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1.5T and 3.0T 8ch Wrist Array Coils
Veenpluis 6
5684 PC Best
The Netherlands
www.dunlee.com/healthcare
Revision B, 03/2022
4535-303-04992 Rev B
Operator's Manual
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
English
GE Healthcare
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Table of Contents
Related Manuals for GE 5160986-2
Summary of Contents for GE 5160986-2
- Page 1 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 GE Healthcare Veenpluis 6 5684 PC Best The Netherlands www.dunlee.com/healthcare...
- Page 2 (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, please contact your GE Healthcare representative to discuss coil compatibility issues. Failure to do so may void your warranty.
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Page 3: Table Of Contents
March 2022 Table of Contents Introduction ..............................6 Residual risks ............................6 Device description ..........................6 Indications for use ..........................6 Contraindications ..........................7 Basic Operating Principles ........................7 Target patient groups ......................... 7 Intended users ............................ 7 Clinical benefits and undesirable side effects ..................7 Compatibility ............................ - Page 4 March 2022 5.2.8 After scanning ..........................22 Workflow Imaging with the Wrist over the Patient’s Head (Superman) .......... 22 5.3.1 Positioning the baseplate for Imaging with the Wrist over the Patient’s Head ......22 5.3.2 Attaching the Baseplate Riser ....................23 5.3.3 Locking the Baseplate Riser .......................
- Page 5 March 2022 Cleaning ............................. 30 Disinfection ............................30 Spaulding classification ........................30 Recommended cleaning agents ......................30 Recommended disinfection agents ....................30 Cleaning and disinfectant agent warnings ..................31 Prevention ..............................32 Preventing residue on MR coil ......................32 Cleaning and disinfection frequency ....................32 Cleaning and disinfecting procedure for non-critical diagnostic MR coils and pads ......
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Page 6: Introduction
3.0T HD 8ch Wrist Array Coils and 8ch Wrist Coils with a P-Port Connector (all referred to as Wrist Array Coils for the rest of this document), for use with GE 1.5T or 3.0T MRI Systems. The Wrist Array Coils are Receive-Only coils. -
Page 7: Contraindications
Scanning patients with intracranial aneurysm clips is contraindicated. Basic Operating Principles This RF coil is designed for use with GE MRI scanners with HD or P-port connectors. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the human body while blocking the radio frequency magnetic field applied by the MRI system at specified timings. -
Page 8: Compatibility
Instructions for Use/Operations manual for any undesirable side effects related to the use of MR scanners. Compatibility The Wrist Array Coils are compatible with the following GE systems and connectors. Consult your GE representative for Software level requirements. Dunlee Part... -
Page 9: Explanation Of Symbols
March 2022 2 Explanation of Symbols Device Designation / Title of Symbol Reference Standards Description of Symbol Transport and Storage Reference number Requirements ISO 15223-1: Medical devices - Symbols to be used with ISO 15223-1, medical device labels, labelling Symbol 5.3.1 Indicates a medical device and information to be supplied Fragile;... - Page 10 March 2022 Designation / Packaging Unit Title of Symbol Reference Standards Description of Symbol Reference number IEC 60878: Graphical symbols Indicates the number of Packaging unit for electrical equipment in IEC 60878, Symbol pieces in the package. medical practice 2794 Designation / Mandatory Actions Before Use Title of Symbol...
- Page 11 March 2022 WARNING indicates a hazard with a medium level of risk which, if not avoided, could result in Warning / None – Internal death or serious injury. None – Internal symbol Caution symbol CAUTION indicates a hazard with a low level or risk which, if not avoided, could result in minor or moderate injury.
- Page 12 March 2022 Hazard Identification / Designation / Title of Symbol Reference Standards Description of Symbol Warning Symbols Reference number Indicates the magnetic field strength and the appropriate Magnetic field None – Internal strength MR scanner (1.5T or None – Internal symbol strength symbol 3.0T) that the medical device...
- Page 13 March 2022 REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Indicates the product is a Medical Device MDR 2017/745 Directive 2001/83/EC, medical device. Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and...
- Page 14 March 2022 The ETL Listed Mark indicates that the product ETL Listed has been tested by None Mark Intertek and found in compliance with accepted national standards. Classification and Designation / Identification of Electrical Title of Symbol Reference Reference Standards Description of Symbol Equipment number...
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Page 15: Wrist Array And Accessories
The connector on your coil my look different and the patient comfort pads may be grey. Description Part number Dunlee Order Part number 1.5T HD 8ch Wrist Array (Receive only) 5160986-2 4535-300-8344* HD 8ch Wrist Array (Receive only) 5160986-2 3000-073-1409* 3.0T HD 8ch Wrist Array... - Page 16 March 2022 *Represents the revision number **There will only be one baseplate raiser included with your coil. The riser is determined based on the MR system table type. The Wrist Array Coils replacement pads and pad kit numbers are listed in the table below. Please inspect upon receipt to make sure all parts have arrived and are in good condition.
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Page 17: Safety
March 2022 4 Safety Training This manual contains the detailed information regarding the set-up, positioning and use of the Wrist Array Coils. Before attempting to operate the coil, you must read these Instructions for Use, noting and strictly observing all Warnings and Caution notices. The instructions must be read carefully and thoroughly before attempting to scan patients with this coil. -
Page 18: Emergency Procedures
March 2022 or near the eye should be carefully screened before undergoing an MR exam. • Certain transdermal patches may cause burns to the underlying skin due to absorption of RF energy. The supplier of the patches should be consulted or the patch should be removed to avoid burns. A new patch should be applied after the examination. - Page 19 March 2022 must be installed and used in a shielded scan room provided with the MR magnet and system. The user must ensure that the scan room door is closed during system use. Failure to do so may cause reciprocal interference with portable and mobile RF communications equipment, affecting the performance of the MR coil and/or such equipment.
