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29.  DISPOSAL 

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

28.  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 93/42/EEC and Annex IX Rule 13 

of MDR 2017/745 Governing medical devices. The unit is marked with CE andis compliant to ANSI / 

AAMI EC 60601 - 1:2005.

Prima 

6137000-795

Prima 

Issue 1.9

Printed on Sept,2021

58

Содержание PRIMA DNT

Страница 1: ...ing 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 6137000 795...

Страница 2: ...anges to the product described in this user manual without notice and without incorporating those changes in any products already sold ISO 9001 13485 Certi ed LABOMED products are designed and manufac...

Страница 3: ...13 WARNING AND CAUTIONS 35 36 14 EXPLANATION OF SYMBOLS 37 15 STANDARDS AND DIRECTIVES 38 16 CONDITION OF INSTRUMENT AT TIME OF UNPACKING SUPPLY 39 17A INSTALLATION OF BASE MOBILE STAND 40 41 17B MICR...

Страница 4: ...ar surgery from ve di erent magni cations 3 Cold light illumination with a high intensity 50W LED lamp is provided in magnichanger for proper illumination The illumination is further adjustable up to...

Страница 5: ...Fine focusing knob 7 Suspension arm movement locking knob 21 On O switch 8 Inclined Coupling locking knob 22 Power inlet 9 Inclined coupling 10 Carrier Locking knob 11 Suspension arm hydraulic movemen...

Страница 6: ...Coupling locking knob 22 On O switch 9 Inclined coupling 23 Power inlet 10 Carrier Locking knob 11 Suspension arm hydraulic movement lock 12 Suspension arm spring tension adjustment 13 Swivel arm cove...

Страница 7: ...IGN FORMULA TO CALCULATE MICROSCOPE COLUMN LENGTH COLUMN LENGTH FLOOR TO CEILING HEIGHT 1755mm GIVEN EXAMPLE COLUMN LENGTH 3660mm 1755mm 1905mm 525mm 600mm 91mm 250mm 180 150 CONCRETE ROOF 3660mm 12 1...

Страница 8: ...LONG SUSPENSION ARM 525mm 922mm 91mm 250mm 180 150 CONCRETE ROOF 3660mm 12 1426mm 260mm 1730mm 1106mm 1571mm 1401mm DIMENSIONS OF CEILING MOUNT continued Fig 3 Prima 6137000 795 Prima Issue 1 9 Print...

Страница 9: ...CEILING MOUNT ALTERNATIVE INSTALLATION TO THE PATIENT S SIDE WITH STANDARD ARM 4 INSTALLATION REFERENCES CEILING MOUNT Fig 4 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 6...

Страница 10: ...CEILING MOUNT ALTERNATIVE INSTALLATION TO THE PATIENT S SIDE WITH LONG ARM 986mm 799mm INSTALLATION REFERENCES CEILING MOUNT continued Fig 5 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 7...

Страница 11: ...WORK RANGE RECOMMENDED FOR IDEAL INSTALLATION SITE STANDARD ARM INSTALLATION REFERENCES CEILING MOUNT continued Fig 6 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 8...

Страница 12: ...RK RANGE RECOMMENDED FOR IDEAL INSTALLATION SITE LONG ARM 986mm R 1 2 7 0 m m R1633mm 933mm INSTALLATION REFERENCES CEILING MOUNT continued Fig 7 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021...

Страница 13: ...MARKING REFERENCE A B C D E 175mm 175mm 175mm 175mm 400mm 400mm INSTALLATION REFERENCES CEILING MOUNT continued Fig 8 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 10...

Страница 14: ...2016 96 308 155 69 60 1935 38 400 INSTALLATION REFERENCES CEILING MOUNT continued Fig 9 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 11...

Страница 15: ...les on wooden membrane refering gure 4 Drill Eight 8 1 4 6mm pilot holes either direct into Joist or the additional wooden membrane as per the roof available 5 Place a 10mm at washer over each of the...

