Instruction Manual
48 Pages
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The D4000/D4000A System Instruction Manual
Proprietary Information This manual contains information deemed proprietary to CONMED Corporation. The information contained herein, including all of the designs and related materials, is the sole property of CONMED and/or its licensors. CONMED and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of CONMED. CONMED reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.
Linvatec, Hall, PowerPro, PowerProMax, MPower, Zen and MPower 2 are trademarks or registered trademarks of Linvatec Corporation.
Ó CONMED Corporation 2022. All Rights Reserved.
Record the Model and Serial Numbers of the Console and date received. Retain for future reference.
Console Model No.�������������� Serial No�����������������
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Table of Contents
1.0
Page
INTRODUCTION 1.1.
Operating Principle...1
1.2.
Indications for Use...1
1.3.
Intended Use...1
1.4.
Contraindications...1
1.5
Warnings and Precautions...2 1.5.1 Warnings...2 1.5.2 Precautions...4
1.6
Environmental Directives...5
1.7
Product Photographs and Drawings...5
1.8
Symbol Definitions...6 1.8.1 Product Symbols...6 1.8.2 Warning and Information Symbols...7
2.0
SYSTEM INSTALLATION AND OPERATION 2.1
Product Description...9 2.1.1 Console Front Panel...9 2.1.2 Console Back Panel...10
2.2
Assembly/Installation Instructions...11
2.3
Operating Instructions...13 2.3.1 Power On/Run Screen...13 2.3.2 Irrigation Control - D4000A Only...14 2.3.3 Corded Footswitch Operation...15 2.3.4 Wireless Footswitch Operation (If Equipped)...17 2.3.5 Communication with the CONMED 24k Irrigation System...19 2.3.6 Menu Operation...20 2.3.7 Using the Handpiece Cord Button to Change Speed/Mode...22 2.3.8 Using the Shaver Handpiece Buttons to Change Speed ...22 2.3.9 Turbo Mode Using Ultra Series Shaver Blades (Console software revision V 2.0 or higher)... 22 i
Table of Contents
Page
2.3.10 Using Shaver Blade Window Indexing...23 2.4
3.0
Preoperative Functional Test...23
MAINTENANCE 3.1
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Cleaning Information...24 Warnings, Precautions and Notes...24 3.1.2 Manual Cleaning Instructions...24 3.1.3 Corded Footswitch and 24K Pump Interface Cable Cleaning Instructions...25 3.1.4 Handpiece and Wireless Footswitch Cleaning Instructions...25
3.2
Sterilization Information ...25 Warnings, Precautions and Notes...25 3.2.2 Sterilization Instructions...25 3.2.3 Corded Footswitch and 24K Pump Interface Cable Sterilization Instructions... 25 3.2.4 Handpiece and Wireless Footswitch Sterilization Instructions...25
4.0
3.3
Troubleshooting...26
3.4
Maintenance Schedule...28
3.5
Fuse Replacement...29
TECHNICAL SPECIFICATIONS 4.1
Product Technical Specifications...30 4.1.1 Technical Specifications...30 4.1.2 Power Cord Requirements...32 4.1.3 Tubing Set Technical Specifications ...32 4.1.4 Handpiece Technical Specifications...32 4.1.5 Corded Footswitch (5020-053 and C9863) Technical Specifications...34 4.1.6 Wireless Footswitch (W1000) Technical Specifications...34
4.2
Product Environmental Requirements...35 4.2.1 Environmental Technical Specifications...35 4.2.2 Electromagnetic Requirements...36
4.3
Accessories...40 ii
Table of Contents
5.0
Page
CUSTOMER SERVICE 5.1
Assistance and Repair...42
iii
1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean, or sterilize this or associated equipment. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Service intervals, as listed in section “3.4 Maintenance Schedule”, are required to keep the equipment at its optimum operating performance.
