Users Guide
496 Pages
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User’s Guide
GENERATOR
Bolder Surgical 331 S. 104th Street, Suite 200 Louisville, CO 80027 USA www.BolderSurgical.com Tel: 866.683.1743 Patent Information www.BolderSurgical.com/patents ICE-DO-18103 Rev. D Issue Date: 2021-06-03 www.BolderSurgical.com/IFUs
2797 Bolder Surgical
Bolder Surgical Made in USA. Printed in USA. © 2021 Bolder Surgical All rights reserved. CoolSeal™ Generator
Generator User's Guide
GENERATOR
CoolSeal ™ Generator REF CSL-200-50
en – User’s Guide da – Brugsanvisning de – Gebrauchsanweisung el – Οδηγίες χρήσης es – Instrucciones de uso fi – Käyttöohjeet fr – Mode d’emploi is – Notkunarleiðbeiningar it – Istruzioni per l’uso nl – Gebruiksaanwijzing no – Bruksanvisning pt – Instruções de utilização sv – Bruksanvisning
For use with software version 1.X.X
Table of Contents Preface...4 Equipment covered in this manual... 4 Patent Information:... 4 Trademark acknowledgements... 4 Manufactured by: ... 4 For information call... 4 Conventions Used in this Guide... 4 Chapter 1. Overview and General Features...5 Introduction ... 5 Indication for Use... 5 Contraindications for Use... 5 Front Panel... 6 Rear Panel ... 6 Bottom View... 7 List of Accessories... 7 Compatible Vessel-Sealing Instruments... 7 Chapter 2. Patient and Operating Room Safety...8 Warnings and Cautions ... 8 Overview... 8 Generator Setup Safety... 8 Electromagnetic Compatibility... 9 Fire Hazard During Oropharyngeal Surgery... 9 Pacemakers and ICDs ... 9 Connecting a CoolSeal™ Instrument...10 Cleaning the CoolSeal™ Generator...10 Servicing the CoolSeal™ Generator...10 Chapter 3. Setup and Use of the CoolSeal™ Generator...11 Unpacking the CoolSeal™ Generator...11 Inspecting the CoolSeal™ Generator...11 Setup Safety ...11 Setting up the CoolSeal™ Generator...12 Adjusting the volume...13
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Connecting a CoolSeal™ Instrument...13 Connecting a CoolSeal™ Instrument to the CoolSeal™ Generator...13 Activating a CoolSeal™ Instrument...13 Descriptions of Alert Conditions...14 Chapter 4. After Surgery...17 Turning Off the CoolSeal™ Generator...17 Preparing the CoolSeal™ Generator for Reuse...17 Chapter 5. Troubleshooting...18 General Troubleshooting Guidelines...18 Correcting Malfunctions...18 Abnormal Patient Response...18 CoolSeal™ Generator Malfunctions...18 Potential interactions with other device...20 Chapter 6. Periodic Functional Testing, Maintenance and Service...21 Responsibility of the Manufacturer...21 Periodic Functional Testing and Maintenance...21 When should Periodic Functional Testing be performed?...21 When must the power cord be replaced?...21 When should the fuses be replaced?...21 How can the fuses be replaced?...21 Product Service...22 Returning the CoolSeal™ Generator for Service...22 Software Upgrades ...22 Chapter 7. Technical Specifications...23 Performance Characteristics...23 General ...23 Dimensions and Weight...23 Operating Parameters ...23 Transport and Storage ...23 Internal Memory...23 Activation Tone...24 Alert Tones ...24 Input Power...24 Power Cord Specification...24
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Technical Specifications ...25 Input Frequency...25 Input Current ...25 Backup Power ...25 Equipotential Connection...25 Duty Cycle ...25 Low Frequency (50/60 Hz) Leakage Current...25 Standards and IEC Classifications...25 Symbols ...26 Classifications...27 Class I Equipment (IEC 60601-1)...27 Electromagnetic Compatibility (IEC 60601-1-2)...27 Type CF Equipment (IEC 60601-1)...27 IP XX Liquid Ingress/Spillage (IEC 60601-1 and IEC 60601-2-2)...27 Voltage Transients – Energy Platform Mains Transfer (IEC60601-1 and IEC 60601-2-2)...27 Electromagnetic Compatibility (IEC 60601-1-2 and IEC60601-2-2)...27 Output Characteristics...27 Maximum Output for the CoolSeal™ Generator...27 Electromagnetic Immunity...28 Appendix A – Periodic Functional Test...32 Definitions...32 Equipment Required:...32 Pass/Fail Criteria:...32 Procedure: ...33 Periodic Functional Test Summary Form...36 Warranty ...38
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Preface This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for using the CoolSeal™ Generator only.
