcohol using a soft cloth. Clean the device surface with a cloth moistened with soap water; no liquid must enter the device. CAUTION Equipment damage Do not use abrasive or polishing agents. 7.2 Preventive Maintenance 7.3 Disposal of the Product At the end of the product life the PTW-DensiX components must be disposed of in compliance with the applicable waste control regulations. The different materials must be separated and recycled as appropriate. The PTW-DensiX does not contain hazardous materials. The electronic components must be recycled according to local regulations. The cost for an eventual return at the end of the product life time is to be borne by the customer. Check before each use Before each use, visually inspect the device and the cables for signs of mechanical damage If damages or malfunctions are identified, the device must be repaired before it is used again. Calibration Check the calibration weekly (see chapter 6). The PTW-DensiX does not require any other, regular maintenance measures. 10 D148.131.0/3
8 Technical Specifications Only values for which tolerances or limits are specified are guaranteed. Values for which no tolerances are specified are for information only. Device designation Intended Use Warm-up time Light source Length of the measuring arm: Aperture Measuring range DensiX density measurement none built-in, very stable 18 cm, suitable to measure in the center of 35 cm x 35 cm films 7 mm² (0.00... 4.5) D Measuring accuracy at D 1: D < ± 0.02 D > 1: D < ± 1.5 % Reproducibility of a single point measurement D < ± 0.02 Zeroing and calibration LC display Power supply Can be performed by the user. 2 lines, 16 character/line 3 dialog languages adjustable external power supply (100... 240) V / 9.5 V / 500 ma / 50 Hz Outer dimensions length: 240 mm width: 110 mm height: 100 mm Weight 770 g Environmental conditions Transport and storage Ambient temperature: (-10... 50) C Rel. humidity: Atmospheric pressure: (10... 90) %, no condensation (max. 20 g/m³ absolute humidity) (600... 1200) hpa Operation Ambient temperature: (+15... 35) C Rel. humidity: Atmospheric pressure: (30... 75) %, no condensation (max. 20 g/m³ absolute humidity) (700... 1060) hpa D148.131.0/3 11
Order Information 9 Order Information DensiX 52001 densitometer digital densitometer with built-in light source, 3 mm aperture, measuring range 0.00-4.00 OD. Suitable for constancy and acceptance tests. Power supply required Block of 50 forms according to DIN 6868-2 L991069 L504004 12 D148.131.0/3
Index B Button Off... 6 Button On/Next... 6 Button Zero... 6 C Calibration of PTW-DensiX... 9 CAUTION, definition... 4 Cleaning... 10 Control Panel... 6 Current Supply... 7 D DANGER, definition... 4 Dialog Language... 7 Display panel... 6 Disposal... 10 F First Time Operation... 7 G General Information... 2 I Intended Use...4 M Maintenance...10 Measurement...8 O Operating Controls and Indicators...6 Order Information...12 S Safety Information...4 Single Point Measurement...8 T Technical Specifications...11 Type plate...6 Z Zero Adjustment...8 D148.131.0/3 13