Pro-tec Optimax 2010 Manuel utilisateur

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 f lm processor

Model/ID: 116x-x-xx00

Basic UDI-DI: 426050264A002UC

Instruct ons for use

Ident. no. 5160-0-0002

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-Ma l: protec@protec-med.com

Internet: www.protec-med.com

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 of 35

Table of contents

Page

Table of contents ........................................................................................................................... 3

Rev s on Status .............................................................................................................................. 5

General Notes ................................................................................................................................ 6

Mechan cal and Electr c Warn ng ............................................................................................... 6

To the User ..................................................................................................................................... 6

Dev ce Descr pt on .............................................................................................................. 8

1.1 Introduction ......................................................................................................................................................................................... 8

1.2 Description............................................................................................................................................................................................ 8

1.2.1 Versions ...................................................................................................................................................................................... 8

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

1.3 Performance Characteristics ...................................................................................................................................................... 9

1.4 Intended Use ....................................................................................................................................................................................... 9

1.5 Clinical Benefit .................................................................................................................................................................................... 9

1.6 Patient Target Group(s ................................................................................................................................................................. 9

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

1.8 Indications and Contraindications ...................................................................................................................................... 10

1.8.1 Indication................................................................................................................................................................................ 10

1.8.2 Contraindication ................................................................................................................................................................ 10

1.9 Intended User Group ................................................................................................................................................................... 10

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

Safety Instruct ons ............................................................................................................ 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 D splays ....................................................................................... 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 Controls and Displays Standard ............................................................................................................................... 15

3.2.2 Controls and Displays 2 pumps ................................................................................................................................ 16

Handl ng ............................................................................................................................. 17

4.1 Operation of the automated X-ray film processor .................................................................................................... 17

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

4.1.2 Working procedure .......................................................................................................................................................... 18

4.1.3 After work ............................................................................................................................................................................... 18

4.1.4 Stand-by mode ................................................................................................................................................................... 18

4.1.5 Switching on the device ............................................................................................................................................... 18

4.1.6 Automatic mode ............................................................................................................................................................... 18

4.1.7 Anti-crystallization function ........................................................................................................................................ 19

4.1.8 Time replenishment ........................................................................................................................................................ 19

4.1.8.1 Setting off the time replenishment ................................................................................................................. 19

4.1.9 Working parameters ........................................................................................................................................................ 19

4.1.9.1 Display working parameters ................................................................................................................................ 19

4.1.9.2 Setting working parameters ................................................................................................................................. 19

4.1.10 Processing time .................................................................................................................................................................. 19

4.1.11 Developer temperature ................................................................................................................................................. 20

4.1.12 Dryer temperature ............................................................................................................................................................ 20

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 4 of 35

4.1.13 Replenishment time ........................................................................................................................................................ 20

4.1.14 Machine cover safety disconnection .................................................................................................................... 21

4.1.15 Auto fill function ................................................................................................................................................................ 21

4.1.15.1 Starting up the auto fill function ....................................................................................................................... 22

4.1.15.2 Manual cancellation of the auto fill function ............................................................................................. 22

4.1.16 Manual mode ...................................................................................................................................................................... 22

4.1.16.1 Switching to manual mode .................................................................................................................................. 22

4.1.16.2 Switching back to automatic mode ................................................................................................................ 22

4.1.16.3 Manual starting and stopping the film transport .................................................................................... 22

4.1.16.4 Manual replenishment ............................................................................................................................................ 22

4.1.17 Water saving mode .......................................................................................................................................................... 22

4.1.17.1 Activating the water saving mode ................................................................................................................... 22

4.1.17.2 Stop film transport ..................................................................................................................................................... 22

4.1.18 Use of memory function ............................................................................................................................................... 23

4.1.18.1 Store processing parameters ............................................................................................................................... 23

4.1.18.2 Recall processing parameters.............................................................................................................................. 23

4.1.18.3 To leave memory mode without change .................................................................................................... 23

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

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

Safety and Ma ntenance ................................................................................................... 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

Techn cal 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 during Shipping and Storage ....................................................................... 31

Descr pt on of Symbols, Labels and Abbrev at ons ..................................................... 32

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

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

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

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

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

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 5 of 35

NOTE

The information contained in this document conforms to the configuration of the

equipment as of the date 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.

Rev s on Status

Rev s on Date Updated pages Comment Author

4.0 04/12/2018

all new pumps, new main drive,

new document layout

5.0 17/04/2019

22, 53,

Warning hot air new, max.

power consumption in

processing changed to 2,0.

6.0 2021-05-25

all V5.0 transferred to new layout

(MDR MB

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 6 of 35

General Notes

WARNING!

In order to ma nta n the set and tested requ rements of the 60601 ser es of

standards, the ME system must not be mod f ed dur ng ts actual operat ng

l fe.

Mechan cal and Electr c Warn ng

WARNING!

All mov ng parts of the equ pment should be operated w th care. They must

be nspected and ma nta ned regularly and n accordance w th the

manufacturer's recommendat ons conta ned n the accompany ng

documents.

