FUNDUS MODULE 300 Instruction Manual Rev 4.0 Aug 2016

CONTENTS 1

Safety ... 2 1.1

Symbols ... 2

1.2

Ambient conditions ... 4

1.3

Intended use ... 5

1.4

Contraindication... 5

1.5

Warranty ... 6

2

Introduction ... 7 2.1

Purpose of the device ... 7

2.2

Description of the device ... 8

3

Device preparations...12 3.1

Part list, unpacking and first time preparations ... 12

3.2

Daily use preparations ... 15

4

Commissioning ...16

5

Operation...17 5.1

Settings... 17

5.2

Imaging ... 21

5.3

Error messages ... 23

6

Decommissioning ...24

7

Technical data...26

8

Maintenance...29 8.1

Cleaning... 29

8.2

Servicing ... 31

Appendix ...32 A

Accessories ... 32

B

Battery replacement ... 33

C

Classification ... 35

D

Disposal ... 36

E

Electromagnetic compatibility ... 37

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1 SAFETY WARNING! Read the instruction manual carefully before commissioning this product. It contains important information regarding the safety of the user and patient. The instruction manual explains the safety precautions, introduces the device, preparation, operation and maintenance of the FUNDUS MODULE 300. Correct operation of the system is imperative for its safe and successful functioning. The device must be used according to this instruction manual. The instruction manuals and other documentation enclosed with the FUNDUS MODULE 300 should be kept accessible to users at all times to ensure that the information required for use of the FUNDUS MODULE 300 is readily available.

1.1 Symbols The symbols used in this instruction manual or on device labels refer to important safety information which may warn against possible health risks or fatal injuries and contain useful notes. Whenever you see these symbols, read the accompanying information carefully and observe all safety notes and information in this instruction manual and on device labels.

DANGER! Failure to comply with these instructions may result in material damage or pose a danger to patients or users.

WARNING! These warnings must absolutely be complied with to guarantee safe operation of the device and to avoid any danger to users and to patients.

NOTE! Important information: please read carefully.

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SYMBOL

DESCRIPTION European certificate of conformity CE marking with notified body identification numbering indicates the conformity of 93/42/EEC Medical Device Directive. Read the instructions for use attentively Failure to follow these instructions could place the patient or operator at risk. Plug socket for power supply (Positive polarity) Voltage and current Disposal specification European directive on waste electrical and electronic equipment (WEEE) 2012/19/EU. Manufacturer

Year of manufacture

Serial number

Reference number

Strong permanent magnets

Remove the plug from the mains

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1.2 Ambient conditions The device is intended to be used indoors. Do not store or use the device in ambient conditions other than those prescribed. Please note also that electromagnetic compatibility information and recommended separation distances between portable and mobile RF communications equipment and the FUNDUS MODULE 300 are given in Appendix E.

DANGER! FUNDUS MODULE 300 is not suitable for use in explosion risk areas or in the presence of flammable anesthetics.

WARNING! FUNDUS MODULE 300 is intended to be used inside in a normal room temperature and normal humidity. Do not use the device in an environment where there is a possibility that water condenses to or inside the device.

Transport:

Temperature: Relative humidity: Atmospheric pressure:

from ─20C to from 45% to from 500 hPa to

+50C 85% 1060 hPa

Storage:

Temperature from ─20C to +35C Relative humidity: from 45% to 85% Atmospheric pressure: from 500 hPa to 1060 hPa Please note that storage atmospheric pressure for Release Module RM02 is from 700 hPa to 1060 hPa. Use:

Temperature: Relative humidity: Atmospheric pressure:

from +10C to from 10% to from 800 hPa to

IP Code:

IPX0 (Equipment not protected against the ingress of water)

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+35C 80% 1060 hPa

1.3 Intended use FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human eye.

1.4 Contraindication WARNING! The light emitted from this instrument is potentially hazardous. The longer the duration of exposure and the greater the number of pulses, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum output will exceed the safety guideline after: Maximum number of pulses (still images) allowed daily: 

6300 pulses (still images) / eye / day

Or alternatively Total daily usage time for continuous light (= video usage time + aiming light duration) shall be limited to:  1 h 30 min video usage / eye / day

Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit. While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the patient's eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakias and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography. The FUNDUS MODULE 300 is classified as Group 2 based on standard ISO 15004-2:2007. The daily usage time and maximum allowed number of pulses presented above in warning box is calculated based on optical classification results according to standard ISO 15004-2:2007.

