GE 5160986-2 Скачать руководство пользователя страница 13 | Manualshive

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Page 13

March 2022

Medical Device

MDR 2017/745

REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC

Indicates the product is a
medical device.

CE Mark

MDR 2017/745

MDD 93/42/EEC

Annex XII

REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC

Indicates the product
conforms with applicable
requirements set forth in
MDR 2017/745 or MDD
93/42/EEC for conformity
assessment.

Authorized
Representative
in the
European
Community

ISO 15223-1,
Symbol 5.1.2

MDR 2017/745
/ MDD
93/42/EEC

ISO 15223-1: Medical
devices - Symbols to be
used with medical device
labels, labelling and
information to be supplied
- Part 1: General
requirements

REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC

Indicates the Authorized
Representative in the
European Community

Authorized
representative
for Switzerland

Swiss Medical
Devices
Ordinance Art.
51 para. 1

N/A

Indicates the authorized
representative in
Switzerland

Chinese
Environmental
Symbol

SJ/T 11364
equivalent to
2011/65/EU
(EU/RoHS 2)

China RoHS Standard SJ/T
11364: Regulations for the
Labelling of the Use of
Restrained Hazardous
Substances on Electronic
and Electric Products

Indicates Chinese

‘Environmentally Friendly’

Period.

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Содержание 5160986-2

Страница 1: ...Coils 1 5T HD 8ch Wrist Array Receive only 3 0T HD 8ch Wrist Array 1 5T HD 8ch Wrist Array Flat base 3 0T HD 8ch Wrist Array Flat base 1 5T 8ch Wrist Coil with a P Port connector Veenpluis 6 5684 PC Best The Netherlands www dunlee com healthcare GE Healthcare Revision B 03 2022 ...

Страница 2: ...rate and up to date information to users Non Philips product names may be trademarks of their respective owners Proper performance of this coil is guaranteed only while the coil is being used on the MR system hardware software level specified at the time of purchase Upgrades or other modifications to the system software and or hardware may affect compatibility Prior to upgrading your MR system ple...

Страница 3: ...mbols 9 3 Wrist Array and Accessories 15 4 Safety 17 Training 17 Precautions 17 Cautions potential hazards 17 Emergency procedures 18 Technical considerations 18 5 Using the Wrist Array Coils 20 Choosing the best coil position 20 Workflow Imaging with the Wrist at the patient side 20 5 2 1 Positioning the base plate 20 5 2 2 Mount the coil on the base plate 20 5 2 3 Pad configuration 21 5 2 4 Unla...

Страница 4: ...ient 24 5 3 7 Locking the Coil 24 5 3 8 Coil Landmark 24 Connecting the cable to the system 25 Patient hearing protection 25 6 Scanning 26 Autoshim 26 Localizer scans 26 Fat Saturation Techniques 26 Scan protocols 26 7 Installation and Maintenance 27 Installation and configuration 27 Quality assurance 27 7 2 1 Tools required 27 Ambient operating conditions 27 Storage 27 7 4 1 Storage Location 27 7...

Страница 5: ... 30 Cleaning and disinfectant agent warnings 31 9 Prevention 32 Preventing residue on MR coil 32 Cleaning and disinfection frequency 32 10 Cleaning and disinfecting procedure for non critical diagnostic MR coils and pads 33 Inspection 33 General cleaning instructions 33 Disinfecting instructions 34 11 EMC Information 35 12 Complaints 37 ...

Страница 6: ... you have any questions or comments regarding this manual or need any assistance with the use of the product please contact your GE Healthcare representative Residual risks To ensure that a procedure is safely performed follow this instruction and the MR system instructions for use Device description The Wrist Array coils are a phased array design to be used vertically at the patient s side or hor...

Страница 7: ...d undesirable side effects Magnetic resonance images are noninvasive and do not employ ionizing radiation The technique relies on a different principle for image production than other imaging techniques An MR image represents the relative response of specific nuclei to absorbed radio frequency energy Similar to other imaging techniques this image is a function of density in this case the distribut...

Страница 8: ...re level requirements Dunlee Part number GE Part numbers Description Field Strength Connector Table Geometry 4535 300 8344 107293 as appears on rating label 5160986 2 HD 8ch Wrist Array Receive only 1 5T HD connector Curved 3000 073 1409 5160986 2 HD 8ch Wrist Array Receive only 1 5T HD connector Curved 4535 302 1916 5268024 2 HD 8ch Wrist Array 3 0T HD connector Curved 3000 072 9275 5268024 2 HD ...

Страница 9: ...o be supplied Part 1 General requirements IEC 60878 Graphical symbols for electrical equipment in medical practice Indicates the temperature limits to which the medical device and its packaging can be safely exposed The upper and lower limits are shown adjacent to the upper and lower horizontal lines Humidity limitation ISO 15223 1 Symbol 5 3 8 IEC 60878 Symbol 2620 ISO 15223 1 Medical devices Sym...

