Pro-tec PROGNOST XP Manuel utilisateur

PROTEC GmbH & Co. KG

In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

Telephone: +4 (0) 7062/ 2 55-0 E-Mail: [email protected]

Version: 1.0

Issued: 2021-05-17

Subject to alterations

PROGNOST XP, XPE & XPE-Akku

Basic diagnos ic X-ray sys em able,

non-powered or powered

Model/ID: 7036-0-17xx

Basic UDI-DI: 426050264X00 ZT

Model/ID: 7037-x-17xx

Basic UDI-DI: 426050264X011ZE

Model/ID: 7038-9-17xx

Basic UDI-DI: 426050264X024ZP

Ins ruc ions for use

ID No. 5038-0-0002

*Figure PROGNOST XPE-Akku

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 others or other use is prohibited without

the express written consent of PROTEC´s law department. Knowledge of violations

of these regulations must be reported immediately to PROTEC GmbH & Co. KG.

Comments and questions about the documentation, please contact:

PROTEC GmbH & Co. KG

In den Dorfwiesen 14 | 71720 Oberstenfeld

Germany

Phone: (+ 4 ) 7062 – 2 55 0

Fax: (+ 4 ) 7062 – 2 55 60

E-Mail: protec@protec-med.com

Internet: www.protec-med.com

V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku

Instructions for use 5038-0-0002

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Table of con en s

Page

Table of con en s ........................................................................................................................... 3

Revision S a us .............................................................................................................................. 6

General No es ................................................................................................................................ 7

Mechanical and Elec ric Warning ............................................................................................... 7

To he User ..................................................................................................................................... 7

Device Descrip ion .............................................................................................................. 8

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

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

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

1.2.1.1 PROGNOST XP .................................................................................................................................................................. 8

1.2.1.2 PROGNOST XPE ............................................................................................................................................................... 8

1.2.1.3 PROGNOST XPE-Akku ..................................................................................................................................................

1.2.2 Hardware and Network System Requirements .................................................................................................

1.2.3 Installation ................................................................................................................................................................................

1.2.3.1 Floor Loading Capacity............................................................................................................................................ 10

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

1.3.1 X-ray System Table PROGNOST XP ......................................................................................................................... 10

1.3.2 X-ray System Table PROGNOST XPE & PROGNOST XPE-Akku ............................................................... 10

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

1.5 Clinical Benefit ................................................................................................................................................................................. 11

1.6 Patient Target Group(s) .............................................................................................................................................................. 11

1.7 Medical Conditions to be diagnosed ................................................................................................................................ 11

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

1. Intended User Group ................................................................................................................................................................... 11

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

Safe y Ins ruc ions ............................................................................................................ 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 ....................................................................................................................................................... 13

2.1.4 Crushing and Collision Hazard .................................................................................................................................. 13

2.1.4.1 PROGNOST XP ............................................................................................................................................................... 13

2.1.4.2 PROGNOST XPE & XPE-Akku ................................................................................................................................. 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

Con rol Elemen s and Displays ....................................................................................... 16

3.1 Main Switch of the PROGNOST XP-series ....................................................................................................................... 16

3.2 Emergency Stop Switches of the PROGNOST XP-series ........................................................................................ 16

3.2.1 Emergency Stop Switch PROGNOST XP ............................................................................................................. 16

3.2.2 Emergency Stop Switch PROGNOST XPE & PROGNOST XPE-Akku .................................................... 16

3.3 Control Elements and Displays of the PROGNOST XP-series .............................................................................. 16

3.3.1 Control Elements and Displays PROGNOST XP .............................................................................................. 16

3.3.1.1 Brake Rollers ................................................................................................................................................................... 17

3.3.1.2 Brake Bracket for the Table Top .......................................................................................................................... 17

3.3.1.3 Hand Grips (optional) ............................................................................................................................................... 17

3.3.1.4 Lateral Edge Protection (optional) ................................................................................................................... 17

3.3.1.5 Shock Protection Profile (optional) .................................................................................................................. 17

3.3.1.6 Center Stop (optional) ............................................................................................................................................. 17

3.3.2 Control Elements and Displays PROGNOST XPE & PROGNOST XPE-Akku ..................................... 18

3.3.2.1 Brake Rollers ................................................................................................................................................................... 18

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3.3.2.2 Brake Bracket for the Table Top .......................................................................................................................... 18

3.3.2.3 Hand Grips (optional) ............................................................................................................................................... 18

3.3.2.4 Fixing Mechanism (optional) ............................................................................................................................... 1

