Pro-tec PROGNOST XS User manual

PROTEC GmbH & Co. KG
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Telephone: [phone] E-Mail: [email protected]
Version: 4.0
Issued: 2021-05-26
Subject to alterations
PROGNOST XS
Basic diagnostic X-ray system tab e,
non-powered
Mode /ID: 7034-0-0000
Basic-UDI-DI: 426050264X023ZM
Instructions for use
Ident. No. 5034-0-0002

NOTE
This
document contain
s
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.
© 2021 PROTEC GmbH & Co. KG, Oberstenfeld
Comments and questions about the documentation, please contact:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Germany
Phone: (+ 49) 7062 – 92 55 0
Fax: (+ 49) 7062 – 92 55 60
E-Mai : [e-mail]
Internet: www.protec-med.com

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Tab e of contents
Page
Tab e of contents ........................................................................................................................... 3
Revision Status .............................................................................................................................. 5
Genera Notes ................................................................................................................................ 6
Mechanica and E ectric Warning ............................................................................................... 6
To the User ..................................................................................................................................... 6
1 Device Description .............................................................................................................. 7
1.1 Introduction ......................................................................................................................................................................................... 7
1.2 Description............................................................................................................................................................................................ 7
Types ............................................................................................................................................................................................ 7
Hardware and Network System Requirements ................................................................................................. 7
Installation ................................................................................................................................................................................ 7
1.2.3.1 Floor Loading Capacity............................................................................................................................................... 7
1.3 Performance Characteristics ...................................................................................................................................................... 8
X-ray positioning table ...................................................................................................................................................... 8
1.4 Intended Use ....................................................................................................................................................................................... 8
1.5 Clinical Use ............................................................................................................................................................................................ 8
1.6 Patient Target Group(s) ................................................................................................................................................................. 8
1.7 Diagnosable Medical Conditions ............................................................................................................................................ 8
1.8 Indications and Contraindications ......................................................................................................................................... 8
1. Intended User Group ...................................................................................................................................................................... 8
1.10 Conformity ............................................................................................................................................................................................
2 Safety Instructions ............................................................................................................ 10
2.1 General Safety Instructions ...................................................................................................................................................... 11
Operating of device ......................................................................................................................................................... 11
Operating Personnel ....................................................................................................................................................... 11
Crushing and Collision Hazards ................................................................................................................................ 11
Explosion Protection ....................................................................................................................................................... 11
Interaction with External Devices ............................................................................................................................ 11
Electromagnetic Environment and the Interference of Devices ......................................................... 11
3 Contro E ements and Device Disp ays .......................................................................... 12
3.1 Main switch of the PROGNOST XS ...................................................................................................................................... 12
3.2 Emergency stop switch of the PROGNOST XS ............................................................................................................ 12
3.3 Control elements and displays of the PROGNOST XS ............................................................................................. 12
Brake rolls ............................................................................................................................................................................... 12
4 Hand ing ............................................................................................................................. 13
4.1 Requirements before and during Operation ................................................................................................................ 13
4.2 Operation of PROGNOST XS .................................................................................................................................................... 13
Exposures with the PROGNOST XS ......................................................................................................................... 13
4.3 Function of the PROGNOST XS ............................................................................................................................................. 14
Switching the PROGNOST XS ON and OFF ....................................................................................................... 14
5 Safety and Maintenance ................................................................................................... 15
5.1 Introduction ...................................................................................................................................................................................... 15
5.2 Reusability .......................................................................................................................................................................................... 15
5.3 Cleaning and Disinfection ........................................................................................................................................................ 15
Cleaning .................................................................................................................................................................................. 15
Disinfection ........................................................................................................................................................................... 15
5.4 Inspection and maintenance ................................................................................................................................................. 15
Daily monitoring before and during the examination operation ....................................................... 16
Regular Monitoring .......................................................................................................................................................... 16
5.4.2.1 Safety-related checks ................................................................................................................................................ 16
Maintenance ........................................................................................................................................................................ 16
5.4.3.1 Maintenance checklist ............................................................................................................................................. 16

