Reina TM-CO-DRXL User manual

TM-CO-DRXL Installation and
User Guide
MAN-0014-B
RELEASED 07.22.20
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
TM-CO-DRXL Mobile Trans-Former
Installation and User Guide
Model: TM-CO-DRXL
Revision: July 2020

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 2 of 17
Table of Contents
i
Intended Use
3
ii
Safety and Compliance
3
iii
Warranty
4
1
About This Manual
5
1.1
Disclaimer
5
1.2
Additional Information Concerning Risks
5-6
1.3
Changes to This Manual
6
2
Product Description and Specifications
6
2.1
Product Description
6
2.2
Product Specifications
6-7
3
Required Tools and Equipment
6
3.1
Uncrating
6
3.2
Assembly
6
4
Uncrating the Device
7
4.1
Uncrating –Two People to Remove from Pallet
7
4.2
Removing Cardboard Container
7
Installation Precautions
7-8
5
Installing the Long-Length DR Panel and Grid
9
5.1
Factory Set Position of Detector Mount
9
5.2
Mounting the Long-Length DR Panel
9-10
5.3
Mounting the Grid
10
5.4
Securing the Long-Length DR Panel and Grid
11
5.5
Removing the Red Safety Screw
11
5.6
Moving the Device
11-12
6
User Operations: Height Adjustment and Rotation
13-15
6.1
Height Adjustment –Force Required
13
6.2
Height Adjustment of Long-Length DR Panel
13
6.3
Long-Length DR Panel Rotation
14
6.4
Device Position
14
6.4.1
Stabilizer Legs
15
6.5
Patient Position
15
7
Product Maintenance
15
7.1
Maintenance
15
7.2
Cleaning
15
8
Changes to This Document
16

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
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i. Intended Use
The TM-CO-DRXL Mobile Trans-Former (Model# TM-CO-DRXL) is designed to hold and
position the Long-Length DR Panel for use in general radiography. There are no
contraindications for use of this device.
ii. Safety and Compliance
Precautions!
•The unit is pre-assembled but take care in uncrating, as the device is very heavy.
•Use only on a flat, level surface.
•Follow any warning labels on the unit and these instructions.
•Do not attempt to adjust the Detector Mount height prior to reading the
instructions.
•Failure to adhere to the Precautions listed herein may result in injury to user or
patient!
Compliance
The TM-CO-DRXL Mobile Trans-Former is a Class 1 Medical Device (510k exempt) in the
USA and is registered to:
Reina Imaging
6107 W. Lou Avenue
Crystal Lake, IL 60014 USA
Phone: [phone]
The TM-CO-DRXL Mobile Trans-Former has been labeled and declared:
This model has been classified as a Class 1, Annex VII device.
European Authorized Representative:
Pinchet Rx SRL
Contact: Paolo Pinchet
Via Don Gnocchi 24 20148 Milano Italy
Phone: 02 / 48707603

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 4 of 17
iii. Warranty
Reina Imaging warrants to the Original Purchaser that this product will be free from
defects in its workmanship and materials, under normal use and service conditions, as
described herein. “Defects” as used in this warranty, is defined as any imperfections
which impair the use of the product. The company will repair or replace, at its option,
without charge to the original purchaser only, the defective products or parts for a
period of 1 year from the date of purchase and while owned by the Original Purchaser.
Should any component fail under normal use during this period, it is the buyer’s
responsibility to contact customer service at 800-752-4918.
Not Covered Under this Warranty
Damage caused by user abuse, misuse, negligence, accidental misuse and normal wear
will not be covered under this warranty. Users are responsible for reading all
instructions prior to using the product(s).
NOTE: Some images in this manual do not reflect the Long-Length DR
Panel, however, the work instructions are the same.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 5 of 17
1. About This Manual
1.1. Disclaimer - This manual was written to provide proper guidelines for using the
TM-CO-DRXL Mobile Trans-Former. Using the TM-CO-DRXL Mobile Trans-Former
in a manner other than detailed in this manual can be dangerous and can cause
serious property damage and injury. The user accepts all risks and Reina Imaging
shall not be responsible for any liability caused by improper use. Reina Imaging
assumes no responsibility to assess the user’s technical ability or clearance to
operate the TM-CO-DRXL Mobile Trans-Former. Use of the TM-CO-DRXL Mobile
Trans-Former constitutes the user’s acceptance of all responsibility for liability
caused by its use.
1.2. Additional Information Concerning Risks - Throughout this manual additional
information is presented to the user to aid in understanding of risks during
certain operations. This additional information is not comprehensive of all risks
assumed by the user and this product should only be operated by trained
persons possessing the technical expertise required for safe operation.
There are three types of additional risk-related information presented to the
user:
•Caution –Cautions in this manual contain information to help the user
avoid minor risks such as product problems due to improper assembly or
usage. Failure to heed this level of warning may result in product failure,
minor product damage, unusable product, property damage and the like.
The user or patient may also experience minor injuries.
The Caution Symbol
•Warning –Warnings in this manual contain information to help the user
understand substantial risks. Failure to heed this level of warning could
result in serious product damage and serious property damage.
The user or patient may also experience serious injuries that would likely
require medical attention.
The Warning Symbol

