fundus link model: 20D001 instructions manual
Product Description Fundus Link is an adapter lens that can be clipped over the camera on smartphone, intended for examiner to place Fundus Link close to subject’s eye for retinal imaging. It is an ultra-compact, ultra-wide field smartphone ophthalmoscope. Digital images of the back of the eye can be captured by the smartphone with Fundus Link.
Warnings and Cautions WARNING • • • • • • • No modifications to the Fundus Link hardware are permitted. To prevent fire or electrical shock. Do not expose or use the device in raining or moisture. The Fundus Link is not protected against the ingress of water and should not be used in the presence of liquids which may enter the device. Portable and mobile RF communications equipment can affect the Fundus Link performance.
CAUTION • • • • • • • • • • Use only smartphone that are listed as compatible with the Fundus Link. The Fundus Link avoid using the device in a dusty environment. The Fundus Link avoid subjecting the device to vibration or shock. Do not sterilize the device. Keep the device away from any heat source. All servicing of this device is to be performed by C-MER RainsOptics Limited or by a centre approved by C-MER RainsOptics Limited Do not the device in direct sunlight.
Eye Safety The Fundus Link has been tested against BS EN ISO 15004-2:2007 – Ophthalmic Instruments – Fundamental requirements and test methods Part 2: Light hazard protection. The illumination levels of all supported Fundus Link implementations have been shown to comply with Group 1 classification as per the referenced standard. Group 1 classification of the Fundus Link product assumes a continuous light exposure time of less than 1 hours.
Battery Charger Only connect the equipment to computers or laptops or battery charger that have passed the safety standard for information technology equipment IEC 60601-1, EN 60601-1, ANSI/AAMI ES 60601-1, IEC 62368-1, EN 623681 to ensure the safety of the USB electrical connection. Electromagnetic compatibility Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
Notice of compliance The device complies with the FCC rules, Part 15. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. FCC rules This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
FCC Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
This equipment complies with Canada radiation exposure limits set forth for uncontrolled environments. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Déclaration d’IC sur l’exposition aux radiations: Cet équipement est conforme aux limites d’exposition aux radiations définies par le Canada pour des environnements non contrôlés. Cet émetteur ne doit pas être installé au même endroit ni utilisé avec une autre antenne ou un autre émetteur.
Table of Contents Product Description ................................................................................................................................................. 1 Intended Use ............................................................................................................................................................. 1 Contraindications .......................................................................................................................................
Parts and Feature of Fundus Link 1 2 3 4 5 6 IFU-20D001-20220913 Page 10
Part # 1 2 3 4 5 6 Part Name Power On/Off button Indicator: Power ON: Bluetooth Connection: Preview Mode: Low battery: Battery charging: Focus Ring Shutter button Battery charging socket Reset IFU-20D001-20220913 Green LED indicator will be flashing Blue LED indicator will be constant on Green LED indicator will be constant on Amber LED indicator will be flashing Amber LED indicator will be constant on Page 11
Procedures for before use 1. Charging the Fundus Link • Fundus Link is delivered uncharged. Before the first use, you must fully recharge it for about 4 hours with the supplied battery charger, or until the YELLOW indicator light turns off. • The use of any other charger will automatically suspend the warranty. • During subsequent charges, the charging should take approximately 4 hours. • Please connect the charger to the Fundus Link and to the mains.
3. Bluetooth connection Bluetooth connection is the process of linking two Bluetooth® devices, so that they can communicate. The Bluetooth connection only needs to be done once. Afterwards, every time you power on your Fundus Link, it will automatically connect to your smartphone (Bluetooth® of smartphone is on and set to automatically connection). 3. Once the smartphone detects the device, a message is displayed with the following information: “Fundus Link_xxxxx”. 4.
Procedures for Mounting the Fundus Link onto the iPhone 1 2 Pull out the bottom clamp IFU-20D001-20220913 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 iPhone is aligned to the designed aperture on the mount Page 14
Investigation WARNING Ensure the Fundus Link DO NOT contact with the subject eye.
Open the “Camera” app in smartphone to start the investigation • Do the investigation in a dark environment. • The device is intended to be used in the population with the pupil size above 2.5mm without mydriasis. Dark 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.
4. 5.
6. Press and Hold the SHUTTER button 2-4 seconds to off the preview light for pupil dilation 7. Release the SHUTTER button for flash lighting and remote control the smartphone to capture the image. CAUTION IFU-20D001-20220913 Capturing failures could be due to limited pupil size, blinking and alignment issues. Repeat capturing is required. If repeat capturing still fails, it is recommended to capture after mydriasis.
Cleaning Fundus Link When you perform the detailed cleaning steps, please note the following: • Ensure the cleaning wipe is not dripping, but is saturated with cleaner solution. • Always replace the wipe when visibly dust. Fundus Link Body: ⚫ Using a soft dry cotton cloth wipe the body gently. Fundus Link Lens: ⚫ Disconnect the USB cable from the device. ⚫ Remove the eyecup from the device. ⚫ Using a commercially blower to blow away dust when it adheres to the lens.
If a replacement eyecup is needed, please contact customer service or your local distributor. 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 Link is not intended to be sterilized Ensure that no moisture penetrates the system during cleaning and disinfection.
Fundus Link Care ⚫ ⚫ ⚫ ⚫ ⚫ ⚫ ⚫ ⚫ This Fundus Link is a precision instrument. Do not drop it or subject it to physical shock. The Fundus Link is not waterproof. If you accidentally drop the Fundus Link into water, promptly send the instrument back to C-MER RainsOptics Ltd. Wipe off any water droplets with a dry and clean cloth. If the Fundus Link has been exposed to salty air, wipe it with a well-wrung wet cloth. Do not leave the Fundus Link in excessive heat, such as in a car in direct sunlight.
Product Specification Product Name / model Service life Width x Depth x Height: Weight View Angle Diopter Minimal Pupil Diameter size Light source Operating Environment Storage / Transport Environment Compatible smartphones model Power Source Battery charger (model no. UES06WNCPU-050100SPA) Operating Time Charging Time Firmware version IP class IFU-20D001-20220913 Fundus Link / 20D001 5 years 51 mm x 106 mm x 160 mm 235 g 30 Degree (Typical) -15 - +15D (Typical) 2.
Accessories Eyecup 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 15004-2:2007 as a Group I exempt product.
Troubleshooting TBD IFU-20D001-20220913 Page 24
Important Symbols Symbols Descriptions Warning. The warning statement in this instruction for use identify conditions or practices that could lead to illness, injury, or death. Caution. Consult the instructions for use for important cautionary information. The user is advised of important operating and maintenance instructions. To identify electrical equipment designed primarily for indoor use.
Indicates a carrier that contains UDI information Indicates the medical device manufacturer, as defined in the EU Regulation (EU) 2017/745. To identify the country of manufacture of products CN Indicates the Authorized representative in the European Community. XXXX Mandatory marking for devices entering the European market to indicate conformity with the essential health and safety requirements set out in European Regulation.
Contact 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.cmerrainsoptics.
