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Prima Mµ

6210000-795

Prima Mµ

Issue 1.6

Printed on Jan.,2021

22

Prima Mµ

19. DISPOSAL

Disposal of the instrument must comply with locally applicable laws and regulations.

18. AMBIENT REQUIREMENT

For Operation

For Transportation and Storage

Temperature
Rel. Humidity
(without condensation)
Air Pressure

Temperature
Rel. Humidity
(without condensation)
Air Pressure

500hPa........1,060hPa

700hPa........1,060hPa

10%........100%

30%........90%

-40˚C......+70˚C

+10˚C......+40˚C

The unit meets the essential requirements stipulated in Annex I of the MDR 2017/745
Governing medical devices. The unit is marked with CE and is compliant to ANSI / AAMI EC 60601
- 1-1.

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Содержание PRIMA Mm

Страница 1: ...1 6 Printed on Jan 2021 PRIMA M User Manual MICROSCOPE Caution To ensure proper use of this instrument as well as to avoid injury while operating Instrument understanding this manual completely before...

Страница 2: ...nge 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 ISO...

Страница 3: ...ement Data Plate Details Wiring Coding Diagram Control Elements Instruction for using the microscope Changing the Objective Eyepieces Use of Accessories Tension Adjustment while using accessories Movi...

Страница 4: ...hanger for proper illumination The illumination is further adjustable up to its most suitable brightness using intensity control knob suitably located at the suspension arm and is easily approachable...

Страница 5: ...vel Arm Locking Knob 7 Suspension arm movement locking knob 8 Coupling movement locking knob 9 Suspension arm hydraulic movement lock 10 Suspension arm spring tension adjustment 11 Swivel arm cover 12...

Страница 6: ...N A MANNER NOT SPECIFIED BY LABOMED WARNING DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUT AUTHORIZATION FROM LABOMED ANY REPAIR OR SERVICE TO THIS INSTRUMENT MUST BE PERFORMED BY EXPERIENCED PERSON...

Страница 7: ...MAGE TO THE UNIT MAY OCCUR SEE THE CARE AND MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTIONS CAUTION MEDICAL ELECTRONIC EQUIPMENT NEEDS SPECIAL PRECAUTIONS WITH RESPECT TO ELECTROMAGNETIC CHARGE...

Страница 8: ...ect upright position of the transport package Keep dry the transport package shall be kept away from rain Year of manufacture used on product data plate Fragile content of the transport package are fr...

Страница 9: ...1 13485 quality management systems approved by UL notified body ISO 14971 2007 Risk management to medical devices DIRECTIVE USED MDR 2017 745 Annex IX and Rule B Directives 93 42 EEC Articles II Secti...

Страница 10: ...Mobile supporting base with brakes on castor wheels or the type of mounting system 2 Column depending on the type of mount ordered 3 Swivel arm and suspension arm assembly with fiber optic cable 4 Cov...

Страница 11: ...ed by fixing the column C on the shaft E Engage the column onto the shaft by aligning three tapped holes Referring Fig 2 tighten three allen screws H with 4mm allen wrench 7 3 Retrieve the swivel arm...

Страница 12: ...er comes pre routed through swivel arm that houses the power system and the suspension arm Insert the power supply wire into the receptacle in the microscope till it properly tighten into position as...

Страница 13: ...om on off switch 1 Note Power supply is 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 8 1...

Страница 14: ...Prima M 6210000 795 Prima M Issue 1 6 Printed on Jan 2021 11 8 4 WIRING CODING DIAGRAM ELECTRICAL CONNECTIONS...

Страница 15: ...roscope is not in use for longer time 9 2 INTENSITY CONTROL KNOB It is located in front of the suspension arm shown as A in Fig 10 Brightness of field of view can be adjusted as per user comfort using...

Страница 16: ...f tension adjusting screw 3 Lock the up Down movement of suspension arm using locking knob B in fig 12 after focusing of the area of interest 4 Adjust the eye distance as per IPD scale According to yo...