Страница 16: ...ount as shown in Figure and to check the Vertical leveling Use Shims as required and adjust the RAWL Bolts Lag bolts until the column is Vertical 3 Tighten all screws securely NOTICE Shims and Shim ma...

Страница 17: ...t 6 socket head bolts M12 X 40 after aligning the 6 mounting holes 7 Slightly tighten all the bolts using Allen key 10mm 8 Use a level to ensure the column assembly is Leveled vertically Refer Section...

Страница 18: ...805 1 NOS M4x10 SOCKET HEAD CAP SCREW SS 630 2 NOS M6x10 SOCKET SET SCREW SS 174 4 NOS PIN 6137200 003 1 NOS BOLT M1Ox75mm SS 854 8 NOS FIXED IN RAVAL PLUG RAVAL PLUG M10x75mm SS 854 8 NOS TO BE FIXE...

Страница 19: ...CEILING CONNECTIONS CONNECTOR INSTALLATION REFERENCES CONCRETE CEILING MOUNT Fig 14 Prima Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 16...

Страница 20: ...12 0 25 25 25 25 125 125 LIST OF CONTENTS 1 Paper template for marking 1 2 Wall Mount Assembly 1 3 Hexagonal Lag bolts for wooden walls 6 4 Plain Washer 6 5 RAWL Anchor Bolts for Masonry walls 6 6 Cap...

Страница 21: ...1730mm 250mm WALL MOUNT WITH STANDARD SUSPENSION ARM 1106mm 1570mm 1400mm 1320mm THRU HOLE 12 0mm 406mm 1312mm 125mm 125mm Fig 16 DIMENSIONS OF WALL MOUNT ASSEMBLY continued Prima 6137000 795 Prima I...

Страница 22: ...0mm 150 525mm 922 6mm 250mm WALL MOUNT WITH LONG SUSPENSION ARM 1106mm THRU HOLE 12 0mm 406mm 1312mm 125mm 125mm Fig 17 DIMENSIONS OF WALL MOUNT ASSEMBLY continued Prima 6137000 795 Prima Issue 1 9 Pr...

Страница 23: ...8 INSTALLATION OF WALL MOUNT WALL MOUNT WITH STANDARD SUSPENSION ARM SWIVELARM WITH 8 EXTENSION ARM Fig 18 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 20...

Страница 24: ...9 DIMENSIONS OF WALL MOUNT Fig 19 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 21...

Страница 25: ...1021mm Wall mount Alternative installation to the patient s side With standard suspension arm Fig 20 10 INSTALLATION REFERENCES WALL MOUNT Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 22...

Страница 26: ...1182mm Wall mount Alternative installation to the patient s side with long suspension arm Fig 21 INSTALLATION REFERENCES WALL MOUNT continued Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 23...

Страница 27: ...Wall Mount Assembly C Distance from Floor Refer suitable height as per ordered con guration from gure 1 2 or 4 Fig 22 6 COUNTER HOLE 16mm x 2 0mm DEEP THRU HOLE 11 0mm 406mm 125mm 125mm A B C INSTALLA...

Страница 28: ...OUNT INSTALLATION Before Initiating the installation of Labomed Wall Mount Microscopes You must ensure that there is proper space available as per the con guration selected Refer to Figure 21 and 22 M...

Страница 29: ...MOUNT INSTALLATION FOR WOODEN WALL WALL MOUNT 6137100 806 6NOS WASHER 6 NOS HEX HEADWOODEN SCREW 10x100 CAP RAWAL PLUG M10 PART NO SS 855 6 NOS Fig 24 Prima 6137000 795 Prima Issue 1 9 Printed on Sept...

Страница 30: ...11B WALL MOUNT INSTALLATION FOR SOLID BRICK WALL Fig 25 WALL MOUNT 6137100 806 Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 27...

Страница 31: ...ll studs spaced on 16 406 mm Inch centers it is recommended that 3 8 x 4 hex head lag screws are used WARNING THE MOUNTING HARDWARE SUPPLIED FOR WOODEN WALL IS NOT DESIGNED FOR INSTALLATION TO WALL WI...

