Haag-Streit LI 900 User manual

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
INSTRUCTIONS FOR USE
LED illumination set
LI 900¨
11. Edition / 2021 – 08

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
INSTRUCTIONS FOR USE
LED illumination set
LI 900¨
11. 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.
WARNING!
This device is equipped with high intensity light emitting diodes.
Excessive exposure of patients in treatment with certain medication may
lead to phototoxic adverse reactions, due to higher photosensitivity.

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
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 Light toxicity ...................................................................................................................................5
◦ 1.7 Disinfection ....................................................................................................................................5
◦ 1.8 Warranty and product liability ........................................................................................................6
◦ 1.9 Reporting obligation.......................................................................................................................6
◦ 1.10 Description of symbols.................................................................................................................6
¥ 2 Purpose of use...............................................................................................................................6
¥ 3 Introduction .....................................................................................................................................7
◦ 3.1 Device description..........................................................................................................................7
◦ 3.2 Overview........................................................................................................................................7
◦ 3.3 LED illumination LI02 plus .............................................................................................................7
▪ 3.3.1 Blue filter.............................................................................................................................7
▪ 3.3.2 Background illumination......................................................................................................7
◦ 3.4 Power supply PS-LED ...................................................................................................................7
▪ 3.4.1 Versions..............................................................................................................................7
▪ 3.4.2 Description..........................................................................................................................8
¥ 4 Device assembly / installation .............................................................................................8
◦ 4.1 Power supply for instrument table HSM 901..................................................................................8
◦ 4.2 Power supply on HSM 600 and third-party tables..........................................................................9
◦ 4.3 Guidelines for assembly on HSM 600 and third-party tables.........................................................9
◦ 4.4 Installation on HSM 600 and on third-party tables.........................................................................9
▪ 4.4.1 Calibrating illumination controls of an third-party supplier ..................................................9
◦ 4.5 Converting tungsten to LED illumination........................................................................................9
¥ 5 Commissioning ...........................................................................................................................10
◦ 5.1 Switching on the device ...............................................................................................................10
¥ 6 Operation.........................................................................................................................................10
◦ 6.1 Reduced operation.......................................................................................................................10
◦ 6.2 LED indicator Illumination head ...................................................................................................10
◦ 6.3 LED indicator (PS-LED power supply).........................................................................................10
◦ 6.4 Error messages (illumination head) .............................................................................................11
◦ 6.5 Error messages (PS-LED power supply).....................................................................................11
¥ 7 Decommissioning......................................................................................................................12
¥ 8 Technical data..............................................................................................................................12
◦ 8.1 LI01 / LI02 plus ............................................................................................................................12
◦ 8.2 Power supply PS-LED / PS-LED HSM 901..................................................................................12
◦ 8.3 Dimensions.................................................................................................................................. 12
¥ 9 Maintenance.................................................................................................................................. 12
◦ 9.1 Servicing...................................................................................................................................... 12
◦ 9.2 Cleaning and disinfection ............................................................................................................13
¥ 10 Appendix ...................................................................................................................................... 13
◦ 10.1 Accessories / functionals parts / detachable parts / consumables ............................................13
◦ 10.2 Legal regulations .......................................................................................................................13
◦ 10.3 Classification ............................................................................................................................. 14
◦ 10.4 Disposal..................................................................................................................................... 14
◦ 10.5 Observed standards ..................................................................................................................14
◦ 10.6 Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) .14
▪ 10.6.1 General........................................................................................................................... 14
▪ 10.6.2 Emitted interference .......................................................................................................15
▪ 10.6.3 Electromagnetic immunity environment tested (part 1).................................................. 16
▪ 10.6.4 Electromagnetic immunity environment tested (part 2).................................................. 17
▪ 10.6.5 Recommended separation distances between portable and mobile RF communications
equipment and this product....................................................................................................... 19

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
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.
• Grounding reliability can only be achieved when unit is connected to
a hospital grade receptacle. (Not valid for EU countries).
• 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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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
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!
• The device must be switched off after every use. Otherwise there is
a risk of overheating when a protective dust cover is used.
• 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.
• To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
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 'Purpose of use' chapter.
1.6 Light toxicity
WARNING!
• The light from this device may be dangerous. The risk of eye
damage increases with the exposure time. An exposure time with
this device at maximum intensity of longer than 131 seconds
exceeds the guideline value for a risk.
• As extended, intensive illumination can damage the retina, the use
of the device in the examination of the eye should not be prolonged
unnecessarily. The illumination of this slit lamp emits a radiation in
the range between 400 and 750 nm. Detailed information on the
radiation can be provided on request.
• The retinal dose for a photochemical risk is composed of the product
of the radiance and the exposure time. If the radiance is halved, the
time until the exposure time limit value is reached will double
accordingly. To date, no acute, optical radiation hazard has been
detected in slit lamps. Nevertheless, we recommend keeping the
intensity of the light reaching the patient's retina to the minimum
possible for the respective diagnosis. Children, people with aphakia
and people suffering from eye conditions are most at risk. An
increased risk may also occur if the retina is exposed to the same or
a similar device with a visible light source within 24 hours. This
applies, in particular, if the retina has been photographed with a
flashbulb in advance.
1.7 Disinfection
NOTE!
The device can, but does not need to be disinfected. For more
information, please refer to the 'Maintenance' chapter.

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
1.8 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.
1.9 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.
1.10 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
Earth (ground) Disconnect the plug before
opening the device
Slit lamp illumination Background illumination
Illumination control of an
external supplier On (Power)
2Purpose of use
The illumination set LI 900 was developed exclusively for Haag-Streit slit lamps BQ
900, BP 900 and BM 900. The intensities of the slit and background illumination can
be set via the illumination controls.

