Hand-held Fundus Camera (Model :HFC) Operating Manual V1.0 July. 2015
Preface Thank you for purchasing our HFC (Handheld Fundus Camera). Please read this manual carefully before using this instrument in order to operate it properly and safely. Scope of Application Hand-held Fundus Camera is used to record magnified images of the ocular fundus through the pupil. Product contraindications:n/a Symbols Notice: please read precautions and operating instructions in operation manual Type B applied part Date of manufacture. Manufacture Please refer to the instructions for use. Don t throw away. Keep dry Fragile Upward Handle with care 2
Cautions Please read carefully about following cautions to avoid unexpected personal injury as well as the product being damaged and other possible dangers. 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. Always use the HFC in accordance with the directions and recommendations contained in this User Manual. When operating this product, please do not use optical lens to touch the eyes or nose of patient, avoiding harm to the patient. Avoid subjecting the HFC to vibration or shock. When the product is not in use, please disconnect the power plug and keep it in a safe place. Before operation, please make sure the unit appears no damage or break. If there are breaks in the device cover or other visual defects, please contact Microclear. Only use Li-ion Battery 3.6V2200mAh which shall be provided by Microclear. If you purchase different memory capacity of SD Card it must be formatted to FAT32. Do not increase the illumination light more than required, otherwise harmful to the eye. For illumination and photography, do not select much higher exposure than required. Do not illuminate the eye over the normal exam time, otherwise, harm may be caused to the eyes. WARNING: Do not modify this equipment without authorization of the manufacturer. 3
Contents Preface... 2 Scope of Application... 2 Cautions... 3 Structure instruction... 5 1. Intended Use... 5 2. User Interface... 5 Operation... 8 1. Battery Installation... 8 2. Lens Installation... 8 3. How to Take a Picture... 9 4. Image display...10 5. Data Transferring...11 6. Battery charging...11 7. Power Indicator...12 8. Battery Replacement...12 9. Maintenance...13 Technical Specifications...14 1. Operation Environment...14 2. Storage Environment...14 3. Technical Description...14 4. Classifcation...15 5. Liability...15 6. Warranty...16 7. Standards...16 8. Attention...16 9. Packing list...17 10.EMC Information...17 4
1. Intended Use Structure instruction Hand-held Fundus Camera is used to record magnified images of the ocular fundus through the pupil. 2. User Interface LCD Monitor Picture Mode Reduce Light Level Menu Home: Capture/Enter Increase Light Level Front View 5
Power Button Top View Lens Connect Ring Lens Assembling Mark Lens Connecting Pins Focus Wheel Battery Cover Rear View 6
AV out Mini USB Micro SD Slot Note:AV port is reserved for later use. Bottom View and Memory Slot Optical Lens of Digital Fundus Scope 7
1. Battery Installation Operation Pry Open the battery cover and remove the cover by lifting it up. 2. Lens Installation Step 1: Align the mark of the Optical Lens and Control Unit. Step 2: Hold Optical Lens and attach it on Control Unit. 8
Step 3: Rotate and fasten Optical Lens as shown until the lens stops. 3. How to Take a Picture Step 1: Please press the switch on the top of the device for about 5 seconds, and it will take 5-8 seconds to start up. Step 2: Please turn the focus wheel to get clear view of the anterior segment, then get closer to the eye and slightly turn focus wheel till clear image on screen. Step 3: Please hold the handle with your right hand, and use your left hand to prop the lens up between your thumb and index finger as well as put your left hand palm on the forehead of the patient, then keep the lens steady with 15 to horizontal. 9
Step 4: Please aim at white spot on pupil and push in slightly to fit closely to the orbit with eye patch. Step 5: Please make sure fundus image fully fills the field of view as well as slightly adjust the focus till the vessels shows clear enough, then take a photo Step 6: Get high definition fundus image. 4. Image display Press camera button to take photo and store automatically. After getting pictures, press + or - button to magnify or diminish the image, checking more images by pressing / Press Menu to display/delete image, checking stored images by pressing / 10
5. Data Transferring Place the HFC in the station and connect the mini USB cable to the station. The computer must meet CE or other related international safety standards. Connector to computer for data transfer. Mini USB slot Connector 6. Battery charging Place the HFC in the station and connect the mini USB cable to the station. Connector to computer/transformer for recharging. 11
