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.

3
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

4

5
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.

6
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.

7
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.

8
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.

9
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)

10
M1128 SYSTEM OVERVIEW

11
M1128 System Overview Key
1
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.
2
Handset Controller: Controls the simultaneous up and down movement of the panels and curtains
attached to the mast:
•Top buttons – raise and lower both the radial and lower extremity panels simultaneously.
•Bottom buttons – raise and lower the lower extremity panel attached to the mast.
3
Panel Mounting Brackets: Durable, acetal plastic brackets of varying shapes are used in M1128
assembly of the panels and shelves, curtains and handlebar.
4
Rotation Locks: The M1128 comes with two rotation locks:
•An upper rotation lock which locks and unlocks the movement of the lower extremity panel and
curtain
•A lower rotation lock which locks and unlocks the movement of the radial panel and curtain
5
Radial Panel: Adjustable acrylic panel with a half circle arm cutout and 1 mm lead-equivalent
protection. This is one of the two large primary radiation shielding panels motorized for movement via
attachment to the mast assembly.
6
Radial Curtain: Pliable curtain with 0.5 mm lead-equivalent protection which attaches to the radial
panel and provides flexible, shapeable radiation protection by conforming to a patient’s body.
7
Radial Panel Handle and Radial Panel Bracket: A fixed handle and bracket attached to the radial
panel. These parts are designed to better facilitate manipulation and positioning of the M1128.
8
Lower Extremity Panel: Adjustable acrylic panel with 1 mm lead-equivalent protection. This is one of
the two large primary radiation shielding panels motorized for movement via attachment to the mast
assembly.
9
Lower Extremity Curtain: Pliable curtain with 0.5 mm lead-equivalent protection which attaches to the
lower extremity panel.
10
Handlebar: A handlebar attached to the lower extremity panel aids in steadying and positioning the
M1128.
11
Base Block: The base of the M1128 comes with four configurable base legs and four base access
panels which can swing open to provide access to components in the base. The rechargeable battery,
charging cord and the controller are attached on the underside, and the telescopic mast on top.
12
Rechargeable Battery: The rechargeable battery is attached under the base block for mobile
operation. It requires a minimum of 10 hours to fully charge and can remain charging when not in use
without damaging the battery. The battery must be charged once every 12 months.
13
Controller: The control box located under the M1128 base receives input from the handset controller
to raise or lower the panels and curtains attached to the mast.
14
Base Legs: The base legs are mounted to the M1128 base, adjusts to a variety of configurations and
can fold inward to create a minimal footprint for Transit Mode (p. 15) or Storage (p. 31.)
15
Lockable Casters: Industrial grade, smooth-rolling casters attached to each leg of the M1128 allow
smooth configuration of the base legs, transportation of the M1128, and are lockable.
16
Leg lock: There are four leg locks, one on each leg. Unlock the individual leg lock on each leg to
reposition legs. Lock to keep legs from changing positions.
17
Base Access Panels: There are four base access panels, one on each vertical side of the base that
swing open and closed to allow access to M1128 base block contents.
18
Charging Port: Connects the rechargeable battery and controller under the base to the wall outlet.
19
Center Mast Accessory (CMA): The CMA assembly includes a pliable, articulating 1 mm lead-
equivalent protection CMA curtain able to adjust in height along a CMA guide shaft and lock into
place via the CMA clamping handle, all of which are attached to the lower extremity panel via the
white box-shaped CMA mounting bracket. A curtain hook on the bottom of the CMA curtain is used
to fold up the curtain for Transit Mode (p. 15)or Storage (p. 31).

12
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.
•Pliable radiation shielding curtains able to conform to patient body shapes
attach to the bottom of the radial and lower extremity panels and extend
the M1128 protective coverage area.
•The CMA assembly provides height-adjustable articulating radiation
protection between the radial and lower extremity panel.
•The M1128 legs are also adjustable to fit most intervention procedure
tables.
•The M1128 panels and curtains remain sterile when properly draped.
•The M1128 panels and curtains can be configured into an efficient mobile
or storage position when not in use.
•A below-table lead-equivalent protective modular shield, is available for
purchase through RampartIC, and can be used with the M1128 to provide
further radiation protection to the physician and lab tech on the shielded
side of the table.
TECHNICAL SPECIFICATIONS
Power Supply
The M1128 uses a rechargeable nickel manganese cobalt lithium-ion oxide battery
attached to the underside of the M1128 base.
•25.9 VDC output voltage
•10 A maximum discharge current
•300 mA charging current
•2.25 Ah / 58.28 Wh battery capacity
•IPX6 washable protection class
•10-hour full battery charge time
•10.5 feet (3.2 meter) cord length
ATTENTION!
The M1128 must be fully charged at least once every 12
months.
Controller
Rechargeable
Battery
Charging Port
Underside of
M1128 Base Block

13
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)
•Maintenance (p. 29)
The M1128 at its maximum
dimensions is positioned
with both upper and lower
mast actuators extended,
panels positioned at a 180-
degree angle, and a leg
positioned generally under
each panel and attached
curtain. This configuration
allows for proper weight
distribution and balance
while the M1128 is at its
largest configured size: 95.2
inches (2419 mm) tall by 70
inches (1778 mm) wide
Operating Environment
The M1128 system is designed for indoor use and storage only and must not be
subjected to weathering, UV light or corrosive environments. The working
environment defined for this device is a clinical or hospital surgical suite with a
working temperature range of 50°F (10°C) to 77°F (25°C) at 20% to 75% non-
condensing humidity. Storage temperature is between 14°F (-10°C) to 104°F
(40°C).
Weight
•The assembled M1128 radiation shield is over 300 pounds (>136 kg).
•The M1128 handset controller is 1.10 pounds (0.5 kg).
IP Protection Class
The M1128 radiation shield is rated in the IPX6 washable protection class.
95.2”
(2419 mm)
70” (1778 mm)

