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Meanings of Symbols

Symbol for “Type B applied part”.

Symbol for “Power ON”.

Symbol for “Power OFF”.

Symbol for “Follow instruction for use”.

Symbol for “Caution”.

Symbol for “Warning High-voltage”.

Symbol for “Caution High-temperature”.

Symbol for “MANUFACTURER”.

Symbol for “AUTHORISED
REPRESENTATIVE IN THE
EUROPEAN COMMUNITY”.

Содержание Nonmyd 8S

Страница 1: ...Non mydriatic Retinal Camera KOWA KOWA nonmyd 8s US EU INSTRUCTION MANUAL ...

Страница 2: ......

Страница 3: ...tion or requires hospitalization or long term outpatient treatment 2 Bodily injury means an injury burn electric shock and so forth that will not necessitate hospitalization or long term outpatient treatment 3 Property damage means extensive damage to a house and or household goods as well as a domestic animal and pet Meanings of Symbol Graphical indication of any warning and caution What is warne...

Страница 4: ...osed etc immediately unplug the instrument from the power outlet Continued use poses risk of fire or electric shock Make sure to insert the power plug into the power outlet completely and securely A loosely connected electrical plug may cause a fire or electric shock Do not damage modify or rest heavy object on the power supply cable Damage to the power supply cable may result in the exposure of l...

Страница 5: ...uch as benzene or ether Doing so may cause discoloration or degradation Obligatory The power supply must be provided for the sole use of this instrument Sharing the same pow er supply with other external devices may cause instrument malfunction When moving the chin rest up or down to adjust the height of the examined eye carefully op erate the instrument while checking the position of the patient ...

Страница 6: ...t Symbol for Power ON Symbol for Power OFF Symbol for Follow instruction for use Symbol for Caution Symbol for Warning High voltage Symbol for Caution High temperature Symbol for MANUFACTURER Symbol for AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY ...

Страница 7: ... and connectors at the same time as it may adversely affect the safety 11 Using alcohol disinfect the parts accessible by the patient 12 The power supply must be provided for the sole use of this instrument 3 Precautions when using a digital camera or this instrument 1 Carefully handle the objective lens as soiled or scratched parts of an objective lens may be imaged as white spots 2 Always cover ...

Страница 8: ...hall be considered after using the instrument 1 Turn OFF the instrument after setting control switches dials and so forth to their initial status following with a specified procedure 2 Do not pull cables for removal because an excessive force is exerted on them 3 The following shall be considered regarding storage location Store at a location away from water or accidental splashing Store at a loca...

Страница 9: ...ecified to this system 6 Power supply to this system or Multi tap with Isolation Transformer must be provided individually Do not route the power supply through other multi tap to the system or Multi tap with Isolation Transformer 7 The power supply cable for electrical equipment that composes a medical system must have durability that meets IEC 60245 IEC 60227 or higher standards 8 Assure that th...

Страница 10: ...NT LEAKAGE CUR RENT to exceed limits See Note 1 Verify total PA TIENT LEAK AGE CURRENT 1bItems A and B are ME EQUIP MENT powered via a MULTI PLE SOCKET OUTLET A IEC 60601 B IEC 60601 MULTIPLE SOCKET OUTLET Earth conductor of the MULTIPLE SOCKET OUTLET is broken See also 1a Additional PROTECTIVE EARTH CON NECTION for A or B or Separating trans former 1c Item A is ME EQUIPMENT and B is Non ME EQUIPM...

Страница 11: ...hous ing for SIGNAL INPUT OUTPUT PART or SEPARATION DEVICE 3c Item A is ME EQUIPMENT and item B in is ME EQUIPMENT or non ME EQUIPMENT a Potential differ ence between PROTECTIVE EARTH CON NECTIONS of A and B b Due to high TOUCH CUR RENT of B See rationale for 16 5 Additional PROTECTIVE EARTH CON NECTION for A or SEPARATION DEVICE or Do not use metal connector housing in the PATIENT ENVI RONMENT NO...

