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Octopus 900
EyeSuite Perimetry
3. Edition / 2012 04
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Foreword
EyeSuite Perimetry
Purpose of use
Octopus 900
3. Edition / 2012 04
SVENSKA
We thank you for deciding for a HAAG-STREIT device. Provided you comply carefully with the regulations in these operating instructions, we can guarantee you reliable and unproblematic use of our product.
The Perimeter Octopus 900 is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other
functions of the human eye. The application is by trained personnel in examination
rooms at room temperature.
ATTENTION!
Federal law restricts this device to sale by or on the order of a physician or practitioner.
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Contents
1. Safety ........................................................................4
1.1
Ambient conditions.................................................................................. 4
1.2
Shipment and unpacking........................................................................ 4
1.3
Installation warnings............................................................................... 4
1.4 General................................................................................................... 5
1.5
Transporting the appliance...................................................................... 5
1.6
Warranty and product liability.................................................................. 6
1.7
Pictograms and type plate...................................................................... 6
2. Introduction...............................................................7
2.1
Description of the instrument.................................................................. 7
2.1.1 Housing................................................................................................... 9
2.1.2 Cupola..................................................................................................... 9
2.1.3 Forehead rest.......................................................................................... 9
2.1.4 Chin rest.................................................................................................. 9
2.1.5 Swing arm............................................................................................... 9
2.1.6 Refractive lens holder............................................................................. 9
2.1.7 Patient-response button........................................................................ 10
2.1.8 Mains connection.................................................................................. 10
2.1.9 Light sources......................................................................................... 10
2.1.10 Light intensities..................................................................................... 10
2.1.11 Stimulus................................................................................................ 10
2.1.12 Background lighting.............................................................................. 10
2.1.13 Fixation marks....................................................................................... 10
2.1.14 Fixation control...................................................................................... 10
2.1.15 Examination data.................................................................................. 11
Support stand.........................................................12
3.1
4.1
4.1.1
4.1.2
Minimum PC requirements................................................................... 11
6.
Legal regulations....................................................16
7.
8.
9.
Classification..........................................................17
8.1 Cleaning................................................................................................ 16
8.1.1 Cleaning the cupola.............................................................................. 16
8.1.2 Response button, chin and forehead rest, eye occluder....................... 16
8.1.3 Display, control panel............................................................................ 16
8.2
Light sources......................................................................................... 17
10. EMC..........................................................................17
11. Standards................................................................17
12. Environment............................................................17
A.
Additional information...........................................17
B.
EMC Supplement....................................................19
A.1 Manufacturer......................................................................................... 17
A.2
Octopus 900 technical data.................................................................. 18
A.3
Octopus support stand (optional) technical data................................... 18
B.1
B.2
B.3
B.4
B.5
B.6
B.7
B.8
General................................................................................................. 19
System components............................................................................. 19
Connecting cables................................................................................ 19
Significant operating characteristics..................................................... 19
Table 1: Emitted interference................................................................ 19
Table 2: Interference immunity.............................................................. 20
Table 3: Immunity (not life-support equipment)..................................... 21
Table 4: Recommended safe distances (not life-support equipment)... 22
5.1
Octopus 900.......................................................................................... 15
5.1.1 Support stand........................................................................................ 15
5.1.2 Software................................................................................................ 16
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1. Safety
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Ambient conditions
-40C to +70C
700 hPa to 1060 hPa
10% to 95%
Storage Temperature
Atmospheric pressure
Rel. humidity
-10C to +55C
700 hPa to 1060 hPa
10% to 95%
Operation: Temperature
Atmospheric pressure
Rel. humidity
+10C to +40C
700 hPa to 1060 hPa
20% to 75%
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incorrect handling or damage. If this is the case, notify the transport company
that has delivered you the goods. Unpack the appliance together with a representative of the transport company. Make a report on any damaged parts. This
must be signed by you and by the representative of the transport company.
Leave the instrument a few hours in the packaging before unpacking (condensation).
Check the appliance for damage after it is unpacked.
