BLS-1000 Light Source User Manual Rev H Dec 2015

© 2009, 2010, 2011, 2012, 2013, 2015 Cogentix Medical, Inc. All rights reserved. Printed in the United States of America. The information contained herein is the exclusive and confidential property of Cogentix Medical, Inc. No part of this manual may be disclosed or reproduced in whole or in part without permission from Cogentix Medical, Inc.

How to Use This Manual This User’s Manual contains an overview of the BLS-1000 Battery Powered Light Source, installation instructions, operation procedures, and information about the BLS-1000 features and settings. 

If you are a first time user, read this manual in its entirety to familiarize yourself with the BLS-1000, and to learn about preparation and proper use of the unit.



If you are an experienced user, select the chapter and/or sections that pertain to BLS-1000 features and functions you wish to utilize.

Organization of this Manual Following is a list of the chapters included in this User’s Manual. Each chapter's title is listed at the top of all pages after the title page, so that you can quickly access the information you need.

Chapter 1, Symbols and Terms – Defines the symbols on the Light Source unit. Also included is a brief summary of terms commonly used in the manual. Chapter 2, Important Information – Provides a summary of critical Warning and Caution statements, outlines important safety precautions to be observed when using the instrument, and provides preparation instructions. Chapter 3, Equipment and Features – Introduces the BLS-1000 features and controls of the unit. Also provides a list of Cogentix Medical catalog numbers for equipment and accessories associated with the unit. Chapter 4, BLS-1000 Operation – Describes operating procedures of the Light Source, and recommends a thorough inspection of the unit prior to use. Chapter 5, Reprocessing – Contains important instructions on the proper cleaning and disinfection of the Light Source unit. Strict adherence to the instructions provided in this chapter will ensure the unit’s longevity and optimal performance during each procedure. Chapter 6, Care and Storage – Recommends basic and essential practices for medical staff to follow when using the Light Source; and describes how to care for and maintain the unit. If the unit will not be used for an extended period of time, this chapter provides information on safe, secure storage. Chapter 7, Troubleshooting – Describes possible problems that may be encountered and suggests corrective actions. Chapter 8, Warranty and Service – Contains the terms of the Cogentix Medical warranty on the Light Source unit, and restrictions that apply. Also provides user actions that may void the warranty if taken. This chapter includes shipping instructions in case the BLS-1000 must be returned to Cogentix Medical for repair.

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How To Use This Manual

Appendix A, Specifications – Contains the technical specifications for the BLS-1000 Battery Powered Light Source.

Additional Information The information in this User’s Manual is subject to change without notice. If you have any questions regarding any of the material contained in this manual, or wish to confirm that this is the most comprehensive information available for this product, please contact your local distributor or Cogentix Medical Customer Service Department at 866-258-2182 (toll free in U.S.) or (+1) 952-426-6189 (international).

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BLS-1000 Battery Powered Light Source User’s Manual

Table of Contents How to Use This Manual ...i Organization of this Manual ... i Additional Information ... ii

1

Symbols and Terms ... 1 Symbols ... 1 Terms ... 1

2

Important Information ... 3 Intended Use ... 3 User Qualifications ... 3 Reprocessing... 3 Maintenance and Repair ... 3 Signal Words ... 3 Important Safety Precautions ... 4 Preparation/Installation ... 4 Prior To Use ... 5 During Use ... 5 After Use... 6

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Equipment and Features ... 7 BLS-1000 Standard Set ... 7 BLS-1000 Diagram ... 8 BLS-1000 Compatibility ... 8

4

BLS-1000 Operation ... 11 Installing/Changing a Battery in the BLS-1000... 11 Connecting the BLS-1000 to a Cogentix Medical Endoscope... 11 On/Off Control on the BLS-1000 ... 11 Removing the BLS-1000 from a Cogentix Medical Endoscope... 12

5

Reprocessing ... 13 Cleaning and Disinfection of the BLS-1000 ... 13 Cleaning the Light Source ... 13 Disinfecting the Light Source... 13 Sterilizing the Light Source ... 14

