Seiler COLPOSCOPE 955 User Manual
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Seiler COLPOSCOPE 955 User Manual

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COLPOSCOPE 955
USER'S MANUAL
Including installation instructions for all mounting
options
This document is property of Seiler Instrument & Mfg. Co., Inc.
No part of this manual should be reproduced or transmitted without the expressed written consent being
obtained. All the figures and images appearing in this manual are for illustration purposes only and
may vary according to the version of the device purchased. The information contained in this manual is
subject to change without notice. Please contact Seiler whenever additional information is needed.
This device is restricted to the sale and the use by authorized and trained personnel.
MEDICAL DIVISION

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Summary of Contents for Seiler COLPOSCOPE 955

  • Page 1 All the figures and images appearing in this manual are for illustration purposes only and may vary according to the version of the device purchased. The information contained in this manual is subject to change without notice. Please contact Seiler whenever additional information is needed. MEDICAL DIVISION...

  • Page 2: Table Of Contents

    Table of Contents INTRODUCTION ..........................3 INTENDED USE ........................... 5 TECHNICAL DATA ..........................5 BINOCULARS ............................6 OBJECTIVE ............................6 COLPOSCOPE ASSEMBLY ....................... 6 PREPARATIONS FOR USE ........................ 8 COLPOSCOPE USE ........................9-10 OPTICAL AND FIELD MAGNIFICATION TABLE ................11 CLEANING ............................11 TROUBLESHOOTING ........................
  • Page 3 SYMBOLS USED IN THIS MANUAL OR DEVICE ...............26-27 WARNINGS ............................28 WARRANTIES ..........................29-30 CERTIFICATE OF CONFORMITY ..................... 31 DECLARATION OF CONFORMITY ....................32 - 3 -...

  • Page 4: Introduction

    To Our Valued Professionals, On behalf of the Seiler Medical Division, I would like to thank you for your recent purchase. We stand by our products and are thrilled that when choosing one of the most important aspects of your practice, you chose us.

  • Page 5: Intended Use

    The Seiler Colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP, conization, etc.

  • Page 6: Binoculars

    binoculars 1. Binoculars body 2. Eyepieces with diopter adjustment 3. Eye Protectors objective The Colposcopes are factory shipped with the following objective: F = 300 mm The following optional objectives are available: F = 200 mm F = 250 mm F = 300 MM F = 400 mm colposcope assembly...
  • Page 7 Step 3 Place Pantographic arm into post. Step 4 Install Light Guide into bottom cover of arm. Step 5 Install extension arm by pulling plunger and inserting into Pantographic arm. Plunger Step 7 Install Binocular Head onto the Optic Pod and tighten thumb screw. Step 6 Install Optic Pod into the extension arm.

  • Page 8: Preparations For Use

    The Eye Protectors The Eye Protectors are threaded to the Binoculars. The Eye Protectors protect the eyes, prevent the intake of lateral lights and create a suitable darkroom to the observer. Precautions The Binoculars contain optical parts internally that cannot be cleaned without disassembly. It is therefore advisable to keep the eyepieces inserted in the eye tubes at all times in order to keep impuri- ties from getting inside the housing.

  • Page 9: Colposcope Use

    or farsightedness (hyperopia). Other eye defects, such as astigmatism, cannot be corrected using the diopter setting and require the use of corrective lenses (i.e. contacts or glasses.) The eyepiece diopters should only be adjusted during this parafocalizing procedure. During normal colposcope use, do not adjust the eyepiece diopters.
  • Page 10 PANTOGRAPHIC ARM BALANCING The pantographic arm is factory adjusted for balancing and allows relatively effortless positioning of the colposcope head to the desired viewing position. The colposcope should not drift after the releasing in the desired position. If the Pantographic Arm drifts up or down then tension adjustment is required. Turn count- er-clockwise to add tension, clockwise to release tension on pantographic arm.

  • Page 11: Optical And Field Magnification Table

    MAGNIFICATION SETTINGS The 955 and 985 colposcopes offer 5 magnification settings. To set the magnification, simply rotate the mag- nification selector to the desired position. Setting 1 offers the lowest magnification and widest field of view. As the selector number increases, magnification also increases but field of view decreases. When the col- poscope is configured with a 300mm objective lens and straight binocular the magnifications are 2.8x, 4.25x, 7x, 11.3x and 17.7x.

  • Page 12: Troubleshooting

    Seiler’s LED Heliolux is intended for use in a professional healthcare facility environment. Seiler’s LED Heliolux is only to be used with light cables having the exact mating profile necessary to ensure proper coupling of the light source to the light cable.

  • Page 13: Federal Law May Govern The Use Of This Device

    1.3 FEDERAL LAW MAY GOVERN THE USE OF THIS DEVICE Federal law restricts the use of certain medical devices. Seiler’s LED Heliolux is intended to be a sub-com- ponent of a medical device (system). Such device (system) may be regulated by Federal Law. It is the user’s responsibility to ensure that the device is being used in a manner appropriate with Federal Law.
  • Page 14 2007 Radiated Immunity Pass 2010 Radiated Immunity Pass EN 61000-4-4 2012 Pass IEC 61000-4-4 2012 2KV Open Circuit for AC Mains – 1KV for I/O Ports Pass EN 61000-4-5 2014 Surge Pass IEC 61000-4-5 2014 Surge 0.5 / 1.0 KV – Diff. and Common Mode –...