Return defective appliances in the appropriate packaging.
Keep packaging material carefully, so that it can be used for possibly returning
the appliance or when moving.
Transport: Temperature
Atmospheric pressure
Rel. humidity
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Symbols
1.1
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perfectly.
Make sure that the appliance is connected only to power supplies as defined on
the type plate. The appliance must be separated absolutely from the mains before maintenance and cleaning work is performed.
Computers and further ancillary devices (printers, etc.) must comply with the EN
60601-1 standard, or else be connected through galvanic isolation to external
networks (isolating transformer, galvanic Ethernet isolator, etc.)
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1.4
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General points
NOTES!
The present appliance may be used only for the purpose described in
these instructions for use.
Installation only by trained skilled personnel.
The appliance may not be transported, stored or operated outside the
specified ambient conditions (see section 1.1).
The appliance is used in a room in the medical area with attenuated
light.
Keep these instructions for use at a place where they are accessible
at any time to persons who work with the appliance.
Warranty claims can be made only if the instructions in these instructions for use are complied with.
The manufacturer of the appliance is not liable for loss or damage
due to unauthorised handling of the same. All warranty claims arising
in this case are null and void.
Do not use the appliance in areas endangered by explosion, do not
keep any volatile solvents (alcohol, benzine, etc.) and combustible
anaesthetics in its vicinity.
Always remove the dust cover before switching the appliance on. The
light sources can be destroyed by overheating. Make sure on the other hand that the appliance is switched off before it is covered.
Housing parts may be removed and repairs performed only be appropriately trained and authorised skilled personnel. Considerable hazards for operating staff and patients can arise due to incorrect repairs.
Only original spare parts and original accessories may be used for
repairs.
The software must be installed by trained personnel.
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 used for a long time.
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WARNINGS!
The physician or the operator is obliged to inform the patient about
the safety instructions concerning him and to ensure that these instructions are complied with.
The examination of the patients, the operation of the appliance and
the interpretation of the results may be performed only by trained and
experienced persons (who can explain the tests to the patient and
who are competent in the manual acquisition, processing and deletion of data). All users must be correspondingly trained and familiar
with the contents of the instructions for use, especially with regard to
the safety instructions contained in them.
1.5
Transport the appliance over larger distances in its original packaging. For short distances, grasp and lift the appliance with both hands holding it underneath (see section 5.1).
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according to the latest methods. They have left our factory in perfect condition.
Should you have any complaints despite this, please contact your dealer.
The manufacturer grants on the appliance a warranty, the duration of which is
determined by the relevant authorised local HAAG-STREIT dealer and which
must be enquired there. Malfunctions and defects which are caused by materials
and design come under the manufacturer's warranty. Malfunctions and defects
which are caused by incorrect use and external influences are excluded from the
warranty.
All warranty claims are rejected after interventions by unauthorised persons.
If a product damaged by incorrect handling continues to be used, this can lead to
personal injury. In this case no liability is assumed by the manufacturer.
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 you the goods. Unpack the appliance together with a representative of the transport company. Make a report on any damaged parts. This
must be signed by you and by the representative of the transport company.
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a) Manufacturer
b) Serial number
c) HS reference number
d) Carefully read the instructions for use
e) Disposal instructions
f) Date of manufacture
g) Product classification Type B
h) Pull out the mains plug!
i) Protective conductor connection
j) Pushing forbidden. Appliance can tilt due to pushing on the side.
k) This appliance fulfils the European Directive 2002/95/EC (RoHS).
Product: Perimeter
Type:
Octopus 900
Input: 100-120V/145VA
220-240V/165VA
50/60Hz, T3.15AL
1250
HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz, Switzerland
DEUTSCH
REF XXXXXXX
ENGLISH
XXXX
SN XXXXX
Made in Switzerland
Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner
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2.
