Haag-Streit LENSTAR LS 900 User manual

1
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
INSTRUCTIONS FOR USE
Biometer
Lenstar LS 900®
14. Edition / 2020 – 02
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2
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
INSTRUCTIONS FOR USE
Biometer
Lenstar LS 900®
14. Edition / 2020 – 02
Introduction
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 trou‑
ble‑free use of our product.
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.
Intended use
The LS 900 is a non-invasive, non-contact OLCR (optical low-coherence reectom‑
etry) biometer used for obtaining ocular measurements and performing calculations
to assist in the determination of the appropriate power and type of IOL (intraocular
lens) for implantation after removal of the natural crystalline lens. The LS 900 mea‑
sures:
• Axial eye length
• Corneal thickness
• Anterior chamber depth
• Aqueous depth
• Lens thickness
• Corneal curvature
• Radii for at and steep meridian
• Axis of the at meridian
• White‑to‑white distance
• Pupil diameter
Contents
1. Safety ..................................................................................... 4
1.1 Areas of application of the device .............................................................................4
1.2 Patient population .....................................................................................................4
1.3 Ambient conditions....................................................................................................4
1.4 Shipment and unpacking...........................................................................................4
1.5 Installation warnings..................................................................................................4
1.6 Operation, environment.............................................................................................5
1.6.1 Plausibility of the measurements ..............................................................................5
1.6.2 IOL calculation ..........................................................................................................6
1.6.3 References................................................................................................................6
1.6.4 IOL constants............................................................................................................7
1.6.5 IOL constants derived using data from an immersion ultrasound biometer..............7
1.6.6 IOL constants derived from data from a contact ultrasound biometer.......................7
1.7 Optical radiation ........................................................................................................7
1.8 Disinfection................................................................................................................7
1.9 Warranty and product liability....................................................................................7
1.10 Description of symbols .............................................................................................8
2. Introduction ........................................................................... 8
2.1 Basic construction.....................................................................................................8
2.2 Examination components (LS 900)...........................................................................8
2.3 Control component (PC) ...........................................................................................9
2.4 Instrument table (option) ...........................................................................................9
3. Appliance assembly / installation........................................ 9
3.1 Computer connection................................................................................................9
3.2 Installing a short forehead band when using the
optional T‑Cone.........................................................................................................9
4. Operation ............................................................................. 10
4.1 Position of patient during measurement..................................................................10
4.2 Measuring with Lenstar APS (optional)...................................................................10
4.3 Optional T‑Cone......................................................................................................10
4.3.1 Fitting the optional T‑Cone......................................................................................10
4.3.2 Measuring with the optional T‑Cone........................................................................11
4.3.3 Removing the optional T‑Cone................................................................................11
4.4 Fixation....................................................................................................................11
4.5 Measured variables.................................................................................................11
4.5.1 A‑Scan ....................................................................................................................11
4.5.2 Keratometry.............................................................................................................11
4.5.3 White‑to‑white distance...........................................................................................12
4.5.4 Pupillometry & visual axis .......................................................................................12
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
5. Commissioning ................................................................... 12
5.1 Switching on the device ..........................................................................................12
5.2 Switching off the device ..........................................................................................12
6. Technical data...................................................................... 12
6.1 Weight.....................................................................................................................12
6.2 Power supply...........................................................................................................12
6.2.1 Primary side ............................................................................................................12
6.2.2 Secondary side .......................................................................................................12
6.3 Illumination modalities.............................................................................................12
6.3.1 Eye length measurement (A-Scan) and central xation..........................................12
6.3.2 Keratometry.............................................................................................................12
6.3.3 Illumination..............................................................................................................12
6.3.4 Positioning aid (from serial number 2000) ..............................................................12
6.4 Measured variables Lenstar LS 900 .......................................................................13
6.4.1 Central corneal thickness (CCT).............................................................................13
6.4.2 Anterior chamber depth (ACD)................................................................................13
6.4.3 Lens thickness (LT).................................................................................................13
6.4.4 Axial length (AL)......................................................................................................13
6.4.5 Keratometry (R).......................................................................................................13
6.4.6 White‑to‑white distance (WTW) ..............................................................................13
6.4.7 Pupillometry ............................................................................................................13
6.4.8 Study design ...........................................................................................................13
6.5 Technical data of T‑Cone (option)...........................................................................14
6.5.1 Normative considerations........................................................................................14
6.5.2 Measuring accuracy ...............................................................................................14
6.5.3 Reproducibility.........................................................................................................14
7. Software / Help menu / Error messages ........................... 14
8. Maintenance ........................................................................ 14
8.1 Function check / zero adjustment ...........................................................................15
8.2 Cleaning..................................................................................................................15
8.3 Maintenance of T‑Cone (option)..............................................................................15
A. Appendix.............................................................................. 15
A.1 Accessories / consumables / spare parts / upgrade ...............................................15
B. Legal regulations ................................................................ 15
C. Classication...................................................................... 16
C.1 Lenstar LS 900 biometer.........................................................................................16
C.2 T‑Cone (option) .......................................................................................................16
D. Disposal ............................................................................... 16
E. Standards............................................................................. 16
F. Information and manufacturer’s declaration
concerning electromagnetic compatibility
(EMC).................................................................................... 17
F.1 General ...................................................................................................................17
F.2 Emitted interference (standard table 1)...................................................................17
F.3 Immunity (standard table 2) ....................................................................................18
F.4 Immunity on non‑life support devices (standard table 4) ........................................19
F.5 Safe distances on non‑life support devices (standard table 6) ...............................20
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
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, Iike
doctor’s practices, hospitals and optometrists and opticians premises, except near
of HF surgical equipment and RF shielded rooms of ME‑systems for magnetic res‑
onance imaging. Some portable radiofrequency 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 ot this precaution may lower the correct func‑
tion of the instrument. If unexpected disturbances are observed which manifest
themselves as communication problems between LS 900 and EyeSuite software,
the cause could be a cell phone or RF telephone in the immediate vicinity to the
LS 900 or its power supply. Increase the distance to the unit until the interference
disappears. The communication between LS 900 and PC may be interrupted, if the
device is exposed to a mains power supply delivering excessively transient distur‑
bances or short voltage interruptions. If this happens, the PC needs to be restarted
and the measurement has to be repeated.