1.1. Operating Principle The D4000/D4000A console functions as a powered instrument console for driving powered instruments and accessories used in the cutting of soft tissue and bone at the surgical site. The D4000/D4000A console is a non-sterile device and must be located in a non-sterile area of the operating suite. Additionally the D4000A console offers an irrigation pump that, when used with tubbing sets, provides a sterile fluid supply to the blades, burs, and drill bits, at the surgical site, for lavage and cooling. The handpiece, handpiece cord, and irrigation tube sets are sterile. The handpiece is used in the sterile field with the cord connected to the console. The irrigation tube set is used on the handpiece in the sterile field with the cassette connected to the console. The footswitch is non-sterile and placed on the floor. The console provides two handpiece drive ports that are used with a variety of handpieces. Handpiece functionality can be controlled directly by the handpiece, and/or by a corded footswitch or wireless footswitch (if equipped). Handpiece speed, direction, user settings, irrigation flow rate, and footswitch settings are controlled with the touch-screen displays. Consult the associated CONMED handpiece or footswitch instruction manual prior to operating this equipment.
1.2. Indications for Use The D4000/D4000A System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.
1.3. Intended Use Same as Indications for Use above.
1.4. Contraindications The D4000A console’s irrigation pump and tubing sets are contraindicated for distention. 1
1.5 Warnings and Precautions DO NOT bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient.
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The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING - A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a Warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff.
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PRECAUTION - A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment.
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NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment. 1.5.1 Warnings
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Warnings: Console 1. Eye protection is recommended when operating equipment. Eye injury may result.
2. It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories. 3. Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering. 4. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 5. To avoid the risk of electric shock, this equipment must be connected to a supply mains with protective earth. The voltage and frequency characteristics must be compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices may defeat the safety ground and could result in injury. 6. Do not use sterile equipment beyond the expiration date listed on the label. Sterility of the product cannot be assured beyond the expiration date. 7. Do not excessively bend or kink the power cord or accessory cord. Always inspect cords for signs of excessive wear or damage. If wear or damage is found, discontinue use and replace immediately. Using a damaged power cord could possibly cause injury. 8. Do not immerse the equipment in fluids. Immersion may render the device inoperable. 9. Do not attempt to attach or remove a tubing set, handpiece, footswitch, or cable while the console is operational. Damage or injury could occur. 10. The front panel power switch places the console in standby mode. To remove mains power, disconnect the power cord. Position the console with easy access to the power cord. 2
11. Do not simultaneously contact the console and patient. This may contaminate the sterile field and create an unsafe electrical condition. 12. This system may cause radio interference or may disrupt the operation of nearby equipment. Avoid stacking equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the D4000/D4000A or shielding the location. Warnings: Handpieces, Attachments and Accessories 1. When a handpiece is not in use and prior to connecting or removing attachments and accessories, always place the handpiece in its SAFE or OFF position. 2. Do not place a handpiece on a patient. Failure to comply may cause patient injury, such as burns or tissue injury. 3. Do not place a handpiece on or near a magnetic device. A magnetic field can activate a handpiece. Failure to comply may cause injury to the patient or operating room personnel. 4. Continually check all handpieces and attachments for overheating. If overheating is sensed, immediately discontinue use and return equipment for service. Overheating of the bur, bit or blade may cause damage to the bur, bit or blade and may cause thermal necrosis. 5. Avoid contact with other non “BF” rated powered instruments while in contact with the patient, as this may create a current leakage path to earth. 6. Do not connect known damaged equipment or equipment that is corroded or wet. Failure to comply may cause injury or result in damage to equipment. 7. Do not contact the moving parts on the handpiece. Injury to the operator may occur. 8. All cutting accessories and tubing sets are single-use only. Do Not Re-sterilize. Single Use STERILIZE 2 Only. The ability to effectively clean and re-sterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device. After use, dispose of properly. 9. The tubing sets used on this device contains the phthalate plasticizer DEHP, which may leach into the patient during administration of irrigant. Animal studies have shown that high-level exposure to DEHP may affect male fertility and reproductive development; these findings have not been confirmed in clinical studies. In determining use of this device in a child, or a pregnant or nursing female, the clinical benefits should outweigh any potential risk to the infant. 10. Refer also to appropriate Handpiece and Wireless Footswitch Instructions for Use. Warnings: 24k Irrigation System 1. Refer to 24k Irrigation System Instruction for Use.
