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Labomed PRIMA Mu User Manual

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PRIMA Mµ
MICROSCOPE
User Manual
Caution:
To ensure proper use of this instrument as well as to avoid injury while operating Instrument, understanding this
manual completely before use is highly recommended.
6210000-795
Prima M
Issue 1.8
Issue 1.8
Printed on June.,2023
Printed on June.,2023

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  • Page 1 PRIMA Mµ MICROSCOPE User Manual Caution: To ensure proper use of this instrument as well as to avoid injury while operating Instrument, understanding this manual completely before use is highly recommended. 6210000-795 Prima M Issue 1.8 Issue 1.8 Printed on June.,2023 Printed on June.,2023...
  • Page 2 All other trademarks are the property of their respective owners. change without prior notice. LABOMED reserve the right to make changes to the product described in this user manual without notice and without incorporating those changes in any products already sold.

  • Page 3: Table Of Contents

    Prima Mµ TABLE OF CONTENTS Introduction and Intended use Product Description 3 - 4 Warning & Cautions Explanation of Symbols Standard and Directives applicable Condition of instrument at the time of unpacking/supply Installation Instruction 8 - 9 Installation Electrical Connection Replacing the illumination source Fuse Replacement Data Plate Details...

  • Page 4: Introduction And Intended Use

    Catalogue No. Prima Mu - ENT 6212000 Prima Mu - DNT 6211000 Prima Mu - OPH - Cataract 6214000 Prima Mu - Table Mount Dental trainer 6215000 Prima Mu - Table Mount ENT trainer 6212100 6210000-795 Prima M Issue 1.8...

  • Page 5: Product Description

    16. Illumination Control Knob 5. Suspension arm 17. Magnichanger tiltation control knob 6. Swivel Arm Locking Knob 18. Inlet for LABOMED camera 7. Suspension arm movement locking knob 19. Fine focusing knob 8. Coupling movement locking knob 9. Suspension arm hydraulic movement lock 10.
  • Page 6 WARNING: THIS INSTRUMENT SHOULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUCTIONS OUTLINES IN THIS USER’S GUIDE. THE SAFETY OF THE OPERATOR AND THE PERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY LABOMED. WARNING: DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUT AUTHORIZATION FROM LABOMED.

  • Page 7: Warning & Cautions

    WARNING: LED RADIATION - DO NOT STARE DIRECTLY INTO THE BEAM WHEN THE MICROSCOPE IS IN THE ‘ON’ POSITION. WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, BY LABOMED AND OTHER UNAUTHORIZED REPLACEMENT PARTS FOR THE INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE EQUIPMENT.

  • Page 8: Explanation Of Symbols

    Prima Mµ 4. EXPLANATION OF SYMBOLS Caution: Observe all warning labels and notes! If any label in missing on your instrument or has become illegible, please contact us or one of our Brightness Control: adjust brightness by turning the knob appropriately. Accompanying documents must be consulted.

  • Page 9: Standard And Directives Applicable

    Prima Mµ 5. STANDARDS AND DIRECTIVES The instrument described in this user manual has been designed in compliance with the following standards: • ISO 15004-2 First edition 2007-02-15. O protection. • • ISO 14971-2019 Risk management to medical de ces. DIRECTIVE USED •...

  • Page 10: Condition Of Instrument At The Time Of Unpacking/Supply

    Prima Mµ 6. CONDITION OF INSTRUMENT AT TIME OF UNPACKING/SUPPLY The appliance is delivered in sub-assembled modular groups along with one Installation Kit and one user manual. 1. Mobile supporting base with brakes on castor wheels, or the type of mounting system. 2.

  • Page 11: Installation Instruction

    Prima Mµ 7. INSTALLATION on the metal plate (D) as shown in Fig.-1 by of the metal plate. Fig. 1 Fig. 1a Referring Fig.- 2 tighten three allen screws (H) with 4mm allen wrench. Fig. 2 7.3 Retrieve the swivel arm and suspension arm assembly from the packing box and follow Instruction as below (refer Fig.-3) Ensure loosening of swivel arm lock knob (A).

  • Page 12: Installation

    Prima Mµ INSTALLATION 7.4 Retrieve the carrier assembly from the packing and follow as below refer Fig.-4. • Install the coupling to the suspension arm by arm. • Lock the inclined coupling with the threaded plug (2). Fig. 4 • •...

  • Page 13: Electrical Connection

    Prima Mµ 8. ELECTRICAL CONNECTIONS Connect the power cable to the AC inlet socket Note: Power supply designed with universal input 100V - 240V AC, 50/60HZ. To plug in follow Instruction on electrical label provided at bottom of the arm as shown (3) here in Fig.-7. Fig.