7. Power Indicator Power Indicator Color Green Light Orange Light Flashing Orange Light No Light Status Battery is higher than 25% when the unit is ON Battery is lower than 25% when the unit is ON Recharging mode The unit is power OFF. 8. Battery Replacement + - Open the battery cover by digging out the gap in the bottom of battery cover with a finger or something pointed. Remove the battery cover by lifting up. Remove the original battery and replace with a new battery, making sure to keep the battery facing the correction direction. Re-cover the battery cover. Warning:Incorrect way of battery replacement will cause HFC not to start up normally. 12
9. Maintenance 9.1Battery and charger safe use and maintenance 1) Please do not recharge and use different model battery to avoid probable explosion or severe damage. 2) Lithium battery has no memory function, so it can be recharged with left electricity inside, not reducing its capacity. 3) Lithium battery is not allowed to over time use when the power indicator turns to orange, please stop use and recharge it. 4) There is over recharging protecting function for the battery, so please do not worry about over recharging. 5) All rechargeable batteries have maximum recharging and releasing times, please do not frequently recharge and release electricity. 6) Lithium battery will work in its best condition between 0 to 35. At too low or too high temperature, it will not work well, so please do not recharge it at lower than 0 or higher than 40. 7) If the device is in stock for long time, please fully recharge the battery and take it out of the device, then store it separately. 8) If the battery is broken, replace it with batteries supplied by Suzhou Microclear Medical Instruments Co., Ltd If wrong type of battery is used, there can be fire hazard. 9) Please do not place the battery together with metal things in a pocket to avoid short circuit causing fire. 10) Please do not use broken battery or battery without shell. 11) Please make battery short circuit, or take apart it, or throw it in fire. 12) Please use charger supplied by our company to recharge the battery. 13) If the power indicator darkens or light off, please recharge. 14) After fully recharging the battery, please disconnect the device with charger, over recharging may cause damage to battery. 15) A battery can be recharged more than 300 times. Recharging times depends on left power in battery during recharging, the less the power is, the longer battery working life will be. 16) After recharging or not using charger, please unplug the charger. 17) During recharging, please do not cover the charger to avoid fire. 9.2 Maintenance The HFC is a precision photo-electronic instrument that shall be handled with specific care. 13
Please note the following cleaning instructions: Power off the HFC before cleaning it. It is recommended to clean the optical lens with cleaning cloth or lens cleaning tissue. Not using HFC for a long time, please take out the battery and place it separately.and please recharge it once a month. HFC needs to be cleaned once a week. Battery maintenance and precaution 1. Operation Environment Ambient temperature 0 to +35 Relative humidity range 10% to 80% Technical Specifications Atmospheric pressure 760hPa ~ 1060hPa 2. Storage Environment Ambient temperature -10 to 40 Relative humidity range 80% Air pressure: 760hPa~1060hPa Production date: See product label Note: It is recommended to remove the battery if the HFC is stored more than 2 weeks. 3. Technical Description Power Source: Rechargeable Lithium battery model:ncm18650-220 3.6V / 2200mAh made in DLG Dimension: 16 9 19cm 3 Weight: 450Grams(Typical) View Angle: 40 Degree(Typical) 14
Diopter: -20D ~ +20D Focus: Manual Focus Camera Resolution: 1920 1080 pixels Search Fundus Lighting: Two modes, natural white Light Emitting Diode(LED) or infrared LED Camera / video flash: Natural white LED LCD Monitor: 3.5 Full Color TFT-LCD Image Format: JPEG(Photograph) Interface: Mini USB File Transfer: Mini USB Port to PC File Storage: SD card up to 16G. Fuse:Fuse model:reomax12.000.2 Size: 3.2*1.6*0.65mm Amps:2A Volts:72VDC 4. Classifcation Electrical protection: internal power equipment Applied part: Type B Mode of operation: Continuous operation Ingress protection: IPX0 Not AP/APG equipment 5. Liability Microclear considers itself responsible for the effects on safety, reliability and performance of this product only if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized. The electrical installation of the relevant room complies with the requirements. The equipment is used in accordance with these instructions for use. 15