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1.5 Warranty This product is covered by a limited warranty granted by your seller.

SUBMITTING CLAIM Any claim under this warranty must be submitted in writing before the end of warranty period to your local dealer. The claim must include a written description of the failure that the device have.

WARRANTY DOES NOT COVER Products that have been subjected to abuse, accident, alternation, modification, tampering, misuse, faulty installation, lack of reasonable care, repair or service in any way that is not contemplated in the documentation of the product, or if the model or serial number has been altered, tampered with, defaced or removed. Warranty does not cover damage caused by dropping the device or damage caused by normal wearing. Repair or service done by non-HAAG-STREIT authorized service facility is not covered by warranty.

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2 INTRODUCTION 2.1 Purpose of the device WARNING! The device may only be used for the specified purpose and according to national regulations, consistent with the applicable industry standards and occupational safety and accident prevention regulations. This device is an accessory for HAAG-STREIT slit lamps BQ 900 or BP 900, and with different adapters for BI 900 or BM 900. FUNDUS MODULE 300 is designed to be used together with the Release Module RM02. FUNDUS MODULE 300 is intended to capture digital images and videos of the fundus of the human eye for documentation and consultation. FUNDUS MODULE 300 is designed to be used in medical environment. FUNDUS MODULE 300 is intended for non-mydriatic imaging. This means that infrared light is used for the targeting image to the eye fundus and visible light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. Constant white light illumination for targeting can be selected from device menu if mydriatic drops are used. Images can also be taken using infrared lightning for both aiming and capturing. The FUNDUS MODULE 300 has 9 internal fixation targets for the patient to fixate at during imaging.

NOTE! Federal law restricts this device to sale by or on the order of a physician or licensed practitioner.

NOTE! This equipment must only be operated by qualified and trained personnel. The owner is responsible for the training. This device may only be used in accordance with intended use.

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2.2 Description of the device

The FUNDUS MODULE 300 device set (A) for retinal imaging consists of:  FUNDUS MODULE 300 Camera with base plate and lens cover  Battery  Camera USB cable  FUNDUS MODULE 300 Cradle  Power supply  Cradle USB cable FUNDUS MODULE 300 is intended to be used as slit lamp accessory with Haag-Streit slit lamps BQ 900, BP 900, BI 900 and BM 900. The imaging system consists of FUNDUS MODULE 300 device set (A) described above and Release Module RM02 (B) including power supply (D) and Medical PC including EyeSuite software (C) presented below.

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The imaging system and FUNDUS MODULE 300 device set are presented in figure below.

Next figure presents the imaging system and FUNDUS MODULE 300 device set when Imaging Module IM 900 or IM 600 or Imaging Set for BI 900 slit lamp is connected to Release Module RM02. In that case the camera USB cable (2.95 m) is connected directly to the Medical PC.

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FUNDUS MODULE 300 DISPLAY ICONS AND KEYS

KEY

Left soft key

PRESS

FUNCTION

DESCRIPTION

Short

Fixation target level: Hi / Low / Off

Fixation target is high by default and it can be changed low or turned off by pressing left soft key.

Long

Power On/Off

Camera is powered on and off by pressing the left soft key for 2 seconds.

Very long

Reset

Camera’s hardware is reset by pressing the left soft key over 20 seconds when camera is placed on the cradle. This makes forced shut down.

Short

Focus mode: Manual / Auto

Switch between focus modes by pressing the right soft key. Manual focus is on by default.

Long

Open Menu

Open camera menu by pressing the right soft key for 2 seconds.