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
3Introduction
3.1 Device description
• The illumination set LI 900 consists of an LED illumination unit, a power supply
PS-LED and an illumination control. A light conductor set is also required for the
version with background illumination. Slit lamps with LED lighting may only be
used with the intended PS-LED or RM02 power supply.
• Both the supply current for the LED and the signals for communication between
the power supply and illumination are conducted by the two-pole connection
cable.
• The light intensity of slit and background illumination can be controlled
continuously with the illumination controls. The illumination controls can be
connected to the power supply PL-LED with a longer connection cable.
NOTE!
The instruction manual for the slit lamp must be complied with.
3.2 Overview
1. LED illumination LI02 plus with background illumination
2. LED illumination LI01 without background illumination
3. Plug connection for headrest
4. Filter wheel for blue filter
5. Background illumination connection
6. Lid
3.3 LED illumination LI02 plus
3.3.1 Blue filter
7. The rotating wheel is used to pivot the blue filter for the background
illumination. Marking points at the same height = blue filter is on.
3.3.2 Background illumination
The background illumination can only be used in
conjunction with an LED illumination LI02 plus.
8. Background illumination fixed
9. Background illumination pivoting
3.4 Power supply PS-LED
3.4.1 Versions
10. Power supply PS-LED, for installation on third-party tables and units
11. Power supply PS-LED HSM 901 insert, for the instrument table HSM 901

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
3.4.2 Description
12. Rocker switch
Switch in position 0 = ’OFF’: Power supply device is deenergized.
Switch in position 1 = ’ON’: Pilot lamp lights up green.
13. Main and fixing lamp connection
14. Connection illumination control from an third-party supplier (Power Jack 2.1
mm)
15. Connection Haag-Streit illumination control IC01x (USB mini B)
16. Type plate (on housing)
17. S1, button
18. L1, LED indicator (green / red)
19. Connection function ground (M3)
20. 3-pole mains connection
WARNING!
No other USB device may be connected to port 15 (USB mini-B), which
is exclusively reserved for the Haag-Streit IC01x lighting control
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 Power supply for instrument table HSM 901
NOTE!
Haag-Streit recommends connecting the aluminum tray to the protective
conductor connection of the power supply.
21. Plug alignment
22. Main and fixing lamp connection
23. Type plate on housing
24. Mains connection
NOTE!
The instruction manual 'Instrument table HSM 901' must be complied
with.

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
4.2 Power supply on HSM 600 and third-party tables
• Connect all cables, relieve the mains cable with a cable tie if necessary.
•Fix the power supply PS-LED in place with 4 screws.
• Connect the multi-pole jump lead connection between the head holder and the
instrument table.
• Connect the main lamp cable (27) on the upper part of the illumination unit.
WARNING!
• When mounting the guide rail and the head holder, it is important to
ensure that there is no electrical connection to any metal part of the
table. Otherwise, a grounding wire must be mounted on the head
holder.
• To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
• Cables must not be trapped as this can cause a short circuit!
• Work on cables or device components, which are in contact with the
power supply, may only be carried out by qualified personnel.
4.3 Guidelines for assembly on HSM 600 and third-party tables
If a power supply is installed on a third-party table, then it will be necessary to
observe Directive 93/42 EEC in conjunction with the standards EN 60601-1 “Medical
electrical equipment - Part 1: General requirements for basic safety and essential
performance” and EN 60601-1-2 “Electromagnetic compatibility.”
4.4 Installation on HSM 600 and on third-party tables
An illumination control of an third-party supplier can be connected via connection
(25) on the power supply PS-LED.
• It must first be calibrated for the relevant potentiometer value.
• Controls between 5 and 50 kΩ can be calibrated.
25. Protective cap
26. Connection
27. LED L1
28. Button S1
4.4.1 Calibrating illumination controls of an third-party
supplier
• Remove the protective cap for access to the connection (25).
• Connect the third-party illumination control (Power Jack 2.1 mm) and set to
maximum illumination (knob to the right stop).
• Switch on the power supply PS-LED.
• Press the button S1 > 1 sec. The device switches to calibration mode. The
orange LED (27) signals that the illumination control is being calibrated.
• The calibration process is complete after approx. 1 to 3 seconds (depending on
the illumination control). This is indicated by the green LED (27) flashing briefly
twice.
4.5 Converting tungsten to LED illumination
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.
Slit lamps with tungsten illumination can be converted to LED illumination by
technicians trained by Haag-Streit. If an LED upper part of the illumination unit with
background illumination is used, there is no need to use an additional cold light
source.

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220591‑04110 – 2021 – 08
5 Commissioning
5.1 Switching on the device
• Connect the power supply to the mains and press the rocker switch. When the
device is switched on, the green lamp lights up in the rocker switch.
• Set the knob of the illumination control to a position between ’1’ and ’10’.
6Operation
The light sources are switched on if the knob of the illumination control IC01 is in a
position between ’1’ and ’10’. In the 0 position, the light sources are switched off.
(Standby).
• Slit and background illumination can be set
separately with the potentiometers.
• The blue dial on the illumination head can be
used to switch the background illumination
between white and blue light.
29. Background illumination knob
30. Slit illumination knob
WARNING!
Illumination control cables can only be used for connecting an
illumination control IC01 and a power supply PS-LED. Only connect
illumination controls to suitable devices!
6.1 Reduced operation
To guarantee a long service life of the light sources, the output of the background
illumination is reduced slightly once the maximum operating temperature is reached.
After a short cooling time, the full output can be used again. This operating state is
only achieved if both light sources remain switched on together for a prolonged
period and are therefore outside the specified temperature range.
6.2 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
6.3 LED indicator (PS-LED power supply)
Normal operation Green