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Table of Contents 6

Care and Storage... 15 Routine Care and Maintenance ... 15 Storage... 15 Disposal ... 16

7

Troubleshooting ... 17

8

Warranty and Service... 19 Warranty Information ... 19 Cogentix Medical Service Information ... 20 Shipping to Cogentix Medical or Distributor... 20

Appendix... 21 Specifications BLS-1000 ... 21

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Symbols and Terms

Symbols

Power OFF

Power ON Alerts the user to the presence of important operating, maintenance, and service instructions. Refer to the User’s Manuals for warnings and safety precautions associated with equipment used in the procedure. Serial number of the unit Equipment bearing this mark has been designed, tested, and certified as essentially compliant with all applicable European Union (EU) regulations and recommendations. Consult Instructions for Use The presence of this symbol on the product or packaging indicates that the device is RoHS compliant.

Terms The “BLS-1000,” “Unit,” “Equipment,” “Instrument” and/or “Light Source” all refer to the Cogentix Medical BLS-1000 Battery Powered Light Source.

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Important Information

Intended Use The equipment and the information in this manual are intended for physicians, medical staff and other licensed practitioners. This unit is intended to be used as an LED light source for endoscopic procedures, and is compatible only with Cogentix Medical fiberoptic endoscopes. Do not use this equipment for any other purpose.

User Qualifications This equipment should only be used in a medical facility by or under the supervision of a physician trained in endoscopy.

Reprocessing The BLS-1000 Battery Powered Light Source should be thoroughly cleaned after each use in a clinical procedure; it should also be disinfected when exposed to direct contamination. See Chapter 5, Reprocessing, for information on reprocessing equipment and procedures.

Maintenance and Repair The BLS-1000 Battery Powered Light Source contains no user-serviceable parts. Never attempt to modify or repair it. Doing so may cause equipment damage. The unit may only be serviced or repaired at an authorized Cogentix Medical facility.

Signal Words Alerts the user to situations which, if not avoided, could jeopardize personal safety. Alerts the user to situations which, if not avoided, could result in equipment damage.



NOTE: Indicates additional helpful information.

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Important Information

Important Safety Precautions The following precautions should always be exercised with the use of all electromedical equipment to ensure safety for all involved parties: user(s), patient(s), etc. FAILURE TO FOLLOW INSTRUCTIONS AND PROPER HANDLING OF LITHIUM-ION BATTERIES POSES A RISK OF FIRE OR EXPLOSION. DO NOT exceed 30 minutes of continuous usage to avoid extreme temperatures on the body of the BLS-1000. Allow a minimum 10 minute cool-down period between uses. DO NOT attempt to disassemble any part of the BLS-1000 Light Source other than to replace the battery; there are no user-serviceable parts in or on this unit. Refer to all relevant manuals for proper use of endoscopic equipment and optional battery powered light sources.

Preparation/Installation The Cogentix Medical Battery Charger (07-3048) must not be used in the immediate patient contact area of 6 feet (1.83 meters). Place the Battery Charger in a location where it cannot come in contact with the patient or physician during a medical procedure. The BLS-1000 and the Battery Charger should NEVER be installed or used in the presence of flammable or explosive gases or chemicals. DO NOT attempt to recharge lithium disposable (non-rechargeable) type batteries. Doing so may cause a risk of fire or explosion. Observe proper polarity (+ / – direction) when inserting batteries into the BLS-1000 or the Charger. The BLS-1000 Light Source or the battery charging equipment should NEVER be used in areas where the unit could be exposed to environmental conditions such as high temperature, humidity, direct sunlight, dust, salt, etc., which could adversely affect the equipment. DO NOT alter, disassemble or expose the Cogentix Medical Battery Charger to high temperatures or water. This equipment should NEVER be subjected to extreme vibration. When using an isolation transformer for any ancillary equipment, ensure the power requirements of the devices do not exceed the capacity of the isolation transformer. For further information, contact your local Cogentix Medical distributor or Customer Service.

