Haag-Streit IM 900 User manual

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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220551‑04070 – 2021 – 08
INSTRUCTIONS FOR USE
Imaging module
IM 900
7. Edition / 2021 – 08

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220551‑04070 – 2021 – 08
INSTRUCTIONS FOR USE
Imaging module
IM 900
7. Edition / 2021 – 08
Preface
Thank you for choosing a Haag-Streit device. Provided you comply carefully with the
regulations in these instructions for use, we can guarantee reliable and trouble-free
use of our product.
WARNING!
Read the instruction manual carefully before commissioning this product.
It contains important information regarding the safety of the user and
patient.
NOTE!
For USA only: Federal law restricts this device to sale by or on the order
of a physician or licensed practitioner.

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Contents
• 1 Safety...................................................................................................................................................4
◦ 1.1 Comments on these instructions for use........................................................................................4
◦ 1.2 Ambient conditions.........................................................................................................................4
◦ 1.3 Shipment and unpacking ...............................................................................................................4
◦ 1.4 Installation warnings ......................................................................................................................4
◦ 1.5 Operation, environment .................................................................................................................5
◦ 1.6 Disinfection ....................................................................................................................................5
◦ 1.7 Warranty and product liability ........................................................................................................5
◦ 1.8 Reporting obligation.......................................................................................................................5
◦ 1.9 Description of symbols...................................................................................................................6
• 2 Intended purpose / intended use .......................................................................................6
• 3 Introduction .....................................................................................................................................6
◦ 3.1 Description of the device................................................................................................................6
◦ 3.2 System components ......................................................................................................................6
◦ 3.3 LED illumination (prerequisite).......................................................................................................7
◦ 3.4 Camera module CM03...................................................................................................................7
◦ 3.5 Release module RM02 ..................................................................................................................7
◦ 3.6 Power supply .................................................................................................................................7
• 4 Device assembly / installation .............................................................................................8
◦ 4.1 Placement of adhesive label for the automatic left/right detection.................................................8
◦ 4.2 Connecting the CM03 in the beam path ........................................................................................8
◦ 4.3 Weight compensation facility .........................................................................................................9
◦ 4.4 Cabling of the CM03 and the RM02 (diagram) ..............................................................................9
▪ 4.4.1 Step-by-step cabling.........................................................................................................10
• 5 Commissioning ...........................................................................................................................11
◦ 5.1 Switching on the device ...............................................................................................................11
• 6 Operation.........................................................................................................................................11
◦ 6.1 Changing the depth of sharpness................................................................................................11
◦ 6.2 Camera module CM03.................................................................................................................11
◦ 6.3 Camera module CM03 30/70.......................................................................................................11
◦ 6.4 Field of view.................................................................................................................................12
◦ 6.5 History trigger...............................................................................................................................12
◦ 6.6 White balance ..............................................................................................................................12
▪ 6.6.1 Slit lamp preparation.........................................................................................................12
▪ 6.6.2 Conducting a white balance..............................................................................................12
◦ 6.7 Software / Help menu / error messages ......................................................................................13
◦ 6.8 LED indicator illumination head ...................................................................................................13
◦ 6.9 LED indicator power supply .........................................................................................................13
◦ 6.10 LED indicator release module RM02 .........................................................................................13
◦ 6.11 LED indicator camera module CM03 .........................................................................................13
◦ 6.12 Error messages (illumination head) ...........................................................................................14
◦ 6.13 Error messages release module RM02 .....................................................................................14
◦ 6.14 Error messages camera module CM03..................................................................................... 14
• 7 Decommissioning ..................................................................................................................... 15
• 8 Technical data ............................................................................................................................. 15
◦ 8.1 Power supply............................................................................................................................... 15
◦ 8.2 Dimensions.................................................................................................................................. 15
◦ 8.3 Minimum PC requirements.......................................................................................................... 15
◦ 8.4 Camera........................................................................................................................................ 15
• 9 Maintenance.................................................................................................................................. 16
◦ 9.1 Device inspection ........................................................................................................................ 16
◦ 9.2 Servicing...................................................................................................................................... 16
◦ 9.3 Cleaning and disinfection ............................................................................................................16
• 10 Appendix ...................................................................................................................................... 16
◦ 10.1 Accessories / functionals parts / detachable parts / consumables ............................................16
◦ 10.2 Legal regulations .......................................................................................................................17
◦ 10.3 Classification ............................................................................................................................. 17
◦ 10.4 Disposal..................................................................................................................................... 17
◦ 10.5 Observed standards ..................................................................................................................17
◦ 10.6 Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) .17
▪ 10.6.1 General........................................................................................................................... 17
▪ 10.6.2 Emitted interference .......................................................................................................18
▪ 10.6.3 Electromagnetic immunity environment tested (part 1).................................................. 19
▪ 10.6.4 Electromagnetic immunity environment tested (part 2).................................................. 20
▪ 10.6.5 Recommended separation distances between portable and mobile RF communications
equipment and this product....................................................................................................... 22

