STR-5000 Stroboscopy Unit Users Manual Rev C Dec 2015

©2008, 2009, 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 the recommended procedures for preparing and using the Cogentix Medical STR-5000 Stroboscopy Unit. It is intended for physicians and other medical personnel who will come in contact with the unit before, during, and after any patient procedures performed with it. The manual also contains pertinent information on the proper care and handling of the unit. Please read and become familiar with this entire manual before using the unit. This manual contains the following information: 

The equipment’s intended use

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Description of the unit, its components and features

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Complete instructions on preparation, inspection, operation, cleaning, and storage of the unit

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Warning and Caution statements that must be observed by users to ensure patient and user safety

If you are a first-time user of the STR-5000 Stroboscopy Unit, Cogentix Medical strongly recommends that you read this manual from beginning to end and become intimately familiar with the unit’s features and use. If you are an experienced user of the STR-5000 Stroboscopy Unit, select specific chapters and/or sections that pertain to features and procedures that you are using.

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 – This chapter defines the symbols on the unit and peripheral equipment. There is also a brief list of the terms that are commonly used in the manual.

Chapter 2, Important Information – The information in this chapter is a

summary of critical Warning and Caution statements in the manual. This information is essential to the safe operation of the unit. Cogentix Medical strongly recommends that this chapter be read thoroughly and completely understood by all users before working with the unit.

Chapter 3, Equipment and Accessories – Introduces the STR-5000 Stroboscopy Unit and compatible equipment. This chapter includes instrument diagrams, identifies components, and defines their functions.

Chapter 4, Preparation and Inspection – This chapter describes how to

prepare the unit for use, and the assembly of the system in which the unit operates. The chapter also leads you through a detailed inspection procedure to confirm that the unit is undamaged and working properly before it is used in a procedure.

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How to Use This Manual Chapter 5, Menus and Settings – This chapter details the menus available to the user on the STR-5000 Stroboscopy Unit. Each menu contains settings related to the unit’s functionality.

Chapter 6, Operating the STR-5000 – This chapter defines how to perform the main functions of the STR-5000 Stroboscopy Unit.

Chapter 7, Care and Storage – This chapter contains important instructions on the proper cleaning and storage of the unit.

Chapter 8, Troubleshooting – This chapter discusses potential problems users

may encounter while operating the unit and possible causes of the problems. For each problem, one or more corrective actions is suggested.

Chapter 9, Warranty and Service – This chapter contains the terms of the Cogentix Medical warranty on the unit, any restrictions that apply and user actions that may void the warranty if taken. This chapter also includes shipping instructions in case the unit must be returned to Cogentix Medical or authorized facility for repair.

Appendix A contains the technical specifications for the STR-5000 Stroboscopy Unit.

Appendix B contains electromagnetic compatibility and immunity information.

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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Table of Contents How to Use This Manual ... i Organization of this Manual... i Additional Information ... ii Table of Contents... iii 1

Symbols and Terms ... 1 Symbols ... 1 Terms ... 2

2

Important Information ... 3 Intended Use ... 3 User Qualifications ... 3 Cleaning and Disinfection ... 3 Maintenance and Service ... 3 Electromagnetic Compatibility ... 4 Signal Words ... 4 Safety Precautions ... 4 Before Use ... 4 During Use ... 5

3

Equipment and Accessories ... 7 Inspect the Standard Set ... 7 Equipment Diagrams ... 8 STR-5000 Stroboscopy Unit Front Panel ... 8 STR-5000 Stroboscopy Unit Rear Panel ... 9 Accessories ... 10 Microphone ... 10 Foot Pedal ... 10

4

Preparation and Inspection ... 11 Installation and Connection ... 11

5

Menus and Settings ... 13 Display ... 13 Adjusting the Display ... 13 Using the Setting Menu ... 14

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Table of Contents Sub-Menus ... 15 SPL Unit ... 15 Slow Motion ... 15 Self-Test ... 16 Version ... 16 Audio Out Gain ... 17 Calibration ... 17 Exit ... 17 6

Operating the STR-5000 Stroboscopy Unit ... 19 Using the Foot Pedal ... 19 Image Brightness Control ... 20

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Care and Storage ... 21 After Use ... 21 Routine Periodic Inspection ... 21 Cleaning and Surface Disinfection ... 22 Cleaning and Disinfection Materials... 22 For Cleaning ... 22 For Surface Disinfection ... 22 Cleaning the STR-5000 Stroboscopy Unit ... 23 Surface Disinfection of the STR-5000 Stroboscopy Unit ... 23 Sterilizing the STR-5000 Stroboscopy Unit ... 23 Maintenance and Repair ... 23 Replacing the Fuses... 24 Storage ... 25 Disposal ... 25

