Labomed PRIMA DNT User Manual

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6137000-795

Prima ENT/DNT

Issue 1.5

Printed on Feb.26,2019

PRIMA ENT/DNT

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.

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Prima ENT/DNT

PRIMA ENT/DNT is a Trade name of LABOMED Microscopes.

LABOMED is a registered trademark of Labo America, Inc.

All other trademarks are the property of their respective owners.

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.

ISO 9001/13485 Certified - LABOMED products are designed and manufactured under quality processes that meet ISO 9001/13485 requirements.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means: electronic, mechanical, recording, or otherwise, without the prior written permission of LABOMED.

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Prima ENT/DNT

TABLE OF CONTENTS

Introduction and Intended use

Product Description

Warning & Cautions

Explanation of Symbols

Standard and Directives applicable

Condition of instrument at the time of unpacking/supply

7A Installation of Base (Mobile Stand) 7B Microscope Installation

Electrical Connection

Replacing the illumination source Fuse Replacement Data Plate Details Wiring Coding Diagram

Control Elements

Instruction for using the microscope

Changing the Objective & Eyepieces

Use of Accessories

Thermal Cut-Off

Tension Adjustment while using accessories

Moving Position

Care and Maintenance

Ambient Requirement

Disposals

Troubleshooting Table

Technical Specification

Guidance Tables

Measures & Weight

Glossary

Warranty

2 - 3

4 - 6

10 - 11 12 - 13

14 14 14 15

17 - 18

20 - 21

24 - 25

28 - 29

31 - 34

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

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1. INTRODUCTION AND INTENDED USE

The LABOMED Prima ENT/DNT is a surgical and diagnostic microscope which is adaptable for different surgical needs for consistent visualization during all intra operative phases of ENT & dentistry surgeries by providing magnified view of the surgical field without compromise to performance.

The microscope provides extremely high optical image quality, good depth of focus and wide field of view for precise surgery. Illumination control, inbuilt tilt, adjustment of the observation head help to reduce the Surgeon's work fatigue and allow comfortable use over long period.

Salient features of this Microscope are:

1. The observation head can easily be positioned with the help of a suspension arm.

2. An advanced 5-step magnification changer allows an optimal magnification for a particular surgery from five different magnifications.

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 its most suitable brightness using intensity control knob suitably located at the suspension arm, and is easily approachable to the surgeon.

4. When the colposcope is not in use, the suspension arm can be folded over the main body to store it compactly.

5. Dual iris Diaphragm allows greater depth of field particularly valuable for photography.

6. Rigid H-form base with castor wheels provides greater stability as well as mobility to the instrument.

INTENDED USE

Prima ENT/DNT Surgical Microscope is an AC powered device intended for use during diagnosis and Surgery to provide a magnified view of surgical field. .

Note:

The use of Prima ENT/DNT Microscope is purely for intended use.

CONFIGURATIONS

Microscope

Catalogue No.

Prima ENT

6137000-000

Prima DNT 6138000-000

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2. PRODUCT DESCRIPTION

Fig. 1

1. Wheel with Brakes 15. Magnification changer

2. H shape metal Base 16. Handle

3. Column 17. Common Main Objective

4. Swivel arm 18. Magnichanger inclination movement lock

5. Suspension arm 19. Illumination Control Knob

6. Swivel Arm Locking Knob 20. Fine focusing knob

7. Suspension arm movement locking knob 21. iVu Camera inlet

8. Coupling movement locking knob 22. On/Off switch

9. Inclined coupling 23. Power inlet

10. Inclined coupling movement knob

11. Suspension arm hydraulic movement lock

12. Suspension arm spring tension adjustment

13. Swivel arm cover

14. Binocular head with eyepieces

Catalog no. 6138000-000 Model : Prima DNT

Fig. 1.1

1. Wheel with Brakes 15. Magnification changer

2. H shape metal Base 16. T - Handle

3. Column 17. Common Main Objective

4. Swivel arm 18. Magnichanger inclination movement lock

5. Suspension arm 19. Illumination Control Knob

6. Swivel Arm Locking Knob 20. Foot Paddle for Z- axis

7. Suspension arm movement locking knob 21. Fine focusing knob

8. Coupling movement locking knob 22. iVu Camera inlet

9. Inclined coupling 23. On/Off switch

10. Inclined coupling movement knob 24. Power inlet

11. Suspension arm hydraulic movement lock

12. Suspension arm spring tension adjustment

13. Swivel arm cover

14. Binocular head with eyepieces

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LABOMED

LABO AMERICA, I9N2C0,. Auburn Court Fremont CA 94538 USA

www.laboamerica.com

Part # ..................

