Braun Aesculap ELAN 4 Manual

AESCULAP®
en Instructions for use/Technical description
Notes on the electromagnetic compatibility (EMC) for ELAN 4 electro con-
trol unit GA800
de Gebrauchsanweisung/Technische Beschreibung
Hinweise zur elektromagnetischen Verträglichkeit (EMV) für ELAN 4 electro
Steuereinheit GA800
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AESCULAP®
Notes on the electromagnetic compatibility (EMC) for ELAN 4 electro control unit
GA800
Contents
1. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2. Guidance and manufacturer’s declaration. . . . . . . . . . . . . . . . . 2
2.1 Classification of medical electrical equipment acc. to CISPR 11 2
2.1.1 Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.1.2 Classes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.1.3 Set-up environment/set-up location . . . . . . . . . . . . . . . . . . . . . 2
2.2 Electromagnetic emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.3 Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4 High frequency conducted disturbance - IEC 61000-4-3 . . . . 7
2.5 Separation distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.6 Wireless coexisting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4. Distributor in the US/Contact in Canada for product
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1. Scope
This information on electromagnetic compatibility (EMC) applies to the
following medical electrical device:
Note
The use of cables other than those provided by or recommended by
Aesculap may result in increased electromagnetic emissions or reduced
immunity to interference.
2. Guidance and manufacturer’s declara-
tion
2.1 Classification of medical electrical equipment acc.
to CISPR 11
According to CISPR 11, all medical electrical equipment is divided into
groups and classes. Different guidelines concerning electromagnetic emis-
sions apply, depending on which group or class the equipment belongs to.
2.1.1 Groups
The group any medical electrical equipment belongs to depends on the
way in which it uses RF energy.
Group 1
Group 1 is the group of “equipment and systems which generate or use RF
energy exclusively for their internal functions”, such as camera systems,
light sources and motor systems. Group 1 also comprises “equipment that
feed energy into the patient, but not energy in the form of high-frequency
electromagnetic energy“, e.g. infusion equipment.
RF surgery devices also belong to group 1 since, according to IEC 60601-
2-2, they are assessed with the RF output inactive.
Group 2
Not relevant for Aesculap products.
2.1.2 Classes
The class to which medical electrical equipment belongs depends on the
electromagnetic environment at the site where the equipment is operated.
Class A
Devices are of Class A if they are identified in the instructions for use as
"CISPR Class A".
Class B
Devices are of Class B if no particular classification is specified in the
instructions for use, or if they are identified there as "CISPR Class B".
2.1.3 Set-up environment/set-up location
The equipment is intended for use in a specific environment. It may be
used in areas in which medical treatments are performed with HF surgical
devices.
"Do not put device directly next to other devices or stack them with
other devices, except with or on Aesculap devices.
"When operation directly next to other devices or must be stacked with
other devices: observe the device to ensure proper operation in this
configuration.
Necessary precautions for use in the vicinity of AM, FM and TV transmit-
ters (e.g. at a distance of less than 1.5 km), or other local sources of elec-
tromagnetic interference or wireless communication devices:
"Observe the device to ensure proper operation over the expected ser-
vice life.
Art. no. Designation
GA800 ELAN 4 electro control unit
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2.2 Electromagnetic emission
"Always observe guidelines according to the group and class the equip-
ment belongs to.
"For details regarding the meaning of different groups and classes, see
Classification of medical electrical equipment acc. to CISPR 11 in the
previous section.
Guidance and manufacturer´s declaration - Electromagnetic emission
The ELAN 4 electro control unit is intended for operation in the electromagnetic environment specified below. The user of the equipment should assure
that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - Guidance
RF emissions CISPR 11 Complies with group 1 The equipment 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.
Harmonic emissions
acc. to IEC 61000-3-2
Consistent with Class A
(IEC 61000-3-2)
–
Voltage fluctuations/flicker emissions
acc. to IEC 61000-3-3
Complies –
RF emissions acc. to CISPR 11 Class A The EQUIPMENT is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those directly
connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes, provided the following warning is
heeded:
Warning: The device/system is only intended for use by medical person-
nel. This is a device/system of class A pursuant to CISPR 11. In the resi-
dential area, this device/system can cause radio interference, so that it
may be necessary to take suitable corrective measures, such as rearrange-
ment, reorientation or shielding of the device or filtering the connection
to the location.
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2.3 Electromagnetic immunity
Guidelines and Manufacturer Explanation - Electromagnetic Compatibility - IEC 60601-1-2, 3rd edition
The ELAN 4 electro control unit is intended for use in the electromagnetic environment listed below. The user of the ELAN 4 electro control unit should
assure that it is used in such an environment.
