Oakworks Medical CFPMFXH, CFPM100, CFPM400 Instruction Manual

INSTRUCTION MANUAL
Fluoroscopy Table
CFPMFXH
integrated headrest top
CFPM100
integrated headrest top
CFPMFXH
rectangular top
CFPM100
rectangular top
CFPM400
integrated headrest top
CFPM400
rectangular top
© Copyright 2007 OAKWORKS®, Inc.
Manual Part # MMMNST0008, rev.02.19.10
1st Edition, October 2007 2nd Edition, March 2008 3rd Edition, February 2009 4th Edition, September 2009 Printed in U.S.A.
All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of OAKWORKS®, Inc.
OAKWORKS® is a registered trademark of OAKWORKS®, Inc.
Notice
The information contained in this document is subject to change without notice and should not be construed as a commitment by OAKWORKS®, Inc.
OAKWORKS®, Inc. assumes no responsibility for any errors that may appear in this docu­ment nor does it make expressed or implied warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.
OAKWORKS®, Inc. shall not be liable for inci­dental or consequential damages in connec­tion with or arising out of the furnishing, performance, or use of this document and the program material which it describes.
TABLE OF CONTENTS
Symbol Identification ........................................................................... pg 1
Indications & Contraindications ......................................................... pg 2
Warnings & Precautions ....................................................................... pg 2
Section I: Product Description & Photo
CFPMFXH - 22” x 84” Integrated Headrest Top.................... pg 4
CFPMFXH - 24” x 80” Rectangular Top................................ pg 5
CFPM100 - 22” x 84” Integrated Headrest Top.......................... pg 6
CFPM100 - 24” x 80” Rectangular Top.......................................... pg 7
CFPM400 - 22” x 84” Integrated Headrest Top.......................... pg 8
CFPM400 - 24” x 80” Rectangular Top.......................................... pg 9
TABLE OF CONTENTS
TABLE OF CONTENTS
Section II: Directions for Use
Adjusting Height (CFPM100 & 400 only)............................................... pg 10
Adjusting Tilt & Longitudinal Travel (CFPM400 only)....................... pg 11
Patient Positioning Strap ............................................................................ pg 11
Adjusting Table Top Pad ................................................................................ pg 12
Adjusting Cranial Positioning Pads (integrated headrest only)........ pg 12
Moving the Fluoroscopy Table ........................................................................ pg 13
Emergency Stop ...................................................................................................... pg 13
Usable Imaging Area Diagrams
CFPMFXH & CFPM100 - integrated headrest tops.................. pg 14
CFPMFXH & CFPM100 - rectangular tops................................. pg 15
CFPM400 - integrated headrest tops........................................ pg 16
CFPM400 - rectangular tops....................................................... pg 17
Weight Capacity Limitations ............................................................................. pg 18
Section III: Troubleshooting
Ground Point Testing ........................................................................................... pg 19
If the table top will not change height or tilt .......................................... pg 19
Hand & Foot Control Replacement Instructions .................................. pg 20
Section IV: Product Care and Maintenance ...................................................... pg 21
TABLE OF CONTENTS
Section V: Optional Accessories
Carbon Fiber Arm Board ............................................................ pg 22
Patient Positioning Strap ............................................................ pg 22
Spine Positioning System ............................................................... pg 23
Fluoro Extender ........................................................................... pg 23
Section VI: Product Identification ..................................................... pg 24
power cord variables ........................................................................... pg 25
TABLE OF CONTENTS
TABLE OF CONTENTS
LIFETIME LIMITED WARRANTY
Section VII: List of Parts ............................................................... pg 26
Section VIII: Specifications CFPMFXH, 100 & 400............................. pg 27
Guidance & Manufacturers Decloration - Emissions (all systems)..... pg 28
Recommended Separations - Distances from the CFPM400 .......... pg 29
Guidance & Manufacturers Decloration - Immunity ..................... pg 30
Guidance & Manufacturers Decloration - Emmissions
(Equipment that is NOT life supporting) ................................ pg 31
Contact Information .................................................................. Back Cover
View complete warranty details at www.oakworks.com
All warranties are limited to factory-provided replacement parts, factory repair or replace­ment, at the discretion of OAKWORKS®. OAKWORKS® only covers parts and labor on field repair of stationary products.
