Syris v900L Directions For Use Manual

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v900L
Visualization System
TM
Directions for Use
v900L-DFU Doc #9001_1
TM
Scientific

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Summary of Contents for Syris v900L

  • Page 1 Visualization System Directions for Use v900L-DFU Doc #9001_1 Scientific...
  • Page 2 Syris Scientific and v900L are trademarks of Syris Scientific LLC. All contents of this manual are the proprietary copyright property of Syris Scientific LLC and are subject to change at the discretion without notification by the manufacturer. No parts of this manual may be copied, transmitted or disseminated to other parties without express written permission from the manufacturer.
  • Page 3: Table Of Contents

    Wearing the Device-Adjusting For Use Turning the Device On/Off and Adjustments Headband Replacement MAINTENANCE & SUPPORT Handling and Storage Cleaning v900L Specifications v900L Standards v900L, Parts and Accessories Ordering Information Service and Support Warranty Appendix A Immunity All Equipment and Systems...
  • Page 4: Introduction

    Visi-Shield provides magnification and a clear field of view. Safety & Clinical WARNING: The v900L is for vision enhancement use by a qualified medical professional during dermal procedures. Read all Warnings, Cautionary Statements and Directions in their entirety before operating the v900L.
  • Page 5: Patient And User Safety

    Fragile, handle with care Allowable temperature Temperature limitation range MRI Unsafe Power on/off DO NOT plug AC power IEC 61140 Class II supply into control module Electrical Appliance Patient and User Safety WARNINGS: The v900L is for use by qualified medical personnel only.
  • Page 6: General Equipment Safety

    VTS1000 Power Supply is a part of the v900L system and should only be used with battery Charger Base VTS1000-Charger. DO NOT use the Charger Base, or insert or remove the Syris battery from the v900L Control Module in an oxygen enriched environment.
  • Page 7 Directions For Use v900L DO NOT operate machinery, equipment or vehicles with the v900L positioned on the head and do not walk or climb stairs while wearing the v900L to avoid a tripping or falling accident. Turn v900L off before storage.
  • Page 8: Electrical Cautions

    Setup & Use of Device Unpacking & Inspection Please ensure your v900L Vision Enhancement System includes all of the items listed below. Visually inspect all items for any damage. Contact Syris prior to use if any items are missing or appear to be damaged.
  • Page 9 Directions For Use v900L Item Part # 1. v900L, Vision Enhancement System v900L-00 2. Control Module v900L-70 3. Battery VTS1000-BAT 4. Battery Charger System * VTS1000-CHARGER 5. Carrying Case Control Module Belt ** Carrying Case Strap ** 6. Directions For Use (DFU) ***...
  • Page 10: V900L Component Parts

    WARNING: To avoid the risk of electrical shock, inspect the battery charger cable and plug for damage before use. Do not use the v900L or accessories if damaged. Use only Syris supplied battery charger, control box, cable, battery, and accessories. In the event of visible damage, do not use and contact Syris for replacement.
  • Page 11: Charging The Battery

    Charging is complete when the indicator light on the charger base unit turns solid green, approximately five hours for initial full charge. To avoid downtime, it is recommended that a second battery (VTS1000-BAT) be acquired to allow the use of the v900L while the depleted battery is being charged. Indicator Light...
  • Page 12: Installing / Removing The Battery

    Base indicates a faulty battery. WARNING: Do not use the Charger Base, or insert or remove the Syris battery from the v900L Control Module in an oxygen enriched environment. Install the Battery into the Control Module by inserting the battery tabs at the bottom of the battery into the battery tab pockets of the Control Module.
  • Page 13: Control Module Indicator Lights And States

    Wearing the Device-Adjusting for Use CAUTION: To reduce the potential of cross contamination between users, it is recommended that the v900L be cleaned and/ or the disposable headband pads be replaced; and/or sanitary head covering, such as a bouffant be used.
  • Page 14 Directions For Use Syris Scientific After placing the v900L device on the user’s head, the head basket is adjusted by turning the adjustment knobs. See Figure 4. Upper adjustment knob: Turn clockwise to raise and counter-clockwise to lower. Back adjustment knob: Turn clockwise to tighten and counter–clockwise to loosen.
  • Page 15: Turning The Device On/Off And Adjustments

    Control Module, press the blue power button once to turn the v900L on with its brightest light. An audible beep and a green LED will indicate the unit is on. Push the button a second time to reduce light intensity, indicated by an audible beep and the green LED will remain on.
  • Page 16: Headband Replacement

    Headband Replacement The Headband Pads may be cleaned or replaced as desired. To maintain the comfort level designed into the v900L and for sanitary purposes, it is recommended that the comfort Headband pads be replaced monthly. Purchase additional Headband Pads (v900L-80) through Syris Scientific.
  • Page 17: Handling And Storage

    The v900L head basket can be wiped down using any common non-abrasive chlorine or alcohol based cleaners found in a medical environment. The v900L is an optical instrument and the optical surfaces need to be kept clean for optimum image quality.
  • Page 18: V900L Specifications

    Directions For Use Syris Scientific CAUTIONS: DO NOT immerse any component of the v900L (including battery charger, control box, cable or batteries) in water or other liquids. DO NOT sterilize or autoclave the v900L or its accessories. DO NOT allow any liquids to enter into any connectors or into the Illuminator Module.
  • Page 19: V900L Standards

    WARNING: Use only Syris supplied battery charger, control box, cable, battery, and accessories. In the event of visible damage, do not use and contact Syris for replacement. VTS1000 Power Supply is a part of the v900L system and should only be used with battery Charger Base VTS1000-Charger.
  • Page 20: Service And Support

    Warranty Syris Scientific (Syris) warrants that the Equipment conforms to any specifications provided in writing by Syris to Customer for that Equipment, is of sound materials and workmanship, is new and unused, unless otherwise specified. Standard Warranty 1. Standard Warranty Period. The Warranties with respect to any Equipment shall remain in effect for the following period of time after delivery of the Equipment to the Customer (the “Warranty Period”): (1) One year for the v900L;...
  • Page 21: Appendix A Immunity All Equipment And Systems

    (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter. Recommended Separation Distances between portable and mobile RF Communications Equipment and the v900L Equipment and Systems that are NOT Life-supporting. Separation (m) Separation (m) Separation (m) 80...
  • Page 22 Syris Scientific Guidance and manufacturer’s declaration – electromagnetic emissions The v900L is intended for use in the electromagnetic environment specified below. The customer or the user of the v900L should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 23 Directions For Use v900L NOTES...
  • Page 24 Thank you for purchasing Syris Products! Syris Scientific, LLC 22 Shaker Rd. P.O. Box 127 Gray, Maine 04039 207.657.7050 TEL 207.657.7051 FAX WWW.SYRISSCIENTIFIC.COM M-13251R1...

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