14
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
•Manufacturer Name
•Manufacturer City, State and Zip
•Manufacturer Website
•Manufacturer Phone

15
Transit Mode
The M1128 radiation shield must be placed into Transit Mode to be safely and
efficiently moved. Transit Mode consists of configuring the M1128 to its smallest
profile while maintaining stability. When in Transit Mode, the M1128 upper and
lower mast actuators are collapsed and the panels and attached curtains are folded
so that the M1128 dimensions are: 65.7 inches (1669 mm) tall by 58.9 inches (1497
mm) long and 27.3 inches (694 mm) wide; able to easily fit through standard
hospital doorways.
WARNING!
Before transport, the RampartIC M1128 must be in Transit Mode
(p. 15) and disconnected from charging.
WARNING:
Tipping
Hazard
•CONFIGURATION DURING USE: 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 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 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.
58.9” (1497 mm)
27.3”
(694 mm)
65.7”
(1669 mm)

16
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.
CAUTION:
Trip Hazard
•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, narrow enough to fit through standard
walkways. 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.
•Always maintain awareness of the positioning of M1128 legs
and casters to avoid tripping when moving around the M1128.
Note: A training video demonstrating configuration into Transit Mode is available at
www.RampartIC.com/training.
TO MOVE IN TRANSIT MODE
1. Remove and set aside the charging cord.
2. Fold up the CMA curtain by hooking
the curtain hook located on the
bottom of the curtain onto the
CMA curtain bar.
3. Unlock the CMA curtain for
movement by turning the CMA
clamping handle straight up.
4. Raise the CMA curtain to the
highest vertical position.
5. Lock the CMA clamping handle
by turning it straight down.
6. Put both rotation locks on the mast
into mid-position auto lock mode.
CMA
Guide Shaft
CMA Curtain Bar
CMA Clamping Handle
in locked position
CMA
Curtain
Lower Rotation Lock Upper Rotation Lock

17
7. Lower all panels and curtains
using the Handset Controller (p. 23).
8. 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.
9. Unlock all casters by pressing the top
half of the tab on each caster lock.
10. Unlock all four legs by
turning the leg lock
down on each leg.
11. Position all four legs into Transit
position according to the leg angle labels
adhered to the base of the M1128. When
positioned according to these labels,
the legs fully support the panels and curtains
while properly balancing the M1128 for transit.

18
12. Lock legs into place by turning
the leg lock up on each leg.
13. Make sure all doors between the current location and the destination are
unlocked and opened.
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 RampartIC logo.
17. Secure the equipment by placing one hand on the mast and the other
hand on the folded panels.
18. Walk with the M1128, guiding and pushing it to the desired location.
19. Lock casters upon arriving to destination.

19
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
that the M1128 remain plugged in continuously–if not in use or in transit–to
maintain a full charge.
•Continuous beeping from the battery indicates low charge and need for
charging. Continuously charging an M1128 in storage will not damage the
battery.
•It is important to battery life to charge the M1128 in full at least once every
12 months.
CAUTION!
•The M1128 must be fully charged at least once every
12 months.
•The M1128 must be charged 10 hours to obtain full
charge.
•Always unplug the M1128 radiation shield prior to
transport and before use.
1. Move the M1128 radiation shield to Storage (see p. 31) or another safe
location out of the way of foot traffic and activity, and where there is a
standard wall outlet. See Transit Mode (p. 15) for directions on how to
safely move the M1128.
2. Connect the charging cord to the base of the M1128.
3. Connect the other end of charging cord to the wall outlet.
4. Charge for a minimum of 10 hours to obtain a full charge.
Note: The M1128 can remain plugged in whenever not in use to safely
maintain a full charge.
5. When charged and needed, unplug the M1128 radiation shield before
moving and place in Transit Mode (p. 15).
LED INDICATOR - BATTERY STATUS
There is an LED indicator on the edge of the battery affixed to the bottom-side of the
M1128 base. The appearance of the LED indicates battery charge status as follows:
LED Battery Status Indication
Solid light Battery is charging.
Light off Battery is fully charged.
Flashing light There is a charging error.

20
Instructions for Use
The four legs, extendable mast, acrylic panels and attached curtains of the M1128
can be arranged in a variety of configurations to accommodate patient positions,
specific access points, technician location, multiple procedure table types, and other
lab equipment in various procedures. The M1128 can also be folded down to
Transit Mode (p. 15), providing a minimal footprint for safe and efficient movement
between rooms.
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
fluoroscopy where an operator stands on the right side of the procedure table and
uses the following specific access points: bi-radial, bi-femoral, pedal, popliteal, and
brachial.
CONTRAINDICATIONS, WARNINGS AND CAUTIONS
Contraindications include internal jugular and axillary access points and emergent
TAP procedures.
Note: A training video demonstrating usage tips is available at
www.RampartIC.com/training.
WARNING:
Radiation
Exposure
•Failure to set M1128 panels and curtains at the proper height
and position may cause unwanted 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 Imaging4, 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 acrylic panels provide a protection level of 1 mm lead
equivalency and the curtains provide 0.5 mm lead
equivalency against radiation exposure.
•The acrylic panels and curtains 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 (p. 29).
4 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,
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