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Troubleshooting ... 27

9

Warranty and Service ... 29 Warranty Information ... 29 Cogentix Medical Service Information... 30 Shipping to Cogentix Medical or Distributor... 30

Appendix A – Specifications... 33 STR-5000 Stroboscopy Unit Specifications ... 33 Appendix B ... 35 Electromagnetic Compatibility Information ... 35 Emissions ... 35

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Table of Contents Immunity ... 36 Separation from RF Equipment ... 38

Index of Figures Figure 3-1: STR-5000 Stroboscopy Unit – Front Panel ...8 Figure 3-2: STR-5000 Stroboscopy Unit – Rear Panel ...9 Figure 4-1: Connect the Foot Pedal ... 11 Figure 4-2: Connect the Video Processor/Strobe Cable ... 12 Figure 4-3: Connect the Microphone ... 12 Figure 4-4: Connect the Power Cord ... 12 Figure 5-1: Frequency/Volume Display During Use ... 13 Figure 5-2: Mean Frequency/Volume Display After Procedure... 13 Figure 5-3: Contrast Adjustment Buttons on the Front Panel ... 14 Figure 5-4: Access the Setting-Menu ... 14 Figure 5-5: SPL Unit Selections ... 15 Figure 5-6: Slow Motion Menu ... 15 Figure 5-7: Confirm Selftest ... 16 Figure 5-8: Display After Successful Selftest ... 16 Figure 5-9: Date/Time of Latest Software Version Update ... 16 Figure 5-10: Audio Out Gain... 17 Figure 5-11: Foot Pedal Calibration Steps ... 17 Figure 6-1: Foot Pedal Positions and Operating Modes ... 19 Figure 7-1: Fuse Replacement Steps ... 24

Index of Tables Table 3-1: STR-5000 Stroboscopy Unit – Standard Set ...7 Table 8-1: Troubleshooting ... 27 Table B-1: Electromagnetic Emissions Compatibility ... 35 Table B-2: Electromagnetic Immunity Compatibility... 36 Table B-3: Separation Between STR-5000 Unit and RF Equipment ... 38

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1 Symbols and Terms Symbols The symbols listed below can be found on the STR-5000 Stroboscopy Unit and on other components of the system.

Type BF applied part (Safety degree specified by IEC 60601-1)

Serial number of the stroboscopy unit

Power off

Power on Alerts the user to the presence of important operating, maintenance, and service instructions. Refer to and become familiar with the user’s manuals for all equipment used in the procedure Equipotentiality grounding terminal The equipment has been designed, tested, and certified as essentially compliant with all applicable European Union (EU) regulations and recommendations Fuse type and rating

Foot Pedal connection

Microphone connection

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Symbols and Terms

LED

LED Output connection to Video Processor Unit Do not dispose of as household waste. This product is designated for separate collection at an appropriate collection facility.

The presence of this symbol on the product or packaging indicates that the device is RoHS compliant.

Consult Instructions for Use

Date of Manufacture

Terms The following terms are used throughout this User’s Manual: “STR-5000”, “Stroboscopy Unit”, and “Unit” are all used to refer to the STR5000 Stroboscopy Unit. Phonation is the process of producing sound by vibration of the vocal folds in the larynx.

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2 Important Information The information in this chapter is essential for the correct and safe operation of the STR-5000 Stroboscopy Unit. Please read and understand this information before preparing or using the Stroboscopy Unit or any peripheral equipment with which it will be used.

Intended Use The Cogentix Medical STR-5000 Stroboscopy Unit is intended to be used when performing stroboscopic examination and diagnostic procedures in the larynx, in conjunction with endoscopes, and additional video equipment. Do not use the Unit for any purpose other than these intended uses. This unit may be used with a Cogentix Medical DPU-5000 or DPU-7000 Series Video Processor. Carefully read and follow the instructions given in this User’s Manual as well as those of all other accessory equipment to be used in conjunction with the STR-5000 Stroboscopy Unit. Failure to thoroughly understand the interoperability of all system components can compromise patient or user safety and/or cause equipment damage.

User Qualifications The Unit should only be used in a medical facility by or under the supervision of a physician trained in laryngoscopy. Only use the Unit and accessory equipment according to the instructions and under the operating conditions given in this User’s Manual. Failure to do so could result in compromised safety, equipment malfunction and/or damage.

Cleaning and Disinfection Only use recommended cleaners and disinfecting solutions when cleaning or disinfecting the STR-5000 Stroboscopy Unit. Always prepare and use the solutions as recommended by the manufacturer.