All warranties exclude damage caused by improper set-up, accident, abuse, misuse, neglect, use for other than intended purpose or reasonable wear such as tears in the upholstery.
All warranties are invalidated by non-factory modifications and unauthorized repairs, which will immediately terminate all liability by OAKWORKS® for the product or damages caused by its use.
The buyer and its customers shall be responsible for proper set-up and use of the products as well as any supervision required for safety. In no event shall OAKWORKS® be liable for any special, indirect, consequential, incidental, exemplary or punitive damages or costs. Use of non-approved cleaning solutions voids the guarantee on all fabrics.
The warranties set forth herein are the sole and exclusive warranties provided by OAKWORKS®. There are no other warranties, representations or guarantees provided by OAKWORKS® either expressed or implied, including warranties of merchantability and fitness for a particular purpose. Warranty valid with proof of purchase.
SYMBOL IDENTIFICATION
The OAKWORKS® Fluoroscopy Table is a radiographic table intended for use with mobile or compact stationary C-arm Fluoroscopy Systems. It is ideally suited for pain management imaging and therapeutic procedures.
This symbol, when used in this manual and on product labels, represents a caution warning. Be sure to read and comply with all precautions and warnings.
This symbol, when used in this manual and on product labels, warns against an electrical shock hazard. Be sure to observe and comply with all warnings.
This symbol, when used in this manual and on product labels, indicates the potential of exposure to harmful x-rays. Be sure to read and comply with all warnings.
This symbol, when used in this manual and on product labels, indicates that the table and components are a Type B Applied Part pursuant to IEC 601.1 and EN 60601-1: 1990.
SYMBOL IDENTIFICATION
SYMBOL IDENTIFICATION
~
This symbol, when used in this manual or on product labels, indicates a Protective Earth (Ground) Terminal.
This symbol when used in this manual or on product labels, warns that during trans­port there should be no stacking of containers.
This symbol, when used in this manual or on product labels, indicates that the product should be protected from moisture. The humidity specifications for Transport & Storage are listed on page 23.
This symbol, when used in this manual or on product labels, indicates that information is given regarding the recommended temperature limits during transport and storing.
This symbol, when used in this manual or on product labels, indicates the date of manufacture of the device.
This symbol, when used in this manual or on product labels, indicates alternating current (AC).
This symbol, when used in this manual or on product labels, indicates direct current (DC).
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1
WARNINGS / PRECAUTIONS
WARNINGS / PRECAUTIONS
INDICATIONS
The OAKWORKS Fluoroscopy CFPM tables are indicated for use with mobile or compact C-arm Fluoroscopy Imaging Systems where the x-ray generator is located below the tabletop. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. These tables
may be used for surgical and non-surgical procedures.
CONTRAINDICATIONS
The OAKWORKS Fluoroscopy Table should not be used with Fluoroscopy systems having intensifier screens or film cassettes larger than 12 inches (30 cm) when an oblique angle of view is being used.
WARNINGS / PRECAUTIONS
The table is not designed for and should not be used with Magnetic Resonance Imaging procedures.
WARNINGS
Improper use of this device can cause injury. Be sure to read all operating instructions prior to use.
Weight limit (patient and accessories): Carbon Fiber Top: 227 kg / 500 lbs. distribured evenly Do not sit beyond warning line on carbon fiber top. Lock casters when mounting and dismounting.
The table utilizes four locking casters to permit movement of the table within the imaging suite. Accidental movement of the table may occur. Lock casters prior to accomplishing imaging of the patient.
There may be pinch points under the table top. Do not have any body part under the top when the table is in motion.
Be certain that the table is completely lowered prior to discharging an ambulatory patient. The patient may lose balance and fall. (CFPM100 & 400 only)
The CFPMFXH is a fixed height table. It is recommended that all patients are assisted onto the table (physical assistance & step stools with side rails is recommended.)