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1Safety
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 product and to avoid any danger to users and to
patients.
NOTE!
Important information, please read carefully.
1.1 Comments on these instructions for use
NOTE!
In these instructions for use the point is used as decimal separator.
1.2 Ambient conditions
Temperature −40 °C ... +70 °C
Air pressure 500 hPa ... 1060 hPa
Transport
Relative humidity 10 % ... 95 %
Temperature −10 °C ... +55 °C
Air pressure 700 hPa ... 1060 hPa
Storage
Relative humidity 10 % ... 95 %
Temperature +10 °C ... +35 °C
Air pressure 800 hPa ... 1060 hPa
Use
Relative humidity 30 % ... 90 %
1.3 Shipment and unpacking
• Before unpacking the device, check whether the packaging shows traces of
improper handling or damage. If this is the case, notify the transport company
that delivered the goods to you.
• Unpack the device together with a representative of the transport company.
Make a report of any damaged parts. This report must be signed by you and by
the representative of the transport company.
• Leave the device in the packaging for a few hours before unpacking it
(condensation).
• Check the device for damage after it is unpacked.
• Return defective devices in the appropriate packaging.
• Store packaging material carefully so that it can be used for potential returns or
when moving.
1.4 Installation warnings
WARNING!
•Do not modify this device without authorization of the manufacturer.
Installation and repairs may only be performed by trained
specialists.
• Any third-party device must be connected in compliance with the EN
60601-1 standard.
• Only original Haag-Streit spare parts may be used.
• Use of this device adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this device and the other equipment should
be observed to verify that they are operating normally.
• The device should be set up in such a way that the plug is always
easily accessible and the device can easily be disconnected from
the mains.

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1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where
volatile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
• This device must not be operated near of high frequency surgical
equipment and the radio frequency shielded room of a medical
electrical system for magnetic resonance imaging, where the
intensity of electromagnetic disturbances is high.
• Portable radio frequency communications equipment (including
peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the device,
including cables specified by Haag-Streit. Otherwise, degradation of
the performance of this device could result.
• The imaging module is intended for documentation purposes. The
ocular image is critical for diagnosing a patient.
• Before every examination, check that the automatic left to right
detection works correctly from the release module.
• The release module is affixed with strong magnets. Keep magnet-
sensitive storage media (e.g. credit cards) away from the magnet.
NOTE!
• This device must only be operated by qualified personnel. The
owner is responsible for their training.
• This device may only be used in accordance with the instructions in
the 'Intended purpose / intended use' chapter.
• If unexpected disturbances are observed which manifest themselves
as communication problems between the imaging module and the
EyeSuite software, the cause could be a cell phone or a radio
frequency telephone in the immediate vicinity to the slit lamp or
power supply. Increase the distance to the unit until the interference
disappears.
• The communication between imaging module and PC may also be
disturbed or interrupted, if the device is exposed to a mains power
supply delivering excessively transient disturbances or short voltage
interruptions. If this happens, the USB connector needs to be
disconnected for a short time or the PC needs to be restarted.
1.6 Disinfection
NOTE!
The device can, but does not need to be disinfected. For more
information, please refer to the 'Maintenance' chapter.
1.7 Warranty and product liability
• Haag-Streit products must be used only for the purposes and in the manner
described in the documents distributed with the product.
• The product must be treated as described in the ‘Safety’ chapter. Improper
handling can damage the product. This would void all guarantee claims.
• Continued use of a product damaged by incorrect handling may lead to personal
injury. In such a case, the manufacturer will not accept any liability.
• Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
• Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
• This product is covered by a limited warranty granted by your seller.
• For USA only: This product is covered by a limited warranty, which may be
reviewed at www.haag-streit-usa.com.
1.8 Reporting obligation
NOTE!
Any serious incident that has occurred in relation to the device must be
reported to Haag-Streit and the competent authority of the Member
State in your country.