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1.5.2 Precautions 1. United States Federal law restricts sale of this device to or on the order of a physician.
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2. This device should only be used in compliance with its intended use.
3. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service.
4. Use only associated CONMED approved equipment, attachments and accessories. They have been tested and certified to specific medical standards. Using unapproved accessories may result in improper operation, may negatively affect EMC performance and may result in non-compliance to medical standards. 5. The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: • The device or the accessories are improperly used, prepared or maintained; • The instructions in the manual are not adhered to; • Non-authorized persons perform repairs, adjustments or alterations to the device or accessories. 6. There are no user-serviceable parts inside. No modification of this equipment is allowed. Removing the cover may introduce an electrical shock hazard by exposing you to dangerously high voltages or other risks. 7. Prior to each use, perform the following: • Ensure all accessories are correctly and completely attached. (Refer to section “2.2 Assembly/Installation Instructions”) • Perform the required Preoperative Functional Tests for the equipment and accessories. (Refer to section
“2.4 Preoperative Functional Test”
8. Clean and sterilize all the equipment and associated accessories according to instructions for use. (Refer to section “3.1 Cleaning Information” and section “3.2 Sterilization Information”). 9. Do not handle the equipment by the cord. Do not pull on the cord to remove it from other equipment. Damage can occur. 10. Do not use any instrumentation, especially sharp objects, to make selections on the touchscreen displays. Damage may result. 11. Ensure the optical cassette sensor window next to the pump cassette mechanism is kept clean at all times. Precautions: Handpieces, Attachments and Accessories 1. Refer to appropriate Handpiece and Wireless Footswitch Instructions for Use. Precautions: 24k Irrigation System 1. Refer to 24k Irrigation System Instruction for Use.
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1.6 Environmental Directives WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electric Equipment (WEEE) European Directive. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact CONMED. A Lithium battery is used in this device. Disposal of the battery shall be based on national regulations. Battery must be recycled or disposed of properly. NOTE for State of California, USA:
W42-000-111 A
State of California Requirement: Lithium Batteries contain Perchlorate Material - special handling may apply. See “http://www.dtsc.ca.gov/HazardousWaste/Perchlorate”.
1.7 Product Photographs and Drawings The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.
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1.8 Symbol Definitions 1.8.1 Product Symbols
menu
Stand-by (ON/OFF)
Prime Button
Menu Button
Handpiece Port
24K Port (Output)
Corded Footswitch Port
CONMED Communications Port (Input/Output) NOTE: Refer to Section “2.3.6 Menu Operation” for button descriptions and functionality.
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1.8.2 Warning and Information Symbols
SN
Catalog Number
REF
! EC REP
Manufacturer
Date of Manufacture
Consult Instructions for Use
Refer to Instruction Manual/Booklet (for critical safety instruction). The color is blue.