1.2 Patient population
The patient must be capable of sitting up straight and keeping his head still. He
must be physically and mentally able to cooperate well and mentally capable of fol‑
lowing the examination. Patients must be at least 6 years old.
1.3 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%
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%
1.4 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 equipment 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 representa‑
tive 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 possible returns or when
moving.
• Only use the original packaging material for moving the device.
• Check that the contents of the packaging correspond to the contents specied on the
leaet included in the packaging.
1.5 Installation warnings
WARNING!
• Only use a Haag‑Streit approved external medical power supply (EN
60601‑1).
• The plug, cable and socket must function perfectly.
• Before carrying out maintenance or cleaning work, the device must al‑
ways be disconnected from the mains by unplugging the power supply
or plug.
• Computers and further ancillary devices (printers, etc.) must comply with
the EN 60601‑1 standard, or be connected with galvanic isolation to ex‑
ternal networks (isolating transformer, galvanic Ethernet isolator, etc.).
• For connection to PC, use only the supplied USB cable (2 m).
• The power supply must be positioned in such a way that proper heat dis‑
persion is guaranteed.
• The device should be set up in such a way that the plug is always eas‑
ily accessible and the device can easily be disconnected from the pow‑
er supply.
• The device must not be stacked or placed in close proximity to other
electronic devices.
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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. 1500.7220055.04140 – 14. Edition / 2020 – 02
1.6 Operation, environment
DANGER!
• It is not permitted to make modications to the measuring device.
• It is expressly forbidden to open the device!
• Never use the device in potentially explosive environments where volatile
solvents (alcohol, benzine, etc.) and combustible anaesthetics are in use.
WARNING!
• The doctor or the operator is under an obligation to inform the patient
about safety instructions concerning them and to ensure that these in‑
structions are complied with.
• Only staff trained and experienced in the assessment of measuring data
and calculations and the manual entry, editing and deletion of data may
examine patients, operate the device and interpret results.
• All users must be appropriately trained and familiarised with the contents
of the instructions for use, especially with regard to the safety instructions
contained therein.
• Measurements can be carried out with dilated or undilated pupils. Dilation
of the pupil only inuences pupillometry.
• We recommend checking the calibration of the optional T-Cone when t‑
ting it and repeating this if necessary (see chapter “Function check”).
NOTE!
• This device may only be used for the purpose described in these instruc‑
tions for use.
• Installation only by trained specialists.
• The PC on which the EyeSuite software is installed may not contain any
other software which could restrict the correct operation of EyeSuite.
• Please switch the computer off if it is not to be used for a long time.
• The device may not be transported, stored or operated outside the speci‑
ed ambient conditions (see chapter "Ambient conditions").
• The device is to be used in a room in the medical area with attenuated
light.
• If the device or accessories to it are exposed to the effects of an exter‑
nal force (e.g., by being accidentally knocked or dropped), this sensitive
measuring device must be promptly checked according to chapter “Func‑
tion check” and, if necessary, returned to the factory for repair.
• If the device is moved/transported, a functional check must be performed
in accordance with chapter "Function check".
• Perform a zero adjustment and function check when prompted by the
software.
• The selected measuring mode must be checked before every measure‑
ment.
• Keep these instructions for use in a place where they are accessible at all
times to those working with the device.
• Warranty claims can only be made if the instructions for use have been
complied with.
• The manufacturer of the device is not liable for loss or damage due to un‑
authorised handling of the same. All warranty claims arising in this case
are null and void.
• Always remove the dust cover before switching the device on. The light
sources can be destroyed by overheating. Likewise, make sure that the
device is switched off before attaching the dust cover.
• Repairs may only be conducted by suitably trained and authorised spe‑
cialist personnel. Incorrect repairs can pose considerable risks for operat‑
ing staff and patients.
• Only original spare parts and original accessories may be used
for repairs.
• The software must be installed by trained personnel.
• The optional T‑Cone may only be used with the Lenstar.
• The optional T‑Cone may only be used with Lenstar devices with a serial
number of ≥ 2000 or Lenstar devices converted to white light illumination.
• The optional T‑Cone must be checked for damage before use.
• The optional T‑Cone must not be exposed to strong direct sunlight.
1.6.1 Plausibility of the measurements
WARNING!
• Users must check measurement readings for plausibility. This includes
the checking of the A‑scan and the cursors, which automatically adjust
to the signal, the keratometry values, the white‑to‑white distance and the
pupillometry, whenever one of the measurements displays an unusual‑
ly high standard deviation. The operator must also take into account the
type (e.g., posterior subcapsular cataract) and density of the cataract
when evaluating plausibility.