Right soft key

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Middle key

Navigation key

Navigation key

Long

Create new Patient folder

When EyeSuite software is not used, it is recommended to create a new patient folder for each patient. New patient folder is created by pressing the middle key for 3 seconds. If the current patient folder does not have any images, a new folder cannot be created.

Change Brightness

Illumination level icon must be active to change brightness. To activate icon press right soft key. Use left and right navigation keys to adjust brightness of capture light.

Move Fixation target

Fixation target level icon must be active to move fixation target. To activate icon press left soft key. Use left and right navigation keys to move fixation target left or right.

Set Manual focus

Focus mode icon must be active to set focus when manual focus is on. To activate icon press right soft key. Use up and down navigaton keys to adjust focus: Up when patient has hyperopia and down when patient has myopia.

Move Fixation target

Fixation target level icon must be active to move fixation target. To activate icon press left soft key. Use up and down navigation keys to move fixation target up or down.

Left/Right

Up/Down

RELEASE MODULE RM02 KEYS

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3 DEVICE PREPARATIONS WARNING! No modification of this equipment is allowed.

WARNING! Installation and repairs may only be performed by authorized specialists. Contact your HAAG-STREIT representative for installation, repairs and modification work on the system. The contact details are available at www.haag-streit.com.

3.1 Part list, unpacking and first time preparations SALES PACKAGE

ADAPTER KIT FOR BI 900

FUNDUS MODULE 300 Camera Base plate Base plate screw Lens cover Battery (2 pcs) Camera USB cable (right angled connector): camera to RM02 (0.6 m) OR camera to PC (2.95 m) Cable holder (curved version, 1 pcs) Cable holders (straight version, 2 pcs) FUNDUS MODULE 300 Cradle Cradle USB cable: cradle to PC (1.5 m) Power supply Instruction manual Cleaning cloth Memory stick

BI 900 Base plate adapter Adapter screw for BI 900 Base plate adapter Camera USB cable (left angled connector): camera to RM02 (0.6 m)

ADAPTER KIT FOR BM 900 BM 900 Base plate adapter Adapter screw for BM 900 Base plate adapter Camera USB cable (left angled connector): camera to RM02 (0.6 m)

Open the cardboard packaging. Remove FUNDUS MODULE 300 and accessories from the sales package and check that all parts are present and undamaged. Packaging materials should be retained for future relocation or repair.

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WARNING! It is only allowed to attach USB cables and power source provided in the sales package. If you need replacement to the USB cables or power source please contact your local dealer. USB cable must be connected only to the USB port of a PC that complies with the IEC 60950 standard. Only connect FUNDUS MODULE 300 and Release Module RM02 to an electricity supply which corresponds to the supply voltage of the devices.

WARNING! Use only accessories and battery provided by HAAG-STREIT with this product.

WARNING! Place cradle outside the patient environment (at least 1.5 meters distance from the patient).

WARNING! Use only medically approved PCs or operate via medically approved isolating transformer.

WARNING! If the PC connected to a customer network make sure to apply appropriate safety measures, such as Antivirus and Firewall protection.

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PREPARING THE CRADLE AND CHARGING THE FUNDUS MODULE 300







Place the cradle (1) on a desk next to the PC. The cradle shall be outside the patient environment at least 1.5 meters distance from the patient. Connect the cradle USB cable (2) between the PC and the cradle. Avoid using excessive force or twisting the connector when connecting the USB cord to a PC. Connect the power supply cable (3) to the cradle and to the mains.

  



Install the battery to the FUNDUS MODULE 300 as instructed in the Appendix B. Place the FUNDUS MODULE 300 to the cradle for charging. The FUNDUS MODULE 300 will fit into the cradle when front part is positioned onto the support (4) and rear part is carefully moved into the connector (5). Excessive force shall be avoided in order to prevent the camera and the cradle connectors from breaking. Charge the battery for 4 hours before the first use. In daily use charge the battery when battery level is low. Charging battery at any level is not harmful for battery.

PLACING THE FUNDUS MODULE 300 TO BASE PLATE



Attach FUNDUS MODULE 300 to base plate by connecting the bayonet legs (6) of camera to bayonet holes (7) of base plate so that alignment marks (8) are lined up.

