Haag-Streit FUNDUS MODULE 300 User manual

SERVICE MANUAL
INSTALLATION GUIDE
Tradition and Innovation –Since 1858, visionary thinking and a
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FUNDUS MODULE 300
Edition 2.00 / 2020 –08

FUNDUS MODULE 300 | SERVICE MANUAL / INSTALLATION GUIDE
2© HAAG-STREIT AG, 3098 Koeniz, Switzerland –HS-Doc. No. 7220676 - Edition 2.00 / 2020 –08
SERVICE MANUAL / INSTALLATION GUIDE
FUNDUS MODULE 300
Edition 2.00 / 2020 –08
NOTES!
This manual is only intended for maintenance and repair on FUNDUS MODULE 300 units.
This manual is only to be used by trained engineers that have attended an official HAAG-
STREIT training course.
Further important information:
•Operation of the appliance for performance of an examination, as well as the description of the
EyeSuite software are described in a separate operating manual and can be called up in the
EyeSuite software using the 'F1' key.
•Instructions regarding the function check can be found in the enclosed ‘Instruction manual.
•‘EyeSuite Setup manual’ (7220060) regarding the installation of EyeSuite on a PC or laptop.
•‘Instruction Manual regarding the purpose of use and description of the instrument.
•Information on how to unpack and lift the device can be found in the ‘Instruction Manual”.

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Contents
1. Safety Instructions....................................................................................................................................................... 4
1.1 Safety Instructions in text............................................................................................................................................... 4
1.2Pictograms ..................................................................................................................................................................... 4
1.3 EMC ............................................................................................................................................................................... 4
1.4 Lithium Batteries ............................................................................................................................................................ 5
1.5 Transport and unpacking ............................................................................................................................................... 5
1.6 Warranty and product liability......................................................................................................................................... 5
1.7 Environment................................................................................................................................................................... 5
2. Overview ....................................................................................................................................................................... 6
3. Installation .................................................................................................................................................................... 6
3.1 Quick Installation Guide ................................................................................................................................................. 7
3.2 Charging the FUNDUS MODULE 300 ........................................................................................................................... 8
3.3 Attaching the label for automatic left/right detection ...................................................................................................... 9
3.4 Preparation for slit lamps BQ 900 and BP 900 ............................................................................................................ 10
3.5 Preparation for slit lamps BI 900 and BM 900 ............................................................................................................. 11
3.6 Mounting the FUNDUS MODULE 300 to the base plate ............................................................................................. 13
3.7 Weight compensation facility ....................................................................................................................................... 14
3.8 Cabling of the FUNDUS MODULE 300 and the RM02................................................................................................ 14
3.8.1 FUNDUS MODULE 300 connected to Release Module RM02 ................................................................................... 14
3.8.2 FUNDUS MODULE 300 connected to medical PC...................................................................................................... 15
3.9 Step-by-step cabling .................................................................................................................................................... 15
3.10 Fundus Module 300 –Portable version (7220694)...................................................................................................... 18
3.11 Mounting pin ................................................................................................................................................................ 20
4. Maintenance and repair............................................................................................................................................. 21
4.1 Tools ............................................................................................................................................................................ 21
4.2 Cleaning....................................................................................................................................................................... 21
4.3 Replacing the batteries ................................................................................................................................................ 21
4.4 Storing FUNDUS MODULE 300 without battery.......................................................................................................... 24
5. Software...................................................................................................................................................................... 24
5.1 Updating / flashing ....................................................................................................................................................... 24
5.1.1 Required devices and programs .................................................................................................................................. 24
5.1.2 Flashing instructions .................................................................................................................................................... 24
5.1.3 Formatting instructions................................................................................................................................................. 24
6. Troubleshooting......................................................................................................................................................... 25
List of modifications.................................................................................................................................................. 27