• Prior to the measurement, the user must verify that the patient is not
wearing contact lenses. Wearing contact lenses will result in erroneous
measuring results.
• It may not be possible, under certain circumstances, to carry out mea‑
surements on persons with xation problems.
• In cases of thick cataracts and uncertain measurement of the axial
length, ultrasound biometry should be performed as a control examina‑
tion.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
• Dense lenticular opacities may make it impossible to measure the axial
eye length and lens thickness.
• Pronounced opacities of the central cornea can likewise make it impossi‑
ble to measure corneal thickness, anterior chamber depth, lens thickness
or axial eye length.
• Blood in the vitreous may make it impossible to measure the axial eye
length.
• Keratometry may be erroneous in eyes that have undergone keratore‑
fractive surgery because such eyes may signicantly deviate from spher‑
ical surfaces.
• The user should make a visual check when carrying out the measure‑
ment procedure, to ensure that all light spots are present.
• If the device repeatedly generates error messages, stop using it and con‑
tact the customer service.
• You are recommended always to examine both of the patient’s eyes ve
times. The user should subject the measurement readings to extra scru‑
tiny if there is a notable difference between the right and left eye. The fol‑
lowing are classed as notable differences:
•More than 1 D with respect to central corneal refractive power
=> 0.18 mm difference with respect to the corneal curvature radius
• More than 0.3 mm with respect to axial eye length
• More than 1 D with respect to emmetropic IOL refractive power
• The user must check the A‑Scan when measuring anterior chamber
depth in pseudophakic mode. If only one IOL signal is visible, it is not
clear whether this signal relates to the front or back of the IOL. Uncer‑
tainty in this case can lead to the displayed reading for anterior chamber
depth being inaccurate by the thickness of the IOL (approx. ±1 mm).
• The measured corneal thickness is not intended as a basis for the correc‑
tion of intraocular pressure readings for diagnosing glaucoma.
• An excessively tilted or decentered IOL may make it impossible to mea‑
sure the anterior chamber depth, lens thickness and aqueous depth.
• Measurement readings obtained from patients with a non‑intact cornea
(e.g., due to a corneal transplant, corneal opacity or corneal scarring,
etc.) may possibly be inaccurate (this applies to keratometry in particu‑
lar), and the user should check the data for plausibility.
• Ambient light has a bearing on pupil‑diameter measurement readings.
The user is responsible for ensuring the correct level of ambient light
when carrying out pupillometry. The LS 900 cannot monitor ambient light,
so do not use pupillometry as the decisive factor when considering kera‑
torefractive surgery.
• Keratometry may not be accurate in eyes with keratoconus, and so the
user must verify its plausibility.
• The user must verify that the eye assignment (OD, OS) is correct for the
measured eye.
• The white‑to‑white distance reading is merely an indirect measurement
of the inner lateral dimensions of the anterior ocular section. It therefore
provides only approximate indications of the actual inner lateral dimen‑
sions of the anterior ocular section and of the size of the implant used.
• The measured results of patients with asteroid hyalosis may not be accu‑
rate (in particular the axial length measurement) and must therefore be
veried by the user in terms of their plausibility.
• If the optional T‑Cone is used, the user should verify the even illumina‑
tion of the cone.
1.6.2 IOL calculation
The measurements taken with the LS 900 are a central element of every IOL cal‑
culation. A further important parameter in calculating the lens to be implanted is the
IOL constant. When using the Lenstar LS 900, only IOL constants optimised for opti‑
cal biometers should be used. Please contact your IOL manufacturer for information
on optimised IOL constants for optical biometry. An alternative source of information
for IOL constants optimised for optical biometry is the website of the “User Group for
Laser Interference Biometry” (ULIB) at the University of Wuerzburg, Germany. Even
though the constants published there have been optimised for a different optical bi‑
ometer, published data [1, 2, 3] indicate that these IOL constants can also be used
for calculating IOL power with the Lenstar. Downloadable IOL Constants les for the
Lenstar, featuring the ULIB IOL‑Constants for the Haigis, Hoffer Q, Halladay I, SRK/T
and SRK II ‑ Formulae as well as IOL Constants for the use with the Olsen Formula
are available in the Key‑User section of the Haag‑Streit homepage.
To further improve the clinical result, Haag‑Streit recommends that every surgeon
creates personally optimised IOL constants based on pre‑operative measurement
data generated with the Lenstar and reliable postoperative data (e.g., 3 months after
the operation).
1.6.3 References
[1] Buckhurst P J, Wolffsohn J S, Shah S, Naroo S A, Davies L N, Berrow E J, “A
new optical low coherence reectometry device for ocular biometry in cataract pa‑
tients”, British Journal of Ophthalmology 2009;93:949‑953 [2] Holzer M P, Mamusa
M, Auffarth G U, “Accuracy of a new partial coherence interferometry analyser for
biometric measurements”, British Journal of Ophthalmology 2009;93: 807‑810
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
[3] Rohrer K, Frueh B E, Wälti R, Clemetson I A, Tappeiner C, Goldblum D, “Com‑
parison and Evaluation of Ocular Biometry Using a New Noncontact Optical
Low-Coherence Reectometer”, Ophthalmology 2009, 116:2087-2092
1.6.4 IOL constants
Haag‑Streit recommends using personalised IOL constants to achieve maximum pre‑
diction accuracy of the IOL calculation. Using personalised IOL constants minimis‑
es the effects of individual surgical techniques, individual measurement and surgical
equipment and individual physiological differences in the patient cohort under treat‑
ment on the IOL calculation.