IP X6

Catalog no. 6137000-000 Model : Prima ENT

PRODUCT DESCRIPTION

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3. WARNING 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.

A WARNING is an instruction that draws attention to the risk of injury or death.

WARNING: USERS OF THIS EQUIPMENT SHOULD BE THROUGHLY TRAINED IN THE APPROPRIATE

MEDICAL PROCEDURES. FURTHERMORE, THEY SHOULD TAKE THE TIME TO READ AND UNDERSTAND THESE INSTRUCTIONS BEFORE PERFORMANCE ANY PROCEDURE. THEY SHOULD ALSO READ AND UNDERSTAND THE INSTRUCTIONS FOR ANY OTHER EQUIPMENT USED IN CONJUNCTION WITH THIS MICROSCOPE (i.e. ELECTRO SURGICAL GENERATORS). FAILURE TO DO SO MAY RESULT IN INJURY TO THE PATIENT AND/OR DAMAGE TO THE MICROSCOPE.

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 THE MANUFACTURER. ANY REPAIR OR SERVICE TO THIS 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 ALLOWED. ANY MODIFICATION TO THIS UNIT BE AUTHORIZED BY LABOMED OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY OCCUR.

WARNING: IF THIS INSTRUMENT IS MODIFIED, APPROPRIATE INSPECTION AND TESTING MUST BE CONDUCTED TO ENSURE CONTINUED SAFE USE OF THIS INSTRUMENT.

WARNING: TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH OR DAMAGE TO THIS INSTRUMENT AND/OR INJURY TO THE OPERATOR OR PATIENT MAY OCCUR.

WARNING: ENSURE THAT THE VOLTAGE APPLIED TO THE UNIT IS THE SAME AS THE VOLTAGE THAT IS INDICATED ON THE DATA PLATE OR DAMAGE TO THE UNIT MAY OCCUR. TO USE IN FLUCTUATION VOLTAGE ENVIRONMENT CONSTANT VOLTAGE STABILIZER IS RECOMMENDED FOR SAFE & EFFICIENT USE OF DEVICE.

WARNING: THIS INSTRUMENT MUST BE PLUGGED INTO AN OUTLET WITH AN EARTH GROUND. DO NOT REMOVE OR DEFEAT THE EARTH GROUND CONNECTION ON POWER INPUT CONNECTOR OR THE UNIT’S POWER CORD OF THIS INSTRUMENT OR DAMAGE TO IT AND/OR INJURY TO THE OPERATOR OR PATIENT MAY OCCUR.

WARNING: THE EQUIPMENT OR SYSTEM SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED USE IS NECESSARY, THE EQUIPMENT OR SYSTEM SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED.

WARNING AND CAUTIONS

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WARNING: THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE.

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, WITH THE EXCEPTION OF THOSE SOLD BY THE MANUFACTURER AS REPLACEMENT PARTS FOR THE INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM.

WARNING AND CAUTIONS

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A CAUTION is an instruction that draws attention to the risk of damage to the product.

CAUTION: THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTAIN ELECTROSTATIC SENSITIVE

DEVICES (ESD) THAT MAY BE SENSITIVE TO STATIC CHARGES PRODUCED BY THE HUMAN BODY. DO NOT REMOVE THE COVERS WITHOUT TAKING PROPER ESD PRECAUTIONS.

CAUTION: DO NOT USE SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART 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 RESPECT TO ELECTROMAGNETIC CHARGE (EMC) AND NEEDS TO BE INSTALLED AND SERVICED ACCORDING TO THE EMC INFORMATION PROVIDED IN THE ACCOMPANYING DOCUMENTS.

CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT.

CAUTION: THIS INSTRUMENT IS NOT TO BE USED NEAR HIGH-FREQUENCY EMITTING SURGICAL EQUIPMENT.

CAUTION: DO NOT CONNECT ANY EQUIPMENT TO THE DEVICE OTHER THAN THOSE INTENDED FOR USE WITH THE DEVICE.

CAUTION: DO NOT USE A CONVERTER ADAPTER THAT WILL CONVERT THE THREE-PRONG AC PLUG TO A TWO-PRONG LINE PLUG, THE POWER SUPPLY IN THIS MICROSCOPE WILL NOT BE PROPERLY GROUNDED, AND ELECTRIC SHOCK MAY RESULT.