Immunity test Compatibility test level
IEC 60601-1-2, 3rd Edition
Compliance level Electromagnetic environment -
Guidance
Electrostatic Discharge (ESD)
acc. to IEC 61000-4-2
±6 kV contact ±6 kV Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humid-
ity should be at least 30 %.
±8 kV air ±8 kV
Rapid transient electrically con-
ducted disturbance
acc. to IEC 61000-4-4
±2 kV for power supply lines ±2 kV Mains power quality should be that of a
typical commercial or hospital environ-
ment.
±1 kV for power supply lines ±1 kV
Surges
acc. to IEC 61000-4-5
±1 kV voltage outer conductor-
outer conductor
±1 kV Mains power quality should be that of a
typical commercial or hospital environ-
ment.
±2 kV voltage external conductor -
earth
±2 kV
Voltage dips, short interruptions
and voltage variations on power
supply input lines
acc. to IEC 61000-4-11
<5 % UT1
(>95 % dip in UT)
for 0.5 cycle
Complies Mains power quality should be that of a
typical commercial or hospital environ-
ment. If the user of the ELAN 4 electro
requires continued operation during
power mains interruptions, it is recom-
mended that the ELAN 4 electro be
powered from an uninterruptible power
supply or a battery.
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Magnetic field at power supply fre-
quency (50/60 Hz)
acc. to IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
Note 1 UTis the AC mains voltage prior to application of the test level..
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Guidelines and Manufacturer Explanation - Electromagnetic Compatibility - IEC 60601-1-2, 4th edition
The ELAN 4 electro control unit is intended for use in the electromagnetic environment listed below. The user of the ELAN 4 electro control unit should
assure that it is used in such an environment.
Immunity test Compatibility test level
IEC 60601-1-2, 4th Edition
Compliance level Electromagnetic environment -
Guidance
Electrostatic discharge (ESD)
acc. to IEC 61000-4-2
±8 kV contact ±8 kV Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humid-
ity should be at least 30 %.
±15 kV air ±15 kV
Electrostatic transient/burst
acc. to IEC 61000-4-4
±2 kV for power supply lines ±2 kV Mains power quality should be that of a
typical commercial or hospital environ-
ment.
±1 kV for power supply lines
Modulation 100 kHz
±1 kV
Modulation 100 kHz
Surge
acc. to IEC 61000-4-5
±1 kV voltage external conductor -
external conductor
±1 kV Mains power quality should be that of a
typical commercial or hospital environ-
ment.
±2 kV voltage outer conductor-
protective earth
±2 kV
Voltage dips, short term interrup-
tions and fluctuations in power
supply
acc. to IEC 61000-4-11
0 % UT1
at 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315° for 1/2 periods
Complies Mains power quality should be that of a
typical commercial or hospital environ-
ment. If the user of the ELAN 4 electro
requires continued operation during
power mains interruptions, it is recom-
mended that the ELAN 4 electro be
powered from an uninterruptible power
supply or a battery.
0 % UT; one period
70 % UT
25/30 periods
Single phase: at 0°
0 % UT; 250/300 periods
Magnetic field at power supply fre-
quency (50/60 Hz)
acc. to IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hos-
pital environment.
Note 1 UTis the AC mains voltage prior to application of the test level.
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Guidance and manufacturer´s declaration – Electromagnetic immunity - For equipment that are not life supporting
The ELAN 4 electro control unit is intended for use in the electromagnetic environment listed below. The user of the ELAN 4 electro control unit should
assure that the ELAN 4 electro is used in such an environment.
