Gammex 163-DIG User manual

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User’s Guide, Mammography Digital Compres-
sion Scale
© 2019 by Gammex Inc. All rights reserved.
The information contained in this guide is copyrighted and all rights are reserved by Gammex Inc.
Copying, duplicating, selling, or otherwise distributing any part of this manual without the prior writ-
ten consent of Gammex Inc. is prohibited.
Gammex Inc. reserves the right to make periodic modifications to this manual without obligation to
notify any person or entity of such revision.
This guide is written for Model 163-DIG.
Document 009287-00-00
Gammex Inc.
7600 Discovery Drive
Middleton, WI 53562 USA
[phone]
www.gammex.com

Contents
163-DIG Scale Overview . . . . . . . . . . . . . . . . . . 1
Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Assemble the Platform . . . . . . . . . . . . . . . . . . . . 1
Battery & Install. . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conditions for Use, Transportation, &
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
High Oxygen Warning . . . . . . . . . . . . . . . . . . . . . 2
Limitation of Use . . . . . . . . . . . . . . . . . . . . . . . . . 2
Independent Failure Mode Warning . . . . . . . . . . 2
Features & Specifications. . . . . . . . . . . . . . . . . 3
How it Works. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Initialization Sequence . . . . . . . . . . . . . . . . . . . . 4
Zero/Tare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Hold/Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Overload Warning . . . . . . . . . . . . . . . . . . . . . . . . 4
Energy Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Detachable Display Panel . . . . . . . . . . . . . . . . . . 5
Scale Specifications . . . . . . . . . . . . . . . . . . . . . . . . 6
Using the 163-DIG . . . . . . . . . . . . . . . . . . . . . . . 7
General Operation . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Standard Setup (0-degree) . . . . . . . . . . . . . . . . . 7
Prone/Stereotactic Setup (90-degree). . . . . . . . . . . 8
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Routine Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Calibration Process . . . . . . . . . . . . . . . . . . . . . . . . . 9
Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Maintenance and Support . . . . . . . . . . . . . . . . 10
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Contacting Gammex Support . . . . . . . . . . . . . . . . 10
Gammex Symbols . . . . . . . . . . . . . . . . . . . . . . . . . 11
Quality and Regulatory Systems . . . . . . . . . . . . . . 11
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . 11
Reporting Health or Safety Related Issues or
Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Modifications to Equipment . . . . . . . . . . . . . . . . . . 12
Contents

Product Overview 1
1 163-DIG Scale Overview
Product Overview
The Gammex Digital Compression Scale, Model 163-DIG, measures the compression force applied
by mammography systems.
Accurate compression during mammographic image acquisition is essential to minimizing dose to
the patient while achieving acceptable image quality. Compression minimizes patient motion,
reduces scattered radiation, increases image contrast, and diminishes radiation exposure to the
breast by spreading out and reducing the overall thickness of the breast tissue.
Routine testing of compression force with the Gammex Digital Compression Scale allows clinical
users to comply with internationally recognized standards and manufacturer recommendations. For
example, countries that follow ACR & MQSA guidelines can use the 163-DIG to fulfill the MQSA
requirements for compression performance. For more information, please see the ACR
Mammography Quality Control Manual, Technologist’s Section on Compression.
Getting Started
Capacity
Assemble the Platform
Add the scale platform to the scale body by aligning the pins with the holes on the body and evenly
pushing in all the pins.
Battery & Install
Batteries are not included with the 163-DIG product. Refer to Scale Specifications on page 6 for the
type of batteries to use. A display of Lo or the battery symbol ( ) on the 163-DIG readout
indicates low batteries and replacements are required.
To install batteries in the 163-DIG:
1On the bottom of the 163-DIG, press and slide the battery cover.
2Note the polarity (+) and (-) and insert the batteries in the correct orientation.
3Ensure all contacts make a strong connection with batteries. If necessary, use a small screw
driver to bend battery terminals for a better connection.
4Slide the battery cover into place until clicks shut.
Conditions for Use, Transportation, & Storage
When the 163-DIG is not in regular use or transported, removing one or more batteries is
recommended to preserve battery life. If transporting, removing all batteries is recommended to
prevent damage to the battery housing.
Transportation and storage within a soft case (sold separately) is recommended. Contact your
Gammex sales associate (g[email protected]) for a transportation case to fit the 163-
DIG.
Never store and transport in extreme heat or cold conditions, refer to Scale Specifications on page 6
for normal operating conditions. Also avoid high humidity, vibration, dusty, or magnetic
environments in all cases of use, transport, and storage. Failure to follow guidelines voids the
product warranty. Refer to Scale Specifications on page 6 for Operating Temperature.
WARNING: Overloading the 163-DIG might permanently damage the scale – do not
overload! The scale capacity is 0-55 lbs. (0-25 kg).

