Invivo dS HiRes Hand/Wrist 16ch 1.5T Скачать руководство пользователя страница 1

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dS HiRes Hand/Wrist 16ch coil

Instructions for Use

dS HiRes Hand/Wrist 16ch 1.5T
dS HiRes Hand/Wrist 16ch 3.0T

Invivo Corporation

3545 SW 47

Avenue

Gainesville, FL 32608-7691 USA

Phone: +1 800-722-937

[email protected]

www.philips.com/healthcare

300008312591

Содержание dS HiRes Hand/Wrist 16ch 1.5T

Страница 1: ...s for Use dS HiRes Hand Wrist 16ch 1 5T dS HiRes Hand Wrist 16ch 3 0T Invivo Corporation 3545 SW 47th Avenue Gainesville FL 32608 7691 USA Phone 1 800 722 937 invivo service_and_accessories philips co...

Страница 2: ...yright holder Unauthorized copying of this publication may not only infringe copyright and reduce the ability of Invivo Corporation to provide accurate and up to date information to users Proper perfo...

Страница 3: ...nciples 8 Compatibility 8 2 Explanation of Symbols 9 3 Safety 16 Training 16 Precautions 16 Cautions and Warnings 16 Emergency procedures 17 Technical considerations 17 EMC Information 18 Ambient oper...

Страница 4: ...ng classification 34 Recommended cleaning agents 34 Recommended disinfection agents 34 9 Prevention 35 Preventing residue on MR coil 35 Cleaning and disinfection frequency 35 10 Cleaning and disinfect...

Страница 5: ...ient Caution A Caution alerts you to where special care is necessary for the safe and effective use of the product Failure to observe a caution may result in minor or moderate personal injury or damag...

Страница 6: ...includes a rigid base plate with two positions to fixate the coil one for overhead and one for at the side examinations Available for On the sticker on the coil you see the MRI system type and field...

Страница 7: ...nically activated implants cardiac pacemakers for example The magnetic and electromagnetic fields produced by the MR System and coil may interfere with the operations of thesedevices Scanning patients...

Страница 8: ...ly any orientation without repositioning the patient This translates into greater convenience for medical staff and minimized patient discomfort Plus magnetic resonance provides chemical information n...

Страница 9: ...ices 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 Indicat...

Страница 10: ...ISO 7000 Graphical symbols for use on equipment Indicates relevant information for use of the product is available in electronic form rather than or in addition to printed paper form The eIFU indicato...

Страница 11: ...supplied Part 1 General requirements IEC 60878 Graphical symbols for electrical equipment in medical practice Indicates the Unique Device Identification which provides traceability of the device for...

Страница 12: ...may pinch fingers Manufacturer Country of Origin Title of Symbol Designation Reference number Reference Standards Description of Symbol Manufacturer ISO 15223 1 Symbol 5 1 1 IEC 60878 Symbol 3082 ISO...

Страница 13: ...n equipment Identifies the entity distributing the medical device into the locale Prescription Device 21 CFR Part 801 109 21 CFR Part 801 109 Prescription Devices Indicates Prescription Device Caution...

Страница 14: ...SJ T 11364 Regulations for the Labelling of the Use of Restrained Hazardous Substances on Electronic and Electric Products Indicates Chinese Environmentally Friendly Period ETL Listed Mark None The E...

Страница 15: ...300008312591 Rev A 10 2021 2021 Invivo Corporation All rights Page 15 10 2021 Equipment CAUTION US Federal law restricts this device to the sale distribution and use by or on the order of a physician...

Страница 16: ...ected receive coils and electric cables from the RF transmit coil during the examination Patient burns could result Avoid direct contact of the patient s skin with the coil and cable surfaces patient...

Страница 17: ...nditions for several hours prior to using Extreme temperature and or humidity during storage and or transportation could have allowed condensation to form inside the coil No modification of this equip...

Страница 18: ...not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The dS HiRes Hand Wrist 16ch Coil and MR system is suitable for use in all establishments other than...

Страница 19: ...ould be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable Not applicable Surge IEC 61000 4 5 1 kV line s to line s 2 kV l...

Страница 20: ...ns to the system 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 i...

Страница 21: ...Res Hand Wrist 16ch 1 5T 4598 012 9548 4598 017 2886 4598 012 9548 4598 017 2886 dS HiRes Hand Wrist 16ch 3 0T 4598 012 9553 4598 017 2887 4598 012 9553 4598 017 2887 2 Base plate 4598 014 0058 4598 0...

Страница 22: ...iRes Hand Wrist 16ch 6 Using the dS HiRes Hand Wrist 16ch coils The dS HiRes Hand Wrist 16ch coils can be used in two different orientations Coil Setup Overhead Examination Joint horizontally attached...

Страница 23: ...otation 6 1 2 Positioning the base plate The dStream interface d is on the tabletop and plugged into the FlexConnect socket Place one short mattress SM one long mattress LM and the T shape TM mattress...

Страница 24: ...st end of the coil and lift the anterior section of the coil 6 1 5 Place pads for patient comfort Place Base plate pad On the bottom of the coil either the long or short palm pad For smaller patients...

Страница 25: ...l verify that the patient s skin cannot be pinched between coil parts Note The posterior palm pad is optional for patients with large hands because it could hamper the coil being closed Note Depending...

Страница 26: ...ave been given Warning Hearing protection is required for all people in the scan room during a scan to prevent hearing impairment Acoustic levels may exceed 99 dB A Hearing protection must have a Nois...

Страница 27: ...adaptor Align the two hubs on the mount adaptor to the holes in the base plate and pull mount adaptor from base plate 6 3 8 Remove base plate Remove base plate and all pads Store all coil and accesso...

Страница 28: ...the rail on the base plate with the cable pointing toward the bore Connect the coil to the dStream socket on the dStream Interface Note Verify there are no loops in the cable 6 4 3 Open the coil Pull...

Страница 29: ...r palm pad over the patient s hand 6 4 7 Close the coil Close the coil carefully pay attention to the location of the patient s fingers While closing the coil verify that the patient s skin cannot be...

Страница 30: ...e hand Patient hearing protection Provide earplugs for the patient after all instructions have been given Warning Hearing protection is required for all people in the scan room during a scan to preven...

Страница 31: ...4 Dismiss the patient Assist the patient off the table 6 6 5 Remove pads Remove remaining pads 6 6 6 Disconnect coil Detach coil by sliding hub out of the rail of the base plate 6 6 7 Remove base plat...

Страница 32: ...and Wrist 16ch 7 Scanning Scan protocols Specific choice of protocols is entirely the responsibility of the radiologist and or technologist Additionally you may refer to the Hand Wrist protocols for t...

Страница 33: ...ng 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 germicidal and other harsh cleaning c...

Страница 34: ...oorganisms and organic soil during patient care e g blood body fluids The dS HiRes Hand Wrist 16ch MRI coil and accessories are classified as Non Critical Diagnostic Coil devices and require intermedi...

Страница 35: ...without actual cleaning and disinfection does not prevent the spread of infectious agents Infectious residue warnings Risk of cross infection Always clean and disinfect the bore tabletop mattresses p...

Страница 36: ...ce of the base plate and mount adaptor 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 instructio...

Страница 37: ...a lint free cloth dampened with clean utility water to remove the residual solution Air dry for 2 minutes or dry with a clean lint free cloth Warning If a pre mixed solution is used be sure to observ...

Страница 38: ...lation and configuration Coil installation and configuration requires the services of your Philips Service Representative Quality assurance Quality Assurance SPT testing will be performed upon receipt...

Страница 39: ...mpetent 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 th...

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