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Warranty .................................................................................................................................................................................. 1
Product life ............................................................................................................................................................................ 1
Parts with direct patient contact ............................................................................................................................. 1
Disposal notes ..................................................................................................................................................................... 1
6 Power supp y ...................................................................................................................... 20
7 Technica Data .................................................................................................................... 21
7.1 Dimensions ........................................................................................................................................................................................ 21
7.2 Attenuation Equivalent .............................................................................................................................................................. 21
Protection Type and Protection Class .................................................................................................................. 22
7.3 Environmental Conditions ....................................................................................................................................................... 22
Environmental conditions during operation ................................................................................................... 22
Environmental conditions for shipping and storage .................................................................................. 22
8 Description of Symbo s, Labe s and Abbreviations ..................................................... 23
8.1 Symbols ............................................................................................................................................................................................... 23
8.2 Identification Label ....................................................................................................................................................................... 24
8.3 Labels .................................................................................................................................................................................................... 24
8.4 Position of the Symbols and Labels ................................................................................................................................... 25
8.5 Abbreviations ................................................................................................................................................................................... 25

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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 of the
PROTEC GmbH & Co. KG Technical Service Organisation.
Revision Status
Revision Date
List of effective pages Comments Author
4.0 2021-05-26 all
REV03 transferred to the
new layout (MDR) MB

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Genera Notes
WARNING!
In order to maintain the set and tested requirements of the 60601 series of
standards, the ME system must not be modified during its actua operating
ife.
Mechanica and E ectric Warning
WARNING!
A of the movab e assemb ies and parts of this equipment shou d be operated
with care. They must be routine y inspected in accordance with the
manufacturer's recommendations contained in the accompanying
documents. Maintenance and service is on y to be performed by personne
authorized by PROTEC GmbH & Co. KG.
Touching ive e ectrica termina s and connections can be dead y.
Do not remove the f exib e high-tension cab es from the X-ray tube cover or
high-tension generator or open the housing of the X-ray generator.
Protective conductor connections must be provided in comp iance with the
nationa regu ations for a components of the equipment.
Fai ure to comp y may resu t in serious or fata injuries to present persons.
To the 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 description of the product
and to observe the points it contains.
NOTE
The usage of the product in combination with
attachments,
accessories
or other
non-approved components not authorized by PROTEC is not permitted.
NOTE
A
ccording to r
egulation (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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1 Device Description
1.1 Introduction
The instructions for use describes the performance characteristics and operational aspects, required for
efficient and effective use of the PROGNOST XS.
Prior to working with the PROGNOST XS, the operator is required to read through the instructions for
use, especially the safety notes as well as the chapter regarding operation.
1.2 Description
The PROGNOST XS X-ray exposure tables are lightweight, mobile patient positioning tables with solid
laminate table top with melamine resin layer for easy cleaning.
Types
PROGNOST XS
Table frame colour RAL 003 7034-0-0000
Table top 1 63mm x 655mm x 6mm
Optiona Accessories
•Mattress 1 00mm x 600 mm x 15mm
Hardware and Network System Requirements
As a stand-alone product, the PROGNOST XS has no hardware or network connection and therefore no
hardware or network requirements.
Insta ation
NOTE
The installation of the
PROGNOST XS
must be performed by
the
PROTEC Customer
Service Department or a service authorized by them.
For more information, please see the separate “Installation manual” of the PROGNOST XS.
Contact information of persons qualified to perform installations are available upon request at:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Telephone: +4 (0) 7062 – 2 55 0
Fax: +4 (0) 7062 – 2 55 60
E-Mail: [e-mail]
Internet: www.protec-med.com
1.2.3.1 F oor Loading Capacity
NOTE
The
PROGNOST XS
is primarily made of metal pieces. This has a corresponding effect
in the weight of the device.
The PROGNOST XS has a weight of 48kg.
Every technician is obliged to check the floor loading capacity. Also raised floors and
hollow floors have to be taken into account.

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1.3 Performance Characteristics
X-ray positioning tab e
•Wide range of applications
•High reliability
•Mobile, easy manoeuvrability
•Table top colour white
•Large radiolucent working area
1.4 Intended Use
The PROGNOST XS mobile X-ray system table is intended to be used as a component of a diagnostic X-
ray system for patient positioning for various routine applications in planar X-ray imaging in human
medicine.
1.5 C inica Use
In isolated observation no clinical use can be shown for X-ray system tables.
As components of diagnostic X-ray systems in human medicine, they contribute to the clinical utility of
the X-ray systems, which is the generation of conventional two-dimensional X-ray images for diagnosis
or the specification of findings as the basis for treatment decisions.
1.6 Patient Target Group(s)
The intended patient group 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.
1.7 Diagnosab e Medica Conditions
As stand-alone products, X-ray system tables, have no function to diagnose, treat and/or monitor
medical conditions.
1.8 Indications and Contraindications
As stand-alone products, X-ray system tables have no intended main effect in or on the human body.
Therefore, when viewed in isolation, no indications and contraindications can be identified for them.
1.9 Intended User Group
The PROGNOST XS is exclusively designated for use by professional users who have been trained in the
operation of diagnostic X-ray systems in accordance with the corresponding national regulations, and
who have been instructed in the proper handling, application and operation as well as in the
permissible connection with other medical devices, objects and accessories.
Suitable operators could include the following: X-ray technicians, radiologists, medical-technical
radiologists, surgeons, trauma surgeons, orthopaedists and other trained medical personnel.

