biodex SURGICAL C-ARM TABLE User manual

FN: 19-259-CLR 9/19
SURGICAL C-ARM TABLE™
INSTRUCTIONS FOR USE
058-840
058-845
058-840-10
058-845-10

2
Surgical C-Arm Table™
This instructions for use document covers safe operation of the Surgical C-Arm Tables 058-
840, 058-845, 058-840-10, and 058-845-10 .
Additional information and resources are available upon request or directly from the Biodex
website, www.biodex.com/tables840.
If the desired information is not found, contact a local distributor or Biodex directly at
[e-mail]
Thank you,
Biodex Medical Systems, Inc.
Contact information
Manufactured by:
Biodex Medical Systems, Inc.
20 Ramsey Road, Shirley, New York, 11967-4704
Tel: [phone] (Int’l 631-924-9000)
Fax: [phone]
email: [email protected]
www.biodex.com

3
Table of Contents
Definition of Symbols................................................................................................................ 4!
Product Certifications and Classifications .................................................................................. 5!
Before Proceeding ..................................................................................................................... 6!
Important Safety Information .................................................................................................... 7!
1.!Introduction ........................................................................................................................ 8!
Intended Use ................................................................................................................. 8!
Indications for Use......................................................................................................... 8!
Contraindications .......................................................................................................... 8!
Control Made Easy ......................................................................................................... 8!
Free-Float Feature.......................................................................................................... 8!
2.!Operating Instructions....................................................................................................... 10!
The Locking Brakes and Swivel Casters ........................................................................ 10!
Using the Hand-Held Controller ................................................................................... 12!
Using the Foot Controller............................................................................................. 12!
Disposable Skirt (Optional) .......................................................................................... 14!
Catheter Tray Extension............................................................................................... 15!
I.V. Pole (Optional) ....................................................................................................... 15!
Charging the Battery.................................................................................................... 15!
3. ! Maintenance and Cleaning .......................................................................................... 17!
4.!Specifications .................................................................................................................... 18!

4
Definition of Symbols
The following symbols and their associated definitions are used and implied throughout this
manual.

5
Product Certifications and Classifications
The Surgical C-Arm Table has received the following certifications, and falls within the
following classifications:
●ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010
●CAN/CSA C22.2 No: 60601-1:14
●IEC 60601-2-46
●CAN/CSA-C22.2 NO:60601-2-46
●FDA Class II Equipment
●CE Class I Non Measuring
●Type B Applied Part
●Electromagnetic Compatibility: This equipment complies with the Medical Equipment
IEC 60601-1-2:2014 EMC Standard.
Authorized European Community Representative:
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands

6
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 device.
WARNING: 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.
WARNING: If this equipment is modified, appropriate inspection and testing must
be conducted to ensure continued safe use of equipment.
Training
This operation manual includes assembly and operating instructions. Operating/assembly
questions can be directed to the service department during business hours.

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.
CAUTION: Biodex devices are designed for use in a client 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.
CAUTION: Operation for 058-840 and 058-840-10: 115 VAC.
CAUTION: Operation for 058-845 and 058-845-10: 230 VAC.
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.
It is provided with wheels for relocation which should be used when moving.