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BLS-1000 Battery Powered Light Source User’s Manual

Important Information Never drop this equipment or subject it to severe impact as it could compromise the functionality and/or safety of the unit. Should this equipment be mishandled or dropped, do not use it. Return it to an authorized Cogentix Medical service facility for inspection and repair. Only Lithium-Ion rechargeable batteries supplied by Cogentix Medical should be used in conjunction with the Battery Charger. All devices connecting to the BLS-1000 must be Classified Medical Equipment. If additional equipment is connected to the BLS-1000 the operator must determine that all equipment complies with the appropriate end-product safety standard (such as IEC 60950-1 or IEC 60065) and Standards for Medical Electrical Equipment (UL 60601-1 or IEC 60601-1).

Prior To Use Confirm that this equipment functions properly and check the operation of the switch, lamp, etc. Confirm that other devices used in conjunction with equipment function properly and that these other devices will not adversely affect the operation or safety of this equipment. If any component of the endoscopic system is not functioning properly, the procedure should not be performed.

During Use The light emitted by the BLS-1000 Battery Powered Light Source is extremely intense and can cause permanent eye damage if viewed directly with the unprotected eye. Do not look directly at the light exiting the endoscope or into the light emitting area on the light source while the unit is turned on. Continually monitor this equipment and the patient for any signs of irregularities. If the operation of any of the components of the endoscopic system fails during the procedure, and the visualization of the procedure is lost or compromised, make sure the bending section of the endoscope is in the neutral position, and slowly withdraw the endoscope. This equipment should only be used according to the instructions and operating conditions described in this manual. Failure to do so could result in compromised safety, equipment malfunction or instrument damage. Be careful to minimize continuous usage in environments where the operating temperature approaches the highest recommended limit of 38°C.

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Important Information Always wear appropriate personal protective gear when using this unit and other endoscopic equipment, such as a gown, gloves, and face and eye shields.

After Use

Refer to the operating instructions supplied with all the components of the endoscopic system to establish the correct order in which components should be turned off. To prolong the life of the lamp and electronic components, and to avoid extreme temperatures on the body of the light source, turn the power switch to the “off” position and allow the light source to cool for at least ten minutes after each use. Do not exceed 30 minutes of continuous use.

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Equipment and Features

The Cogentix Medical BLS-1000 offers excellent performance for endoscopic viewing using a battery powered light source. Designed with portability in mind, its compact size, ease of attachment to endoscope, versatility, and quality of light emission make the BLS-1000 a superior endoscopic accessory. This Light Source can be used with Cogentix Medical flexible endoscopes.

BLS-1000 Standard Set When the BLS-1000 is shipped to you from Cogentix Medical, immediately inspect your shipment upon receipt. Confirm that all items ordered (listed below) were shipped, and check them for damage. If any item is missing or damaged, do not use the equipment. Contact Cogentix Medical Customer Service to obtain a replacement part. BLS-1000 STANDARD SET CATALOG NO. 07-3053*

DESCRIPTION BLS-1000 Battery Powered Light Source Set Includes Batteries and Battery Charger BLS-1000 User’s Manual (this document) REPLACEMENT ITEMS

07-3050

BLS-1000 Battery Powered Light Source

07-3048*

Cogentix Medical Lithium-Ion Battery Charger

07-3049

BLS-1000 Rechargeable Batteries (2)

*Contact the distributor or manufacturer for region-specific configuration

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Equipment and Features

BLS-1000 Diagram

Components: 1. 2. 3. 4. 5. 6.

Casing / Rotary Switch Battery Cooling Fins Face Seal Light Port O-Ring

BLS-1000 Compatibility ENDOSCOPES The BLS-1000 is designed to be used ONLY with the following Cogentix Medical endoscopes:  CST-4000/4000i Cystoscope/Hysteroscope  ENT-4000/4500 Nasopharyngo-Laryngoscope  BRS-4000 Bronchoscope

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BLS-1000 Battery Powered Light Source User’s Manual

Equipment and Features

BATTERIES FAILURE TO FOLLOW INSTRUCTIONS AND PROPER HANDLING OF LITHIUM-ION BATTERIES POSES A RISK OF FIRE OR EXPLOSION. The BLS-1000 is designed to be used only with the following approved batteries: 

Cogentix Medical 3.7 Volt Lithium-Ion Rechargeable Battery, Catalog # 07-3049



3.0 Volt Lithium Disposable Battery type CR123 or CR123A. When using disposable Lithium batteries, only use batteries which comply with the Underwriters Laboratory Recognized Component mark certification.



