Syris v300H Manual

v300HTM Visualization System
Directions for Use
TM
Scientific

2
Directions For Use
Syris Scientific
Syris Scientific, LLC.
22 Shaker Rd.,
P.O. Box 127, Gray, Maine, USA 04039
Phone: [phone]
Fax: [phone]
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 v300H 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 and 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 v300H
Table of Contents
TABLE OF CONTENTS 3
INTRODUCTION 4
SAFETY & CLINICAL 4
     
      
      
     
      
       
SETUP & USE OF DEVICE 9
      
   
   
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 
    
 
     
     
                   
       
      
      
   
                   
       
  

4
Directions For Use
Syris Scientific
Introduction
The v300H Vision Enhancement System combines proprietary halogen
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.
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 v300H 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 v300H.
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 v300H
Caution, consult
accompanying documents
Manufacturer
Consult instructions for use
Fragile, handle with care
Temperature limitation
Power on/off
IEC 61140 Class II
Electrical Appliance
Dangerous Voltage!
On
Off
CE Conformity
Consult Operating Instrctions
Qty
Keep dry
Quantity
Dispose of accordingly
Allowable humidity range
Allowable temperature
range
MRI Unsafe
DO NOT plug AC power
supply into Control Box
Direct Current (DC)
Alternating Current (AC)
Volts Direct Current
Amperes
Symbol for hot surface
VDC
A

6
Directions For Use
Syris Scientific
Patient and User Safety:
WARNING:
The v300H is for use by qualified medical personnel only.
General Equipment Safety:
WARNING:
To avoid the risk of electrical shock, inspect the control box, power supply and
cables for damage before use. Do not use the v300H or accessories if damaged.
Use only Syris supplied control box, cables, power supply and accessories. In the
event of visible damage, do not use and contact Syris for replacement.
DO NOT use the v300H Control Box/Switch in an oxygen-enriched environment.
DO NOT operate the system in a flammable or explosive atmosphere.
Unplug the Power Supply from the AC main wall outlet to remove main power.
DO NOT position Power Supply where it is difficult to disconnect the Power
Supply from the AC main wall outlet.
DO NOT modify the v300H equipment without authorization of Syris Scientific.
DO NOT touch illuminator during use of the v300H.
Ensure the power supply pig tail din connector aligns properly with the Lower
DC cable connector to form a proper fit.
To avoid the risk of electric shock, this equipment must only be connected to
supply mains with protected earth.
Use only Syris supplied Control Box/ Switch z4093-04, Power Supply z2077-00,
cables and accessories. In the event of visible damage, do not use and contact
Syris for replacement.

7
Directions For Use v300H
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.
DO NOT operate machinery, equipment or vehicles with the v300H positioned on the
head and do not walk or climb stairs while wearing the v300H to avoid a tripping or falling
accident.
Turn v300H off before storage.
Clean the v300H between users.
To reduce the potential of cross contamination between users, it is recommended that the
v300H be cleaned and /or the disposable headband pads be replaced; and / or sanitary
head covering, such as a bouffant be used.
DO NOT sterilize or autoclave the v300H or its accessories using heat, steam or pressure.
Never clean any component of the system with abrasive cleaners or objects.
Use only non-abrasive, lint free materials to clean the device.
DO NOT use ammonia-based cleaners.
DO NOT apply cleaner directly onto device or its components.
The v300H 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 v300H if you experience any strain in the neck, eyes or other areas.
DO NOT use the system without the fan operating and the opening free for air flow.
DO NOT clean when v300H is on.
CAUTIONS:
General Cautions:

8
Directions For Use
Syris Scientific
Electrical Cautions
DO NOT allow any liquids to enter into any connectors or into the Illuminator
Module.
DO NOT immerse any component of the v300H (including control box, cables or power
supply) in water or other liquids.
Only use an approved, grounded outlet when using the Power Supply.
DO NOT allow metal objects or body parts to touch electrical connections.
DO NOT insert any objects into any opening on the v300H.
Use only Syris supplied Control Box / Switch z4093-04, Power Supply z2077-00, cables and
accessories. In the event of visible damage, do not use and contact Syris for replacement.
Fire Cautions
DO NOT block any opening of the system; this may cause overheating of the Illuminator
Module.
Avoid operating the system in dusty environments.