8
1. Introduction
Intended Use
The Surgical C-Arm Table 840 is designed for image-guided procedures where stability, access,
and precise, quiet, vibration-free positioning are essential. A cantilevered low attenuation
carbon fiber tabletop, with choice of contoured or rectangular design, accommodates portable
or ceiling-suspended C-Arms. The contoured top provides ample workspace for
anesthesiologists, yet the narrowness required for cervical procedures. The rectangular top
offers additional space to allow for superior image quality for long-leg runoff studies. Select the
top that best suits the requirements to achieve optimum image resolution.
Indications for Use
The extra-large radiolucent area, free-float X-Y tabletop, motorized control of height, lateral
roll, Trendelenburg motions and the catheter tray extension make the Surgical C-Arm Table -
840 ideal for cardiovascular procedures. The radiolucent area is free of cross members,
allowing full fluoroscopic visualization and unobstructed C-Arm positioning. Functional design
provides complete access with reduced radiation exposure to clinicians. Patient comfort and
stability are assured by two-inch thick table padding and three adjustable straps with hook and
loop fastening. The contoured tabletop features a face cutout for prone positioning.
Contraindications
The Catheter Tray Extension is not radiolucent and not suitable for patient support.
Control Made Easy
The portable hand-held and foot operated controllers ensure quick and safe tabletop
positioning, and can be positioned from any point around the table. Both controllers offer the
freedom to adjust height, lateral roll and Trendelenburg motions. The hand-held controller
provides the back to level function. The foot-operated controller also releases the tabletop for
X-Y positioning and is ideal when hands are busy with other functions.
Free-Float Feature
A mushroom top release for the free-float feature is located at the end of a handgrip.
Both AC and battery power are standard. When operating on battery, there are no power cords
to catch on feet or block table wheels. Battery charging can be accomplished during off hours
by plugging in the AC power cord. An optional battery with separate charging unit can provide
continuous cordless operation.
IMPORTANT NOTE: Remove battery if storing the table for a prolonged time.

9
NOTE: The 840 tabletop is manufactured of carbon fiber. This material, as used in this product, is
certified to meet all the requirements of radiation performance standards of 21 CFR Subchapter J.
Figure 1.1. Parts and Adjustment Mechanisms
Standard Parts and Adjustments:
1. Hand-Held Controller
2. Foot Controller
3. Mushroom Top Control for Free-Float Motion
4. Foot End Locking Brakes and Swivel Casters
5. Battery Pack
6. Front End Caster Brake Locking Bar

10
2. Operating Instructions
CAUTION: Refer to instruction manual before operating or servicing system.
NOTE: This table can be operated with the power cord connected to an outlet or by
using the battery. The battery recharges automatically while the table is plugged into
an outlet even if the table is being used.
CAUTION: Hospital grade plug to be plugged into a hospital grade receptacle
only to achieve grounding reliability.
CAUTION: Before transferring a patient onto or off the table, ensure all four caster
brakes are locked. Secure the restraining straps immediately after positioning the
patient on the table.
CAUTION: The restraining straps are not intended to restrain an uncontrolled
patient. `
The Locking Brakes and Swivel Casters
The locking brakes and swivel casters allow this table to glide effortlessly on hard surfaces and
across firm rugs. The foot end casters are locked from either side of the table while the head
end casters are locked together using the Caster Brake Locking Bar.
1. To lock the foot end brakes and swivel casters, step down on the foot end caster brake
locking lever on either side of the table.
2. To release the lock on the brakes and swivel casters at the foot end of the table, use a toe
to lift up on the foot end caster brake locking lever on either side of the table.
3. To lock the brakes and swivel casters for the head end of the table, use a toe to press down
on the center of the head end caster brake locking bar.
4. To release the head end brake and swivel casters, use a toe to lift up on either end of the
head end caster brake locking bar.
NOTE: The head end caster brake locking bar, when pressed down in the lock position, raises
the head end casters slightly off the ground. The amount that casters are raised can be
adjusted by simply using a 5/8" open-end wrench to adjust up or down the support foot located
under the head end caster brake locking bar.

11
Figure 2.1. Locking Brakes and Swivel Casters
Figure 2.2. Head End Lock Bar

12
Using the Hand-Held Controller
The hand-held controller may be used to adjust table height, Trendelenburg/Reverse
Trendelenburg, lateral roll and X-Y positioning. When not in use, the Hand-Held Controller can
be hooked onto the metal loop on the restraining strap, or on the accessory rail.
CAUTION: Before moving the tabletop, be sure that all I.V. lines, attachments
and restraining straps, and such, are out of the way. Ensure that the patient is
fully secured to the tabletop by the restraining straps.
To adjust the table position, press and hold the appropriate switch on the hand-held controller. The
tabletop will move or rotate in the direction indicated by the switch. Release the switch when the
tabletop achieves the desired position.
Using the Foot Controller
The Foot Controller activates all motions. The four separate rocker style pedals control two
movements each. From left to right on the Foot Control, press and hold down the appropriate
rocker switch to adjust Trendelenburg/Reverse Trendelenburg positioning, lateral roll, tabletop
height, and X-Y motion. Releasing the rocker switch at any time immediately stops the motion.
NOTE: 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.
Note for Hand-Held and Foot Controllers:
NOTE: The table can perform only one motorized function (i.e. raising or lowering the
tabletop, lateral roll, X-Y movement, Trendelenburg/Reverse Trendelenburg) at a time. If
a second button on the Hand-Held Controller (or the Foot Controller) is pressed while
the table is already performing a motorized function the tabletop movement will stop.
At that point, all buttons must be released before the selected function can resume.
Figure 2.3. Hand-Held Controller