Equipment covered in this manual CoolSeal™ Generator – CSL-200-50
Patent Information https://BolderSurgical.com/patents/
Trademark acknowledgements CoolSeal™ Generator
Manufactured by: Bolder Surgical 331 S. 104th Street, Suite 200 Louisville, CO 80027 Tel: 866.683.1743 www.BolderSurgical.com
Authorized Representative:
Emergo Europe B.V. Prinsessegracht 20 2514 AP The Hague The Netherlands
For information call 866.683.1743
Made in USA
Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury Notice Indicates a hazard, which may result in product damage. Important Indicates an operating tip or maintenance suggestion.
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Chapter 1. Overview and General Features This section includes the following information: • Introduction • Indications for Use • Contraindications for Use • Front Panel • Rear Panel • Bottom View • List of Accessories • Compatible Vessel-Sealing Instruments Caution Read all warnings, cautions, and instructions provided with this generator before use. Specific instructions for CoolSeal™ instruments are not included in this manual. Refer to the CoolSeal™ instrument’s instructions for use for warnings, cautions, and instructions for its use. Federal (USA) law restricts this device to sale by or on the order of a physician.
Introduction The CoolSeal™ Generator provides Radio Frequency (RF) energy for vessel-sealing applications. The CoolSeal™ Generator automatically detects coded instruments and configures the CoolSeal™ Generator accordingly. Safety and diagnostic functionality include automatic fail-safe functions.
Indication for Use The CoolSeal™ Generator is intended to provide Radio Frequency (RF) energy to compatible CoolSeal™ instruments for vessel-sealing applications. The specific application will depend on the compatible surgical device that is connected to the generator. This generator is designed to be used only with surgical devices compatible with the CoolSeal™ technology.
Contraindications for Use None known specifically for the CoolSeal™ Generator.
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Front Panel
(1) (2) (3) (4)
Illuminated Power Button Activation Display CoolSeal™ Instrument Receptacle Instrument Receptacle Display
Rear Panel
(5) (6) (7) (8) (9)
Volume Adjustment Control Power Cord Inlet Fuse Drawer Equipotential Connector Safety Warnings & Cautions Label
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Bottom View
(10) Final Test Date Label (11) Software Version Label (12) Manufacturing Information Label
List of Accessories Power Cord - US Specific CSL-FTC Functional Test Cable (not included)
Compatible Vessel-Sealing Instruments Compatible CoolSeal™ instruments will have connectors that match the following illustration. Refer to the CoolSeal™ instrument’s instructions for use for compatibility with the CoolSeal™ technology.
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Chapter 2. Patient and Operating Room Safety The safe and effective use of electrosurgery depends to a large degree upon factors solely under the control of the operator. There is no substitute for a properly trained and vigilant surgical team. It is important that the operating instructions supplied with this or any electrosurgical equipment be read, understood and followed. Electrosurgery has been used safely in numerous procedures. Before starting any surgical procedure, the surgeon should be trained in the particular technique and surgical procedure to be performed, should be familiar with the medical literature related to the procedure and potential complications, and should be familiar with the risks versus the benefits of utilizing electrosurgery in the procedure. To promote the safe use of the CoolSeal™ Generator, this section presents the warnings and cautions that appear throughout this user’s guide. It is also important that you read, understand, and follow the instructions for use in the CoolSeal™ instrument’s instructions for use.
