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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

fi – Käyttöohjeet

fr – Mode d’emploi

is – Notkunarleiðbeiningar

it – Istruzioni per l’uso

nl – Gebruiksaanwijzing

no – Bruksanvisning

pt – Instruções de utilização

ro – Ghidul utilizatorului

sv – Bruksanvisning

tr – Kullanıcı Kılavuzu

Bolder Surgical

Made in USA. Printed in USA.
© 2021 Bolder Surgical
All rights reserved.

www.BolderSurgical.com
Tel: 866.683.1743

Patent Information

www.BolderSurgical.com/patents

ICE-DO-18103 Rev. F
Issue Date: 2021-09-30
www.BolderSurgical.com/IFUs

Bolder Surgical

331 S. 104th Street, Suite 200
Louisville, CO 80027
USA

2797

GENERATOR

Generator User's Guide

Содержание CoolSeal CSL-200-50

Страница 1: ...l uso nl Gebruiksaanwijzing no Bruksanvisning pt Instru es de utiliza o ro Ghidul utilizatorului sv Bruksanvisning tr Kullan c K lavuzu Bolder Surgical Made in USA Printed in USA 2021 Bolder Surgical...

Страница 2: ...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...

Страница 3: ...al 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 P...

Страница 4: ...tibility 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...

Страница 5: ...r Manufactured by Bolder Surgical 331 S 104th Street Suite 200 Louisville CO 80027 Made in USA Tel 866 683 1743 www BolderSurgical com For information call 866 683 1743 Conventions Used in this Guide...

Страница 6: ...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 detect...

Страница 7: ...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 Equipo...

Страница 8: ...mation 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...

Страница 9: ...ific 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 re...

Страница 10: ...mful 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 Natio...

Страница 11: ...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 War...

Страница 12: ...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 p...

Страница 13: ...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 s...

Страница 14: ...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...

Страница 15: ...s 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...

Страница 16: ...tion 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 functi...

Страница 17: ...es 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 Confi...

Страница 18: ...sconnecting 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 Gene...

Страница 19: ...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 malfunctio...

Страница 20: ...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 conditio...

Страница 21: ...ated frequencies Ask your biomedical engineering department to check with the manufacturer of the monitor Some manufacturers offer RF choke filters for use in monitor leads The filters reduce interfer...

Страница 22: ...sting and Maintenance When should Periodic Functional Testing be performed Bolder Surgical recommends that a Periodic Functional Test of the CoolSeal Generator be performed at least once every two yea...

Страница 23: ...wing information ready when you call Hospital clinic name customer number Your telephone number Department address city state and zip code Model number Serial number Description of the problem Type of...

Страница 24: ...by switch Connector ports LED illuminated connector detection Mounting Operating room boom systems Any stable flat surface such as a table or cart top Dimensions and Weight Width 30 5 cm 12 in Depth 3...

Страница 25: ...ng 1 A Mains line frequency range nominal 50 Hz to 60 Hz Mains line voltage range nominal 100 240 V Fuses 2 Type T5AH 250V or equivalent 5 mm x 20 mm 5A 250V slow acting high breaking capacity Power i...

Страница 26: ...of the CoolSeal Generator to allow connection of a potential equalization conductor if required Duty Cycle Under maximum power settings and rated load conditions the CoolSeal Generator is capable of...

Страница 27: ...ements of FCC part 15 Volume adjustment for activation tones clockwise increases volume Equipment must not be disposed in trash Symbols Consult instructions for use Warning Electricity To reduce the r...

Страница 28: ...ents Energy Platform Mains Transfer IEC60601 1 and IEC 60601 2 2 The CoolSeal Generator continues to operate normally with no errors or system failures when transfer is made between line AC and an eme...

Страница 29: ...lSeal Generator is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purp...

Страница 30: ...t power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined...

Страница 31: ...d additional measures may be necessary such as re orienting or relocating the CoolSeal Generator b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Guidance and Man...

Страница 32: ...l Generator as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance from transmitter d 2 P 0 01 0 20 0...

Страница 33: ...shock Notice Only qualified individuals should conduct the CoolSeal Functional Test Important An optional form is supplied below to record the results of the Periodic Functional Test Warning Do not at...

Страница 34: ...g AMBER RECORD RESULTS 5 Power the UUT off then on again to reset from the previous step Set the switch on the Functional Test Cable to the Open position and depress and hold the activate button The a...

Страница 35: ...into the corresponding ESuA VAR LOAD sockets 5 Insert the Functional Test Cable into the UUT 6 Confirm that the Power Button is GREEN and the instrument receptacle display is WHITE before continuing I...

Страница 36: ...ton 23 At 50 Ohms observe the maximum power reading at 50 Watts RECORD RESULTS 24 Stop the test on the ESuA 25 Set the load of the ESuA to 225 Ohms 26 Start the test on the ESuA 27 Press and hold the...

Страница 37: ...P F 2 Normal Instrument Insertion White Receptacle Display P F 3 Stuck Button During Power On 1 GREEN Power Button and 3 Tones 2 1 Tone then flashing AMBER Receptacle P F 4 Stuck Button After Power O...

Страница 38: ...Normal Closed no Cable _____ A P F 13 Normal Open no Cable _____ A P F 14 Reverse Open no Cable _____ A P F 15 Reverse Closed no Cable _____ A P F Impedance 10 Impedance 25 Power 25 W 20 W 30 W ______...

Страница 39: ...NONINFRINGEMENT NOTWITHSTANDING ANY OTHER PROVISION HEREIN OR IN ANY OTHER DOCUMENT OR COMMUNICATION TO THE CONTRARY IN NO EVENT WILL BOLDER SURGICAL BE LIABLE FOR LOSS OF PROFIT OR REVENUES LOSS OF...

Страница 40: ...l uso nl Gebruiksaanwijzing no Bruksanvisning pt Instru es de utiliza o ro Ghidul utilizatorului sv Bruksanvisning tr Kullan c K lavuzu Bolder Surgical Made in USA Printed in USA 2021 Bolder Surgical...

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