NOTE: When using a 3.0 Volt Lithium Disposable battery, the light output of the BLS-1000 may be slightly reduced. Use the Cogentix Medical 3.7 Volt Li-Ion Rechargeable batteries for optimal operating time and illumination between battery replacements/ recharging.

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4

BLS-1000 Operation

Installing/Changing a Battery in the BLS-1000 DO NOT ATTEMPT TO RECHARGE DISPOSABLE LITHIUM BATTERIES. Charging of disposable batteries may cause a risk of explosion, fire or damage to equipment. Only use Cogentix Medical Lithium-Ion Rechargeable Batteries (Catalog # 07-3049) in the Cogentix Medical Charger (Catalog # 07-3048).

The Cogentix Medical Battery Charger (07-3048) should not be installed in an immediate patient contact area of 6 feet (1.83 meters). Only use the Battery Charger in a location where patient or physician contact is not possible during an endoscopic procedure. Please refer to the Battery Charger Instructions for Use to ensure proper installation and use of the equipment. Use only approved Lithium-Ion 3.7V Rechargeable or Lithium 3.0V Disposable batteries with the BLS-1000. Ensure proper installation to avoid damage or improper function of unit. Open the BLS-1000 by gently unthreading the back Casing counterclockwise. Place the battery into the Battery Slot positive (+) end first. Holding the lamp away from eyes, thread the back Casing onto the unit clockwise until secure. If lamp illuminates after securing the Casing, rotate slightly into the ‘off’ position to avoid using battery power until necessary.

Connecting the BLS-1000 to a Cogentix Medical Endoscope Before connecting to the endoscope, confirm battery power and light emission are functioning. Place illuminating end of the BLS-1000 onto the Light Post of the endoscope. Holding the BLS-1000 by the fins, thread clockwise until unit is securely attached. Verify unit is secure before transport or use of the endoscope.

On/Off Control on the BLS-1000 : If using the BLS-1000 on a Cogentix Medical Endoscope utilizing  Nthe EndoSheath Protective Barrier, take care to avoid contamination by OTE

®

improperly handling the light source during an endoscopic procedure. Please refer to the EndoSheath® Instructions for Use for detailed information on the use of that system.

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BLS-1000 Operation

Gently rotate the back Casing into the ON position. If attached to an endoscope, turn the unit ON before inserting the endoscope’s insertion tube into the patient. View through eyepiece to ensure light output. To power off the unit, gently rotate into the OFF position until light emission stops. When powering off after a procedure, do not handle unit with contaminated gloves.

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NOTE: Before storing the BLS-1000 during non-use or for brief downtimes, make certain lamp is turned OFF to avoid draining battery power. If illumination of the lamp begins to noticeably fade, the battery power is almost exhausted. If fading occurs during an endoscopic evaluation, make certain a new/recharged battery is installed in the unit before performing another procedure.

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NOTE: The Lithium-Ion Rechargeable Batteries may be recharged many times before needing replacement (typically 300 times or more). However, with repeated use, the batteries will begin to lose the ability to hold a full charge and may have a shortened operating time. If the batteries exhibit shortened operating times, replace them with new Cogentix Medical LithiumIon Rechargeable Batteries (catalog #07-3049).

Removing the BLS-1000 from a Cogentix Medical Endoscope Verify unit is in the OFF position. Holding the BLS-1000 by the fins, turn counterclockwise until unit disengages from the endoscope.