Immunity test Test level IEC 60601-1-2 Compliance level Electromagnetic environment - Guidance2
Portable and mobile RF communications equipment should be
used no closer to any part of the ELAN 4 electro control unit
including cables, than the recommended separation distance cal-
culated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance1:
Conducted RF
acc. to IEC 61000-4-6
3 Veff
150 kHz to 80 MHz
3 Veff
150 kHz to 80 MHz
d = 1,2 x P
6 Veff
80 % AM at 1 kHz
for ISM bandsc
6 Veff
80 % AM at 1 kHz
for ISM bandsc
Transmitted RF
acc. to IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
3 V/m
80 MHz to 2.7 GHz
d = 1,2 x P
80 MHz to 800 MHz
d = 2,3 x P
for 800 MHz to 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 fixed RF transmitters, as determined by an
electromagnetic site surveyashould 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 separation distance for the higher frequency range 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 fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ELAN 4 electro is used
exceeds the applicable RF compliance level above, the ELAN 4 electro should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the ELAN 4 electro control unit.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c The ISM bands (en: frequency bands used for Industrial, Scientific and Medical purposes) between 0.15 MHz and 80 MHz are 6.765 MHz to
6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz. The amateur radio frequency bands between 0.15
MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz,
18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
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2.4 High frequency conducted disturbance - IEC 61000-4-3
Test frequency
range (MHz)
Band (MHz) Service Modulation Max. output (W) Distance (m) Conducted distur-
bance test level
(V/m)
385 380–390 TETRA 400 Pulse modulation
18 Hz
1.8 0.3 27
450 430–470 GRMS 460, FRS 460 FM
±5 kHz deviation
2 0.3 28
710 704–787 LTE-Band 13, 17 Pulse modulation
217 Hz
0.2 0.3 9
745
780
810 800–960 GSM 800/900, TETRA 800,
IDEN 820, CDMA 850,
LTE-Band 5
Pulse modulation
18 Hz
2 0.3 28
870
930
1 720 1 700–1 990 GSM 1 800, CDMA 1 900,
GSM 1 900, DECT, LTE-
Band 1, 3, 4, 25, UMTS
Pulse modulation
217 Hz
2 0.3 28
1 845
1 970
2 450 2 400–2 570 Bluetooth, WLAN 802.11
b/g/n, RFID 2 4500, LTE-
Band 7
Pulse modulation
217 Hz
2 0.3 28
5 240 5 100–5 800 WLAN 802.11 a/n Pulse modulation
217 Hz
0.2 0.3 9
5 500
5 785
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2.5 Separation distances
2.6 Wireless coexisting
Risk category according AAMI TIR69:2020 is: Category D: NEGLIGIBLE (No
Significant Risk Level).
3. Technical Service
"For service and repairs, please contact your national B. Braun/Aesculap
agency.
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
Or in the US:
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
4. Distributor in the US/Contact in Canada
for product information and complaints
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
Recommended protective distances2between portable and mobile HF telecommunications devices and the ELAN 4 electro control unit
The ELAN 4 electro control unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the
ELAN 4 electro control unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF com-
munications equipment (transmitters) and the ELAN 4 electro control unit as recommended below, according to the maximum output power of the com-
munications equipment.
PORTABLE HF communication devices (radio devices), including their ACCESSORIES (such as antenna cables and external antennas) should not be used
at a distance of less than 30 cm from the lines of the ELAN 4 electro control unit. Non-observance may lead to a reduction of the device performance
features.
Rated maximum output of trans-
mitter [W] Separation distance1according to frequency of transmitter [m]
150 kHz to 80 MHz
d = 1,2 x P
80 MHz to 800 MHz
d = 1,2 x P
800 MHz to 2.7 GHz
d = 2,3 x P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters [m] can be determined using the
equation applicable to the frequency of the transmitter, where Pis the maximum output power rating of the transmitter in watts [W] according to the
transmitter manufacturer.
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
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AESCULAP®
Hinweise zur elektromagnetischen Verträglichkeit (EMV) für ELAN 4 electro Steu-
ereinheit GA800
Inhaltsverzeichnis
1. Geltungsbereich. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2. Leitlinien und Herstellererklärung . . . . . . . . . . . . . . . . . . . . . . . 10
2.1 Klassifizierung von medizinischen elektrischen Geräten gemäß
CISPR 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.1 Gruppen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.2 Klassen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.3 Aufstellumgebung/Aufstellort . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 Elektromagnetische Aussendungen . . . . . . . . . . . . . . . . . . . . . . 11
2.3 Elektromagnetische Störfestigkeit . . . . . . . . . . . . . . . . . . . . . . . 12
2.4 Störgrößen HF – IEC 61000-4-3 . . . . . . . . . . . . . . . . . . . . . . . . 15
2.5 Schutzabstände . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.6 Drahtlose Koexistenz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3. Technischer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1. Geltungsbereich
Diese Hinweise zur elektromagnetischen Verträglichkeit (EMV) gelten für
folgendes medizinisches elektrisches Gerät:
Hinweis
Die Verwendung von anderen Kabeln, als den von Aesculap gelieferten oder
empfohlenen, kann zu einer erhöhten Aussendung oder zu einer reduzierten
Störfestigkeit führen.
2. Leitlinien und Herstellererklärung
2.1 Klassifizierung von medizinischen elektrischen
Geräten gemäß CISPR 11
Medizinische elektrische Geräte werden gemäß CISPR 11 in Gruppen und
Klassen eingeteilt. Je nach ihrer Zugehörigkeit zu einer Gruppe/Klasse gel-
ten unterschiedliche Leitlinien im Hinblick auf ihre elektromagnetische
Aussendung.
2.1.1 Gruppen
Die Gruppenzugehörigkeit richtet sich danach, in welcher Weise das medi-
zinische elektrische Gerät HF-Energie nutzt.
