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Related Manuals for Invivo dS HiRes Hand/Wrist 16ch 1.5T
Summary of Contents for Invivo dS HiRes Hand/Wrist 16ch 1.5T
- Page 1 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 invivo.service_and_accessories@philips.com www.philips.com/healthcare 300008312591...
- Page 2 Licenses and Trademarks © 2021 Invivo Corporation Invivo Corporation reserves the right to make changes to both this Instructions for Use and to the product it describes. Product specifications are subject to change without notice. Nothing contained within this Instructions for Use is intended as an offer, warranty, promise or contractual condition, and must not be taken as such.
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Page 3: Table Of Contents
Patient hearing protection ...................... 26 After scanning ......................... 26 Workflow for hand at the patient’s side examination ............27 Patient hearing protection ...................... 30 After scanning ......................... 30 Scanning ............................32 300008312591 Rev A 10/2021 Page 3 © 2021 Invivo Corporation All rights... - Page 4 Inspection ..........................36 General cleaning instructions ....................36 Disinfecting instructions ......................36 Installation and maintenance ...................... 38 Installation and configuration ....................38 Quality assurance ........................38 Complaints ........................... 39 300008312591 Rev A 10/2021 Page 4 © 2021 Invivo Corporation All rights...
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Page 5: Introduction
10/2021 1 Introduction This manual describes the features, use and care of the dS HiRes Hand/Wrist 16ch 1.5T and 3.0T coil for use with a Philips Ingenia MRI System. All coils shall be referred to as dS HiRes Hand/Wrist 16ch coils for the rest of this document. The dS HiRes Hand/Wrist 16ch coils are receive only coils. - Page 6 The coil can be used at the patient’s side, with the joint vertically, and over- head with the joint horizontally. dStream Interface Required Connector dStream socket/connector on the dStream Interface 300008312591 Rev A 10/2021 Page 6 © 2021 Invivo Corporation All rights...
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Page 7: Coil Dimensions
16.91 Indications for use The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy that can be interpreted by a trained physician. -
Page 8: Basic Operating Principles
Images can be acquired in any plane. Compatibility The dS HiRes Hand/Wrist 16ch 1.5T MR coil is compatible with Philips Ingenia MRI 1.5T Scanners with a dStream interface. The dS HiRes Hand/Wrist 16ch 3.0T MR coil is compatible with Philips Ingenia MRI 3.0T Scanners with a dStream interface. -
Page 9: Explanation Of Symbols
- Part 1: General exposed. The atmospheric IEC 60878, requirements pressure limitations are Symbol 2621 shown adjacent to the upper 300008312591 Rev A 10/2021 Page 9 © 2021 Invivo Corporation All rights... - Page 10 Warning / None – Internal injury. Caution symbol CAUTION indicates a hazard with a low level or risk which, if not avoided, could result in minor or moderate injury. 300008312591 Rev A 10/2021 Page 10 © 2021 Invivo Corporation All rights...
- Page 11 - Part 2- receive only coil. RF coil, receive IEC 60601-2-33, 33: Requirements for the Table 201.D.102 basic safety and essential performance of magnetic resonance equipment for medical diagnosis 300008312591 Rev A 10/2021 Page 11 © 2021 Invivo Corporation All rights...
- Page 12 Symbols 6049 alpha-2 country code (“CC”) IEC 60878: Graphical symbols defined in ISO 3166-1. ISO 3166-1 for electrical equipment in medical practice 300008312591 Rev A 10/2021 Page 12 © 2021 Invivo Corporation All rights...
- Page 13 PARLIAMENT AND OF THE requirements set forth in MDD 93/42/EEC MDR 2017/745 or MDD COUNCIL of 5 April 2017 on Annex XII 93/42/EEC for conformity medical devices, amending 300008312591 Rev A 10/2021 Page 13 © 2021 Invivo Corporation All rights...
- Page 14 Indicates separate collection 60417, Symbol WEEE electrical and for waste electric and 6414 electronic electronic equipment (WEEE) ISO 7000 / IEC 60417: equipment is required. Graphical Symbols for Use on 300008312591 Rev A 10/2021 Page 14 © 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. 300008312591 Rev A 10/2021 Page 15 © 2021 Invivo Corporation All rights...
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Page 16: Safety
Such objects will interfere with the imaging capabilities of the system and coil. Certain transdermal patches may cause burns to the underlying skin due to absorption of RF 300008312591 Rev A 10/2021 Page 16 © 2021 Invivo Corporation All rights... -
Page 17: Emergency Procedures
User should avoid touching any exposed connector pins and the patient at the same time. Users must be trained on the safe and effective use of the MRI scanner before attempting to operate the coil. 300008312591 Rev A 10/2021 Page 17 © 2021 Invivo Corporation All rights... -
Page 18: Emc Information
Cables or options other than those used for the current product must not be used. If cables or options other than those used for the current product are used, the EMI performance may deteriorate. 300008312591 Rev A 10/2021 Page 18 © 2021 Invivo Corporation All rights... -
Page 19: Ambient Operating Conditions
<5% U for 5 Not applicable Not applicable power supply line IEC seconds 61000-4-11 Ambient operating conditions Symbol Measurement Type Operating Conditions Humidity 40 to 70% non-condensing Temperature 18-22 C (64-72 300008312591 Rev A 10/2021 Page 19 © 2021 Invivo Corporation All rights... -
Page 20: Product End Of Life
Damaged connector and pins - damaged cable pins and connector may damage the connector and affect coil or system performance. Cracked coil casing – cracked coil casings can expose electrical components, rendering the coil unsafe for the patient and/or user. 300008312591 Rev A 10/2021 Page 20 © 2021 Invivo Corporation All rights... -
Page 21: Ds Hires Hand/Wrist 16Ch Coil And Accessories
Use this guide to refer to part names throughout this manual. Description Part number Field Replacement Unit Part number dS HiRes Hand/Wrist 16ch 1.5T 4598-012-9548* 4598-012-9548* 4598-017-2886* 4598-017-2886* dS HiRes Hand/Wrist 16ch 3.0T... -
Page 22: 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 Coil Setup: At the Side Examination Joint vertically attached to the baseplate Joint horizontally attached to the baseplate 300008312591 Rev A 10/2021 Page 22 © 2021 Invivo Corporation All rights... -
Page 23: Workflow For Overhead Examination
Verify that the rail is in the table groove and the base is placed securely. Note 6.1.3 Attach the coil to the base plate Attach the coil to the mount adaptor, with the cable pointing to the head end. 300008312591 Rev A 10/2021 Page 23 © 2021 Invivo Corporation All rights... - Page 24 Position the patient Head-First prone on the tabletop with their hand in the coil. Put a pillow under the patient's chest for comfort. Fine-tune the coil angle to make the patient as comfortable as possible. 300008312591 Rev A 10/2021 Page 24 © 2021 Invivo Corporation All rights...
