Pro-tec Compact 2 User manual

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

COMPACT 2

COMPACT 2 Mammo

Automated X-ray film pro essor

Model/ID: 119x-x-x000

Basic UDI-DI: 426050264A003UE

Instru tions for use

Ident. no. 5190-0-0002

NOTE

All sheets of this document contain proprietary and confidential information of

PROTEC GmbH & Co. KG and is intended for exclusive use by current PROTEC GmbH

& Co. KG customers. Copying, disclosure to other or other use is prohibited without

the express written authorization of PROTEC´s law department. Report any violations

of this requirement to PROTEC GmbH & Co. KG.

Comments and questions about the documentation please contact:

PROTEC GmbH & Co. KG

In den Dorfwiesen 14, 71720 Oberstenfeld

Germany

Tel: (+ 49) 7062 – 92 55 0

Fax: (+ 49) 7062 – 92 55 60

E-Mail: prote @prote -med. om

Internet: www.prote -med. om

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Table of ontents

Page

Table of ontents ........................................................................................................................... 3

Revision Status .............................................................................................................................. 6

General Notes ................................................................................................................................ 7

Me hani al and Ele tri Warning ............................................................................................... 7

To the User ..................................................................................................................................... 7

Devi e Des ription .............................................................................................................. 9

1.1 Introduction ......................................................................................................................................................................................... 9

1.2 Description............................................................................................................................................................................................ 9

1.2.1 Versions ...................................................................................................................................................................................... 9

1.2.2 Installation ................................................................................................................................................................................ 9

1.3 Performance Characteristics ................................................................................................................................................... 10

1.4 Intended Use .................................................................................................................................................................................... 10

1.5 Clinical Benefit ................................................................................................................................................................................. 10

1.6 Patient Target Group(s .............................................................................................................................................................. 10

1.7 Medical Conditions to be diagnosed ................................................................................................................................ 10

1.8 Indications and Contraindications ...................................................................................................................................... 11

1.8.1 Indication................................................................................................................................................................................ 11

1.8.2 Contraindication ................................................................................................................................................................ 11

1.9 Intended User Group ................................................................................................................................................................... 11

1.10 Declaration of Conformity ........................................................................................................................................................ 11

Safety Instru tions ............................................................................................................ 12

2.1 General Safety Instructions ...................................................................................................................................................... 13

2.1.1 Requirements for Operation ...................................................................................................................................... 13

2.1.2 Device Operation .............................................................................................................................................................. 13

2.1.2.1 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 Devices .................................................................... 14

Control Elements and Displays ....................................................................................... 15

3.1 Main switch of the automated X-ray film processor ................................................................................................ 15

3.2 Control Elements and Displays of the automated X-ray film processor ...................................................... 15

3.2.1 Standard Controls and Displays ............................................................................................................................... 15

Handling ............................................................................................................................. 16

4.1 Operation of the automated X-ray film processor .................................................................................................... 16

4.1.1 Before starting ..................................................................................................................................................................... 17

4.1.2 Working procedure .......................................................................................................................................................... 17

4.1.3 After work ............................................................................................................................................................................... 17

4.1.4 Stand-by mode ................................................................................................................................................................... 17

4.1.5 Switching on the device ............................................................................................................................................... 17

4.1.6 Automatic mode ............................................................................................................................................................... 17

4.1.7 Anti-crystallization function ........................................................................................................................................ 18

4.1.8 Time replenishment ........................................................................................................................................................ 18

4.1.8.1 Setting of the time replenishment ................................................................................................................... 18

4.1.9 Working parameters ........................................................................................................................................................ 18

4.1.9.1 Display working parameters ................................................................................................................................ 18

4.1.9.2 Setting working parameters ................................................................................................................................. 18

4.1.10 Processing time .................................................................................................................................................................. 18

4.1.11 Developer temperature ................................................................................................................................................. 19

4.1.12 Dryer temperature ............................................................................................................................................................ 19

4.1.13 Replenishment time ........................................................................................................................................................ 19

