User Manual
29 Pages
Preview
Page 1
Issue date:2020/3/16
Surgical Microscope OMS2350 User Manual
The CE mark indicates that the product complies with the European medical device regulation (EU) 2017/745.
Zumax Medical Co., Ltd. 5 Zhiying Street, Suzhou New District, Suzhou, Jiangsu, China 215129 Phone:+86 512 66650502 Fax: +86 512 66909655 http://www.zumaxmedical.com E-mail:[email protected] MedNet EC-REP GmbH Borkstrasse 10, 48163 Münster, Germany
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Preface Thank you for purchasing our Surgical Microscope. To prevent damage to your product or injury to you or to others, read the following safety precaution in their entirety before using this equipment. Keep these safety instructions where all those who use the product will read them.
Precautions 1.
Do not use this instrument in the environment prone to fire and blast or where there is much dust and with high temperature. Use it in the room and simultaneously be careful to keep it clean and dry;
2.
Check that all the wires are correctly and firmly connected before using. Ensure that the instrument is well grounded.
3.
Please pay attention to all the rated values of the electrical connecting terminal.
4.
Only use fuse according to the specifications and rated values stipulated by our product.
5.
Use the power cable supplied with this instrument only;
6.
Do not touch the surface of the lens and prism with hand or hard objects.
7.
Turn off the main power first before replacing the illumination bulb and fuse.
8.
To prevent the instrument from falling down to floor, it should be placed on the floor where the inclination angle is less than 10º.
9.
Turn off the power and cover the instrument with dust-proof hood when it is not in use.
10. In case there is any trouble, please first refer to the trouble-shooting guide. If it still cannot work, please contact the authorized distributor or our After-sales Service Department.
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* THE MARKS USED IN THIS INSTRUMENT
Operating
Warning
Caution
instruction
Protective earth (ground).
ESD
s
The black dot is the video interface
The blue dot is the LED power interface
light-dimmer Increase the brightness clockwise
Balance adjustment
Reduce the brightness counterclockwise
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Contents 1. Purpose and Features ... 1 1.1 Purpose... 1 1.2 Features ... 1 2. Main components ... 2 3. Assembly ... 7 3.1 Assembly of base ... 8 3.2 Assembly of the first arm ... 8 3.3 Assembly of 120 deg coupling ... 9 3.4 Assembly of microscope head... 9 3.5 Assembly of 180ºinclinable binocular tube... 9 3.6 Assembly of handle ... 10 3.7 Assembly of the LED power cable ... 10 3.8 How to connect the power cable ... 10 4. Use of the microscope ... 11 4.1 Working conditions ... 11 4.2 Installation and Adjustment before use ... 12 4.2.1Adjusting the balance of second arm ... 12 4.2.2 Adjusting the microscope ... 12 4.3 Inspection before use ... 13 4.4 Using the microscope ... 14 4.5 Movement and Storage after use ... 14 5. Maintenance ... 16 5.1Replacing the consumable parts ... 16 5.1.1Replacing the LED ... 16 5.1.2 Replacing the fuse ... 16 5.1.3 Replacing the power supply cords ... 16 5.2 Cleaning and Sterilization ... 16 5.2.1 Cleaning the surface of equipment ... 17 5.2.2 Cleaning the surface of the optical lens ... 17 5.2.3 Cleaning and disinfection of sterilizable caps ... 17 5.2.4 Sterilization of sterilizable caps ... 17 6. Microscope accessories list ... 18 7. Trouble-shooting guide ... 21 8. Technical specification ... 22 9. EMC (electromagnetic compatibility) ... 23
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1. Purpose and Features 1.1 Purpose The microscope OMS2350 is used for ENT surgery, dental surgery, neurosurgery, dermatology or other surgery except ophthalmology.
1.2 Features OMS2350 is based on a hanging arm design, it helps the operator by automatically adjusting the exposure, fatigue is minimized even after prolonged use. Six–step magnification for the main microscope, the optical system assures a perfectly clear images. Cool illumination by LED lamp. Natural colors.