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4© HAAG-STREIT AG, 3098 Koeniz, Switzerland –HS-Doc. No. 7220676 - Edition 2.00 / 2020 –08
1. Safety Instructions
1.1 Safety Instructions in text
Safety instructions have been added throughout the text where applicable. They are classified according to
importance and designed to help avoid risk to patients and operating staff, while preventing damage to the FUNDUS
MODULE 300 appliance and helping to ensure that it functions safely and remains in perfect working order.
FORBIDDEN!
Neglecting these notes will lead to material damage and the endangering of users and patients.
WARNING!
These signs must be strictly adhered to, to ensure safe operation of the instrument and to avoid
endangering users and patients.
NOTE!
Important notes! Please read carefully.
1.2 Pictograms
Marking with notified body identification no. 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
HS reference number
Strong permanent magnets
Remove the plug from the mains
1.3 EMC
The FUNDUS MODULE 300 fulfils the requirements on electromagnetic compatibility according to IEC 60601-1-2:
2014 (edition 4.0). The instrument is built so that the generation and emission of electromagnetic interference is
limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that it
itself has appropriate immunity to electromagnetic interference. Additional information can be found in the “instruction
manual”.
WARNING!
MEDICAL ELECTRICAL SYSTEM needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL SYSTEM.
Fundus Module 300 should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the EQUIPMENT or SYSTEM should be observed to verify
normal operation in the configuration in which it will be used.

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1.4 Lithium Batteries
WARNING!
Always remove the Lithium batteries from the device before sending. Refer to the IATA guidance
document UN3480/PI965.
1.5 Transport and unpacking
•Before you unpack the instrument, check whether the packing shows traces of improper handling or damage. If
this is the case, inform the haulier which has delivered the product to you. Unpack the instrument together with a
representative of the haulier. Prepare a protocol describing parts that are possibly damaged. This must be signed
by you and by the representative of the haulier.
•Leave instrument in the packing for several hours before unpacking (condensation).
•After unpacking, check if the instrument has been damaged. Return the defective equipment in an appropriate
packaging.
1.6 Warranty and product liability
•The instrument should be operated in accordance with the chapter 'Safety'.
•Incorrect operation can damage the instrument. Thus, no warranty claims can be accepted.
•Continued use of an instrument that has been damaged by incorrect operation can lead to personal injury. The
manufacturer cannot accept liability in this case.
•Repairs and alterations on this equipment should only be carried out by HAAG-STREIT service technicians or by
authorized persons.
1.7 Environment
•Electric and electronic equipment must be separated from house waste! This equipment has been introduced into
the market after the 13th of August 2005.
•Disposal via your local collecting point or your HAAG-STREIT representative.
•Please take the old batteries to a professional disposal.
•Thus, it is ensured, that no harmful materials get into the environment and that valuable raw materials can be
used again.

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2. Overview
3. Installation
NOTE!
The software and an installation manual are included in the scope of delivery.
Please install the latest EyeSuite Software first and then the FUNDUS MODULE 300 software.
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.
WARNING!
•No modification of this equipment is allowed.
•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 the FUNDUS MODULE 300 and Release Module RM02 to an electricity supply
which corresponds to the supply voltage of the devices.
•Use only accessories and battery provided by HAAG-STREIT with this product.
•When connecting the device, the operator is responsible for operating of the device and for
meeting the safety and EMC requirements defined in IEC 60601-1-1 or IEC 60601-1:2005,
chapter 16 (medical electrical systems) and IEC 60601-1-2.
•Additional extension cables or portable multiple sockets may not be used.
•The electrical installation must conform to IEC 60364-7-710 (for USA and CANADA only: for
single-phase power systems with 120 V AC, NEMA 5-15P power plugs must be used) or the
applicable national regulations. This includes the existence of a ground fault circuit interrupter
(GFCI).
•To avert the risk of an electric shock this device may only be connected to a power supply with
a protective earth conductor.
•The device should be set up so that the power cable can be disconnected from the power
supply quickly and easily without any tools.
•The cables for the accessories should be laid to prevent any risk of the examiner tripping over
them or their presenting any danger to the patient.
Fundus Module 300 Camera
Lens cover
Fundus Module 300 Cradle
Battery
Power Supply
Cradle USB cable
Base plate
Camera USB cable

