Labomed PRIMA DNT Trainer User Manual

R
PRIMA DNT Trainer
User Manual
Operating Surgical Microscopy
To ensure proper use of this instrument as well as to avoid injury while operating instrument,
understanding this manual completelybefore use is highly recommended.
Part No: 6167500-795
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Prima DNT Trainer
Warnings & 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.
Instrument is not used in accordance with this User’s Guide.
WAR NING : AN INST RU CT ION THAT DRAWS AT TENTION TO RISK OF I NJURY OR DEAT H.
WARNING: UNITED STATES FEDERAL LAW AND EUROPEAN REGULATIONS
REQUIRE THAT THIS DEVICE BE PURCHASED ONLY BY A PHYSICIAN OR A PERSON ACTING ON BEHALF OF A PHYSICIAN.
WARNING: THIS INSTRUMENT SH OULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS USER’S GUIDE. THE SAFETY OF THE
OPERATOR AND THE P ERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY LABOMED TECHNOLOGIES.
WARNING: DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUT AUTHORIZATION FROM THE MANUFACTURER. ANY REPAIR OR SERVICE TO THIS INSTRUMENT M UST BE PERFORMED BY EXPER IENCED PERSONNEL 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 MUST 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 USEOF THIS INST RU M ENT.
WARNING : T O AVOI D R ISK OF ELECT RI C SHOCK, THIS EQUIPMENT M UST ON LY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH OR DAMAGE TO THIS I NST RUMENT AN D/ OR I NJURY TO THE OPER ATOR OR PATIEN T MAY OCC UR.
WARNING : ENSURE THAT THE VOLTAGE APPLIED TO THE UNIT IS THE SAME AS THE VOLTAGE THAT IS INDICATED ON THE DATA PLATE OR DAM AGE TO THE UNIT MAYOCCUR.
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 E QUIP MENT OR S YS TEM SHOULD NOT BE USED ADJACENT TO OR STACKED W ITH OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED U SE IS NECESSARY, THE EQUIPM ENT OR SYSTEM SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT W ILL BE USED.
WARNING : THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE.
WARNING : B ECAUSE PROLONGED INTENSE LIGHT EXPOSURE CAN DAMAGE THE RETINA, THE USE OF THE DEVICE FOR OCULAR EXAMINATION SHOULD NOT BE UNNECESSARILY PROLONGED, AND THE BRIGHTNESS SETTING SHOULD N OT EXCEED WHAT IS NEEDED TO PROVIDE CL EAR VISUALIZATION OF THE TAR GET STRUCTURES. THIS DEVICE SHOULD BE USED WITH FILTERS THAT ELIMINATE UV RADIATION <400 NM) AND, W HENEVER POSSIBLE, F ILTERS THAT ELIMINATE
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Prima DNT Trainer
Warnings& Cautions (continued)
CAUTION: AN INST RUCT ION THAT DRAWS ATTENTION TO TH E RI SK OF D AMAG E T O TH E PRODUCT.
CAUTION : TH E INTERN AL CIRC UITR Y O F TH E INSTR UMENT CONTAIN S
ELECTROSTATIC DISCHARGE SENSITIVE DEVICES (ESDS) THAT MAY BE SENSITIVE TO STATIC C HARGES PRODUCED BY THE HUMAN BODY. DO NOT REMOVE THE COVERS WITHOUT TAKING PROPER ESDS PRECAUTIONS.
CAUTION: DO NOT USE SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART OF TH IS INSTRUMEN T AS DA MAGE TO THE U NI T M AY OCCUR. SEE MAINTENANCE SECTION FOR DETAILED CL EANING INSTRUCTION.
CAUTION: MEDICAL ELECTRONIC EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EM C I NFORMATION PROVIDED IN THE ACCOMPANYING DOCU MENTS.
CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT C AN AFFECT MEDICAL ELECTRICAL EQUIPMENT.
CAUTION: T HI S I NSTRUMEN T IS NOT TO BE US ED N EAR HIGH-FREQUEN CY EMITTING SURGICAL EQUIPMENT.
CAUTION: T HI S I NSTRUMEN T I S N OT IN TENDED TO B E CONNEC TED TO EQUIPMENT OUTSIDE THE CONTROL OF LABOMED OR M UST BE TESTED TO AN APPLICABLE IEC OR ISO STANDARDS.