  • Page 15: Symbols Used In This Manual Or On The Device

    2.0 SYMBOLS USED IN THIS MANUAL OR ON THE DEVICE The following symbols are used in these Instructions for Use and/or on the Device itself. NOTE! This term contains important information regarding set-up and operation to facilitate ease of use and obtain effective results. WARNING! This term contains critical information by identifying conditions or practices that may result in injury or loss of life if these instructions are not followed.

  • Page 16: Installation Instructions/Preparing And Siting

    STOP and arrange for qualified maintenance personnel to inspect. If, at any point, you suspect something is wrong then terminate installation / operation of the Seiler’s • LED Heliolux by pressing the MAINS ON/OFF (blue switch with international 0/1 designation). The blue light should be off.

  • Page 17: Installation Instructions

    • should be positioned as far from the patient as is possible within the constraints • Seiler’s LED Heliolux of the larger system and the light cable. is not designed for use in STACKED Configuration. Do not stack multiple units •...

  • Page 18: Hazards Associated With Improper Use

    STOP and arrange for qualified maintenance personnel to inspect. If, at any point, you suspect something is wrong then terminate operation of the Seiler’s LED Heliolux • by pressing the MAINS ON/OFF (blue switch with international 0/1 designation). The blue light should be off.

  • Page 19: Hazards Associated With Improper Use

    Read the rear label at angle under 10 degrees from distance less than 0.25 meter with minimum • lighting of 1500 lux. • Confirm device has been properly installed. Appropriate light cable is installed at both ends (Seiler’s LED Heliolux and device requiring • illumination). Hospital grade power cable is properly installed. •...

  • Page 20: Field Maintenance Instructions

    STOP and arrange for qualified maintenance personnel to inspect. If, at any point, you suspect something is wrong then terminate operation of the Seiler’s LED Heliolux • by pressing the MAINS ON/OFF (blue switch with international 0/1 designation). The blue light should be off.

  • Page 21: Cleaning Instructions

    6.0 CLEANING INSTRUCTIONS Seiler’s LED Heliolux is not designed to resist spillage from any direction. Keep the device dry and free from spillage at all times. To clean: •...

  • Page 22: Front Panel

    8.2 FRONT PANEL CAMERA POWER Jack - For installation 12 VDC at 500 ma max of LIGHT CABLE 8.3 rear panel Exhaust Fan IFC Mains Power Inlet Factory Connector (Do Not Use) Mains ON/OFF Switch - 2 2 -...

  • Page 23: Controls

    8.4 controls CONTROL PAD LCD DISPLAY There are (3) basic controls. The top line of the display identifies the company or brand. An UP button for increasing intensity. The bottom line displays status as well as dim- A DOWN button for decreasing intensity. ming level.

  • Page 24: Other Specifications

    Should your product prove to have such defects within three years of the shipment. Seiler Instrument will repair or replace the product or component part without charge. Should your LED Light Source product(s) need servicing under this warranty, please contact, Seiler Instrument return authorization documentation.

  • Page 25: End Of Product Life

    • Customer Service: 314-218-6336 10. END OF PRODUCT LIFE We encourage our customers to recycle this product whenever possible. Disposal of this unit must be performed in accordance with the applicable local environmental regulations. In the United States a list of recyclers in your area can be found at: http:/www.eiae.org/. Please contact customer service to issue a return authorization to return product to manufacturer at the end of prod- uct life.

  • Page 26: Symbols Used In This Manual Or Device

    SYMBOLS USED IN THIS MANUAL OR DEVICE MARKING/SYMBOL MEANING Symbol for “Consult instructions for use” or “Consult operating instructions.” Symbol for “Caution, consult accompanying documents” or “Attention, see instructions for use.” Symbol for “Caution Hot Surface”. This symbol cautions that surface should not be touched as it may be hot and could be a burn hazard.
  • Page 27 Symbol for “Serial Number.” This symbol shall be followed by, or above, the manufacturer’s serial number. Symbol for “Authorized Representative in the European Community.” This symbol shall be adjacent to the name and address of the authorized representative in the European Community.

  • Page 28: Warnings

    WARNINGS This manual contains critical information regarding safe handling, use and care of this system. Harm to personnel or property damage could result if all instructions are not followed. Hazard Description Hazard Mitigation Failure to read and understand these Personnel tasked with use and Instructions for Use is hazardous and maintenance of the device should may result in injury to personnel.

  • Page 29: Warranties

    Except as set forth in this Three (3) Year International Warranty, Seiler Instrument Company (“SIC”) hereby warrants that each Seiler microscope product manufactured and/or sold by SIC shall be free from defects in materials and workmanship under normal use and service for three years. International Warranty includes mechanics, optics, and hardware (such as casters, knobs, tension band).
  • Page 30 Except as set forth in this Limited Lifetime Warranty, Seiler Instrument Company (“SIC”) hereby warrants that each Seiler microscope product manufactured and/or sold by SIC shall be free from defects in materials and workmanship under normal use and service for the life of the product. Lifetime Warranty includes mechanics, optics, hardware (such as casters, knobs, tension band).

  • Page 31: Certificate Of Conformity

    - 3 1 -...

  • Page 32: Declaration Of Conformity

    - 3 2 -...
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  • Page 34 THIS PAGE INTENTIONALLLY LEFT BLANK - 3 4 -...
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  • Page 36 MEDICAL DIVISION 3433 Tree Court Industrial Blvd. St. Louis, Missouri 63122 Toll Free: (800) 489-2282 Local: (314) 968-2282 Email: micro@seilerinst.com www.seilerinst.com Atlantico Systems Ltd. 34 Oldfield Kingston, Galway Ireland www.atlanticosystems.com Phone: +35391443609 MED8012 Rev.2 February 2019...

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