  • Page 14: Wiring Coding Diagram

    Prima Mµ ELECTRICAL CONNECTIONS 8.4. WIRING CODING DIAGRAM Issue 1.8 6210000-795 Prima M Printed on June.,2023...

  • Page 15: Control Elements

    Prima Mµ 9. CONTROL ELEMENTS 9.1 ON/OFF SWITCH (SHOWN AS 1 IN FIG. 7 ABOVE) It is located on the back of the swivel arm. At ‘ON’ position, green LED glows and cooling fan starts running. Keep the intensity control knob at minimum level before switching on the system.

  • Page 16: Instruction For Using The Microscope

    Prima Mµ 10. INSTRUCTIONS FOR USING THE MICROSCOPE WARNING: INSTRUMENT IS UNSAFE FOR MRI ENVIRONMENT. SETTING UP OF MICROSCOPE: setting up of microscope on the attendance area for stability. Tension 2. Although tension on microscope is factory adjustment screw user can adjust up and down force by tuning the allen screw clockwise or anticlockwise with the help of a 8mm allen wrench.
  • Page 17 Prima Mµ MAIN MICROSCOPE and focal lengths of 250mm is available for The ergo binocular tube (optional: straight and 45° 12.5X) Fig. 14 6210000-795 Prima M Issue 1.8 Printed on June.,2023...

  • Page 18: Changing The Objective & Eyepieces

    Prima Mµ 11. CHANGING THE OBJECTIVES & EYEPIECES 1. The objectives can be taken out by rotating it in anti-clock wise direction. It can be threaded in by rotating in clockwise direction. 2. To install the eyepieces, insert in the eye tubes of observation head.

  • Page 19: Use Of Accessories

    Prima Mµ 12. USE OF ACCESSORIES Prima M 6210000-795 Issue 1.8 Printed on June.,2023...

  • Page 20: Tension Adjustment While Using Accessories

    Prima Mµ USE OF ACCESSORIES 1. Install double beam splitter by replacing the binocular tube (straight or ergo). 2.1 DSLR camera adapter for Nikon, Canon and Sony 2.2 CCD camera adapter for Mintron. 2.3 Adapter for Sony Handy-Cam. 4. Reinstall binocular tube (straight or ergo) on double beam splitter. Prima Mµ...

  • Page 21: Moving Position

    Prima Mµ 14. MOVING POSITION OF THE SYSTEM Position of the system for safe transportation Fold the system as shown before moving Fig. 19 RELOCATING THE STAND 2. Disconnect the power cable. control unit. 4. Release locks by pressing the upper parts of the locks downwards. 6.
  • Page 22 Prima Mµ 15. CARE AND MAINTENANCE Maintenance if handed carefully. To ensure optimum performance and safe working order of the Instrument, its safe functioning must be checked once every 12 months as per table below. We Maintenance work. If a failure occurs which you cannot correct using the trouble-shooting table, attach part or circuit diagram etc.

  • Page 23: Care And Maintenance

    • Clean optical components using a lint-free cloth. Soak the cloth using a little methanol or Glass clean -er.Do not use ethanol and spirit. • LABOMED Max Lite coating are fungal resistant. If you clean as described above, the coatings will not be damaged.

  • Page 24: Cleaning And Disinfection

    3. Alcohol is flammable,its use as a surface disinfectant should be in well-ventilated spaces only. Prima Mµ 17. AUTOCLAVING The rubber caps, sleeves and grips supplied by labomed are recommend for the following program for • Temperature: 134 C • Time: 10 minutes •...

  • Page 25: Ambient Requirement

    Prima Mµ 18. AMBIENT REQUIREMENT +10 C..+40 C For Operation Temperature 30%..90% Rel. Humidity (without condensation) Air Pressure 700hPa..1,060hPa -40 C..+70 C Temperature For Transportation and Storage Rel. Humidity 10%..100% (without condensation) Air Pressure 500hPa..1,060hPa - 1-1. Prima Mµ 19. DISPOSAL Disposal of the instrument must comply with locally applicable laws and regulations.

  • Page 26: Troubleshooting Table

    Prima Mµ 20. TROUBLESHOOTING TABLE PROBLEM POSSIBLE CAUSE REMEDY No illumination at all Power cable not plugged in Plug in power cable Power switch in OFF position Press the power switch to ON position Defective instrument fuse Change the fuse Defective power cable Change the power cable Contact in-house technician...

