Inhaltsverzeichnis
Werbung
Kennzeichnungen
Typ BF (Body Floating)
IPX1 Tropfwassergeschützt
ACHTUNG
Vor Anwendung die Bedienungsanleitung lesen.
Herstellungsdatum
Verbrauchte Batterien nicht mit dem Hausmüll
entsorgen. Batterien sollten bei Sammelstellen
zur Entsorgung von Altbatterien abgegeben
werden. Zum Ende seiner Einsatzdauer sollte das
Gerät nicht mit dem regulären Hausmüll entsorgt
werden. Informieren Sie sich über Möglichkeiten zur
umweltgerechten und sachgerechten Entsorgung.
Beachten Sie örtliche Vorschriften.
EMC-Hinweise und Erklärung des Herstellers
Recommended separation distances between portable and mobile RF communications equipment and the ME equipment
The Finger-tip pulse oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Finger-tip pulse oximeter can help prevent electromagnetic interference by maintain-
ing a minimum distance between portable and mobile RF communications equipment (transmitters) and the Finger-tip pulse
oximeter as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter / m
Rated maximum output
150 kHz to 80 MHz , d=[3.5/
power of transmitter / W
V1]√P
0.01
0.12
0.1
0.37
1
1.17
10
3.7
100
11.67
Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING and
are specified for use only in a shielded location
The Finger-tip pulse oximeter declaration – electromagnetic immunity
The Finger-tip pulse oximeter system is intended for use in the electromagnetic environment specified below. The customer or
the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level
Conducted RF
3 Vrms
3V
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
3V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
Declaration – electromagnetic immunity
The Finger-tip pulse oximeter system is intended for use in the electromagnetic environment specified below. The customer or
the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Electrostatic discharge
±6 kV contact
(ESD) IEC 61000-4-2
±8 kV air
Electrical fast
±2 kV for power sup-
transient/burst IEC
ply lines
61000-4-4
±1 kV for input/output
lines
Surge IEC 61000-4-5 ± 1kV differential mode
± 2kV common mode
Voltage dips, short
<5% UT(>95% dip in UT)
interruptions and
for 0,5 cycle
voltage variations on
40% UT(60% dip in UT)
power supply input
for 5 cycles
lines IEC 61000-4-11
70% UT(30% dip in UT) for
25 cycles
<5% UT(>95% dip in
UT) for 5 s
Power frequency
3 A/m
(50/60 Hz) magnetic
field IEC 61000-4-8
Declaration – electromagnetic emissions
The Finger-tip pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the user
of the Finger-tip pulse oximeter should assure that it is used in such an environment.
Emission test
Compliance
CE emissions CISPR11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions IEC
Complies
61000-3-3
80 MHz to 800 MHz , d=[3.5/
800 MHz to 2,5 GHz , d=[3.5/
E1]√P
0.12
0.37
1.17
3.7
11.67
Electromagnetic environment-guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the EQUIPMENT or SYSTEM including cables,
than the recommended separation distance calculated from the equa-
tion applicable to the frequency of the transmitter. Interference may
occur in the vicinity of equipment marked with the following symbol.
Compliance level
Electromagnetic environment-guidance
±6 kV contact
Floors should be wood, concrete or ceramic
±8 kV air
tile. If floors are covered with synthetic mate-
rial, the relative humidity should be at
least 30 %.
±2 kV for power sup-
Mains power quality should be that of a typi-
ply lines
cal commercial or hospital environment.
± 1kV differential mode
Mains power quality should be that of a typi-
± 2kV common mode
cal commercial or hospital environment.
<5% UT(>95% dip in UT)
Mains power quality should be that of a
for 0,5 cycle
typical commercial or hospital environment.
40% UT(60% dip in UT)
If the user of the EQUIPMENT or SYSTEM
for 5 cycles
requires continued operation during power
70% UT(30% dip in UT) for
mains interruptions, it is recommended that
25 cycles
the EQUIPMENT or SYSTEM be powered from
<5% UT(>95% dip in
an uninterruptible power supply or a battery.
UT) for 5 s
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical loca-
tion in a typical commercial or hospital
environment.
Electromagnetic environment-guidance
The Finger-tip pulse oximeter 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.
The Finger-tip pulse oximeter 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.
Ein nicht invasives Diagnosegerät für ein
schnelles Screening der Gefäßelastizität.
E1]√P
0.23
0.74
2.33
7.37
23.33
Garantie
Der Hersteller gewährt auf K2 Control® eine zweijährige Garantie
ab Datum des Erstkaufes.
In folgenden Fällen erlischt die Garantie:
• Die Seriennummer des Gerätes wurde entfernt oder unleserlich
gemacht.
• Das Gerät wurde durch falsche Verbindung mit anderen Geräten
beschädigt.
• Das Gerät wurde durch Unfall beschädigt.
• Das Gerät wurde ohne Autorisierung durch den Hersteller
verändert.
Kundenname: _______________________________________
Adresse: ___________________________________________
Telefon: ____________________________________________
E-Mail Adresse: _____________________________________
Produktinformation:
Kaufdatum: _________________________________________
K2 DIAGNOSTIC UG
Gartenstraße 41, D-49744 Geeste, Germany
Die Inhalte dieses Dokumentes können sich ohne
Vorankündigung ändern.
Version: 1 ; 8. März, 2016
Rossmax InnoTek Corp.
12F., No. 189, Kang Chien Rd., Taipei, 114, Taiwan.
Tel: + 886-2-2659-7888 Fax: + 886-2-2659-7666
www.rossmax.com
Rossmax Swiss GmbH,
Tramstrasse 16, CH-9442 Berneck, Switzerland
Fingerpulsoximeter
Werbung
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