Mirion Technologies BIODEX SOUND PRO 058-710 User manual

SOUND PRO
™
COMBINATION TABLE
OPERATION MANUAL
058-710
058-715
7 Vreeland Road, Florham Park, NJ 07932
[phone] | [phone] | www.biodex.com
FN: 08-233 Rev E 4/23

SOUND PRO
™
COMBINATION TABLE
This manual covers operation procedures for the following products:
058-710 Sound Pro Combination Table, 115 VAC
058-715 Sound Pro Combination Table, 230 VAC
Contact Information
Manufactured by:
Mirion Technologies (Capintec), Inc.
7 Vreeland Road, Florham Park, NJ 07932
[phone] | [phone] | Fax: [phone]
email: [e-mail] | www.biodex.com

TABLE OF CONTENTS
Definition of Symbols..........................................................................................................................4
Before Proceeding ...............................................................................................................................5
Important Safety Information ..............................................................................................................7
Chapter 1: Introduction ..................................................................................................................8
Table Parts and Adjustments ..........................................................................................................9
Chapter 2: Assembly and Table Operation ......................................................................................10
Relocating the Table.......................................................................................................................10
Height Adjustment.........................................................................................................................10
Trendelenburg Positioning .............................................................................................................10
Fowler Back Adjustment .................................................................................................................11
Leveling the Table ..........................................................................................................................11
Adjustable Sonographer Cutout Cushion.........................................................................................11
Cardiac Scanning Cutout Cushion...................................................................................................11
Installing and Using Accessories .....................................................................................................12
Foot Controller...............................................................................................................................12
Articulating Scanning Arm Board ....................................................................................................13
Side Rails .......................................................................................................................................14
Headrest ........................................................................................................................................15
Paper Dispenser .............................................................................................................................16
Retractable Stirrups........................................................................................................................17
IV Pole ...........................................................................................................................................18
Appendix A - Specifications ............................................................................................................19

4
Symbol
Definition
Carefully read these instructions prior to use
Operating Instructions
Caution
General Warning
General Mandatory Action
Dangerous Voltage
“On” Power
“Off” Power
Pinch Point
Earth (ground)
Alternating Current
Fuse
USB Connector/Cable
Non-Ionizing Electromagnetic Radiation
Waste in Electrical Equipment
Disposal Classification and Identification of Equipment
Date of Manufacture
Manufactured By
Type B Applied Part
Medical Device
Contains Lead

5
Before Proceeding
NOTE: The warnings, cautions and instructions provided in this manual must be read,
followed, and kept available for consultation at all times. Observing the information,
instructions and procedures presented throughout this manual is essential for using
this product both properly and safely.
SPECIFIC CAUTIONS
•Allow only qualified, trained personnel to operate or service this product.
•If the equipment is used in a manner other than specified in this operation manual,
the protection provided by the equipment may be impaired and results could be
compromised.
•Never leave patient unattended on table.
•When the table is used in a wet environment, it is recommended that the foot
controller be covered with a plastic bag and sealed as watertight as possible.
CAUTION: Unauthorized modifications to this product are not permitted and will void
the manufacturer’s warranty. Unauthorized modification of the product may result in
a hazard to the user and/or patient. Do not modify this equipment without
authorization from the manufacturer.
CAUTION: Before moving the table with a patient, make sure side rails are in the up
position and body straps in place to secure the patient.

6
Training
This operation manual includes assembly and operating instructions. Operating/assembly
questions can be directed to our service department during business hours.
User Profile
Patient
The product (without accessories) shall accommodate patients fitting the following profile:
Height: from infant to 74 inches (6ft - 2in)
Weight: up to 500 lbs.
Age: No limits
Operator
The operator is a trained and certified sonographer, ultrasound technician, or
ultrasound technologist.
Product Certifications and Classifications
The Sound Pro Combination Table has received the following certifications, and falls within the
following classifications:
•IEC 60601-1-2:2014+A1:2020 (ed 4.1) Medical Electrical Equipment –Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
•IEC 60601-1:2005+A1:2012+A2:2020 Ed 3.2 Medical Electrical Equipment. Part 1. General
Requirements for Basic Safety and Performance.
•ANSI/AAMI ES60601-1:2005+A1:2012+A2:2020 Issued: 2020 Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
•CAN/CSA-C22.2 No. 60601-1:14/A2-2022: (2022) –Medical electrical equipment –Part 1:
General requirements for basic safety and essential performance
Authorized European Community Representative:
Atlantico Systems Ltd.
34 Oldfield, Kingston, Galaway, Republic of Ireland

