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Summary of Contents for Labomed PRIMA Mm
- 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 Issue 1.6 Prima Mµ Printed on Jan.,2021...
- Page 2 The information contained in this document was accurate at the time of publication. Specifications are subject to 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.
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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
Prima Mµ INTRODUCTION The LABOMED Prima Mµ is a surgical and diagnostic microscope which is adaptable for different surgical needs for consistent visualization during all intra operative phases of DNT surgeries by providing magnified view of the surgical field without compromise to performance. -
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 20. On/Off switch 9. - 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.
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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 Authorized representatives. We will supply the missing labels. Brightness Control: After the illumination has been switched on, the user can continuously adjust brightness by turning the knob appropriately. -
Page 9: Standard And Directives Applicable
PRIMA Mu 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. Ophthalmic instruments and test methods. Part 2: light hazard protection. • ISO 9001/13485 quality management systems approved by UL(notified body). •... -
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. Please check for the following when unpacking the device: 1. Mobile supporting base with brakes on castor wheels, or the type of mounting system. 2. -
Page 11: Installation Instruction
Prima Mµ 7. INSTALLATION 7.1 Install the base by fixing the both sides (A) & (B) on the metal plate (D) as shown in Fig.-1 by tighten the allen screws provided from the bottom of the metal plate. Fig. 1 7.2 Referring Fig.- 1.a the base is installed by fixing the column (C) on the shaft (E). -
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 sliding the guiding shaft (1) into the suspension arm. • Lock the inclined coupling with the threaded plug (2). -
Page 13: Electrical Connection
Prima Mµ 8. ELECTRICAL CONNECTIONS Connect the power cable to the AC inlet socket (2) provided on the back of the swivel arm as shown in the fig.-7. Switch on the power from on/off switch (1). Note: Power supply designed with universal input 100V - 240V AC, 50/60HZ. -
Page 14: Wiring Coding Diagram
Prima Mµ ELECTRICAL CONNECTIONS 8.4. WIRING CODING DIAGRAM Issue 1.6 6210000-795 Prima Mµ Printed on Jan.,2021... -
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: 1. Lock all the brakes on base wheels after setting up of microscope on the attendance area for stability. Tension 2. Although tension on microscope is factory adjustment screw present as per the ordered configuration. - Page 17 Prima Mµ MAIN MICROSCOPE The objective lenses with fine focusing knob and focal lengths of 250mm is available for different working distances. The ergo binocular tube (optional: straight and 45° inclined) is provided for the main surgery. The standard equipment includes eyepieces with a magnification factor of 10X (option: 12.5X) Fig.
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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 Issue 1.6 6210000-795 Prima Mµ Printed on Jan.,2021... -
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. Total four accessories are provided as follows 2.1 DSLR camera adapter for Nikon, Canon and Sony 2.2 CCD camera adapter for Mintron. 2.3 Adapter for Sony Handy-Cam. -
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 1. Turn off the unit at the power switch. 2. Disconnect the power cable. 3. - Page 22 Prima Mµ 15. CARE AND MAINTENANCE This instrument is a high grade technological product and not required any special periodical 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 Recommended having this check performance by our service representative as part of regular Maintenance work.
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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
2. While cleaning, muslin cloth should not be dripped wet to prevent seepage and rusting to running/bare parts. 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 autoclaving: • Temperature: 134˚C •... -
Page 25: Ambient Requirement
Prima Mµ 18. AMBIENT REQUIREMENT +10˚C..+40˚C For Operation Temperature Rel. Humidity 30%..90% (without condensation) Air Pressure 700hPa..1,060hPa Temperature -40˚C..+70˚C For Transportation and Storage Rel. Humidity 10%..100% (without condensation) Air Pressure 500hPa..1,060hPa The unit meets the essential requirements stipulated in Annex I of the MDR 2017/745 Governing medical devices. -
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 Change the fuse Defective instrument fuse Defective power cable Change the power cable Line power failure... -
Page 27: Technical Specification
Prima Mµ 21. TECHNICAL SPECIFICATIONS Straight viewing tube 90°, IPD 45-78mm Binocular Tubes Optional: 45° inclined head and 0-210° Ergo head, IPD 49-78mm WF 10x/18mm with retractable eye guards, Eyepieces diopter adjustment ± 8mm Optional: WF 12.5x/18mm; fixed eye guards. 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 Mµ is intended for use in the electromagnetic environment specified below. The customer or user of the Prima Mµ should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance... - 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 Mµ is intended for use in the electromagnetic environment specified below. The customer or user of the Prima Mµ should ensure that it is used in such an environment. Electromagnetic Environment IEC 60601 Test Immunity Test...
- 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 Mµ is intended for use in the electromagnetic environment specified below. The customer or user of the Prima Mµ...
- Page 31 Prima Mµ GUIDANCE TABLES (continued) Recommended separation distance between Portable and Mobile RF Communications equipment and the Prima Mµ for ME equipment and ME systems that are not Life-supporting. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Recommended separation distance for between Portable and Mobile RF Communications equipment and the Prima Mµ...
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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 6210000-795 Issue 1.6... -
Page 33: Glossary
Prima Mµ 24. GLOSSARY Compensation of short-or-far-sightedness. This can be done for each Ametropia Compensation eye using the two individual eyepieces (range: +5 to -5 diopters). 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 34 Prima Mµ GLOSSARY (continued) Serves the same purpose as the DBS but in addition it provides a 60° inclined DBSi position, creating greater comfort, ideal for prolonged use applications or where patient is always supine. Provides optical extension for a more comfortable working angle. Extender Enables you to comfortably view your specimen at an angle by tilting the Rotoplate...
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Page 35: Warranty
LABOMED factory or authorized LABOMED Dealer. All claims under this warranty must be in writing and directed to the LABOMED factory or its authorized dealer for this device making the original sale and must be accompanied by a copy of the purchaser’s invoice. - Page 36 920 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...
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