RAMPART M1128-RTV V2 User manual

M1128
®
-RTV
V2
RADIATION SHIELD
USER GUIDE
M1128-UGD, Rev. A
LBL-087, Rev. A
Date of Issue: July 2023

This document should be stored with or within the immediate vicinity of the M1128
radiation shield and the medical team using the unit.
Rampart®, M1128®, Shed the Lead®, Fight the Good Fight®, Protect The Team™,
and You Are Worth It™ are trademarks of RampartIC.
The M1128 radiation shield is protected in the United States under U.S. patent
numbers 11,207,039 and 11,660,056. Additional patents are pending in the United
States and in other countries.
The contents of this publication may not be reproduced, copied or translated in
whole or in part without prior consent from RampartIC.
Pursuant to continuous product improvement, RampartIC reserves the right to
change the equipment design and the technology at any time.
All rights under the copyright laws are expressly reserved by RampartIC.
Within the bounds of legal requirements, the manufacturer is only responsible for
the technical safety characteristics of this device if the maintenance, repairs and
modifications to this apparatus are performed by RampartIC or an approved
RampartIC representative.
The RampartIC M1128 radiation shield is available in the following options:
•Mobile Right Table Version (M1128-RTV V2)
MANUFACTURER
RampartIC
Birmingham, Alabama USA
Phone: [phone]
Website: www.RampartIC.com
Email: [e-mail]
LIVE TECHNICAL SUPPORT
Live technical support is available at [phone] between the hours of
7 am to 6 pm Central Standard Time (CST), Monday through Friday. Phone calls
received outside business hours will be returned as quickly as possible.
TRAINING
Training videos and a PDF version of this user guide are available at
www.RampartIC.com/training.

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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 .............................................................................................................12
Technical Specifications ..................................................................................................... 12
Power Supply ..................................................................................................................12
Dimensions ..................................................................................................................... 13
Operating Environment...................................................................................................13
Weight .............................................................................................................................13
IP Protection Class ......................................................................................................... 13
Identification Tag................................................................................................................. 14
Transit Mode ..................................................................................................... 15
To Move in Transit Mode.................................................................................................... 16
Charging ............................................................................................................ 19
LED Indicator - Battery Status ............................................................................................19
Instructions for Use .......................................................................................... 20
Intended User Group .......................................................................................................... 20
Intended Patient Populations ............................................................................................. 20
Contraindications, Warnings and Cautions........................................................................20
Sample Configurations .......................................................................................................22
Handset Controller .............................................................................................................. 23
Resetting the Handset Controller ................................................................................... 23
Using the M1128.................................................................................................................24
Drape Instructions........................................................................................................... 26
Maintenance ...................................................................................................... 29
Cleaning .............................................................................................................................. 29
Cleaning .......................................................................................................................... 30
Disinfection ..................................................................................................................... 30
Storage................................................................................................................................31
Preventative Inspection ...................................................................................................... 31
Parts and Accessories ........................................................................................................32
Suggestions ........................................................................................................................ 32
Adjustable Legs ..............................................................................................................32
Under & Above Table Lower Body Protection ............................................................... 32
Transit Mode ...................................................................................................................32
Limited Warranty .................................................................................................................33
Disposal...............................................................................................................................33

