Haag-Streit LI 900 User manual

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
DOC. no. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
LED illumination set
LI 900®
10. Edition / 2019 – 06
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
01-IFU_LI900-7220591-04100_eng.indd 1 24.06.2019 16:03:12

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
INSTRUCTIONS FOR USE
LED illumination set
LI 900®
10. Edition / 2019 – 06
Introduction
Thank you for choosing a Haag-Streit device. Provided you comply carefully
with the regulations in this instructions for use, we can guarantee the reliable and
unproblematic use of our product.
Purpose of use
The LED 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.
Contraindication
There are no known absolute contraindications for tests with this device. Appropri‑
ate professional assessment and caution are necessary.
WARNING!
Read the instruction manual carefully before commissioning this pro-
duct. It contains important information regarding the safety of the user
and patient.
NOTE!
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. Exces-
sive exposure of patients in treatment with certain medication may lead
to phototoxic adverse reactions, due to higher photosensitivity.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
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Contents
1. Safety ................................................................................... 4
1.1 Areas of application of the device...........................................................................4
1.2 Ambient conditions..................................................................................................4
1.3 Shipment and unpacking ........................................................................................4
1.4 Installation warnings ..............................................................................................4
1.5 Operation, environment ..........................................................................................4
1.6 Light toxicity ............................................................................................................5
1.7 Disinfection .............................................................................................................5
1.8 Warranty and product liability..................................................................................5
1.9 Description of symbols............................................................................................5
2. Introduction.......................................................................... 5
2.1 Device description...................................................................................................5
2.2 Overview ................................................................................................................6
2.3 LED illumination LI02 plus ......................................................................................6
2.4 Bluelter.................................................................................................................6
2.5 Background illumination .........................................................................................6
2.6 Power supply PS‑LED ............................................................................................6
2.6.1 Versions ..................................................................................................................6
2.6.2 Description..............................................................................................................6
3. Equipment assembly / installation..................................... 6
3.1 Power supply for instrument table HSM 901...........................................................6
3.2 Power supply on HSM 600 and third‑party tables...................................................7
3.3 Guidelines for assembly on HSM 600 and third‑party tables .................................7
3.4 Installation on HSM 600 and on third‑party tables ..................................................7
3.4.1 Calibrating illumination controls of an third‑party supplier.......................................7
3.5 Converting tungsten to LED illumination.................................................................7
4. Commissioning.................................................................... 7
4.1 Switching on the appliance .....................................................................................7
5. Operation.............................................................................. 8
5.1 Reduced operation..................................................................................................8
5.2 LED indicator Illumination head ..............................................................................8
5.3 LED indicator (PS‑LED power supply)....................................................................8
5.4 Error messages (illumination head) ........................................................................8
5.5 Error messages (PS‑LED power supply) ................................................................9
6. Decommissioning................................................................ 9
7. Technical data...................................................................... 9
7.1 LI01 / LI02 plus .......................................................................................................9
7.2 Power supply PS‑LED / PS‑LED HSM 901...........................................................10
7.3 Dimensions ...........................................................................................................10
8 Maintenance....................................................................... 10
8.1 Repair ...................................................................................................................10
8.2 Cleaning and disinfection......................................................................................10
A. Appendix ............................................................................ 10
A.1 Accessories / consumables / spare parts / upgrade .............................................10
B. Legal regulations................................................................11
C. Classication .....................................................................11
D. Disposal...............................................................................11
E. Standards ............................................................................11
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC) .................................................................................. 12
F.1 General .................................................................................................................12
F.2 Emitted interference (standard table 1).................................................................12
F.3 Immunity (standard table 2) ..................................................................................13
F.4 Immunity for non‑life support devices (standard table 4) ......................................14
F.5 Safe distances for non‑life support devices (standard table 6) .............................15
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
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1. Safety
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 Areas of application of the device
The device is intended to use in professional health care facility environment, like
doctor's practices, hospitals and optometrists and opticians premises, except near
of HF surgical equipment and in RF shielded rooms of ME‑systems for magnet‑
ic resonance imaging. Some portable radio frequency equipment, like cell phones
or RF telephone equipment including antennas may interference medical devices.
