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PROTEC GmbH & Co. KG 

In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 
Telefon: +49 (0) 7062/92 55-0 E-Mail: [email protected]

 

Version: 6.0 

Issued: 2021-05-25 

Subject to alterations

 

 

 
 
 

 

OPTIMAX 2010 

OPTIMAX 2010 Mammo 

 
 

Automated X-ray film processor 

 

Model/ID: 116x-x-xx00 

Basic UDI-DI: 426050264A002UC

 

 

 

Instructions for use 

 

Ident. no. 5160-0-0002 

 
 

 

 

Содержание 1160-1-2800

Страница 1: ...y Telefon 49 0 7062 92 55 0 E Mail protec protec med com Version 6 0 Issued 2021 05 25 Subject to alterations OPTIMAX 2010 OPTIMAX 2010 Mammo Automated X ray film processor Model ID 116x x xx00 Basic...

Страница 2: ...use is prohibited without the express written authorization of PROTEC s law department Report any violations of this requirement to PROTEC GmbH Co KG 2021 PROTEC GmbH Co KG Oberstenfeld Comments and...

Страница 3: ...1 2 1 Operating Type 13 2 1 3 Operating Personnel 14 2 1 4 Ventilation 14 2 1 5 Explosion Protection 14 2 1 6 Interaction with Other Devices 14 2 1 7 Electromagnetic Environment and influencing of Dev...

Страница 4: ...4 2 1 Switching the automated X ray film processor on and off 24 5 Safety and Maintenance 25 5 1 Introduction 25 5 2 Reusability 25 5 3 Cleaning and Disinfecting 25 5 3 1 Cleaning 25 5 3 2 Daily clean...

Страница 5: ...of manufacture Revisions to the equipment subsequent to the date of manufacture will be addressed in service updates distributed to the PROTEC Technical Service Organization Revision Status Revision D...

Страница 6: ...al sequence which have a considerable influence on operation Assembly and customer service work on the system described here must be carried out by the authorized and qualified personnel of PROTEC Gmb...

Страница 7: ...th attachments or accessories not authorized by PROTEC or other non approved components is not permitted NOTE According to Regulation EU 2017 745 on medical devices all serious incidents that have occ...

Страница 8: ...oprocessor control processing conditions can be adjusted to suit a wide variety of films and chemicals The developer and fixing solutions are temperature controlled circulated and automatically replen...

Страница 9: ...sor is intended for automatic development of X ray films in human medicine 1 5 Clinical Benefit The clinical benefit of using X ray film processors is the development of X ray films into two dimension...

Страница 10: ...bdominal overview radiograph urethrogram cystogram 1 8 Indications and Contraindications 1 8 1 Indication As X ray film processors have no intended main effect in or at the human boy no indications ca...

Страница 11: ...requirements of Regulation EU 2017 745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices including all applicable corrigenda The declaration of conformity is av...

Страница 12: ...read and adhered to NOTE After the initial installation the commissioning must be logged with Default function test NOTE The X ray film processors may only be commissioned if all safety measures for...

Страница 13: ...the chemicals WARNING Inhalation of chemical vapors can be harmful and must be avoided For this reason sufficient ventilation must be ensured at the installation site WARNING If chemicals get into th...

Страница 14: ...WARNING Inhalation of chemical vapors can be harmful to health and must be avoided For this reason sufficient ventilation must be ensured at the installation site 2 1 5 Explosion Protection The autom...

Страница 15: ...ray film processor is switched on or off by the main switch 3 2 Control Elements and Displays of the automated X ray film processor 3 2 1 Controls and Displays Standard Short Overview and Control Pane...

Страница 16: ...er value 3 Arrow button down decrease parameter value Mode Button 4 Processing time in minutes 5 Developer temperature in C 6 Dryer output in 7 Replenishment time developer in seconds 8 Replenishment...

Страница 17: ...ructions CAUTION Never operate the machine without liquid CAUTION Do not place any objects on the device NOTE High or low room temperature can affect the functionality of the X ray film processor If t...

Страница 18: ...button 5 is flashing It is possible that the chemical bath has not reached the required temperature even after the Start cycle has been completed You need to wait until the developer temperature is r...

Страница 19: ...achine develops fixes rinses and dries the film materials automatically The film and chemical requirements can be adjusted accordingly and stored in the control unit 4 1 9 1 Display working parameters...

Страница 20: ...aterial to be processed 95 for example corresponds to 95 of the maximum output of the dryer heating To avoid dryer spots on the film the dryer output may not be set too high Adjust the temperature so...

Страница 21: ...without the cover In the event that the machine cover is removed during film throughput the film transport will be stopped On the display the error message E1 will be displayed This will render the fi...

Страница 22: ...d down 3 simultaneously 4 1 16 3 Manual starting and stopping the film transport 1 Switch to manual mode 2 Press the processing time button 4 the button illuminates 3 Start the film transport by press...

Страница 23: ...the parameter memory P1 or P2 These save the parameters old values will be overwritten 4 Press the button 5 Store to store parameters and to leave the memory mode 4 1 18 2 Recall processing parameters...

Страница 24: ...OTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 24 of 35 4 2 Function of the automated X ray film processor 4 2 1 Switching the automated X ray film processor on and off The automated...

Страница 25: ...achine WARNING Make sure that no liquid enters the inside of the housing during cleaning and disinfection to prevent electrical short circuits and or corrosion Do not allow any liquids to run into the...

Страница 26: ...Depending on the film throughput the machine must be thoroughly cleaned every 3 to 6 months by PROTEC customer service or a service authorized by PROTEC Appropriate tank cleaners are available for th...

Страница 27: ...ation Operation n a See Chapter Cleaning 5 4 2 Regular Monitoring n a See Chapter Cleaning 5 4 3 Maintenance PROTEC Customer Service or a service authorized by it must carry out the required maintenan...

Страница 28: ...own risk 5 4 6 Further information Detailed information on the individual chapters and on safe operation transport and storage can be found in the Technical Description and Installation Instructions o...

Страница 29: ...label Typ 116x 1 x000 230 V 10 8 8A 50Hz Typ 116x 2 x000 Typ 116x 9 x000 230 V 10 8 8A 60Hz 230 V 10 7 1A 60Hz for 110V operation Device according to IEC 1010 EN 61010 VDE 0411 Overvoltage category II...

Страница 30: ...ontinuously circulated by a circulation pump Replenishment Automatic by film surface measurement in relation to processed film replenishment can be switched off time replenishment can be activated Dev...

Страница 31: ...rkroom Surrounding temperature 18 40 C 51 6 104 F ventilated room room temperature must be lower than set bath temperature If the ambient temperature exceeds the set bath temperature the image quality...

Страница 32: ...handle with care This way up Attention observe accompanying documents CE marking Manufacturer Medical Device Order reference Serial number Unique Device Identification Production date www protec med...

Страница 33: ...wiesen 14 71720 Oberstenfeld Germany 33 of 35 Operating parameters display Increase set value Decrease set value Processing time Developer temperature Dryer capacity in Developer replenishment time Fi...

Страница 34: ...OTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 34 of 35 Control panel foil standard Control panel foil 2 pump version Designation hose connections Description of the fuse 2x T sb 10A...

Страница 35: ...y 35 of 35 8 4 Positioning of the Signs and Labels 8 5 Abbreviations mm Millimetre cm Centimetre Lb Pound kg Kilogram C Degree Celsius hPa Hectopascal DIN German Industry Standard EN European Standard...

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