13
Positioning the X-Y Free-Float Tabletop
The X-Y free-float tabletop is positioned using the mushroom top tabletop handgrips. The
mushroom top is pressed down to allow the table to move in both the X and Y planes. To move
the tabletop, depress the mushroom top on the handgrip and, using both handgrips, slide the
tabletop to the desired position. Release the mushroom top to lock the tabletop in place.
The tabletop handgrips may be positioned at any point along the accessory rail. To position the
grips, loosen the handgrip locking knob, slide the grip to the desired position along the
accessory rail, then tighten the locking knob to secure the grip.
NOTE: The X-Y Free-Float Tabletop mushroom top will not allow the tabletop to “float” if the
table is tilted with lateral roll.
Figure 2.5. Push button (on handle) releases tabletop for free-float X-Y motion.
Figure 2.4. Foot Controller

14
Disposable Skirt (Optional)
The Biodex Surgical C-Arm Table can be ordered with the optional Plastic Sanitary Skirts to
protect the table bellows from patient blood and other liquids. The table has plastic clips
located immediately above the bellows. Secure the skirt to the clips as described below:
1. Slide the plastic skirt underneath the clip at the foot end of the table and lower the clip
pressing along the entire length of the clip to hold the skirt in place.
2. Work around the table, tucking the top edge of the plastic skirt under each clip and
lowering the clip to secure the plastic until the bellows are completely covered. Be sure
to overlap the skirt across the entire length of the table’s foot end.
3. Remove and replace the plastic skirt for each new patient.
NOTE: Additional Bellows Skirts (part #056-802) can be ordered from Biodex Medical Systems,
Inc.
Figure 2.6. Plastic Skirt Clip Open Position.
Figure 2.7. Slide the plastic skirt underneath and lower the clip to hold the skirt in
place.

15
Catheter Tray Extension
The removable extension can be used to provide additional table length for accommodation of
catheters within the patient’s sterile field. This makes the procedure easier, safer and reduces
the risk of breaking the sterility of the catheters.
CAUTION: The Catheter Extension is not radiolucent and not suitable for patient
support.
To attach the Catheter Tray Extension, simply hook the Extension guides over the accessory
rails at the foot end of the table and lower the extension into position.
Figure 2.8. Catheter Extension.
I.V. Pole (Optional)
The adjustable height I.V. pole should be installed onto the O.R. accessory rail. Loosen the I.V.
pole locking knob at the base of the slide block and slide the block and pole onto the accessory
rail until it is in the desired position. Tighten the locking knob to secure the pole.
To adjust the height of the I.V. pole, loosen the height adjustment locking knob and raise or
lower the top section of the pole to the appropriate height. Tighten the locking knob to secure.
Charging the Battery
This table can be operated with the power cord connected to an outlet or by using the battery.
The battery recharges automatically while the table is plugged into an outlet even if the table is
being used. An optional wall-mounted battery charger is also available.

16
NOTE: The table must remain plugged into an outlet when the battery is removed or
reinstalled. If the battery is removed for any reason while the table is not plugged into a
working outlet, the battery will discharge at a faster rate. Once the battery has been
reinstalled, and it has been verified that the table is operating, the power cord plug can be
removed from the outlet and operate on battery power.
Safety Guidelines:
1. Secure restraining straps immediately after placing the patient on the table.
The restraining straps prevent the patient from rolling off the side of the
table.
NOTE: The restraining straps are not intended to restrain an uncontrolled
patient.
2. Always lock the casters before moving a patient onto or off the table.
3. This table is rated to support patients weighing up to a maximum of 500
pounds.