Hanging arm design, so the arm can be moved randomly. A special switch has been fitted into the Second Arm: The lamp will keep “on” when the arm is working in its normal range, in "parking" position, the lamp will turn off automatically.
Fig.1 Microscope head
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2. Main components
Fig.2 General assembly of microscope
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25 12 13 14 Fig.3 Back-side view
27
28
Fig.4 Integrated full HD camera
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Fig.5 Interface details [1] Star handler fixation screw. Hang the microscope on the second arm using this nut. [2] Balance adjustment screw for second arm. Rotate the screw with 8mm special spanner to adjust the balance of the second arm. [3] Star handler fixation screw. Use this screw to adjust the vertical moving balance on the second arm. [4] Fixation nut. Hang the microscope on the second arm using this nut. [5] Star handler fixation screw. Use this screw to adjust the damping of the horizontal movement of the first arm. [6] Main power socket, fuse socket. Pull out the power table, right side is fuse socket, fuse specification: T1.25 A/H250 V for 220VAC; T2.5 A/H250 V for 110VAC. [7] Main Power Switch. To turn on or turn off the m1ain power of the microscope. [8] Foot Wheel. Lock the brakes to fix the microscope in place. [9] Star handler fixation screw. Use this screw to adjust the damping of the120ºconnecting arm. [10] Illumination brightness adjusting button. Rotate this button to adjust the brightness of the illumination. A contact
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switch installed in the second arm serves to switch off the bulb when the microscope is in "parking" position. [11] Binocular tube [12] LED power cable and the joint for power cable. [13] Column [14] Filter selection button. Rotate this button to select the filters. There are positions: No filter/ Green filter/ Yellow filter [15] Manipulating handle. For rough focusing, move the microscope up and down or right and left. Available in Type ‘8’. (BFR: I don`t understand, this needs a bit of explanation or leave the text away) [16] Fixation nut. Hang the microscope on the 120ºcoupling using this nut. [17] Star handler fixation screw. Use this handle to adjust the damping of the microscope’s hanging axis. [18] Star handler fixation screw. Use this handle to adjust the damping of the microscope’s pitch. [19] Locking pin. Keep the microscope from falling when assembling and disassembling accessories. [20] Fixation screw of main microscope. Used to fix the main eyepiece tube. [21] Manipulating handle position. Available in Type ‘T’. [22] Fine focusing adjustment knob. Rotate this knob to adjust the focus of the objective, focusing distance: 11mm. [23] 110V/220V Voltage selector. Pushing the selector upwards, input voltage is 110V, pushing the selector downwards, input voltage is 220V. [24] The joint for monitor (Optional) It can output video of built-in camera. [25] video interface (Optional)
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[26] HDMI debug interface (Optional) [27] Integrated full HD camera with SD card (Optional) Microscope head has two buttons as shown in the figure3. Press the left button will take a picture; press the right button will record video. Interface details on the arm as shown in the figure4. [28] Interface details on the arm(LAN、HDMI、SD Card、USB、Debug) (Optional) [29] Inner Camera Remote Control Kit (Optional) The details see instruction of inner camera remote control kit.
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3. Assembly The microscope is packed in one package. Please open the package and take out all parts and assemble them according to the following procedures.
Fig 6. Assembly drawing of microscope
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3.1 Assembly of base (1) Please take out the base support from the package, lay it on the ground. (2) Take out the pole, turn out the inner hexagonal screw and gasket. Insert the pole into the hole of the floor stand, make sure that the pin of the floor stand installed in the hole of the pole. Assemble everything in the following order: gasket, spring gasket, socket screw. Finally fasten the socket screw firmly with an 8mm allen key.
Fig 7. Assembly of base
3.2 Assembly of the first arm Take out the first arm,please pay attention, the star handler fixation screw [3] must be tightened in advance, insert the hole to the axis, then use jump ring pliers to fix the two axis with jump ring in the circle groove, put on the cover. Caution:The Second Arm use a spring to keep the balance. The star handler fixation screw [3] can only to tighten the arm, the arm can not be locked by this screw. The second Arm must be held before loosening the star handler fixation screw [3].