1.6.5 IOL constants derived using data from an immersion
ultrasound biometer
If there are optimised IOL constants available from an immersion ultrasound biome‑
ter, they may be used as a starting point for further optimisation of IOL calculation with
the Lenstar. Differences in IOL calculation may still occur, as the keratometry data are
collected in different ways. The “User Group for Laser Interference Biometry” (ULIB) at
the University of Würzburg, Germany has published on its website a manual explain‑
ing how to correct the effect of keratometry on the IOL constants. Still, the IOL con‑
stants acquired in this way should only be used as a starting point for further optimisa‑
tion/personalisation.
1.6.6 IOL constants derived from data from a contact
ultrasound biometer
If there are optimised IOL constants available based on data from a contact ultra‑
sound biometer, they must be stringently recalculated for use with the Lenstar. The
“User Group for Laser Interference Biometry” (ULIB) at the University of Würzburg,
Germany has published on its website a manual explaining how to correct the effect
of ultrasound biometry and keratometry on the IOL constants. Constants acquired
in such a way should only be used as a starting point for further optimisation/per‑
sonalisation.
1.7 Optical radiation
WARNING!
The light from this device may be dangerous. The risk of eye damage
increases with the irradiation period. An exposure time with this device
at maximum intensity of over 100 individual measurements per patient
eye with dilated pupil per day exceeds the risk guideline value.
NOTE!
In accordance with EN 60825‑1, the limiting values for class 1 lasers
are respected when the device is used in the dened manner.
The device complies with the limit values for risk group 1 in accordance
with EN 62471 insofar as no more than 100 individual measurements
are performed per day and per patient’s eye with dilated pupil. If this lim‑
it value of 100 individual measurements is exceeded, the patient’s eye
may be damaged by the white illumination. (Radiance 1800 Wm‑2 sr‑1)
1.8 Disinfection
NOTE!
• The device does not need to be disinfected.
• If the optional T‑Cone is used, its tip must be cleaned with max. 70% al‑
cohol after each patient.
For more information on cleaning, please refer to the ‘Maintenance’ chapter.
1.9 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 han-
dling 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.
The optional T-Cone must be stored in its original dust cover and protected from
direct sunlight.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
For US
A only:
1.10 Description of symbols
Follow instruction for use
Read the instructions for use
attentively
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
General warning: Read the ac-
companying documentation
Notes on disposal, see the
'Disposal' chapter
MET Listed Mark with approval
for USA and Canada
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
European certificate of
conformity Date of manufacture
Manufacturer HS reference number
Serial number Housing protection
Direct current Alternating current
Trademark of the manufacturer
Haag-Streit AG
2. Introduction
2.1 Basic construction
The system is divided into two parts: one concerned with examination (LS 900) and
the other with control (Notebook, PC). The examination part communicates via a
USB connection with the external PC. The LS 900 is operated using the "EyeSuite"
software installed on the PC. Integral, automatic error recognition for measurements
guarantees reliable examination results.
2.2 Examination components (LS 900)
Overview 81
2
3
4
5
7
9
10
11
12
13
6
1. Front ring
2. Housing
3. Service cover
4. Cable cover
5. Control lever
6. Type plate
7. Side identication sticker
Head rest (option)
8. Head rest
9. Headband
10. Mark for optimum eye
height
11. Chin rest
12. Chin rest height adjust‑
ment
13. Hand grips for patient
T-Cone (option)
14. Dust cover for storage packaging
15. T‑Cone topography add‑on
16. “Top” – shows which side of the T‑Cone is up.
17. Locking/release clip
18. Type plate
19. Base plate for storage packaging
20. Short forehead band with four Phillips screws
14
15
16
17
18
19
20
Device state
The device state indicator allows device monitoring without PC software:
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21. State indicator Dark Off
21
Orange Standby
Green On
Blue Light source on
RED ERROR
Control lever
The joystick is used to position the device in
relation to the patient’s eye.
22. Trigger
22
Connections
23. USB‑device connection
24. DC‑device connection
25. USB 2.0 cable
26. DC cable
27. Cable tension compensator
23
24
25
26
27
2.3 Control component (PC)
A commercial PC is used as the control component for the biometer. (See chapter
„Installation Warnings“).
WARNING!
The software must be installed by trained personnel in accordance with
the separate installation instructions. For further information, please
contact your Haag‑Streit representative.
2.4 Instrument table (option)
An adjustable instrument table (option) allows the height of the device to be set at a
comfortable height for the individual patient.
28. Table top
29. Left‑hand drawer (for external medical power supply) / Switch box SB01
30. Right‑hand drawer (empty)
31. Elevator column (mechanical with spring)
32. Stand base with castors
28
29
30
31
32
3. Appliance assembly / installation
WARNING!
The device must be installed by trained personnel in accordance with
the installation instructions provided in the separate service manual.
3.1 Computer connection
WARNING!
For connection to PC, only use the supplied USB cable (2 m)
• Connect the electric power supply cable. Integral mains components work with the
voltages specied under chapter A.1.1 "Electrical data". It is not necessary to select
the voltage on the device.
• If an instrument table HSM 901 (option) has been supplied, the power supply of the
LS 900 can be connected to the Switchbox SB01 (left drawer). Use the instructions for
use enclosed with the switchbox and the instrument table.
3.2 Installing a short forehead band when using the
optional T-Cone
NOTE!
• If the Lenstar LS 900 biometer with the optional T‑Cone topography add‑
on is used on an instrument table with a Haag‑Streit head rest (REF:
7200123), the short forehead band delivered with the optional T‑Cone
must be used on the head rest for better measurability.
