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v300H

TM

 Visualization System

Directions for Use

TM

Scientific

Summary of Contents for v300H

Page 1: ...v300HTM Visualization System Directions for Use TM Scientific ...

Page 2: ...s 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 manufa...

Page 3: ...v300H Component Parts 10 Wearing the Device Adjusting for Use 10 Headbasket Adjustment 11 Set Up of Wiring System and Turning on The v300H on off 12 Product Operation 13 Illuminator Replacement and Condition Indicator 14 Headband Replacement 15 MAINTENANCE SUPPORT 16 Handling and Storage 16 Cleaning 17 v900L Specifications 18 v900L Standards 18 v900L Parts and Accessories Ordering Information 19 S...

Page 4: ...l WARNING Thev300Hisforvisionenhancementusebyaqualifiedmedicalprofessional 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 situ...

Page 5: ... 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 ...

Page 6: ...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 connect...

Page 7: ...ts 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 r...

Page 8: ...tlet 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 cau...

Page 9: ...093 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 Shi...

Page 10: ... 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 ...

Page 11: ...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 baske...

Page 12: ...nator 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 Swi...

Page 13: ...ly 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...

Page 14: ...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 clo...

Page 15: ... 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 ...

Page 16: ...c 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 retu...

Page 17: ...asive 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 ...

Page 18: ...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 Standard...

Page 19: ...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 207 657 7050 Facsimile 207 657 7051...

Page 20: ... 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 2 Repairs and Replacements If within the applicable Warranty Period the Customer notifies Syris Scientific that any Equipment does not comply with any of the Warrant...

Page 21: ...at of a typical commercial or Magnetic Field hospital environment EN IEC 61000 4 8 Emissions Equipment and Systems that are NOT Life supporting Immunity Test EN IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF 3 Vrms V1 Vrms EN IEC 61000 4 6 150 kHz to 80 MHz Portable and mobile communications equipment should be separated from the v300H by no less than the d...

Page 22: ...d below The customer or the user of the v300H should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The v300H uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The v3...

Page 23: ...23 Directions For Use v300H 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 Syris Doc 9003 R02 ...

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