2Section 1. 163-DIG Scale Overview
High Oxygen Warning
Limitation of Use
Product is only to be used as intended and as described herein. Follow instructions to avoid misuse
and errors that might potentially lead to voiding product warranty.
Independent Failure Mode Warning
Do not use results from the 163-DIG to make changes to your system, do use the results to perform
additional system checks.
WARNING: The 163-DIG is not intended to be used in oxygen rich environments or in
the presence of anesthetic agents or gases. These environments are not within the
scope of use for the 163-DIG.

How it Works 3
2 Features & Specifications
How it Works
The Digital Compression Scale uses an array of load cells to measure the compression force
applied to the platform. The Scale continuously displays the maximum force as applied by the
compression paddle and is thus well suited for testing compression over time. You can freeze the
display of the maximum force reading by pressing the Pause/Hold button. Press the Zero button to
reset.
Components
Figure 2-1. Model 163-DIG Diagram
Table 2-1. Parts and Accessories
Part Number Description
163-DIG Digital Compression Scale
603061 Compression Foam Block
805972 Soft Case for 163-DIG (optional)
Platform
lined with thin foam
Display
Removable & Backlit
LCD panel
Power
On / Off
Hold
Freezes display value Tare
Zero display value
Capacity
& Accuracy Units
Select kg, lbs

4Section 2. Features & Specifications
Features
Initialization Sequence
Upon power-on, 163-DIG performs a startup sequence countdown. Keep the unit on a flat and stable
surface during initialization. At the end of initialization 163-DIG automatically zeroes.
Zero/Tare
Zero/Tare allows users to zero the scale for relative measurements, or measurements in different
orientations. Before any compression measurement is taken, the 163-DIG should be zeroed.
Note: After a tare force is removed, the Scale will read a negative value. Press Zero/Tare to re-zero
the 163-DIG.
Hold/Pause
Hold/Pause (⏸) allows users to freeze the display on the Scale. Press it again to cancel, or use
Zero/Tare.
Overload Warning
Do not exceed the scale capacity – this can cause permanent damage and void warranty. Refer to
the Scale Specifications on page 6 for the scales capacity. If the scale is overloaded, the display
shows Err-0 and the load should be removed immediately.
Energy Saver
The scale automatically powers off after 90-seconds of inactivity to preserve batteries. Activity
includes any button presses or change in force measurement.
Table 1: Accessories
Foam Compression Block Soft Case

Features 5
Detachable Display Panel
Users might find removing the display helpful for testing prone or stereotactic systems. To remove
the Display Panel of the 163-DIG:
1On the bottom, push the release tab with arrow indicting direction.
2Wriggle and slide the Display Panel upwards in the direction of the Platform while holding the
release tab.
3The separated Display Panel is corded to the Platform Body and ready for use in desired
orientation. Tare the scale when changing orientation.
Figure 2-2. Display panel removed from 163-DIG

6Section 2. Features & Specifications
Scale Specifications
Table 2-2. Specification table
Parameter Value
Capacity 0-55 lbs. (0-25 kg)
Accuracy ± 0.005 lb [0 - 2 lb], ± 0.02 lb [2 - 55 lb], ±0.002 kg [0 - 1 kg], ±0.01 kg [1 - 25 kg]
Display Units g, lb:oz, kg, lb, oz
Scale Dimensions 8.9 x 8.2 x 2.9 in. (225 x 208 x 73 mm)
Platform Dimensions 7.87 x 6.22 in. (200 x 158 mm)
Foam Compression Block Dimensions 7.25 x 4.75 x 1 in.
Scale Weight 2 lbs. (0.95 kg)
Power Alkaline Batteries Size C (4x) (not included)
Energy Saver | Auto-Off 90 seconds
Operating Temperature 50 – 104° F (10-40° C)
RoHS Complaint Yes