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1.9 Description of symbols
Follow instruction for use Read the instructions for use
attentively
General warning, read the
accompanying documentation
European certificate of
conformity
Date of manufacture Manufacturer
Haag-Streit reference number Serial number
Trademark of the manufacturer
Haag-Streit AG
Notes on disposal, see the
'Disposal' chapter
Listed European Authorized
Representative Medical Device
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
MET Listed Mark with approval
for USA and Canada
Plug socket USB 3.0 micro B
on RM02 for computer
Plug socket USB 3.0 on RM02
for camera
Strong permanent magnets Plug socket on RM02 for power
supply
Slit lamp illumination Background illumination
Rotating knob on camera
symbol = 70 % of the light goes
to the camera
On (Power)
2Intended purpose / intended use
The imaging module IM 900 was developed exclusively for the Haag-Streit slit lamp
BQ 900, which can be used to produce digital photographs and videos for
documentation of the eye.
3Introduction
3.1 Description of the device
The system allows for creation of digital images and videos that can be viewed in
the right beam path of the microscope: The divider mirror can be switched off with a
switch (rotating knob) so that 100% of the light reaches the eyepiece. With the
release module, it is possible to release images or videos and to change the
camera's exposure time without letting go of the joystick.
3.2 System components
The imaging module IM 900 is a system made up of the following main components:
A. Camera module CM03
B. Release module RM02
C. EyeSuite software
D. Power supply

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3.3 LED illumination (prerequisite)
1. Lamp cable with special connection plug for LI01 plus / LI02 plus
2. LED illumination head with background illumination (see separate instructions
for use)
3. Fiber optic line for background illumination
4. Headrest (see separate instructions for use)
5. Rail cover
3.4 Camera module CM03
6. Camera module CM03
7. Beam splitter switch (rotating knob)
8. Diaphragm selection (rotating knob)
9. Camera cable (CM03 to RM02)
10. Operational control LED
11. Cable holder
3.5 Release module RM02
12. Sticker left/right identification
13. Release module RM02
14. Cable harness
3.6 Power supply
15. Power supply
16. Mains connector (country-dependent)

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4 Device assembly / installation
WARNING!
•Do not modify this device without authorization of the manufacturer.
Installation and repairs may only be performed by trained
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.
• Only original Haag-Streit spare parts may be used.
4.1 Placement of adhesive label for the automatic left/right
detection
17. Protective film
18. Rest of the sticker
19. Roller rail
20. Gliding plate
• Remove rail cover (5) and place slit lamp aside. Clean surface of table.
• Remove protective film (17) from the back of the adhesive label. Carefully start
at the corner opposite the black surface.
• Position the sticker against the right roller rail (19) and the gliding plate (20).
Press firmly on the white/black surface, press away any air bubbles.
• Carefully tear off the remainder of the adhesive label (18) (the 'positioning tool')
along the perforation.
• Reassemble the slit lamp and rail cover.
4.2 Connecting the CM03 in the beam path
21. Cover caps
22. Marking points
23. Arrow (lock)
•Disassemble the breath shield.
• Remove the black and white cover caps (21).
• Align the marking points (22) on the upper side of the parts to be connected.
• Turn the locking ring in the direction of the arrow shown (23) to tighten.

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4.3 Weight compensation facility
24. Setting screws weight compensation facility
The slit lamp's crosstree carriage offers the option of
balancing the weight of the accessory so that the height
adjustment on the joystick remains smooth (24). To do
so, please follow the instructions in the instruction
manual for the slit lamp.
4.4 Cabling of the CM03 and the RM02 (diagram)
WARNING!
• Only use the supplied USB 3.0 cable (REF 1022373) for the
connection to the PC.
• Only use medically approved PCs or 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 mains at any time.
25. Mains
26. Medical approved isolating
transformer
27. Instrument table (IT)
28. Medical approved power supply
29. Printer
30. Screen
31. Personal computer
32. Local network
33. Galvanic isolation (EN 60601-1)
34. Headrest
35. Cable headrest / LED illumination /
RM02
36. Release module RM02
37. LED illumination
38. Camera module CM03
NOTE!
To ensure that the system works correctly, Haag-Streit recommends not
using laptops and using a high-quality desktop computer instead.
39. Fastening screw
40. Two-pole connection plug
If the middle LED lights up red
during operation, the two-pole
connection plug (40) is connected
incorrectly.
•Disconnect the device from the mains.
• Remove the cover on the upper part of the illumination facility by loosening the
fastening screw (39).
• Turn the two-pole connection plug (40) 180°.
• Fix the cover on the upper part of the illumination facility with the fastening
screw (39).
• Connect the device to the mains again.