Maintenance and Service The STR-5000 Stroboscopy Unit contains no user-serviceable parts (except for fuse replacement); never attempt to modify or repair it. Doing so may cause further equipment damage and/or compromise patient safety if the Stroboscopy Unit is subsequently used in a procedure. The Unit may only be serviced/repaired at an authorized Cogentix Medical facility.

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Important Information In addition to thoroughly inspecting the Unit before each procedure, it should be periodically inspected to determine if there is wear or damage that requires attention. Refer to Chapter 7, Care and Storage for procedures on maintaining the STR5000 Stroboscopy Unit. Refer to Chapter 9, Warranty and Service for information on returning the STR5000 Stroboscopy Unit to Cogentix Medical or distributor for service.

Electromagnetic Compatibility The STR-5000 Stroboscopy Unit meets the immunity to interference requirements of IEC 60601-1-2 / EN 60601-1-2, “Electromagnetic Compatibility – Medical Electrical Devices.

Signal Words Information included in this manual to alert users of the possibility of patient injury and/or equipment damage is signified by the Warning and Caution symbols below. Notes are also included in the manual to supply additional helpful information to users. Alerts the user to situations which, if not avoided, could result in death or serious injury. Alerts the user to situations which, if not avoided, could result in moderate or minor injury to the user or patient. It is also used to alert the user to conditions and actions that could cause equipment damage.



NOTE: Indicates additional helpful information.

Safety Precautions The following precautions should always be exercised when using the STR-5000 Stroboscopy Unit and all other electromechanical equipment used during the procedure to ensure safety for all involved parties – user(s), patient(s), etc.

Before Use Do not allow any liquids on the surface or inside of the unit, other than those approved for cleaning the exterior of the Unit (see cleaning instructions in Chapter 7). This could cause a fire or electric shock hazard. If liquids penetrate the inside of the unit, immediately contact Cogentix Medical and arrange for it to be evaluated by service personnel.

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Important Information Do not use any accessories that are not in compliance with the equivalent safety requirements of this equipment. Doing so may reduce the operational safety of the system and could cause patient and/or user injury. For all accessories, confirm the safety certifications have been performed in accordance with the appropriate standard (IEC 60601-1-2 / EN 60601-1-2). Never drop the Unit or subject it to severe impact, as it could compromise its functionality and/or safe operation. Should the Unit be mishandled or dropped, do not use it. Immediately return it to an authorized Cogentix Medical service facility for inspection and repair. Carefully inspect the Unit and all accessories before use in a procedure, and do not use any equipment that is damaged or excessively worn. Doing so could lead to patient injury and/or further damage to the equipment.

During Use Do not use the Unit in the presence of a flammable anesthetic mixture containing air, oxygen or nitrous oxide. There is a possibility of fire or explosion. If any of the components of the Unit malfunction during the procedure, immediately stop using it. Using a Unit that is not functioning properly risks user or patient injury and/or further equipment damage. Users must never touch the device’s interfaces and the patient simultaneously. User and/or patient injury could occur. Always wear appropriate personal protective equipment when using the unit in a procedure, such as a gown, gloves, and face and eye shields.

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3 Equipment and Accessories During the laryngoscopic procedure, the patient makes a sustained vocal sound. The Microphone picks up the sound; the STR-5000 Stroboscopy Unit measures its frequency and triggers the strobe function of the video processor to enable viewing of the vocal folds on the monitor. The display on the front panel of the Unit will indicate both the measured vocal frequency and sound pressure (volume). When the Microphone ceases to pick up sound from the patient, the strobe function is disabled and the light remains on continuously. The LEDs on the front panel of the STR-5000 Stroboscopy Unit will indicate exactly which operating mode is currently active. The Foot Pedal shipped with the STR-5000 Stroboscopy Unit gives the user the ability to perform “hands-free” operation of the Unit’s light modes.

Inspect the Standard Set Do not use any equipment that is observed to be damaged or excessively worn. Doing so could lead to patient injury and/or further damage to the equipment. When the Unit is received from Cogentix Medical, immediately confirm that all of the items listed below have been shipped, and inspect them for damage. If any item is missing or damaged, do not use the Unit. Contact Cogentix Medical to obtain a replacement part.

