Summary of Contents for RAMPART M1128-RTV V2
- Page 1 M1128 -RTV V2 ® ADIATION HIELD UIDE M1128-UGD, Rev. A LBL-087, Rev. A Date of Issue: July 2023...
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Page 2: Manufacturer
All rights under the copyright laws are expressly reserved by Rampart Within the bounds of legal requirements, the manufacturer is only responsible for the technical safety characteristics of this device if the maintenance, repairs and... -
Page 3: Table Of Contents
Contents Manufacturer ......................... 2 Live Technical Support ......................2 Training ..........................2 Overview ......................5 Intended Use ......................... 5 Safety & Liability ........................5 Safety & General Symbols ....................6 Explanation of Symbols ....................9 M1128 System Overview....................10 M1128 System Overview Key ..................11 Key Characteristics ...................... -
Page 5: Overview
® in the cath lab. We think YOU ARE WORTH IT™. This user guide provides guidance for the proper use of the Rampart M1128 and for training personnel. Please read this document in its entirety, especially the warnings and caution statements identified throughout and summarized under before use. -
Page 6: Safety & General Symbols
Transit with leg locks locked into place to prevent legs from changing angle during transit. The person moving the device should carefully walk on the side of the device with Rampart logo to push and guide the M1128 during transit. - Page 7 Equipment- • M1128 assembly, repairs and maintenance may only be performed by Injury Risk Rampart personnel or people authorized by Rampart The M1128 acrylic panels and curtain attachments will be permanently damaged if cleaned with abrasive cleaners. When cleaning acrylic...
- Page 8 When in Transit Mode, the M1128 is stable and narrow enough to fit through standard walkways. The person moving the device should carefully walk on the side of the device with the Rampart logo to push and guide the M1128 during transit.
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Page 9: Explanation Of Symbols
Explanation of Symbols Reference Number Use By Serial Number Keep Dry Instructions for Use Quantity Found at www.RampartIC.com Complies with Batch Number Applicable European Union Regulations Prescription User or Manufacturer Licensed Healthcare Practitioner Use Only Manufactured Date Medical Device Transit Mode Do Not Re-Sterilize Do Not Use If Package is Damaged... -
Page 10: M1128 System Overview
M1128 SYSTEM OVERVIEW... -
Page 11: M1128 System Overview Key
M1128 System Overview Key Telescopic Mast: This stainless-steel mast is the backbone of the M1128, supporting the weight and height adjustment of all attached panels and curtains by control of the handset controller. The total height of the M1128 can be adjusted between 65.7 inches (1669 mm) tall when the mast is fully collapsed and up to 95.2 inches (2419 mm) tall when the mast is fully extended. -
Page 12: Key Characteristics
KEY CHARACTERISTICS Acrylic panels with a full 1 mm of lead-equivalent protection rotate • smoothly around the mast to provide customized protection for most approach positions including bilateral radial, bilateral femoral and bilateral pedal. • Panels are adjustable vertically to adapt to table and physician height, by use of a handset controller. -
Page 13: Dimensions
Dimensions The four legs, extendable mast, acrylic panels and attached radiation shielding curtains of the M1128 can be configured in a variety of ways with the overall measurements varying accordingly: • Instructions for Use (p. 20) • Transit Mode (p. 15) •... -
Page 14: Identification Tag
IDENTIFICATION TAG An identification tag can be found at the base of the M1128 identifying key information about your product that may need to be referenced during service calls. Product Name • Reference Number • Serial Number • Bar Code •... -
Page 15: Transit Mode
The person moving the device Hazard should carefully walk on the side of the device with Rampart logo to push and guide the M1128 during transit. When in Transit Mode and moved correctly, the M1128 is narrow... -
Page 16: To Move In Transit Mode
M1128 is stable, narrow enough to fit through standard CAUTION: walkways. The person moving the device should carefully walk Trip Hazard on the side of the device with Rampart logo to push and guide the M1128 during transit. • Always maintain awareness of the positioning of M1128 legs and casters to avoid tripping when moving around the M1128. - Page 17 Lower all panels and curtains using the Handset Controller (p. 23). Fold the radial panel, the lower extremity panel and CMA curtain together between legs 1 and 4. Both rotation locks will automatically lock when panels are in the correct position. Unlock all casters by pressing the top half of the tab on each caster lock.
- Page 18 14. Make sure that the pathway to the destination is unobstructed. 15. Alert individuals in proximity that equipment is coming through. 16. Stand on the side of the M1128 with the Rampart logo. 17. Secure the equipment by placing one hand on the mast and the other hand on the folded panels.
