Labomed PRIMA OPH User Manual

Operating surgical microscopy
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PRIMA OPH
User Manual
Operating Surgical Microscopy
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.
Part No: 6135000-795
Issue 1.6
Printed on: July, 2020

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  • Page 1 PRIMA OPH User Manual Operating Surgical Microscopy To ensure proper use of this instrument as well as to avoid injury while operating instrument, Part No: 6135000-795 Issue 1.6 Understanding this manual completely before use is highly recommended. Printed on: July, 2020...
  • Page 2: Table Of Contents

    Prima OPH TABLE OF CONTENTS INTRODUCTION SAFETY INSTRUCTIONS WARNINGS AND CAUTIONS SPECIAL INSTRUCTION FOR INSTALLATION & WARNING LABELS AND NOTES DESCRIPTION OF PARTS 11-12 SYSTEM DIAGRAM UNPACKING 14-15 INSTALLATION & INSTRUCTION 16-17 INSTALLATION ELECTRIC CONNECTION CONTROLS PRIMA WIRING CODING DIAGRAM...
  • Page 3: Introduction

    Prima OPH INTRODUCTION The LABOMED Prima OPH is a surgical and diagnostic microscope, which is adaptable for different Surgical needs for consistent visualization during all intra operative phases of ophthalmic surgery by providing a magnified view of the surgical field without compromise to performance.
  • Page 4: Safety Instructions

    SAFETY The instrument described in this manual has been developed and tested in accordance with LABOMED safety standards and with national and international regulations. A high degree on Instrument safety is thus ensured. Additional safety notes are also contained in other parts of this user’s manual; they are marked with a warning triangle containing an exclamation mark as shown here.
  • Page 5: Warnings And Cautions

    Prima OPH WARNINGS AND CAUTIONS LABOMED is not responsible for the safety and reliability of this instrument when: - Assembly, disassembly, repair, or modification is made by unauthorized dealers or persons. - The instrument is not used in accordance with this user manual.
  • Page 6 CAUTION: THIS INSTRUMENT IS NOT TO BE USED NEAR HIGH-FREQUENCY EMITTING SURGICAL EQUIPMENT. CAUTION: THIS INSTRUMENT IS NOT INTENDED TO BE CONNECTED TO EQUIPMENT OUTSIDE THE CONTROL OF LABOMED OR MUST BE TESTED TO AN APPLICABLE IEC OR ISO STANDARDS. Issue 1.6 PRIMA OPH...
  • Page 7: Special Instruction For Installation

    . • Only use the instrument with the accessories supplied. Should you wish to use other accessories with this equipment, make sure that LABOMED has certified its use for safety of the instrument. • It is recommended that the user’s manual be kept accessible always.
  • Page 8 Prima OPH SPECIAL INSTRUCTIONS FOR INSTALLATION & USE REQUIREMENT FOR OPERATION Installation of the instrument must only be carried out by an authorized LABOMED agent or Representative. Please make sure that the following requirements for operation remain fulfilled in the future: - All mechanical connections (details in the user’s manual) which are relevant to safety...
  • Page 9: Warning Labels And Notes

    Prima OPH WARNING LABELS AND NOTES Caution Observe all warnings labels and notes! If any label is missing on your instrument or has become illegible, please contact us or one of our authorized representatives. We will supply the missing labels.
  • Page 10 Prima OPH WARNING LABELS AND NOTES (continued) This Way Up-Indicates correct upright position of the transport package. Keep Dry- Transport package shall be kept away from rain. The CE mark (an acronym for the French “Conformity Europeenne”) Certifies that a product has met European Union Health, safety and...
  • Page 11 Prima OPH WARNING LABELS AND NOTES (continued) Issue 1.6 PRIMA OPH 6135000-795 Printed on: July, 2020...
  • Page 12: Description Of Parts

    Prima OPH DESCRIPTION OF PARTS ® LABOMED Part # ....LABO AMERICA, INC. 920, Auburn Court Fremont CA 94538 IP X6 www.laboamerica.com Fig. 1 Metal base Wheel with brake Swivel Arm Column Swivel arm locking knob Suspension Arm Coupling movement locking knob Suspension arm movement locking knob 10.
  • Page 13: System Diagram