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3.1 Quick Installation Guide
Install the EyeSuite Software Version i8.2.1.0 or newer
on your Computer.
NOTE!
The usage of the portable version of the
Fundus Module requires EyeSuite
version i9.0.2.0 or higher.
Fig. 1
Install the FM300 software 1.7.
It can be found on our service CD:
Service_CD\01_Service-CD_General Diagnostics\019_Fundus Module
300\02_Software\Firmware_FM300_1.7
Fig. 2
Plug the provided crypto box to the PC and enter the
software dongle which can be found on a separate
document included in the accessories box.
Fig. 3
Select an import directory (up to EyeSuite version i8.2.2.)
Go to: EyeSuite →Tools →Preference →Imaging →
All Devices →Tab: Fundus Camera
Select any folder on your Computer. It’s just used as
temporary saving folder. The window user needs full
rights on this folder.
Fig. 4
Turn off the USB writing protection of the device:
Press the “Menu” button on the front of the device, go
to “Device”, scroll down to “USB write-protection” and
select “Off”.
Fig. 5
Firmware update
Place the FM300 on the cradle and copy the “system”
folder onto the FM300.
The folder can be found on our service CD:
Service_CD\01_Service-CD_General Diagnostics\019_Fundus
Module 300\02_Software
Fig. 6
Make sure the Fundus Module 300 is charged at least for 60%. Remove it from the cradle and it will automatically
start updating.
Dongle
123456
Dongle
123456

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3.2 Charging the FUNDUS MODULE 300
WARNING!
•Place cradle outside the patient environment (at least 1.5 meters distance from the patient).
•Use only medically approved PCs or operate via medically approved isolating transformer.
•If the PC connected to a customer network make sure to apply appropriate safety measures,
such as Antivirus and Firewall protection.
Place the cradle on a desk next to the PC. The cradle
shall be outside the patient environment at least 1.5
meters distance from the patient.
Fig. 7
Connect the power supply cable to the cradle.
Connect the cradle USB cable between the PC and
the cradle. Avoid using excessive force or twisting the
connector when connecting the USB cord to a PC.
Fig. 8
Guide the cables underneath the cradle through the
cable holders and plug the power supply cable to the
mains.
Fig. 9

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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 and rear
part is carefully moved into the connector. 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.
Fig. 10
3.3 Attaching the label for automatic left/right detection
NOTE!
Clean the table surface before positioning the side identification sticker (1022535) Make sure that no
oil and grease residue remains on the surface.
NOTE!
Make sure you use side identification sticker 1022535 together with RM02.
6. Rail cover
7. Protective film
8. Roller rail
9. Table
10. “Positioning tool” sticker
Fig. 11
•Remove the rail cover (6) and move away the slit lamp. Clean the surface of the table.
•Remove protective film (7) from the back of the sticker. Start lifting it off carefully from the corner opposite the
black area.
•Position the sticker against the right roller rail (8) and the edge of the gliding plate (9). Press the white/black
surface, smooth out air bubbles.
•Carefully tear off the remainder of the adhesive label along the perforation (10).
•Mount the slit lamp and rail cover again.

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3.4 Preparation for slit lamps BQ 900 and BP 900
Screw the base plate tight to the accessory pin of the
slit lamp.
Fig. 12
Attach the curved cable holders near to the base
and the regular version above onto the microscope
arm.
Fix the USB cable to the holders.
Fig. 13
Connect the right-angled camera USB cable 0.6 m
to the base plate.
Fig. 14

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Connect the camera USB cable 0.6 m to the
Release Module RM02.
Fig. 15
3.5 Preparation for slit lamps BI 900 and BM 900
Unlike to the slit lamp BQ 900 and BP 900, a base plate adapter must be mounted first on the models BI 900 and BM
900.
Only for BI 900:
Mount the base plate adapter on the microscope of
the BI 900.
Fig. 16
Only for BM 900
Mount the base plate adapter on the microscope of
the BM 900.
Fig. 17
NOTE!
•Adapter kit BI 7220669 (BI base plate adapter assembly, USB cable 560mm, adapter screw)
•Adapter kit BM 7220670 (BM base plate adapter assembly, USB cable 560mm, adapter screw)

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Screw the base plate to the base plate adapter.
Fig. 18
Attach the regular cable holders onto the microscope
arm.
Fix the USB cable to the holders.
Fig. 19
Connect the left angled camera USB cable 0.6 m to
the base plate.
Fig. 20

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Connect the camera USB cable 0.6 m to the
Release Module RM02.
Fig. 21
3.6 Mounting the FUNDUS MODULE 300 to the base plate
Attach the FUNDUS MODULE 300 to the base plate
by connecting the bayonet legs of camera to bayonet
holes of the base plate.
Fig. 22
Align it to the mark and the screw.
Fig. 23