• If the Lenstar is operated without the optional T‑Cone, the short forehead
band does not need to be replaced with the long one.
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NOTE!
• Make sure that the Lenstar APS is free to move in any direction for opti‑
mum performance of the automated measurement process.
• Before using the Lenstar APS, ensure that the cross slide xation screw
is unlocked.
4.3 Optional T-Cone
4.3.1 Fitting the optional T-Cone
• Remove the dust cover from the storage packaging.
• Hold the T‑Cone with the locking clip (17) pressed down
next to the metal ring and t it on the front ring of the Len‑
star as shown on the illustration.
• Keep the locking clip depressed so that the T‑Cone lies
ush with the front ring. Make sure that "TOP" on the metal
ring of the T‑Cone is at the top. The T‑Cone is held in place
on the front ring of the Lenstar LS 900 biometer by strong
magnets.
TO
TO
P
P
17
• Ensure that the red safety mark is no longer visible on the locking clip. If the red safety
mark is still visible, remove the T-Cone and t it again.
The T-Cone is tted correctly. The red
safety mark is not visible.
The T-Cone is not tted correctly. The red
safety mark is visible. Please remove the
T-Cone and t it again.
WARNING!
• The T‑Cone can only be used with the Lenstar with which it was calibrat‑
ed. To use the T‑Cone on another Lenstar or to use another T‑Cone on a
Lenstar with an already saved T‑Cone calibration, the calibration must be
performed again.
• The measuring distance from the T‑Cone to the eye (apex) is approx. 6
mm. Depending on the anatomy of the patient, the tip of the T‑Cone may
touch the eyelid or bridge of the nose. To avoid injuries, care must always
be taken when moving the Lenstar with tted T-Cone towards the patient.
33. Phillips screws
34. Forehead band
• Detach the forehead band by removing the four Phil‑
lips screws (34) using a size 1 Phillips screwdriver.
• Remove the forehead band (33).
• Insert the short forehead band ( REF: 1021653 )into
the head rest and align the holes with the holes in
the head rest.
• Attach the short forehead band using the four Phil‑
lips screws supplied.
33
34
4. Operation
4.1 Position of patient during measurement
Positioning of the device is done manually by the user. The patient must be posi‑
tioned in such a way that the distance from the measuring head to the eye is ap‑
prox. 68 mm. A steady head position is promoted by resting the patient’s head in
good contact with the chin rest and forehead band, and by the patient holding on to
the handles supplied. This can positively inuence adjustment time and measuring
accuracy. The patient should sit up as straight as possible.
68 mm
NOTE!
In order to get the best possible results, the patient should be request‑
ed to keep the eye as wide open as possible during the measurement
and to focus on the measuring beam. Blinking is permitted, but should
be kept to a minimum.
4.2 Measuring with Lenstar APS (optional)
WARNING!
The Lenstar APS (Automated Positioning System) device moves au‑
tonomously during the automated measurement process. To avoid
trapping ngers, do not touch any moving parts during the measure‑
ment.
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NOTE!
• When you use the T-Cone for the rst time with the Lenstar LS 900 biom‑
eter, the software will prompt you to calibrate the T‑Cone with the Lenstar
LS 900 biometer. To do so, follow the software wizard and read the soft‑
ware operating instructions (F1 key).
• We recommend performing a test measurement every time the T‑Cone
is tted and removed. The test measurement can be invoked in the soft‑
ware’s biometry menu. To do so, follow the software wizard and read the
software operating instructions (F1 key).
4.3.2 Measuring with the optional T-Cone
• Fit the T‑Cone as described in 4.2.1.
• Prior to every measurement procedure, the tip of the T‑Cone should be cleaned with
a lint‑free cloth soaked in 70% alcohol. To do so, use a moistened cotton bud or lint‑
free cloth. The cloth or cotton bud must not be so wet that it drips. Ensure that the
T‑Cone is dry after the cleaning. Information on cleaning the T‑Cone can be found un‑
der "Cleaning".
• Retract the Lenstar / T‑Cone completely before positioning the patient in the head rest.
Always start the measuring procedure with the Lenstar / T‑Cone in the position furthest
away from the patient.
• Explain to the patient that he should focus on the red, ashing light (measuring beam)
in the centre of the T‑Cone. The second eye (the one not being measured) can be cov‑
ered with the eye patch on the optional head rest.
• Start the measuring procedure by pressing the button on the joystick and following the
instructions on your PC screen. Detailed information on the measuring procedure can
be found in the operating instructions for the software (F1 key).
NOTE!
Ensure that the Lenstar / T‑Cone is in the position furthest away from
the patient before switching from the rst eye to the second eye. This
ensures that the T‑Cone will not touch with the bridge of the patient’s
nose.
4.3.3 Removing the optional T-Cone
• Hold the T‑Cone by the metal ring and press the locking clip
(17). Now remove the T‑Cone by tilting it off the front ring of
the Lenstar as shown in the image.
• Place the T‑Cone on the base plate of the storage pack‑
aging (19).
• Place the dust cover (14) on the base plate of the storage
packaging (19) to protect the T‑Cone from dust and dirt.
TO
TO
P
P
17
4.4 Fixation
To obtain usable results, the patient must stare at the red xation light in the mea‑
suring lens during measurement. If the patient has difculty seeing the xation light
with the eye being measured, this can be remedied by xating a remote object with
the other eye.