    Prima OPH SYSTEM DIAGRAM 6134130-111 BAYONET MOUNT NIKON 6134130-110 BAYONET MOUNT CANAN 6134130-113 6134130-112 BAYONET MOUNT BAYONET MOUNT CANON EOSM M10 SONY NEX-5N 6137200 EYE PIECE 10X16 EYE PIECE 12.5X16 6120010 6135012 6165000-811 6138000-815 6134131-106 6134131-107 COMS CAMERA CAMERA MOUNT DSLR...
  • Page 14 Prima OPH SYSTEM DIAGRAM (continued) DESCRIPTION OF PART NO. DESCRIPTION PART NO. Swivel arm assembly 6165000-811 Suspension arm assembly 6138000-815 XY Coupling 6136000-827 Z Axis Coupling 6136000-825 12.5x Eyepiece 6135012 10x Eyepiece 6120010 45°inclined Binocular Head 6121035P 210° tiltable binocular tube...
  • Page 15: Unpacking

    Prima OPH UNPACKING The appliance is delivered in sub-assembled groups along with one set of Installation Kit and one instruction / service manual. Please check following at the time of unpacking: 1. Mobile supporting base with brakes on castor wheels, or the type of mounting system.
  • Page 16: Installation & Instruction

    Prima OPH INSTALLATION Cut the tape of one of wheel support assembly box as shown in fig.-1. Fig 1 Remove the 4 no’s of Foam sheets as shown in fig.-2. Fig 2 Uplift the Wheel Support assembly as shown in fig.-3.
  • Page 17 Prima OPH INSTALLATION-Base (continued) 7. Cut the tape of Centre support assembly box as shown in fig.-7. Fig 7 Remove the 2 no’s of Foam sheets as shown in fig.-8. Fig 8 9. Uplift the Centre Support Assembly as shown in fig.-9.
  • Page 18 Prima OPH MICROSCOPE INSTALLATION Open the microscope box. Remove column from the box. Engage this column onto the shaft by aligning three guide holes on column and shaft, shown as B in fig.-13. Fig 13 Tighten three allen screws from the sides, shown as C in fig.- 14.
  • Page 19 Prima OPH MICROSCOPE INSTALLATION (continued) Retrieve the XY or Z-axis coupling assembly (as ordered) from the packing and follow as below refer Fig.5. • Install the coupling to the suspension arm by sliding the guiding shaft (1) to the suspension arm.
  • Page 20: Electric Connection

    Prima OPH 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-8. Switch on the power from on/off switch (2). Note: Power supply is designed with universal input 100V-240V AC, 50/60Hz.
  • Page 21: Prima Wiring Coding Diagram

    Prima OPH PRIMA WIRING CODING DIAGRAM Issue 1.6 6135000-795 PRIMA OPH Printed on: July, 2020...
  • Page 22: Instruction For Using The Microscope

    Prima OPH INSTRUCTIONS FOR USING THE MICROSCOPE SETTING UP OF MICROSCOPE: 1. Lock all the brakes on base wheels after setting up of microscope on the attendance area for stability. 2. Although tension on microscope is factory preset as per the ordered configuration. Still user can adjust up and down force by tuning the allen screw clock- wise or anticlockwise with the help of a 8.0mm allen...
  • Page 23 Prima OPH INSTRUCTIONS FOR USING THE MICROSCOPE INTENDED USE: The PRIMA OPH surgical microscope has been designed surgical procedures field of ophthalmology, i.e. the microscope meets the special requirements of this discipline. DESCRIPTION OF THE MODULES The PRIMA OPH surgical microscope comprises the...
  • Page 24 Prima OPH INSTRUCTIONS FOR USING THE MICROSCOPE The ergonomic 45 or 210 degree binocu- lar tube is provided for the main surgeon. The large tilt range allows work with minimum fatigue. standard equipment includes eyepieces with a magnification factor of 10x (option: 12.5x).
  • Page 25: Changing The Objective & Eyepieces

    Prima OPH 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 clock wise direction. 2. To install the eyepieces, insert in the eye tubes of observation head.
  • Page 26: Thermal Cut Off

    LED is above 70°C. In case if thermal cut-off fails, no risk will happen to the instrument, only LED may get fuse. Here user needs to replace the LED only and thermal cut-off will start working again. To replace LED user may call LABOMED service personal or authorized dealer. LED Specification: 3.7V 13.5 Amp...
  • Page 27: Moving Position