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
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•Dangers –Dangers defined in this manual contain information to help the
user understand extreme risks. Failure to heed this level of warning
could result in total product destruction and catastrophic property
damage.
The user or patient may also experience grievous personal injury
resulting in hospitalization or death.
The Danger Symbol
•Device-specific Cautions –Some cautions listed in this manual are specific
to this device. The “Do Not Lean” symbol means that the user or patient
should not lean on the TM-CO-DRXL, as it is a mobile device and could
shift or move.
The Do Not Lean Symbol
1.3. Changes to This Manual - User manuals are updated from time to time to offer
information about product improvements, to reflect engineering changes,
general workflow and the like. As these updates are released, they will be made
available for download by users. It is the user’s responsibility to consult our
website or call our support line for the latest materials regarding this system
prior to use. Users should check back periodically for updates and checking
before installation of the product(s) is recommended.
2. Product Description and Specifications
2.1. Product Description - The TM-CO-DRXL Mobile Trans-Former is designed to hold
and position the Long-Length DR Panel and an Anti-Scatter Grid for use in
general radiography. It is mobile with a wheeled base and features a lift-assist
mechanism and a rotating detector mount.
2.2. Product Specifications
Weight (with Long-Length Panel and Grid
mounted)
150lbs/68kg
Dimensions (lowest portrait position)
50”H x 24”W x 22”D
127cm x 61cm x 56cm
Total Vertical Stroke
22”/56cm
Max. Height Active Imaging Area - Portrait
76”/193cm
Min. Height Active Imaging Area - Portrait
2.5”/6.35cm

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
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Max. Height Active Imaging Area - Landscape
59.25”/150.5cm
Min. Height Active Imaging Area - Landscape
12.75”/32.5cm
Environmental Operating Conditions
+4°C to 38°C (40°F to 100°F),
Relative Humidity < 90%,
Barometric Pressure 29.92 In Hg /
760 mm Hg to 11.12 In Hg / 282.4
mm Hg
3. Required Tools and Equipment
3.1. Uncrating –Philips screwdriver, razor knife
3.2. Assembly –No tools required
CAUTION!
The device is heavy. Take care to move it with caution.
4. Uncrating the Device
4.1. The device comes fully assembled and can be lifted off the pallet by two people.
4.2. Cut the packing tape connecting the lid and box and remove the box top.
Remove the remainder of the box from the pallet. Remove all bracing and
strapping.
Removing Cardboard Container
Figure 4.2
Installation Precautions:
•The unit is pre-assembled but take care in uncrating, as the device is heavy.
•Follow all warning labels on the unit and these instructions.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 8 of 17
•Use only on a flat, level surface.
•Do not attempt to adjust height prior to reading the Warnings and instructions
for mounting the Long-Length DR Panel.
•Do not remove red safety screw near release pin in the right-side handle until
instructed to do so in Section 5.
•Failure to adhere to the Precautions listed above may result in injury to user!
WARNING!
The device’s lift-assist mechanism employs a forceful coiled spring. Attempting to
adjust the height of the Detector Mount before installing the Long-Length DR Panel
and the Anti-scatter Grid could cause the top of the Detector Mount to be driven
upward with high force and velocity, possibly causing injury to the torso, arms, neck,
face or head of the user. Do not actuate the release pin prior to reading the
instructions in Section 5. Remove the red safety screw only after reading the complete
instructions.
CAUTION!
To install the Long-Length DR Panel and Grid, leave the red safety screw in place and
do not attempt to adjust the height of the Detector Mount. The Long-Length DR Panel
must be mounted with the Detector Mount in the factory-set position.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 9 of 17
5. Installation of Long-Length DR Panel and Grid onto the Detector
Mount
5.1. Leave the Detector Mount in the factory set position with the red safety screw
in place.
Factory-Set Detector Mount and Safety
Screw Position
Figure 5.1
5.2. Mounting the Long-Length DR Panel –Make sure the tensioner knobs on the
rear of the Detector Mount are fully loosened by turning them clockwise until
they stop (see Figure 5.4 for reference). Install the Long-Length DR Panel into
the Detector Mount by sliding it between the support guides in the portrait
orientation and carefully pushing it until it is fully seated against the stops.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 10 of 17
Mounting the Long-Length DR Panel
Figure 5.2
5.3. Mounting the Grid - Install the Grid in either the storage position (behind the
Long-Length DR Panel) or in the clinical use position (in front of the Long-Length
DR Panel) by sliding it into the Detector Mount in the portrait orientation, taking
care to keep it straight so it slides easily into position.
Mounting the Grid
Figure 5.3