9
Directions For Use v300H
Setup & Use of Device
Unpacking & Inspection
Please ensure your v300H 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.
Item Part # Qty
1. v300H Headgear Z4093-00 1
1a. v300H Illuminator Z4093-07 1
1b. Visi Shield Z2075-00 1
2. Upper DC Power Cable Z1762-00 1
3. Control Box/Switch Z4093-04 1
4. Lower DC Power Cable Z2079-00 1
5. Power Supply Z2077-00 1
6. AC Power Cord *
*1 AC Power Cord included Z2077-UK 1
7. Carrying Case Z1770-00 1
8. V300H DFU-Directions for Use v300H-DFU 1
1a. v300H
Illuminator
1. v300H
Headgear
Figure: 1 v300H and Components
8. DFU
1b. Visi-Shield
2. Upper DC
Cable
3. Control
Box/Switch 4. Lower DC
Power Cable
7. Carrying Case
6. AC
Power Cord
5. Power
Supply

10
Directions For Use
v300H Component Parts:
Wearing the Device-Adjusting for Use
WARNING:
To avoid the risk of electrical shock, inspect the control box, power supply and
cables for damage before use. Do not use the v300H or accessories if damaged.
Use only Syris supplied Control Box/Switch z4093-04, Power Supply z2077-00,
cables and accessories. In the event of visible damage, do not use and contact
Syris for replacement.
Syris Scientific
Figure: 2 v300H Component Parts
Head basket
adjustment-
Visi-Shield
adjustment
knob
Illuminator Module
Adjustable
Polarizer
Visi-Shield
CAUTION: To reduce the potential of cross contamination between
users, it is recommended that the v300H be cleaned and /or the
disposable headband pads be replaced; and / or sanitary head
covering, such as a bouffant be used.

11
Directions For Use v300H
DO NOT wear the v300H if you experience any strain in the neck,
eyes or other areas.
Place the v300H on the user’s head to check for fit. The head basket is adjusted
by adjusting the head basket strap and rear adjustment knob.
Head basket Adjustment
1. Begin by adjusting the height of the top strap of the head basket.
This strap is adjusted by separating the strap and sliding it to a new
position. The strap is secured by locking the plastic button on the
lower strap into the holes of the upper strap. 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. See Figure 3
2. Loosen the head basket by pushing in the outer ring surrounding
the rear knob at the back of the head basket and turn it counter-
clockwise.
3. Position the head basket on your head, ensuring that the front of
the headband sits comfortably above your eyebrows and the rear of
the head basket at the base of the occipital lobe. This system will be
uncomfortable and top heavy without this adjustment. If the head
basket sits too high or too low on your head, repeat step one.
4. Tighten the head basket by pushing in the outer ring surrounding
the rear knob and turn it clockwise until it fits securely.
5. Adjust the position of the Visi-Shield by turning the knobs on both
sides of the head basket, counter clockwise to loosen and clockwise
to tighten. When properly positioned, the magnifying lens should
be in your normal line of sight. See Figure 4
Figure 3: Head basket strap Figure 4: Visi-Shield Knobs
Plastic Button

12
Directions For Use
Syris Scientific
Set-Up of Wiring System and Turning the v300H On/Off
Plug the Medical AC power input cord into the Power Supply Module. Make sure it is a
tight fit by pushing twice.
Plug the prong end of the power cord into the wall outlet.
After completing the wiring setup procedure, place it on your head, adjust the position of
the illuminator for your subject and then turn the switch of the Control Box/Switch to on.
CAUTION: DO NOT look or have patients look directly into the
Illuminator Module.
Plug the “straight end” of the Upper DC Cable into the back of the Illuminator Module.
Place the cord under the “Syris” velcro strip located at the rear of the headband to keep
it in place.
Plug the phone plug angled end of the Upper DC Cable into the “output” section located
on the top of the Control Box/Switch.
Plug the angled end of the Lower DC Cable into either side of the Control Box/Switch.
Plug the female end of the DIN connector of the Lower DC Cable into the male DIN pigtail
connector of the Power Supply. Line up male pins to female connector and avoid twisting
that will cause damage.
Upper DC Cable
Control
Box/Switch
Lower DC Cable
AC Power Cord
Power Supply
Figure: 5 v300H Wiring System