6. Warranty Microclear provides the HFC one year warranty for the parts. Warranty for battery is six months. The warranty starts at delivery date. Natural disasters, man-made damage, lack of reasonable care, disassembly, upgrade, warranty sticker torn off, or any phase-out parts are not included in the warranty. 7. Standards Electrical safety IEC 60601-1 : 2005 + A1: 2012 (EN 60601-1 : 2006 + A1: 2013) EMC and regulatory compliance IEC 60601-1-2 : 2007(EN 60601-1-2 : 2007) Wellkang Ltd t/a Wellkang Tech Consulting, (Suite B,29 Harley Street LONDON W1G 9QR England, United Kingdom) 8. Attention If the user s qualified technician repairs the repairable parts designated by producer, please contact the producer to ask for circuit diagram, component list,figure,detailed correction rules,etc. Environment protection: The producer shall collect and dispose the replaced circuit board, control board and power supply box, in order to reduce environment pollution. At the end of the device working life, the producer should do product tracking and recycle the waste camera according to local regulations. Fundus camera and its function can be affected by electromagnetic interference, so please make sure be far away from magnetic objects and strong magnetic field( 1mT). Fundus camera produces and releases electromagnetic energy,and normal use will not interfere with other equipment. Incorrect installation or incorrect use may affect other equipment. 16
9. Packing list Hand-held fundus camera control unit 1 Hand-held fundus camera lens tube 1 Power supply adapter 1 USB cable 1 Charger 1 Battery 18650(Model No.) 1 Eye patch 1 User manual 1 Software disk 1 Dust cover 1 10.EMC Information Guidance and manufacturer s declaration - electromagnetic emissions - for all ME EQUIPMENT and ME SYSTEM. Table 1:Guidance and manufacturer s declaration electromagnetic emissions The HFC is intended for use in the electromagnetic environment specified below. The customer or the user of the HFC should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ Flicker emissions IEC 61000-3-3 Group 1 Class A A Complies The HFC 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 The HFC is suitable for use in all establishments other than domesticand those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes 17
Guidance and manufacturer s declaration - electromagnetic immunity - for all ME EQUIPMENT and ME SYSTEM. Table 2:Guidance and manufacturer s declaration electromagnetic immunity The HFC is intended for use in the electromagnetic environment specified below. The customer or the user of the HFC should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Electrostatic Discharge(ESD) IEC 61000-4-2 ±6 kv contact ±8 kv air ±6 kv contact ±8 kv 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 ±2 kv for power supply lines ±2 kv for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000-4-5 ±1 kv lines to lines ±2 kv lines to earth ±1 kv lines to lines ±2 kv lines to earth Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% U T (>95% dip in U T ) For 0,5 cycle 40% U T (60% dip in U T ) For 5 cycle <5% U T (>95% dip in U T ) For 0,5 cycle 40% U T (60% dip in U T ) Mains power quality should be that of a typical commercial or hospital environment. If the user of HFC requires continued operation during power mains interruptions, it is recommended that the HFC be powered from an uninterruptible power supply or a battery. 70% U T For 5 cycle (30% dip in U T ) 70% U T For 25 cycle <5% U T (>95% dip in U T ) (30% dip in U T ) For 25 cycle For 5 cycle <5% U T (>95% dip in U T ) For 5 cycle Power frequency 3A/m 3A/m Power frequency magnetic fields should 18
(50/60Hz) magnetic field IEC 61000-4-8 be at levels characteristic of a typical location in a typical commercial or hospital environment Note: U T is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer s declaration electromagnetic immunity for ME EQUIPMENT and ME SYSTEM that are not LIFE-SUPPORTING. Table 3: Guidance and manufacturer s declaration electromagnetic immunity The HFC is intended for use in the electromagnetic environment specified below. The customer or the user of the HFC should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the SYSTEM,including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC 61000-4-6 3 Vrms 150 khz to 80MHz 3V Recommended separation distance 3.5 d [ ] V 1 P Radiated RF IEC 61000-4-3 3 Vrms 80MHz to 2.5GHz 3V/m 3.5 d [ ] P 80MHz to 800MHz E 1 7 d [ ] P 800MHz to 2.5GHz E 1 Where P is the maximum output power rating of the transmitter in watts(w) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. 19
Interference may occur in the vicinity of equipment marked wigh the following symbol: Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT and ME SYSTEM for ME EQUIPMENT and ME SYSTEM that are not LIFE-SUPPORTING. Recommended separation distances between portable and mobile RF communications equipment and the HFC The HFC is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HFC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HFC as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m W 150kHz to 80 MHz 80MHz to 800MHz 800MHz to 2.5GHz 3.5 d [ ] V 1 P 3.5 d [ ] E 1 P 7 d [ ] E 1 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 20
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