PRAXISDIENST 480255W e-scope Otoscope Diagnostic Instruments Instructions
- June 3, 2024
- PRAXISDIENST
Table of Contents
PRAXISDIENST 480255W e-scope Otoscope Diagnostic Instruments Instructions
Important information to take note of before taking the product into
operation
You have acquired a valuable Riester diagnostic set manufactured in compliance
with Directive 93/42/EEC for medical products and subject to continuous
stringent quality control, whose excellent quality will ensure reliable
diagnoses. Please read these Operating Instructions carefully prior to startup
and keep in a safe place. Should you have any queries, please contact the
Company or your Riester Agent who will be pleased to assist you. For addresses
see last page of these Operating Instructions. The address of your authorised
Riester Agent will be supplied to you on request. Please note that any
instruments described in these Operating Instructions are only suited for
application by trained operators. Please also note that correct and safe
operation of instruments will only be guaranteed when Riester instruments and
accessories are used throughout.
Warning:
Please note that the proper and safe functioning of our instruments is only
guaranteed if both the instruments and their accessories are exclusively from
Riester. The use of other accessories may result in increased electromagnetic
emissions or reduced electromagnetic immunity of the device and may lead to
incorrect operation.
Caution/Contraindications
- There may be a risk of ignition of gases when the instrument is used in the presence of flammable mixtures or mixtures of pharmaceuticals.
- The instrument heads and battery handles must never be placed in liquids.
- In the case of a longer eye examination with the ophthalmoscope, the intensive exposure to light can damage the retina.
- The product and the ear specula are non-sterile. Do not use on injured tissue.
- Use new or sanitised specula to limit the risk of cross-contamination.
- The disposal of used ear specula must occur in accordance with current medical practices or local regulations regarding the disposal of infectious, biological medical waste.
- Only use accessories/consumables from Riester or Riester-approved accessories/ consumables.
- Cleaning frequency and sequence must comply with regulations on the cleaning of non-sterile products in their respective facility. Cleaning/disinfection instructions in the operating manual must be observed.
- The product may only be used by trained personnel.
Safety instructions:
Manufacturer
CE marking
Temperature limits in °C for storage and transport
Temperature limits in °F for storage and transport
Relative humidity
Fragile, handle with care
Store in a dry place
„Green Dot“ (country-specific)
Warning, this symbol indicates a potentially dangerous situation.
Device of protection class II
Application part type B
For single use only
Attention: Used electrical and electronic equipment should not be treated as normal household waste but should be disposed of separately in accordance with national or EU directives
Batch code
Serial number
Please observe the operating instructions
Battery handles and start-up
Purpose
Riester battery handles described in these Instructions for Use supply the instrument heads with power (the lamps are included in appropriate instrument heads), also serving as a bracket.
Readiness for operation (insertion and removal of batteries)
Turn off instrument head from handle in counter-clockwise direction. Insert
two commercial type ”AA” Mignon alkaline batteries of 1.5 V (IEC standard
reference LR6) into the case of the handle with the plus poles towards the
upper section of the handle.
Warning:
-
Should the unit not be used for an extended period of time or whilst travelling,
remove batteries from handle. -
Insert new batteries when light intensity of the unit is reduced, thus affecting examination.
-
For maximum light yield it is recommended to always insert new high-quality batteries on replacement.
-
Ensure that no fluid or condensation penetrates into the handle.
Disposal:
Please note that batteries are subject to separate disposal. For details ask
your local authority and/or your environmental officer.
Attachment of instrument heads
Turn instrument head in clockwise direction on to the handle.
Starting and stopping
When pushing the slide up, the unit is switched on, when pushing it down, the
unit
is off.
Instructions for care General information
Cleaning and disinfection of the medical devices serves to protect the
patient, the user and third parties and to preserve the value of the medical
devices. Due to the product design and the materials used, no defined limit
can be specified for the maximum number of reprocessing cycles that can be
carried out. The life span of the medical devices is determined by their
function and by gentle handling of the devices. Defective products must
undergo the reprocessing procedure described before being returned for repair.