CAUTION: REMOVE THE AC POWER PLUG FROM THE WALL SOCKET WHILE CHECKING FOR A BLOWN FUSE.

CAUTION: DO NOT ROLL THE COLPOSCOPE OVER CABLES OR HOLES.

CAUTION: DO NOT REMOVE FERRITE BEADS IF APPLIED TO CABLES.

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.

Accompanying documents must be consulted.

Compliance to medical device directive 93/42/EEC.

Protective earth.

This way up – indicates the correct 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 fragile and should be handled with care.

Electromagnetic interference can occur in the vicinity of devices carrying this symbol.

Alternate current.

Recycling of packaging materials.

Do not over balance more than 5 degree.

Separate disposal of waste electrical equipment.

Unsafe for use with MR (Magnetic Resonance).

Permissible humidity range during transport and storage.

Permissible pressure range during transport and storage.

The product complies with US and Canadian safety requirements.

Permissible temperature range during transport and storage.

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5. STANDARDS AND DIRECTIVES

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The instrument described in this user manual has been designed in compliance with the following standards:

• ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and Optical instruments-Medical endo scopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics.

• ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments-Medical endoscopes and endo scopic Accessories Part 3: Determination of field of view and direction of view of endoscopes with 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 9001/13485 quality management systems approved by UL(notified body).

• ISO 14971-2007 Risk management to medical devices.

DIRECTIVE USED

• Directives 93/42/EEC, Article II, Section 5, Annex VIII.

•

IEC 60601-1-3rd edition (2005)

• IEC 60601-1-2

• EN 55011:2007

CLASSIFICATIONS

• For Europe, per Directive 93/42/EEC, the unit is a Class I instrument, Annex IX.

• For the United States, the FDA classification is Class I.

• Please observe all applicable accident prevention regulations.

6. CONDITION OF INSTRUMENT AT TIME OF UNPACKING/SUPPLY

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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. Column, depending on the type of mount ordered.

3. Swivel arm and suspension arm assembly with fiber optic cable.

4. Inclined coupling with magni-changer assembly and objective (as ordered)

5. Observation Head, (inclined or ergo) as ordered.

6. Pair of eyepieces, as ordered.

7. Power cord.

8. Installation Kit a. Allen wrench 5 mm b. Allen wrench 8 mm

9. User manual

7A. INSTALLATION OF BASE (MOBILE STAND)

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Fig 1

Fig 2

Fig 3

Fig 4

Fig 5

Fig 6

1. Open the center support assembly box as shown in fig.-1.

2. Remove the tool kit and foam sheets as shown in fig.-2.

3. Lift up the Centre Support assembly as shown in fig.-3.

4. Place the Centre Support assembly on the floor as shown in fig.-4.

5. Open the Wheel Support assembly boxes as shown in fig.-5.

6. Remove the foam sheets as shown in fig.-6.

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INSTALLATION

Fig 7

Fig 8

Fig 9

Fig 10

7. Lift the wheel support assembly and cover as shown in fig. 7. Place it (Wheels down) under one end of the center support as shown in Fig.-8. Repeat procedure for the other wheel support assembly.

8. Align the holes of the centre support with the holes of both wheel supports and tighten the screws as shown in Fig.-8. using the 8mm allen wrench.

9. Remove the ring, and open 3 screws from shaft as shown in Fig.-9. Unscrew with 4mm allen wrench as shown in Fig.-9.

10. Tighten all screws using the 8mm allen wrench. Place top cover on both wheel support assemblies as shown in fig.-10.

7B. MICROSCOPE INSTALLATION

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Fig.11

Fig.12

Fig.13

Fig.14

7.1 Open the Microscope Box. Remove pillar (Column) from the box. Engage this column onto the shaft matching the guide holes on column has shaft, as shown as B in Fig.-11.

7.1a Align the tapped holes of the column with the shaft and tighten three allen screws from the sides, as shown as C in Fig.-12.

7.2 Make sure that during assembly of the column ring D is fixed in place, as shown in Fig.-13.

7.3 Remove the arm assembly from the box and follow the instructions below (see Fig.-3).

A. Ensure loosening of swivel arm lock knob (A).

B. Place the arm assembly on the column shaft (1) shown in Fig.-3.

C. Screw in the threaded plug from the top (2).

D. Put the protective cap (3) in place, and loosen the suspension arm locking knob (B) so that it can be rotated.

Do not unscrew knob A completely (see fig.14). loosen only a few threads; otherwise the lock ring inside the column guide may disconnect and installation may not possible.