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3.7 Weight compensation facility
The slit lamp’s cross slide carriage offers the option
of balancing the weight of the accessory so that the
height adjustment on the joystick remains smooth by
adjusting setting screws of weight compensation
facility (1001152). To do so, please follow the
instructions in the “Instruction for use” of the slit
lamp.
Fig. 24
3.8 Cabling of the FUNDUS MODULE 300 and the RM02
WARNING!
•Only use supplied USB cable (3m long HS art. no. 1022373s) for the connection to the PC. With
lengths of over 3m, the cable with active signal amplification (HS art. no. 7220736) must be used.
•Only use medically approved PCs. Otherwise operate via a medically approved isolating
transformer.
•Auxiliary units on the PC (e.g. printer, monitor) must be operated through an isolating transformer.
•Ethernet may only be used through a galvanic isolation in accordance with EN 60601-1.
•The power supply unit’s mains connector must be accessible in order to allow for disconnection
from the electric mains at any time.
3.8.1 FUNDUS MODULE 300 connected to Release Module RM02
Fig. 25
A. Power grid
B. Medically approved isolating transformer
C. Instrument table (IT)
D. Medically approved power supply
E. Printer
F. Screen
G. Personal computer
H. Local network
I. Galvanic isolation (EN 60601-1)
J. Headrest
K. Cable headrest/LED illumination/RM02
L. Release module RM02
M. LED illumination
N. FUNDUS MODULE 300 Camera
O. FUNDUS MODULE 300 Cradle

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3.8.2 FUNDUS MODULE 300 connected to medical PC
Fig. 26
A. Power grid
B. Medically approved isolating transformer
C. Instrument table (IT)
D. Medically approved power supply
E. Printer
F. Screen
G. Personal computer
H. Local network
I. Galvanic isolation (EN 60601-1)
J. Headrest
K. Cable headrest/LED illumination/RM02
L. Release module RM02
M. LED illumination
N. FUNDUS MODULE 300 Camera
O. FUNDUS MODULE 300 Cradle
P. Imaging Module (IM 600/IM 900/Imaging set for BI 900)
3.9 Step-by-step cabling
WARNING!
The Release Module RM02 is affixed with strong magnets. Keep magnet-sensitive storage media (e.g.
credit card) away from the magnets.
Computer cable USB 3.0 (a), power supply cable (b)
and cable headrest/LED illumination/RM02 (c) must
be fed through in the braided sleeving.
Fig. 27
a
b
c

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Place the RM02 and the cable cover upside-down.
Plug the power supply cable and the computer cable in
the corresponding sockets of the RM02.
Fig. 28
To prevent accidental unplugging, make a loop in the
power cable.
Fig. 29
Fix the loop to the computer cable by using a tie wrap.
Fig. 30
Tighten the braided sleeving and fix it with a tie wrap.
Fig. 31

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Mount the cable cover (1022516) to the RM02 and put
the RM02 on the cross slide.
Fig. 32
Connect the computer cable USB 3.0 to the PC and the
power supply to the power network.
Fig. 33
Insert the camera USB cable connector plug in the
socket.
Fig. 34
Connect the headrest cable with the counterpart on
the headrest.
Fig. 35

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•Mount the tabletop and place the slit lamp on the table.
•Connect the computer cable USB 3.0 to the PC.
•Connect the electric power supply lead to the power supply.
•Connect the power supply connector plug to the power grid.
Plug the headrest cable into the lamp head.
Fig. 36
3.10 Fundus Module 300 –Portable version (7220694)
Move the slit lamp to the limit in direction of the
examiner.
Pivot the illumination tower and the microscope arm
to the side as shown below.
Mount the Fundus Module 300 to the pin.
Fig. 37

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Attach the Fundus Module to the tonometer pin. No
further cabling is needed.
Fig. 38
Put the Fundus Module back in the cradle after the
examination. The pictures will now automatically be
transferred to EyeSuite.
NOTE!
Automatically image import is only
available with EyeSuite software
version i9.0.2.0 and higher.
Fig. 39

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3.11 Mounting pin
The portable version of the Fundus Module 300 can be mounted on Haag-Streit slit lamps but also on many non-
Haag-Streit slit lamps. It’s hooked to the 12mm tonometer pin as the R-Type tonometer is.
Ask the manufacturer of the third party slit lamp for matching mounting pins.
Fig. 40
Mounting pin
Fig. 41
Orientation pin
Fig. 42