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1.10 Conformity
This product complies with the requirements of Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5th April 2017 concerning medical devices, including all
applicable corrigenda.
The declaration of conformity is available upon request from PROTEC:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Telephone: +4 (0) 7062 – 2 55 0
Fax: +4 (0) 7062 – 2 55 60
E-Mail: [e-mail]
Internet: www.protec-med.com

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2 Safety Instructions
NOTE
Contains information that are relevant to the usage.
xxx
CAUTION!
Contains information that can cause damage to properties at
nonconformity.
xxx
WARNING!
Contains information that can cause personal injuries at
nonconformity.
xxx
WARNING!
Warning of radioactive substances or ionisating rays. Contains
information that can cause personal injuries at nonconformity.
xxx
NOTE
All
manual
s
supplied with the PROGNOST XS must be observed and any
contained
safety instructions must be read carefully and complied with.
NOTE
After the initial
installation, the commissioning must be recorded with the PROTEC
acceptance protocol FB-04-07A4.
NOTE
The commissioning of the
PROGNOST XS
can only be done if all safety notes
and
operator security measures have been met. These operator safety measures can be:
door contact, marked area, dosimeter, safety clothing …
CAUTION!
The manua contains a safety re evant information for the commissioning of
the PROGNOST XS. Operating the device is exc usive y for specia y trained
staff. In this context, there are re evant safety symbo s on every operating
e ement. Further information and instructions can be found on the provided
medium (USB, CD or DVD). This serves as additiona information and has to be
observed.
NOTE
All operating elements are described
in detail again
in
this i
nstructions for use
.

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2.1 Genera Safety Instructions
Operating of device
In the event of malfunctions, the PROGNOST XS must no longer be used and the PROTEC customer
service department or a service department authorized by PROTEC must be notified.
Operating Personne
NOTE
Only properly trained and authorized personnel are permitted to operate the
PROGNOST XS.
NOTE
The operating personnel must familiarize themselves with all warnings signs located
on the PROGNOST XS. They serve to ensure their own safety and that of others and
guarantee proper operation.
Crushing and Co ision Hazards
WARNING!
Ensure that whi e operating the moving parts of the PROGNOST XS, no
persons or objects finds themse ves in the obvious danger zone of the device.
Fai ure to do so may resu t in bodi y injury to persons or damage to the
PROGNOST XS or other objects.
Crushing of fingers and hands is possible at the points marked with arrows in the picture below. Please
ensure that neither the patient nor the personnel are staying uncontrolled in the movement area when
moving the table.
Exp osion Protection
The PROGNOST XS is not designated for use within areas with explosive hazards.
Interaction with Externa Devices
Interaction with external devices is not known.
E ectromagnetic Environment and the Interference of Devices
Electromagnetic influence by devices is not known.

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3 Contro E ements and Device Disp ays
3.1 Main switch of the PROGNOST XS
The PROGNOST XS does not have a main switch, as it is a non-active medical device.
3.2 Emergency stop switch of the PROGNOST XS
The PROGNOST XS does not have an emergency stop switch, as it is a non-active medical device.
3.3 Contro e ements and disp ays of the PROGNOST XS
1. Brake rolls
2. Table top
Brake ro s
To fix the positioning table in all directions on the ground, it has 4 total locking devices, which must be
locked on the left and right side before the patient is descending or ascending.
1.
2.