Patient Safety Strap must be secured prior to using the Trendelenburg/Reverse Trendelenburg function. (CFPM400 only)
2
WARNINGS: (CONTINUED)
WARNINGS: (cont.)
Electrical Shock Hazard. (CFPM100 & 400 only) The power supply/control mod­ule is located inside lifting column and under the top. No user serviceable parts are inside. Refer servicing to qualified personnel. Unplug wall connector prior to con­tact with any cables connected to the power supply.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents. (CFPM100 & 400 only)
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. (CFPM100 & 400 only)
The CFPM100 & 400 (only) should not be used adjacent to or stacked with other equipment due to the risk of electronic interference. If adjacent or stacked use is necessary, the table should be observed to verify normal operation in the configuration in which it will be used.
WARNINGS / PRECAUTIONS
WARNINGS / PRECAUTIONS
The potential of exposure to harmful x-rays exists when this table is in use. The use of adequate x-ray barrier devices is necessary to provide protection to both the operator and the patient. X-ray barrier devices are recommended for the patient outside of the intended target area to prevent exposure to scattered radiation from the x-ray generating source.
The tabletop has a typical aluminum filtration equivalence of .62 mm as measured at 100 kVp and a half-value layer (HVL) of 2.7 mm. (1.10 mm as measured at 100 kVp and a half value (HVL) of 3.6 mm)
The OAKWORKS Fluoroscopy Table may be used for x-ray imaging where the x-ray generator is located below the tabletop and the image receptor is located above the tabletop. This is the recommended method. This table may also be used for x-ray imaging where the x-ray generator is located above the tabletop and the image receptor is located below the tabletoop. This application will result in greater patient exposure to x-rays. The operator must weigh this issue with the imaging requirements and patient exposure issues.
• The Fluoroscopy Table may be used with the x-ray generator above the tabletop and a film cassette located on the tabletop.
• The x-ray generator should never be located above the tabletop when the O Positioning System/Prone Pillow are used together. This type of use requires that the x-ray generator is located below the tabletop and the imaging intensifier or film cassette located above the tabletop.
AKWORKS Fluoroscopy Table and the OAKWORKS Spine
Disconnect the power supply plug prior to cleaning any surfaces below or inside of the base of the table.
3
PRODUCT DESCRIPTION - CFPMFXH 22” X 84” INTEGRATED HEADREST TOP
Carbon Fiber Top with
Hand Rail
Removable Table Top Pad
PRODUCT DESCRIPTION - CFPMFXH
PRODUCT DESCRIPTION
CAUTION
The CFPMFXH is a fixed height table. It is recommended that all patients are assisted onto the table (physical assistance & step stools with side rails is recommended.)
Locking Casters (2 sets)
Integrated Face Rest with Face Cushion
3)
Includes 3-pad Set:
1) 2”H x 12”SQ Pad
2) 4”H x 12”SQ Pad
3) Crescent Face Pad
1)
2)
Table Specs* :
• Width: 22” (56 cm)
• Length: 84” (214 cm)
• Patient
Capacity: 500 lbs.(227 kg.) distributed evenly
• Table Weight: 350 lbs. (159 kg.) shipping 400 lbs.(182 kg.)
Included Accessories: Table Top Pad with 1” Medical Grade Foam & TerraTouch™ Fabric
• Height: 37” (91 cm) (optional heights are available)
1- 2”H x 12” SQ Head Rest Pad 1 - 4”H x 12” SQ Head Rest Pad 1 - Crescent Face Pad
Optional Accessories: Carbon fiber arm board, Spine Positioning System, Fluoro-Extender, 2” Table top pad
4
PRODUCT DESCRIPTION - CFPMFXH 24” X 80” RECTANGULAR TOP
Carbon Fiber Top with Removable Table Top Pad
Locking Casters (2 sets)
PRODUCT DESCRIPTION - CFPMFXH
Hand Rail
PRODUCT DESCRIPTION
CAUTION
The CFPMFXH is a fixed height table. It is recommended that all patients are assisted onto the table (physical assistance & step stools with side rails is recommended.)