STR-5000 STROBOSCOPY UNIT STANDARD SET COGENTIX MEDICAL CATALOG NO. DESCRIPTION 07-5070 STR-5000 Stroboscopy Unit 07-5071 Microphone for use with laryngoscope 07-5072 Foot Pedal 07-5073 Output Cable (to DPU) ACCESSORIES

07-7027 07-5076 07-5075 07-5074 07-3070

Audio Cable for use with DPU-7000 Data Cable for use with DPU-7000 SLS-1000 External LED Handpiece Fuses (Type T2.5A/H) Power Cord (North American) STR-5000 User’s Manual (this document)

Table 3-1: STR-5000 Stroboscopy Unit – Standard Set

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Equipment and Accessories

Equipment Diagrams STR-5000 Stroboscopy Unit Front Panel 2 3 4 5

1

6

9

8

7

Figure 3-1: STR-5000 Stroboscopy Unit – Front Panel

1. Control Knob: While operating the Unit, turn this knob to adjust the intensity of the LED light, which in turn changes the brightness of the picture on a connected monitor. 2. Display: View and navigate through menus on this screen. The display also shows frequency and volume levels during the procedure, and can show the mean frequency and mean volume after phonation. 3. “Slow Motion” indicator: This light is illuminated when the Unit is operating in “Slow Motion” mode with slow motion view of vocal chords. See Chapter 5, Menus and Settings on page 13 for details on setting this parameter. 4. “Locked Phase” indicator: This light is illuminated when the Unit is operating in “Locked Phase” mode with stop motion view of vocal chords. 5. “Continuous” indicator: This light is illuminated when the Unit is operating in “Continuous” mode (i.e., when the light remains on with no strobe effect). 6. Power Switch: Press to turn the Unit on and off. 7. LED Connector: Connect the male end of the video processor/strobe cable here, and connect the other end to the strobe input connector on the rear panel of the DPU-5000/7000 Series Video Processor. 8. Microphone Connector: Connect the enclosed microphone’s connector here. For the procedure, clip the microphone to the endoscope or to the patient’s clothing in a location close to their mouth so that sounds can be detected.

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Equipment and Accessories

9. Navigation Arrows: Press these buttons to display the Unit’s submenus, navigate through the menus, and set parameters. See Chapter 5, Menus and Settings, on page 13 for details on navigating through menus and setting parameters.

STR-5000 Stroboscopy Unit Rear Panel 1

2

3

9

4

8

5

7

6

Figure 3-2: STR-5000 Stroboscopy Unit – Rear Panel

1. Holder Light Handle: Not used on Cogentix Medical Videoscopes. 2. F-Out: Not used on Cogentix Medical Videoscopes or Video Processors. 3. Audio Out Connector: Used for optional audio recording. When used with a DPU-7000 processor, use Audio Cable (07-7027) connected to “Line In” on the DPU to allow for recording of audio. 4. Foot Pedal Connector: Connect the enclosed foot pedal to this connector. This will enable “hands-free” operation of the STR-5000 Stroboscopy Unit. 5. Potential Equalization Connector: Used for an equipotential grounding connection if required for the medical facility. 6. Data: Used for optional display of parameters (FRQ and SPL) on the DPU-7000 processor only. Connect the Data Cable (07-5076) to the Data port on the rear panel of the DPU-7000 to allow display of strobe exam parameters. 7. Power Cord Connector / Fuse Access: Connect to the mains power supply. The Unit’s fuses can also be accessed through this connector (see Replacing the Fuses on page 24 for instructions on fuse replacement). 8. Interlink: Not used on Cogentix Medical Videoscopes or Video Processors. 9. Trigger: Not used on Cogentix Medical Videoscopes or Video Processors.

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Equipment and Accessories

Accessories Do not use any accessories that are not in compliance with the equivalent safety requirements of this equipment. Doing so may reduce the operational safety of the system and could cause patient and/or user injury. For all accessories, confirm the safety certifications have been performed in accordance with the appropriate standard (IEC 60601-1-1 / EN 60601-1-1). Use of accessories not specified in this manual or sold by Cogentix Medical may result in increased electromagnetic emissions or decreased immunity of the equipment or system.

Microphone

The Microphone shipped with the STR-5000 Stroboscopy Unit is positioned near the patient’s mouth. It picks up the patient’s vocal emanation and transmits it to the Unit, where its frequency (“f”) and volume (“SPL”) are determined. When these have been determined, the strobe output is activated at the determined frequency to allow visualization of the vocal folds.

Foot Pedal In addition to its automatic operation, the included Foot Pedal allows users to control the Unit’s light output ‘manually’. The position of the pedal controls the three light settings on the STR-5000 Stroboscopy Unit. For further information on operating the Foot Pedal, see Chapter 6, Operating the STR-5000 Stroboscopy Unit.

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4 Preparation and Inspection Before using the STR-5000 Stroboscopy Unit, the various cables and accessories must be connected to it. Only then may the unit be turned on and used in the procedure. Refer to the following procedure and Figures 4-1 through 4-4 below for the proper connections.

