How it Works
OAKWORKS
Loading...
CFPMB301
User Manual
40 pgs8.3 Mb0

OAKWORKS CFPM300, CFPMFXH, CFPM400, CFPM301, CFPM100 User Manual

...
USER MANUAL
Imaging Tables
CFPM300
integrated headrest top
CFPM400
integrated headrest top
CFPM301
integrated headrest top
CFPM401
integrated headrest top
CFPMFXH
integrated headrest top
CFPM100
integrated headrest top
CFPM300
CFPM400
CFPM301
CFPMB301
rectangular top - Bariatric Version
CFPM401
CFPMFXH
CFPM100
CFUR301
Urology Table
CFUR401
Urology Table
www.oakworksmed.com · 717.235.6807
CFLU401
Lithotripsy Table
made in the USA
with US & imported parts
© Copyright 2018 OAKWORKS® , Inc.
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 within this document is subject to change without notice and should not be construed as a commitment by OAKWORKS®, Inc.
OAKWORKS®, Inc. encourages requests for technical specifications and the like documentation to ensure accu­racy. The appropriate documentation is available upon request.
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
Product Use Description ....................................................................................................1
Important Safety Instructions
Symbol Identification ........................................................................................................1
Contraindications ..............................................................................................................1
Safety Instructions ........................................................................................................2-3
Product Description & Photo
CFPMFXH ............................................................................................................................... 4
CFPM100 ................................................................................................................................ 5
CFPM300 ................................................................................................................................ 6
CFPM400 ................................................................................................................................ 7
CFPM301 ................................................................................................................................ 8
CFPMB301 - Bariatric ............................................................................................................. 9
CFPM401 ...............................................................................................................................10
CFLU401 - Lithotripsy ............................................................................................................11
CFUR301 - Urology ................................................................................................................12
CFUR401 - Urology ................................................................................................................13
Installation
Grounding .....................................................................................................................14
Directions for Use
Hand Control / Foot Control Operations .....................................................................15-16
Bubble Levels .................................................................................................................17
Angle Indicator ...............................................................................................................17
Patient Restraint Strap ...................................................................................................17
Remove / Replace the Table Top Pad ...........................................................................18
Adjusting Cranial Positioning Pads (integrated headrest tops only) ................................18
Locking Casters Use ......................................................................................................19
Emergency Stop ............................................................................................................19
Weight Capacity & Patient Use .......................................................................................20
Urology Table Bag Hoop ................................................................................................20
Lithotripsy/Urology & Urology Table Lateral Extensions ..................................................21
Lithotripsy/Urology & Urology Table End Extensions ......................................................22
Lithotripsy Table used as Urology Table .........................................................................22
Carbon Fiber Arm Board .................................................................................................23
Adjustable T-Rail Clamp .................................................................................................23
Spine Positioning System II ............................................................................................24
Fluoro Extender ..............................................................................................................24
Reference - Usable Imaging Area Diagrams
CFPMFXH & CFPM 100 - Integrated Headrest & Rectangular Tops ..........................25-26
CFPM400, CFPM300, CFPM401 & CFPM301 - Integrated Headrest Top .......................27
CFPM400, CFPM300, CFPM401, CFPM301 & CFPMB301 - Rectangular Top 28
CFUR301 & CFUR401 - Urology Top .............................................................................29
CFLU401 - Lithotripsy / Urology Top ..............................................................................30
Cleaning & Disinfection / Inspections / Warranty
Recommended Disinfectants / Cleaners .........................................................................31
Cleaning Process ...........................................................................................................32
Inspections & Maintenance .............................................................................................32
Warranty Information ......................................................................................................32
Unique Device Identification (UDI) Information ............................................................33
Specifications
Product Specifications ....................................................................................................34
Environmental Conditions ...............................................................................................34
Electrical Specifications ..................................................................................................34
Guidance and manufacturer’s declaration -
Electromagnetic emissions .............................................................................................35
Recommended separation distances ..............................................................................35
Guidance and manufacturer’s declaration -
Product Disposal ............................................................................................................36
Contact Information......................................................................................back cover
PRODUCT USE DESCRIPTION / IMPORTANT SAFETY INSTRUCTIONS
PRODUCT USE DESCRIPTION
OAKWORKS® Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. 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. The CFLU and CFUR Tables are designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical envi­ronment. No special training is required but a review of the following Safety Instructions is important for the safe­ty of the operator and patient. The healthcare professional should read and understand this entire manual before use with a patient.
NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or re-orienting the equipment.
SYMBOL IDENTIFICATION
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 60601-1: 2005.
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, 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).