Страница 12: ...tion target 3 This instrument is not designed to be used adjacent to other instrument or placing one on top of another Therefore do not apply such use Nevertheless if such use is inevitable it is necessary to constantly monitor whether if the instrument is functioning normally after such use has been adopted 4 Accessories and options used with this instrument are tested for EMC when combined with ...

Страница 13: ...tact 8kV air 6kV contact 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 EN 61000 4 4 2kV for power supply lines 1kV for input output lines 2kV for power supply lines 1kV for input output lines Mains power quality should be that of a typical commercial or h...

Страница 14: ...ssess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the KOWA nonmyd 8s is used exceeds the applicable RF compliance level above the KOWA nonmyd 8s should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as rec...

Страница 15: ...s 2 Others INSTRUCTION MANUAL 1 Digital camera setting manual 1 Optional Accessories Numeric keypad 1 External fixation target 1 K9L LE57 Disital imaging system filing software VK 2 1 User s guide 1 Installation manual 1 0 00 1 2 3 4 5 6 7 8 9 Enter Back Space Num Lock PC for filing software 1 OS Windows 7 8 1 10 HDD 10GB for filing software 100GB for data storage CPU Celeron single core 2GHz Memo...

Страница 16: ...ponent for a Short Distance 13 4 4 Raising and Lowering the Optical Component 13 4 5 Raising and Lowering the Chin Rest 13 5 Preparations for Photography 14 5 1 Preparing the Instrument 14 5 2 Preparations for Patient s Eye Examination 14 6 Operational Procedure in Photography 15 6 1 Basic Photography 15 6 2 Precautions for Continuous Photography 21 6 3 Terminating Photography 21 7 Advanced Photog...

Страница 17: ...ages 1 3 Operator Persons with specialized knowledge of ophthalmic care and who received introductory education of retinal camera pho tography are required to operate this instrument Please use this instrument indoors without a bright light which causes miosis of patient pupils 1 4 Features 1 Field angle available is 45 2 Functions that support mosaic photography 3 A high resolution digital camera...

Страница 18: ...trument You can also switch the inter nal fixation target position for the auto setting of the internal fixation target position during mosaic photography LCD monitor Black and white live image of the anterior segment or retina appears for you to use for alignment and fo cusing Digital camera Shutter button Pressing this button turns the flash on and takes a photo Control lever Use this lever to m...

Страница 19: ...on turns OFF during mosaic photography and the internal fix ation target selection function becomes disabled Anterior segment button Pressing this button switches the image shown on the LCD monitor between anterior segment and retina The button illuminates when the anterior seg ment is selected Optical component fixing screw Tighten the screw when you need to fix the optical component SP button Us...

Страница 20: ...the lamp cover Eye level mark Used for aligning the verti cal position of the patient s eye with this mark Forehead rest Used for resting the patient s forehead against it Anterior segment observation lamp Infrared LED lamp that illu minates when the anterior segment is observed Power supply unit See the next page for details Air vent 1 System Description ...

Страница 21: ...onnect a PC to the instrument Numeric keypad connecting terminal Type A Connect a numeric keypad optional accessory using this terminal when you define an internal fixation target position of your choice for mosaic photography Cable clamps Used for holding cables to keep them from being disconnected External fixation target connecting terminal A terminal which you connect an external fixation targ...

Страница 22: ...0 Left or right eye This indicates which eye you are currently observing Left eye L Right eye R 11 SP Used for a small pupil diameter ON SP OFF none 12 Diopter compensation This indicates the diopter compensation knob position Without compensation 12 D to 13 D none compensation 10 D to 35 D D compensation 32 D to 10 D D 13 Mosaic photography sequence or positions This indicates the current photogr...

Страница 23: ... appear during the retinal observation for ad justing the working dots No aid appears in mosaic photography 19 Working dots These dots are shown optically for adjusting the distance and position of a patient s eye No dot appears in mosaic photography 20 Data Transfer in Progress This is indicated while the instrument is transferring data 21 Charging indicator This is indicated that it is being cha...