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Introduction
Overview
1. Top cover for stimulus projector
2. Front cover
3. Housing / cupola
4. Forehead rest
5. Rear panel
6. TFT display
7. Refractive lens holder with IR illumination
8. Control panel
9. Chin cup with integrated sensors for detecting the head position
10. Chin rest
11. IR cover
12. Mark for optimum eye height
13. Connection socket for patient response button
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1
2
3
4
5
6
7
8
9
10
11
12
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LCD-Display
The high-contrast TFT colour display enables the video image to be observed under
a large angle of view. The following messages are shown on the display:
14. Display of a ' ' during the stimulus presentation
15. Display of a ' ' if the patient response button is pressed
16. The crosshairs help to centre the eye, scale = 1mm interval
17. Warning or error message
18. Display of left (OS) or right eye (OD)
Control panel
The control panel is made of a pleasant hard-wearing rubber material. All buttons
are backlit with white light to make navigation easy in a darkened room. The light
sources can be switched off if required, except for the display brightness setting.
19. Turning the refractive lens holder in and out
20. Start examination
21. Display brightness setting
22. Chin rest positioning left, right, up, down
14
15
16
17
18
Figure 6-2
19
20
Connections
23. Mains switch
24. Holder for two T3.15 AL 250 V fuses
25. Mains connection
26. Ethernet connection
27. Plug-in mains power unit
WARNING!
All externally connected devices must comply with the standards relevant to safety.
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21
Figure 6-3
22
23
24
25
26
Figure 6-4
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2.1.1 Housing
The optical components and electronics are protected from light and dust by five
housing covers. They can be removed in just a few moments for servicing. Once
the four screws in the back panel have been removed, the panel, hood and both IR
covers can be lifted out. The optical unit and electronic components of the Octopus
900 are now accessible.
WARNING!
Always disconnect the appliance from the mains power supply by pulling out the mains cable before opening the appliance. Housing components may be removed only by correspondingly trained and authorised
skilled personnel.
2.1.2 Cupola
The cupola of the Octopus 900 has a diameter of 600mm and thus conforms to the
Goldmann standard. Test zones with eccentricity up to the following levels can be
measured:
Nasal 89
Temporal 89
Superior 60
Inferior 70
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An automatic swing arm allows the refractive lens holder to be turned in and out during
the examination without changing the position of the patient. This swing arm can be operated either at the control panel or on the control unit (PC) with the computer mouse.
Once the refractive lens holder has been swung in, it can be finely adjusted to the correct distance from the eye being examined.
NOTE!
Always use the control panel buttons of the appliance or on the PC to
swing the refractive lens holder in or out. Do not attempt to move the
refractive lens holder manually.
Refractive lenses can be used during examinations with 30 eccentricity. The corresponding lenses are inserted before the examination. The refractive lens holder can
be tilted forward by about 25 to make it easier to change the refractive lenses.
A wide, ergonomically designed forehead rest allows the patient to have a comfortable posture during the examination.
The chin rest and thus the position of the patient's head is adjusted with the four
buttons. Fine adjustment can also be performed at the control unit (PC) using the
mouse. Sensors in the chin rest detect the correct position of the patient's head.
There is an optional attachment for the chin rest for examining children.
(HS-Part number 1820075)
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Figure 6-5
Figure 6-6
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The patient-response button is connected to the bottom of the forehead rest holder
(RJ11 plug connection).
The Ethernet connection is located at the back of the appliance. Always use a
shielded cable of category 5e permitting transmissions of 100MHz without interference. This network connection is electrically isolated and has a dielectric strength of
4kV according to EN 60601-1.
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The white background brightness amounts to 31.4 or 4asb for W/W perimetry. You
can also select a yellow background with 314asb for B/Y perimetry. The background
brightness consists of two light sources, each equipped with several LEDs. The
background LEDs have a service life of >20,000h and are thus maintenance-free.
The backgound brightness is measured by a separate light sensor.
Three different fixation marks can be selected and their brightness changed electronically in 10 steps. A green LED, which is maintenance-free with a service life of
>20,000h, serves as light source.
LEDs are installed for periphery or background illumination, fixation assistance and
stimulus. LEDs develop only very low heat losses and active cooling is therefore not
required.