Gruppe 1
In die Gruppe 1 gehören “Geräte und Systeme, die HF-Energie ausschließ-
lich für ihre interne Funktion erzeugen oder nutzen”, z. B. Kamerasysteme,
Lichtquellen, Motorensysteme. Ebenfalls in die Gruppe 1 gehören “Geräte,
die dem Patienten Energie zuführen, jedoch in einer anderen als der hoch-
frequenten elektromagnetischen Form”, z. B. Infusionsgeräte.
Auch HF-Chirurgiegeräte gehören in Gruppe 1, da sie gemäß IEC 60601-
2-2 bei nicht aktiviertem HF-Ausgang betrachtet werden.
Gruppe 2
Für Aesculap-Produkte nicht relevant.
2.1.2 Klassen
Die Klassenzugehörigkeit richtet sich nach der elektromagnetischen
Umgebung am Einsatzort des medizinischen elektrischen Geräts.
Klasse A
Der Klasse A werden Geräte zugeordnet, wenn sie in der Gebrauchsanwei-
sung den Hinweis CISPR Klasse A enthalten.
Klasse B
Der Klasse B werden Geräte zugeordnet, wenn sie in der Gebrauchsanwei-
sung keine Angaben zur Klassifizierung oder den Hinweis CISPR Klasse B
enthalten.
2.1.3 Aufstellumgebung/Aufstellort
Das Gerät ist für den Einsatz in einer besonderen Umgebung geeignet. Es
darf in Bereichen eingesetzt werden, in denen medizinische Behandlungen
mit HF-Chirurgiegeräten durchgeführt werden.
"Gerät nicht unmittelbar neben anderen Geräten oder mit anderen
Geräten gestapelt verwenden, außer neben oder auf Aesculap-Geräten.
"Wenn der Betrieb unmittelbar neben anderen Geräten oder mit ande-
ren Geräten gestapelt erforderlich ist: Gerät beobachten, um den
bestimmungsgemäßen Betrieb in dieser Anordnung sicherzustellen.
Notwendige Vorkehrungen für die Verwendung in der Umgebung von AM-
, FM- TV- Sendern (z. B. in Entfernung weniger als 1,5 km), oder kabellos
kommunizierenden Geräten oder sonstigen lokalen elektromagnetischen
Störquellen:
"Gerät beobachten, um den bestimmungsgemäßen Betrieb über die zu
erwartende Betriebs-Lebensdauer aufrechtzuerhalten.
Art.-Nr. Bezeichnung
GA800 ELAN 4 electro Steuereinheit
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2.2 Elektromagnetische Aussendungen
"Leitlinien gemäß Gruppen-/Klassen-Zugehörigkeit des Geräts beach-
ten.
"Details zur Bedeutung der Gruppen-/Klassen-Zugehörigkeit, siehe Klas-
sifizierung von medizinischen elektrischen Geräten gemäß CISPR 11 im
vorigen Abschnitt.
Leitlinien und Herstellererklärung - Elektromagnetische Aussendungen
Die ELAN 4 electro Steuereinheit ist für den Betrieb in einer wie unten angegebenen elektromagnetischen Umgebung bestimmt. Der Anwender des Geräts
sollte sicherstellen, dass das Gerät in einer derartigen Umgebung betrieben wird.
Störaussendungsmessungen Übereinstimmung Elektromagnetische Umgebung - Leitlinien
HF-Aussendungen nach CISPR 11 Stimmt überein mit Gruppe 1 Das Gerät verwendet HF-Energie ausschließlich zu seiner internen Funk-
tion. Daher ist seine HF-Aussendung sehr gering und es ist unwahrschein-
lich, dass benachbarte elektronische Geräte gestört werden.
Aussendung von Oberschwingungen
nach IEC 61000-3-2
Stimmt überein mit Klasse A
(IEC 61000-3-2)
–
Aussendungen von Spannungsschwan-
kungen/Flicker
nach IEC 61000-3-3
Stimmt überein –
HF-Aussendungen nach CISPR 11 Klasse A Das Gerät ist für den Gebrauch in anderen Einrichtungen als dem Wohn-
bereich und solchen geeignet, die unmittelbar an ein öffentliches Versor-
gungsnetz angeschlossen sind, das auch Gebäude versorgt, die zu Wohn-
zwecken benutzt werden, vorausgesetzt, der folgende Hinweis wird
beachtet:
Warnung: Dieses Gerät/System ist nur zum Gebrauch durch medizinische
Fachkräfte vorgesehen. Dies ist ein Gerät/System der Klasse A nach CISPR
11. Im Wohnbereich kann dieses Gerät/System Funkstörungen hervorru-
fen, so dass es in diesem Fall notwendig sein kann, geeignete Abhilfemaß-
nahmen zu treffen, wie z. B. neue Ausrichtung, neue Anordnung oder
Abschirmung des Geräts oder Filterung der Verbindung zum Standort.
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