Warnings and Cautions Overview Caution Read all warnings, cautions, and instructions provided with this generator before use. Specific instructions for CoolSeal™ instruments are not included in this manual. Refer to the CoolSeal™ instrument’s instructions for use for warnings, cautions, and instructions for its use. Federal (USA) law restricts this device to sale by or on the order of a physician. Generator Setup Safety Warning Electric Shock Hazard: Connect the system power cord to a properly grounded power receptacle. Do not use power plug adapters. Fire Hazard: Do not use extension cords or multiple socket outlets. Patient Safety: Use the CoolSeal™ Generator only if the power-up self-test has been completed as described in this manual, otherwise inaccurate power outputs may result. This equipment is for use only by trained, licensed physicians. Use of this equipment without such training can result in serious patient injury. The CoolSeal™ Generator is only compatible with CoolSeal™ Instruments. No other bipolar instruments can be used. Do not wrap the instrument cords around metal objects. This may induce stray currents that could lead to shocks, fires, or injury to the patient or surgical team. Electric Shock Hazard: Do not connect wet instrument connectors to the CoolSeal™ Generator. Ensure that all instruments and adapters are correctly connected. Inspect equipment cable for breaks, cracks, nicks and other damage before every use. If damaged, do not use. Damaged equipment cables may result in injury or electrical shock to the patient or surgical team.
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Caution Set the system volume control at a level that ensures the activation tones can be heard. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when the CoolSeal™ Generator is delivering RF energy. Examine all instruments and connections to the system before using. Ensure that the instruments function as intended. Improper connection may result in arcs, sparks, instrument malfunction, or unintended surgical effects. A non-functioning CoolSeal™ Generator may cause interruption of surgery. A backup system should be available for use. The use of appliance couplers, i.e., power cords, other than those specified may result in increased emissions or decreased immunity of the equipment. Provide as much distance as possible between the CoolSeal™ Generator and other electronic equipment such as monitors. Do not cross or bundle electronic devices cords. This generator may cause interference with other electronic equipment. If interference occurs, relocate the equipment. Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means.1 1.
U.S. Department of Health and Human Services. National Institute for Occupational Safety and Health (NIOSH). Control of Smoke from Laser/Electric Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128, September 1996.
Electromagnetic Compatibility Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Portable RF communication equipment should be used no closer than 30 cm (12 inches) to any part of the CoolSeal™ Generator including cables specified by Bolder Surgical. Otherwise, degradation of the performance of this equipment could result. Fire Hazard During Oropharyngeal Surgery Warning Verify endotracheal tubes are free from leaks and that the cuff seals properly to prevent oxygen leaks. Pacemakers and ICDs Warning DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged.
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Connecting a CoolSeal™ Instrument Warning Electric Shock Hazard • Do not connect wet instruments to the CoolSeal™ Generator • Ensure that all instruments are correctly connected and that no metal is exposed at any connection point Properly seat the instrument in the receptacle. Improper connection may result in inadvertent instrument activation or other potentially hazardous conditions. Follow the instructions provided with CoolSeal™ Vessel Sealing Instruments. The instrument receptacle on this system is designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing so will cause simultaneous activation of the instruments.
Caution Inspect instruments and cords for breaks, cracks, nicks and other damage before every use. If damaged, do not use. Damaged instruments or cords may result in injury or electrical shock to the patient or surgical team.
Cleaning the CoolSeal™ Generator Warning Electric Shock Hazard Always turn off and unplug the CoolSeal™ Generator before cleaning. Servicing the CoolSeal™ Generator Warning Electric Shock Hazard Do not remove the CoolSeal™ Generator cover. Do not attempt to service the CoolSeal™ Generator. All service and repair must be conducted by a Bolder Surgical™ technician.
Caution The CoolSeal™ Generator must not be disposed of at the end of life with other waste. To recycle waste equipment, obtain instructions from Bolder Surgical (call 866.683.1743) or contact your local sales representative to discuss local waste disposal solutions and processes. The CoolSeal™ Generator poses disposal risks similar to consumer electronics such as computers. There are no radioactive substances, batteries, or hazardous liquids that may leak in the CoolSeal™ Generator.