13
Directions For Use v300H
Product Operation
WARNING: DO NOT touch illuminator of the V300H during operation.
The v300H Visualization System is intended to enhance the vision of medical
professionals when used in the patient environment during inspections and
procedures.
To prevent shock to the Illuminator Module, the system is designed to gradually turn on
the Illuminator over a five second period.
To turn off the v300H Vision System, disconnect the AC Power Input Cable from the wall outlet.
The plug of the specified power supply cord serves as the disconnect device.
Important: To prevent shock to the Illuminator Module, the system is designed to
gradually turn on the Illuminator over a five second period.
Important: If there is no evidence of the light when you turn the system on, immediately
turn off using the Control Box / Switch. Check the wiring setup again.
Important: To avoid creating fractures in the Lower DC cable and pigtail of the Power
Supply, do not wrap the Lower DC Cable around the Power Supply.
The v300H Visualization System is designed to enhance the surface or the sub-
surface features of a patient’s skin. This is accomplished by parallel-polarizing
or cross-polarizing the light emitted from the Illuminator Module. To change
between surface and sub-surface viewing mode, use the following simple
procedure:
1. While wearing the Headgear and before turning it on, locate the Illuminator
Module with your free hand.
2. Slide your hand down the Illuminator Module until you locate the adjustment
peg located at the front of the barrel.
3. Gently grasp the adjustment peg and rotate it as shown in Figure 6.
4. As worn on the head, the surface (parallel-polarized) mode will be seen
when the adjustment pin is at the 12 O’clock position. The sub-surface
(crossed-polarized) mode will be seen when the adjustment peg is at the 3
O’clock position.
5. When you have adjusted the illuminator to the desired position on your
subject you can then turn on the device using the Control Box/Swich.
NOTE: In order to observe the effects of the system, the user must look through
blue polarized section of the Visi-Shield.

14
Directions For Use
Syris Scientific
The v300H Series is equipped with one of the most sophisticated diagnostic
systems of any lighting or vision system in the medical world. A powerful
microprocessor constantly monitors the entire system of the lighting and
cooling to ensure maximum performance. Part of this computer’s function set is
a display of the Illuminator Module’s condition. Three colored LED’s are installed
to be visible through the air outlet vents on the rear of the illuminator.
Green: Will remain visible for the first 75% of its life expectancy.
Yellow: Will indicate 5-24% of life expectancy remains. It is suggested to order
replacement at this point.
Red: Will indicate less than 5% of life expectancy remains. The bulb will
alternate dim and bright 7 times at startup during this critical stage
showing that the illuminator module has reached its life expectancy.
The LED’s flash a readout of the elapsed hours on the Illuminator Module 30
seconds after the power is applied. The red LED flashes the number of hundreds
of hours, the yellow flashes the number of 10s of hours and the green flashes
Sub-Surface view-
12 o’clock position
Surface view -
3 o’clock position
Adjustment peg
Illuminator Replacement
As with any intense illumination source, the v300H Illuminator Module will wear out with
use. Exacting tolerances and high output cooling of the Illuminator Module extends the
expected life to 400+ hours under normal conditions.
Please use the following procedures to replace the Illuminator Module in your v300H
Visualization System. If you have any questions, please contact our customer service at
800.714.1374 (within US) or 207.657.7050.
Figure 6: v300H Sub-Surface / Surface Adjustments
Illumination Condition Indicator