Страница 24: ... supply unit and lift the instrument as shown in the right figure Do not lift the instrument holding any parts other than shown Make sure the place where you are going to set the instrument is flat with no obstacle that may catch your hand Be careful not to get your hand caught during installation 2 Make sure the power switch is in the OFF position 3 Install the digital camera in the camera mount ...

Страница 25: ...ds to be disconnected from the instrument when the instrument is to be relocated or the inside of the digital camera is to be cleaned In such a case contact Kowa or your Kowa dealer in advance for the correct procedures and precautions for detaching the digital camera The digital camera supplied with this instrument is set for retinal camera photography Do not change the set tings Do not detach th...

Страница 26: ...s in the IT NETWORK configuration or disconnecting items from the IT NETWORK Connection of additional items to the IT NETWORK Update or upgrade of equipment connected to the IT NETWORK Required characteristics configuration technical specification of the IT NETWORK USB 2 0 1 1 Image Transfer Protocol Media Transfer Protocol Image Condition Transfer Protocol Refer to 12 1 OS Windows 7 8 1 10 0 HDD ...

Страница 27: ...ll as details of how to use the software see the attached Installation manual filing software and User s guide filing software 3 2 Saving Captured Images in an SD Memory Card Color images can be stored in the SD memory card Insert an SD memory card into the digital camera Captured images will be stored in the SD memory card Captured images saved in an SD memory card Captured images saved in an SD ...

Страница 28: ...er tightly in upright position 4 3 Fine Motion Moving the Optical Component for a Short Distance In order to move the optical component for a very short distance hold the control lever gently and tilt it lengthwise or crosswise 4 4 Raising and Lowering the Optical Component In order to move the optical component up and down turn the rubber ring of the control lever Turning the ring to right moves ...

Страница 29: ...n it is at a position other than the reference position the indica tor illuminates Diopter compensation knob Pushed position D or D does not appear on the LCD monitor when it is in the initial position 5 2 Preparations for Patient s Eye Examination 1 Reduce room s illumination as bright as to make letters on this manual barely readable so that the patient s pupil can naturally turn to the size of ...

Страница 30: ...e in the center of the LCD monitor Move the optical component to place two working dots in the anterior segment working dot position aids shown on the LCD monitor 5 Check the pupil diameter Normal pupil photography Pupil diameter φ 4 0 mm or greater SP Small pupil photography Pupil diameter φ 3 3 mm to 4 0 mm 6 Adjusting flash intensity Change the flash intensity depending on pupil diameter 7 Chec...

Страница 31: ...display Make sure that ANTERIOR is shown at the upper part of the LCD monitor Press anterior segment button when ANTERIOR is not shown 6 1 3 Guiding patient s fixation Instruct the patient to look straight ahead Perform the step described in 6 1 5 Alignment Anterior Ask the patient to look straight ahead at the green blinking spot when the patient s pupil becomes shown in the center of the LCD mon...

Страница 32: ...rd or upward downward in order to capture the pupil at the center of the LCD monitor Rotate the focusing knob until the black line engraved on the knob faces upwards After the pupil image is captured successfully move the optical component forward until two working dots come in two pairs of round brackets Beginning of alignment Focusing knob position Alignment completed ...

Страница 33: ...hat the pupil dilation can be facilitated It would be difficult to capture a clear image when the pupil diameter is insufficient However it may not be appli cable to some patients 6 1 6 Adjusting flash intensity Change the flash intensity by the flash intensity control knob as needed depending on the condition of dilation The flash intensity is automatically set to the standard level sufficient fo...

Страница 34: ...etinal observation After alignment of the anterior segment is completed press the anterior segment button to switch to retinal observation When you would like to go back to anterior segment observation press the button again ANTERIOR and the pupil diameter aid of the LCD monitor disappear during retinal observation Anterior segment work ing dot position aids changes to retinal working dot position...

Страница 35: ... at the green blinking light Patients would recognize the fixation target at the locations shown in the right table depending on whether the right or left eye is examined and which fixation target position is selected 6 1 11 Alignment Retinal Move the optical component slightly until the sizes of the two working dots become the smallest and the dots are aligned on the top of the left and right ret...