Only personnel author zed by PROTEC GmbH & Co. KG may carry out

ma ntenance and repa r work. Touch ng l ve parts and connect ons can be

fatal.

To the User

NOTE

The user of these accompanying documents is required to carefully read and

consider the instructions, warnings and cautions contained therein before

beginning operation.

Even if you have already operated similar equipment, the equipment described here

may nevertheless have undergone changes in design, manufacture and functional

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 GmbH & Co. KG. Assembly

personnel and other persons who are not employees of the Technical Service

Department of PROTEC GmbH & Co. KG are requested to contact the local branch

office of PROTEC GmbH & Co. KG before starting any assembly or service work.

For assembly and service work, it is necessary to use the "Technical Description” of

the Product and to observe the points contained therein.

Even if the product has been the subject of a hazard analysis and the design

corresponds to the current state of the art, residual risks remain during clinical use.

These are illustrated in the following instructions for use by application limits,

warnings and precautions.

Assembly and customer service work on the X-ray film processor described here

must be carried out by the authorized and qualified personnel of PROTEC GmbH &

Co. KG. Assembly personnel and other persons who are not employees of the

Technical Service Department of PROTEC GmbH & Co. KG are requested to contact

the local branch office of PROTEC GmbH & Co. KG before starting any assembly or

service work.

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 7 of 35

NOTE

The use of the product with 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 occurred in connection with the device must be reported to the manufacturer

and the competent authority of the Member State in which the user and/or patient

is resident.

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 8 of 35

Dev ce Descr pt on

1.1 Introduct on

These instructions for use describe the performance characteristics and operation required for efficient

and effective handling of the automated X-ray film processor.

Before working with the automated X-ray film processor, the complete operating instructions must be

read, in particular the safety instructions and the chapter Handling.

NOTE

The instructions for use are fully valid for all model variants of the automated X-ray

film processor described.

1.2 Descr pt on

The automated X-ray film processor is a laboratory device used for automatic development of X-ray

films in human medicine.

The device is equipped with a precise roller transport system that can process sheet films.

Automatic film acquisition starts as soon as a film is fed into the feeder.

The film materials are developed, fixed, watered and dried.

With the easy-to-use microprocessor 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

replenished.

This instructions for use provide important information on the installation, operation and maintenance

of the unit. Please follow the instructions given carefully to ensure reliable operation of your automated

X-ray film processor.

1.2.1 Vers ons

OPTIMAX 2010, 220-240V, 50Hz 1160-1-8000

OPTIMAX 2010, 220-240V, 50Hz, 2 pumps 1160-1-2800

OPTIMAX 2010, 220-240V, 60Hz 1160-2-8000

OPTIMAX 2010, 220-240V, 60Hz, 2 pumps 1160-2-8000

OPTIMAX 2010, 220-240V, 60Hz, for 110V operation 1160-9-8000

OPTIMAX 2010, 220-240V, 60Hz, 2 pumps for 110V operation 1160-9-2800

OPTIMAX 2010 Mammo, 220-240V, 50Hz 1161-1-8000

OPTIMAX 2010 Mammo, 220-240V, 50Hz, 2 pumps 1161-1-2800

OPTIMAX 2010 Mammo, 220-240V, 60Hz 1161-2-8000

OPTIMAX 2010 Mammo, 220-240V, 60Hz, 2 pumps 1161-2-8000

OPTIMAX 2010 Mammo, 220-240V, 60Hz, for 110V operation 1161-9-8000

OPTIMAX 2010 Mammo, 220-240V, 60Hz, 2 pumps for 110V operation 1161-9-2800

Opt onal accessor es

The following optional accessories are available for the automated X-ray film processor:

•Base table 1267-0-0000

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 9 of 35

1.2.2 Installat on

NOTE

The installation of the automated X-ray film processor must be performed by

PROTEC Customer Service or a service authorized by it.

The automated X-ray film processor is intended for operation in a darkroom or in premises specially

darkened for this purpose.

For detailed information, please refer to the installation instructions of the automated X-ray film

processor.

Contact information of persons qualified by designation of the manufacturer to perform the installation

is available upon request from:

PROTEC GmbH & Co. KG

Germany

In den Dorfwiesen 14, 71720 Oberstenfeld

Telephone: +49 (0 7062 – 92 55 0

Fax: +49 (0 7062 – 92 55 60

E-Mail: protec@protec-med.com

Internet: www.protec-med.com

1.3 Performance Character st cs

•Memory for 2 programs

•Variable processing speed

•Adjustable dryer heating

•Overflow protection

•Water save mode selectable

•Compatible with all common types of film and chemicals

1.4 Intended Use

The automated X-ray film processor is intended for automatic development of X-ray films

in human medicine.

1.5 Cl n cal Benef t

The clinical benefit of using X-ray film processors is the development of X-ray films into two-

dimensional X-ray images for creation or specification of findings as a basis for treatment decisions.

In analog X-ray diagnostics, X-ray film processing plays a very important role and makes an essential

contribution to the application of this procedure. After the human body and the X-ray films have been

irradiated, the X-ray film is generated with the aid of chemicals. Only after X-ray film generation, the X-

ray films can be used for examination or diagnosis. Therefore, for the X-ray film processors, the general

clinical benefit is valid for analog conventional X-ray examinations within the intended use.