4.5 Measured variables
4.5.1 A-Scan
Depending on the patient’s gaze at the xation light,
the optical path length of the visual axis is measured
(34).
AD
AL
CCT LT
34
CCT:
AD:
LT:
AL:
Central corneal thickness
Aqueous depth (back of cornea to front of
lens).
Lens thickness
Axial eye length (front of cornea to the inner
limiting membrane).
NOTE!
Since the device measures up to the retinal pigmented epithelium, the
reading displayed is adjusted to the internal limiting membrane, either
automatically, as a function of axial length, or manually, according to
the mode selected. (Manual correction is not available in the USA)
4.5.2 Keratometry
Keratometry is calculated through the position of 32 projected light reections. Two
rings, with sixteen measuring points on each eye are arranged in two rings with the
following diameters
(standard eye R=7.8 mm) Outer measuring points:
Inner measuring points:
2.3 mm
1.65 mm
For each measuring point, the equivalent of an ideal sphere is calculated.
The values displayed (at radius, steep radius) corre‑
spond to the radii of an ellipsoid that ts into the array
of points. The axis of its rotation is measured count‑
er-clockwise from the horizontal to the at radius (35).
• e: Flat radius
• f: Steep radius
• g: Axis of rotation
35
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4.5.3 White-to-white distance
The white‑to‑white distance (WTW) is determined using the image of the iris and
the eye radii obtained from keratometry. The value displayed corresponds to the di‑
ameter of an ideal circle (36).
36 37
4.5.4 Pupillometry & visual axis
Pupil diameter (Ø) corresponds to the diameter of an ideal circle, with the smallest
error perpendicular to the established pupil border. At the same time, the shift of
visual axis towards the centre of the pupil is provided. The calculated dimensions
are located on the theoretically derived level of the iris. The image enlargement
achieved by the refraction of the eye is disregarded (37).
5. Commissioning
Power for the Lenstar LS 900 is supplied by a medical grade power supply which is
provided with the device. Only use the power supply provided with the device.
5.1 Switching on the device
• Connect the power supply plug to the mains.
• Switch on the PC.
• Start the software on the PC.
5.2 Switching off the device
• Exit the software on the PC.
• Switch off the PC.
• Disconnect the power supply plug from the mains if you do not intend to use the de‑
vice for an extended period of time.
6. Technical data
Type designation:
Dimensions (W × D × H):
LS 900
310 × 260 × 420 mm
6.1 Weight
Lenstar
Lenstar APS
6.2 kg
6.6 kg
6.2 Power supply
Lenstar FRIWO FW7401M/12:
Globtek GTM96180‑1117:
REF: 1020392
REF: 1023299
Lenstar APS ICCN EXERGY, ELPAC POWER SYSTEMS,
Model: MWA030018B: REF: 1022106
6.2.1 Primary side
Voltage:
Current Lenstar FRIWO FW7401M/12:
Current Lenstar Globtek GTM96180‑1117:
Current Lenstar APS:
100 – 240 V / 50 – 60 Hz
310 mA
600 mA
800 mA
6.2.2 Secondary side
Lenstar
Lenstar APS
Voltage:
Current:
Voltage:
Current:
12 V ±5%
1 A
18 V ±5%
1.7 A
6.3 Illumination modalities
6.3.1 Eyelengthmeasurement(A-Scan)andcentralxation
Light source:
Wavelength:
Power on patient’s eye:
Superluminescent diode
820 nm
< 0.6 mW
6.3.2 Keratometry
Light source:
Wavelength:
LED
950 nm
6.3.3 Illumination Serial number of the system
Up to 1999* From 2000
Light source: LED LED
Light colour: Green White
* Devices with a serial number < 1999 can be subsequently converted to white light illumination
6.3.4 Positioning aid (from serial number 2000)
Light source:
Wavelength:
LED
940 nm
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6.4 Measured variables Lenstar LS 900
Measurement ranges are based on the ‘Phakic’ measurement mode.
6.4.1 Central corneal thickness (CCT)
Measurement range:
Display resolution:
In vivo repeatability (1.SD):
300 – 800 μm
1 μm
±2.3 μm
6.4.2 Anterior chamber depth (ACD)
Measurement range:
Display resolution:
In vivo repeatability (1.SD):
1.5 – 6.5 mm
0.01 mm
±0.04 mm
6.4.3 Lens thickness (LT)
Measurement range:
Display resolution:
In vivo repeatability (1.SD):
0.5 – 6.5 mm
0.01 mm
±0.08 mm
6.4.4 Axial length (AL)
Measurement range:
Display resolution:
In vivo repeatability (1.SD):
14 – 32 mm
0.01 mm
±0.035 mm
6.4.5 Keratometry (R)
Measurement range radius:
Display resolution:
In vivo repeatability (1.SD):
Measuring area of axial angle:
Display resolution:
In vivo repeatability (1.SD):
5 – 10.5 mm
0.01 mm
±0.03 mm
0 – 180°
1°
±11°
6.4.6 White-to-white distance (WTW)
Measurement range:
Display resolution:
In vivo repeatability (1.SD):
7 – 16 mm
0.01 mm
±0.04 mm
6.4.7 Pupillometry
Measurement range:
Display resolution:
2 – 13 mm
0.01 mm
The above mentioned measurement ranges correspond to the default setting for the
automatic analysis. The in vivo reproducibility was evaluated in a clinical study of
cataract patients (see Tables 1 "All eyes" and 2 "Special eyes")
6.4.8 Study design
• The clinical trial for deriving in vivo reproducibility was approved by the local ethics
committee. The study was planned and conducted as a prospective, non‑randomised
comparative study.