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WARNING!
• Keep magnet-sensitive storage media (e.g. credit cards) away from
the magnets on the release module RM02.
• Only external medical power supplies approved by Haag-Streit that
fulfill EN 60601-1 may be used.
4.4.1 Step-by-step cabling
• Place the release module RM02 over the slit lamp's cross slide. Four magnets
are used for fixing.
NOTE!
• No external USB devices may be connected to USB ports (59) and
(61).
• With BQ 900 slit lamps with a date of manufacture before 1998, the
cover plate is fixed on the crosstree carriage with screws. The two
screws at the back must be removed before the RM02 is mounted.
• Insert the camera cable connector plug (50) in the socket (59).
• Press the camera cable into the cable holders (49).
• Computer cable USB 3.0 (47), power supply cable (46) and cable headrest /
LED illumination / RM02 (45) must be fed through in the braided sleeving (44).
• Insert the connector plug of the power supply cable (46) in the socket (60).
• Insert the connector plug of the computer cable USB 3.0 (47) in the socket (61).
• Pull on the braided sleeving taught and mount a cable tie (43) on each end.
• Connect the headrest cable (42) with the counterpart (41) on the headrest.
• Mount the table top and place the slit lamp on the table.
• Connect the computer cable USB 3.0 (47) to the PC.
• Connect the electric power supply lead (16) to the power supply (15).
• Connect the power supply connector plug to the mains.
• Plug the headrest cable (1) into the lamp head.
41. Connection plug headrest
42. Connector plug headrest / LED
illumination / RM02
43. Cable tie
44. Braided sleeving
45. Cable headrest / LED illumination /
RM02
46. Power supply cable
47. Computer cable USB 3.0
48. Camera (not shown)
49. Recess on the microscope arm
50. Connector plug camera cable
51. Release module RM02
52. RM02 operational control LED
53. On/Off key
54. Rotating knob, background
illumination
55. Rotating knob, slit illumination
56. Selector key A
57. Selector key B
58. Release key RM02
59. Socket camera cable
60. Socket for power supply connector
plug
61. Socket computer cable USB 3.0
micro B
62. Threaded bolt
63. Pin assignment
64. Cable cover

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5 Commissioning
5.1 Switching on the device
• Connect the power supply to the mains and press the On/Off key (53) on the
release module RM02. The green operational control LED (52) lights up when
the device is switched on. The camera has no On/Off key and switches on
automatically when the PC is switched on. The status is displayed by the
indicator light (10).
• Turn the rotating knob on the slit illumination (55) to a position between '1' and
'10'.
6Operation
NOTE!
The slit lamp's eyepieces must be adjusted in accordance with the
refraction of the examiner. See instructions for use for the slit lamp BQ
900.
6.1 Changing the depth of sharpness
Select a diaphragm with the rotating knob (8).
1 = Largest diaphragm (lowest depth of sharpness)
6 = Smallest diaphragm (highest depth of sharpness)
Select the exposure time on the release module RM02.
Image via trigger key on the release module RM02
6.2 Camera module CM03
Set the beam splitter switch (7) to the camera symbol
• 70% of the light goes to the camera
• 30% of the light goes to the examiner
Set the beam splitter switch (7) to the top
• 100% of the light goes to the examiner (applies to both beam paths)
6.3 Camera module CM03 30/70
Set the beam splitter switch (7) to the camera symbol
• 30% of the light goes to the camera
• 70% of the light goes to the examiner
Set the beam splitter switch (7) to the top
• 100% of the light goes to the examiner (applies to both beam paths)