17
3. Maintenance and Cleaning
The Biodex Surgical C-Arm Table is virtually maintenance free. By following the instructions
below at suggested time intervals, or as often as necessary, the table will remain in “like new”
condition.
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
CAUTION: Disconnect power from source before removing panel or covers. Reliable
grounding achieved only by connecting this unit to an equivalent marked hospital
only or hospital grade receptacle.
Disposal
An appropriate waste disposal company is to be contacted (i.e., the local collection point for
waste separation). Properly dispose of the device at the end of its service life:
•The device packaging is disposed of through resource recycling.
•The metal parts of the machine go to scrap metal disposal.
•Plastic parts are disposed of as hazardous waste.
The disposal of equipment must be in accordance with the respective
national regulations.
Wear parts are considered hazardous waste! After being replaced, wear
parts must be disposed of according to country-specific waste laws.

18
4. Specifications
Dimensions: 97" l x 26" w (246 x 66 cm) with OR accessory rails
Tabletop: 97" l x 24" w (246 x 61 cm) – choice of classic contoured or rectangular design
Catheter Tray Extension (removable): 18" l x 24" w (45.7 x 61 cm) non-radiolucent
Radiolucent Area: 75" l x 24" w (191 x 61 cm)
Tabletop Material: Carbon fiber with integral head section (contoured or rectangular end)
Mattress: Seamless, 2" thick (5 cm)
Attenuation: 1.2 mm Aluminum equivalence
Motions:
Height Adjustable: 33.5" to 43.5" (84 to 109 cm)
Tabletop X Motion (head-to-toe float): 35" (89 cm)
Tabletop Y Motion (side-to-side float): 10" (25.4 cm)
Trendelenburg: 0° to 20°
Reverse Trendelenburg: 0° to 20°
Isocentric Lateral Roll: 0° to ±15°
Controls:
Hand Control: height, lateral roll and Trendelenburg motions
Foot Control: activates all motions (has release for float). Tested to and complies with IPx6.
Mushroom Top: releases X-Y Tabletop motions
Fuses on Control Box:
F1 250V, AC, 16A, Fast blow / 6,3x32mm
F2 250V, AC, 16A, Fast blow / 6,3x32mm
F3 250V, AC, 2A, Fast blow / 6,3x32mm
Wheels:
Head End - 3" (7.62 cm) swivel casters, integral locking system on base
Foot End - 5" (12.7 cm) swivel casters with central locking
Accessory Rails: Standard OR accessory rails
49.5" x 1.12" x .375" (124 x 2.86 x .95 cm) mounted near foot end of table
Patient Restraints: Three body straps
Finish: Stainless Steel
Patient Capacity: 500 lb (227 kg)
Weight: 641 lb (291 kg)
Shipping Weight: 865 lb (392 kg)
Power: 115 VAC or 230 VAC and Battery. Battery automatically charges when table is plugged in.
An additional battery can be charged with optional wall-mounted charger.
Standard Accessory:
- Catheter Tray Extension (removable)
Warranty: Two years parts and labor
Certifications: ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010 CAN/CSA C22.2 No:
60601-1:14, IEC 60601-2-46, CAN/CSA-C22.2 NO:60601-2-46 and CE Marked.

19
Optional
056-862 Battery and Charging Unit, 115 VAC
056-863 Battery and Charging Unit, 230 VAC
056-850 IV Pole, Rail Mounted
056-865 Arm Board, Carbon Fiber, one arm
056-866 Arm Board, Carbon Fiber, two arms
058-864 Arm Board, Surgical, Carbon Fiber
058-849 Clamp, Accessory, C-Arm Table
058-856 Radiation Shield, Head/Cervical
058-857 Radiation Shield, Thoracic/AB
Replacement
056-802 Bellows Skirt, disposable plastic, 250/roll Fits Surgical C-Arm Tables
840, 800, 810, and 820
046-275 Dispenser, Disposable Protective Roll

20