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3.2 Daily use preparations 

Power the device on by pressing left soft key for 2 seconds. The green power LED below display illuminates when device is powered on.



Attach the FUNDUS MODULE 300 to base plate as described in previous subchapter.



Place the camera to imaging position by pushing shaft forward as presented in the image.



To power on the Release Module RM02 press the On/Off key on the RM02. The green operational control LED illuminates when the Release Module RM02 is switched on.



Open the Eye Suite software on the PC. First select Patients icon and enter patient data. Second select Fundus Imaging icon from the left side. EyeSuite is ready for imaging.

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4 COMMISSIONING FUNDUS MODULE 300 is powered on and off by pressing left soft key for 2 seconds. Menu is opened by pressing right soft key for 2 seconds. Menu has two tabs: Device tab and Imaging tab. The navigation key is used to move between tabs (right/left) and to move between settings (up/down). When EyeSuite is not used it is recommended to create a new patient folder for each patient. New folder is created by pressing middle key for 3 seconds. It is also recommended that image data storage is always erased between patients after the images have been transferred to PC via cradle.

SELECTING FIXATION TARGET Select fixation target level to be off, low or high by pressing left soft key. There are 9 fixation targets as shown in the graphics in lower left corner of the display. Middle fixation target is on by default and it provides a macula centred image. When fixation target level icon is active (blue), fixation target can be moved by using navigation keys.

SELECTING FOCUS MODE Select focus mode to be manual or auto by pressing right soft key. When focus mode is set to manual a diopter scale is shown on the screen and focus can be adjusted. In autofocus mode the camera finds correct focus automatically. Autofocus range is from ─11 to +3 diopters. When manual focus is selected and patient has a refractive error, focus need to be adjusted. Focus mode icon above right soft key must be active (blue) to adjust focus by using navigation keys.  Hyperopia: camera is focused by pressing navigation key up. One click of the key is approximately 1 diopter.  Myopia: camera is focused by pressing navigation key down. One click of the key is approximately 1 diopter.

SETTING BRIGHTNESS Imaging light brightness can be adjusted from 0 to 10 and default value is 6. It is also possible to reduce the brightness setting below 1, to 0.8, 0.6, 0.4 and 0.2, if needed. To adjust brightness use left or right navigation keys when icon above right soft key is active (blue). To activate the icon press right soft key. Brightness can also be changed from Release Module RM02 by using selector keys: press lower multifunction key to decrease brightness and upper multifunction key to increase brightness. When using Infrared/White illumination mode changing brightness affects only the white capturing flash. While using Infrared/Infrared or White/White illumination modes the brightness of both aiming and capturing light are changed.

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5 OPERATION 5.1 Settings Menu is opened by pressing the right soft key for 2 seconds. Menu has two tabs: Device tab and Imaging tab. The navigation key (left/right) is used to move between tabs. Active tab is indicated by blue color. Camera stores selected menu settings for next time use when it is powered off. The naviagation key (up/down) is used to scroll settings in the chosen tab. The navigation key (left/right) changes values. Active value is indicated with blue color. Changed values are saved by pressing ‘Ok’ using the left soft key and cancelled by pressing ‘Cancel’ using the right soft key. To select operations like preview images, new patient folder etc. press the middle key. The help field is shown below the menu items to guide the selection for each setting. The table below also guides how to select operations or change setting values.

DEVICE SETTINGS TAB Setting and values (default bolded)

Description

Preview images

To preview the images on camera press middle key. To browse folders and images use navigation keys and to select the wanted image press middle key. To browse possible red-free, IR and low-red images use navigation keys. Image can be zoomed while previewing by pressing middle key. To change between the four zoom levels (1x, 2x, 4x and 8x) press middle key. To move around the zoomed image use navigation keys. To erase selected image press left soft key. To exit current folder press left navigation key.

Ok

New patient folder Ok

To create a new patient folder press middle key. The new patient folder can also be created in live view by pressing the middle key for 3 seconds. If the current patient folder is empty a new folder cannot be created.