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Overview
Congratulations on your purchase of the Rampart®M1128®radiation shield!
RampartIC ensures your team is equipped with the latest, state-of-the art radiation
protection equipment and has freedom of mobility during fluoroscopic procedures.
We hope you will PROTECT THE TEAM™and SHED THE LEAD®associated with
lead aprons as you FIGHT THE GOOD FIGHT®in the cath lab. We think YOU ARE
WORTH IT™.
This user guide provides guidance for the proper use of the RampartIC M1128 and
for training personnel. Please read this document in its entirety, especially the
warnings and caution statements identified throughout and summarized under
Safety & General Symbols (see p. 6), before use.
WARNING!
To reduce risk of injury to user(s) and patient(s), user(s)
must read and understand this user guide and be trained
prior to using the M1128.
Note: Training videos and a PDF version of this user guide are available at
www.RampartIC.com/training.
INTENDED USE
The RampartIC M1128 is a protective radiation shield intended to safeguard users
from radiation exposure during fluoroscopic medical procedures. Sterile disposable
drapes are placed over each individual panel and attached curtain assembly to
maintain a sterile environment.
SAFETY & LIABILITY
RampartIC assumes no liability for the safe and reliable operation of the M1128
radiation protection system where:
•Installation, modifications or repairs are not performed by RampartIC
technicians or people authorized by RampartIC.
•Authorized RampartIC replacement parts are not used.
•Authorized RampartIC sterility protection accessories are not used.
•The M1128 has not been installed or set up for a procedure in accordance
with the steps in this user guide.
•The M1128 is not moved in accordance with steps in this user guide.
•The M1128 is moved or transported to another building location without
proper moving containers and a RampartIC authorized technician.
•The M1128 is used in a manner other than its intended use as stated
above.
Notice to Users: Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.

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SAFETY & GENERAL SYMBOLS
Please pay special attention to important safety information marked with
WARNING, CAUTION or ATTENTION keywords and symbols.
WARNING!
Indicates a potentially hazardous situation which could result in the serious risk of
injury or death to the patient or operator, and/or damage to equipment or
property.
•To reduce risk of injury to user(s) and patient(s), user(s) must carefully read
and understand this user guide and be trained prior to using the M1128.
•Repairs must only be performed by RampartIC authorized personnel.
•Before transport, the RampartIC M1128 must be placed into Transit Mode
(p. 15)and be disconnected from charging.
•The weight of the M1128 panels and attached curtains must not be altered in
any way.
•The base unit and legs must not be altered in any way and must be used only
as outlined in this user guide.
•The panels and curtains can only be adjusted up and down using the handset
controller provided.
•When positioning, the panels and curtains must be carefully monitored to
avoid damage to persons or property.
WARNING:
Rare Earth
Magnet
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 Federal law.
WARNING:
MR-Unsafe
The M1128 system is MR-unsafe. MR-unsafe items should not be brought into
MRI scanner rooms.
WARNING:
Tipping Hazard
•CONFIGURATION DURING USE: The M1128 panels and attached curtains
can be placed safely at any needed angle during use, so long as one leg is
positioned in the general direction of each panel and curtain to provide proper
weight distribution and stabilization of the equipment, and to prevent the
equipment from tipping.
•CONFIGURATION DURING TRANSIT: To move the M1128 to another
location, the M1128 must be placed into Transit Mode (p. 15). First, the mast
must be collapsed to the lowest position and the panels and attached curtains
folded together and locked forward between legs 1 and 4. Then, all four legs
should be positioned for 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 RampartIC logo to push and guide
the M1128 during transit. When in Transit Mode and moved correctly, the
M1128 is narrow enough to fit through standard walkways.

