Protec 7034-0-0000 Instructions For Use Manual Download Page 5 | Manualshive

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Protec 7034-0-0000 Instructions For Use Manual Download Page 5

V4.0_2021-05-26

PROGNOST XS

Instructions for use

5034-0-0002

5 of 25

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)

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Summary of Contents for 7034-0-0000

Page 1: ...y Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 4 0 Issued 2021 05 26 Subject to alterations PROGNOST XS Basic diagnostic X ray system table non powered Model ID 7034 0 0000 Basic U...

Page 2: ...ithout 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 Comment...

Page 3: ...onnel 11 Crushing and Collision Hazards 11 Explosion Protection 11 Interaction with External Devices 11 Electromagnetic Environment and the Interference of Devices 11 3 Control Elements and Device Dis...

Page 4: ...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 shippi...

Page 5: ...f 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 Servi...

Page 6: ...ccompanying 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...

Page 7: ...d Network System Requirements As a stand alone product the PROGNOST XS has no hardware or network connection and therefore no hardware or network requirements Installation NOTE The installation of the...

Page 8: ...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 c...

Page 9: ...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 G...

Page 10: ...E 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 op...

Page 11: ...ion Crushing and Collision Hazards WARNING Ensure that while operating the moving parts of the PROGNOST XS no persons or objects finds themselves in the obvious danger zone of the device Failure to do...

Page 12: ...ice 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 Control elements and displays of the PROGNOST XS 1 Brak...

Page 13: ...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 as...

Page 14: ...05 26 PROGNOST XS Instructions for use 5034 0 0002 14 of 25 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 medic...

Page 15: ...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...

Page 16: ...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 sche...

Page 17: ...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 syst...

Page 18: ...S Instructions for use 5034 0 0002 18 of 25 Final Report No safety or function relevant problems detected Next maintenance in 6 12 ____ months Remarks notes Inspector Date Signature Doctor Doctors off...

Page 19: ...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...

Page 20: ...V4 0_2021 05 26 PROGNOST XS Instructions for use 5034 0 0002 20 of 25 6 Power supply NOTE The PROGNOST XS does not require power supply...

Page 21: ...brakes of the wheels are mechanically operated 7 2 Attenuation Equivalent WARNING The PROGNOST XS attenuation factor must be considered during the acceptance test The aluminium attenuation equivalent...

Page 22: ...contain any applied parts 7 3 Environmental Conditions Environmental conditions during operation Ambient Temperature 10 C to 40 C Relative humidity 30 to 70 non condensing Atmospheric pressure 700 hPa...

Page 23: ...ions 8 1 Symbols Air pressure limit Temperature limit Humidity limit Keep dry Fragile Handle with care This way up Attention observe warnings and precautions Refer to the manual CE marking Manufacture...

Page 24: ...rical and Electronic Equipment Protective earth Do not exceed the maximum indicated weight Do not exceed the maximum indicated weight Table movements for exposure Longitudinal movement of the table Tr...

Page 25: ...ble crushing hazards to fingers or hands during movements of the table or X ray unit 8 4 Position of the Symbols and Labels 8 5 Abbreviations mm Millimetre cm Centimetre lb Pound kg Kilogram C Degree...

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