Страница 32: ...ck plate 4 Adjust the back plate until it is level and tighten the three lag screws on the bottom leaving the top lag screws loosened slightly 5 Place a level vertically along the face of the wall Mou...

Страница 33: ...s 5 Place the RAWL bolts through the holes and carefully insert the bolts into the wall 6 Take out the threaded bolt 7 Position the wall mount against the wall Place at washer under head of coach bolt...

Страница 34: ...Fig 29 Shim Level Wall Mount Assembly WALL MOUNT INSTALLATION PROCEDURE continued Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 31...

Страница 35: ...e back plate is not perpendicular insert shim material between the back plate and the wall next to the RAWL bolts Check with the level and tighten the toggle bolts once the mount is level 7 Check the...

Страница 36: ...all 2500 Nm minimum Parallel to the wall 2000 Nm minimum Also take into account any additional loads acting on the wall and any other loads anchored in the wall The wall construction must comply the r...

Страница 37: ...site on Ceiling ange The terminals for power connection are allocated on Ceiling Mount Potential equalization Take the necessary actions in the building to include the instrument in the protective me...

Страница 38: ...IS INSTRUMENT MUST BE PERFORMED BY EXPERIENCED PERSONAL OR DEALERS WHO ARE TRAINED BY LABOMED OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY OCCUR WARNING MODIFICATIONS TO THIS INSTRUMENT ARE NOT AL...

Страница 39: ...RT OF THIS INSTRUMENT AS DAMAGE TO THE UNIT MAY OCCUR SEE THE CARE AND MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTIONS CAUTION MEDICAL ELECTRONIC EQUIPMENT NEEDS SPECIAL PRECAUTIONS WITH RESPEC...

Страница 40: ...ckage 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 fragile and should be handled with care El...

Страница 41: ...th optics ISO 8600 5 First edition 2005 03 15 Optics and phonetics Medical endoscopes and endotherapy devices Part 5 Determination of optical resolution of rigid endoscopes with optics ISO 13485 quali...

Страница 42: ...kes 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 ber optic cable 4 Inclined coupling with magni changer...

Страница 43: ...30 2 Remove the tool kit and foam sheets as shown in g 31 3 Lift up the Centre Support assembly as shown in g 32 4 Place the Centre Support assembly on the oor as shown in g 33 5 Open the Wheel Suppor...

Страница 44: ...Align the holes of the centre support with the holes of both wheel supports and tighten the screws as shown in Fig 37 using the 8mm allen wrench 9 Remove the ring and open 3 screws from shaft as show...

Страница 45: ...ring D is xed in place as shown in Fig 42 3 Remove the arm assembly from the box and follow the instructions below see Fig 43 A Ensure loosening of swivel arm lock knob A B Place the arm assembly on t...

Страница 46: ...he receptacle Insert the light guide into the receptacle in the microscope till it properly tighten into position as shown as A in Fig 45 Make sure that wire has been routed in such a way that the car...

Страница 47: ...gned 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 47 1 REPLACING THE ILLUMINATION SOURCE Open the sw...

Страница 48: ...4 PRIMA WIRING CODING DIAGRAM ELECTRICAL CONNECTIONS continued Prima 6137000 795 Prima Issue 1 9 Printed on Sept 2021 45...

Страница 49: ...s you to lock the movement of swivel arm at the desired position after initial focusing of the attendance area by turning it clockwise knob is shown as B in Fig 50 4 SUSPENSION ARM LOCKING KNOB This k...

Страница 50: ...ded on caster wheels To unlock press upper portion of brake See Fig 54 8 LED FEATURES Single Chip White LED with over 2250 white lumen s Large monolithic chip with uniform emitting area of 9mm Lumen m...

Страница 51: ...crew 3 Lock the up Down movement of suspension arm using locking knob B in g 50 after focusing of the area of interest 4 Adjust the eye distance as per IPD scale according to your convenience 5 The il...

Страница 52: ...7 NuVar 10 and NuVar 20 also available on demand For more details of NuVar refer brochure The ergonomic straight or 210 degree binocular tube is provided for the main surgeon The large tilt range all...