Cleaning and disinfection
The battery handles can be cleaned externally with a moist cloth until
visually clean. Wipe-disinfection as specified by the disinfectant
manufacturer. Only disinfectants with proven efficacy should be used, taking
into account the national requirements. After disinfection, wipe the
instrument down with a moist cloth to remove possible disinfectant residues.
PLEASE NOTE!
Never immerse the handles in liquids! Take care to ensure that no liquids get
inside the casing! This item is not approved for automated reprocessing and
sterilization. These procedures cause irreparable damage!
Otoscope and accessories
Purpose Riester otoscopes described in these Instructions for Use have
been produced for lighting and examination of the auditory canal, combined
with a Riester ear speculum
2. Insertion and removal of ear speculum
Position the selected speculum on the chromium plated metal socket of the
otoscope. Turn speculum to the right until a resistance is felt. The size of
the speculum is
marked on the reverse.
Swivel lens for magnification
The swivel lens is fixed to the device and can be swivelled 360°
Insertion of external instruments into the ear
If you wish to insert external instruments into the ear (e.g. tweezers), you
have to rotate the swivel lens (approx. 3-fold magnification) located on the
otoscope head by 180°.
Pneumatic test
In order to perform a pneumatic test (= examination of the ear drum), you will
require a bulb which is not included in the normal scope of supply but may be
ordered separately (see Spare parts and accessories). Take metal connector
which is not included in the normal scope of supply but may be ordered
separately (see Spare parts and accessories) and insert in recess provided on
the side of the otoscope head. Attach hose of ulb to connector. Carefully
introduce the required air volume into the auditory canal.
Replacement of lamp
e-scope® otoscope with direct illumination Remove the speculum socket by
turning
it to the left with your thumb and index finger until it stops. Pull the
speculum socket forward to remove it. Unscrew the bulb counterclockwise. Screw
the new bulb in clockwise and reattach the speculum socket. e-scope® otoscope
with fiber optics Unscrew the instrument head from the battery handle. The
LED/bulb is located in the lower part of the instrument head. Pull the bulb
out of the instrument head using your thumb and index finger or a suitable
tool. When replacing an LED with a bulb, the optionally available adapter is
additionally required; when replacing a bulb with an LED, the adapter must
first be removed from the bulb unit. Firmly insert the new LED/bulb.
Instructions for care
General information
Cleaning and disinfection of the medical devices serves to protect the
patient, the
user and third parties and to preserve the value of the medical devices. Due
to the
product design and the materials used, no defined limit can be specified for
the maximum number of reprocessing cycles that can be carried out. The life
span of the
medical devices is determined by their function and by gentle handling of the
devices.
Defective products must undergo the reprocessing procedure described before
being returned for repair.
Cleaning and disinfection
The otoscope can be cleaned externally with a moist cloth until visually
clean. Wipe disinfection as specified by the disinfectant manufacturer. Only
disinfectants with proven efficacy should be used, taking into account the
national requirements. After
disinfection, wipe the instrument down with a moist cloth to remove possible
disinfectant residues.
PLEASE NOTE!
Never immerse the otoscope in liquids! Take care to ensure that no liquids get
inside the casing! This item is not approved for automated reprocessing and
sterilization. These procedures cause irreparable damage!