3.3.2.5 Deflector (optional) .................................................................................................................................................... 1

3.3.2.6 Lateral Edge Protection (optional) ................................................................................................................... 1

3.3.2.7 Shock Protection Profile (optional) .................................................................................................................. 1

3.3.2.8 Protection Foil (optional)........................................................................................................................................ 1

3.3.2. Center Stop (optional) ............................................................................................................................................. 1

3.3.3 Emergency Stop Switch and Status Indication ............................................................................................... 20

3.3.3.1 Acoustic Status Indications ................................................................................................................................... 22

3.3.3.2 Acoustic and Visual Status Indications at Column Drive Blockage .............................................. 22

3.3.4 Hand Control ........................................................................................................................................................................ 23

Handling ............................................................................................................................. 24

4.1 Requirements before and during Operation ................................................................................................................ 24

4.2 Operation of the PROGNOST XP-Series............................................................................................................................ 24

4.2.1 Operating of the PROGNOST XP .............................................................................................................................. 24

4.2.1.1 Exposures with the PROGNOST XP .................................................................................................................. 24

4.2.2 Operating of the PROGNOST XPE & PROGNOST XPE-Akku ..................................................................... 25

4.2.2.1 Height adjustment of the table top ................................................................................................................ 25

4.2.2.2 Table heights - Zero balance performance ................................................................................................ 25

4.2.2.3 Saving and setting preferred table heights ................................................................................................ 25

4.2.2.4 Exposures with the PROGNOST XPE & PROGNOST XPE-Akku ......................................................... 25

4.2.3 Specifications for PROGNOST XPE-Akku Operation ..................................................................................... 26

4.2.3.1 Energy Saving Mode ................................................................................................................................................. 26

4.2.3.2 Battery Box ...................................................................................................................................................................... 26

4.2.3.3 Battery Charge Level ................................................................................................................................................. 28

4.2.3.4 Battery Box Charging Station ............................................................................................................................... 28

4.2.3.5 Charging the Battery Box ....................................................................................................................................... 2

4.2.3.6 Charging Cycle and Meaning of the Charging Control LED ............................................................ 30

4.3 Functions of the PROGNOST XP-Series ............................................................................................................................ 30

4.3.1 Switching the PROGNOST XP device on and off ........................................................................................... 30

Safe y and Main enance ................................................................................................... 31

5.1 Introduction ...................................................................................................................................................................................... 31

5.2 Reusability .......................................................................................................................................................................................... 31

5.3 Cleaning and Disinfection ........................................................................................................................................................ 31

5.3.1 Cleaning .................................................................................................................................................................................. 31

5.3.2 Disinfection ........................................................................................................................................................................... 31

5.4 Inspection and Maintenance .................................................................................................................................................. 32

5.4.1 Daily Monitoring before and during the Examination Operation....................................................... 32

5.4.2 Regular Monitoring .......................................................................................................................................................... 32

5.4.2.1 Quality control by the operator ......................................................................................................................... 32

5.4.2.2 Safety-related Controls ............................................................................................................................................ 32

5.4.3 Maintenance ........................................................................................................................................................................ 33

5.4.4 Warranty .................................................................................................................................................................................. 33

5.4.5 Product Service Life ......................................................................................................................................................... 33

5.4.6 Further Information ......................................................................................................................................................... 33

5.4.7 Applied Parts and Parts Considered as Applied Parts ................................................................................. 33

5.4.8 Disposal Notes .................................................................................................................................................................... 33

Power Supply ..................................................................................................................... 34

6.1 PROGNOST XPE ............................................................................................................................................................................... 34

6.2 PROGNOST XPE-Akku .................................................................................................................................................................. 34

6.3 Electromagnetic Compatibility (EMC) according to EN 60601-1-2 ................................................................ 35

6.3.1 Guidelines and Manufacturer’s Declaration – Electromagnetic interference .............................. 35

Technical Da a .................................................................................................................... 38

7.1 Dimensions ........................................................................................................................................................................................ 38

7.1.1 Dimensions PROGNOST XP ......................................................................................................................................... 38

7.1.2 Dimensions PROGNOST XPE ...................................................................................................................................... 38

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7.1.3 Dimensions PROGNOST XPE-Akku ......................................................................................................................... 3

7.2 Attenuation Equivalent .............................................................................................................................................................. 40

7.2.1 Protection Type and Protection Class .................................................................................................................. 40

7.3 Environmental Conditions ....................................................................................................................................................... 40