This symbol is used to indicate that the operator should consult the user manual.
Sitting is prohibited in this area.
CONTRAINDICATIONS
The Oakw ork s® Imaging Tables should not be used with Imaging systems having intensifier screens or film cas­settes larger than 12 inches (30 cm) when an oblique angle of view is being used. The tables are not designed for
and should not be used with Magnetic Resonance Imaging procedures.
1
IMPORTANT SAFETY INSTRUCTIONS
IMPORTANT SAFETY INSTRUCTIONS
CAUTION
After unpacking your table, inspect it thoroughly for damage. If you suspect a problem do not use the table and call our customer service department at 800-916-4612.
Improper use of this device can cause injury. Be sure to read all operating instructions prior to use.
IMPORTANT - If the Foot Control is ordered, you must install a Foot Control Cradle per Installation Instruction part number MMINMD0008-EN.
Weight limit (patient and accessories): 227 kg / 500 lbs. distributed evenly. (Bariatric Table only: 340 kg / 750 lbs.)
Do not sit beyond warning line on carbon fiber top. On Lithotripsy / Urology Top - Do not sit on any extensions (Weight Limit: 200 lbs. / 91 kg.)
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. Lock casters when the patient is mounting & dismounting the table.
The table should not be used adjacent to or stacked with other equipment and that 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.
The use of Accessories, transducers, and cables other than those specified (with the exception of transducers and cables sold by the Manufacturer of this device as replacement parts for internal components) may result in increased Emissions or decreased Immunity of the table.
The table is designed to be a standalone table used with radiographic equipment. This table must not be modified or incorporated into any other equipment.
There may be pinch points under the table top. Do not have any body part under the top when the table is in motion.
READ AND SAVE THESE INSTRUCTIONS
Be certain that the table is completely lowered prior to discharging an ambulatory patient. The patient may lose balance and fall. NOTE: 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 must be secured with Safety Restraint Strap prior to using the tables.
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 specifications at the end of this manual. (Excluding CFPMFXH)
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. (Excluding CFPMFXH)
This table is not suitable for use in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide.
Electrical Shock Hazard. (Excluding CFPMFXH) The power supply/control module is located inside the 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.
To avoid the risk of electric shock, this equipment must only be connected an outlet this is properly grounded. See GROUNDING instructions in this manual.
Grounding reliability can only be achieved when this equipment is connected to an equivalent 3 prong receptacle marked “Hospital Only” or “Hospital Grade”.
Oakworks medical tables are designed and built to provide many years of dependable service. Please follow local regulations and laws when disposing of the electrical components used in this table.
2
IMPORTANT SAFETY INSTRUCTIONS
WARNING
To reduce the risk of burns, fire, electric shock or injury to persons:
1. Unplug this furnishing from the electrical outlet before cleaning.
2. Unplug from outlet before adding or removing parts.
3. Never operate this furnishing if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or dropped into water. Contact Oakworks Customer Service before use.
4. Keep the cord away from heated surfaces.
5. Never drop or insert any object into any opening.
6. Do not use outdoors.
7. Do not operate where aerosol (spray) products are being used or where oxygen is being administered.
DANGER
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 1.10 mm as measured at 100 kVp and a half value (HVL) of 3.6 mm. (NOTE: Bariatric Top has a typical aluminum filtration equivalence of 1.50 mm. as measured at 100 kVp and a half value (HVL) of 3.6 mm.)
• Oak wor ks® Imaging Tables 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. The tables 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 tabletop. 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 Imaging Tables may be used with the x-ray generator above the tabletop and a film cassette located on the tabletop. (See contraindications regarding film cassette size.)
• The x-ray generator should never be located above the tabletop when the Oakw orks® Imaging Table and the Oakw ork s® Spine 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.
3
PRODUCT DESCRIPTION
CFPMFXH
Carbon Fiber Integrated Headrest Top
Hand Rail
with Removable Table Top Pad
24” X 80” RECTANGULAR TOP
Integrated Face Rest with Crescent Face Pad
Locking Casters
STANDARD SPECIFICATIONS
Fixed Height 37” (91cm)
Choice of Tabletop:
- Integrated Headrest
- Rectangular
Table Voltage Options 120V/60Hz or 230V/50Hz
Table Capacity 500 lbs. (227 kg.) distributed evenly
4” (10cm) Locking Casters
Padding 1” (3cm) Comfort Foam™
Crescent Face Pad Integrated Headrest Only
Patient Restraint Strap Must be used during all procedures
Upholstery Terra Touch™
Table Weight 368 lbs. (167 kg.)