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6.4 Field of view
WARNING!
The images and videos should only be used for documentation
purposes. Only the image in the eyepiece may be used for diagnosis.
Field of view of the object, see table
Circle: The field of view of the object observed through the microscope's
eyepiece.
Rectangle: Surface area of the sensor:
Object image section in the
eyepiece (mm)
Object image section in the
camera
12.5 × Recording mode 4:3
6.3 × ø 33 34 × 46
10 × ø 20 21 × 28
16 × ø 12.7 13 × 17.5
25 × ø 8 8.3 × 11
40 × ø 5.1 5.2 × 7
6.5 History trigger
• Press the release key (58) on the release module RM02
• Select the desired image via selector key (56) or (57)
• Press the release key (58) on the release module RM02 again – the image is
saved
6.6 White balance
The Haag-Streit IM 900 is optimized for maximum image quality with the Haag-Streit
slit lamp BQ 900. The image quality is dependent, among other things, on the
correct calibration of the color tones to the respective slit lamp illumination. We
recommend performing a white balance in order to improve the image quality and
achieve a realistic color reproduction.
6.6.1 Slit lamp preparation
1. Turn the slit lamp on.
2. Filter position 'open' (no filter).
3. Select a 16 × magnification.
4. Completely open the slit diaphragm.
5. Connect the diffuser upstream.
6. Position the Haag-Streit greycard in front of the slit lamp and use it for
focusing.
7. The brightness of the slit lamp's illumination should be set in such a way that
the greycard's structure is clearly discernible.
6.6.2 Conducting a white balance
1. Start the 'EyeSuite Imaging' software
2. Activate the intensity auto mode
3. Open the 'White balance' application
4. Start the 'White balance' by activating the 'Calibration' function
WARNING!
To achieve an optimal result during the white balance, the image must
be homogeneously illuminated.
Set white balance greycard (REF 1021485)

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Image is blurry or overexposed Structure is discernible
6.7 Software / Help menu / error messages
The EyeSuite software's help section contains instructions and guidance for
performing an examination as well as descriptions of the error messages. Help can
be opened by pressing the F1 key or by going to the [?] - [Help] menu.
WARNING!
The software must be installed by trained personnel in accordance with
separate installation instructions.
6.8 LED indicator illumination head
1) 2) 3)
Background
illumination
Polarity
reversal
Slit lamp
illumination
Operating state
Standby mode Green, pulsing x Green, pulsing
Normal operation
Slit and background
illumination on
Green x Green
Only slit illumination on Green, pulsing x Green
Only background illumination
on
Green x Green, pulsing
Reduced background
illumination operation
High LED temperature, thus
reducing background
illumination operation
Green, flashing x Green, flashing
6.9 LED indicator power supply
Normal operation Green
6.10 LED indicator release module RM02
Normal operation Green
LED illumination switched off Green, pulsing
Establishing connection Orange
6.11 LED indicator camera module CM03
Normal operation Green
Establishing connection Orange

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6.12 Error messages (illumination head)
1) 2) 3)
Background
illumination
Polarity reversal Slit lamp
illumination
ERROR
Error messages Measures
E1 Incorrect supply polarisation Contact your Haag-Streit representative. x Red x
E2 Illumination control not
recognized
Connect illumination control or replace, if necessary. Red xRed
E3 Temperature is too high The light sources’ power will be reduced. Normal operation is
ensured once the permissible temperature has been reached.
Red, flashing x Red, flashing
E4 No communication between
power supply and illumination
Contact your Haag-Streit representative. Red, flashing 2 × x Red, flashing 2 ×
E6 General error Send PS-LED to the appropriate service branch. Red, flashing 4 × x Red, flashing 4 ×
6.13 Error messages release module RM02
ERROR Error messages Measures Operational control LED (75)
E14 No communication with LED illumination LI01 plus / LI02 plus Contact your Haag-Streit representative. Red, flashing 2 ×
E16 General error Send device to the appropriate service branch. Red, flashing 4 ×
6.14 Error messages camera module CM03
ERROR Error messages Measures Operational control LED (26)
E18 No communication with LED illumination LI01 plus / LI02 plus Contact your Haag-Streit representative. Red