The light intensity of stimulus and periphery is measured with independent light sensors and adjusted to the preset nominal values each time the Perimeter is switched
on.
2.1.11 Stimulus
The stimulus light is projected indirectly into the cupola via a mirror unit. Five different diaphragm diameters can be selected in the user-defined programs. The attenuation of the stimulus intensity is infinitely adjustable via an electronic control unit.
Stimulus presentations of 100-500ms are permitted. A mechanical lock and optical
damping elements are no longer required.
White stimulus for W/W perimetry and optionally blue and red stimulus for B/Y and
R/W are possible. The stimulus intensity is detected with a light sensor which also
serves as reference point for the system of coordinates of the test zones. The stimulus LED has a service life of >20,000h and is thus maintenance-free.
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All examination data are transmitted via the Ethernet interface to the control unit
(PC / laptop), where they are saved and managed in a database. It is possible to
export data to a server. Examination data can also be printed out on a printer connected to the control unit.
3.
A standard PC can be used as control unit (PC) for the Perimeter. The control unit
(PC) software runs on WINDOWS XP SP3, WINDOWS VISTA SP2 and WINDOWS
7.
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4.
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Support stand
An electronically adjustable support stand (option) enables the height of the appliance to be adjusted easily to the height of the patient. The support stand offers ample leg room and is wheelchair-compatible.
28. Table top with holders for the patient-response button
29. Electrical connection box
30. Patient-response button
31. Electrical lifting column
32. Stand base with castors
28
WARNING!
Check that the mains voltage is correct before connecting to the power
supply.
31
32
Figure 6-10
33
34
Figure 6-11
Figure 6-12
35
36
Figure 6-13
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4.1
4.1.1
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Mains connection
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If a medically approved control unit (PC) or a control unit (PC) with medically approved power supply unit without printer and without optional LAN connection is in
operation, neither a safety isolating transformer nor a distance of > 1.5 m from the
Octopus 900 are required. For reasons of safety, it is recommended that the distance of > 1.5 m is complied with if at all possible. Otherwise all non-medical devices must be operated through a safety isolating transformer.
LAN connection
**
Mains connection
Network
switch
USB cable
Figure 6-14
< 1.5 m **
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** If the control unit (notebook, PC) and printer are more than1.5 m distant from the Octopus 900, then in accordance with EN 60601-1 the safety isolating transformer can be
omitted.
Mains connection
LAN connection
**
Mains connection
Ethernet Kabel *
Network
switch
USB cable
PC / Control unit
Figure 6-15
< 1.5 m **
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Figure 6-16
Push the connection plug into the connection socket so far until your hear the retaining catch click into place. To remove the response button, push the retaining
catch towards the headrest and pull the cable downwards.
Connect the Octopus 900 and PC with two Ethernet cables via the network
switch provided with the instrument. A computer network can also be connected
via the network switch. You will find further information in section 4.1 'Safe system configuration in accordance with EN 60601-1'.
Connect the electric power supply cable. The built-in mains power units operate
with the voltages specified in the Technical Data section. It is not necessary to
select the voltage on the appliance. If a support stand was also supplied, the Octopus 900 can be connected to the power socket in the electrical connection box
of the support stand.
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Figure 6-18
37
Figure 6-17
38
39
The support stand is supplied in a separate package. Assemble the support stand in
accordance with the instructions supplied with it and ensure that you select the correct mains voltage before connecting the power supply cable.
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5.1.2 Software
WARNING!
The software must be installed by trained personnel in accordance with
separate installation instructions.
6.
Legal regulations
7.
8.
WARNING!
The housing components of the Perimeter appliance may be removed
only by suitably qualified service personnel.
The ON/OFF switch does not isolate the Perimeter from the mains.
Before removing the housing components, ensure that the appliance
is unplugged from the mains power socket.
Repairs may be made only by correspondingly trained and authorised
skilled personnel. Considerable hazards for patients and operating
staff can arise due to incorrect repairs.