• Two phases were scheduled in the approved study protocol. In the rst phase, mea‑
surements of axial length (AL), central corneal thickness (CCT), anterior chamber
depth (ACD), central lens thickness (LT), median corneal radius (R) and the axis posi‑
tion of the at meridian (axis) were taken.
• The white‑to‑white distance (WTW) was measured in the second phase.
• A total of 144 eyes in 80 subjects were included in study phase 1 and a total of 40
eyes in 20 subjects in study phase 2.
• Subjects with different conditions of the anterior and posterior segment of the eye (cat‑
aract in different stages, pseudophakia with different IOLs, aphakia, silicone-oil ll) and
subjects with healthy eyes were included in this clinical study. Data were analyzed for
all eyes (see Tab. 1) and for a subgroup of eyes with special health conditions (see
Tab. 2), with a complete set of 5 repeat measurements on both eyes of each subject.
• The special eyes group included eyes with one or more of the following conditions:
pseudophakia, aphakia and silicone-oil ll.
Tab. 1: All Eyes
[unit] n Meangrand SDrepeat CV
AL [mm] 45 / 90 23.973 0.035 0.00145
CCT [μm] 53 / 106 557.1 2.3 0.00407
ACD [mm] 34 / 68 3.19 0.04 0.01220
LT [mm] 27 / 54 4.56 0.08 0.01784
R [mm] 34 / 68 7.67 0.03 0.00396
Axis [°] 27 / 54 72 11 0.14191
WTW [mm] 9 / 18 12.27 0.04 0.00337
Tab. 2: Special Eyes
[unit] n Meangrand SDrepeat CV
AL [mm] 10 / 20 24.087 0.056 0.00234
CCT [μm] 11 / 22 564.4 2.8 0.00496
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
ACD [mm] 5 / 10 7.75 0.03 0.00333
Axis [°] 3 / 6 80 13 0.16092
Abbreviations
nNumber of subjects / number of eyes
Meangrand Overall mean of results on all eyes
SDrepeat Repeatability standard deviation
CV Coefcient of variation
SD Standard deviation LT Lens thickness
AL Axial length RCorneal radius of curvature
CCT Central corneal thickness Axis Axis of at meridian
ACD Anterior chamber depth WTW White‑to‑white distance
6.5 Technical data of T-Cone (option)
Type designation:
Diameter:
Length
T‑Cone
ø 84 mm
63,5 mm
Weight:
Placido rings:
Covered optical zone:
0,2 kg
11
≤ 6 mm
6.5.1 Normative considerations
• The T‑Cone complies for the central and medial measuring zones with the standard
EN ISO 19980 for corneal topography systems, type B. The T‑Cone does not cover
the peripheral measuring zone.
• The T‑Cone complies for the central and medial measuring zones with the standard
ANSI Z80.23 for corneal topography systems, type B. The T‑Cone does not cover the
peripheral measuring zone.
6.5.2 Measuring accuracy
Test surface (axial curvature difference in mm / elevation difference in µm)
Central zone (Diameter ≤ 3 mm) Middle zone (3 < Diameter ≤ 6 mm)
Mean value
Curvature
diff.
2 st. dev.
Curvature
diff.
2 st. dev.
Elevation
diff.
Mean value
Curvature
diff.
2 st. dev.
Curvature
diff.
2 st. dev.
Elevation
diff.
Toric (mm),
R1=7.987,
R2=7.584
0.006 0.065 0.66 0.004 0.044 0.33
Ellipsoid (mm),
R=7.79,
k=−0.255
0.001 0.083 0.78 0.020 0.038 1.51
Sphere 1 (mm),
R=6.448 0.013 0.037 0.61 0.012 0.025 1.12
Sphere 2 (mm),
R=7.804 −0.008 0.034 0.33 −0.008 0.026 0.75
Sphere 3 (mm),
R=8.844 −0.017 0.056 0.46 −0.024 0.038 1.61
Sphere 4 (mm),
R=10.501 −0.040 0.082 0.48 −0.069 0.044 0.58
Sphere 1: ø11.5 mm
Toric, ellipsoid, sphere 2,3,4: ø14 mm
All surfaces: Precision ± <1 μm
Test surfaces were centred within ± 0.1 mm and their symmetry axes aligned within
± 0.5° with regard to their measuring axis.
6.5.3 Reproducibility
Human cornea (axial curvature difference, D / elevation difference, µm)
Central Zone
(Diameter ≤ 3 mm)
Middle zone
(3 < Diameter ≤ 6 mm)
Mean value 1 st. dev. 2 st. dev. Mean value 1 st. dev. 2 st. dev.
−0.001 / − 0.38 / 0.66 0.76 / 1.31 −0.020 / − 0.36 / 3.22 0.72 / 6.45
n = 42 eyes
7. Software / Help menu / Error messages
The software’s help section contains instructions and help for performing an exam‑
ination and descriptions of the error messages. The help can be opened via the F1
key or in the [?] – [Help] menu.
WARNING!
The software must be installed by trained personnel in accordance with
the separate installation instructions.
8. Maintenance
The LS 900 is practically maintenance‑free and requires only minimum care to work
for as long as possible to your complete satisfaction. However, we recommend in‑
structing a service engineer to inspect the biometer periodically. Haag‑Streit or your
local agent will be happy to provide further information.