Sterilization
a) Reusable ear specula The ear specula can be sterilized in the steam
sterilizer at 134°C with 10 minutes hold time. Single use
ATTENTION: Repeated use could cause infection
Spare parts and accessories Reusable ear specula
-
2 mm Pack of 10 St. No.: 10775
-
2.5 mm Pack of 10 St. No.: 10779
-
3 mm Pack of 10 St. No.: 1078315
-
4 mm Pack of 10 St. No.: 10789
-
5 mm Pack of 10 St. No.: 10795
Reusable ear specula -
2 mm Pack of 100 St. No.: 14061-532 Pack of 500 St. No.: 14062-532 Pack of 1.000 St. No.: 14063-532
-
2.5 mm Pack of 100 St. No.: 14061-531 Pack of 500 St. No.: 14062-531 Pack of 1.000 St. No.: 14063-531
-
3 mm Pack of 100 St. No.: 14061-533 Pack of 500 St. No.: 14062-533 Pack of 1.000 St. No.: 14063-533
-
4 mm Pack of 100 St. No.: 14061-534 Pack of 500 St. No.: 14062-534 Pack of 1.000 St. No.: 14063-534
-
5 mm Pack of 100 St. No.: 14061-535 Pack of 500 St. No.: 14062-535 Pack of 1.000 St. No.: 14063-535 Replacement lamps for e-scope® otoscope with direct illumination Vacuum, 2.7 V, pack of 6 No.: 10488 XL, 2.5 V, pack of 6 No.: 10489
for e-scope® F.O. Otoscope
XL 2.5 V, Packung à 6 Stück No.: 10600 LED 3.7 V No.: 14041
Technical data of the lamp for e-scope® otoscope with direct illumination
Vacuum, 2.5 V 300 mA mean life span 15 h XL, 2.5 V 750 mA mean life span 16.5
h
for e-scope® F.O. Otoscope
XL 2.5 V 750 mA mean life span 15 h LED 3.7 V 52 mA mean life span 20.000 h
Other spare parts
No.: 10960 Bulb for pneumatic test
No.: 10961 Connector for pneumatic test
Ophthalmoscope and accessories
Purpose
Riester ophthalmoscopes described in these Instructions for Use have been
designed for the examination of the eye and its background. The examination
lamp e-xam was produced for the purpose of examining body orifices.
Furthermore, it can also be used for pupil reaction examination.
(Photobiological test report EN 62471:2008)
ATTENTION!
Because prolonged intense exposure to light can damage the retina, the use of
the eye exam device should not be unnecessarily prolonged, and the brightness
setting should not be set higher than needed for a clear representation of the
target structures. The irradiation dose of the photochemical exposure to the
retina is the product of irradiance and duration of irradiation. If the
irradiance is reduced by half, the irradiation time may be twice as long to
reach the maximum limit. Although no acute optical radiation hazards have been
identified for direct or indirect ophthalmoscopes, it is recommended that the
intensity of light directed into the patient‘s eye be reduced to the minimum
required for examination / diagnosis. Infants children, aphasics and people
with eye diseases are at a higher risk. The risk may be increased if the
patient has already been examined with this or another ophthalmological
instrument during the last 24 hours. This is especially true when the eye has
been exposed to retinal photography. The light of this instrument may be
harmful. The risk of eye damage increases with the duration of irradiation. An
irradiation period with this instrument at maximum intensity of longer than >5
min. exceeds the guideline value for hazards. This instrument does not pose a
photobiological hazard according to DIN EN 62471 but still features a safety
shutdown after 2/3 minutes.
Lens wheel and correcting lenses
The correcting lenses may be adjusted on the lens wheel. The following
correcting
lenses are available:
D+ 1 | 2 | 3 | 4 | 6 | 8 | 10 | 15 | 20
D- 1 | 2 | 3 | 4 | 6 | 8 | 10 | 15 | 20
Readings will be displayed on a lit panel. Plus values are displayed in black digits, minus values in red digits.
Diaphragms and filters
The following apertures and/or filters may be selected by the aperture and
filter wheel:
Aperture Function
Semi circle: For examinations with turbid lenses.
Small circle For reduction of reflexes of small pupils.
Large circle: For standard fundus examination.
Fixation star: For definition of central and eccentric fixation.
. Replacement of lamp
e-scope® ophthalmoscope Remove the instrument head from the battery handle.
The LED/bulb is located in the lower part of the instrument head. Remove the
bulb from the instrument head using your thumb and index finger or a suitable
tool. When replacing an LED with a bu b,
the optionally available adapter is additionally required; when replacing a
bulb with an LED, the adapter must first be removed from the bulb unit. Firmly
insert the new LED/bulb.