Страница 36: ...ted due to the flash light in the previous photography In such a case wait for a while and make sure that the pupil diameter is sufficient for photography 6 2 2 Photographing the other side of the eye When continuously photographing the other side of the eye pull the optical component toward you so that it will not con tact the patient s eye or nose then move the optical component to the other sid...

Страница 37: ...onent leftward rightward and upward downward to position the pupil image in the center of the LCD monitor Move the optical component to place two working dots in the anterior segment working dot position aids shown on the LCD monitor 6 Check the pupil diameter Normal pupil photography Pupil diameter φ 4 0 mm or greater SP Small pupil photography Pupil diameter φ 3 3 mm to 4 0 mm 7 Adjusting flash ...

Страница 38: ...ids on anterior segment observation display changes depending on the photographing part of the eye In auto setting one internal fixation target is automatically switched to another after completing each photography and the corresponding photographing part of the eye is also changed consequently When you want to photograph again because of poor photo quality press the left key of the menu buttons S...

Страница 39: ...ypad Keys of a numeric keypad are used to select the internal fixation target positions in manual setting Relationship between the keys and the internal fixation target positions is shown below Back Space Keys of a numeric keypad Right eye Left eye Shaded keys are invalid The numbers from 1 to 9 that appear at the bottom of the display indicate photographing parts of the eye and keys of a numeric ...

Страница 40: ...fferent positions as shown in the figures below Align appropriately so that the working dots fit within the anterior segment working dot position aids FIX TARGET appears at the lower right of the LCD monitor during retinal observation in order to indicates the eye fixa tion direction for a patient the position of the internal fixation target from a patient Tell the patient the direction shown on t...

Страница 41: ...FF EXT appears at the lower right corner of the LCD monitor when the external fixation target is in use 7 3 Diopter Compensation Range When clear focus can not be obtained by focusing pull out diopter compensation knob Pulling out the diopter compensation knob to the first stop enables the minus diopter compensation D and pulling out to the second stop enables the plus diopter compensation D Slowl...

Страница 42: ...nstrument is positioned too close to the patient s eye The instrument is positioned too far from the patient s eye Locate the optical component to the position where working dots become smallest If flare still persists pull the optical component a little or move the optical component to the patient Working dots may be fades a little The image is dark The pupil diameter is small Turn the flash inte...

Страница 43: ...igital camera to manual mode Trigger cable is not fully inserted Fully insert the trigger cable to the end Although image are successfully captured and shown on the LCD monitor of the digital camera the monitor of the PC presents no im age The USB cable is not fully in serted Fully insert the USB cable to the end Images are captured without the flash lamp turned ON The synchronous cable is not ful...

Страница 44: ... There could be a failure of an internal circuit ERROR 6 POWER OFF CALL SERVICE PERSON Initialization to the internal memory failed There could be a failure of an internal circuit ERROR 12 POWER OFF CALL SERVICE PERSON Initialization to an internal circuit failed There could be a failure of an internal circuit NOW COOLING PLEASE WAIT 120 s Cooling has been started since the recharge circuit temper...

Страница 45: ...ixation Target in Mosaic Photography The internal fixation target switching method is defined in this item You can select either manual mode that requires a numeric keypad optional accessory for operation or Auto mode which automatically switches the fixation targets You also set the illuminating order for auto mode and select the mirror symmetry of illuminating orders for the left and right eyes ...

Страница 46: ...umber corresponding to the part of the eye in the order you want to photograph Press the menu button to set the illuminating order When you terminate setting highlight SET and press menu button When you would like to restart the setting highlight RESET and press menu button Also you can select the mirror symmetry of illuminating orders for the left and right eyes When you want to apply the mirror ...

Страница 47: ... Other Setting Menu Press the menu button while OTHER SETTING is highlighted to access the sub menu screen for other settings of this instrument 9 4 1 POWER ON MODE This item allows you to select the default state of Blue Brown selection switch when turning the power ON Setting BROWN Brown eye Factory setting BLUE Blue eye How to set Press t or u menu buttons to switch the setting while POWER ON M...