Caution
DEHP Symbol
Authorized Representative in the European Community
Non Sterile
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STERILIZE
EO
Sterile - Sterilized Using EO
CE Mark of Conformity
2797
Prescription Only: Federal Law restricts this device to sale by or on the order of a physician
STERILE
Serial Number
No User Service Recommended. Refer servicing to qualified CONMED service personnel
STERILE STERILE
R
Sterile Sterile - Sterilized Using Irradiation
Do Not Steam Sterilize
Do Not Sterilize
Do Not Resterilize
Do Not Reuse (for Single Use Only)
Do Not Use Oil
Do Not Use for Plunge Cutting
Eye Protection Required
Biohazard Risk
Do Not Immerse
QTY
Quantity
Type B Applied Part
Type BF Applied Part
UL Classification Mark
UL Recognized Components
Rating Fuse
Fuse Location
7
~
Alternating Current
Protective Earth Ground
Equipotentiality (Equipment Potential)
Non-Ionizing Electromagnetic Radiation (RF Symbol)
Temperature Limitation
Humidity Limitation
Atmospheric Pressure Limitation
Use by Date
Fragile
This Side Up
Do Not Use if Package is Damaged
Keep Dry
Warning: Corrosive Substance
Warning: Electrical Hazard/High Voltage
Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union endof-life of product, indicating separate collection for electrical and electronic equipment Recycle. Batteries contain materials which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1 (866) 426-6633, or outside the U.S. contact your local CONMED representative for additional information on battery disposal or recycling. Japan Radio Law Certification Telecommunications Business Act Certification W42-000-111 A 6-05
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2.0 SYSTEM INSTALLATION AND OPERATION 2.1 Product Description 2.1.1 Console Front Panel
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6a
1
2a
3
6b
2b
5
4a
4b
1. Power Button and Indicator - Press this standby button to activate the console, LED indicator illuminates green. Press this button again to set the console to stand-by mode, LED indicator will illuminate amber. 2. Handpiece Ports (2a and 2b) - Connect handpieces to either Port. When handpiece requires irrigation or cooling (D4000A), connect only to right Port (2b). 3. Footswitch Port - Connect a corded footswitch here. 4. Tubing Cassette Receptacle - Accepts various tubing sets if irrigation is used (4b). Optical sensor confirms when a tubing set is connected (4a). Available on D4000A model only. 5. Prime Button - When a tubing set is installed, press and hold to run the pump to prime the tubing set. Available on D4000A model only. 6. Color Touch Screen Displays - Touchscreen displays (6a and 6b) show attached equipment information such as handpiece description, speed, mode, direction, irrigation information and other status messages. Touchscreen buttons allow the user to change settings for the handpiece, footswitch or irrigation connected to the associated handpiece or footswitch Port. Any settings related to irrigation are accessible only from the right display (6b), and right Port (2b). 7. Menu Button - Press to access the menu system. Menu selections are shown on 6a and the available options to each selection on 6b. (Refer to section “2.3.6 Menu Operation”).
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menu
2.1.2 Console Back Panel
6
1
3
2
4
5
1. CONMED Communication Port - Input/Output. 2. 24k Connector - The 24k Pump Interface Cable (D4024) connects between here and the connector on the 24k Irrigation System. The D4000/D4000A communicates that a shaver handpiece is in use. The D4000/D4000A will not communicate by touch screen with the 24k Irrigation System without this cable connected. 3. Fuse Module - Contains two T8AL 250V fuses. To replace, Refer to section “3.5 Fuse Replacement” 4. Power Input Receptacle - Accepts hospital grade power cord (100 - 240 V~, 50/60 Hz). 5. Potential Equalization Connector - Potential Equalization Connector per DIN 42801. 6. Irrigation Bag Holder Receptacle - This receptacle is designed to accept an optional Fluid Bag Holder Rod (Cat. number 5040-180).
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2.2 Assembly/Installation Instructions Installation: 1. Place the console on a sturdy flat surface or use the Controller Stand. 2. Plug the power cord into the console receptacle and to a properly grounded supply outlet (e.g., receptacle marked “Hospital Grade” or “Hospital Only”). 3. Press the “POWER” button. The LED indicator changes to green. If no handpiece is connected, console displays “Connect Handpiece”. If a handpiece is connected, the corresponding display will show the current handpiece settings. 4. Connect handpiece(s). With the red dot on the cord connector facing upward, insert it into either handpiece Port. When handpiece requires irrigation or cooling (D4000A), connect to right Port (2b) only. 5. For handpieces with a removable cord, plug the other end of the handpiece cord(s) into the handpiece(s) cord connector. Push together until fully seated. NOTE: When a handpiece is connected, the console recognizes the handpiece model. The default or lastused settings show on the associated display. Refer to section “2.3 Operating Instructions” to adjust user settings.