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3.3 Assembly of 120 deg coupling (1) Rotate the star handler fixation screw [9] a little bit until the screw tip does not above the shaft hole; Rotate the Locking pin [19] a little bit until the tip does not above the shaft hole. (2) Take out the Fixation nut [4] from 120ºcoupling, apply a little bit engine oil or grease on its axis, insert the axis into the hole of second arm from the bottom to up, tighten the locking pin [19] make the locking pin [19] into the axis groove, tighten the fixation nut [4] finally.
Fig 8 Assembly drawing of 120ºcoupling
3.4 Assembly of microscope head Take out the microscope head connect it with the hanging axis. Use the method as same as 3.3 to assemble the microscope head to the 120ºcoupling.
3.5 Assembly of 180ºinclinable binocular tube Take out the 180ºinclinable binocular from the package, fix it to the microscope head make sure the pin is in the right position, then tighten the screw [21].
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3.6 Assembly of handle Manipulating handle [15] is fixed on the lower part of microscope, T type handle [21] is fixed on the front of microscope. Assemble the manipulating handle [15] or T type handle supplied with your equipment, then tighten the screw. According your needs, select manipulating or T type handle.
3.7 Assembly of the LED power cable The LED power cable is fixed on the first and second arm. Plug LED power cable into the joint [12]. Caution:The terminals of LED power cable must be plugged in the right holes of the joint.
3.8 How to connect the power cable Take out the power cable and plug it into the power socket [6].
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4. Use of the microscope
Warning: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Warning: To avoid the risk of mechanical hazards, this equipment must only be used in room without threshold.
Warning: Exposure to eyes limit tmax =90 seconds.
4.1 Working conditions Please make check the following points, and continue thereafter: ● Please check whether the main voltage and frequency complies with what required by this equipment. If you will operate the equipment at 110V, please switch the selecting switch [23] to the 110V block and change the fuse to type T2.5 A/H250 V as supplied. If you will operate the equipment at 220V, please switch the selecting switch [23] to the 220V block and change the fuse to type T1.25 A/H250 V as supplied. ● Check the grounding of power supply. Make sure the equipment has a good ground-wire connection. ● Please use the power cable supplied with this equipment. ● Please make sure that all mechanical parts important for your security are assembled correctly. cautions: ● Please never watch the light source directly through the objective. ●The terminals of LED power cable must be plugged in the right holes of the joint. ● Please do not cover the heat elimination grooves of power source. ● Please pay special attention to the caution signs on the equipment.
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4.2 Installation and Adjustment before use 4.2.1Adjusting the balance of second arm ● Hold the second arm, unscrew the star handle fixation screw [3]. ● Insert an 8 mm inner hexagon spanner into the screw [2]. ● Rotate the screw [2] to adjust the balance of second arm. ● Adjust the second arm, check the balance of second arm in multiple positions. ● Adjust the star handle fixation screw [3] until the upwards and downwards resistance are almost equivalent. ● When adding or removing accessories, readjustment of the balance of the second arm is necessary. Caution:The second arm must be held firmly before unscrewing the star handle fixation screw [3].
4.2.2 Adjusting the microscope ● Carry out this adjustment in your normal working position, switch to 0.3 x magnification,adjust the working distance and pupil distance of the microscope. ● Emmetropes/ operators who do not need corrective glasses:adjust the eyepiece to 0. ● Operators using his/her corrective glasses: adjust the eyepiece to 0. ● Ametropes/ operators who need corrective glasses who know their refractive powers and perform surgery without wearing their glasses:adjust the eyepiece to his/her own eyesight. ● Ametropes/ operators who need corrective glasses, who do not know their refractive powers and perform surgery without wearing their glasses, use the following procedure:Adjust both eyepieces to +5D,take the eyepiece and eyepiece tube from the microscope, observe a distant object through the eyepiece, just like using a telescope. Then rotate the diopter adjustment hoop until the image is clear. If necessary, repeat this process for three times. Use the same method to adjust the second eyepiece. Assemble the eyepiece and eyepiece tube back to microscope head, tighten the fixation screw [20]. ● Adjust the eye-cover until the whole visual field can be observed. Adjust the magnification to 3x, when you feel image clear, return to the magnification you want. The image is still clear when you change the magnification, but different in
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depth of field for each magnification. Caution: It is necessary to make a form if several doctors share an operation microscope. Every doctor’s diopter should have noted. Keep the form where all those doctors who use the microscope find it.