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Page 19: Charging
Charging The M1128 radiation shield is powered by a rechargeable battery designed to be charged only when the M1128 is not in use or in transit. Though it takes 10 hours for the M1128 to fully charge, it is recommended •... -
Page 20: Instructions For Use
The M1128 operates on battery power only. INTENDED USER GROUP The intended user group for the Rampart M1128 radiation shield are physicians and their staff. INTENDED PATIENT POPULATIONS The Rampart M1128 is indicated for any interventional procedure that utilizes... - Page 21 The M1128 system is MR-unsafe. MR-unsafe items should not be brought into MRI scanner rooms. WARNING: MR-Unsafe • The M1128 is heavy and caution must be used when handling the system. • Failure to maintain control when moving the system can result in personal injury or property damage.
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Page 22: Sample Configurations
SAMPLE CONFIGURATIONS Transit Mode with mast fully collapsed, Panels and curtains at 180 deg for radial panels and curtains folded together between (bi-radial) and femoral procedures and to legs 1 and 4, and legs in transit mode accommodate biplane angles. Panels and curtains at 180°... -
Page 23: Handset Controller
HANDSET CONTROLLER Keep rare-earth magnets away from anyone with a pacemaker and away from magnetic media. Dispose of rare-earth magnets in compliance with local, state and WARNING: Federal law. Rare Earth Magnet The handset controller accompanying the M1128 is used to raise and lower the procedures and circumstances. -
Page 24: Using The M1128
Ionizing Radiation in Cardiovascular Imaging protection is in place when a minimum of 0.5 mm lead equivalency is placed between the radiation source and medical personnel. When used correctly, the Rampart M1128 panels provide a protection level WARNING: of 1 mm lead equivalency and the curtains provide 0.5 mm lead Radiation equivalency against radiation exposure. - Page 25 Upper Unlock the lower extremity panel by pulling the upper Rotation rotation lock to its furthest position out away from the mast. Lock Rotate the lower extremity panel into the desired position. The lower extremity panel can open a maximum of 210 degrees. Note: The upper rotation lock must be unlocked and the lower extremity panel opened to at least a 90-degree angle before panels can be raised.
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Page 26: Drape Instructions
21. Remove the rest of the adhesive backings from drape 4. 22. Secure the rest of the drape 4 backings to completely cover the mast. Note: Drapes are sold separately at Rampart and not included with purchase of the M1128. A training video demonstrating how to use the drape kit is available at... - Page 27 CAUTION: curtains or other equipment are being adjusted. Pinch Point 31. Position Rampart anti-fatigue mat(s) according to the comfort of physician and staff. Note: A Rampart anti-fatigue mat is provided with each M1128. To purchase additional anti-fatigue mats, email info@RampartIC.com.
- Page 28 Transit with leg locks locked into place to prevent legs from changing angle during transit. The person moving the device should carefully walk on the side of the device with Rampart logo to push and guide the M1128 during transit. When in Transit Mode and moved correctly, the M1128 is stable, narrow enough to fit through standard walkways.
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Page 29: Maintenance
Maintenance The Rampart M1128 requires post-procedure cleaning, routine inspections and repairs by Rampart authorized personnel to maintain optimal performance. • The M1128 is heavy and caution must be used when handling the system. • Failure to maintain control when moving the system can result in personal injury or property damage. -
Page 30: Cleaning
• The use of disinfecting products may cause panel discoloration over time. • Rampart cleaning cloths are designed for safely cleaning M1128 panels and curtains and are available for purchase. To purchase, email info@RampartIC.com. -
Page 31: Storage
Preventative maintenance following the equipment specific maintenance plan will default to the policies and procedures of the institution related to inspecting shielding. Rampart service team will perform a visual inspection of attenuating components to determine appropriateness. If institution participation is available to operate fluoroscopic equipment, such testing will be performed via institution staff. -
Page 32: Parts And Accessories
Under & Above Table Lower Body Protection Rampart requires the use of a below-table lead-equivalent protective shield in conjunction with the M1128 radiation shield such as the Rampart L148 table- mounted shield available for purchase through Rampart . When used in the correct configuration, the physician and the lab technician will be shielded from 98% to 99.9% radiation exposure. -
Page 33: Limited Warranty
LIMITED WARRANTY Rampart warrants to Customer that this product, manufactured by Rampart sold to Customer, will be free from defects in materials and workmanship for a period of one (1) year after delivery to Customer. This warranty shall not apply to... - Page 36 1500 Urban Center Drive, Suite 140, Birmingham, Alabama USA (205) 236-3000 Office, (833) 978-0052 Technical Support info@RampartIC.com www.RampartIC.com...