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Fig. 6

Fig. 4

Fig. 5

Fig. 6a

INSTALLATION

7.4 Retrieve the inclined coupling 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 (3).

Make sure that safety screw must tight in place at position (2) to avoid sudden falling of the coupling. Safety screw tagged within the arm.

7.5 Mounting the light guide

• Switch off the illumination system

• The light guide comes pre-routed through swivel arm

(that houses the LED illumination system) and the suspension arm.

• Remove the dust cap from the receptacle.

• Insert the light guide into the receptacle in

the microscope till it properly tighten into position as shown as A in Fig.-5.

• Make sure that wire has been routed in such a way that the carrier system and the surgical microscope are not obstructed, and that they can be moved in their entire range of movement without stretching, extreme, kinking or twisting of the light guide.

7.6 Adjusting of Magnichanger counter Balancing Force

• Spring loaded counter Balancing mechanism is provided

to adjust force on clockwise/anticlockwise rotation of carrier Arm to take care of extra loads of accessories. Refer Fig.-6a.

• Referring Fig.-6a, unscrew the cap X and tighten nuts W1 and W2 with a hexagonal wrench to Adjust Counter Balancing force as per requirement. Refix the nut X in position.

8. ELECTRICAL CONNECTIONS

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Fig. 7

Fig. 8

Fig. 9

AC Inlet

On/off Switch

Device Name

Model Number

Serial Number

Input Voltage

Frequency

Max. Load

Separate Disposal waste electric device

Manufacturer

Company Trademark

Label Control Number

Fuse Rating

IEC60601-1:2005 Labeling for Canada

IEC60601-1:2005 Labeling for USA & Europe

Accompanying Document must be consulted

UL Mark Safety Certification

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 (2).

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.-8.

8.1 REPLACING THE ILLUMINATION SOURCE

Open the swivel arm covers. Detach the fibre optic cable and replace the illumination assembly A with new assembly. Secure back the arm covers.

8.2 FUSE REPLACEMENT

The fuse is located with the AC inlet, provided near the on/off switch. Use a flat head screw driver to open the fuse compartment. Two fuses are provided in this, i.e. one is live fuse and second as spare fuse. Replace the blown fuse with live fuse and secure back the fuse compartment. For fuse replacement refer label shown in fig.-9.

8.3 DATA PLATE FOR PRIMA ENT/DNT MICROSCOPE

8.4. PRIMA WIRING CODING DIAGRAM

ELECTRICAL CONNECTIONS

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9. CONTROL ELEMENTS

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Fig. 11

Fig. 10

Fig. 12

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.

To save burning life of LED, switch OFF the appliance if the microscope 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 intensity control knob.

9.3 SWIVEL ARM LOCKING KNOB

This knob helps 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.- 10.

9.4 BRAKES

Locks the stand from unwanted movement by pressing down the two brakes provided on caster wheels. To unlock press upper portion of brake. See Figure-11.

9.5 ADJUSTING TENSION ON ROTATORY MOTION OF INCLINED CARRIER

10. INSTRUCTIONS FOR USING THE MICROSCOPE

Fig. 13

Fig. 14

Tension adjustment screw

WARNING: INSTRUMENT IS UNSAFE FOR MRI ENVIRONMENT.

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14a

14b

(A)

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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 present as per the ordered configuration. Still user can adjust up and down force by tuning the allen screw clockwise or anticlockwise with the help of a 8mm allen wrench. Refer section 14 for more details. Refer Fig.-13 to see the exact location of tension adjusting screw.

3. Lock the up & Down movement of suspension arm using locking knob (B) in fig.-10 after focusing of the area of interest.

4. Adjust the eye distance as per IPD scale according to your convenience.

5. The illumination is controlled through the control knob (A), fig.-13. Rotate it clockwise or anticlockwise to achieve desired illumination level.

SETTING UP OF MAGNIFICATION (Ref. Fig. 14)

1. Adjust to highest magnification with one of the rotating knobs (14a) provided at magnifica tion changer.

2. Fine focusing is done through fine focus knob or foot paddle.

3. Absolute centering of focused area in field of view can be done by manual handles (14b).

4. Make sure that the magnification changer is engaged in the index point at the click stop position.

Fig. 15

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MAIN MICROSCOPE

The objective lenses with focal lengths of 250mm, 300mm and 400mm are available for different working distances.

The ergonomic straight or 210 degree binocular tube is provided for the main surgeon. The large tilt range allows work with minimum fatigue.