Such equipment has to be kept in a distance of more than 30 cm (12 inches) from
any part of the instrument. Inobservance of this precaution may lower the correct
function of the instrument.
1.2 Ambient conditions
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage:
Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use:
Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
90%
1.3 Shipment and unpacking
• Before you unpack the appliance, check whether the packaging shows traces of
incorrect handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the equipment together with a represen‑
tative 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 (conden‑
sation).
• Check the appliance for damage after it is unpacked. Return defective appliances
in the appropriate packaging.
• Store packaging material carefully, so that it can be used for possible returns or
when moving.
1.4 Installation warnings
WARNING!
• Do not modify this equipment 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 (HS) replacement parts may be used.
The device must not be stacked or placed in close proximity to other
electronic devices.
Grounding reliability can only be achieved when unit is connected to
a hospital grade receptacle. (Not valid for EU countries).
•
•
•
•
1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where vola-
tile 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.
WARNING!
To avoid the risk of electric shock, this equipment must only be con‑
nected to a supply mains with protective earth.
NOTE!
This equipment 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 "Purpose of use".
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
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1.6 Light toxicity
WARNING!
As extended, intensive illumination can damage the retina, the use of the de-
vice 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
750nm. 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 increas-
ed 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. The light from this
instrument may be dangerous. The risk of eye damage increases with the
exposure time. An exposure time with this instrument at maximum intensity of
longer than 131 seconds exceeds the guideline value for a risk.
1.7 Disinfection
NOTE!
The device does not need to be disinfected. For more information on
cleaning, please refer to the 'Maintenance' chapter.
1.8 Warranty and product liability
Haag-Streit products must be used only for the purposes and in the manner des-
cribed in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper hand-
ling 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.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
•
•
•
•
•
•
For US
A only:
•
1.9 Description of symbols
Read the instructions for use
attentively Follow instruction for use
Notes on disposal, see the
'Disposal' chapter
European certificate of
conformity
Date of manufacture Manufacturer
Earth (ground)
Disconnect the plug before
opening the device
On (Power) Serial number
HS reference number Slit lamp illumination
Background illumination
Illumination control of
an external supplier
ETL Listed Mark with approval
for USA and Canada
MET Listed Mark with approval
for USA and Canada
2. Introduction
2.1 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 ca‑
ble.
• The light intensity of slit and background illumination can be controlled continu‑
ously 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.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
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2.2 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lter
5. Background illumination connection
6. Lid
1 2
3
4
5
6
7
2.3 LED illumination LI02 plus
2.4 Bluelter
7. Theblueltercanbeswiveledinusingtherotaryknob.Markingpointsatthe
sameheight=bluelteron.
2.5 Background illumination
The background illumination can only be used in con‑
junction with an LED illumination LI02 plus.
8. Backgroundilluminationxed
9. Background illumination pivoting
2.6 Power supply PS-LED
2.6.1 Versions
8 9
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
10 11
2.6.2 Description
12. Rocker switch
switch in position 0
= ’OFF’ power sup‑
ply device is deen‑
ergized.
Switch in position
1 = ’ON’ pilot lamp
lights up green. 12
O
I
13 14 15 16 17 18 19 20
13. Mainandxing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
3. Equipment assembly / installation
WARNING!
Do not modify this equipment 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 replacement parts may be used.
•
•
3.1 Power supply for instrument table HSM 901
NOTE!
Haag‑Streit recommends connecting the aluminum tray to the protec‑
tive conductor connection of the power supply.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
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(25) on the power supply PS‑LED.
• Itmustrst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
25 26 27 28
3.4.1 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 maxi‑
mum 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)ashingbriey
twice.
3.5 Converting tungsten to LED illumination
WARNING!
Do not modify this equipment 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 replacement parts may be used.