4.3 Inspection before use Please inspect the following points before the operation: - Check if all fixation screws and lock pins have been tightened. - Turn on the power switch, then check the following items: Illumination: ● LED should be in good condition. ● When moving the second arm up and down, the LED light must switch on and off. The LED turns off automatically when the microscope is in "parking" position. ● The LED power cable has been connected. Set balance: ● Ground must be level, so the column will be level. ● The damping of first arm, second arm, 120ºconnecting arm (optional accessories) and the microscope has already been adjusted. Microscope: Adjusting the magnification: ●Magnifying knob is [13] working correctly. Eyepiece: ● The screw [11] to fix the eyepieces has been tightened. ● Operating microscope and eyepieces have been adjusted in a suitable position for the operation. ● Pupil distance has been adjusted. ● The eye-cover height has been adjusted to assure the whole visual field can be observed. ● The diopter has been adjusted. ● The images are clear in each magnification setting. Filter selector:
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●Filter selector [14] is in good condition. Base: ● The foot wheels’ brakes have been set. Disinfection cover and handles: ● Star handle fixation screws, magnifying knob, illumination brightness adjusting button、pupil distance adjustment knob, fine focusing adjustment knob etc. have been equipped the sterile covers. ● Microscope head may be equipped with a single use sterile cover according to doctor’s requirement. Caution: When foot wheels are fixed, pushing horizontal prohibited
4.4 Using the microscope - Please make sure the above steps had been taken care of. - The equipment had been inspected according to the requests of Inspection Form. ● Turn on the power switch. ● Move the second arm up and down to the right working position. ● Adjust the illumination. ● Select the filter which will be used. ● Move the microscope lens into the operation area, then adjust it to a suitable position. ● Adjust the magnification. ● Move the operation microscope, adjust rough focusing through the eyepieces, then adjust fine focus. ● Move the second arm to working scope, set an available angle, then lock it by Star handler fixation screw [3]. ● if the equipment is not in use, main power should be off. Caution:Make sure the heat elimination groove is not covered.
4.5 Movement and Storage after use ● Put off all sterilizable caps and handles which can be sterilized in autoclaves. ● Fold the microscope back near the column. Fasten every star knob firmly to fix the arm and the microscope.
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● Release the brakes of the wheels. ● While moving the equipment, hold the movement handles and make the equipment move slowly and carefully to avoid falling and bumping. ● When the storage place has been reached, lock the brakes of the wheels. ● Put on the dust cover.
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5. Maintenance 5.1Replacing the consumable parts 5.1.1Replacing the LED Please contact the after-sales service department. 5.1.2 Replacing the fuse The fuse is integrated with main power input socket. Please replace the fuse according to the following steps: ● Turn off the main power switch. ● Pull out the power plug from the main power plug [6]. ● Find the fuse socket on the right side of power plug [6], take out the fuse socket from the side with a small screwdriver. ● Take out the melted fuse. ● Insert a new fuse and insert the fuse socket back again. ● Plug in power cable. ● Turn on the main power switch. Specification of fuse:T1.25 A/H250 V for 220VAC T2.5 A/H250 V for 110VAC Caution:Please use the bulb specially designed for this equipment.
5.1.3 Replacing the power supply cords Replacement the power supply cords should by the manufacturer specifies service person. Warning: To avoid the unacceptable risk, please use the special cords for the equipment.
5.2 Cleaning and Sterilization
Caution: Dirt on the lens must be cleaned immediately after the surgery. It will be hard to clean when the dirt air-dried.
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