If an abnormality is detected when preparing the unit, do not use the equipment. Contact your regional distributor or Cogentix Medical Customer Service. Thoroughly inspect all accessories to be used in conjunction with the STR-5000 Stroboscopy Unit. Do not use any equipment that is observed to be damaged. Doing so could cause user or patient injury and/or cause further equipment damage.

Installation and Connection Excessive pressure placed on the cables connecting the Unit to ancillary equipment may damage the cables and could affect the light emitted from the STR-5000 Stroboscopy Unit or the operation of the ancillary devices. Only use the STR-5000 Stroboscopy Unit under the ambient conditions specified in Appendix A (page 33). Failure to do so will affect the proper operation of the unit and could cause damage to the unit and/or accessories. 1. Place the STR-5000 Stroboscopy Unit on a flat, level, stable surface. Make sure that it is placed in a well-ventilated location, in clear view and within easy reach of operators. 2. Connect the Foot Pedal cable to the Foot Pedal Connector on the unit’s rear panel (see Figure 4-1).

Figure 4-1: Connect the Foot Pedal

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Preparation and Inspection 3. Insert the video processor/strobe cable into the LED connector on the front panel of the STR-5000 Stroboscopy Unit, as shown in Figure 4-2. Connect the other end of the cable to the Strobe connector on the rear panel of the DPU5000 Series Video Processor. When the STR-5000 is used with a rigid laryngoscope and add-on camera connected to the DPU, the optional LED Handpiece (Cat. # 07-5075) is plugged into the LED connector on the STR-5000 and the LED Handpiece is attached to the light post of the rigid scope.

Figure 4-2: Connect the Video Processor/Strobe Cable

4. Connect the Microphone to the unit as shown in Figure 4-3. The microphone connector is on the front panel of the STR-5000 Stroboscopy Unit.

Figure 4-3: Connect the Microphone

5. Clip the Microphone on the upper portion of the endoscope’s cable close to the control section (handle), or to the patient’s clothing in a location close to their mouth. 6. Audio Out and Data connections only for the DPU-7000 Series Video Processors may be made using the Audio Cable (07-7027) and Data Cable (07-5076) to allow for recording of audio and display of strobe information. 7. Finally, connect the Power Cord to both the connector on the rear panel of the Unit and to a wall mains outlet, as shown in Figure 4-4.

Figure 4-4: Connect the Power Cord

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5 Menus and Settings The front-panel display on the STR-5000 Stroboscopy Unit shows both measured values and menus from which the various settings are made. This chapter will cover the display and all of the menus, which are navigated through and selected using the buttons on the front panel.

Display Figure 5-1 shows the display of the STR-5000 Stroboscopy Unit during normal operation. When the microphone has been positioned near the patient’s mouth and the patient’s vocal emanation is measured, the display output shows both the frequency (f, in hertz) and sound pressure level (SPL) or volume (in decibels).

Figure 5-1: Frequency/Volume Display During Use

After the procedure is complete, the display shows both the mean frequency and the mean volume measured during the procedure (see Figure 5-2).

Figure 5-2: Mean Frequency/Volume Display After Procedure

Adjusting the Display The only adjustment that can be made on the display screen is the contrast, which can either be increased or decreased using the corresponding arrow buttons on the front panel (see Figure 5-3 on page 14). Users can either press the button repeatedly to change the contrast, or simply press and hold the button for continuous adjustment.

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Menus and Settings

Figure 5-3: Contrast Adjustment Buttons on the Front Panel

Using the Setting Menu Settings and options for the STR-5000 Stroboscopy Unit’s LED Light Source can be accessed via the Setting Menu. From here, the user has access to the six (6) sub-menus that provide information, testing, and operational settings. The full procedure to access the Setting Menu is shown in Figure 5-4 below.

Figure 5-4: Access the Setting-Menu

1. If the STR-5000 Stroboscopy Unit is on, it must be turned off before beginning. 2. Turn on the Unit’s Power Switch while pressing and holding the “Down” arrow simultaneously. The display momentarily reads “Startup”, then goes blank. 3. Release the “Down” arrow. The display reads “Setting Menue” [SPL Unit]. This is the first sub-menu. 4. To open or close any sub-menu, press the “Up” arrow. 5. To change a selection within a submenu, press the “Down” arrow. 6. To scroll through all available menus while not in a sub-menu, press the “Down” arrow. 7. After scrolling through all menus and making all necessary setting changes, you will see the last submenu [Exit]. To exit, press the “Up” arrow. Then you will see the message “Please switch off and on again.” The STR-5000 Stroboscopy Unit must be restarted for the setting changes to be stored.

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