Haag-Streit LI 900 User manual

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© 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
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© 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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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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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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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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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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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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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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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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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

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6.4 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 the illumination control or replace if necessary. Red xRed
E3 Temperature is too high The output of the light sources is reduced. Normal operation is
guaranteed again when the permissible temperature is 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 RM02 to the appropriate service branch. Red, flashing 4 × x Red, flashing 4 ×
6.5 Error messages (PS-LED power supply)
ERROR Error messages Measures LED indicator L1 (27)
E12 Illumination control not recognized Connect the illumination control or replace if
necessary.
Red
E14 No communication with LED illumination LI02 Contact your Haag-Streit representative. Red, flashing 2 ×
E16 General error Send device to the appropriate service branch. Red, flashing 4 ×

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7 Decommissioning
The LED illumination can be switched off with the illumination controls. The power
supply remains switched on during this process and the switch lights up green. To
switch off the system completely, the rocker switch must be moved to position 0 =
’OFF’. This creates a two-pole isolation from the mains.
NOTE!
Disconnect the power supply from the mains if you do not intend to use
it for an extended period of time.
8 Technical data
8.1 LI01 / LI02 plus
NOTE!
• Observe the respective Haag-Streit instructions for use. For further
information, please contact your Haag-Streit representative.
• This device must only be operated with PS-LED and PS-LED HSM
901 Haag-Streit power supplies and the RM02 release module.
NOTE!
Detailed information regarding the radiation can be provided on request.
8.2 Power supply PS-LED / PS-LED HSM 901
Mains voltage: 100 - 240 V
Power consumption: 60 VA
Operating frequency: 50-60 Hz
8.3 Dimensions
PS-LED PS-LED HSM 901
Length: 164 mm Length: 316 mm
With: 140 mm With: 146 mm
Height: 60 mm Height: 69 mm
Weight: 450 mm Weight: 750 mm
Illumination control IC01 Illumination control IC01 T
Length: 75 mm Length: 90 mm
With: 35 mm With: 51 mm
Height: 33 mm Height: 33 mm
Weight: 32 mm Weight: 32 mm
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.
The LED illumination can be operated maintenance-free for its entire service life.
9.1 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.

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9.2 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!
• 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.
NOTE!
IP code: IPX0 (device is not protected against liquids)
10 Appendix
10.1 Accessories / functionals parts / detachable parts /
consumables
NOTE!
An asterisk (*) indicates that you should contact your Haag-Streit
representative for further information. Two asterisks (**) indicate a need
to refer to the separate instructions for use.
Components REF
Background illumination fixed FI01f 1020886
Background illumination pivoting FI01p 1020887
Illumination control cable USB 2000 mm 1020940
Illumination control cable USB 5000 mm 1020956
Illumination control IC01 (double, slit and background 'on table')** 1020883
Illumination control IC01-1 (single, slit only 'on table')** 1021020
Illumination control IC01T (double, slit and background 'in table')** 1021022
Illumination control IC01T-1 (single, slit only 'in table')** 1021024
Mains cable CH, length: 2500 mm 1001319
Mains cable US, length: 3100 mm 1001316
Mains cable US, length: 760 mm 1002147
Power supply PS-LED 1020881
Power supply PS-LED HSM901** 1020882
Release module RM02 (with power supply see 7220546) 1022052
10.2 Legal regulations
• This device was developed and designed taking the EN 60601-1, EN ISO
10939, EN 60601-1-2 and EN ISO 15004-2 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.
• Statutory accident regulations are to be observed.

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10.3 Classification
Standard EN 60601-1 As equipment safety class I
Operating mode: Continuous operation
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
EN ISO 10939
EN ISO 15004-2
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!
• 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
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Fulfilled
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 Ð 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

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28 V/m
1700 – 1990 MHz
50% PM 217 Hz
28 V/m
2400 – 2570 MHz
50% PM 217 Hz
9 V/m
5100 – 5800 MHz
50% PM 217 Hz
28 V/m
1700 – 1990 MHz
50% PM 217 Hz
28 V/m
2400 – 2570 MHz
50% PM 217 Hz
9 V/m
5100 – 5800 MHz
50% PM 217 Hz
CDMA 850: max 2 W
LTE Band 5: max 2 W
GSM 1800/1900: max 2 W
CDMA 1900: max 2 W
DECT: max 2 W
LTE Band 1, 3, 4, 25: max 2 W
UMTS: max 2 W
Bluethooth: max 2 W
WLAN 802.11b/g/n: max 2 W
RFID 2450: max 2 W
LTE Band 7: max 2 W
WLAN 802.11 a/n: max 0.2 W
Interference may occur in the vicinity of equipment marked with the
following symbol:
* The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are: 6.765 – 6.795 MHz, 13.553 – 13.567 MHz, 26.957 – 27.283 MHz, 40.66 – 40.7
MHz. The amateur radio bands between 0.15 MHz and 80 MHz are: 1.8 MHz – 2 MHz, 3.5 – 4.0 MHz, 5.3 – 5.4 MHz, 7 – 7.3 MHz, 10.1 – 10.15 MHz, 14 – 14.2 MHz,
18.07 – 18.17 MHz, 21.0 – 21.4 MHz, 24.89 – 24.99 MHz, 28.0 – 29.7 MHz, 50.0 – 54.0 MHz.
If the measured field strength in the location in which this product is used exceeds the applicable RF compliance level above, 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.

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10.6.5 Recommended separation distances between portable and mobile RF communications equipment and this product
This product is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as
recommended below, according to the maximum output power of the communication equipment.
Separation distance according to frequency of transmitter [m]
Rated maximum output power of
transmitter [W]
150 kHz Ð 80 MHz outside ISM and
radio amateur bands *
d = 1.2 √P **
150 kHz Ð 80 MHz in ISM and radio
amateur bands *
d = 2.0 √P
800 MHz Ð 2.7 GHz (for define RF
Wireless transmitters see table
before)
d = 2.0 √P
0.01 0.12 0.20 0.20
0.1 0.38 0.63 0.63
1 1.2 2.0 2.0
10 3.8 6.3 6.3
100 12 20 20
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres [m] can be determined using the equation
applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer.
* The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are: 6.765 – 6.795 MHz, 13.553 – 13.567 MHz, 26.957 – 27.283 MHz, 40.66 – 40.7
MHz. The amateur radio bands between 0.15 MHz and 80 MHz are: 1.8 MHz – 2 MHz, 3.5 – 4.0 MHz, 5.3 – 5.4 MHz, 7 – 7.3 MHz, 10.1 – 10.15 MHz, 14 – 14.2 MHz,
18.07 – 18.17 MHz, 21.0 – 21.4 MHz, 24.89 – 24.99 MHz, 28.0 – 29.7 MHz, 50.0 – 54.0 MHz.
** Formulas coming from Edition 3 of the IEC 60601-1-2.

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Should you have any further questions, please contact your Haag-Streit representative at:
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