CAUTION: The pin of the bulb has to be inserted into the guide slot on
the adapter and the adapter into the guide slot on the instrument head. e-xa
Remove the instrument head from the battery grip. The XL lamp or LED is
located in the lamp head. Turn white insulation counter clockwise. Remove
insulation with contact. Lamp will fall out. Insert new lamp, turn contact
with insulation clockwise.
General information
Cleaning and disinfection of the medical devices serves to protect the
patient, the user and third parties and to preserve the value of the medical
devices. Due to the product design and the materials used, no defined limit
can be specified for the maximum number of reprocessing cycles that can be
carried out. The life span of the medical devices is determined by their
function and by gentle handling of the devices. Defective products must
undergo the reprocessing procedure described before being returned for repair.
Cleaning and disinfection The ophthalmoscope can be cleaned externally with
a moist cloth until visually clean. Wipe-disinfection as specified by the
disinfectant manufacturer. Only disinfectants with proven efficacy should be
used, taking into account the national requirements. After disinfection, wipe
the instrument down with a moist cloth to remove possible disinfectant
residues.
PLEASE NOTE!
Never immerse the ophthalmoscope in liquids! Take care to ensure that no
liquids get inside the casing! This item is not approved for automated
reprocessing and sterilization. These procedures cause irreparable damage!
Maintenance
These instruments and their accessories do not require any specific
maintenance. Should an instrument have to be examined for any specific reason
whatsoever, please return it to the Company or an authorised Riester dealer in
your area. Addresses to be supplied on request.
6. Notes Ambient temperature: 0 ° to +40 ° C Relative Humidity: 30 % to 70 % noncondensing Storage location: -10° to +55° Relative Humidity: 10 % to 95 %
CAUTION:
There is possibly a risk of ignition if the equipment is operated in the
presence of flammable mixtures of substances with air or with oxygen, nitrous
oxide and anesthetic gases. Safety information according to the international
safety standard IEC 60601-1 Electrical safety of medical devices: Opening of
the handle in patient vicinity and simultaneously touching the batteries and
patient is not allowed.
Electromagnetic compatibility Accompanying documents according to IEC
60601-1-2, 2014, Ed. 4.0
Attention: Medical electrical equipment is subject to special precautions
regarding electromagnetic compatibility (EMC). Portable and mobile radio
frequency communication devices can affect medical electrical equipment. The
ME device is for operation in an electromagnetic environment for home health
care and intended for professional facilities such as industrial areas and
hospitals. The user of the device should ensure that it is operated within
such an environment.
Warning :
The ME device may not be stacked, arranged or used directly next to or with
other devices. When operation is required to be close to or stacked with other
devices, the ME device and the other ME devices must be observed in order to
ensure proper operation within this arrangement. This ME device is intended
for use by medical professionals only. This device may cause radio
interference or interfere with the operation of nearby devices. It may become
necessary to take appropriate corrective measures, such as
redirecting or rearranging the ME device or shield. The rated ME device does
not exhibit any basic performance features in the sense of EN60601-1, which
would present an unacceptable risk to patients, operators or third parties
should the power supply fail or malfunction.
Warning: Portable RF communications equipment (radios) including
accessories, such as antenna cables and external antennas, should not be used
in closer proximity than 30 cm (12 inches) to parts and cables of the e-scope®
instrument head with hand grips specified by the manufacturer. Failure to
comply may result in a reduction in the device‘s performance features.
Leitlinien und Herstellererklärung -‐ elektromagnetische Emission
Das e-‐scope® Instrument ist für den Betrieb in einer wie unten angegebenen
elektromagnetischen Umgebung bestimmt. Der Kunde oder der Anwender des
e-‐scope® sollte sicherstellen, dass es in einer solche Umgebung benutzt
wird.