- Page 25 Scanning is not possible until the coil is fully closed. Note Ensure patient is as comfortable as possible. Elevate the patient’s legs slightly by putting a pillow under their ankles. Note 300008312591 Rev A 10/2021 Page 25 © 2021 Invivo Corporation All rights...
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Page 26: Patient Hearing Protection
6.3.3 Remove posterior pads Remove pads on top of patient’s hand and wrist. 6.3.4 Dismiss the patient Assist the patient off the table. 300008312591 Rev A 10/2021 Page 26 © 2021 Invivo Corporation All rights... -
Page 27: Workflow For Hand At The Patient's Side Examination
Store all coil and accessories in secure location. Workflow for hand at the patient’s side examination 6.4.1 Positioning the base plate The dStream interface, (d) is on the tabletop and plugged into the FlexConnect socket. 300008312591 Rev A 10/2021 Page 27 © 2021 Invivo Corporation All rights... - Page 28 Against the head end of the coil position the elbow/arm pad with the thick side to the coil For smaller patients, add an extra palm pad. 300008312591 Rev A 10/2021 Page 28 © 2021 Invivo Corporation All rights...
- Page 29 Note Always fully close the coil. Push the top end down until it fully closes. Note Scanning is not possible until the coil is fully closed. Note 300008312591 Rev A 10/2021 Page 29 © 2021 Invivo Corporation All rights...
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Page 30: Patient Hearing Protection
Pull the lock button towards the wrist end of the coil and lift the anterior section of the coil. 6.6.3 Remove posterior pads Remove pads on top of patient’s hand and wrist. 300008312591 Rev A 10/2021 Page 30 © 2021 Invivo Corporation All rights... - Page 31 Detach coil by sliding hub out of the rail of the base plate. 6.6.7 Remove base plate Remove base plate and all pads. Store all coil and accessories in secure location. 300008312591 Rev A 10/2021 Page 31 © 2021 Invivo Corporation All rights...
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Page 32: Scanning
Additionally, you may refer to the Hand/Wrist protocols for the dS HiRes 16ch HandWrist in the Philips data base located on the system for scanning with this coil. 300008312591 Rev A 10/2021 Page 32 © 2021 Invivo Corporation All rights... -
Page 33: Cleaning And Disinfection
Cleaning generally removes rather than kills microorganisms. Cleaning is accomplished with water, detergents and mechanical action. Cleaning is an essential prerequisite for effective disinfection. Disinfection 300008312591 Rev A 10/2021 Page 33 © 2021 Invivo Corporation All rights... -
Page 34: Spaulding Classification
(15°C-25°C or 59°F- 77°F) 1:200 Bleach solution (250 ppm 5 minutes Room temperature chlorine) (5ml household bleach minimum (15°C-25°C or 59°F- in 1 L water 77°F) 300008312591 Rev A 10/2021 Page 34 © 2021 Invivo Corporation All rights... -
Page 35: Prevention
Use proper personal protection and precautions when removing blood or residual contrast media. Cleaning and disinfection frequency Cleaning and disinfection must occur as soon as possible after each patient; avoid delays. 300008312591 Rev A 10/2021 Page 35 © 2021 Invivo Corporation All rights... -
Page 36: Cleaning And Disinfecting Procedure
2. Wipe the surfaces with a soft lint free cloth dampened in one of the recommended disinfectants (see Table 1 for recommended disinfectants) Never use a bleach solution more than 250ppm. Warning Never use bleach Wipes. 300008312591 Rev A 10/2021 Page 36 © 2021 Invivo Corporation All rights... - Page 37 Leaving residual cleaning or disinfecting agents on the coils may deteriorate the surface of the coils and cause cracks in surfaces. Dispose of any used disinfection materials in accordance with your facility's disposal protocols. Warning 300008312591 Rev A 10/2021 Page 37 © 2021 Invivo Corporation All rights...
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Page 38: Installation And Maintenance
Quality Assurance (SPT) testing will be performed upon receipt of the coil by the Philips Service Representative to establish a baseline of coil performance. The procedure should then be repeated at regular intervals. 300008312591 Rev A 10/2021 Page 38 © 2021 Invivo Corporation All rights... -
Page 39: Complaints
FDA. Follow the applicable laws or regulations on reporting device-related incidents or adverse events in the jurisdiction(s) in which the system is being used. 300008312591 Rev A 10/2021 Page 39 © 2021 Invivo Corporation All rights...
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