Hologic CoolSeal Generator Guida utente

Bolder Surgical CoolSeal™ Generator

For use with software version 1.X.X

User’s Guide

CoolSeal™ Generator

REF CSL-200-50

GENERATOR

en – User’s Guide

da – Brugsanvisning

de– Gebrauchsanweisung

el – Οδηγίες χρήσης

es – Instrucciones de uso

 – Käyttöohjeet

fr – Mode d’emploi

is – Notkunarleiðbeiningar

it – Istruzioni per l’uso

nl – Gebruiksaanwijzing

no – Bruksanvisning

pt – Instruções de utilização

sv – Bruksanvisning

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

Bolder Surgical

Made in USA. Printed in USA.

2797

GENERATOR

Generator User's Guide

Bolder Surgical en - CoolSeal™ Generator

Page | 1

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

Bolder Surgical en - CoolSeal™ Generator

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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 O 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 Specications ..................................................................................... 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 Specication ............................................................................................................................................24

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Technical Specications ...........................................................................................................................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 Classications ............................................................................................................................25

Symbols ..........................................................................................................................................................26

Classications ...............................................................................................................................................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

Denitions .............................................................................................................................................................................32

Equipment Required: ......................................................................................................................................................32

Pass/Fail Criteria: ................................................................................................................................................................. 32

Procedure: .............................................................................................................................................................................33

Periodic Functional Test Summary Form ................................................................................................................36

Warranty ................................................................................................................................38

Bolder Surgical en - CoolSeal™ Generator

Page | 4

Preface

This manual and the equipment it describes are for use only by qualied 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

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.

Authorized Representative:

Emergo Europe B.V.

Prinsessegracht 20

2514 AP The Hague

The Netherlands

Bolder Surgical en - CoolSeal™ Generator

Page | 5

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. Specic 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 congures 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 specic 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 specically for the CoolSeal™ Generator.

Bolder Surgical en - CoolSeal™ Generator

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Front Panel

(1) Illuminated Power Button

(2) Activation Display

(3) CoolSeal™ Instrument Receptacle

(4) Instrument Receptacle Display

Rear Panel

(5) Volume Adjustment Control

(6) Power Cord Inlet

(7) Fuse Drawer

(8) Equipotential Connector

(9) 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 Specic

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.

Bolder Surgical en - CoolSeal™ Generator

Page | 8

Chapter 2. Patient and Operating Room Safety

The safe and eective 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 benets 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. Specic 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,

res, 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 en - CoolSeal™ Generator

Page | 9

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 eects.

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 specied 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 specied 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 cu seals properly to prevent oxygen leaks.

Pacemakers and ICDs

Warning

DO NOT USE in patients who have electronic implants such as cardiac pacemakers without rst consulting a qualied

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.

Bolder Surgical en - CoolSeal™ Generator

Page | 10

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 o 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.

Bolder Surgical en - CoolSeal™ Generator

Page | 11

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. Specic 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,

res, 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 en - CoolSeal™ Generator

Page | 12

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 eects.

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 specied 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 at, 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 dicult 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 ( ) on the front of the unit. Observe the following during the

power-up self-test:

• 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

Refer to the Alert Conditions or Troubleshooting sections for additional information

Bolder Surgical en - CoolSeal™ Generator

Page | 13

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.

Bolder Surgical en - CoolSeal™ Generator

Page | 14

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 ve (5) seconds

OR

User either opened the instrument

jaws or released the activation button,

which causes the seal cycle to be in-

terrupted 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 reac-

tivate the seal cycle

5. Visually inspect seal before

cutting

Possible use conditions include:

Grasping thin tissue or activating in

open air.

Open the jaws and conrm that

a sucient 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 uids

around the instrument tip.

1. Minimize or remove

excess uids

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.

Bolder Surgical en - CoolSeal™ Generator

Page | 15

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

o the generator

2. Wait at least 30 seconds

3. Press the power button to turn

on the generator

4. Conrm the power button

illuminated green before use.

If the system error reoccurs:

• Do not use the generator.

• Use a dierent 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 ashes

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. Conrm the instrument

receptacle display

illuminates green

If the Instrument Error reoccurs:

• Do not use the instrument

• Use a dierent CoolSeal™

Instrument.

Possible use conditions include:

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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Page | 16

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. Conrm the instrument

receptacle display

illuminates green

If the Instrument Error reoccurs:

• Do not use the instrument

• Use a dierent CoolSeal™

Instrument.

Possible use conditions include:

Instrument connected is not

CoolSeal™ technology compatible.

Conrm 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.

Conrm 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.

Bolder Surgical en - CoolSeal™ Generator

Page | 17

Chapter 4. After Surgery

This chapter covers the following topics:

• Turning O the CoolSeal™ Generator

• Preparing the CoolSeal™ Generator for Reuse

Caution

Read all warnings, cautions, and instructions provided with this generator before use. Specic 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 O the CoolSeal™ Generator

1. Turn o 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 o.

If necessary, the generator can be powered o 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 o and unplug the CoolSeal™ Generator before cleaning.

Notice

Clean the CoolSeal™ Generator with non-ammable 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 o 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 uids to enter the chassis.

Bolder Surgical en - CoolSeal™ Generator

Page | 18

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. Specic 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 o 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 specic 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.

Bolder Surgical en - CoolSeal™ Generator

Page | 19

System is on, but did

not successfully complete

the self-test or stopped

functioning during use –

A single-pulsed tone and

power button illuminates red

Unit stored in a cold location Allow unit to warm to ambient temperature.

Recoverable Software Malfunction Use a backup CoolSeal™ Generator.

Contact your biomedical engineering department or a Bolder Surgical™

technical service representative for assistance.

Internal component malfunction or

Non-recoverable Software Malfunction

Internal component malfunction.

System is on, with a single

tone, and a ashing amber

instrument receptacle

display.

System initiated with faulty instrument

plugged into Instrument Receptacle

Incorrect or expired instrument

Instrument Failure

Disconnect Instrument.

Turn o the CoolSeal™ Generator.

Turn on the CoolSeal™ Generator.

Plug in the instrument.

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

Firmly re-insert the instrument.

Recoverable Software Malfunction Turn o the system, then turn the system back on.

Internal component malfunction or

Non-recoverable Software Malfunction

Use a backup CoolSeal™ Generator.

Contact your biomedical engineering department or a Bolder Surgical™

technical service representative for assistance.

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.

Incomplete Seal / Reactivate

– Three-pulsed tone sounds,

amber activation display on

generator front panel and RF

output is disabled

Seal cycle was in excess of 5 seconds

OR

Handswitch was released before the

end tone sounded

Additional time and energy are needed to complete the sealing

cycle. Reactivate the seal cycle without removing or repositioning

the instrument.

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 conrm that a sucient amount of tissue is inside the

jaws. If necessary, increase the amount of tissue and repeat the procedure.

Pooled uids around instrument tip Minimize or remove excess uids. 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 connected

but vessel sealing will not

activate

Instrument is not fully seated in

instrument receptacle

Disconnect instrument, reconnect and wait a moment.

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