The standard equipment includes eyepieces with a magnification factor of 10X (option:12.5X).

11. CHANGING THE OBJECTIVES & EYEPIECES

Fig. 16

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1. The objectives can be taken out by rotating 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 can be selected by choice.

Fig. 17

12. 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.

2.4 Assistoscope for assistant viewing

3. Install any one or two accessories on any side (Left or right) of the beam splitter

4. Reinstall binocular tube (straight or ergo) on double beam splitter.

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Part No.: 6138000-000 Model: Prima DNT

DSLR CAMERA ADAPTER

SONY HANDY CAM ADAPTER

ASSISTOSCOPE

CCD CAMERA ADAPTER

ERGO HEAD

FLOOR MOUNT

CMO 350

CMO 250

DBS

CMO 400

CMO Nu-Var

ROTO PLATEEXTENDER

Double Iris

Fig. 18

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.

2.4 Assistoscope for assistant viewing

3. Install any one or two accessories on any side (Left or right) of the beam splitter

4. Reinstall binocular tube (straight or ergo) on double beam splitter.

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STRAIGHT BINOCULAR TUBE

DSLR CAMERA ADAPTER

SONY HANDY CAM

ADAPTER

ASSISTOSCOPE

CCD CAMERA ADAPTER

FOOT CONTROL Z AXIS

FLOOR MOUNT

CMO 350

CMO 250

DBS

CMO 400

Part No.: 6137000-000 Model: Prima ENT

DOUBLE IRIS

13. THERMAL CUT-OFF

14. TENSION ADJUSTMENT

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Fig. 19

Fig. 20

Fig. 21

Although instrument is designed for safe working condition thru sufficient cooling facility provided with proper free and forced air circulation by the fans provided in electrical box. Further instrument is designed with an inbuilt safety mechanism with “auto thermal cut-off” if the temperature of 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 the LED user may call LABOMED service personal or authorized dealer.

LED Specifications: 3.7 V, 13.5 Amp

After Supplementary accessories are mounted, the additional load of suspension arm must be Compensated by adjusting tension on tension control screw provided on suspension arm by moving it clockwise or anticlockwise.

Refer fig.-19

1. Remove plate by unscrewing two holes.

2. Loosen two allen bolts by using allen wrench of 4 mm as shown in fig.-20.

3. Use hexagonal wrench of 8mm in bolt (A) shown in fig.-21 rotate it clockwise to increase desired tension on Gas spring.

4. Re tighten the two screws.

5. Put back the plate.

15. MOVING POSITION OF THE SYSTEM

RELOCATING THE STAND

1. Turn off the unit at the power switch.

2. Disconnect the power cable.

3. Remove the video cable from the video modules (e.g., video monitor, USB monitor) and the camera control unit.

4. Release 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 go over steps and edges: the stand ,might topple!

9. Be extremely careful when moving over slopes.

10. Do not park the stand on slopes

11. Press lock downwards.

12. Check whether the stand is locked in position.

Fold the system as shown before moving

Position of the system for safe transportation

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16. CARE AND MAINTENANCE

Surgical Microscope Maintenance/Servicing Check

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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. If a failure occurs which you cannot correct using the trouble-shooting table, Attach a sign to the instrument stating out of order and contact our service representative for servicing Part or circuit diagram etc.

CARE INSTRUCTIONS

• Keep accessories away from dust when not in use, e.g. protect them from dust cover.

• Remove dust with a pneumatic rubber bulb and soft rush.

• Use special optics cleaning cloths and pure alcohol for cleaning lenses and eyepieces.

• Protect your colposcope from moisture, fumes, acids and cosmetic materials. Do not store chemicals

close to the instrument.

• Protect it from improper handling. Never install other deviced sockets or unscrew optical system and

mechanical parts unless explicitly instructed to do so in this manual.

• Protect the microscope from oil and grease. Never oil or grease the guide surfaces or mechanical

parts.

CARE AND MAINTENANCE

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• Remove coarse contamination using a damp disposable cloth.

• Use disinfectants based on the following ingredients: aldehyde, alcohols, quaternary ammonium

compounds.

• Camera: Clean optical components using a lint-free cloth. Soak the cloth using a little methanol or glass cleaner. Do not use ethanol and spirit.

• Do not clean products and optical components in a cleaning/disinfecting device or ultra sound bath.

• LABOMED MaxiLite 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:

• Keep optical parts clean.

• Use and store them in a clean environment only.

• Store under UV light when not in use.

• Use in continuously climate-controlled rooms only.

