Syris v900L Manual
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.
3
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.
5
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
10
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
11
Directions For Use
Charging the Battery Using Charger Base/Power Supply
WARNING: DO NOT use the Charger Base, or insert or remove the
Syris battery from the v900L Control Module in an oxygen enriched
environment.
WARNING: Unplug the VTS1000 Power Supply from the AC main wall
outlet to remove main power.
WARNING: 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.
Fully charge the battery before initial use of the v900L. A fully charged battery
will provide approximately 4 hours of continuous use.
Batteries are shipped in a partially charged state.
Select appropriate AC adapter and ensure that the AC adapter snaps securely
into Power Supply. Prior to initial use, plug the power supply into an approved
100-240 VAC, 50/60Hz wall outlet. Insert battery into Charger Base and the
indicator light begins to blink green indicating that charging has begun.
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.
v900L
Indicator Light
Figure 2: Charger Base and Battery
Charger indicator lights can have four possible states as follows:
Solid Red No battery detected
Blinking Red Fault condition, battery
or charger defective
Blinking Green Charging
Solid Green Fully charged
12
Directions For Use
Installing/Removing Battery from the Control Module
CAUTION: Do not use batteries if visibly damaged or the Charger
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. Press
down the blue tab on the top of the Battery and pivot the battery into the
Control Module. Release the blue tab making sure the Battery securely locks
into place. See Figure 3.
To remove the Battery, press down the blue tab and pivot the Battery out of the
Control Module.
Note: After inserting Battery into Control Module, attach Control Module onto
belt. Make sure belt is secure on the body before inserting the L-shaped plug of
the Illuminator Cable into the Control Module as shown in Figure 3.
Status Indicator
Illuminator
Cable Plug
Power / Illumination
Intensity Button (Blue)
Figure 3: Control Module and Battery
Syris Scientific
Blue Tab
13
Directions For Use
Control Module Indicator Lights and States
WARNING: DO NOT plug power supply L-shaped into
connector into Control Module.
Power on/off
Depressing the blue on/off button on the Control Module once provides full
power. Depressing it a second time reduces the light intensity. Depressing it a
third time shuts off the power. See figure 3 on page 12.
- Green – Over 30* minutes of operation time at full power remain.
- Orange – Less than 30* minutes of operation time at full power
remain.
- Red – Less than 10* minutes of operation time at full power
remain.
When the battery indicator is red the unit will emit 3 tones every 30 seconds
until the unit automatically shuts down.
*Time is typical
Reducing the light intensity to the low setting will extend the operation time by
approximately 33%.
v900L
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.
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.
Figure 4: Head basket adjustments
Raise/Lower
Upper Adjustment
Knob
Tighten/Loosen
Back Adjustment
Knob
1. It is critical that the top strap of the head basket be adjusted to
allow the rear section of the head basket to fit below the occipital lobe.
2. Position the v900L on your head, ensuring that the front of the
headband sits comfortably above your eyebrows and the rear of the
headband sits at the base of the occipital lobe. If the head basket sits
too high or too low on your head, repeat step 1.
3. Adjust the position of the Visi-Shield by gently raising and lowering
the support arm, using forefinger and thumb, up or down and the
Visi-Shield in or out. When properly positioned, the magnifying lens
should be in your normal line of sight. See Figure 5 on page 15.
15
Directions For Use v900L
Note:
Figure 5: Illuminator and Visi-Shield adjustments.
12
3
4
1. The Visi-Shield support arm raises and lowers with the finger and thumb.
2. The Visi-Shield pivots toward or away from the user.
3. The Illuminator Module lifts up and down.
4. The Adjustable Polarizer slides from left to right
CAUTION: DO NOT look or have patients look directly into
the Illuminator Module.
Turning the v900L On/Off and Adjustments
With a charged battery installed in the Control Module and the illuminator cable
connected to the 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. Press the button a third
time to turn the unit off, indicated by another audible beep and the green LED
off.
16
Directions For Use
Maintenance & Support
The v900L does not require any periodic maintenance other than routine
cleaning. There are no user serviceable components within the device. To obtain
additional batteries, comfort Headband Pad sets, replacement parts or service,
call Syris Scientific at 207-657-7050, Monday-Friday, 8:00 a.m. to 5:00 p.m. EST
or visit the website www.syrisscientific.com.
Syris Scientific
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.
Figure 6: Headband Pad locations
17
Directions For Use
Handling and Storage
CAUTION: Store the device where it will not be accessible by children
or untrained people.
When not in use, power off the v900L to preserve battery life.