15
Directions For Use v300H
the number of single hours, so 124 hours would be 1 red, 2 yellow and 4 green.
This is followed in another 15 seconds by a second series of flashes showing the
number of on/off cycles. This sequence differs from the first in that it is divided
by 10, so 120 would be 1 yellow and 2 green flashes.
A typical life span for an Illuminator Module is in excess of 400 hours. Should
your illuminator fail prior to 400 hours, a pro-rated warranty will apply.
v300H Illuminator Module Replacement
1. Turn off the v300H Visualization System and disconnect the AC Power Input
Cable from the wall outlet. Disconnect the Upper DC Power Cable from the
old Illuminator Module.
2. Allow illuminator to cool at least 5 Minutes before proceeding.
3. Loosen the plastic wing nuts on either side of the old Illuminator Module
approximately one turn, and remove it from the Headgear frame.
4. Install the new Illuminator Module on the Headgear frame and tighten the
plastic wing nuts.
5. Connect the Upper DC Power Cable to the Illuminator Module, and plug AC
Power Input Cable into a wall outlet.
6. Turn the system on and make sure the both the lamp and fan are functioning.
Headband Replacement
To reduce the potential of cross contamination between users, it is recommended
that the v300H be cleaned and /or the disposable headband pads be replaced;
and / or sanitary head covering, such as a bouffant be used.
The Headband Pads may be cleaned or replaced as desired. To maintain
the comfort level designed into the v300H and for sanitary purposes, it
is recommended that the Headband Pads be replaced monthly. Purchase
additional Headband Pads (v300H-80) through Syris Scientific.
CAUTIONS:

16
Directions For Use
Maintenance & Support
The v300H does not require any periodic maintenance other than routine
cleaning. There are no user serviceable components within the device. To obtain
additional 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.
Handling and Storage
CAUTION: Store the device where it will not be accessible by children
or untrained people.
Syris Scientific
Figure 7: Headband Pad locations
Replacement
Headband Pads
Turn v300H off before storage.
Use carrying case to move the v300H an extended distance.
• To protect the system, store in the carrying case provided with unit.
• For short term storage, the Power Supply may remain plugged in, but the
Power Control Box/Switch should be turned off.
• For long term storage, Power Supply should be unplugged.
NOTE: When returning the unit into the case, release side knobs on head
basket so unit is in flat position. Position illuminator to a horizontal position and
the polarizer pin is to one side.
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.

17
Directions For Use
Cleaning
Clean the v300H between users.
DO NOT immerse any component of the v300H (including control box, cables
or power supply) in water or other liquids.
DO NOT sterilize or autoclave the v300H or its accessories.
DO NOT apply cleaner directly onto device or its components.
DO NOT use ammonia based cleaners.
Use only non-abrasive, lint free materials to clean the device.
Never clean any component of the system with abrasive cleaners or objects.
DO NOT sterilize the v300H or its accessories using heat, steam or pressure.
DO NOT allow any liquids to enter into any connectors or into the
Illuminator Module.
DO NOT clean when v300H unit is on.
The v300H head basket can be wiped down using any common non- abrasive
chlorine or alcohol based cleaners found in a medical environment.
The v300H is an optical instrument and the optical surfaces need to be kept
clean for optimum image quality.
Clean the Visi-Shield and magnifying lenses with a lint-free lens cloth dampened
with an alcohol-base, non-abrasive cleanser typically used for cleaning glasses.
v300H
CAUTIONS:

18
Directions For Use
v300H Specifications
Headset weight <12 oz.
Approx. system ship weight 6 pounds
Working distance with #3 Lens 14 inches
with #4 Lens 10 inches
with #5 Lens 8 inches
Power Supply Input Input: 100-250 VAC, 50-60HZ
Output Output: 13.8 VDC, 3A maximum
Illuminated Viewing Area 6-8 inches
Power Source AC 110-240V
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
v300H 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
Syris Scientific

19
Directions For Use v300H
v300H, Parts and Accessories Ordering Information
z4093-00 v300H Vision Enhancement System
z4093-07 v300H Illuminator
z1762-00 Upper Cable
z2096-00 Visi-Shield #4 Lens
z2098-00 Visi-Shield #5 Lens
z4093-04 Control Box/Switch
z2077-00 Power Supply
z2383-00 Headband Pads
v300H-DFU Directions For Use
Note: Manuals are available in English, French, German, Italian, and Spanish, by
downloading from www.syrisscientific.com.
Service and Support
CAUTION: The v300H 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.
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: [phone] /Facsimile: 207.657.7051
Email: info@syrisscientific.com
WARNING:
Use only Syris supplied control box, cables, power supply and accessories. In the
event of visible damage, do not use and contact Syris for replacement.
Use only Syris supplied Control Box/ Switch z4093-04, Power Supply z2077-00,
cables and accessories. In the event of visible damage, do not use and contact
Syris for replacement.