Страница 48: ...segment observation after photography or not Setting AUTO The display automatically switches back to anterior segment MANUAL The display does not automatically switch back to anterior segment How to set Press t or u menu buttons to switch the setting while EXTERNAL ALIGNMENT NORMAL is selected Select END and press menu button while the setting of your choice is highlighted to select the setting Re...

Страница 49: ...ation image Use the image to set the LCD monitor screen brightness or contrast Press p or q menu buttons to increase or decrease the brightness or contrast While looking at the observation image on the LCD monitor select an appropriate brightness or contrast and press menu button 9 4 6 Exiting menu To exit menu mode select END in any of the menu screen ...

Страница 50: ...ntact Kowa or your Kowa dealer 6 Disconnect the power supply cable when the instrument is not used for an extended period of time 10 2 Daily Inspection Inspect this instrument in accordance with KOWA nonmyd 8s daily inspection table below When an anomaly found during the inspection may not be solved using any of the maintenance methods described in this instruction manual contact Kowa or your Kowa...

Страница 51: ...3 Using high pressure air blow off debris or dust 4 When the air does not clean the objective lens moisten cleaning paper with anhydrous ethyl alcohol and clean the lens starting from its center in a circular motion Tips for lens cleaning Do not reuse cleaning paper Use a new lens cleaning paper with cleaning solution to obtain the best results Cleaning the lens without removing soils or applying ...

Страница 52: ... was squeezed off 10 7 Replacing Flash Lamp Warning Unplug Warning High Voltage When replacing the flash lamp make sure the power is turned OFF and then unplugged from the power outlet Otherwise there may occur electrical shock Warning Unplug Warning High Voltage This instrument is equipped with a storage ca pacitor for photography light Replacing the flash lamp while this capacitor is still not y...

Страница 53: ...F and the flash lamp is fully cooled down about 10 minutes after the power is turned OFF unscrew the two screws with a screwdriver and remove the flash lamp socket 6 Hold the lamp and its socket in your hand remove the flash lamp and install a new lamp in the socket When replacing the flash lamp pull straight out and push straight in the bulb towards the direction of electrode pin Do not twist the...

Страница 54: ...utes for safety 3 Press down the fuse holder with a screwdriver and turn the fuse holder to the direction of the arrow counterclockwise for removal 4 Pull out the old fuse and replace it with a new one Make sure that the fuse type and rating are correct 5 Press down the fuse holder with a screwdriver and turn the fuse holder to the opposite direction of the arrow clockwise and install it in place ...

Страница 55: ...i B Numeric keypad input USB Type A Power supplies Input AC100 240V 50 60Hz Power consumption 150VA Dimensions 310 W x 504 D x 548 H mm Weight 21kg 46lbs excluding the attached digital camera S L Image size set on the digital camera Compliance Standard IEC 60601 1 2005 A1 2012 EN 60601 1 2006 A1 2013 IEC 60601 1 2 2007 EN 60601 1 2 2007 Classification Equipment based on IEC 60601 1 EN 60601 1 Acco...

Страница 56: ...ted specifications Baud rate 38400 Data length 8 bit Parity even Stop bit 1 bit Flow control none Output data Output item Description Example Model name Fixed value K9L61 Instrument number 10 digit number 19077 SP mode NORMAL SP NORMAL Flash intensity control position 2 1 0 1 2 0 Blue or brown eye BLUE BROWN BLUE Diopter compensation 0 D D 0 Left or right eye L R R Fixation target INT EXT INT Inte...

Страница 57: ...For EU Market ...

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Страница 60: ...com 3 1 Chofugaoka 3 chome Chofu Tokyo 182 0021 Japan 4 14 Nihonbashi honcho 3 chome Chuo ku Tokyo 103 8433 Japan Phone 81 3 3279 7639 Facsimile 81 3 3279 7541 E mail life kowa co jp U R L http www kowa co jp e life World Sales Headquarters Kowa Company Ltd Chofu Factory 2015 2017 Kowa Company Ltd All rights reserved K9L63 V1 6KE 171120 KW Printed in Japan ...

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