22” (56cm) W x 84” (214cm) L 24” (61cm) W x 80” (203cm) L
Locking / Unlocking Casters for mobile or permanent positioning
OPTIONS
5” (13cm) Locking Casters
Custom heights: 31”-37” (79-91cm)
ACCESSORIES
Carbon Fiber Arm Board (Standard or Wide)
Spine Positioning System II
Adjustable T-rail Clamp
2” (5cm) Tabletop Pad
Fluoro Extender
Headrest 2-Pad Set:
1) 2” (5 cm) High x 12” (30.5 cm) Square Pad
2) 4” (10 cm) High x 12” (30.5 cm) Square Pad
For electrical specs, see Specifications section.
4
PRODUCT DESCRIPTION
CFPM100
Hand Rail
Emergency Stop
Carbon Fiber Integrated Headrest Top with Removable Table Top Pad
Electronic Lift Tower
Locking Casters
24” X 80” RECTANGULAR TOP
Integrated Face Rest with Crescent Face Pad
STANDARD SPECIFICATIONS
Height Motion Powered 22”-40” (56-102cm)
Foot Control Height motion
Choice of Tabletop:
- Integrated Headrest
- Rectangular
Table Voltage Options 120V/60Hz or 230V/50Hz
Table Capacity 500 lbs. (227 kg) distributed evenly
4” (10 cm.) Locking Casters
Padding 1” (3cm) Comfort Foam™
Crescent Face Pad Integrated Headrest Only
Patient Restraint Strap Must be used during all procedures
Upholstery Terra Touch™
Table Weight 343 lbs. (146 kg)
For electrical specs, see Specifications section.
5
22” (56cm) W x 84” (214cm) L 24” (61cm) W x 80” (203cm) L
Locking / Unlocking Casters for mobile or permanent positioning
OPTIONS
5” (13cm) Locking Casters
International Electric Congurations
ACCESSORIES
Carbon Fiber Arm Board (Standard or Wide)
Spine Positioning System II
Adjustable T-rail Clamp
2” (5cm) Tabletop Pad
Fluoro Extender
Headrest 2-Pad Set:
1) 2” (5 cm) High x 12” (30.5 cm) Square Pad
2) 4” (10 cm) High x 12” (30.5 cm) Square Pad
PRODUCT DESCRIPTION
CFPM300
Carbon Fiber Integrated Headrest Top with Removable Table Top Pad
Electronic Lift
Integrated Face Rest with Crescent Face Pad
Tower
24” X 80” RECTANGULAR TOP
Hand Rail
Emergency Stop
Locking Casters
STANDARD SPECIFICATIONS
Motion 1 Powered 26”-44” (66-112cm) Height Range
Motion 2 Powered +15°/-12° Trendelenburg
Motion 3 Powered ±15 Lateral Tilt
Hand Control All powered motions
Choice of Tabletop:
- Integrated Headrest
- Rectangular
Table Voltage Options 120V/60Hz or 230V/50Hz
Table Capacity 500 lbs. (227 kg) distributed evenly
4” (10 cm.) Locking Casters
Padding 1” (3cm) Comfort Foam™
Crescent Face Pad Integrated Headrest Only
Patient Restraint Strap Must be used during all procedures
Upholstery Terra Touch™
Table Weight 498 lbs. (226kg)
22” (56cm) W x 84” (214cm) L 24” (61cm) W x 80” (203cm) L
Locking / Unlocking Casters for mobile or permanent positioning
OPTIONS
5” (13cm) Locking Casters
International Electric Congurations
Foot Control
ACCESSORIES
Carbon Fiber Arm Board (Standard or Wide)
Spine Positioning System II
Adjustable T-rail Clamp
2” (5cm.) Tabletop Pad
Fluoro Extender
Headrest 2-Pad Set:
1) 2” (5 cm) High x 12” (30.5 cm) Square Pad
2) 4” (10 cm) High x 12” (30.5 cm) Square Pad
For electrical specs, see Specifications section.