•
•
Slit lamps with tungsten illumination can be converted to LED illumination by techni‑
cians trained by Haag‑Streit. If an LED upper part of the illumination unit with back‑
ground illumination is used, there is no need to use an additional cold light source.
4. Commissioning
4.1 Switching on the appliance
• Connect the power supply to the mains and press the rocker switch. When the de‑
vice 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’.
21. Plug alignment
22. Mainandxinglampcon‑
nection
23. Type plate on housing
24. Mains connection
21
22
23
24
NOTE!
The instruction manual 'Instrument table HSM 901' must be complied
with.
3.2 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 con‑
nected 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qualiedpersonnel.
3.3 Guidelines for assembly on HSM 600 and third-party
tables
If a device power supply is installed on a third‑party table, then it will be neces‑
sary 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.”
3.4 Installation on HSM 600 and on third-party tables
An illumination control of an third‑party supplier can be connected via connection
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
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5. Operation
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 illu‑
mination between white and blue light.
29. Background illumination knob
30. Slit illumination knob
29
30
WARNING!
Illumination control cables can only be used for connecting an illumina‑
tion control IC01 and a power supply PS‑LED. Only connect illumina‑
tion controls to suitable devices!
5.1 Reduced operation
To guarantee a long service life of the light sources, the output of the background il‑
lumination 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.
5.2 LED indicator
Illumination head
a) b) c)
Background illumination Polarity reversal Slit lamp illumination
a) b) c)
Operating state
Standby mode
Greenashing
briey ×
Greenashing
briey
Normal mode
Slit and background illumination on
Green ×Green
Only slit illumination on
Greenashing
briey ×Green
Only background illumination on green ×
Greenashing
briey
Reduced operation of the background
illumination
Increased LED temperature, resulting
in reduced operation of the background
illumination
Greenashing ×Greenashing
5.3 LED indicator (PS-LED power supply)
Normal mode green
5.4 Error messages (illumination head)
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
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ERROR
a) b) c)
a) b) c)
Background illumi- nation Polarity reversal Slit lamp illumination
Error messages Measures
E1 Incorrect polarization of the supply Contact your Haag‑Streit representative. ×Red ×
E2 Illumination control not recognized Connect the illumination control or replace if necessary. Red ×Red
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ashing ×Redashing
E4 No communication between
Power supply and illumination Contact your Haag‑Streit representative. Redashing2× ×Redashing2×
E6 General error Send the PS‑LED to the relevant service branch. Redashing4× ×Redashing4×
5.5 Error messages (PS-LED power supply)
ERROR Error messages Measures
LED indicator
L1 (26)
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ashing2×
E16 General error Send the device to the relevant service branch. Redashing4×
6. Decommissioning
The LED illumination can be switched off with the illumination controls. The power
supply remains switched on and the switch lights up green. To switch off the system
completely, the rocker switch must be moved to position 0 = ’OFF’. There is then
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.
7. Technical data
7.1 LI01 / LI02 plus
NOTE!
Observe the respective Haag-Streit instructions for use. (For further
information, please contact your
Haag-Streit dealer).
This device must only be operated with PS-LED and PS-LED HSM 901
HS power supplies and the RM02 release module.
•
•
NOTE!
Detailed information regarding the radiation can be provided
on request.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
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7.2 Power supply PS-LED / PS-LED HSM 901
Mains voltage: 100 ‑ 240 V
Power consumption: 60 VA
Operating frequency: 50‑60 Hz
7.3 Dimensions
PS-LED PS-LED HSM 901
Length: 164 mm Length: 316 mm
Width: 140 mm Width: 146 mm
Height: 60 mm Height: 69 mm
Weight: 450 g Weight: 750 g
Illumination control IC01 Illumination control IC01 T
Length: 75 mm Length: 90 mm
Width: 35 mm Width: 51 mm
Height: 33 mm Height: 33 mm
Weight: 32 g Weight: 32 g
8 Maintenance
WARNING!
Do not modify this equipment 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 replacement parts may be used.