7
Important Safety Information
CAUTION: Federal Law restricts this device to sale by or on the order of a physician,
sonographer or other licensed professional.
Follow the unpacking and assembly instructions document.
Before using this equipment, read the entire operation manual carefully. Failure to read
the manual may result in user error or injury. Be sure to save all provided documents for
future reference.
Make certain to understand all warning and caution labels as explained in the Before
Proceeding section of this manual.
This product should be used only as specified in the operation manual.
Biodex Imaging Tables are designed for use in a patient environment.
For product specifications, refer to the Table of Contents.
This medical electrical equipment requires special precautions regarding EMC and must
be assembled and placed into service according to EMC information provided in this
manual. For electromagnetic compliance definition, refer to the Table of Contents.
Reference Cleaning and Maintenance Instructions in Table of Contents.
CAUTION: Operation for 058-710: 115 VAC, 60 Hz; 058-715 230 VAC, 50 Hz.
WARNING: Only use approved power supplies.
CAUTION: To avoid risk of electric shock, this equipment must only be connected to
supply mains with protective earth.
CAUTION: The plug is considered the method of disconnecting the product from main
power. Do not place the product in a position where the plug is not easily accessible.
CAUTION: This product is intended to remain in one location during operation. The
product is provided with wheels for relocation and should be used when performing this
operation. Once positioned, engage the central locking system lever to ensure stability.

8
1. INTRODUCTION
Intended Use
The Sound Pro Combination Table is designed to provide a safe ergonomic environment for the
sonographer and patient. The design features are intended to relieve musculoskeletal stress on
the sonographer while scanning, and to provide the utmost patient comfort.
Indications for Use
The Sound Pro Combination Table is typically used in radiology departments, diagnostic imaging
centers and private practice clinics to achieve quality images for a variety of procedures and
patient applications.
Incident Reporting
Any serious incidents occurring with the use of this device should be reported to the
manufacturer and appropriate local regulatory agency by end user, operator, or patient. Examples
of local regulatory agency are USFDA, EU competent authority, or country specific Health Agency.
End of Life
LIFETIME (END OF LIFE) The Family of Ultrasound Tables lifetime (End of Life) is considered to be
ten years after date of shipment. Service, support, and spare parts will be provided for this time.
After ten years, the system is no longer considered “state of the art” and should be replaced.
General Cleaning and Maintenance
1. As required, cleanse all exterior surfaces and tabletop pads with a mild detergent solution,
such as Parker Laboratories Protex Disinfectant or any one-step disinfectant that does not
contain bleach.
2. Keep wheel assemblies free of foreign materials and dirt accumulation.
3. Periodically inspect all welds.
4. Periodically check bolts on table, tighten if necessary.
5. Periodically inspect all strap holders. Any holder that feels loose should be removed and
reattached after adding a spot of Loctite®Threadlocker (Blue #242) to the bolt threads. This
should ensure that the bolt will not loosen again in the future.

9
Table Parts and Adjustments
Figure 1. The Sound Pro Combination Table parts and adjustment include:
Standard Parts and Adjustments:
1. Fowler Back
2. Cardiac Scanning Cutout Cushion
3. Side Rails, Folding
4. Restraining Strap
5. Extra-Wide Tabletop With 500-Lb Patient Capacity
6. Central Floor Locking System Lever
7. Foot Controller (Optional)
8.5" Locking Swivel Casters
9. Return Cardiac Scanning Cushion to Level Lever
10. Adjustable Sonographer Cutout Cushion
11. Arm Board, Vascular Scanning
12. Hand-Held Controller
13. Drop Down Leg Section
Optional:
058-737 I.V. Pole
058-738 Headrest
058-611 Dispenser, Paper, with Cutter Strap
1
2
4
5
6
7
8
9
10
12
3
11
13

10
2. ASSEMBLY AND TABLE OPERATION
Relocating The Table
CAUTION: Before moving the table with a patient, make sure side rails are in the up
position and restraining straps in place to secure the patient.
This table can be easily moved across smooth surfaces.
To move the table, release the central locking system by pressing with your foot on the short end
of the central locking lever. All four wheels release at the same time.
Once positioned, depress the end of the lever to engage the central locking system, ensuring
stability.
NOTE: In addition to the central locking system, each wheel can be locked individually by stepping
down on the individual wheel lock lever.
Height Adjustment
Table height is conveniently adjusted with the hand-held or optional foot
controller. D-ring holders are provided on the end of the straps at each side
of the table frame to hold the hand-held controller when it is not in use. The
hand-held controller can be moved to either side of the table. A power light
on the controller indicates that power from the control box is ON.
•To raise the table: press and hold down the table UP button.
•To lower the table: press and hold down the table DOWN button.
NOTE: The control box, located underneath the tabletop, is labeled with
controller specific information.
Trendelenburg Positioning
The table can provide up to + or - 15° Trendelenburg positioning by raising or lowering either
the head or foot end of the table with the hand or foot controller.
•For Trendelenburg positioning: Press and hold down the foot-end up button on the
hand-held controller. This will simultaneously raise the foot end and lower the head
end of the table. Release the button when the desired angle is achieved.
Figure 2. Hand
–held controller
activates table
positions.