• Keep moisture away using silica gel and cover with a plastic cover.

OCCUPATIONAL SAFETY AND HEALTH PROTECTION:

Observe work safety and health protection of persons responsible for processing contaminated Products. Current regulation of hospital hygiene and prevention of infection must be observed in the Preparation, cleaning and disinfection of the products.

INSTRUCTIONS

WORKPLACE:

Remove surface contamination with a paper towel.

REPROCESSING:

Recommended reprocess a product immediately after use or as & when required as per below cleaning instructions.

CLEANING & SERVICING:

Needed: water, detergent, spirit, microfiber cloth

• Wipe the instrument and stand (non-optics) with a damp (not dripped wet) cloth regularly. Standard mild household detergents should be used at suitable dilution. Afterward wipe with a dry, non-fuzzing cloth.

• Do not use harsh or corrosive cleaning agents, they can cause damage to painted printed

and plastic parts.

• Avoid splashing water, m

ay cause device-as safety clause in IPXO.

• Use 99% isopropyl alcohol to clean optical components.

• Dry optical components using a microfiber cloth; dry the rest of the product using a paper towel.

• For servicing as and when required, inform LABOMED after- sales service department.

17. AMBIENT REQUIREMENT

For Operation

For Transportation and Storage

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

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The unit meets the essential requirements stipulated in Annex I of the 93/42/EEC directive Governing medical devices. The unit is marked with CE and is compliant to ANSI / AAMI EC 60601

- 1:2005.

18. DISPOSAL

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

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19. TROUBLESHOOTING TABLE

Problem Possible Cause Remedy

No illumination

Insufficient illumination

Brightness level set too low

Adjust brightness control knob

Plug in power cable

Press the power switch to ON position

Defective instrument fuse

Change the fuse

Defective power cable

Change the power cable

Line power failure

Contact in-house technician

Failure of suspension system Electronics

Light guide not properly inserted in arm of microscope

Defective light guide (illumination not uniform)

Change the light guide

Insert the light guide properly to get maximum illumination

Inoperative surgical field illumination

Insufficient illumination (continued)

Up and down motion of the suspension system is stiff

Insert the light guide as far as it will go

Failure of electronics

Illuminate the surgical field using an alternate illuminator,and contact the service department

Switch off via limit switch on suspension arm system

Move the suspension system into the working position

The thermal cut-off in the lamp housing is contaminated

Clean the thermal cut-off with a dry brush or blow it clean, with compressed air

Defective fan; failure of system electronics

Contact the service department

The friction adjustment screw on the suspension system is tightened too firmly

Loosen the friction adjustment screw on the suspension system as needed

Power switch in OFF position

Power cable not plugged in

Inoperative surgical field illumination

Contact the service department

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TROUBLESHOOTING TABLE

Problem Possible Cause Remedy

Stand is unstable

The brakes on the wheels are not in use

Engage the brakes

No image is visible in the field of view

Magnichanger is not indexed properly

Index magnichanger properly

20. TECHNICAL SPECIFICATIONS

Binocular Tubes

Eyepieces

Magnichanger

FOV (Field of View)

Objective

Built-in filters

Vertical Movement of Arm

Microscope Carrier

Accessories

Light Source

Power Consumption

Input Voltage

Stand

Elevation Stroke

Stand Height in Horizontal Position

Base (Dimensions)

Stand Height

Net Weight:

Microscope arm with Magnichanger Head and Eyepieces H-Base Floor Column Ceiling Mount Column (for standard 3m ceiling mount) Wall Mount Bracket Ceiling Mount Bracket

Ergo viewing tube 0° - 210° (tiltable), IPD 50-75mm Optional: Straight viewing tube 90°, IPD 55-75mm

WF 10x/18mm with retractable eye guards, diopter adjustment ± 5mm and diopter lock Optional: WF 12.5x/18mm; fixed eye guards.

5 step: 0.4x, 0.6X, 1.0X, 1.6X & 2.5x;

15° - 2.5° (80-13mm)

f= 250mm, manual fine focus

Yellow or Green

500mm

120° Carrier

Double Beam Splitter and Camera Adapters.

50W LED; Maximum intensity 80,000 LUX

130W Maximum

100V-240V; 50/60 Hz

Stable and sturdy H-base stand with 2 lockable wheels.