Emissionstest| Konformität| Elektromagnetische Umgebung -‐ Anleitung
RF emissionsHF-‐Aussendung nachCISPR 11
|
Gruppe 1
| Das e-‐scope® verwendet HF-‐Energie ausschließlich zu einer internen
Funktion. Daher ist seine HF-‐Aussendung sehr gering und es ist
unwahrscheinlich, dass benachbarte elektronische Geräte gestört werden.
RF emissionHF-‐Aussendung nachCISPR 11|
Klasse B
| Das e-‐scope® ist für den Gebrauch in allen Einrichtungen einschließlich Wohnbereichen und solchen bestimmt, die unmittelbar an ein öffentliches Versorgungsnetz angeschlossen sind, das auch Gebäude versorgt, die für Wohnzwecke genutzt werden.
Aussendungen von Oberschwingungen
IEC 61000-‐3-‐2
|
Unzutreffend
Aussendungen von Spannungsschwankungen Flicker
IEC 61000-‐3-‐3
|
Unzutreffend
Leitlinien und Herstellererklärung -‐ elektromagnetische Immunität
Das e-‐scope® Instrument ist für den Betrieb in einer wie unten angegebenen elektromagnetischen Umgebung bestimmt. Der Kunde oder der Anwender des e -‐ scope® sollte sicherstellen, dass es in einer solche Umgebung benutzt wird.
Immunitätstest
|
IEC 60601 Testlevel
|
Konformität
|
Elektromagnetische Umgebung -‐ Anleitung
Entladung statischer Elektrizität (ESD)
IEC 61000-‐4-‐2
| Con:±8 kV Air:±2,4,8,15 kV| Con:±8 kV Air:±2,4,8,15 kV|
Fußböden sollten aus Holz oder Beton bestehen oder mit Keramikfliesen versehen sein. Wenn der Fußboden mit synthetischem Material versehen ist, muss die relative Luftfeuchte mindestens 30% betragen.
Schnelle Transiente elektrische Störgrößen/Bursts
IEC 61000-‐4-‐4
|
5/50 ns, 100 kHz , ±2 kV
|
Unzutreffend
|
Die Qualität der Versorgungsspannung sollte der einer typischen Geschäfts-‐ oder Krankenhausumgebung entsprechen
Stoßspannungen IEC 61000-‐4-‐5
|
± 0,5 kV Spannung Außenleiter-‐Außenleiter
± 2 kV Spannung Außenleiter-‐Erde
|
Unzutreffend
|
Die Qualität der Versorgungsspannung sollte der einer typischen Geschäfts-‐ oder Krankenhausumgebung entsprechen
IEC 61000-‐4-‐11
Spannungseinbrüche, Kurzzeitunterbrechungen und Schwankungen der Versorgungsspannung nach
|
<0% UT 0.5 Periode
bei 0,45,90,135,180,225,270 und
315 Grad
0 % UT 1 Periode und 70% UT 25/30 Perioden Einphasig: bei 0 Grad (50/60 Hz)
|
Unzutreffend
|
Die Qualität der Versorgungsspannung sollte der einer typischen Geschäfts-‐ oder Krankenhausumgebung entsprechen
IEC61000-‐4-‐11| | |
Magnetfeld mit energietechnischen Bemessungs-‐ Frquenzen IEC 61000-‐4-‐8|
30A/m
50/60 Hz
| 30A/m
50/60 Hz
| Netzfrequenz-‐Magnetfelder sollten auf einem Niveau sein, das für einen
typischen Ort in einer typischen kommerziellen Krankenhausumgebung
charakteristisch ist.
ANMERKUNG UT ist die Wechselstromquelle. Netzspannung vor der Anwendung des
Testlevels.
Leitlinien und Herstellererklärung -‐ elektromagnetische Immunität
Das e-‐scope® Instrument ist für den Betrieb in einer wie unten angegebenen
elektromagnetischen Umgebung bestimmt. Der Kunde oder der Anwender des
e-‐scope® sollte sicherstellen, dass es in einer solche Umgebung benutzt
wird.