Use carrying case to move the v900L an extended distance.
Remove Battery from v900L Control Module when not used for an extended
period of time.
Operate at 32°F to 90°F [0°C to 32°C] and 0-80% relative humidity.
Store Between -4 °F and 122 °F [-20°C and 50°C] and 0-95% relative humidity.
Cleaning
Clean the v900L between users.
DO NOT apply cleaner directly onto device or its components.
DO NOT use any product containing ammonia.
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.
It is recommended to clean the Visi-Shield with a lens cloth dampened with an
alcohol-based non-abrasive cleanser typically used for cleaning glasses.
The Visi-Shield and magnifying lenses should be wiped with an optical cloth or
equivalent non-abrasive, lint free cloth.
Never clean any component of the system with abrasive cleaners or objects.
v900L
18
Directions For Use
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.
v900L Specifications
Headset weight <13 oz.
Approx. system ship weight < 5 pounds
Working distance with #3 Lens 14 inches
with #4 Lens 10 inches
with #5 Lens 8 inches
Illumination wavelength 400-700 nanometers
Battery type Sealed 7.4V lithium ion
Battery run time 240 minutes (4 hours) typical
Battery charge time 300 minutes (5 hours) typical
Brass, Cellulose Triacetate,
Exposed materials Glass, Gold, Nickel, Phosphor
Bronze, Stainless Steel
Battery charger input voltage 100-240 VAC, 50/60 Hz
Min/Max operating temperature 32˚F / 90˚F (0˚C / 32˚C)
Min/Max storage temperature -4˚F / 122˚F (-20˚C / 50˚C)
Humidity Storage 0-95% RH
Humidity Operating 0-80% RH
Syris Scientific
19
Directions For Use
v900L Standards
IEC 60601-1 Medical Electrical Equipment
Performance and Safety (3rd edition)
IEC 60601-1-1: Medical Electrical Equipment Safety
IEC 60601-1-2: Medical Electrical Equipment
Electromagnetic Compatibility
ANSI/AAMI American National Standards Institute
Association for the Advancement of
Medical Instrumentation
CSA Canadian Standards Association
UN/DOT 38.3 Transport of Lithium Batteries
v900L
v900L, Parts and Accessories Ordering Information
v900L-00 v900L Vision Enhancement System
v900L-10 Illuminator
v900L-20 Upper Cable
v900L-30 Visi-Shield #3 Lens
v900L-40 Visi-Shield #4 Lens
v900L-50 Visi-Shield #5 Lens
v900L-70 Control Module
v900L-80 Replacement Comfort Headbands, (10 sets)
VTS1000-BAT Battery, Additional
VTS1000-CHARGER Battery Charger Base/Power Supply
v900L-DFU Directions For Use
v900L-DFU-Intl Directions For Use (International)
Note: Manuals are available in English, French, German, Italian, and Spanish, by
downloading from www.syrisscientific.com.
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.
20
Directions For Use
Service and Support
CAUTION: 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.
For Assistance Contact Syris Scientific:
Customer and Technical Support within the U.S. and Canada:
Monday-Friday, 8:00 a.m. to 5:00 p.m. EST
Telephone: 207.657.7050 /Facsimile: 207.657.7051 / Email: info@syrisscientific.com
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;
and (2) Ninety (90) days for any v900L battery.
2. Notice of Warranty Claim. If at any time during the applicable Warranty
Period, the Customer believes that the Equipment does not comply with any of
the Warranties, the Customer shall promptly notify Syris of a Warranty Claim. If
the Customer does not provide notice of Warranty Claim within the Warranty
Period, the Customer shall not have any right to claim that the Equipment does
not comply with the Warranties. The Customer shall inspect the Equipment
promptly after delivery to the Customer and promptly notify Syris of any alleged
breach of any Warranties or any errors relating to the delivery of the Equipment.
3. Repairs and Replacements. If within the applicable Warranty Period the
Customer notifies Syris Scientific that any Equipment does not comply with any
of the Warranties and if in fact the Equipment does not comply with any of
the Warranties (not caused by misuse or abuse), Syris Scientific shall, at Syris
Scientific’s election and expense, either repair or replace the Equipment.
The Customer shall not return any Equipment to Syris Scientific without first
obtaining a return authorization number from Syris Scientific or Syris Scientific’s
authorized distributor. If Customer fails to follow all of Syris Scientific return
instructions, including the packaging of the Equipment, the repair will not be
covered by this Warranty.
For warranty registration or return of product procedure visit our website at
www.syrisscientific.com.
Syris Scientific
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