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Chapter 3. Setup and Use of the CoolSeal™ Generator This chapter covers the following topics: •
Unpacking the CoolSeal™ Generator
•
Inspecting the CoolSeal™ Generator
•
Setup Safety
•
Setting up the CoolSeal™ Generator
•
Adjusting the volume of activation tones
•
Connecting a CoolSeal™ Instrument
•
Activating the CoolSeal™ Instrument
•
Descriptions of Alert Conditions Caution Read all warnings, cautions, and instructions provided with this generator before use. Specific instructions for CoolSeal™ instruments are not included in this manual. Refer to the CoolSeal™ instrument’s instructions for use for warnings, cautions, and instructions for its use.
Unpacking the CoolSeal™ Generator 1.
Remove the CoolSeal™ Generator from the shipping box and packaging material.
2.
Inspect the device for visible damage.
Inspecting the CoolSeal™ Generator Before each use of the CoolSeal™ Generator, verify that the unit and all accessories are in good working order: •
Inspect for damage to the Generator and all its connections.
•
Inspect all cords and connectors for signs of wear, damage, and abrasion.
•
Verify that no errors occur when you turn on the unit.
Setup Safety Warning Electric Shock Hazard: Connect the system power cord to a properly grounded power receptacle. Do not use power plug adapters. Fire Hazard: Do not use extension cords or multiple socket outlets. Patient Safety: Use the CoolSeal™ Generator only if the power-up self-test has been completed as described in this manual, otherwise inaccurate power outputs may result. This equipment is for use only by trained, licensed physicians. Use of this equipment without such training can result in serious patient injury. The CoolSeal™ Generator is only compatible with CoolSeal™ Instruments. No other bipolar instruments can be used. Do not wrap the instrument cords around metal objects. This may induce stray currents that could lead to shocks, fires, or injury to the patient or surgical team. Electric Shock Hazard: Do not connect wet instrument connectors to the CoolSeal™ Generator. Ensure that all instruments and adapters are correctly connected. Inspect equipment cable for breaks, cracks, nicks and other damage before every use. If damaged, do not use. Damaged equipment cables may result in injury or electrical shock to the patient or surgical team. Bolder Surgical
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Caution Set the system volume control at a level that ensures the activation tones can be heard. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when the CoolSeal™ Generator is delivering RF energy. Examine all instruments and connections to the system before using. Ensure that the instruments function as intended. Improper connection may result in arcs, sparks, instrument malfunction, or unintended surgical effects. A non-functioning CoolSeal™ Generator may cause interruption of surgery. A backup system should be available for use. The use of appliance couplers, i.e., power cords, other than those specified may result in increased emissions or decreased immunity of the equipment. Provide as much distance as possible between the CoolSeal™ Generator and other electronic equipment such as monitors. Do not cross or bundle electronic devices cords. This generator may cause interference with other electronic equipment. If interference occurs, relocate the equipment. Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means.1 1.
U.S. Department of Health and Human Services. National Institute for Occupational Safety and Health (NIOSH). Control of Smoke from Laser/Electric Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128, September 1996.
Setting up the CoolSeal™ Generator 1.
Place the CoolSeal™ Generator on a flat, stable surface such as a table, platform, boom system, or cart. Carts with non-conductive wheels are recommended. Refer to the procedures for your local institution or your local codes.
2.
If required by institution or local codes, connect the equipotential connector to a ground source.
3.
Connect the system power cord to the electrical inlet on the rear panel.
4.
Connect the system power cord to a grounded AC wall receptacle. Notice Do not connect the CoolSeal™ Generator to a power strip or extension cord. Do not position the device so that it is difficult to disconnect the power cord. Important If transported or stored at temperatures outside the operating temperature range, allow one hour for the CoolSeal™ Generator to reach operating temperature before use.
Turn on the system by pressing the power stand-by button ( power-up self-test:
) on the front of the unit. Observe the following during the
•
Unit performs start-up self-test.
•
The power button illuminates green.
•
Audible alert sounds three (3) ½ second tones after successful completion of self-check. Notice Verify that the system has successfully completed the start-up self-test before connecting instruments.
If unit fails start-up self-test: •
Power button does not illuminate or illuminates red
•
Audible alert tone sounds one (1) ½ second tone after unsuccessful self-check
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Adjusting the volume The volume of alert and activations tones may be adjusted by turning the volume knob on the back panel of the CoolSeal™ Generator. Notice The minimum volume for alert tones will always be louder than the activation tone.