7.3.1 Environmental Conditions during Operation .................................................................................................. 40

7.3.2 Environmental Conditions for Shipping and Storage ................................................................................ 40

Descrip ion of Symbols, Labels and Abbrevia ions ..................................................... 41

8.1 Symbols ............................................................................................................................................................................................... 41

8.2 Type Label .......................................................................................................................................................................................... 43

8.2.1 Type Label PROGNOST XP ........................................................................................................................................... 43

8.2.2 Type Label PROGNOST XPE ........................................................................................................................................ 43

8.2.3 Type Label PROGNOST XPE-Akku ........................................................................................................................... 43

8.3 Labels .................................................................................................................................................................................................... 44

8.3.1 Labels PROGNOST XP ..................................................................................................................................................... 44

8.3.2 Labels PROGNOST XPE ................................................................................................................................................... 45

8.3.3 Labels PROGNOST XPE-Akku ...................................................................................................................................... 46

8.4 Positions of the Signs and Labels......................................................................................................................................... 48

8.4.1 Positions of the Signs and Labels PROGNOST XP ......................................................................................... 48

8.4.2 Positions of the Signs and Labels PROGNOST XPE ....................................................................................... 4

8.4.3 Positions of the Signs and Labels PROGNOST XPE-Akku .......................................................................... 50

8.5 Abbreviations ................................................................................................................................................................................... 51

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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 Organisation.

Revision S a us

Revision

Da e Upda ed pages Commen s Au hor

1.0 2021-05-17 all

Original issue XP-series

(MDR Layout)

V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku

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General No es

WARNING!

In order o main ain he se and es ed requiremen s of he 60601 series of

s andards, he ME sys em mus no be modified during i s ac ual opera ing

life.

Mechanical and Elec ric Warning

WARNING!

All of he movable assemblies and par s of his equipmen should be opera ed

wi h care and rou inely inspec ed in accordance wi h he manufac urer's

recommenda ions con ained in he equipmen accompanying documen s.

Main enance and service is only o be performed by cus omers au horized by

PROTEC GmbH & Co. KG.

Live elec rical erminals are deadly.

Do no remove flexible high- ension cables from X-ray ube cover or high-

ension genera or and/or access covers from X-ray genera or.

For all componen s of he equipmen pro ec ive ear hing means mus be

provided in compliance wi h he na ional regula ions.

Failure o comply wi h he foregoing may resul in serious or fa al bodily

injuries o he opera or or hose in he area.

To he User

NOTE

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

and carefully consider the instructions, warnings and cautions contained therein

before starting operation.

Even if you have already operated similar systems, changes in the design,

production and functional routine of the system described here may have been

made, which have a significant influence on the operation.

Assembly and service works on the system described here must be carried out by

authorised and qualified personnel from 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 of

PROTEC GmbH & Co. KG before assembly or service work is started.

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

the product and to observe the points it contains.

NOTE

The use of the product with add-on or accessory parts not authorized by PROTEC or

other unapproved components is not permitted.

NOTE

According to Regulation (EU) 2017/745 of medical devices, all serious incidents

related to the device must be reported to the manufacturer and the responsible

authority of the Member State where the user and/or the patient is established.

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Device Descrip ion

1.1 In roduc ion

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

and effective use of the PROGNOST XP-series.

Before you work with a product of the PROGNOST XP-series, the complete instructions for use must be

read, especially the Safety Instructions and the chapter Handling.

1.2 Descrip ion

The PROGNOST XP-series consist of mobile X-ray system tables with floating table top.

The XPE and XPE-Akku variations also have motorized height adjustment of the table.

The table is designated for the installation of an X-ray cassette holder (Bucky or Grid entity), which can

be moved manually in the longitudinal direction, an anti-scatter grid and a 3-field measuring chamber

for operation with an automatic exposure control unit.

The floating table top is locked in horizontal and vertical direction with a mechanical brake and can be

released by a brake bracket.

The wheels of the table can be locked separately by arrester.