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7 Decommissioning
Press the On/Off key (53) on the release module RM02 briefly to switch off the LED
illumination after the examination. This does not switch off the camera. This is
signaled with green pulsing. Pressing the key for approx. 3 sec. switches off the
release module completely and the operational control LED (52) goes out. The
camera has no separate On/Off switch. It switches off automatically when the PC is
switched off.
NOTE!
The On/Off key on the release module RM02 does not disconnect the
device from the electric mains. Disconnect the power supply from the
mains by unplugging the mains connector if you do not intend to use it
for an extended period of time.
8 Technical data
8.1 Power supply
Type ICCNEXERGY, ELPAC POWER SYSTEMS
Model MWA030018B-10A REF 1022106
Mains voltage 100 − 240 VAC
Current consumption 0.8 A
Operating frequency 50 − 60 Hz
8.2 Dimensions
Camera module CM03
Weight: 2.6 kg (incl. packaging)
Dimensions L × W × H: 190 × 127 × 76 mm
Packaging L × W × H: 380 × 270 × 130 mm
8.3 Minimum PC requirements
Processor type Intel i5, 5th gen or higher with 4 cores.
NOTE!
• 6th gen is not recommended.
• 2 cores with hyperthreading are not
recommended.
RAM 8 GB RAM if PC is exclusively used to operate the
imaging module.
16 GB RAM if third-party applications such as patient
administration software are to be used alongside
EyeSuite.
Use 2 RAM module.
Hard disk At least 500 GB (NTFS data system).
Graphics Graphics card with at least 2 GB memory (Nvidia or
AMD chip set recommended).
OpenGL 2.0
Monitor At least 19", 1920 × 1080 pixel resolution.
Operating system Windows 8.1, Windows 10, Windows 11.
64-bit system only.
PCI slot PCI-Express 3.0
PCI Express card Chip set by Renesas / NEC.
8.4 Camera
Camera beam: Beam path right (from the point of view of the doctor)
Interface: USB 3.0
Frame rate: 30 fps (frames per second)
Power consumption: 5 V / 600 mA

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9 Maintenance
WARNING!
•Do not modify this device without authorization of the manufacturer.
Installation and repairs may only be performed by trained
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.
• Only original Haag-Streit spare parts may be used.
9.1 Device inspection
To check the correct function, proceed as follows:
• Insert the test rod into the radial movement bearing, whilst at the same time
aligning the surface to the microscope at a right angle.
• Set the slit length to 8 or 14 mm.
• Set the illumination intensity to 50%.
• Set the magnification in the microscope to max.
• Set the eyepieces in such a way that the test rod is in sharp focus. In doing so,
turn the ocular from the (+) to the (-) side.
• Switch on the camera.
• For all magnifications, the structure of the test rod in the ocular and in the
camera image must be shown in sharp focus.
• Turn on the illumination of the 0.2 mm diaphragm.
• Turn on the crosshairs in EyeSuite; the cross must be inside the illuminated dot.
9.2 Servicing
To guarantee a long service life, the device must be cleaned weekly as described
and protected with the dust cover when not in use. We recommend having the
device inspected once a year by an authorized service technician.
9.3 Cleaning and disinfection
The Haag-Streit slit lamps and their accessories can, if required, be carefully wiped
down with ready-for-use disposable 70% ethanol disinfectant wipes. Surface-friendly
disinfectants (containing aldehyde or aldehyde-free) are also permitted, such as
Kohrsolin FF.
WARNING!
• The preparation instructions provided do not apply to tonometer
measuring prisms.
• Tonometer measuring prisms must be prepared in accordance with
a different manual
• Too strong or aggressive disinfectants or cleaning liquids e.g.
hydrogen peroxide will damage the finish and coating of the device.
•Do not use sprays
• Observe the manufacturer's safety instructions
•Do not use any cloths that drip
• Wring out any soaked cloths before use when necessary
• Ensure that no liquid penetrates the device
• Comply with the stipulated exposure time
• Clean optical surfaces after disinfection with a very soft cloth
NOTE!
IP code: IPX0 (device is not protected against liquids)
10 Appendix
10.1 Accessories / functionals parts / detachable parts /
consumables
Components REF
Set white balance grey card 1021485
Computer cable USB 3.0 1022373

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10.2 Legal regulations
• This device was developed and designed taking the EN 60601-1 and EN
60601-1-2 standards into account.
• The EN 60601-1 standard must be observed when using different medical and/
or non-medical electrical devices in combination.
•Compliance of the device with the Medical Device Regulation 2017/745 is
confirmed by the CE-designation.
• You can request a copy of the declaration of conformity for this device from
Haag-Streit at any time.
• Statutory accident regulations are to be observed.
WARNING!
The device may only be operated in an environment in which standard
values pursuant to standard EN 60601-1 are observed.
10.3 Classification
Standard EN 60601-1 Protection class I
Operating mode Continuous operation
CE Medical Device Regulation
2017/745
Class I
FDA Class II
10.4 Disposal
Electrical and electronic devices must be disposed of separately from
household waste! This device was made available for sale after the
13th August 2005. For correct disposal, please contact your Haag-
Streit representative. This will guarantee that no hazardous
substances enter the environment and that valuable raw materials are
recycled.
10.5 Observed standards
EN 60601-1
EN 60601-1-2
10.6 Information and manufacturer's declaration concerning
electromagnetic compatibility (EMC)
10.6.1 General
This device fulfills the requirements on electromagnetic compatibility according to
IEC 60601-1-2:2014 (4th Edition). The device 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 the
device itself is suitably immune to electromagnetic interference.
WARNING!
Avoid damages due to high electrostatic discharges (ESD). Electrostatic
discharges with voltages exceeding 6 kV to some parts of the slit lamp
like joystick or metallic parts on the instrument base may influence the
device.
• The communication between imaging module and PC could be
interrupted, which would require a restart of the EyeSuite software.
WARNING!
• Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC
instructions contained in this accompanying document.
• Use of accessories, transducers and cables other than those
specified or provided by Haag-Streit could result in increased
electromagnetic emissions or decreased electromagnetic immunity
of this device and result in improper operation.
• Third-party devices may only be connected in compliance with the
IEC 60601-1 standard.