6. Connect attachment or cutting accessory to the handpiece(s). See the associated handpiece manual or IFU for installation information. 7. Connect the corded footswitch. With the red dot on the cord connector facing upward, insert it into the footswitch (center) Port. The footswitch icon shows on both displays. The footswitch defaults to the right display. Press the icon on either display to reassign the footswitch to the other display/handpiece. Mounting to Controller Stand (Optional): 1. Attach the mounting bracket to the bottom of the console with four screws provided. 2. Slide mounting bracket into controller stand until spring loaded retention mechanism engages. Fluid Bag Hanger (Optional): A fluid bag hanger rod (5040-180) is available for irrigation use, to mount to the top of the console. The hanger rod holds a one liter fluid bag. To attach the hanger rod: 1. Insert the threaded portion of the hanger rod into the hole. Turn clockwise until approximately 1/2 in. (12 mm) of the rod is threaded into the hole. 2. Secure the hanger rod by tightening the knurled lock nut. 3. Hang the fluid bag on the arm of the hanger rod.
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Irrigation Use (Optional): Recommended when using the E9010 CoolFlex High Speed Drill, E9005 High Speed Shaver, and Micropower High Speed Drills. Refer to section “4.3 Accessories”. Refer to appropriate Handpiece Instructions for Use for further details. Use surgical aseptic techniques to attach the tubing set as follows: 1. Open the tubing package. 2. Remove the tubing set from the sterile package and pass the black cassette and bag spike line out of the sterile field. 3. Install the cassette over the pump rotor on the console with the black tab behind the plastic bracket. 4. To remove the cassette, pull out on the back tab at the bottom of the cassette.
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2.3 Operating Instructions 2.3.1 Power On/Run Screen When first powered on, the console displays an initialization sequence. When the sequence completes a message to connect a handpiece appears. When a handpiece is connected the run screen appears. Handpiece or System Information
Speed Mode Selected
SINGLE TRIGGER
Decrease Speed
Directional Arrow
100
Increase Speed
%
Oscillate
Mode
Wireless Footswitch
Corded Footswitch
Speed position indicator Mode Selection
When the direction of the handpiece is changed, the arrows on the screen change and show the direction of the handpiece. SINGLE TRIGGER
100
%
Forward
Drill
Mode
SHAVER
Reverse
7000
RPM
SINGLE TRIGGER
100
%
Oscillate
Oscillate
Mode
13
Revolutions Per Minute
For PRO6100 Handpiece Only Some handpieces have different operating modes associated with them, such as: Drill, Oscillate Drill, Screw, Tap. To change the mode of the handpiece using the touchscreen, press the “Mode” button displayed on the screen. Below are some of the available options. Depending on the handpiece attached and the functional options of the handpiece, only valid options will appear. After Pressing the “Mode” Button Handpiece or System Information Message
SINGLE TRIGGER TRIGGER Choose SINGLE Option
Choose Option
Drill Mode Tap Mode
Oscillate Drill Mode
Screw Mode
2.3.2 Irrigation Control - D4000A Only When an irrigation or cooling cassette is installed, the irrigation control bar appears only on the right display. When the handpiece is turned on, the irrigation pump runs at the flow rate set point. When the handpiece is turned off, the irrigation pump stops. Handpiece or System Information HIGH SPEED DRILL
80K 80K
HIGH SPEED DRILL RPM RPM
Decrease Irrigation Flow
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100 % 100 %
Increase Irrigation Flow Flow Set Point
2.3.3 Corded Footswitch Operation • MicroChoice Footswitch, 2 pedal (5020-053) • MicroChoice Footswitch, 3-pedal (C9863) NOTE: PowerPro Handpieces can not be operated with a Footswitch.
When a corded footswitch is connected to the console, a footswitch icon appears on both displays.
Grey Icon
Gold Icon
The gold icon indicates the assignment of the corded footswitch. The gray icon indicates an inactive footswitch. 1. Press either corded footswitch icon to assign the footswitch to the other display/handpiece. The “Move Footswitch?” message appears.
2. Press the check mark button 3. Press the close/exit button
to move to the other port. to cancel the move.
NOTE: A time out occurs if no action is taken and the default screen returns. The footswitch is not moved.
When the check mark is chosen, the “Footswitch Moved” message appears.
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