570mm

1100mm

600mm width 629mm length

1733mm

16.5 Kg 1 Kg 58 Kg 9 Kg 8 Kg

12 Kg 9 Kg

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21. GUIDANCE TABLES

Guidance and Manufacturer’s Deceleration

Electromagnetic Emissions

All Equipment and Systems

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

Emissions Test Compliance Electromagnetic Environment Guidance

The Prima ENT/DNT is intended for use in the electromagnetic environment specified below. The customer or user of the Prima ENT/DNT 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 Class A

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The Prima ENT/DNT is suitable for use in all establishment, other than domestic, and those directly connected to the public low voltage power network that supplies buildings used for domestic purposes.

The Prima ENT/DNT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

GUIDANCE TABLES (continued)

Prima ENT/DNT is intended for use in the electromagnetic environment specified below. The customer or user of the Prima ENT/DNT should ensure that it is used in such an environment.

Guidance and Manufacturer’s Deceleration

Electromagnetic Emissions

All Equipment and Systems

Guidance and Manufacturer’s Deceleration - Electromagnetic Emissions

Immunity Test Compliance Level

ESD IEC 61000-4-2

± 6kv contact ± 8kv Air

± 2kv Mains ± 1kv I/Os

± 1kv Differential ± 2kv Common

± 2kv Mains ± 1kv I/Os

± 6kv contact ± 8kv Air

EFT IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, Dropouts, IEC 61000-4-11

Power Frequency 50/60Hz 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

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Main power quality should be that of a typical commercial or hospital Environment. If the user of the Prima ENT /DNT requires continued operation during power mains interruption, it is recommended that the Prima ENT/DNT be powered from an uninterruptable power supply or battery.

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the R/H should be at least 30%.

Main power quality should be that of a typical commercial or hospital environment.

Power frequency magnetic field should be that of a typical commercial or hospital Environment.

GUIDANCE TABLES (continued)

The Prima ENT/DNT is intended for use in the electromagnetic environment specified below. The customer or user of the Prima ENT/DNT should ensure that it is used in such an environment.

Guidance and Manufacturer’s Deceleration

Electromagnetic Immunity

Equipment and Systems that are NOT Life-Supporting

Guidance and manufacturer’s Deceleration – Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance

Level

Electromagnetic environment

guidance

Recommended Separation Distance:

d=(3.5/v1)(Sqrt P)

d=(3.5/E1)(Sqrt P)

80 to 800 MHz

d=(7/E1)(Sqrt P)

800 MHz to 2.5 GHz

Conducted RF IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 vrms 150kHz - 80MHz

80MHz to 2.5 GHz @ 3V/m

(v1) = 3 vrms

(E1) = 3 V/m

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Portable and mobile Rf communications equipment should be used no closer to any part of the Prima ENT/DNT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Where P is the max output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed Rf transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol.

Note 1: At 80 MHz to 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from Structures, objects and people.

*Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless) 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 RF transmitters, an electromagnetic site survey should be considered. The measured field strength in the location in which the ME Equipment or ME system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment or ME System.

*Over the frequency range 150kHz to 80 MHz, field strengths should be less than [V1] V/m.

GUIDANCE TABLES (continued)

Guidance and Manufacturer’s Deceleration - Electromagnetic Immunity

Max Output Power of Transmitter (W)

Separation (m) 150kHz to 80 MHz d=(3.5/v1) (Sqrt P)

Separation (m) 80 to 800 MHz d= (3.5/E1) (Sqrt P)

Separation (m) 800 MHz to 2.5GHz d= (7/E1) (Sqrt P)

0.01

0.1 1

100

0.1166

0.3689

1.1666

3.6893

11.6666

0.1166

0.3689

0.2333

0.7378

2.3333

7.3786

23.3333

Recommended separation distance between Portable and Mobile RF Communications equipment and the Prima ENT/DNT for ME equipment and ME systems that are not Life-supporting.

Recommended separation distance for between Portable and Mobile RF Communications equipment and the Prima ENT/DNT

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For transmitters rated at 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 output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

The Prima ENT/DNT is intended for use in electromagnetic environments in which radiated RF disturbances are controlled. The customer or user of the Prima ENT/DNT can help prevent electromagnetic interference by Maintaining a minimum distance between portable and mobile RF communications equipment (Transmitters) and the Prima ENT/DNT as recommended below, according to the maximum output power of the communication equipment.

22. MEASURES AND WEIGHT

CEILING MOUNT

WALL MOUNT

FLOOR MOUNT

Prima ENT/DNT- Microscope with Mobile Stand Total Weight: Approx. 88 kgs.