1.2.1 Versions

1.2.1.1 PROGNOST XP

Model/ID: 7036-0-17xx

Table frame colour RAL 003

Table op versions:

Model/ID Ma erial L W Table op color

7036-0-1710 composite fibre 200 cm 65,5 cm white

7036-0-1711 composite fibre 200 cm 75,5 cm white

7036-0-1712 composite fibre 226 cm 75,5 cm white

7036-0-1713 carbon fibre 200 cm 75,5 cm white

7036-0-1714 carbon fibre 226 cm 75,5 cm white

1.2.1.2 PROGNOST XPE

Model/ID: 7037-x-17xx

Table frame colour RAL 003

Table op versions:

Model/ID Ma erial L W Table op color

7037-1-1710 composite fibre 200 cm 65,5 cm white

7037-1-1711 composite fibre 200 cm 75,5 cm white

7037-1-1712 composite fibre 226 cm 75,5 cm white

7037-1-1713 carbon fibre 200 cm 75,5 cm white

7037-1-1714 carbon fibre 226 cm 75,5 cm white

*Model/IDs with in the middle (e.g., 7037- -1710) are operated with 115V

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1.2.1.3 PROGNOST XPE-Akku

Model/ID: 7038- -17xx

Table frame colour RAL 003

Table op versions:

Model/ID Ma erial L W Table op color

7038

1710

composite fibre

200 cm

5,5 cm

white

7038

1711

composite fibre

200

75,5 cm

white

7038

1712

composite fibre

226

75,5 cm

white

7038

1713

carbon fibre

200

75,5 cm

white

7038

1714

carbon fibre

226

,5 cm

white

Op ional Componen s

•X-ray cassette holder (Bucky or Grid entity)

•3- field measuring chamber (ionization or solid state)

•Anti-scatter grid

Op ional Accessories

The PROGNOST XP-series can be equipped or customized with the following accessories:

•Mattress

•Handle long, which is mounted on the back of the table top and facilitates the positioning and

descending of the patient

•Handle short (2 pieces), which is mounted on the front of the table top to facilitate the

displacement of the table or the table top

•Side protection bar for Z-angle, to protect the detector

•Fixing mechanism

•Shock protection profile, for rear table top accessory rail

•Corner protection table top, set of 4

•Center stop, for accurate positioning

1.2.2 Hardware and Ne work Sys em Requiremen s

As a stand-alone product, the PROGNOST XP-series has no hardware or network connection and

therefore no hardware or network requirements.

1.2.3 Ins alla ion

NOTE

The installation of

a PROGNOST XP

series

product

must be performed by

PROTEC

service department or a service company authorized by them.

For more information, please see the Installation manual of the corresponding XP-series product.

Contact information of persons qualified to perform installations are available upon request at:

PROTEC GmbH & Co. KG

In den Dorfwiesen 14 | 71720 Oberstenfeld

Germany

Phone: (+ 4 ) 7062 – 2 55 0

Fax: (+ 4 ) 7062 – 2 55 60

E-Mail: protec@protec-med.com

Internet: www.protec-med.com

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Instructions for use 5038-0-0002

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1.2.3.1 Floor Loading Capaci y

NOTE

The products of the PROGNOST XP-series are primarily made of metal pieces. This

has a corresponding effect in the weight of the device.

The PROGNOST XP has a weight of 103kg.

The PROGNOST XPE has a weight of 114kg.

The PROGNOST XPE-Akku has a weight of 12 kg.

All weights with table top size 2260 x 755 mm.

Every technician is obliged to check the floor load. Raised floors and hollow floors

must also be considered.

1.3 Performance Charac eris ics

1.3.1 X-ray Sys em Table PROGNOST XP

•Floating tabletop

•Table top color white

•Mobile, smooth manoeuvrability

•A low optimized distance from the upper edge of the table top to the film (detector) surface

•Large adjustment range of the table top for positioning the patient

•High reliability

•Lateral profile rails of the table top prepared to attach several table accessories

•Suitable for digital Bucky

1.3.2 X-ray Sys em Table PROGNOST XPE & PROGNOST XPE-Akku

•Floating tabletop

•Table top color white

•Motorized height adjustment of the table top

•Mobile, smooth manoeuvrability

•Automatic stop at pre-programmed table top heights

•A low optimized distance from the upper edge of the table top to the film (detector) surface

•Large adjustment range of the table top for positioning the patient

•High reliability

•Lateral profile rails of the table top prepared to attach several table accessories

•Suitable for digital Bucky

•Battery-supplied accumulator operation via two exchangeable battery boxes (only PROGNOST

XPE-Akku)

•Separate battery box charging station (only PROGNOST XPE-Akku)

1.4 In ended Use

The mobile X-ray system table…

-PROGNOST XP as a component

-PROGNOST XPE as an electrically operated component

-PROGNOST XPE-Akku as a battery-powered component

… of a diagnostic X-ray system for patient positioning is intended for various routine applications in

planar X-ray imaging in human medicine.

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