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WARNING:
Radiation
Exposure
•Failure to set M1128 lead-equivalent acrylic panels and curtain attachments at
the proper height and position may cause radiation exposure. The M1128 is
designed to be used with under-table and above-table lower body protection.
•According to the Expert Consensus Document on Optimal Use of Ionizing
Radiation in Cardiovascular Imaging1, proper radiation 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 RampartIC M1128
panels provide a protection level of 1 mm lead equivalency and the curtains
provide 0.5 mm lead equivalency against radiation exposure.
•The panels and curtain attachments must be handled with care so they are not
damaged due to contact with other objects. If the panels or curtains are
damaged, they must be rechecked according to the Maintenance section on
page 29 of this user guide.
CAUTION:
Pinch Point
When making final adjustments to the panels and curtains, and while the patient
is in position, always monitor the lower edge of the panel and curtain in relation to
the patient to prevent injury. Always maintain visual contact with panels, curtains
and other equipment, in relation to the patient, when panel and curtain
assemblies or other equipment are being adjusted.
CAUTION:
Heavy
Equipment-
Injury Risk
•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.
•Personnel working with the M1128 system(s) must be properly trained.
•M1128 assembly, repairs and maintenance may only be performed by
RampartIC personnel or people authorized by RampartIC.
ATTENTION!
(Without safety
alert symbol)
The M1128 acrylic panels and curtain attachments will be permanently
damaged if cleaned with abrasive cleaners. When cleaning acrylic
panels and curtain attachments, DO NOT use the following cleaning
supplies:
•Alcohol wipes or Sporicidan2disinfectant towelettes, rough or abrasive-
faced sponges, brushes, cleaning pads, scrapers, or metal tools, paper
towels, linen washcloths
•Strong detergents or abrasives such as scouring powders
•Aerosol cleaners with Butyl Cellosolve3
•Hydrocarbon or chlorinated solvents, ammonia (more than 0.5%), or
strong alkali cleaners
•Cleaners that are designed for grease cutting
•Excessively hot water or steam
1 J. W. Hirshfeld and V. A. Ferrari, “2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal
Use of Ionizing Radiation in Cardiovascular Imaging: Best Practices for Safety and Effectiveness,“ 2018,
http://www.onlinejacc.org/content/early/2018/04/30/j.jacc.2018.02.016 (accessed August 10, 2019).
2 Sporicidan® is a registered trademark of Contec, Inc.
3 Butyl Cellosolve™ is a trademark of the Dow Chemical Company.

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CAUTION!
Indicates a potentially hazardous situation which could result in a minor or
moderate risk of injury to the patient or operator, and/or damage to equipment or
property.
•The M1128 must be fully charged at least once every 12 months.
•The M1128 must be charged a minimum of 10 hours to obtain full charge.
Please see Charging on page 19.
•Locking the casters during a procedure may cause damage to the M1128 or
interfere with its proper use.
•When cleaning acrylic panels and curtain attachments, never use rough or
abrasive sponges, steel wool, brushes or cleaning pads.
•When cleaning any component of the M1128, never use scrapers or metal
tools of any kind.
•Potential drag may occur when the radiation shielding curtains are moved
during a procedure. Ensure that the curtain flaps are lying flat against the
patient’s abdomen, pointing towards the patient’s head, to allow for best
visibility and intervention to access points.
CAUTION:
Trip Hazard
•Place controllers and the M1128 legs in a convenient and safe position so as
not to create a tripping hazard for the physician and medical team in the lab.
•Always maintain awareness of the positioning of M1128 legs and casters to
avoid tripping when moving around the M1128.
•CONFIGURATION DURING TRANSIT: To avoid becoming a tripping hazard,
the M1128 must be placed into Transit Mode (p. 15). First, the mast must
collapse to the lowest position and the panels and curtain attachments folded
together and locked forward between legs 1 and 4. Then, all four legs should
be positioned for Transit with leg locks locked into place to prevent legs from
changing angle during transit. 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 RampartIC logo
to push and guide the M1128 during transit.

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Explanation of Symbols
Reference Number
Use By
Serial Number Keep Dry
Quantity
Instructions for Use
Found at
www.RampartIC.com
Batch Number
Complies with
Applicable European
Union Regulations
Manufacturer
Prescription User or
Licensed Healthcare
Practitioner Use Only
Manufactured Date
Transit Mode
Medical Device
Do Not Re-Sterilize
Do Not Use If
Package is Damaged
Do Not Reuse Leg Number (1-4)
Sterilize Using
Ethylene Oxide
European Authorized
Representative
Leg 1 Angle Indicator
(Transit to 45°)
Leg 2 Angle Indicator
(Transit to 45° to 90°)
Leg 3 Angle Indicator
(Transit to 45°)
Leg 4 Angle Indicator
(Transit to 45°)
Lower Rotation Lock
(Lock for Transit,
Auto-Lock, Unlock)
Upper Rotation Lock
(Lock for Transit,
Auto-Lock, Unlock)

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M1128 SYSTEM OVERVIEW