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CONTENTS
- Key to symbols
Prima DNT Trainer
-
- Safety Instructions 2
- Special Instruction for Installation & Use 3-4
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-
- Description of Parts 7
- System Diagram 8-9
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Introduction 1
W
arning labels and notes 5
Unpacking 6
Installation & Instruction
Installation Electric Connection Controls Instruction for using the microscope Changing the Objectives & Eyepieces Replacing the Illumination source
Adjustment of tension
10-11 12
12
13-14
15 15 16
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- Disposal 21
- Specification 22
- Dimensions 23
Cleaning & Servicing 17
Ambient Requirement 18
Troubleshooting T
able 19-20
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The LABOMED Prima DNT Trainer is designed to be used during teaching program in restorative dentistry, which is adaptable for different surgical needswithout 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 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 using a fiber optic guide 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.
INTRODUCTION
4. When the microscope is not in use, the suspension arm can be folded over the main body to store it compactly.
5. 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.
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SAFETY INSTRUCTIONS
2
Safety
This 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.
This manual contains information on safety aspects governing the use of this product and brief summary of important precaution for this user.
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. Please pay special attention to these safety notes.
Safety is only ensures when this instrument is operated properly. Please read this manual carefully before turning the instrument on. Also read through the user’s manuals on the other equipment used with this instrument. You may obtain further information from our service organization or authorization representative.
Directives and standards
The instrument in this manual has been designed in the compliance with the following standards
- EN
- IEC
- UL
- CSA
- As per Directive 93/42/EEC, the unit is a Class I intrument
- For USA: FDA classification Class I
- IEC 60601-1:2007(3rd edition) Compliance
Please observe all applicable accidental prevention regulations.
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SPECIAL INSTRUCTIONS for INSTALLATION & USE
3
Safe Working Order
Do not operate the equipment contained in the delivery package in
- Areas having explosion or inflammability, risk the presence of inflammable anesthetics or
volatile solvents such as alcohol, benzene or similar chemicals.
Do not install, store or use the instrument in damp rooms. It is important and cautionary to protect the instrument from being exposed to humidity, wet conditions, water splashes or water sprays.
Do not use the instrument if you notice any electrical arcing, sparks, abnormal noises,
smokes or fumes. Unplug it immediately and contact authorized LABOMED service representative.
Ensure that the power point is properly grounded
Do not force cable connections. If the male and female parts do not readily connect,
make sure that they are appropriate for one another. If any of the connectors and damaged, have our service representative repair them.
The effects of Radio waves and interference on medical imaging systems and equipment
are unpredictable. It is cautionary to mention that mobile phones or radios not be used in the proximity of the equipment.
Anything concerning repairs, customization and upgradation this instruction must be carried out by LABOMED authorized representative failing which, LABOMED product warranty will not be applicable.
The instrument must be operated for its intended use and only after duly understanding the operation instructions or undergoing training on use of the instrument by a LABOMED authorized representative.
Only use the instrument with the accessories supplied. Should you wish to use other
accessories equipment, make sure that LABOMED or the equipment manufacturer has certified that its use will not repair the safety of the instrument.
It is recommended that the user’s manual be kept accessible always.
Do not pull at the light source cable, at the power cord or at other cable connections.
It is recommended to get the instrument checked once every 12 months to ensure its optimum performance.
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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 and properly connected and screw connections tightened.
- All cable and plugs are in good working condition.
- The voltage setting on the instruments conforms to the rated voltage of the line
supply on site.
- The power cord being used in the one designed for use with this instrument.
Before every use after re-equipping the instrument
Make sure that all “Requirement for operation” are fulfilled.
Go through the checklist
Re- attach or close any covers, panels or caps which have been removed or opened.
Pay special attention to warning symbols on the instrument (triangular warning signs with exclamation marks), labels and any parts such as screws or surfaces painted red).
For every use of the instrument
Avoid looking directly into the light source, e.g. into the microscope objective lens or a light Guide.
All light radiation have an effect on skin and biological tissues. For your own protection and advices to keep the light level to the absolute minimum required for your procedure.
Warning!
Only the right configuration of LABOMED Prima DNT Trainer surgical microscope must be used for related procedure.
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safety compliance brand name
Prima DNT Trainer
for the suspension system about the admissible maximum load.
Com pliance to Medical Device Direct ive 93/42/EE C
Accompanying Document must be consulted
REF
Catalog Number
Protective Earth
5
of 7.5 kg. Please consult the user manual
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