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BLS-1000 Battery Powered Light Source User’s Manual

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Reprocessing

Cleaning and Disinfection of the BLS-1000 Always verify back Casing is secure before cleaning/disinfecting the BLS-1000 Light Source. Failure to do so may result in damage to equipment. Failure to properly clean the unit may render disinfection ineffective.

Cleaning the Light Source Do not use cleaning/disinfecting agents that are not suitable for use with plastics, for example, ammonia, acetone, or salty acids (HCl). Do not allow cleaning agents or liquids to enter the Light Source unit. The Light Source should only be cleaned with cleaning agents designed for external cleaning of electrical equipment, and should only be used according to the manufacturer’s instructions. 1. Gently pat down and wipe the equipment with a soft material (gauze 4x4) to

remove any gross debris.

2. Gently wash all external surfaces with 70% ethyl or isopropyl alcohol or an

instrument-grade cleaning solution designed for electrical equipment.

3. Rinse the unit with lukewarm water. 4. Dry all external surfaces of the Light Source.

Disinfecting the Light Source The Light Source should only be disinfected with agents designed for disinfection of endoscopic equipment, such as glutaraldehyde solutions, and should only be used according to the manufacturer’s instructions. Some methods of disinfection may be harmful to the Light Source and exposure could result in extensive damage. Please contact Cogentix Medical Customer Service to verify compatibility of a cleaning method not listed in this manual. 1. Clean the Light Source, following the cleaning protocol given in this chapter.

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Reprocessing 2. Allow the Light Source to remain immersed in the disinfectant for the period of

time recommended by the disinfectant manufacturer, but no longer than one (1) hour. 3. Rinse the unit thoroughly following disinfection. 4. Carefully wipe the Light Source with 70% ethyl or isopropyl alcohol and wipe all

outside surfaces of endoscope with soft material (gauze 4x4) until completely dry.

5. Ensure the Light Source is free of solution residue.

Sterilizing the Light Source The BLS-1000 Light Source cannot be autoclaved, EtO sterilized or steam-sterilized. The BLS-1000 Light Source cannot be sterilized using traditional methods. For more information, contact your local distributor or Cogentix Medical Customer Service.

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Care and Storage

Routine Care and Maintenance Routine care and maintenance can identify potential problems before they occur, ensuring the BLS-1000 has a reliable and long operating life. Do not use the BLS-1000 if the unit is not functioning properly. Continued use of a unit not functioning properly may impair longterm operability.

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NOTE: Ensuring that all users of the BLS-1000 are properly trained on operating procedures can help prevent mishandling and accidental damage to the unit.

Preventative maintenance involving the use of the unit is not necessary. There are no user-serviceable parts in the BLS-1000. As a general rule, following these simple practices will maintain the Light Source unit in good condition: 

Always confirm switch and light on the BLS-1000 are working properly.

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Verify working condition immediately following transportation or routine cleaning/disinfection.

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Ensure BLS-1000 is installed according to the procedures detailed in this manual and all users are following safety precautions.

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Ensure all users and medical staff are following Cleaning/Disinfection procedures outlined in this manual.

Cogentix Medical does not recommend that users allow outside facilities to perform repairs or service. Repair by any party not authorized by Cogentix Medical will void the warranty.

Storage The BLS-1000 Light Source, the Battery Charger and the Batteries should NEVER be stored in areas where they could be exposed to liquids or environmental conditions such as high temperature, humidity, direct sunlight, dust, salt, etc., which could adversely affect the equipment. This equipment should NEVER be stored in the presence of flammable or explosive gases, or chemicals. Battery Charger Pack, power cords, accessories, etc., should be cleaned and neatly stored. This equipment should be maintained in a clean condition during storage so that it is ready for subsequent use. BLS-1000 Battery Powered Light Source User’s Manual

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Care and Storage

Disposal The equipment should be returned to Cogentix Medical for disposal. Contact your local Cogentix Medical representative or service facility. DO NOT dispose of the Lithium-Ion batteries in an improper manner. Burning or crushing of batteries can potentially cause fire or explosion.

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BLS-1000 Battery Powered Light Source User’s Manual