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4 Hand ing
4.1 Requirements before and during Operation
It must be ensured that the surfaces that come into contact with patients are disinfected before the X-
ray examination of each patient (see chapter 5.3).
4.2 Operation of PROGNOST XS
Exposures with the PROGNOST XS
Following procedure must be observed to prevent collisions with the PROGNOST XS, the image
receiver or other furniture.
• X-ray device, e.g. swivel arm system, to the 0 degree position
• Set the height of the X-ray image receptor to match the height of the table
• Move the table to the intended exposure position for inspection
• Move the table to a position in which the patient can climb onto the surface as easily as possible
• Operate the brake wheel locks and check that the wheels are effectively braked
WARNING!
Before ascending or descending of the patient, the brake ro ers must be
ocked. A ro ers can be braked, but at east two rear ro ers (furthest away
from the ascending patient) must be ocked.
NOTE
The
PROGNOST XS
is not suitable for patient
transport.
It is only used for positioning the patient during examination.
The ascending and descending of the patient has only be done while fixed brakes
and in the center of the table top, under supervision or assistance of the examiner as
otherwise there is a risk of tipping over!
Provide patients with assistance when ascending.
• Provide patients with assistance when ascending. In order to achieve the best possible support of
the table, the patient should climb onto the table in the middle of the table top
• Position the patient for the exposure. If necessary (e.g. open wounds), cover the table surface with
suitable cloths or disposal care pads
WARNING!
Danger of squeezing at the tab e edges and danger of trapping on and be ow
the tab e top!
When the table is moved horizontally, extremities can be squeezed between the
edge of the table and a stationary obstacle (wall, column, X-ray unit).
Therefore, when moving the PROGNOST XS, make absolutely sure that neither the
patient nor the personnel are standing in the direction of the movement.
Pay particular attention that none of the patients extremities protrude over the table
top.
• Release the brake wheel locks and move the PROGNOST XS to the exposure position
• Lock the brakes again
• Perform exposures according to the operating instructions of the X-ray unit
• After the examination, release the fixing brakes and move the table to a position where the patient
can easier get off the table
• Lock the brakes and assist the patient in getting off the table

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4.3 Function of the PROGNOST XS
Switching the PROGNOST XS ON and OFF
The PROGNOST XS does not have a main switch, as it is a non-active medical device.

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5 Safety and Maintenance
5.1 Introduction
In this chapter, you will find details regarding safety and maintenance, which is required to ensure the
correct and reliable function of the device following initial installation.
5.2 Reusabi ity
The PROGNOST XS can be reused without any special reprocessing procedures.
However, it must be ensured that the surfaces that come into contact with patients are disinfected
between patients (see also Chapter 4.1).
The PROGNOST XS must no longer be used with patients if it shows signs of attrition (e.g., metal
abrasion, abrasion of insulations) or dangerous technical defects (e.g., torn cable, bent parts) or if the
resulting image quality (e.g., artefacts in the image) is insufficient.
In this case, please contact PROTEC customer service or a service authorized by PROTEC immediately.
5.3 C eaning and Disinfection
NOTE
Caution!
Changes to material are possible!
C eaning
The PROGNOST XS can be cleaned with ease due to the high quality surface coating. This is usually
done only with a dry cloth.
Do not use any corrosive, dissolving or abrasive cleaning agents as this may damage the surfaces of the
unit or the coating.
Clean device surfaces and painted parts with a damp cloth and a mild to slightly alkaline cleaning
solution (e.g. RBS® Neutral T) and wipe dry.
Chrome parts may only be wiped with a dry wool cloth.
Disinfection
Disinfection must be performed in accordance with the current applicable legal requirements and
guidelines corresponding to disinfection and explosion protection.
For disinfection of surfaces in contact with patients, we recommend commercially available medical
rapid disinfection wipes (e.g. Dr. Schumacher Descosept Sensitive Wipes).
All mechanical components of the PROGNOST XS, including accessories, may only be subjected to
wipe disinfection with suitable surface disinfectants (e.g. Melsept® SF, 15 min. residence time at 2%
concentration). The information provided by the disinfectant manufacturer on concentrations and
residence times must be observed.
5.4 Inspection and maintenance
WARNING!
No maintenance or repair work may be performed whi e the PROGNOST XS is
being used with a patient!
A maintenance and repair work may on y be performed by personne trained
or authorized by PROTEC.