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4.1.14 Dimmer function of display ........................................................................................................................................ 20

4.1.14.1 Changing the intensity of the display ............................................................................................................ 20

4.1.15 Machine cover safety disconnection .................................................................................................................... 20

4.1.16 Auto fill function ................................................................................................................................................................ 20

4.1.16.1 Starting up the auto fill function ....................................................................................................................... 20

4.1.16.2 Manual cancellation of the auto fill function ............................................................................................. 21

4.1.17 Manual mode ...................................................................................................................................................................... 21

4.1.17.1 Switching to manual mode .................................................................................................................................. 21

4.1.17.2 Switching back to automatic mode ................................................................................................................ 21

4.1.17.3 Manual starting and stopping the film transport .................................................................................... 21

4.1.17.4 Manual replenishment ............................................................................................................................................ 21

4.1.18 Use of memory function ............................................................................................................................................... 21

4.1.18.1 Store processing parameters ............................................................................................................................... 21

4.1.18.2 Recall processing parameters.............................................................................................................................. 21

4.1.18.3 Leave memory mode without change ......................................................................................................... 22

4.1.19 Lock function ....................................................................................................................................................................... 22

4.1.19.1 Activating and de-activating of the input lock ......................................................................................... 22

4.1.20 Stop film transport ............................................................................................................................................................ 22

4.1.21 Infrared sensitive materials .......................................................................................................................................... 22

4.1.22 Automatic cooling function ....................................................................................................................................... 22

4.2 Removal and installation of Dryer Rack (two-parts ................................................................................................. 23

4.2.1 Removal................................................................................................................................................................................... 23

4.2.2 Installation ............................................................................................................................................................................. 23

4.3 Function of the automated X-ray film processor ....................................................................................................... 24

4.3.1 Switching the automated X-ray film processor on and off ..................................................................... 24

Safety and Maintenan e ................................................................................................... 25

5.1 Introduction ...................................................................................................................................................................................... 25

5.2 Reusability .......................................................................................................................................................................................... 25

5.3 Cleaning and Disinfecting ........................................................................................................................................................ 25

5.3.1 Cleaning .................................................................................................................................................................................. 25

5.3.2 Daily cleaning ...................................................................................................................................................................... 25

5.3.3 Weekly cleaning ................................................................................................................................................................. 26

5.3.4 Thorough cleaning every 3 months ...................................................................................................................... 26

5.3.5 Not in operation for 2 weeks or longer ............................................................................................................... 27

5.4 Inspection and Maintenance .................................................................................................................................................. 27

5.4.1 Daily Monitoring before and during the Examination Operation....................................................... 27

5.4.2 Regular Monitoring .......................................................................................................................................................... 27

5.4.3 Maintenance ........................................................................................................................................................................ 27

5.4.4 Warranty .................................................................................................................................................................................. 27

5.4.5 Product Service Life ......................................................................................................................................................... 28

5.4.6 Further information.......................................................................................................................................................... 28

5.4.7 Disposal Notes .................................................................................................................................................................... 28

Power Supply ..................................................................................................................... 29

6.1 Electrical Connection .................................................................................................................................................................. 29

6.2 Protection Class .............................................................................................................................................................................. 29

6.3 Power Consumption.................................................................................................................................................................... 29

Te hni al Data .................................................................................................................... 30

7.1 Dimensions ........................................................................................................................................................................................ 31

7.2 Protection Type and Protection Class ............................................................................................................................... 31

7.3 Environmental Conditions ....................................................................................................................................................... 31

7.3.1 Environmental Conditions during Operation .................................................................................................. 31

7.3.2 Environmental Conditions for Shipping and Storage ................................................................................ 31

Des ription of Symbols, Labels and Abbreviations ..................................................... 32

8.1 Symbols ............................................................................................................................................................................................... 32

8.2 Type Label .......................................................................................................................................................................................... 33

8.3 Labels .................................................................................................................................................................................................... 33

8.4 Positioning of the Symbols and Labels ............................................................................................................................ 35

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8.5 Abbreviations ................................................................................................................................................................................... 35