Table Specs* :
• Width: 24” (61 cm)
• Length: 80” (203 cm)
• Patient
Capacity: 500 lbs.(227 kg.) distributed evenly
• Table Weight: 350 lbs. (159 kg.) shipping 400 lbs.(182 kg.)
Included Accessories: Table Top Pad with 1” Medical Grade Foam & TerraTouch™ Fabric
Optional Accessories: Carbon fiber arm board, Spine Positioning System, Fluoro-Extender, 2” Table top pad
• Height: 37” (91 cm) (optional heights are available)
5
PRODUCT DESCRIPTION - CFPM100 22” X 84” INTEGRATED HEADREST TOP
Carbon Fiber Top with
Hand Rail
Removable Table Top Pad
PRODUCT DESCRIPTION - CFPM100
2)
3)
Includes 3-pad Set:
TABLE OF CONTENTS
PRODUCT DESCRIPTION
1) 2”H x 12”SQ Pad
2) 4”H x 12”SQ Pad
3) Crescent Face Pad
1)
Electronic Lift Tower
Power kill switch
Locking Casters (2 sets)
Table Specs* :
• Height Range: 22” - 40” (56 cm - 102 cm)
• Width: 22” (56 cm)
• Length: 84” (214 cm)
• Patient Capacity: 500 lbs.(227 kg.) distributed evenly
• Table Weight: 350 lbs. (159 kg.) shipping 400 lbs.(182 kg.)
• Controls: 1 foot control
Included: Table Top Pad with 1” Medical Grade Foam & TerraTouch™ Fabric
1- 2”H x 12” SQ Head Rest Pad 1 - 4”H x 12” SQ Head Rest Pad 1 - Crescent Face Pad
Integrated Face Rest with Face Cushion
Optional: Carbon fiber arm board, Spine Positioning System, Fluoro-Extender, 2” Table top pad
• Table Options: International Electric Configurations
ELECTRICAL SPECIFICATIONS - CFPM100
Designed For: North America Europe
Input Service
Current Draw
Maximum Momentary Current Consumption
Voltage to Actuators
Electric Shock Protection
Tabletop Applied Part
Mode of Operation
6
120 VAC/15 amps/60Hz
5.8 amps
9.0 amps
120 VDC
Class I Equipment
Type B Applied Part
Continuous Operation
@ 10% Duty Cycle
220 VAC/10 amps/50Hz
3.0 amps
4.5 amps
220 VDC
Class I Equipment
Type B Applied Part
Continuous Operation
@ 10% Duty Cycle
PRODUCT DESCRIPTION - CFPM100 24” X 80” RECTANGULAR TOP
Carbon Fiber Top with Removable Table Top Pad
Electronic Lift Tower
PRODUCT DESCRIPTION - CFPM100
Hand Rail
Locking Casters (2 sets)
Power kill switch
Table Specs* :
• Height Range: 22” - 40” (56 cm - 102 cm)
• Width: 24” (61 cm)
• Length: 80” (203 cm)
• Patient Capacity: 500 lbs.(227 kg.) distributed evenly
• Table Weight: 350 lbs. (159 kg.) shipping 400 lbs.(182 kg.)
• Controls: 1 foot control
Included: Table Top Pad with 1” Medical Grade Foam & TerraTouch™ Fabric
Optional: Carbon fiber arm board, Spine Positioning System, Fluoro-Extender, 2” Table top pad
• Table Options: International Electric Configurations
TABLE OF CONTENTS
ELECTRICAL SPECIFICATIONS - CFPM100
Designed For: North America Europe
Input Service
Current Draw
Maximum Momentary Current Consumption
Voltage to Actuators
Electric Shock Protection
Tabletop Applied Part
Mode of Operation
120 VAC/15 amps/60Hz
5.8 amps
9.0 amps
120 VDC
Class I Equipment
Type B Applied Part
Continuous Operation
@ 10% Duty Cycle
220 VAC/10 amps/50Hz
3.0 amps
4.5 amps
220 VDC
Class I Equipment
Type B Applied Part
Continuous Operation
@ 10% Duty Cycle
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