•
•
The LED illumination can be operated maintenance‑free for its entire service life.
8.1 Repair
To guarantee a long service life, the device should be cleaned weekly as described
and protected with the dust cover when not in use. We recommend having the de‑
vice cleaned annually by an authorized service technician.
8.2 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‑friend‑
ly disinfectants (containing or not containing aldehyde) are also permitted, such as
Kohrsolin FF.
WARNING!
• Do not use sprays
• Observe the manufacturer's safety instructions
• Do not use any cloths that might drip.
• Wring out any soaked cloths completely before use wherever
necessary
• Ensure that no liquid penetrates into the device
• Comply with the stipulated exposure time
NOTE!
IP code: IPX0 (device is not protected against liquids)
A. Appendix
A.1 Accessories / consumables / spare parts / upgrade
NOTE!
An asterisk (*) indicates that you should contact your Haag‑Streit re‑
presentative for further information. Two asterisks (**) indicate a need
to refer to the separate instructions for use.
Components REF
USA power supply lead, length: 3100 mm 1001316
CH power supply lead, length: 2500 mm 1001319
USA power supply lead, length: 760 mm 1002147
USB illumination cable 2000 mm 1020940
USB illumination cable 5000 mm 1020956
Cover T‑0 for recess in table 1021085
Release module RM02 with power supply 7220546
Power supply for LED illumination for third‑party tables 7220741
Power supply for LED illumination, HSM 901** 7220742
Illumination control, double slit and background 'on table'** 7220743
Background illumination FI 01f 7220744
Illumination control, simple, 'on table'** 7220745
Illumination control, double slit and background 'in table'** 7220746
Illumination control, simple, 'in table'** 7220747
Background illumination, swivelling 7220765
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
B. Legal regulations
• The illumination set LI 900 was designed t taking the standards EN 60601‑1, EN
ISO 10939, EN 60601‑1‑2, and EN ISO 15004‑2 into account.
• Compliance of the LI 900 illumination set with the Directive 93/42/EEC is con‑
rmedbytheCEmarking.
• The EN 60601‑1 standard must be observed when using different medical and/or
non‑medical electrical equipment in combination.
• You can request a copy of the declaration of conformity for this instrument from
Haag‑Streit at any time.
• The statutory accident regulations must be observed.
C. Classication
Standard EN 60601‑1 As equipment safety class I
Operating mode: Continuous operation
CE directive 93/42 / EEC Class I
FDA Class II
D. Disposal
Electrical and electronic devices must be disposed of separately from
household waste!
This appliance 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.
E. Standards
EN 60601‑1 EN ISO 10939
EN 60601‑1‑2 EN ISO 15004‑2
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)
F.1 General
TheLEDilluminationsetLI900systemfulllstherequirementsonelectromagnetic
compatibility according to EN 60601‑1‑2:2007 (IEC 3. Edition) + EN 60601‑1‑2:2015
(IEC 4. Edition). The instrument is built so that the generation and emission of elec‑
tromagnetic interference is limited to the extent that other devices are not disturbed
in their use in accordance with the regulations and so that the instrument 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 instruc-
tions contained in this accompanying document.
The operation of other lines or equipment than those listed may lead
to higher emissions or may reduce the device's resistance to interfe-
rence.
Third-party devices may only be connected in compliance with the
EN 60601-1 standard.
•
•
F.2 Emitted interference (standard table 1)
The information is based on the requirements of EN 60601‑1‑2:2007 (IEC 3rd edition) and EN 60601‑1‑2:2015 (IEC 4th edition).
Guidance and manufacturer's declaration – electromagnetic emissions
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 envi-
ronment
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 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.
Emission of harmonics according to
EN 61000-3-2
Class A
Voltage fluctuations / flicker emissions
according to EN 61000-3-3
Fulfilled
Emission test Compliance Electromagnetic environment - guidance
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
F.3 Immunity (standard table 2)
The information is based on the requirements of EN 60601‑1‑2:2007 (IEC 3rd edition).