Immunitätstest| IEC 60601 Testlevel| Konformität| Elektromagnetische Umgebung
-‐ Anleitung
Geleitete HF Störgrößen nach IEC61000-‐4-‐6
| 3 Vrms0,5 MHz bis 80MHz 6 V in ISM-‐ Frequenzbändern zwischen 0,15 MHzund 80 MHz80% AM bei 1 kHz|
Unzutreffend
| Tragbare und mobile HF-‐Kommunikationsgeräte sollten nicht näher an einem
Teil des berührungslosen e-‐scope® einschließlich der Kabel verwendet werden,
als der empfohlene Abstand, der sich aus der für die Frequenz des Senders
geltenden Gleichung berechnet.Empfohlener Trennungsabstand
| | d = 1,2 × P 80 MHz bis 800 MHz d = 2,3 × P 800 MHz bis 2,7 GHz
| | Wobei P die maximale Ausgangsleistung des Senders in Watt (W) gemäß dem
Senderhersteller und der empfohlene Abstand in Metern (m) ist.Feldstärken von
festen HF-‐Sendern, die durch eine elektromagnetische Standortuntersuchung
ermittelt wurden, sollten in jedem Frequenzbereich geringer sein als das
Übereinstimmungsniveau.In der Nähe von Geräten, die mit folgendem Symbol
gekennzeichnet sind, können Störungen auftreten:
| |
Radiated RF IEC 61000-‐4-‐3
Näherungsfelder von drahtlosen HF-Kommunikati- onsgeräten| 3 V/m80 MHz to 2.7
GHz
380 -‐ 390 MHz27 V/m; PM 50%; 18 Hz430 -‐ 470 MHz28 V/m; (FM ±5 kHz, 1kHz sine) PM; 18 Hz 11 704 -‐ 787 MHz9 V/m; PM 50%; 217 Hz800 -‐ 960 MHz28 V/m; PM 50%; 18 Hz1700 -‐ 1990 MHz28 V/m; PM 50%; 217 Hz2400 -‐ 2570 MHz28 V/m; PM 50%; 217 Hz5100 -‐ 5800 MHz9 V/m; PM 50%; 217 Hz
| 10 V/m
27V/m28 V/m
9 V/m
28 V/m
28 V/m
9 V/m
|
ANMERKUNG 1 Bei 80 MHz und 800 MHz gilt der höhere Frequenzbereich.ANMERKUNG
2 Diese Richtlinien gelten möglicherweise nicht in allen Situationen. Die
elektromagnetische Ausbreitung wird durch Absorption und Reflexion von
Strukturen, Objekten und Menschen beeinflusst.
a Feldstärken von festen Sendern, wie z. B. Basisstationen für Funk-‐
(Mobil-‐ / Schnurlos-‐) Telefone und Landmobilfunkgeräte, Amateurfunk, AM-‐
und FM-‐Rundfunk und Fernsehübertragung können theoretisch nicht genau
vorhergesagt werden. Um die elektromagnetische Umgebung aufgrund von festen
HF-‐Sendern beurteilen zu können, sollte eine elektromagnetische
Untersuchung in Betracht gezogen werden. Wenn die gemessene Feldstärke an dem
Ort, an dem das e-‐scope® verwendet wird, den oben genannten RF-‐
Übereinstimmungsgrad überschreitet, sollte das e-‐scope® beobachtet werden,
um den normalen Betrieb zu überprüfen. Wenn eine abnormale Leistung beobachtet
wird, können zusätzliche Maßnahmen erforderlich sein, wie zum Beispiel das
Neuausrichten oder Verschieben des e-‐scope®.
b Über den Frequenzbereich von 150 kHz bis 80 MHz sollten die Feldstärken
weniger als 3 V / m betragen.
Leitlinien und Herstellererklärung -‐ elektromagnetische Immunität
Das e-‐scope® Instrument ist für den Betrieb in einer wie unten angegebenen
elektromagnetischen Umgebung bestimmt. Der Kunde oder der Anwender des
e-‐scope® sollte sicherstellen, dass es in einer solche Umgebung benutzt
wird.