6
PRODUCT DESCRIPTION
CFPM400
Carbon Fiber Integrated Headrest Top with Removable Table Top Pad
Electronic Lift
Integrated Face Rest with Crescent Face Pad
Tower
24” X 80” RECTANGULAR TOP
Hand Rail
Emergency Stop
Locking Casters
STANDARD SPECIFICATIONS
Motion 1 Powered 26”-44” (66-112cm) Height Range
Motion 2 Powered +15°/-12° Trendelenburg Tilt
Motion 3 Powered ±15° Lateral Tilt
Motion 4 Powered 10” (25cm) Longitudinal Travel
Hand Control All powered motions
Choice of Tabletop:
- Integrated Headrest
- Rectangular
Table Voltage Options 120V/60Hz or 230V/50Hz
Table Capacity 500 lbs. (227 kg) distributed evenly
4” (10 cm.) Locking Casters
Padding 1” (3cm) Comfort Foam™
Crescent Face Pad Integrated Headrest Only
Patient Restraint Strap Must be used during all procedures
Upholstery Terra Touch™
Table Weight 498 lbs. (226 kg)
22” (56cm) W x 84” (214cm) L 24” (61cm) W x 80” (203cm) L
Locking / Unlocking Casters for mobile or permanent positioning
OPTIONS
5” (13cm) Locking Casters
International Electric Congurations
Foot Control
ACCESSORIES
Carbon Fiber Arm Board (Standard or Wide)
Spine Positioning System II
Adjustable T-rail Clamp
2” (5cm) Tabletop Pad
Fluoro Extender
Headrest 2-Pad Set:
1) 2” (5 cm) High x 12” (30.5 cm) Square Pad
2) 4” (10 cm) High x 12” (30.5 cm) Square Pad
For electrical specs, see Specifications section.
7
PRODUCT DESCRIPTION
CFPM301
Carbon Fiber Integrated Headrest Top with Removable Table Top Pad
Electronic Lift
Integrated Face Rest with Crescent Face Pad
Tower
24” X 80” RECTANGULAR TOP
Hand Rail
Emergency Stop
Locking Casters
STANDARD SPECIFICATIONS
Motion 1 Powered 25”-43” (64-109cm) Height Range
Motion 2 Powered +15°/-11° Trendelenburg
Motion 3 Powered 10” (25cm) Longitudinal Travel
Hand Control All powered motions
Choice of Tabletop:
- Integrated Headrest
- Rectangular
Table Voltage Options 120V/60Hz or 230V/50Hz
Table Capacity 500 lbs. (227 kg) distributed evenly
4” (10 cm.) Locking Casters
Padding 1” (3cm) Comfort Foam™
Crescent Face Pad Integrated Headrest Only
Patient Restraint Strap Must be used during all procedures
Upholstery Terra Touch™
Table Weight 538 lbs. (244 kg)
22” (56cm) W x 84” (214cm) L 24” (61cm) W x 80” (203cm) L
Locking / Unlocking Casters for mobile or permanent positioning
OPTIONS
5” (13cm) Locking Casters
International Electric Congurations
Foot Control
ACCESSORIES
Carbon Fiber Arm Board (Standard or Wide)
Spine Positioning System II
Adjustable T-rail Clamp
2” (5cm) Tabletop Pad
Fluoro Extender
Headrest 2-Pad Set:
1) 2” (5 cm) High x 12” (30.5 cm) Square Pad
2) 4” (10 cm) High x 12” (30.5 cm) Square Pad
For electrical specs, see Specifications section.
8
PRODUCT DESCRIPTION
CFPMB301 - Bariatric
24” x 80” Bariatric Carbon Fiber Top with Removable Table Top Pad
Electronic Lift Tower
Hand Rail
Emergency Stop
Locking Casters
STANDARD SPECIFICATIONS
Motion 1 Powered 26”-44” (66-112 cm) Height Range
Motion 2 Powered +15°/-11° Trendelenburg
Motion 3 Powered 10” (25cm) Longitudinal Travel
Hand Control All powered motions
Rectangular Top 24” (61cm) W x 80” (203cm) L
Table Voltage Options 120V/60Hz or 230V/50Hz
Table Capacity 750 lbs. (340 kg) distributed evenly
4” (10 cm.) Locking Casters
Padding 1” (3cm) Comfort Foam™
Crescent Face Pad Integrated Headrest Only
Patient Restraint Strap Must be used during all procedures
Upholstery Terra Touch™
Table Weight 573 lbs. (260 kg)
Locking / Unlocking Casters for mobile or permanent positioning
OPTIONS
5” (13cm) Locking Casters
International Electric Congurations
Foot Control
ACCESSORIES
Carbon Fiber Arm Board (Standard or Wide)
Spine Positioning System II
Adjustable T-rail Clamp
2” (5cm) Tabletop Pad
Fluoro Extender
Headrest 2-Pad Set:
1) 2” (5 cm) High x 12” (30.5 cm) Square Pad
2) 4” (10 cm) High x 12” (30.5 cm) Square Pad
For electrical specs, see Specifications section.
9
Loading...
+ 28 hidden pages
Buy Points How it Works FAQ Contact Us Questions and Suggestions Privacy Policy Cookie Policy Terms of Use