Connecting a CoolSeal™ Instrument Warning Electric Shock Hazard • Do not connect wet instruments to the CoolSeal™ Generator. • Ensure that all instruments are correctly connected and that no metal is exposed at any connection point. Properly seat the instrument in the receptacle. Improper connection may result in inadvertent instrument activation or other potentially hazardous conditions. Follow the instructions provided with CoolSeal™ Instruments for proper connection and use. The instrument receptacle on this system is designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing so will cause simultaneous activation of the instruments.
Caution Inspect instruments and cords for breaks, cracks, nicks and other damage before every use. If damaged, do not use. Damaged instruments or cords may result in injury or electrical shock to the patient or surgical team.
Connecting a CoolSeal™ Instrument to the CoolSeal™ Generator 1.
Connect a CoolSeal™ Instrument to the instrument receptacle on the front panel of the CoolSeal™ Generator.
2.
Verify proper placement and connection by observing the green lit instrument receptacle display.
If the CoolSeal™ Generator does not recognize the attached instrument, the instrument receptacle display will Illuminate red or not illuminate and a single alert tone will sound. Refer to the Alert Conditions or Troubleshooting sections.
Activating a CoolSeal™ Instrument 1.
Activate the CoolSeal™ Instrument per the Instrument’s instructions for use.
2.
Observe the following during instrument activation:
•
The activation display illuminates blue and varies in brightness for the duration of energy delivery.
•
An activation tone sounds continuously during energy delivery.
3.
When the seal cycle is complete, observe the following:
•
A three-toned sequence will sound when the seal is completed. The activation button should then be released.
•
The activation display on the CoolSeal™ Generator front panel will momentarily brighten blue.
•
The activation display will then extinguish.
In the case of an alert condition, refer to the Alert Conditions or Troubleshooting sections.
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Descriptions of Alert Conditions When an alert condition occurs: •
An alert tone will sound
•
One of the displays on the CoolSeal™ Generator will display blue, amber or red
•
Energy delivery will be interrupted
Energy will be available after the alert condition has been corrected. Refer to the following table to resolve alert conditions: Alert condition:
Indicated by:
Causes:
To Resolve:
Seal Complete
• A three sequential tone alert • RF energy delivery stops • Activation display brightens blue for a half (0.5) second
Successful vessel seal.
None. Normal operation.
Reactivate / Incomplete Seal
• A three-pulsed alert tone • RF energy delivery stops • Activation display brightens amber for one (1) second
Seal time exceeds five (5) seconds OR User either opened the instrument jaws or released the activation button, which causes the seal cycle to be interrupted before seal was completed OR Current stays at the maximum current limit for longer than four (4) seconds, which indicates an electrical short between the jaws has occurred OR The instrument has been activated in open air.
1. Release the activation button 2. Press the activation button to reactivate the seal cycle without repositioning the instrument 3. Open the instrument jaws and inspect for a successful seal 4. If possible, reposition the instrument and regrasp tissue in another location, then reactivate the seal cycle 5. Visually inspect seal before cutting
Possible use conditions include:
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Grasping thin tissue or activating in open air.
Open the jaws and confirm that a sufficient amount of tissue is inside the jaws. If necessary, increase the amount of tissue and repeat the procedure
Grasping too much tissue between the jaws.
Open the jaws and reduce the amount of tissue which is grasped, and reactivate the seal cycle
Grasping a metal object.
Avoid grasping objects, such as staples, clips or encapsulated sutures in the jaws of the instrument
Activating in excess pooled fluids around the instrument tip.
1. Minimize or remove excess fluids 2. Reactivate the seal cycle without repositioning the instrument
Excessive tissue eschar on electrode tips.
Use a wet gauze pad to clean surfaces and edges of instrument jaws.
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System Error
• A single-pulsed alert tone • RF energy delivery stops Power button illuminates and remains red
Generator not functioning properly, failed an internal self-check.
1. Press the power button to turn off the generator 2. Wait at least 30 seconds 3. Press the power button to turn on the generator 4. Confirm the power button illuminated green before use. If the system error reoccurs: • Do not use the generator. • Use a different CoolSeal™ Generator or alternate means to complete the procedure. Return the malfunctioning generator as instructed in the Product Service section of this guide.