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
Immunity test standard EN 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
EN 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic tile. If fl oors are
covered withs ynthetic material, the relative humidity should
be at least 30%.
Electrical fast transient / burst
EN 61000-4-4
± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial
or hospital environment.
Surge
EN 61000-4-5
± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages
± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages
Mains power quality should be that of a typical commercial
or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply lines
EN 61000-4-11
< 5% UT(> 95% drop in UT)
for ½ cycle
< 40% UT(> 60% drop in UT)
for 5 cycles
< 70% UT(> 30% drop in UT)
for 25 cycles
< 5% UT(> 95% drop in UT)
for 5 s
< 5% UT(> 95% drop in UT)
for ½ cycle
< 40% UT(> 60% drop in UT)
for 5 cycles
< 70% UT(> 30% drop in UT)
for 25 cycles
< 5% UT(> 95% drop in UT)
for 5 s
Mains power quality should be that of a typical commercial
or hospital environment. If the user of this product requires
continued function even in the event of interruptions in the
energy supply, this product should be powered from an un-
interruptible power supply or a battery.
Power frequency (50/60Hz)
magnetic fi eld EN 61000-4-8
Power frequency magnetic fi elds should be at levels char-
acteristic of a typical location in a typical commercial or hos-
pital environment.
NOTE: U
T
= the AC mains voltage prior to application of the test level.
3 A/m 100 A/m
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
F.4 Immunity for non-life support devices (standard table 4)
The information is based on the requirements of EN 60601‑1‑2:2007 (IEC 3rd edition).
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipments hould be used no closer to any part of this product, including cables, than the recommended separation distance cal-
culated from the equation applicable to the frequency of the transmitter.
Immunity test standard EN 60601 test level Compliance level Recommended distance(c):
Conducted RF EN 61000-4-6 3 V
rms
150 kHz – 80 MHz
10 V
rms
D= 0.35
Radiated RF EN 61000-4-3 3 V/m
80 MHz – 2.7 GHz
5 V/m
80 MHz – 2.7 GHz
D= 0.7 80 MHz – 800 MHz
D= 1.4 800 MHz – 2.7 GHz
Where Pis the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and Dis the recommended separation
distance in metres (m). Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level
in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-
cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic
site survey should be considered. If the measured fi eld 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 re-orienting or relocating
this product.
b.
c.
Over the frequency range 150 kHz to 80 MHz,
Possible shorter distances outside the ISM bands do not contribute to improved application in this table.
fi eld strengths should be less than 10 V/m.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
F.5 Safe distances for non-life support devices (standard table 6)
The information is based on the requirements of EN 60601‑1‑2:2007 (IEC 3rd edition).
Recommended safe distances between portable and mobile HF communication devices and this device.
This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of this product can help to
prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and this product, as rec-
ommended below in accordance with the maximum output of the communication system.
Nominal output of the transmitter (W)
Safe distance according to transmission frequency (m)
150 kHz – 80 MHz
D = 0.35
80 MHz – 800 MHz
D = 0.7
800 MHz – 2.7 GHz
D = 1.4
0.01
0.1
1
10
100
For transmitters with a nominal output not listed in the table above, the distance Dcan be calculated in meters (m) using the equation for the respective column, in which P
is the nominal output of the transmitter in watts (W)
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.7 GHz an additional factor of 10/3was used to reduce the
probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area.
These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.NOTE 3:
0.035
0.1
0.35
1.1
3.5
0.07
0.2
0.7
2.2
7
0.14
0.44
1.4
4.4
14
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http://www.haag-streit.com/contact/contact-your-distributor.html
HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz, Switzerland
Phone [phone]
Fax [phone]
eMail [email protected]
Internet www.haag-streit.com
16
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220591.04100 – 10. Edition / 2019 – 06
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
Should you have any further questions, please contact your Haag‑Streit representative at:
01-IFU_LI900-7220591-04100_eng.indd 16 24.06.2019 16:03:20