Страница 10: ...fety signs Registered safety signs Indicates it is a mandatory action for the user to refer to the instruction manual booklet prior to use Consult Electronic Instructions for Use ISO 15223 1 Symbol 5 4 3 ISO 7000 Symbol 3500 ISO 15223 1 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements ISO 7000 Graphical symbols for u...

Страница 11: ... Graphical symbols for electrical equipment in medical practice Indicates the Unique Device Identification which provides traceability of the device for post marketing surveillance Catalogue number ISO 15223 1 Symbol 5 1 6 IEC 60878 Symbol 2493 ISO 15223 1 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements IEC 60878 Gr...

Страница 12: ...dicates the medical device manufacturer Date and country of manufacture ISO 15223 1 Symbol 5 1 3 IEC 60878 Symbols 6049 ISO 3166 1 ISO 15223 1 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements IEC 60878 Graphical symbols for electrical equipment in medical practice Indicates the date when the medical device was manufa...

Страница 13: ...zed Representative in the European Community ISO 15223 1 Symbol 5 1 2 MDR 2017 745 MDD 93 42 EEC ISO 15223 1 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements REGULATION EU 2017 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices amending Directive 2001 83 EC Regulation EC No 178 2002 ...

Страница 14: ...uipment is a Type BF applied part which complies with IEC 60601 1 Class II equipment IEC 60878 Symbol 5172 IEC 60878 Graphical symbols for electrical equipment in medical practice Indicates the medical device equipment meets the safety requirements specified for Class II equipment according to IEC 61140 Title of Symbol Designation Reference number Reference Standards Description of Symbol WEEE was...

Страница 15: ...rray 5268024 2 3000 072 9275 1 5T HD 8ch Wrist Array Flat Base 5406395 2 4535 303 1519 HD 8ch Wrist Array 5406395 2 3000 074 0377 3 0T HD 8ch Wrist Array Flat Base 5406655 2 4535 303 1542 HD 8ch Wrist Array 5406655 2 3000 074 4656 1 5T 8ch Wrist Coil with P Port Connector 5790142 2 4598 014 1222 2 Baseplate for curved table Included with coil N A N A 2A Baseplate Riser for flat tabletop included w...

Страница 16: ...s have arrived and are in good condition Description Part number Dunlee Order Part number Grey Pads Pad Kit includes wrist pad base pad finger pad palm pad upper pad elbow pad 5406395 3 4535 303 03291 Blue Pads 8ch Wrist Coil Base Pad 5160986 7 4535 300 73141 8ch Wrist Coil Finger Pad 5160986 8 4535 300 73151 8ch Wrist Coil Palm Pad 5160986 9 4535 300 73161 8ch Wrist Coil Upper Pad 5160986 10 4535...

Страница 17: ...n your MR system Operators Manual Assure that the patient is not touching the bore If necessary place pads between the patient and the surface of thebore If the patient complains of warming tingling stinging or similar sensations promptly stop the scan procedure examine the patient and contact the responsible physician before continuing the procedure Pay special attention to very young sedated or ...

Страница 18: ... not plugged in Failure to do so may result in injury and or damage to the coil Do not cross or loop cables Arcing and patient burns could result Route cables out of the magnet so that they do not touch the patient Visually inspect the cable insulator jackets strain reliefs and connector boxes before each use If the insulation is broken or if the cable is frayed immediately discontinue use of the ...

Страница 19: ...equipment present in the MR scanner except as specified in the Operator s Manual Tampering with the cable pins and connector may damage the connector and affect the coil or system performance Please verify that the connector and pins are not damaged before use The coil should not be left unplugged in the system during body coil scanning No modification of this equipment is allowed There are no use...

Страница 20: ...t point into the magnet Do not loop or cross cable Arcing and patient burns could result Workflow Imaging with the Wrist at the patient side The base plate or table for your system may look slightly different and the coil pads could be a different color 5 2 1 Positioning the base plate Position the base plate on the table with the rail on the side of interest Curved Baseplate 5 2 2 Mount the coil ...

Страница 21: ...ient comfort and to help prevent motion artifact Pads may be grey 5 2 4 Unlatch coil Unlatch the coil by pushing the lock toward the cable end of the coil and pulling the coil open toward you 5 2 5 Positioning the patient Position the patient with feet first with their hand and wrist fitting the contour of the coil Place the elbow pad under the patient s arm to help keep the wrist straight and use...

Страница 22: ...hing one s fingers Push the latch with an open hand 5 2 7 Landmark Landmark to the coil using the reference marks on the top of the Wrist Array Coil and Advance the patient to Scan 5 2 8 After scanning Note After the scan is completed disconnect the coil cable from the MR system prior to separating the anterior and posterior halves of the coil to get the patient up from the table Workflow Imaging ...

Страница 23: ...ate Curved baseplate 5 3 3 Locking the Baseplate Riser After the baseplate riser knobs are placed into the cutouts slide the baseplate riser away from the bore into the locked position Flat baseplate Curved baseplate 5 3 4 Attaching Coil Align the knobs on the coil with the cutouts in the baseplate riser Slide the coil into the round cutouts ...