    Prima OPH MOVING POSITION Position of the system for safe transportation. Fold the system as shown before moving RELOCATING THE STAND • Turn off the unit at the power switch. • Disconnect the power cable from line power. • Remove the video cable from the video modules (e.g. video monitor.
  • Page 28 Prima OPH CLEANING AND SERVICING CARE & MAINTENANCE (Fig.-11) 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.
  • Page 29: Cleaning & Servicing

    • Do not clean products and optical components in a cleaning/disinfecting device or ultra sound bath. • LABOMED Maxi Lite coatings are fungal resistant. If you clean as described above, the coatings will not be damaged. TROPICAL ENVIRONMENT/FUNGUS: LABOMED employs certain safety precaution in its manufacturing techniques an and materials. other Preventive measures include: •...
  • Page 30: Cleaning And Disinfection

    Prima OPH CLEANING AND DISINFECTION Following disinfectants are recommended for cleaning and disinfection. 1. Normal household bleach (Sodium hypochlorite 5%)- strength 5000 ppm(10 parts water 1 part bleach). 2. 70% Isopropyl alcohol. Procedure: • Take a muslin cloth. • Moist it to feel wet •...
  • Page 31: Troubleshooting Table

    Prima OPH TROUBLESHOOTING TABLE This instruments 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 safety must be checked once every 12 months. We recommended having this check performance by our service representatives as part of regular maintenance work.
  • Page 32 Prima OPH TROUBLESHOOTING TABLE (continued) PROBLEM REMEDY POSSIBLE CAUSE Clean thermal cut-off with a Thermal cut-off in lamp dry brush; blow it clean, if housing is contaminated. necessary. Contact service dept. Defective fan. Failure of Illumination surgical field using system electronics.
  • Page 33: Disposals

    Prima OPH DISPOSAL Disposal must comply with locally applicable laws & regulations. Issue 1.6 6135000-795 PRIMA OPH Printed on: July, 2020...
  • Page 34: Specification

    Prima OPH SPECIFICATIONS Technical Data (Specifications) 45° Inclined head, IPD 55-75mm Binocular tubes: WF 10x/16mm with eye guards; optional WF Eyepieces: 12.5x/16mm. 0.4x, 0.6x, 1.0x, 1.6x & 2.5x Apochromatic magnichanger: f=200, motorized fine focus, Objective: Optional: f=175mm, motorized fine focus...
  • Page 35: Guidance Tables

    All Equipment and Systems Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Prima OPH is intended for use in the electromagnetic environment specified below. The customer or user of the Prima OPH should ensure that it is used in such an environment.
  • Page 36 All Equipment and Systems Guidance and Manufacturer’s Deceleration - Electromagnetic Emissions Prima OPH is intended for use in the electromagnetic environment specified below. The customer or user of the Prima OPH should ensure that it is used in such an environment.
  • Page 37 Guidance and manufacturer’s Deceleration – Electromagnetic Immunity The Prima OPH is intended for use in the electromagnetic environment specified below. The customer or user of the Prima OPH should ensure that it is used in such an environment. Immunity Test...
  • Page 38 The Prima OPH is intended for use in electromagnetic environments in which radiated RF disturbances are controlled. The customer or user of the Prima OPH can help prevent electromagnetic interference by Maintaining a minimum distance between portable and mobile RF communications equipment (Transmitters) and the Prima OPH as recommended below, according to the maximum output power of the communication equipment.
  • Page 39: Dimensions

    Prima OPH DIMENSIONS Wall Mount Ceiling Mount Floor Mount 1733 1280 Issue 1.6 6135000-795 PRIMA OPH Printed on: July, 2020...
  • Page 40: Glossary

    Prima OPH 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...
  • Page 41: 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 42 Diagram added July 05, 2017 DCR/4A/17 UPS requirement S.Bal added June 15, 2019 DCR/20A/19 System Diagram S.Bal updated as per marketing brochure Jan14, 2020 DCR/02/2020 S.Bal Cleaning anf disinfection July, 2020 Issue 1.6 PRIMA OPH 6135000-795 Printed on: July, 2020...
  • Page 43 920 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 A16372 ISO 13485...

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