Syris v900L Handbuch
v900LTM Visualization System
Directions for Use
v900L-DFU Doc #9001_1
TM
Scientific
2
Directions For Use
Syris Scientific
Syris Scientific, LLC.
22 Shaker Rd.,
P.O. Box 127, Gray, Maine, USA 04039
Phone: 207.657.7050
Fax: 207.657.7051
Email: techsupport@syrisscientific.com
Web: www.syrisscientific.com
Service Center Hours: Monday – Friday
8:00AM – 5:00PM US Eastern Time
CEPartner4U BV
Esdoornlaan 13,
3951DB Maarn
The Netherlands
www.cepartner4u.eu
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. Copyright violations will be prosecuted
to the full extent permissible by U.S. and International laws by Syris Scientific LLC.
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Directions For Use v900L
Table of Contents
TABLE OF CONTENTS 3
INTRODUCTION 4
SAFETY & CLINICAL 4
4
Directions For Use
Syris Scientific
Introduction
The v900L Vision Enhancement System combines proprietary LED illumination,
polarization, and magnification technology to enhance the vision of medical
professionals during dermatological procedures. The system removes surface
glare from the patient’s dermal layer promoting improved viewing of sub-surface
features.
Powered by a lithium ion battery, the system provides mobility for the user. The
polarizer rotates to allow for surface and sub-surface viewing. The adjustable
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.
Conventions Used / Symbols
This manual and device packaging uses internationally accepted conventions in
describing information requiring further attention by the user.
WARNINGS: Indicate a hazardous situation which, if not avoided or
adequate precautions taken, could result in loss of life or serious injury to
the user or patient and potential device damage.
CAUTIONS: Indicate a hazardous situation which, if not avoided or
adequate precautions taken, could result in minor or moderate injury to
the user or patient, or device damage.
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Directions For Use v900L
Caution, consult
accompanying documents
Manufacturer
Consult instructions for use
Fragile, handle with care
Temperature limitation
Power on/off
IEC 61140 Class II
Electrical Appliance
Patient and User Safety
WARNINGS:
The v900L is for use by qualified medical personnel only.
Qty
Keep dry
Quantity
Dispose of accordingly
Allowable humidity range
Allowable temperature
range
MRI Unsafe
DO NOT plug AC power
supply into control module
6
Directions For Use
Syris Scientific
General Equipment Safety
WARNINGS:
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. 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.
DO NOT operate the system in a flammable or explosive atmosphere.
Unplug the VTS1000-PS Power Supply from the AC main wall outlet to remove
main power.
DO NOT position VTS1000-Power Supply and VTS1000-Charger Base where it
is difficult to disconnect the Power Supply from the AC main wall outlet.
DO NOT modify the v900L equipment without authorization of the Syris
Scientific.
DO NOT plug power supply L-shaped connector into Control Module.
CAUTIONS:
Store the device where it will not be accessible by children or untrained people.
DO NOT drop any component of the system. Physical shock may cause permanent
damage.
DO NOT use the system as a light to navigate your environment.
General Cautions
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.
Remove battery from v900L Control Module when not used for an extended
period of time.
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.
Clean the v900L between users.
Use only non-abrasive, lint free materials to clean the device.
DO NOT use ammonia based cleaners.
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.
Dispose of batteries and accessories per your facility policy or local regulations.
The v900L and its accessories are not field-serviceable. Do not attempt to repair
or use a malfunctioning unit. Doing so could result in injury and will void the
product warranty.
Servicing is to be performed only by Syris Scientific or their authorized service
centers. Unauthorized servicing voids the warranty.
DO NOT examine eyes, vasculature in the eye, or other structures of the eye.
DO NOT look or have patients look directly into the Illuminator Module.
DO NOT wear the v900L if you experience any strain in the neck, eyes or other
areas.
8
Directions For Use
Syris Scientific
Electrical Cautions
Never immerse any component of the system in any liquids.
DO NOT allow any liquids to enter into any connectors or into the Illuminator
Module.
Only use an approved, grounded outlet to charge the battery.
DO NOT allow metal objects or body parts to touch electrical connections.
DO NOT insert any objects into any opening on the v900L.
Only use provided power supply, Control Module and cable with this system.
DO NOT touch the battery contact of the VTS1000 Battery and the patient at
the same time.
Fire Cautions
DO NOT block any opening of the system. Doing so may cause overheating of
the Illuminator Module.
Avoid operating the system in dusty environments.
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.
9
Directions For Use v900L
Item Part # Qty
1. v900L, Vision Enhancement System v900L-00 1
2. Control Module v900L-70 1
3. Battery VTS1000-BAT 1
4. Battery Charger System * VTS1000-CHARGER 1
5. Carrying Case 1
Control Module Belt ** 1
Carrying Case Strap ** 1
6. Directions For Use (DFU) *** v900L-DFU 1
v900L-DFU-Intl 1
* Includes charger base and power supply
** Included in carrying case
*** One DFU included
1. v900L 5. Carrying Case
** Belt & Strap
*Power
Supply
6. DFU-
V900L-DFU
2. Control Module
V900L-70 4. Battery Charger
System*-
VTS1000 Charger
3. Battery
VTS1000-BAT
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Directions For Use
v900L Component Parts:
Top Adjustment Knob Illuminator Locking Tab
Illuminator Cable
Rear Adjustment Knob
Support Arm
Visi-Shield with polarizer and
magnifying lens
Illuminator Module
Adjustable
Polarizer
Thumbscrews for removal /
attachment of Visi-Shields
Figure 1: v900L, Illuminator, and Visi-Shield
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. VTS1000 Power Supply is a part of the v900L system and should
only be used with battery Charger Base VTS1000-Charger.
Syris Scientific
Andere Handbücher für v900L
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Inhaltsverzeichnis
Andere Syris Scheinwerfer Handbücher