Страница 24: ...e the patient as comfortable as possible and immobilize their hand 5 3 7 Locking the Coil NOTE Close the coil making sure not to pinch the patient s gown or bedding material between the coil halves This would cause poor image quality and possibly result in damage to the coil Slide the oval shaped locking mechanism on the top of the coil housing toward the head end of the coil to the locked positio...

Страница 25: ...imes while in the bore Warning Burn Hazard Remove this coil from the MR System when not plugged in Failure to do so may result in injury and or damage to the coil Warning Do not cross or loop cables Arching and patient burns could result Patient hearing protection Provide earplugs for the patient after all instructions have been given Warning Hearing protection is required for all people in the sc...

Страница 26: ...llows use of a large FOV 40 cm body coil localizer which is helpful in determining the left or right offset required for imaging the wrist Fat Saturation Techniques Off center FOV imaging is a more difficult technique since it is dependent upon the homogeneity of the magnetic field and a definite fat peak signal A small wrist on the edge of the imageable field may produce poor fat saturation For b...

Страница 27: ...ing should then be repeated at regular intervals Ask your GE Service Representative how to perform the Quality Assurance on your software level 7 2 1 Tools required Description GE Part Dunlee Part Quantity Cubicle Unified Phantom 5342681 N A 1 Or 1 5T HD 8ch Wrist Array Phantom only included with 4535 302 1916 3000 072 9275 5160986 5 4535 302 14231 1 Ambient operating conditions Storage 7 4 1 Stor...

Страница 28: ...nly while the coil is being used on the MR system hardware software level specified at the time of purchase Upgrades or other modifications to the system software and or hardware may affect compatibility During ongoing use of the coils immediately discontinue use of this device if the following symptoms of age appear Frayed Cable If the insulation or housing is broken or if the cable is frayed imm...

Страница 29: ...ubmersing in fluids may cause the device to malfunction and will void the warranty Do not allow pooling of cleaning agents after cleaning Coil pads and other accessories must be completely dry before use Use only recommended cleaning and disinfectant solutions or you may void the manufacturer s warranty Harsh chemical agents degrade plastics and will compromise the safety of the device Some germic...

Страница 30: ... and accessories are considered non Critical and require intermediate or low level disinfection for contact with intact skin Recommended cleaning agents Cleaning should be performed using a neutral or near neutral pH detergent such as ENZOL Enzymatic Detergent diluted in utility water 1oz ENZOL per 1 gallon of water at room temperature 15 C 25 C or 59 F 77 F and applied with a soft damp lint free ...

Страница 31: ...rve the solution expiration date Using non recommended cleaning agent or disinfectants using incorrect solution strengths or exposing the coil to the cleaner or disinfectant longer than recommended can damage or discolor the coil and accessories Follow the recommendations of the disinfectant and enzymatic cleaner manufacturer Do not use automated cleaning and or disinfection units Follow the instr...

Страница 32: ...vent the spread of infectious agents Infectious residue warnings Risk of cross infection Always clean and disinfect the bore tabletop mattresses positioning aids coils physiology sensors and cables after each examination of injured or infectious patients where contamination may have occurred Use proper personal protection and precautions when removing blood or residual contrast media Cleaning and ...

Страница 33: ...t free cloth dampened with the enzymatic cleaner wipe all surfaces Warning Do not pour any cleaning solution directly on the coil or baseplate Warning Do not use automated cleaning and or disinfection units Follow the instructions within this document for effective cleaning and disinfection Note After the scan is completed disconnect the coil cable from the MR system prior to separating the anteri...

Страница 34: ...cloth to dry all surfaces Chlorohexidine solution is used Allow at least 2 5 minute contact time with the Chlorohexidine solution Always wipe surfaces with a lint free cloth dampened with clean utility water to remove the residual solution Air dry for 2 minutes or use a soft lint free cloth to dry all surfaces 3 Dispose of any used disinfection materials in accordance with your facility s disposal...

Страница 35: ...urposes Harmonic emissions IEC 61000 3 2 Not applicable Not applicable Voltage fluctuation flicker emissions IEC 61000 3 3 Not applicable Not applicable It is mandatory for the RF shielding effectiveness and filter attenuation in the shielded location to be verified and to ensure that the actual values meet or exceed the specified minimum values Cables or options other than those used for the curr...

Страница 36: ...short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5s Not applicable Not applicable Power frequency 50 60Hz magnetic fields IEC 61000 4 8 3 A m Not applicable Not applicable ...

Страница 37: ...n the European Economic Area EEA the incident should also be reported to the Competent Authority that the Member State in which the user and or patient is established has designated responsible for the implementation of Regulation EU 2017 745 of the European Parliament and of the Council of 5 April 2017 on medical devices In the United States of America the Medical Device Reporting regulation cont...

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