Immunitätstest| IEC 60601 Testlevel| Konformität| Elektromagnetische Umgebung
-‐ Anleitung
Geleitete HF Störgrößen nach IEC61000-‐4-‐6
| 3 Vrms0,5 MHz bis 80MHz 6 V in ISM-‐ Frequenzbändern zwischen 0,15 MHzund 80 MHz80% AM bei 1 kHz|
Unzutreffend
| Tragbare und mobile HF-‐Kommunikationsgeräte sollten nicht näher an einem
Teil des berührungslosen e-‐scope® einschließlich der Kabel verwendet werden,
als der empfohlene Abstand, der sich aus der für die Frequenz des Senders
geltenden Gleichung berechnet.Empfohlener Trennungsabstand
| | d = 1,2 × P 80 MHz bis 800 MHz d = 2,3 × P 800 MHz bis 2,7 GHz
| | Wobei P die maximale Ausgangsleistung des Senders in Watt (W) gemäß dem
Senderhersteller und der empfohlene Abstand in Metern (m) ist.Feldstärken von
festen HF-‐Sendern, die durch eine elektromagnetische Standortuntersuchung
ermittelt wurden, sollten in jedem Frequenzbereich geringer sein als das
Übereinstimmungsniveau.In der Nähe von Geräten, die mit folgendem Symbol
gekennzeichnet sind, können Störungen auftreten:
| |
Radiated RF IEC 61000-‐4-‐3
Näherungsfelder von drahtlosen HF-Kommunikati- onsgeräten| 3 V/m80 MHz to 2.7
GHz
380 -‐ 390 MHz27 V/m; PM 50%; 18 Hz430 -‐ 470 MHz28 V/m; (FM ±5 kHz, 1kHz sine) PM; 18 Hz 11 704 -‐ 787 MHz9 V/m; PM 50%; 217 Hz800 -‐ 960 MHz28 V/m; PM 50%; 18 Hz1700 -‐ 1990 MHz28 V/m; PM 50%; 217 Hz2400 -‐ 2570 MHz28 V/m; PM 50%; 217 Hz5100 -‐ 5800 MHz9 V/m; PM 50%; 217 Hz
| 10 V/m
27V/m28 V/m
9 V/m
28 V/m
28 V/m
9 V/m
|
ANMERKUNG 1 Bei 80 MHz und 800 MHz gilt der höhere Frequenzbereich.ANMERKUNG
2 Diese Richtlinien gelten möglicherweise nicht in allen Situationen. Die
elektromagnetische Ausbreitung wird durch Absorption und Reflexion von
Strukturen, Objekten und Menschen beeinflusst.
a Feldstärken von festen Sendern, wie z. B. Basisstationen für Funk-‐
(Mobil-‐ / Schnurlos-‐) Telefone und Landmobilfunkgeräte, Amateurfunk, AM-‐
und FM-‐Rundfunk und Fernsehübertragung können theoretisch nicht genau
vorhergesagt werden. Um die elektromagnetische Umgebung aufgrund von festen
HF-‐Sendern beurteilen zu können, sollte eine elektromagnetische
Untersuchung in Betracht gezogen werden. Wenn die gemessene Feldstärke an dem
Ort, an dem das e-‐scope® verwendet wird, den oben genannten RF-‐
Übereinstimmungsgrad überschreitet, sollte das e-‐scope® beobachtet werden,
um den normalen Betrieb zu überprüfen. Wenn eine abnormale Leistung beobachtet
wird, können zusätzliche Maßnahmen erforderlich sein, wie zum Beispiel das
Neuausrichten oder Verschieben des e-‐scope®.
b Über den Frequenzbereich von 150 kHz bis 80 MHz sollten die Feldstärken
weniger als 3 V / m betragen.
References
- Rudolf Riester GmbH - Medical devices of the highest standards.
- Rudolf Riester GmbH – Medical devices of the highest standards.
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