Страница 53: ...otating i in anti clock wise direction It can be thread in by rotating in clockwise direction 2 To install the eyepieces insert in the eye tubes of observation head 3 A range of objectives eyepieces c...

Страница 54: ...PTER 6134172 I PHONE 6 6134172 1 6 I PHONE 11 6134172 1 11 SONY HANDICAM 6134130 111 BAYONET MOUNT NIKON 6134130 110 BAYONET MOUNT CANAN 6134130 112 BAYONET MOUNT SONY NEX 5N 6134131 106 CAMERA MOUNT...

Страница 55: ...NDICAM ATLAS CMOS CAMERA VEGA CMOS CAMERA 6134117 TILTABLE ERGO HEAD 0 210 6122015 ASSISTOSCOPE CCD ATTACHMENT 6134110 DSLR CAMERA ADAPTER 6134131 DOUBLE BEAM SPILTER 6134150 EYE PIECE 10X16 6120010 E...

Страница 56: ...auses LED light blinking as an indicator of high LED temperature Allow the LED to cool down before switching it on again After Supplementary accessories are mounted the additional load of suspension a...

Страница 57: ...nwards 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 go over steps and edges the stand might topple 9 Be extrem...

Страница 58: ...ument 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 If a f...

Страница 59: ...not use ethanol and spirit 10 Do not clean products and optical components in a cleaning disinfecting devices or ultra sound bath 11 LABOMED MaxiLite coatings are fungal resistant If you clean as des...

Страница 60: ...rocedure Take a muslin cloth Moist it to feel wet Disinfect clean the surface gently Note 1 Use mask and Gloves while performing cleaning and disinfection 2 While cleaning muslin cloth should not be d...

Страница 61: ...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...

Страница 62: ...l eld illumination Insu cient illumination continued Up and down motion of the suspension system is sti Insert the light guide as far as it will go Failure of electronics Illuminate the surgical eld u...

Страница 63: ...ause Remedy Stand is unstable The brakes on the wheels are not in use Engage the brakes No image is visible in the eld of view Magnichanger is not indexed properly Index magnichanger properly Prima 61...

Страница 64: ...cket Ceiling Mount Bracket Ergo viewing tube 0 210 tiltable IPD 49 78mm Optional Straight viewing tube 90 IPD 45 78mm WF 10x 18mm with retractable eye guards diopter adjustment 7mm and diopter lockOpt...

Страница 65: ...ure 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 Class A The Prima is suitable for use in all establishment other...

Страница 66: ...evel 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 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles 95 Dip for 5...

Страница 67: ...ecom mended separation distance in meters m Field strengths from xed Rf transmitters as determined by an electromagnetic site survey should be less than the compliance levels in each frequency range I...

Страница 68: ...separation Distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according...

Страница 69: ...UNT WALL MOUNT FLOOR MOUNT Prima Microscope with Mobile Stand Total Weight Approx 88 kgs 150 90 525mm 1124 6mm 525mm 1124 6mm 150 150 90 150 150 536mm 525mm 843mm 1464 6mm 90 Prima 6137000 795 Prima I...

Страница 70: ...tion 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 with which the e...

Страница 71: ...rranty strict liability or any other damages resulting from or relating to design manufacture sale use or handling of the product PRODUCT CHANGES LABOMED reserves the right to make changes in design o...

Страница 72: ...l DCR 4A 17 Section 3 0 Warning Updates revised UPS requirement Oct 30 2018 DCR 19A 18 Page 35 updated weight Cleaning and disinfection 1 8 July 2021 DCR 6A 19 DCR 08A 2021 DCR 15 2021 Added section 7...

Страница 73: ...hone 510 445 1257 Fax 510 991 9862 Email sales laboamerica com www laboamerica com EU REP A16372 LABOMED ISO 13485 Labomed Europe Essebaan 50 NL 2908 LK Capelle a d IJssel The Netherlands Tel 31 0 10...

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