Protec 7073-9-0001 Instructions For Use Manual Download

Page: 27 / 30

V4.0_2021-05-26

PROGNOST C Instructions for use

5073-0-0002

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

27 von 30

Description of symbols, labels and abbreviations

8.1

Symbols

Air pressure limit

Temperature limit

Humidity limit

Keep dry

Fragile, handle with care

This way up

Attention, observe accompanying documents

Refer to Instructions for use

CE marking

Classification according to EN 60601-1 (type B applied part)

Caution: pinch-/crushing hazard for hands and fingers

Do not exceed the maximum indicated weight

Manufacturer

Medical Device

Order reference

Serial number

Unique Device Identification

Summary of Contents for 7073-9-0001

Page 1: ...d Germany Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 4 0 Issued 2021 05 26 Subject to alterations PROGNOST C Diagnostic X ray system mechanics Model ID 7073 9 000X Basis UDI DI 4...

Page 2: ...authorization of PROTEC s law department Report any violations of this requirement to PROTEC GmbH Co KG 2021 PROTEC GmbH Co KG Oberstenfeld These accompanying documents were created and distributed b...

Page 3: ...system 11 2 1 3 Operating personnel 11 2 1 4 Pinching and Collision Hazards 12 2 1 5 Explosion protection 12 2 1 6 Interaction with external devices 12 2 1 7 Electromagnetic Environment and the influe...

Page 4: ...Quality control by the user 19 5 4 3 Maintenance 19 5 4 4 Warranty 20 5 4 5 Product Service Life 20 5 4 6 Further Information 20 5 4 7 Applied Parts and parts which get handled like an application par...

Page 5: ...Date List of effective pages Comments Author 1 0 2020 11 26 all Original issue 2 0 2021 02 25 Front Page 7 11 14 15 18 23 27 Product picture Warning mattress Compatible components mattress at characte...

Page 6: ...se in the area 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 st...

Page 7: ...ates a on the radiographic table fixed biocompatible x ray mattress This mattress is specially designed for X ray imaging diagnostics The X ray mattress can be removed for cleaning The tube column sta...

Page 8: ...the installation of a Bucky with anti scatter grid and 3 field measuring chamber intended for the use with automatic exposure control Useable for variable cassette detector sizes Formats from 13 cm x...

Page 9: ...nd patient condition 1 7 Medical Conditions to be diagnosed As standalone products X ray system mechanics have no intended main effect in or at the human body Therefore considered in isolation no indi...

Page 10: ...stem by the PROTEC GmbH Co KG customer service department or a PROTEC GmbH Co KG authorized service technician NOTE Every delivered manual has to be read and the safety notes have to be observed NOTE...

Page 11: ...able must not be carried out without an X ray mattress 2 1 2 Operating of the radiographic system When having troubles with operating of the PROGNOST C immediately call the Service of PROTEC or an aut...

Page 12: ...2 1 7 Electromagnetic Environment and the influence of devices CAUTION The use of other accessories other converters and other cables than those specified by PROTEC or provided in the documentation o...

Page 13: ...r wants to move the tube stand at desired position horizontally it can be moved manually while holding this button UP DOWN When operator wants to move the tube arm vertically at desired position it ca...

Page 14: ...re is the ALL FREE switch By bringing a foot or any object in this area the ALL FREE switch will be activated With the switch checked it is available to move the table top in any direction 3 1 3 Verti...

Page 15: ...on the X ray system table must not be carried out without an X ray mattress Move the table to a position in which the patient can climb onto the table surface as easily as possible Center the table t...

Page 16: ...ion on the table top Move X ray tube to the desired position and adjust SID Press the collimator light switch button 3 figure collimator to turn on the collimator light and view the opening of the col...

Page 17: ...done on the scale 6 and 7 figure Collimator to the according cassette source to image receptor distance SID So the light radiation field is limited to the according cassette 4 2 4 4 Exposure preparati...

Page 18: ...E Caution Possible material changes WARNING Make sure that no liquid enters the interior of the housing during cleaning and disinfection in order to prevent electrical short circuits and or corrosion...

Page 19: ...st could penetrate the device and cause short circuits or corrosion If disinfectants are used that can form explosive gas mixtures the device may only be switched on again when the gas mixtures have e...

Page 20: ...o excluded Warranty work may only be carried out by trained specialists 5 4 5 Product Service Life The PROGNOST C is designed for a service life of 7 years when used in accordance with the specificati...

Page 21: ...tibility EMC after EN 60601 1 2 CAUTION As a medical electrical device the PROGNOST C is subject to special precautionary measures regarding EMC and must be installed and commissioned in accordance wi...

Page 22: ...erial the relative humidity must be at least 30 Fast transient electrical disturbance variables burst EN 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1...

Page 23: ...requency Band in MHz Service in MHz Modulation Immunity Testing Level in V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 27 450 430 470 GMRS 460 FRS 480 FM 5 kHz Deviation 1 kHz Sine 28 710 745 780 7...

Page 24: ...V4 0_2021 05 26 PROGNOST C Instructions for use 5073 0 0002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 24 von 30 7 Technical Data 7 1 Dimensions...

Page 25: ...nic 7 2 1 X ray mattress Length 2190 mm Width 800 mm Height 15 mm Patient load max 200 kg Velcro fastening cleanable biocompatible 7 3 Bucky unit Longitudinal travel 580 mm Table top film distance 75...

Page 26: ...the X ray mattress is typically 0 5 mm Al to EN 6061 1 3 at 100 kV with a first half value layer thickness of 3 7 mm Al The cover vertical wall stand is defined as application part The aluminium atte...

Page 27: ...mit Humidity limit Keep dry Fragile handle with care This way up Attention observe accompanying documents Refer to Instructions for use CE marking Classification according to EN 60601 1 type B applied...

Page 28: ...provided in an electronic format eIFU on our website Disposal instructions WEEE Waste of Electrical and Electronic Equipment Protective earthing 8 2 Type label 8 3 Labels Labels on the side of the ta...

Page 29: ...Label on the X ray mattress The X ray mattress is identified as a component of the PRS 500 C The positioning and support of a patient on the X ray system table must not be carried out without this mat...

Page 30: ...o KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 30 von 30 8 5 Abbreviations mm Millimetre cm Centimetre lb Pound kg Kilogram C Degree Celsius hPa Hectopascal DIN German Industry Standard EN Europ...

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