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Dai y monitoring before and during the examination operation
The locking of the rolls must be checked by operating the fixation brakes.
Regu ar Monitoring
In case of heavy contamination, the rolls must be cleaned to ensure sufficient floor adhesion. The rolls
must be cleaned once a week. Clean the rolls with a damp cloth and a soap-free cleaning agent, or
commercially available medical rapid disinfection wipes and wipe dry.
5.4.2.1 Safety-re ated checks
In the interest of patients, operators and external third parties, it is necessary that all checks regarding
operational safety and/or functionality of the unit are carried out regularly every 12 months by
PROTEC customer service or a PROTEC authorized service provider.
All components within the PROGNOST XS that may pose a risk due to attrition must be inspected and,
if necessary, replaced every 12 months by the PROTEC service department or a PROTEC authorized
service provider.
In the case that the scheduled checks are not carried out, PROTEC GmbH & Co. KG will not be liable for
damage to the user and third parties if and insofar as damage results from insufficient or non-
performed checks.
Maintenance
The required maintenance must be carried out by PROTEC customer service or a service authorized by
PROTEC to ensure the safe and reliable functioning of the device. The maintenance intervals depend on
the frequency of use. In the event that the scheduled maintenance is not carried out, PROTEC GmbH &
Co. KG will not be liable for damage to the user and third parties if and insofar as damage results from
insufficient or non-performed maintenance.
Prior to test operation, the user must satisfy himself that all safety relating devices listed in the
instruction manual are in working order and that the product is ready for operation.
Attrition parts must be replaced with original components.
NOTE
T
he maintenance checklist must be printed out from the instruction manual and
recorded.
NOTE
After
maintenance and service work
, the
re
commissioning must be recorded with
the PROTEC acceptance protocol FB-04-07A4.
5.4.3.1 Maintenance check ist
This maintenance checklist serves as a working aid for maintenance on a “PROGNOST XS” and should
be performed every 6 months for more than 100 patients/day and every 12 months for less than 100
patients/day, depending on the use of the device.
This procedure does not replace the mandatory acceptance test or other procedures for checking X-ray
equipment specified by European standards or internal country standards. This procedure is intended
for the periodic inspection of the X-ray components and its maintenance in accordance with the
requirements of the manufacturer PROTEC GmbH & Co. KG.

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PROTEC Dea er:
Service Technician Name:
Service Technician No.:
Customer:
Customer No.:
P ace of Insta ation:
PROGNOST XS No.: 7034-0-0000 Seria Number:
Annua y for
systems with
ess than 100
patients/day
Semi-annua y
for systems with
more than 100
patients/day
Every 5 years for
systems with ess
than 100
Patients/day
Every 4 years for
systems with
more than 100
patients/day
Visual control Functional control Exchange
Exchange
1
Safety Inspection
OK
Not
OK
Note
1.1.
Check the parts of the X
-
ray system
table for damages
x
1.2. All labels are still fixed and readable x
1.3. Check the 70Nm tightening torque
of the guide rolls fixing screws
x
1.4. Brake functionality of all 4 guide
rolls are working properly
x
1.5. Check all fixing screws, tighten if
necessary (see installation manual)
x
1.6. The table top has no relevant
damage. If necessary perform
control exposures
x

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Final Report:
No safety or function-relevant problems detected
Next maintenance in  6 /  12 /  ____ months
Remarks, notes:
………………………………………………………………………………………………….…………
………………………………………………………………………………………………….…………
………………………………………………………………………………………………….…………
Inspector: ………………………….…………
Date: ……………………
Signature: ………………………………………
Doctor/Doctors office/clinic: ………………………………
Date: ……………………..
Signature: …………………………………………

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Warranty
NOTE
The current conditions of guarantee are deposite
d in the order papers or in the
pricelist valid at the time of purchase.
All repairs and spare parts are excluded from the warranty in event of improper operation.
Warranty service may only be performed by trained specialists.
Product ife
The PROGNOST XS is designed to have a product life of 10 years when used in accordance with the
specifications and is regularly maintained by PROTEC customer service or an authorized service
provider. After the product has reached the end of its product life, further use is at the operator’s own
risk.
Parts with direct patient contact
Part Definition: The components listed below are components that have
direct contact with the patient during intended use
Table top
Direct patient contact
Optiona accessories
Mattress
Direct patient contact
Disposa notes
The
PROGNOST XS
contains different plastics
and heavy metal
.
When
disposing exchange and spare parts, or if necessary, the whole system, the
current rules and regulations must be observed. Please contact your
contractual partner or the service company, or a company specialized in
disposing the respective components.

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6 Power supp y
NOTE
The PROGNOST XS does not require power supply.