C-MER rainsoptics fundus link 20D001 Instruction Manual Download Page 10 | Manualshive

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C-MER rainsoptics fundus link 20D001 Instruction Manual Download Page 10

IFU-20D001-20220913

Page

9

Table of Contents

Product Description

................................................................................................................................................. 1

Intended Use

............................................................................................................................................................. 1

Contraindications

..................................................................................................................................................... 1

Warnings and Cautions

............................................................................................................................................ 2

Notice of compliance

............................................................................................................................................... 6

............................................................................................................................................................... 8

Table of Contents

..................................................................................................................................................... 9

Parts and Feature of Fundus Link

......................................................................................................................... 10

Procedures for before use

..................................................................................................................................... 12

Procedures for Mounting the Fundus Link onto the iPhone

............................................................................. 14

Investigation

........................................................................................................................................................... 15

Cleaning Fundus Link

.............................................................................................................................................. 19

Fundus Link Care

..................................................................................................................................................... 21

Product Specification

............................................................................................................................................. 22

Device Class

............................................................................................................................................................. 23

Troubleshooting

..................................................................................................................................................... 24

Important Symbols

................................................................................................................................................. 25

Contact Information

............................................................................................................................................... 27

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Summary of Contents for fundus link 20D001

Page 1: ...funduslink model 20D001 instructions manual...

Page 2: ...fundus for the purposes of general visualization for the retina or back of the eye It can be operated by health care professional be used for patient as adult Contraindications Because prolonged inte...

Page 3: ...temporary visual disturbances particularly in patients with a history of light sensitivity or migraines Multiple flashes per eye in a single exam may increase the likelihood of occurrence Clean and d...

Page 4: ...y C MER RainsOptics Limited or by a centre approved by C MER RainsOptics Limited Do not the device in direct sunlight Strong ambient light may affect the results Do not use automatic cleansing machine...

Page 5: ...tery Do not disassemble modify crush or destroy the battery pack Doing so can cause battery fluid leakage heat generation burns fire and or explosion Do not replace of battery with an incorrect type t...

Page 6: ...observed to verify that they are operating normally Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inche...

Page 7: ...t generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications However there is...

Page 8: ...at comply with Innovation Science and Economic Development Canada s licence exempt RSS s Operation is subject to the following two conditions 1 This device may not cause interference 2 This device mus...

Page 9: ...Cet quipement est conforme aux limites d exposition aux radiations d finies par le Canada pour des environnements non contr l s Cet metteur ne doit pas tre install au m me endroit ni utilis avec une...

Page 10: ...compliance 6 Trademarks 8 Table of Contents 9 Parts and Feature of Fundus Link 10 Procedures for before use 12 Procedures for Mounting the Fundus Link onto the iPhone 14 Investigation 15 Cleaning Fun...

Page 11: ...IFU 20D001 20220913 Page 10 Parts and Feature of Fundus Link 1 2 3 4 5 6...

Page 12: ...or will be flashing Bluetooth Connection Blue LED indicator will be constant on Preview Mode Green LED indicator will be constant on Low battery Amber LED indicator will be flashing Battery charging A...

Page 13: ...ging should take approximately 4 hours Please connect the charger to the Fundus Link and to the mains During the charging the YELLOW indicator light is constant on The YELLOW indicator light will turn...

Page 14: ...nnection To initiate the Bluetooth connection put both Fundus Link and the smartphone within 0 3 meter 1 foot from each other 1 Power on the Fundus Link the GREEN indicator is flashing 2 Switch on you...

Page 15: ...Fundus Link onto the iPhone 1 Pull out the bottom clamp 2 Insert the iPhone and make sure the alignment bar on the mount have aligned to the side wall of the iPhone Note Make sure the camera on the i...

Page 16: ...IFU 20D001 20220913 Page 15 Investigation WARNING Ensure the Fundus Link DO NOT contact with the subject eye Or use the Eyecup for protect the subject eye...

Page 17: ...ark environment allows pupils naturally dilated during investigation 1 Ensure the Bluetooth connection is well connected between Fundus Link and Smartphone BLUE indicator is constant ON 2 Press the SH...

Page 18: ...ding the device and pressing the shutter with your Left hand Ask the patient to look at your Right ear for fixation Ask the patient to look at your Left ear for fixation Touching the patient s forehea...

Page 19: ...dilation 7 Release the SHUTTER button for flash lighting and remote control the smartphone to capture the image CAUTION Capturing failures could be due to limited pupil size blinking and alignment is...

Page 20: ...m the device Remove the eyecup from the device Using a commercially blower to blow away dust when it adheres to the lens And using a soft cotton cloth wipe the lens gently in a circular motion Fundus...

Page 21: ...or The eyecup should be replaced when Discolored Deteriorated Shattered cracked or disintegrated CAUTION Do not use cleaners that contain organic solvents to clean the Fundus Link body or lens Fundus...

Page 22: ...blow away dust when it adheres to the lens To remove dirt grease or fingerprints clean with a soft cotton cloth rubbing in a circular motion Use of coarse cloth or unnecessary rubbing may scratch the...

Page 23: ...ing Diode LED Operating Environment 10 C to 40 C 30 to 75 700 1060hpa Storage Transport Environment 10 C to 55 C 30 to 75 700 1060hpa Compatible smartphones model Apple iPhone 12 Power Source Recharge...

Page 24: ...yecup Soft pouch Battery charger USB charging cable Instruction for use Soft cloth Dust sweeper Lens cover Activation Card Device Class This product has been tested to meet the requirements under ISO...

Page 25: ...IFU 20D001 20220913 Page 24 Troubleshooting TBD...

Page 26: ...electrical equipment designed primarily for indoor use Symbol for Consult Instructions for Use or Consult Instruction Manual Symbol for Follow instruction for use Do not operate or leave this assembl...

Page 27: ...tering the European market to indicate conformity with the essential health and safety requirements set out in European Regulation US Federal Communication Commission Waste Electrical and Electronic E...

Page 28: ...ct Information Manufacturer C MER RainsOptics Limited Manufacturer Address Room 607 6 F 17W of Hong Kong Science Park No 17 Science Park West Avenue Shatin N T Hong Kong Tel 852 35905755 www cmerrains...

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