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 11 of 17
5.4. Securing the Long-Length DR Panel and Grid - Tighten the four tensioner knobs
on the rear of the Detector Mount by turning them anti-clockwise until tight.
Take care to keep the clamping bars straight by tightening each knob only a few
turns at a time. The Anti-scatter Grid can be mounted in front of the Long-
Length DR Panel for clinical use or stored behind it when not in use. To
maintain proper performance tuning, the Anti-scatter Grid must always be
mounted in the Detector Mount either in front or behind the Long-Length DR
Panel.
Tightening the Tensioner Knobs
Figure 5.4
5.5. Remove the red safety screw after mounting and securing the Long-Length DR
Panel and Grid.
Figure 5.5
Removing Red Safety Screw
5.6. Moving the TM-CO-DRXL –Lower the Detector Mount to its lowermost position.
Make sure stabilizer legs are in the “up” position. Hold the frame from the rear
near the top, place foot on bottom of frame and tilt the device back toward you.
It will then be riding on the wheels. Pass all thresholds and uneven surfaces by
pulling the unit slowly backwards over the obstruction.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
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Moving the Device
Figure 5.6
CAUTION!
This device is designed to have articulating movement with a wide range of motion.
There are no sensors, limit switches or physical stops to avoid collisions with walls,
floors, objects in the room or people. The device itself or the Long-Length DR Panel
may be damaged by collisions. User or patient injury could occur if proper care is not
taken while moving and positioning the device. Avoid pinching, squeezing, crushing,
collision or tipping by moving the device slowly and carefully during operation. Use
the device only a flat, level surface.
CAUTION!
This is a mechanical device that relies upon coil springs and pulleys to control the
height adjustment movements. The unit will move very easily near the center of its
stroke. Extra effort is required to reach the uppermost and lowermost positions. To
reach the uppermost position, use both handles to pull upward. To reach the
lowermost position place your left hand on top of the Detector Mount and apply
downward pressure.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
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6. User Operations: Height Adjustment and Rotation
6.1. Height Adjustment Force –The area marked in green has nearly zero-gravity
balance. The areas marked in yellow require additional force to be applied by
the user to achieve positions near the limits of vertical travel.
Height Adjustment Force
Figure 6.1
6.2. Long-Length DR Panel Height Adjustment - To actuate the Detector Mount’s lift-
assist mechanism and raise or lower the height, pull the release pin in the right-
side handle and raise or lower the Detector Mount.
Adjusting Height of Long-Length DR
Panel
Figure 6.2

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
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6.3. Long-Length DR Panel Rotation - To turn the Long-Length DR Panel from portrait
to landscape orientation, raise then rotate the Detector Mount clockwise into
the 90-degree detent taking care not to hit the floor or other objects. To turn
back to portrait orientation, rotate the Detector Mount anti-clockwise into the
0-degree detent.
Rotating the Long-Length DR Panel
Figure 6.3
CAUTION!
Always make sure the device is perpendicular to the central ray of the x-ray source and
patient is standing on the tongue of the TM-CO-DRXL before performing a
radiographic examination. If the patient is not standing on the tongue, the main body
could move during the examination, potentially causing a patient to lose balance or
fall, or create motion-induced blurring in the resultant image.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
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6.4. Device Position –Be sure to set the device perpendicular to the x-ray source and
to position the patient properly before making exposures.
6.4.1. The stabilizer legs can be flipped into the “down” position to provide
additional stability. Additionally, the rubber feet can be raised or lowered
by turning the adjustment wheel above the rubber foot to provide good
contact with the floor.
Stabilizer Legs
Figure 6.4.1
6.5. Patient Position - The patient must stand on the tongue of the TM-CO-DRXL to
stabilize the device during a radiographic exam.
Standing on the Tongue, PA/AP
Figure 6.5
7. Maintenance & Cleaning
7.1. Maintenance - The unit does not require maintenance under normal operating
conditions, although tightness of all fasteners should be routinely inspected and
should be retightened if they become loose. If the unit is not performing as
expected, contact Reina Imaging for assistance.
7.2. Cleaning - Surfaces can be cleaned using standard disinfection products. Do not
submerge components. Do not autoclave components.

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 16 of 17
8. Changes to this document:
Date
Revision
Description of Changes
06.30.20
A
Initial release
07.22.20
B
Updated Pictures
ALL QUESTIONS AND CONCERNS SHOULD BE FORWARDED TO:
REINA IMAGING
6107 W. LOU AVE., CRYSTAL LAKE, IL 60014
800-752-4918
www.reinaimaging.com

TM-CO-DRXL Installation and User Guide, July 2020
Reina Imaging 6107 W. Lou Ave., Crystal Lake, IL 60014 800-752-4918 www.reinaimaging.com
Page 17 of 17