Erase image memory

To erase images and videos from camera memory card press middle key.

Ok Display brightness Low-Med-High

Icons

Use left and right navigation keys to adjust display brightness. The display brightness selection has three options: low, medium and high. Choose the suitable level of display brightness according to for example how the examination room is lit up. The icons shown while imaging can be enabled or disabled. The most essential icons such as Menu icon are always visible.

On/Off

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Sounds

The sounds can be enabled or disabled. The sound is played when image is captured or when battery level is dropped critically low.

On/Off Keyboard backlight On/Off Select language ENG-FIN-FRA-ITA-JPNPOR-SPA-ZHO-DEU USB write protection On/Off Restore factory settings OK Date DD-MM-YYYY

Keyboard backlight can be enabled or disabled. Backlight is turned on when the device is powered on. Backlight is turned off when the device is in power save mode, in cradle and when the device is powered off. To select language use left and right navigation keys. The camera has nine different languages: English, Finnish, French, Italian, Japanese, Portuguese, Spanish, Chinese and German. Default language is English and the language selection is always shown in English in menu. USB write protection can be enabled or disabled. When USB write protection is on modifying of camera memory card from outside is prevented when connected to the cradle. Copying files from memory card to PC is possible. To restore settings to factory defaults press middle key. The camera also prompts the question “Restore all settings to factory defaults?” for confirmation. The device is restarted. To change date settings press middle key. To set day, month and year use left and right navigation keys and use middle key to select next field. Date format is exceptionally MM DD YYYY for Japanese and Chinese.

(or MM-DD-YYYY) Time HH:MM Camera SW version

To change time settings press middle key. To set hours and minutes use left and right navigation keys and use middle key to select next field. Time is shown in 24 hour format To show camera SW version press middle key. To browse version information use left and right navigation keys.

Show camera SW version Start query Era./Fol./None

Choose the start-up query between erase image memory, new patient folder or no query at all. The camera prompts start-up query after powering on the device. When erasing images is chosen the camera will ask whether all images and videos shall be deleted. When new patient folder query is chosen the camera will ask if a new patient folder shall be created. If no query is selected then camera will go directly to live view after powering on or when lift from the cradle.

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IMAGING SETTINGS TAB Setting and values (default bolded)

Description

Capture mode

To choose capture mode use left and right navigation keys. There are two capture modes: still imaging and video recording.

Still/Video Half press capture On/Off

Mark side On/Off

IR brightness Low/High Red free On/Off Save IR image On/Off Low-red On/Off Illumination mode IR/W, IR/IR or W/W

When camera’s dual action shutter is used, half press capture can be enabled or disabled. If half press capture is enabled: Image is captured when dual action shutter is pressed half way down in manual focus mode, or image is captured when dual action shutter is kept pressed half way down after focusing has ended in auto focus mode. Mark side of the eye can be enabled or disabled. If mark side is enabled a query is presented after image capturing. To choose OS (patient’s left eye) press left soft key and to choose OD (patient’s right eye) press right soft key. The chosen side is marked to image and file name. To adjust aiming light brightness in Infrared/White mode use left and right navigation keys. There are two levels: High (8) or low (4). In IR/IR mode brightness is freely adjusted. Use left and right navigation keys to choose whether red-free copy of image in addition to original image is saved. If red-free image is enabled the camera will save an image using only green channel. Use left and right navigation keys to choose whether to capture image with IR light before capturing image with white light. Both IR image and white light image are saved. This setting is only for Infrared/White mode. Use left and right navigation keys to choose whether low-red copy of image in addition to original image is saved. If low-red is enabled the camera will save a red reduced image. Use left and right navigation keys to select aiming and capture light source. IR/W is default for still imaging and W/W is default for video recording. In IR/W mode aiming is done using infrared light and image is captured using white light. In IR/IR mode both aiming and image capture are done with infrared light. In W/W mode both aiming and image capture are done with white light. W/W works best with dilated eyes.

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