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Page 20: Using The Wrist Array Coils
March 2022 5 Using the Wrist Array Coils Choosing the best coil position The Wrist Array Coil is equipped with an at-side coil rail for imaging at the patient’s side and an over-head coil holder for imaging over the patient’s head (Superman position). The base is designed to rest directly on the patient cradle for stability. -
Page 21: Pad Configuration
March 2022 5.2.3 Pad configuration Six pads are supplied with the Wrist Array. The base pad (1) provides patient comfort. The palm (2), upper (3), wrist (4), and finger (5) pads support the hand and wrist to help prevent motion artifact. The elbow pad (6) supports and stabilizes the forearm for patient comfort and to help prevent motion artifact. -
Page 22: Locking The Coil
March 2022 5.2.6 Locking the coil 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”... -
Page 23: Attaching The Baseplate Riser
March 2022 (Curved baseplate) 5.3.2 Attaching the Baseplate Riser Align the knobs on the baseplate riser with the cutouts in the baseplate. (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. -
Page 24: Unlatch Coil
March 2022 Slide the coil to the right or the left depending upon wrist examination. Rotate the coil for maximum patient comfort. Note: Over rotation may decrease SNR. 5.3.5 Unlatch Coil Unlatch the coil by pushing the lock toward the cable end of the coil and pulling the coil open (up). -
Page 25: Connecting The Cable To The System
March 2022 Connecting the cable to the system For coils with an HD connector: Connect the Wrist Array Coil into the HD phased array port (A or B or C) depending on the system configuration. For Coils with a P-Port connector: Connect the Wrist Array Coil into the P-Port at the magnet end of the table. -
Page 26: Scanning
Generally, when the coil is used at the patient’s side, image quality is often improved by enabling AUTOSHIM. AUTOSHIM is a feature of the GE MRI System to improve image quality. It does this by improving the magnetic field homogeneity within the FOV selected. The improvement in image quality is often dramatic when the selected FOV is far off center, and when acquiring FSE or T2 weighted scans. -
Page 27: Installation And Maintenance
7 Installation and Maintenance Installation and configuration Coil installation and configuration requires the services of your GE Service Representative. Please refer to the service methods DVD. For software revision 14.0 and later, the system will automatically identify the coil when connected. -
Page 28: Space Required
March 2022 7.4.2 Space required To store the 1.5T or 3.0T HD 8ch Wrist Array coil and baseplate, a storage space of 55cm cm/21.5 in (width) x 45 cm/17.6 in (depth) x 35cm/13.7 in (height) is required. Disassembly of Coil 7.5.1 Unlatch Coil Unlatch the coil by pushing the lock toward the cable end of the coil and pulling the coil open (up). -
Page 29: Cleaning And Disinfection
March 2022 8 Cleaning and disinfection Cleaning and disinfection of your MR coils and accessories must comply with your institutions and local, state and federal regulations. The following Cleaning and Disinfection instructions have been tested and validated. Warning • Always detach coil from scanner before attempting to clean. Do not reattach after cleaning until the coil has dried completely. -
Page 30: Cleaning
March 2022 Cleaning Cleaning is the physical removal of foreign material, e.g., dust, soil, organic material such as blood, secretions, excretions and microorganisms. Cleaning generally removes rather than kills microorganisms. Cleaning is accomplished with water, detergents and mechanical action. Cleaning is an essential prerequisite for effective disinfection. -
Page 31: Cleaning And Disinfectant Agent Warnings
March 2022 Cleaning and disinfectant agent warnings • If using disinfection wipes, make sure they have the same active ingredients in the same concentrations listed above and include no other ingredients. • Always use protective eyewear and gloves when cleaning and disinfecting any equipment. •... -
Page 32: Prevention
March 2022 9 Prevention Preventing residue on MR coil Cover the patient contact surfaces of the coil and accessories with a sheet or MR compatible table paper, whenever possible before positioning the patient. Be aware that the use of sheets or paper without actual cleaning and disinfection does not prevent the spread of infectious agents. -
Page 33: Cleaning And Disinfecting Procedure For Non-Critical Diagnostic Mr Coils And Pads
March 2022 10 Cleaning and disinfecting procedure for non-critical diagnostic MR coils and pads Inspection • Inspect the coils and cables for damage, such as cracks, splitting or frayed cables. If coil or cable are damaged, contact your Service representative. −... -
Page 34: Disinfecting Instructions
March 2022 Disinfecting instructions 1. With the coil disassembled clean the surface according to the instructions above 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. -
Page 35: Emc Information
March 2022 11 EMC Information Guidance and manufacturer’s declaration – electromagnetic emissions: The Wrist Array MR coil is intended for use in the electromagnetic environment specified below. The customer or the user of the coil should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance... - Page 36 March 2022 Surge ± 1 kV line(s) to Not applicable Not applicable line(s) IEC 61000-4-5 ± 2 kV line(s) to earth Voltage dips, short <5% UT (>95% dip Not applicable Not applicable interruptions and in UT) for 0,5 cycle voltage variations on 40% UT (60% dip in power supply input lines UT) for 5 cycles...
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Page 37: Complaints
82-31-740-6119 India 91-80-845-2923 GE Healthcare Web Site www.gehealthcare.com In 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.