If components have to be replaced, only original spare parts from
HAAG-STREIT or your dealer may be installed.
Warranty claims can be made only if the instructions in these instructions for use are complied with.
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The Octopus 900 is practically maintenance-free and requires only minimum care to
work to your complete satisfaction. We nevertheless recommend that you have the
Perimeter appliance serviced regularly by a qualified technician. HAAG-STREIT or
your local dealer will be pleased to supply you with further information.
8.1 Cleaning
Occasional dusting with a soft cloth is sufficient. Stubborn dust particles can be removed with a soft cloth dampened with water or alcohol.
NOTE!
Do not allow the appliance to become wet and do not use any other
solvents.
A dust cover is included in the accessories of the Octopus 900. Cover the appliance
when the room is being cleaned or if it is not used for longer periods. Always remove the dust cover before switching on the power.
NOTE!
The appliance must not be switched on when covered (heat build-up,
fire hazard).
The inner surface of the cupola is coated with a special paint finish designed to ensure optimum results in perimetric examinations. It is not necessary to clean this
inner surface in the normal case. Should dust be visible in the cupola, you can remove this by gentle wiping with a soft, dry and fluff-free cloth. A soft cloth dampened
slightly with mild soapsuds may be used for local cleaning only in emergencies,
such as if spots have arisen due to patients' sneezing.
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8.2
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Light sources
In contrast to other perimetric devices, LEDs are used in the Octopus 900 as light
sources for background and stimulus. These have a service life of >20,000h. If any
of the LEDs should notwithstanding have to be replaced, please contact your dealer's customer service department.
9.
Classification
Standard EN 60601-1
Application part
Operating mode:
CE Directive 93/42/EEC
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10. EMC
The Octopus 900 fulfils the requirements on electromagnetic compatibility according to EN 60601-1-2. The instrument is built so that the generation and emission of
electromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that it itself has appropriate immunity to electromagnetic interference.
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12. Environment
A.
Additional information
A.1 Manufacturer
HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz / Schweiz
Tel
+41 31 978 01 11
Fax
+41 31 978 02 82
info@haag-streit.com
www.haag-streit.com
11. Standards
EN 60601-1
EN 60601-1-2
EN ISO 15004-1
EN ISO 12866
EN 62471
CIE S 009/E
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Octopus 900
100 .. 120 VAC, 220 .. 240 VAC
145 VA, 165 VA
50 / 60 Hz
2 x T3.15 AL 250 V
648 mm x 519 mm x 796 mm
25 kg
800 mm x 600 mm x 900 mm
40 kg
See chapter 1.1
See chapter 1.1
Projection cupola perimeter
Bracketing procedure
Adjustable headrest
Permanent video-based fixation control
90
0 .. 47 dB
0.5 dB
3185 cd/m (10000 asb)
White (wide spectrum white LED)
Blue (LED white with 440 nm filter)
Red (LED white with 610 nm filter)
Goldmann I, II, III, IV and V
100 ms, 200 ms, 500 ms, freely selectable
Adaptive, fix 1.5 .. 4 sec
4 asb (1.27 cd/m), 31.4 asb (10 cd/m2)
White (LED)
314 asb (100 cd/m)
Yellow (LED white with OG530 filter)
Ethernet T100
Colour TFT display (320 x 240 pixels)
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IT 02 (HS-Ref. 7220004)
100 V / 60 Hz, 115 V AC / 60 Hz, 250 V / 50 Hz
100 / 115 V / 1 A, 250 V / 0.5 A
2 x T4AH 250 V
600 x 520 x 680 / 880 mm
0.31 m (600 x 520 mm)
15 kg
650 x 570 x 730 mm
20 kg
Lifting column (infinitely adjustable electrically)
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B.
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EMC Supplement
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B.1 General
WARNING!
Electrical medical devices and systems are subject to special measures concerning EMC and must be installed in accordance with the
EMC instructions contained in this accompanying document.
Portable and mobile HF communication systems may interfere with
electrical medical devices.