Instrument Error
• A single-pulsed alert tone • Instrument receptacle display illuminates amber and flashes continuously • Generator will not allow RF energy delivery
Generator not functioning properly, failed an internal self-check.
1. Disconnect instrument from the generator. 2. Ensure instrument activation button is not being pressed. 3. Reconnect instrument to the generator. 4. Confirm the instrument receptacle display illuminates green If the Instrument Error reoccurs: • Do not use the instrument • Use a different CoolSeal™ Instrument.
Possible use conditions include:
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Inadvertent depression of the instrument activation button during instrument connection.
Remove anything depressing the instrument activation button and reconnect instrument.
The instrument switch is malfunctioning.
Replace the instrument.
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Invalid Instrument
• A single-pulsed alert tone • Instrument receptacle display illuminates and remains red • Generator will not allow RF energy delivery
An unusable instrument has been connected.
1. Disconnect instrument from the generator. 2. Ensure instrument is CoolSeal™ compatible 3. Reconnect instrument to the generator. 4. Confirm the instrument receptacle display illuminates green If the Instrument Error reoccurs: • Do not use the instrument • Use a different CoolSeal™ Instrument.
Possible use conditions include: Instrument connected is not CoolSeal™ technology compatible.
Confirm CoolSeal™ technology compatibility of the instrument from the instrument instructions for use.
Instrument connected has been used previously.
Discard instrument.
Instrument is not usable with software version.
Confirm the software version required by the instrument is not greater than the software version labelled on the bottom of the CoolSeal™ Generator. For a software upgrade refer to the Software Upgrade section.
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Chapter 4. After Surgery This chapter covers the following topics: •
Turning Off the CoolSeal™ Generator
•
Preparing the CoolSeal™ Generator for Reuse
Caution Read all warnings, cautions, and instructions provided with this generator before use. Specific instructions for CoolSeal™ instruments are not included in this manual. Refer to the CoolSeal™ instrument’s instructions for use for warnings, cautions, and instructions for its use.
Turning Off the CoolSeal™ Generator 1.
Turn off the system by pressing the power stand-by button ( •
) on the front of the unit. Observe the following:
The power stand-by button light turns off.
If necessary, the generator can be powered off by removing the power cord connection from either the power inlet or wall.
Preparing the CoolSeal™ Generator for Reuse Step 1 – Disconnecting the CoolSeal™ Instruments 1.
Disconnect instrument from the front panel.
2.
Dispose of the single-use instrument according to the procedures for your institution.
Step 2 – Clean the CoolSeal™ Generator Warning Electric Shock Hazard Always turn off and unplug the CoolSeal™ Generator before cleaning.
Notice Clean the CoolSeal™ Generator with non-flammable agents and disinfectants whenever possible. Do not use abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator, such as, chlorinated hydrocarbons or other plastic solvents. • •
Turn off the generator and disconnect the power cord from the wall outlet. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and damp cloth. If using chlorine-based bleaches dilute before cleaning.
•
Follow procedures approved by your institution or use validated infection control procedures.
•
Do not submerge, aggressively rinse or otherwise allow fluids to enter the chassis.
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Chapter 5. Troubleshooting This chapter covers the following topics: •
General Troubleshooting Guidelines
•
Correcting Malfunctions Caution Read all warnings, cautions, and instructions provided with this generator before use. Specific instructions for CoolSeal™ instruments are not included in this manual. Refer to the CoolSeal™ instrument’s instructions for use for warnings, cautions, and instructions for its use.
General Troubleshooting Guidelines If the CoolSeal™ Generator malfunctions, check for obvious conditions that may have caused the problem: •
Verify that all cords are connected and attached properly.
•
Check the system for visible signs of physical damage.
•
Turn the system off and turn it back on.
If the malfunction persists, the system may require service. Contact your institution’s biomedical engineering department, Bolder Surgical or the authorized distributor. If any incidents occur while using the CoolSeal™ system users should report these issues directly to Bolder Surgical by phone (866.683.1743) or by email ([email protected]) and to your local competent authority.