General Operation 7
3 Using the 163-DIG
General Operation
Standard Setup (0-degree)
The ACR requires a mammography system to provide a compression force of no less than 25 lbf
(111 Newtons) for initial power drive mode and no more than 45 lbf (200 Newtons) for subsequent
power drives.
Unless otherwise specified by the manufacturer, the recommended procedure for testing
compression is that described in the ACR Mammography Quality Control Manual. The procedure is
summarized below.
1Raise compression paddle (plate) to maximum height and center it. Turn off Flex-mode.
2Place the Model 163-DIG on the breast support approximately centered on the compression
paddle. Optionally place the Foam Compression Block on top of the 163-DIG Platform, which
is also useful for testing curved paddles.
3Power On the 163-DIG Scale and wait for Initialization to complete.
4Select the Unit for display by toggling to the appropriate unit of measure.
Note: Units can be converted from kg to N by multiplying by 9.81 m/s2 (or by 0.981 to get N)
5Press Tare if the scale is not at 0.
6On the Mammography system, using the initial power drive, activate the compression scale and
allow it to operate until it stops automatically.
7Record the compression force.
8Perform subsequent power-drive modes until it stops.
9Record the compression force.
10 Follow directions from the local mammography QC standard for testing manual drive mode and
compression over time.
Figure 3-1. Setup for 163-DIG on mammography system

8Section 3. Using the 163-DIG
Prone/Stereotactic Setup (90-degree)
The 163-DIG is suitable for measuring compression force for a wide range of patient setup
orientations. For prone or stereotactic systems that compress at 90-degrees, the 163-DIG can be
used on its side. Optionally, the Display Panel can be removed. Refer to the Detachable Display
Panel on page 5 for more information.
To collect measurements in 90-degree orientation:
1Power up and zero the 163-DIG flat and stable surface.
2Rotate the 163-DIG onto its narrow side on a flat and stable surface and zero the scale.
3Bring the 163-DIG to the Mammography system and very carefully apply pressure to clamp the
scale between the compression paddle and detector.
WARNING: Only let go after the scale has pressure (~10 lbs). Damage from
dropping the Scale is not covered by warranty.
4Perform measurements per local Quality Standard (ACR, EUREF, etc.)
5Place hands under 163-DIG at all times when compression force is released.
Figure 3-2. Example setup of 163-DIG on Prone/Stereotactic System. The scale is held in place by
user until the machine applies the appropriate pressure.

Routine Checks 9
4 Calibration
Routine Checks
Gammex no longer offers certificates of conformance for scales – please seek out a local metrology
center for routine recertification if required. If adjustments are needed to dial in the scale, follow
instructions below for the calibration process.
Note: Calibration might be required upon first use. This is especially true after an altitude change,
where gravitational force can vary for the same body of mass. Calibration of scales should be
checked over time as mechanical components are subject to wear.
Calibration Process
Required equipment:
• 10 kg certified weight or combination of certified weights.
Process
1While the 163-DIG is off press and hold the Unit button while holding the Power button until the
display reads CAL. Immediately after, a random set of numbers appear (raw load cell value).
2Press Unit again. The display now shows - - - - - - and then flashes the calibration weight to be
used (10 kg).
3Place the 10 kg calibration weight on the 163-DIG platform.
4When the stable indicator ( ) is displayed, press the Unit button again and the display shows
- - - - - - followed by the new (raw load cell value).
5Press the Power button to turn the scale off and then press the Power button. Calibration is now
complete.

10 Section 5. Maintenance and Support
5 Maintenance and Support
Maintenance
• Avoid contact with alcohol.
• Wipe after use with a damp cloth, if necessary.
Contacting Gammex Support
Technical support is available from Gammex Inc. Contact the Support department:
• By telephone: [phone], option 3, then 3.
• By email: [e-mail]
Gammex Inc.
7600 Discovery Drive
Middleton, WI 53562 USA
[phone]
www.gammex.com

Gammex Symbols 11
Appendix A: Regulatory Supplement
In addition to the regulatory information contained in the body of this manual, the following
supplemental regulatory information is provided.
Gammex Symbols
The following symbols are used in this guide and in Gammex’s product labels.
Quality and Regulatory Systems
Gammex meets worldwide standards including EN ISO 13485 and FDA 21 CFR 820.
Gammex Quality Management System is certified to 13485 by SGS.
Operator Responsibility
The instructions in this manual are intended for trained personnel. The operator is solely responsible
for the accurate setup and use of the scale.
WARNING: This symbol indicates a hazard that could result in major injury or
equipment damage.
This symbol indicates a general mandatory action.
Manufacturer’s Identification (name and address.
Date of Manufacture.
Serial Number.
Catalog Number.
Consult instructions for use.
Do not throw in trash; dispose of in an environmentally friendly way.

12 Appendix A: Regulatory Supplement
Reporting Health or Safety Related Issues or Concerns
Should the need arise to report any safety or health related issues or concerns regarding the use of
Gammex products, contact Gammex directly.
Modifications to Equipment
WARNING: No modifications may be made to this unit without the
expressed written consent of Gammex. Unauthorized changes may
present a risk to user or patients and will void the warranty.

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