The Octopus 900 system is an automatic projection perimeter for examining the
light difference sensitivity of the human eye for the whole field of sight (90).
Compliance
Group 1
The Octopus 900 system uses HF energy exclusively for its internal functioning. Therefore, its HF emission is
very low, and interference with neighboring equipment is unlikely.
Class B
Not applicable
The Octopus 900 system is suitable for use in facilities other than the residential area and facilities such as
those directly connected to a public grid which also supplies buildings used for residential purposes.
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ENGLISH
DEUTSCH
FRANAIS
ITALIANO
ESPAOL
PORTUGUS
NEDERLANDS
SVENSKA
Compliance level
6 kV contact discharge
8 kV air discharge
6 kV contact discharge
8 kV air discharge
Flooring should be made of wood or concrete, or be covered with ceramic tiles. If the floor is covered with synthetic
material, the relative air humidity must be at least 30%.
3 A/m
3 A/m
NOTE: UT = Public alternating current supply before the application of the test level.
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SVENSKA
NEDERLANDS
PORTUGUS
ESPAOL
ITALIANO
FRANAIS
DEUTSCH
ENGLISH
Compliance level
Recommended distance
3Veff
150 kHz - 80 MHz
3Veff
D = 1.2
3 V/m
800 MHz -2,5 GHz
3 V/m
D = 1.2
D = 2.3
'P' is taken as the nominal emission power of the transmitter in Watts 'W' according to the specifications of the transmitter manufacturer and D as the recommended safety distance in meters 'm'. The field strength of stationary radio transmitters is, according to a test on site, less 'a' than the compatible level
'b' for all frequencies. Interference is possible in the vicinity of appliances bearing the following symbol:
NOTE 1: for 80 MHz and 800 MHz the higher value shall apply.
NOTE 2: these guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by the absorption and reflection of buildings,
objects and people
a)
The field strength of stationary transmitters, such as for example the base stations of radio telephones and public mobile telephone services, amateur radio stations, AM- and FM broadcasting- and television stations, is incapable, in theory of being precisely determined in advance. In order to be able to evaluate an electromagnetic environment after the installation of high frequency stationary transmitters, an examination of the location is to be recommended. When the measured field
strength at the location of a Octopus 900 system exceeds the above compatibility level, then the normal operating conditions of the Octopus 900 system at that particular location will have to be more closely examined. If unusual power emission characteristics are observed, then it may be necessary to take additional measures,
e.g. the reorientation or relocation or conversion of the Octopus 900 system.
b)
The field strength is lower than 3 V/m throughout a frequency band from 150 kHz to 80 MHz
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DEUTSCH
FRANAIS
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ESPAOL
PORTUGUS
NEDERLANDS
SVENSKA
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
In regard to transmitters whose nominal power output is not given in the above table, the shielding distance in meters 'm' D can be calculated by using the equation at
the head of the columns whereby P represents the nominal power output of the transmitter in Watts 'W' as per the specifications of the transmitter manufacturer.
NOTE 1: To calculate the recommended shielding distance for transmitters in the frequency band from 80 MHz to 2.5 GHz, an additional factor of 10/3 is used to reduce
the probability, that a portable/mobile communications equipment/appliance is introduced unintentionally into the patient area which might lead to interference.
NOTE 2: These guidelines may not be valid for all situations. The dissemination of electromagnetic wavelengths is influenced by absorption and reflection from buildings,
objects and the human body.
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SVENSKA
NEDERLANDS
PORTUGUS
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ITALIANO
FRANAIS
DEUTSCH
ENGLISH
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ENGLISH
DEUTSCH
FRANAIS
ITALIANO
ESPAOL
PORTUGUS
NEDERLANDS
SVENSKA
http://www.haag-streit.com/contact/contact-your-distributor.html
US
1250
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HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz, Switzerland
Phone
+41 31 978 01 11
Fax
+41 31 978 02 82
eMail
info@haag-streit.com
Internet www.haag-streit.com
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