Correcting Malfunctions If a solution is not readily apparent, use the table below to help identify and correct specific malfunctions. After you correct the malfunction, verify that the system completes the self-test as described in the System Setup chapter. Abnormal Patient Response: Condition:
Causes:
To Resolve:
Abnormal neuromuscular stimulation (stop surgery immediately)
Metal-to-metal sparking
Check all connections to the CoolSeal™ Generator.
Abnormal 50 Hz-60 Hz leakage currents
Use a backup CoolSeal™ Generator. Contact your biomedical engineering department or a Bolder Surgical™ technical service representative for assistance.
CoolSeal™ Generator Malfunctions: Condition:
Causes:
To Resolve:
CoolSeal™ Generator does not respond when turned on
Disconnected power cord or faulty wall outlet
Check power cord connections (CoolSeal™ Generator and wall outlet). Connect the power cord to a functional outlet.
Faulty power cord
Replace the power cord.
Fuses are blown
Contact your biomedical engineering department or a Bolder Surgical™ technical service representative for assistance.
Internal component malfunction
Use a backup CoolSeal™ Generator. Contact your biomedical engineering department or a Bolder Surgical™ technical service representative for assistance.
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System is on, but did Unit stored in a cold location not successfully complete Recoverable Software Malfunction the self-test or stopped functioning during use – A single-pulsed tone and power button illuminates red Internal component malfunction or Non-recoverable Software Malfunction
Allow unit to warm to ambient temperature.
System is on, with a single tone, and a flashing amber instrument receptacle display.
System initiated with faulty instrument plugged into Instrument Receptacle
Disconnect Instrument.
Incorrect or expired instrument
Turn on the CoolSeal™ Generator.
Use a backup CoolSeal™ Generator. Contact your biomedical engineering department or a Bolder Surgical™ technical service representative for assistance. Internal component malfunction.
Turn off the CoolSeal™ Generator. Plug in the instrument.
Instrument Failure
Replace the instrument if it continues to Malfunction.
CoolSeal™ Instrument is not usable with software version
Ask your biomedical engineering department to check with the manufacturer of the device. For a software upgrade refer to the Software Upgrade section.
System is on, power button illuminated green when plugging in the instrument a single tone is heard and a red instrument receptacle display is seen.
Instrument recognition failed due to in intermittent connection
Remove instrument plug
Recoverable Software Malfunction
Turn off the system, then turn the system back on.
Internal component malfunction or Non-recoverable Software Malfunction
Use a backup CoolSeal™ Generator.
CoolSeal™ Generator is on and instrument is activated, but system does not deliver output – no tones or activation display
An alert condition exists
Refer to the Alert Conditions section.
System does not detect vessel sealing instrument
Firmly insert the connector into the receptacle on the CoolSeal™ Generator front panel. Ensure the receptacle display is illuminated green to indicate a CoolSeal™ instrument has been properly seated and recognized.
Internal component malfunction or Non-recoverable Software Malfunction
Contact your biomedical engineering department or a Bolder Surgical™ technical service representative for assistance.
Seal cycle was in excess of 5 seconds
Additional time and energy are needed to complete the sealing cycle. Reactivate the seal cycle without removing or repositioning the instrument.
Incomplete Seal / Reactivate – Three-pulsed tone sounds, amber activation display on generator front panel and RF output is disabled
Instrument is connected but vessel sealing will not activate
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OR Handswitch was released before the end tone sounded
Firmly re-insert the instrument.
Contact your biomedical engineering department or a Bolder Surgical™ technical service representative for assistance.
Visually inspect seal before cutting.
Metal or other foreign object is grasped within jaws
Avoid grasping objects, such as staples, clips, or encapsulated sutures in the jaws of the instrument.
Tissue grasped within jaws is too thin
Open the jaws and confirm that a sufficient amount of tissue is inside the jaws. If necessary, increase the amount of tissue and repeat the procedure.
Pooled fluids around instrument tip
Minimize or remove excess fluids. Clean electrode tips and jaws with a wet gauze pad.
Instrument has been activated in open air
Release activation button. Grasp tissue and activate the seal cycle.
Instrument is not fully seated in instrument receptacle
Disconnect instrument, reconnect and wait a moment.
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