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10.6.2 Emitted interference
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an
environment.
Emission test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 This product 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.
RF emissions
CISPR 11
Class B
Harmonics emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Not applicable
This product is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.

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10.6.3 Electromagnetic immunity environment tested (part 1)
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product 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
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 15 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, 100kHz for power supply lines *
± 1 kV, 100 kHz for input/output lines *
± 2 kV, 100kHz for power supply lines *
± 0.5, ± 1 kV, 100 kHz for input/output
lines *
Mains power quality should be that of a typical
commercial or hospital environment.
*Not applicable for DC and I/O if cable < 3 m.
Surge
IEC 61000-4-5
± 0.5, ± 1 kV line(s) to line(s) *
± 0.5, ± 1, ± 2 kV line(s) to earth *
± 1 kV line(s) to line(s) *
± 0.5, ± 1, ± 2 kV line(s) to earth *
Mains power quality should be that of a typical
commercial or hospital environment.
*Not applicable for DC and I/O if cable < 3 m.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
0% UT: 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0% UT: 1 cycle at 0°
0% UT: 250/300 cycles at 0°
70% UT: 25/30 cycles at 0°
0% UT: 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0% UT: 1 cycle at 0°
0% UT: 250/300 cycles at 0°
70% UT: 25/30 cycles at 0°
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of this product requires continued
operation during power mains interruptions, it is
recommended that this product be powered from an
uninterruptible power supply or battery.
UTis the a.c. mains voltage (100 – 240 V) prior to
application of the test level.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
50/60 Hz
30 A/m
50/60 Hz
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.

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10.6.4 Electromagnetic immunity environment tested (part 2)
Portable and mobile RF communications equipment should be used no closer to any part of this product, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths
from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz – 80 MHz outside ISM
bands and radio amateur band *
6 Vrms
150 kHz – 80 MHz in ISM bands
and radio amateur band *
3 Vrms
150 kHz – 80 MHz outside ISM
bands and radio amateur band *
6 Vrms
150 kHz – 80 MHz in ISM bands
and radio amateur band *
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz – 2.7 GHz
80% AM 1 kHz
3 V/m
80 MHz – 6 GHz
80% AM 1 kHz
Proximity field from RF wireless
communication equipment
IEC 61000-4-3
27 V/m
380 – 390 MHz
50% PM 18 Hz
28 V/m
430 – 470 MHz
FM ± 5 kHz deviation, 1kHz sine
9 V/m
704 – 787 MHz
50% PM 217 Hz
28 V/m
800 – 960 MHz
50% PM 18 Hz
27 V/m
380 – 390 MHz
50% PM 18 Hz
28 V/m
430 – 470 MHz
FM ± 5 kHz deviation, 1kHz sine
9 V/m
704 – 787 MHz
50% PM 217 Hz
28 V/m
800 – 960 MHz
50% PM 18 Hz
If the measured field strength in the location in which this product
is used exceeds the applicable RF compliance level, this product
should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary,
such as reorienting or relocating this product.
Minimum separation distance shall be calculated by following
equation:
E is the immunity test level in [V/m]
d is the minimum separation in [m]
P is the maximum power in [W]
RF wireless equipment maximum output power and
separation distance tested (at 30 cm):
TETRA 400: max 1.8 W
GMRS 460, FRS 460: max 2 W
LTE Band 13 and 17: max 0.2 W
GSM 800/900: max 2 W
TETRA 800: max 2 W
iDEN 820: max 2 W