  • Page 27: Technical Specification

    Prima Mµ 21. TECHNICAL SPECIFICATIONS °, IPD 49-78mm Binocular Tubes Optional: 45° inclined head and 0-210° Ergo head, IPD 49-78mm WF 10x/18mm with retractable eye guards, Eyepieces diopter adjustment ± 7mm diopter adjustment ± 8mm 3 step: 0.6X, 1.0X, 1.6X Magnichanger 15°...

  • Page 28: Guidance Tables

    Prima Mµ 22. GUIDANCE TABLES Guidance and Manufacturer’s Declaration Electromagnetic Emissions All Equipment and Systems Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Prima M user of the Prima M Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Group 1 The Prima M uses RF energy only for its internal function.
  • Page 29 Prima Mµ GUIDANCE TABLES (continued) Guidance and Manufacturer’s Declaration Electromagnetic Emissions All Equipment and Systems Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Prima M user of the Prima M Electromagnetic Environment IEC 60601 Test Immunity Test Compliance Level - Guidance Level ±...
  • Page 30 Prima Mµ GUIDANCE TABLES (continued) Guidance and Manufacturer’s Declaration Electromagnetic Immunity Equipment and Systems that are NOT Life-Supporting Guidance and manufacturer’s Declaration – Electromagnetic Immunity The Prima M user of the Prima M Immunity Test IEC 60601 Test Level Compliance Electromagnetic environment Level guidance...
  • Page 31 Prima Mµ GUIDANCE TABLES (continued) and the Prima M Guidance and Manufacturer’s Declaration - Electromagnetic Immunity and the Prima M The Prima M are controlled. The customer or user of the Prima M can help prevent electromagnetic interference by (transmitters) and the Prima M as recommended below, according to the maximum output power of the Separation (m) Separation (m) 80 to Separation (m) 800...

  • Page 32: Measures & Weight

    Prima Mµ 23. MEASURES AND WEIGHT Prima Mµ- Microscope with Ceiling Mount Prima Mµ- Microscope with Wall Mount Total Weight: Approx. 75 kgs. Total Weight: Approx. 60 kgs. CEILING MOUNT WALL MOUNT Prima Mµ- Microscope with Mobile Stand Total Weight: Approx. 100 kgs. FLOOR MOUNT Issue 1.8 6210000-795...
  • Page 33 Prima Mµ Table Mount FLOOR FIXED 616mm 525mm 20.7” 24” ±135° ±180° ±150° ±147° ±90° 310mm 12.25” Issue 1.8 Prima M 6210000-795 Printed on June.,2023...

  • Page 34: Glossary

    Prima Mµ 24. GLOSSARY Compensation of short-or-far-sightedness. This can be done for each Ametropia Compensation Distance front lens to object level (250mm). Working Distance Refers to the color characteristic of a light source. Using color Color Temperature Temperature, one can set the color of a light source to warm or cold light Relative to the color of natural light.
  • Page 35 Prima Mµ GLOSSARY (continued) ° inclined DBSi position, creating greater comfort, ideal for prolonged use applications or where patient is always supine. Extender Rotoplate Issue 1.8 6210000-795 Prima M Printed on June.,2023...

  • Page 36: Warranty

    LABOMED instruction manual, nor to a product which LABOMED Dealer. All claims under this warranty must be in writing and directed to the LABOMED factory or its the purchaser’s invoice. This warranty is in lieu of all other warranties implied or expressed. All implied warranties of or any other damages resulting from or relating to design, manufacture, sale, use, or handling of the product.
  • Page 37 Prima Mµ Liability release for wall and/or ceiling installations: plates and hardware for the LABOMED Prima microscope(s) purchased is the sole responsibility of the purchaser and appointed contractor, and will comply with applicable building codes and good liability for damage and/or injury caused by improperly installed and secured mounting plates and hardware.
  • Page 38 Revision History DCR # Rev. No. Date of Release Change App. By S.Bal March 22, 2016 Wiring Coding DCR/13/16 Diagram added S.Bal July 05, 2017 DCR/4A/17 added Oct 10, 2018 DCR/19A/18 Weight Updated S.Bal May , 2020 Disinfection and S.Bal Cleaning correction in Jan , 2021...
  • Page 39 920 Auburn Court Fremont, CA 94538 U.S.A. Phone: 510-445-1257 Fax: 510-991-9862 Email: sales@laboamerica.com www.laboamerica.com EU REP. Labomed Europe Essebaan 50 NL-2908 LK Capelle a/d IJssel The Netherlands Tel: +31 (0)10 4584222 Fax: +31 (0)10 4508251 E-mail: info@labomedeurope.com A28240 ISO 13485:2016...

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