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A. Appendix
A.1 Accessories / consumables / spare parts / upgrade
Components REF
Dust cover, small 1001395
Phillips screws for forehead band (4 pcs) 1005072
1023406
Checking gauge (replacement) 1021124
Short forehead band 1021653
Dust cover for storage packaging of T cone 1021665
Base plate for storage packaging of T‑Cone 1021666
Eye patch 1400113
Base Plate small with Pivot 7200162
Base Plate small for head Rest 7220477 7200163
T‑Cone (without Toric Planner) only for use with the Eyesuite IOL Toric Plan‑
ner installed
7220384
EyeSuite IOL Toric Planner 7220396
T‑Cone Toric Platform 7220397
Headrest (LS 900) 7220477
Set of table ttings LS 900 APS 7220750
Pad of chin rest papers 7220756
Mains cable EU 7220760
Mains cable USA 7220761
Mains cable UK 7220762
Upgrade Kit LS 900 7225044
Headrest Please refer to the instructions for use of headrest
B. Legal regulations
• Haag‑Streit maintains a quality management system in accordance with EN ISO
13485. The device has been developed and designed taking into consideration all the
standards listed in chapter E ‘Standards’.
• This is a Class IIa device in accordance with Appendix IX of Directive 93/42/EEC. By
afxing the CE mark we conrm that our device complies with the applicable stan‑
dards and directives.
• You can request a copy of the declaration of conformity for the device from
Haag‑Streit at any time.
8.1 Function check / zero adjustment
The inspection gauge (38) supplied with the device will assist the user in check‑
ing the proper functioning of the unit. The type plate with the serial number can be
found on the rear of the gauge.
This check takes place for the rst time when the device is
commissioned. Subsequent test intervals (1 week) will be
specied by the software (message displayed). For exact
procedure see software instructions for use. Should the
test be outside the tolerance limits, a software message
appears and the unit must be taken out of use. Notify your
Haag‑Streit customer support center.
38
8.2 Cleaning
Regular dusting of the device with a soft cloth is sufcient. More stubborn dirt can
be removed using a soft, lint‑free cloth dampened with water or alcohol at maxi‑
mum 70%.
WARNING!
• Avoid making the device wet and use only the means listed above. Under
no circumstances use solvent or any abrasives.
• The T-Cone must never be immersed in cleaning uid or disinfectant. No
abrasive or otherwise aggressive agents must be used for cleaning/disin‑
fection. Suitable media include water and up to 70% alcohol. Ensure that
the T‑Cone is dry after every cleaning/disinfection.
A dust cover is included in the accessories of the LS 900. Cover the device when
the room is being cleaned or if it is not used for longer periods of time. Always re‑
move the dust cover before switching on the power.
WARNING!
The device must not be switched on when covered! (Heat build-up, re
hazard).
8.3 Maintenance of T-Cone (option)
The optional T‑Cone requires practically no maintenance apart from the cleaning of
the tip between patients (see Measuring with the T‑Cone).
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
C. Classication
C.1 Lenstar LS 900 biometer
EN 60601‑1 Continuous operation
EN 60825‑1 Laser class I
EN 60529 Enclosure protection IP20
EN 62471 Risk group 1
EN ISO 15004‑2 Group 2
93/42/EEC (medical devices) Class IIa
FDA Class II
C.2 T-Cone (option)
EN ISO 19980 Corneal topograph, type B
ANSI Z80.23 Corneal topograph, type B
93/42/EEC (medical devices) Class I
FDA Class I
D. Disposal
Electrical and electronic devices must be disposed of separately from
household waste!
This appliance was made available for sale after the
13
th 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 15004‑1
EN 60601‑1‑2 EN ISO 15004‑2
EN 62471 EN ISO 10343
EN 60825‑1 EN ISO 22665
EN 60529 EN ISO 19980
ANSI Z80.23
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
F. Information and manufacturer’s declaration
concerning electromagnetic compatibility
(EMC)
F.1 General
The LS 900 fullls the requirements on electromagnetic compatibility according to
EN 60601‑1‑2:2007 (IEC 3rd Edition) + EN 60601‑1‑2:2015 (IEC 4th Edition). The
instrument is built so that the generation and emission of electromagnetic interfer‑
ence is limited to the extent that other devices are not disturbed in their use in ac‑
cordance with the regulations and so that the instrument itself is suitably immune to
electromagnetic interference.
WARNING!
Avoid damages due to high electrostatic discharges (ESD). Electrostat‑
ic discharges with voltages exceeding 6 kV to some parts of the sys‑
tem like joystick or metallic parts on the instrument base may inuence
the instrument.
• The communication between the Lenstar LS 900 and the PC could be in‑
terrupted; this requires a restart of the EyeSuite software and a repetition
of the investigation.
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 specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
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 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 emis-
sions according to EN61000-3-3
Fulfilled
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
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 floors are
covered with synthetic 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
3 A/m 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.
30 A/m
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
F.4 Immunity on 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 Vrms
150 kHz – 80 MHz
6 Vrms D= 0.6
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 the transmitter in watts (W) according to the transmitter manufacturer and Dis the recommended separation
distance in meters (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 rangeb. 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 6 V/m.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220055.04140 – 14. Edition / 2020 – 02
F.5 Safe distances on 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 80 MHz – 800 MHz 800 MHz – 2.5 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 2.5 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:
0.14
0.44
1.4
4.4
14
D =0.6
0.06
0.2
0.6
2.0
6
D = 0.7
0.07
0.22
0.7
2.2
7
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