1.6 Pat ent Target Group(s)

As X-ray film processors are not intended for use on patients, no intended patient group can be

identified for them.

The intended patient group for a diagnostic X-ray imaging in human medicine includes all people for

whom a justifying indication for a medical X-ray has been given by a physician with the necessary

expertise in radiation protection.

There are no general or fundamental restrictions on the patient group regarding age, gender, origin

and patient condition.

V6.0_2021-05-25 OPTIMAX 2010 Instructions for use 5160-0-0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 10 of 35

1.7 Med cal Cond t ons to be d agnosed

Conventional X-ray images can be used to diagnose medical conditions.

A complete list of medical conditions to be diagnosed is not feasible, as the range of conventional

radiographs is very diverse and may also very in the course of medical-technical progress.

Examples for medical conditions to be diagnosed are:

•Bone fracture or bony injuries of the skeletal system or pathological changes of the bony tissue.

•Control of the correct set-up of the fracture.

•Luxation and bony ligament tears of the musculoskeletal system.

•Degenerative, inflammatory, traumatic and tumorous diseases and changes of the

musculoskeletal system.

•Deformities and defective positions of the skeletal system.

•Thoracic and pulmonary symptomatology (thorax exposures .

•Sclerosis.

•Inflammatory and expansive processes of the mucous membrane, craniofacial bones and the

expansion of the paranasal sinuses.

•Disease of the abdominal cavity (e.g., acute abdomen, abdominal overview radiograph,

urethrogram, cystogram .

1.8 Ind cat ons and Contra nd cat ons

1.8.1 Ind cat on

As X-ray film processors have no intended main effect in or at the human boy, no indications can be

shown for them.

The indication for diagnostic X-ray imaging in human medicine is always given when the patient

derives a benefit from X-ray diagnostics that outweighs the radiation risk (justifying indication .

1.8.2 Contra nd cat on

As X-ray film processors have no intended main effect in or at the human boy, no contraindications can

be shown for them.

There are no absolute contraindications for diagnostic X-ray imaging in human medicine.

However, only medically indicated radiographs may be performed on individuals.

For pregnant women and children, strong consideration must be given to whether a radiograph is

necessary. If possible, it should be avoided.

1.9 Intended User Group

X-ray film processors are intended exclusively for use by professional users who are trained in the

proper handling, use and operation as well as in the permitted conjunction with other medical

products, objects and accessories.

Appropriate users can be, for example: X-ray technicians, X-ray assistants, medical technical X-ray

assistants, surgeons, casualty surgeons, orthopaedists and other trained medical personnel.

Autres manuels pour optimax 2010

Ce manuel convient aux modèles suivants

Table des matières

Autres manuels Pro-tec Équipement médical

Pro-tec

Pro-tec 7041-5-87 Series Manuel utilisateur

Pro-tec

Pro-tec COMPACT 2 NDT Manuel utilisateur

Pro-tec

Pro-tec UCARE Manuel utilisateur

Pro-tec

Pro-tec optimax 2010 Manuel utilisateur

Pro-tec

Pro-tec PROGNOST B Manuel utilisateur

Pro-tec

Pro-tec PRS 500 C Manuel utilisateur

Pro-tec

Pro-tec 7073-9-000 Series Manuel utilisateur

Pro-tec

Pro-tec ECOMAX Manuel utilisateur

Pro-tec

Pro-tec optimax 2010 Manuel utilisateur

Pro-tec

Pro-tec PROGNOST F 7041-5-8701L Manuel utilisateur

Pro-tec

Pro-tec COMPACT 2 Manuel utilisateur

Pro-tec

Pro-tec ECOMAX Manuel utilisateur

Pro-tec

Pro-tec PRS 500 X Manuel utilisateur

Manuels Équipement médical populaires d'autres marques

TekTone

TekTone Tek-CARE160 Manuel utilisateur

NeuroMetrix

NeuroMetrix Quell 2.0 Manuel utilisateur

AMT

AMT XLR8 Manuel utilisateur

Medipost-Nutristoma

Medipost-Nutristoma MD300K2 Manuel utilisateur

EDAN

EDAN SONOTRAX Pro Manuel utilisateur

Restorative Therapies

Restorative Therapies RT300 Manuel utilisateur

Gendex

Gendex Expert DC Manuel utilisateur

Dexcowin

Dexcowin ADX4000W Manuel utilisateur

Libelium

Libelium MySignals Manuel utilisateur

Acelity

Acelity V.A.C.ULTA 4 Manuel utilisateur

Caputron

Caputron ActivaDose II tDCS Manuel utilisateur

FujiFilm

FujiFilm Sonart Manuel du propriétaire

Plinth 2000

Plinth 2000 93CDT Manuel utilisateur

GE SENOGRAPHE 800T Manuel utilisateur

GE Definium 5000 Manuel utilisateur

Kanmed

Kanmed GE-1380 Manuel utilisateur

Huntleigh

Huntleigh FD1 Manuel utilisateur

Stryker

Stryker SPR Plus Manuel utilisateur