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150

525mm

1124.6mm

525mm

1124.6mm

150150

536mm

525mm843mm

1464.6mm

23. GLOSSARY

Ametropia Compensation

Working Distance

Color Temperature

Light field diameter

Field of View Diameter

Green Filter

Illumination Intensity

LED

Eyepiece

Convergent Beam Path

White Balance

DSLR Camera

CCD Camera

CMOS Camera

DBS

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Compensation of short-or-far-sightedness. This can be done for each eye using the two individual eyepieces (range: +5 to -5 diopters).

Distance front lens to object level (250mm).

Refers to the color characteristic of a light source. Using color temperature, one can set the color of a light source to warm or cold light Relative to the color of natural light. The unit of measure for color temperature is Kelvin (K).

The size of the field, which is illuminated at a distance of 250mm.

The visible area of an object that can be seen through the microscope. The greater the magnification level, the smaller the field of view and vice versa.

A color filter that darkens red and blue light and brightens green light. Thus, the contrast of the image is increased, blood vessels are shown more clearly.

Specifies the luminous flux from a light source onto a certain area. The unit of measure 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, with which the enlarged image produced by the microscope can be viewed.

The two light beams for the right and left eye run together at a point that lies at a distance of 250mm in front of the front lens. This distance is in accordance with the working distance. This way, the eye does not has to focus on this point in its own, as it is the case with a parallel beam path.

White balance is used to calibrate the camera to the color temperature of the light at the location.

(Digital Single Lens Reflex) camera with a digital imaging sensor.

(Charged Coupled Device) camera with a technology to store a charge and move this charge out of the photo sensor in an organized way.

(Complementary Metal Oxide Semiconductor) camera in which images sensor is a silicon chip that captures and reads light.

(Double Beam Splitter) splits light beam into two directions (one to eye and one to side port) for simultaneous user viewing and photography, videography, or co-observation. Ratio of light distribution is 70% for eyes and 30% to side ports for photography, videography and co-observation.

24. WARRANTY

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This product is warranted by LABOMED against defective material and workmanship under normal use for a period of one year from the date of invoice to the original purchaser. (An authorized dealer shall not be considered the original purchaser). Under this warranty, LABOMED’s obligation is to repair or replace the defective part or product at LABOMED’s discretion.

This warranty applies to new products and does not apply to a product that has been tampered with, altered in any way, misused, damaged by accident or negligence, or which has had the serial number removed, altered, or effaced. Nor shall this warranty be extended to a product installed or operated in a manner not in accordance with the applicable LABOMED instruction manual, nor to a product which has been sold, serviced, installed, or repaired other than by a 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.

This warranty is in lieu of all other warranties implied or expressed. All implied warranties of merchantability or fitness for a particular use are hereby disclaimed. No representative or other person is authorized to make any other obligations for a LABOMED product. LABOMED shall not be liable for any special, incidental, 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 CHANGES

LABOMED reserves the right to make changes in design or to make additions to or improvements in its products without obligation to add such to products previously manufactured.

CLAIMS FOR SHORTAGES

We use extreme care in selection, checking, rechecking, and packing to eliminate the possibility of error. If any shipping errors are discovered:

1. Carefully go through the packing material to be sure nothing was inadvertently overlooked when the unit was unpacked.

2. Call the dealer you purchased the product from and report the shortage. The materials are packed at the factory and none should be missing if the box has never been opened.

3. Claims must be filed within 30 days of purchase.

CLAIMS FOR DAMAGES IN TRANSIT

Our shipping responsibility ceases with the safe delivery in good condition to the transportation company. Claims for loss or damage in transit should be made promptly and directly to the transportation company.

If, upon delivery, the outside of the packing case shows evidence of rough handling or damage, the transportation company’s agent should be requested to make a “Received in Bad Order” notation on the delivery receipt. If within 48 hours of delivery, concealed damage is noted upon unpacking the shipment and no exterior evidence of rough handling is apparent, the transportation company should be requested to make out a “Bad Order” report. This procedure is necessary in order for the dealer to maintain the right of recovery from the carrier.

Labo America Inc.

920 Auburn Court

Fremont, CA

94538 U.S.A.

Phone: 510-445-1257

Fax: 510-991-9862

Email: sales@laboamerica.com

www.laboamerica.com

Labomed Europe b.v.

T.a.v.: Cor Treure

Essebaan 52,

2908 LK Capelle a an den Ijssel

THE NETHERLANDS

Phone: +31-10-458-4222,

Fax: +31-10-450-8251

REP.

A16372

LABOMED

ISO 13485

Labomed PRIMA DNT User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual