BIODEX 058-800 Urology and Brachytherapy C-Arm Tables Instructions

BIODEX 058-800 Urology and Brachytherapy C-Arm Tables

Product Information

Urology & Brachytherapy C-Arm Tables
The Urology & Brachytherapy C-Arm Tables are medical equipment designed for safe operation during urological and brachytherapy procedures. The tables come in four different models: 058-800, 058-805, 058-810, and 058-815. The product has received various certifications and classifications, including IEC60601-1:2005, ANSI/AAMI ES60601-1:2005, CAN/CSA C22.2 No: 60601-1:14, CE Class I Non-measuring, and FDA Class II Equipment. The Urology & Brachytherapy C-Arm Tables have also been authorized by an European Community Representative and comply with the Medical Equipment IEC 60601-1-2:2014 EMC Standard.

Product Usage Instructions

Before using the Urology & Brachytherapy C-Arm Tables, it is essential to read the entire operation manual carefully. Failure to read the manual may result in user error or injury. Ensure to save all provided documents for future reference. Specific cautions must be observed while operating or servicing the product, and only qualified, trained personnel must operate or service the product. If the equipment is used in a manner other than specified in this operation, it may lead to serious incidents. In such cases, report to the manufacturer and appropriate local regulatory agency by end-user, operator, or patient.

The product should be used only as specified in the operation manual. Follow the unpacking and assembly instructions document. Operating/assembly questions can be directed to the service department during business hours. Biodex devices are designed for use in a client environment. The transport and storage conditions must be observed, and the operating conditions must comply with the specified pressure (psi).

Definition of Symbols

The following symbols and their associated definitions are used and implied throughout this manual.

Product Certifications and Classifications

The Urology & Brachytherapy C-Arm Tables have received the following certifications, and fall within the following classifications:

• IEC60601-1:2005 (Third Edition) + CORR1:2006+Corr 2:2007 + A1:2012 (or IEC 60601-1:2012 reprint)
• ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010
• CAN/CSA C22.2 No: 60601-1:14
• CE Class I Non-measuring
• FDA Class II Equipment
• IEC 60601-2-46 Edition 3.0
• 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

Before Proceeding

NOTE: The 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

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: If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment.
NOTE: 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 EU competent authority, country specific Health Agency, or FDA.

Training
This operation manual includes assembly and operating instructions. Operating/assembly questions can be directed to the service department during business hours.

Operating Conditions

• Temperature: 10° C to 30° C (50° F to 86° F).
• Humidity Range: 30% to 70% (non-condensing).
• Atmospheric Pressure: 70kpa (10psi) to 106kpa (15psi).

Transport and Storage Conditions

• Temperature: -20° C to 70° C (-4° F to 158° F).
• Humidity Range: 10% to 100%.
• Atmospheric Pressure: Sea Level 101kpa (14.7psi) to 10,000 feet, 69 kpa (10.1 psi).

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 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 058-800 and 058-810: 115 VAC.
• CAUTION: Operation for 058-805 and 058-815: 230 VAC.
• CAUTION: 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.

Introduction

Intended Use
The Urology and Brachytherapy C-Arm Tables feature motorized actuation of height, X-Y tabletop, lateral roll and Trendelenburg motions, and is supported by a full line of optional components. 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 additional, optional battery and charging unit can provide continuous cordless operation.

IMPORTANT NOTE: Remove battery if storing table for prolonged time.

Indications for Use
The table back positioning adjusts with a simple touch-handle lock/unlock mechanism to an 80° angle with incremental stops at 20°, 30°, 40°, 50°, 60°, 70° and 80°.
The table comes equipped with a lightweight, non-imaging patient transfer extension and a radiolucent extension. The radiolucent extension provides capability for vascular, cardiac and other general C-Arm applications. Select from knee crutches or the PAL stirrups, arm boards or drain systems.

Contraindications
The Urology and Brachytherapy C-Arm Tables should not be used for bariatric patients who weigh more than 500 lb.

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.

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, provides continuous cordless operation.

IMPORTANT NOTE: Remove battery if storing the table for a prolonged time.

Standard Parts and Adjustments:

1. Hand-Held Controller
2. Foot Controller
3. Fowler Back
4. Drain Bag Holder and Disposable Bag
5. Left and Right Knee Crutches
6. X-Ray Grid and Film Cassette Tray
7. Rail-Mounted I.V. Pole
8. Read End Locking Brakes and Swivel Casters
9. Vertical Doors (for adding transfer or radiolucent extension)
10. Battery Pack
11. Arm Boards
12. Foot End Individual Locking Casters

NOTE: The Brachytherapy C-Arm Table is the same as the Urology C-Arm Table except it does not have the Drain Pan, Radiolucent Drain Bag Holder and Disposable Bags.

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.

• 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.
• 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.
• 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.
• 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: When pressed down in the lock position, the head end casters are raised 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.

Fowler Positioning

The Fowler Back, manually adjustable to an 80-degree angle (20°, 30°, 40°, 50°, 60°, 70°, 80°) incorporates a touch-handle lock/unlock mechanism for effortless patient positioning.

CAUTION: The Fowler Back must be supported as it is being raised or lowered. The back must lock into one of the eight provided positions.

• To raise the Fowler Back, press the back lock release button on the underside of the Fowler Back handle grasp. Keeping the release button depressed, lift up on the Fowler Back until it attains the desired position. The Fowler Back must be set in one of the eight positions provided.
• To lower the Fowler Back, depress and hold the Fowler Back button on the underside of the Fowler Back grip and position the top as desired.

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.

The Transfer Extension and the Radiolucent Extension
The transfer extension is used to extend the table when putting a patient on or taking a patient off the tabletop. It is not used for imaging. The radiolucent extension, significantly longer than the transfer extension, has a 31″ radiolucent C-Arm area with no metal cross members. Both extensions are installed using the same procedure. Once the Radiolucent Extension is in use, the patient load rating is limited to 400 lb (181.4 kg).

To Install the Extension:

• The Transfer Extension and the Radiolucent Extension
• The transfer extension is used to extend the table when putting a patient on or taking a patient off the tabletop. It is not used for imaging. The radiolucent extension, significantly longer than the transfer extension, has a 31″ radiolucent C-Arm area with no metal cross members. Both extensions are installed using the same  procedure. Once the Radiolucent Extension is in use, the patient load rating is limited to 400 lb (181.4 kg).
• To Install the Extension:

To Remove the Extension:
NOTE: The x-ray grid, film tray and drain pan can remain in place if using the Transfer Extension but must be removed if the Radiolucent Extension is used.

• Stand at the foot end of the table and press the extension release levers located under the middle of each leg extension rail. The extension can be slid out from the table.
• Close the vertical doors.

Disposable Skirt (Optional Component)
The Biodex Urology & Brachytherapy C-Arm Tables (models 058-800 and 058-810) 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.

I.V. Pole (Optional Component)
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.

Knee Crutch Installation (Optional Component)
The optional Knee Crutch set includes a left and right rail clamp and two offset ratchet arms. Install the rail clamps onto the accessory rails and then the offset ratchet arms with knee crutches into the rail clamps. Note that the offset ratchet arms should be inserted into the knee clamps from the foot end of the table. The wide end of the knee crutches face toward the head end of the table.

To adjust positioning of the offset arms, loosen locking lever on the crutch clamps, move the arms to the desired position and re-tighten the lever.

To adjust positioning of the crutch pads, loosen the crutch pad locking levers and tilt the pads as required.

Arm Boards (Optional Component)
Standard or Dura Board Arm Boards are optional. Install the rail clamps onto the accessory rails and then insert the arm board posts into the clamps and tighten to secure. To move the arm boards in a horizontal plane, loosen the locking knob on the block, move the arm board to the desired position and re- tighten the knob.

Drain Bag Holder (Optional Component)
A flexible drain bag holder is available for this table. To install, loosen the clamps on the drain bag holder bar provided. Slide the clamps over the accessory rails at the foot end of the table and tighten the clamps when the bar is appropriately positioned. Lift up the table cushion at the foot end of the table and slide the front (square) section of the flexible disposable bag under the cushion. The reminder of the drain bag is worked into position around the bar. The top of the bag folds over the bar.X-Ray Grid (Optional Component)

Drain Pan (Optional Component)
The stainless steel drain pan and wire mesh screen are optional. To insert the drain pan, open the vertical doors at the foot end of the table (the doors pivot toward the outside of the table. Pull out on the drain pan support bars until they are fully extended. You can now place the pan between the bars so that it is supported by the bars. Slide the pan along the bars until you feel it drop into the notches. If desired, the pan can be stored in the table by simply pushing in on the drain pan support bars.

X-Ray Grid (Optional Component)
The optional, removable x-ray grid is 103 line, 8:1 ratio, 36″ to 44″ focal range grid. There is a set of tracks about 1″ above the film cassette tray tracks which holds the grid in the body of the table. The grid can be inserted or removed from either side of the table.

To remove the x-ray grid, lift the grid up approximately 1/4″ and then slide it out that side of the table. To insert the grid, place the grid on the track with the center line of the grid running “head to toe” and the center line facing upward. Insert the grid into the body of the table until it “drops in” past the stop notch mechanism. The x-ray grid should remain in the table at all times except when the table is being used for fluoroscopic purposes.

Radiographic Film Cassette Tray
The optional Radiographic Film Cassette Tray can be inserted or removed from either side of the table. This tray will hold a 14″ x 17″ film lengthwise or crosswise between the four pegs in the tray. Also provided with the tray is a small film cassette mask. This film cassette mask is designed to hold a 10″ x 12″ film down at that perineal end of the table or for pediatric retrograde pyelogram studies.

To insert the film into the tray, grasp the tray handle and lift upward approximately 1/4″ and extend the film tray out to the desired side of the table. Insert the film cassette into the tray and push the film tray back into the body of the table until it drops in past the stop notch mechanism.

To remove the cassette, grasp the tray handle and lift it up 1/4″ before sliding it toward the side of the table. It is not necessary to remove the tray to remove the cassette. There are holes under the cassette tray. Push up under the tray to raise the cassette enough to grab it and remove it from the table.

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.

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.

Maintenance and Cleaning

The Biodex Urology & Brachytherapy C-Arm Tables are virtually maintenance free. By following the instructions below at suggested time intervals, or as often as necessary, the table(s) 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.

NOTE: When cleaning the pads, do not pull them off the c-arm table forcefully. The industrial strength Velcro will hold the pads in place, causing them to rip. Instead, reach underneath the pads and gently pull the Velcro apart.

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.

Specifications

• Dimensions: 84.5″ l x 25.5″ w (214.6 x 64.8 cm) with OR accessory rails

• Tabletop: 53″ l x 21″ w (134.6 x 53.3 cm); 84″ l (213.4 cm) with extension. Tested and complies with IPx4.
  Lightweight Extension (for patient transfer only, not for imaging): 26.5″ l x 21″ w (67.3 x 53.3 cm)

• Radiolucent Extension: 31″ l x 25.5″ w (78.7 x 64.8 cm) with OR accessory rails

• Radiolucent Area: 54″ l x 17.5″ w (137.2 x 44.5 cm)

• Tabletop Material: Three Fiberesin™ sections – each with individual 2″ mattress

• Mattress: Individual, seamless, 2″ thick (5 cm), one for each section

• Motions:

  • Height Adjustable: 34″ to 43.5″ (86.4 to 110.5 cm)
  • Tabletop X Motion (head-to-toe float): 20″ (51 cm)
  • Tabletop Y Motion (side-to-side float): 10″ (25.4 cm)
  • Trendelenburg: 0° to 20°
  • Reverse Trendelenburg: 0° to 20°
  • Lateral Roll: 0° to 20°
  • Fowler Positioning: Adjusts from 0° to 80° with touch handle lock/unlock

• Controls:

  • Hand Control: activates all motions
  • Foot Control: activates all 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

• Optional Components:

  • X-Ray Film Tray: Removable film cassette tray for 14″ x 17″ film with cassette mask for 10″ x 12″ film. Film cassette tray can be removed from either side of the table.
  • X-Ray Grid: Removable X-Ray grid, 103 line, 8:1 ratio
  • Accessory Rails: Standard OR accessory rails 1.125″ x .375″ (2.86 x .95 cm) on table (rails also on table imaging extension)
  • Patient Restraints: Two body straps, two ankle straps
  • Finish: Powder coat

• Patient Capacity:

  • In urologic position: 500 lb (227 kg)
  • In use with radiolucent extension: 400 lb (181.4) Weight tested to four times the patient load rating.

• Shipping Weight: 903 lb (409.6 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.

• Certifications: IEC60601-1:2005 (Third Edition) + CORR1:2006+Corr 2:2007 + A1:2012 (or IEC 60601- 1:2012 reprint), ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 No: 60601-1:14, IEC 60601-2-46 Edition 3.0, FDA Class II Equipment, CE Class I Non-measuring.
  CDRH registered and FDA Device Listed

• Warranty: Two years parts and labor

Optional Components

• 056-463: Grid, X-ray
• 056-862: Battery and Charging Unit, 115 VAC
• 056-863: Battery and Charging Unit, 230 VAC
• 056-850: IV Pole, Rail Mounted
• 056-851: Drain Bag Frame
• 056-853: Crutch, Knee, Simplicity (pair)
• 058-860: Drain Pan, Stainless Steel
• 058-862: Stirrups, PAL with Boot Pad (pair)
• 058-863: Arm Board, Dura Board with Pad (pair)
• 058-865: Arm Board, Standard (pair)
• 058-866: Cassette Tray, 11″ × 14″

Replacement

• 056-802: Bellows Skirt, disposable plastic, 250/roll (Fits Urology & Brachytherapy C-Arm Tables 840, 800, 810, and 820)
• 046-275: Dispenser, Disposable Protective Roll

Copyright 2021, Biodex Medical Systems, Inc. All rights reserved. Mirion, the Mirion logo, and other trade names of Mirion products listed herein are registered trademarks or trademarks of Mirion Technologies, Inc. or its affiliates in the United States and other countries. Third party trademarks mentioned are the property of their respective owners. The material in this document, including all information, pictures, graphics and text, is the property of Mirion Technologies, Inc. and is protected by U.S. copyright laws and international copyright conventions. Mirion Technologies, Inc. expressly grants the purchaser of this product the right to copy any material in this document for the purchaser’s own use, including as part of a submission to regulatory or legal authorities pursuant to the purchaser’s legitimate business needs. No material in this document may be copied by any third party, or used for any commercial purpose or for any use other than that granted to the purchaser without the written permission of Mirion Technologies, Inc. The information in this document describes the product as accurately as possible, but is subject to change without notice. Printed in the United States of America.

Read User Manual Online (PDF format)

Download This Manual (PDF format)

Download this manual  >>