Страница 17: ...ective 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...

Страница 18: ...ted on Jan 2021 15 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 t...

Страница 19: ...MOUNT DSLR CANAN NIKON 6134131 107 TUBE CAMERA MOUNT NEX 5N 6134130 113 BAYONET MOUNT CANON EOMS M10 ATLAS CMOS CAMERA VEGA CMOS CAMERA EYE PIECE 10X16 6120010 EYE PIECE 12 5X16 6135012 6134117 TILTA...

Страница 20: ...and Sony 2 2 CCD camera adapter for Mintron 2 3 Adapter for Sony Handy Cam 2 4 Assistoscope for assistant viewing 3 Install any one or two accessories on any side Left or right of the beam splitter 4...

Страница 21: ...elease locks by pressing the upper parts of the locks downwards 5 Bring the unit into its moving position 6 Be careful of heights when passing through doorways 7 Avoid collision of any kind 8 Do not g...

Страница 22: ...rmance by our service representative as part of regular Maintenance work If a failure occurs which you cannot correct using the trouble shooting table attach a sign to the instrument stating out of or...

Страница 23: ...aning and disinfection is done as described insection 16 is no impact of multiple cleaning Disinfection on mechanical and optical parts Paints Coating are rigid and life long TROPICAL ENVIRONMENT FUNG...

Страница 24: ...lean the surface gently Note 1 Use mask and Gloves while performing cleaning and disinfection 2 While cleaning muslin cloth should not be dripped wet to prevent seepage and rusting to running bare par...

Страница 25: ...ion For Transportation and Storage Temperature Rel Humidity without condensation Air Pressure Temperature Rel Humidity without condensation Air Pressure 500hPa 1 060hPa 700hPa 1 060hPa 10 100 30 90 40...

Страница 26: ...illuminator and contact the service department Illuminate the surgical field using an alternate illuminator and contact the service department Switch off via limit switch on suspension arm system Mov...

Страница 27: ...inclined head and 0 210 Ergo head IPD 49 78mm WF 10x 18mm with retractable eye guards diopter adjustment 8mm Optional WF 12 5x 18mm fixed eye guards 3 step 0 6X 1 0X 1 6X 15 2 5 80 13mm CMO f 250mm Op...

Страница 28: ...ecified below The customer or user of the Prima M should ensure that it is used in such an environment RF Emissions CISPR 11 Harmonics IEC 61000 3 2 Flicker IED 61000 3 3 Complies Class A Group 1 Clas...

Страница 29: ...Hz Magnetic Field IEC 61000 4 8 3A m 3A m IEC 60601 Test Level Electromagnetic Environment Guidance 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles 95 Dip for 5 Seconds 95 Dip for 0 5 Cy...

Страница 30: ...less telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To access the electromagnetic Environment due to fixed R...

Страница 31: ...a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum out...

Страница 32: ...1 29 23 MEASURES AND WEIGHT CEILING MOUNT WALL MOUNT FLOOR MOUNT Prima M Microscope with Wall Mount Total Weight Approx 60 kgs Prima M Microscope with Ceiling Mount Total Weight Approx 75 kgs Prima M...

Страница 33: ...re for illumination intensity is Lux Lx Light Emitting Diode Electronic semiconductor device that emits light when an electrical current passes through it The optical portion facing towards the eyes w...

Страница 34: ...tion creating greater comfort ideal for prolonged use applications or where patient is always supine Provides optical extension for a more comfortable working angle Enables you to comfortably view you...

Страница 35: ...dental or consequent damages for any negligence breach of warranty strict liability or any other damages resulting from or relating to design manufacture sale use or handling of the product PRODUCT CH...

Страница 36: ...hone 510 445 1257 Fax 510 991 9862 Email sales laboamerica com www laboamerica com EU REP A28240 LABOMED ISO 13485 Labomed Europe Essebaan 50 NL 2908 LK Capelle a d IJssel The Netherlands Tel 31 0 10...

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