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1st Edition: 12 Jul 2017
7th Edition: 26 Feb 2020
NIHON KOHDEN CORPORATION
1-31-4 Nishiochiai, Shinjuku-ku,
Tokyo 161-8560, Japan
Phone +81 3-5996-8041
https://www.nihonkohden.com/
Manufacturer
NIHON KOHDEN EUROPE GmbH
Raiffeisenstrasse 10, D-61191 Rosbach, Germany
Phone +49 6003-827-0 Fax +49 6003-827-599
European Representative
SHANGHAI KOHDEN MEDICAL ELECTRONIC
INSTRUMENT CORP.
No. 567 Huancheng Bei Road
Shanghai Comprehensive Industrial Development Zone
Fengxian District, Shanghai 201401, China
Phone +86 21-5743-6998
Fax +86 21-5743-6939
NIHON KOHDEN AMERICA, INC.
15353 Barranca Parkway, Irvine, CA 92618
Toll-free +1-800-325-0283
Phone +1 949-580-1555 Fax +1 949-580-1550
Copyright Notice
The entire contents of this manual are copyrighted by Nihon Kohden.
All rights are reserved.
Note for users in the territory of the EEA and Switzerland:
Any serious incident that has occurred in relation to the device should be
reported to the European Representative designated by the manufacturer
and the Competent Authority of the Member State of the EEA and
Switzerland in which the user and/or patient is established.
Degree of protection against electrical shock:
Debrillator-proof type BF applied part
or debrillator-proof type CF applied
part 1
1
Depends on the instrument to which
the CO2 sensor kit is connected.
Refer to the instrument manual.
Degree of safety of application in the presence of
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR
WITH OXYGEN OR NITROUS OXIDE:
Equipment not suitable for use in
the presence of FLAMMABLE
ANAESTHETIC MIXTURE WITH
AIR, OR WITH OXYGEN OR
NITROUS OXIDE
Mode of operation: CONTINUOUS OPERATION
Applicable patients (weight):
Refer to “Optional Items” (p. 1).
Operating environment
Temperature: 0 to 40°C (32 to 104°F)
Humidity: 15 to 95% RH (noncondensing)
Atmospheric pressure:
70 to 106 kPa
Transport and Storage environment
Temperature: –25 to +65°C (–13 to +149°F)
Humidity: 10 to 95% RH (noncondensing)
Atmospheric pressure:
70 to 106 kPa
It may take up to 1 hour for the CO2 sensor kit to reach
full performance when the CO2 sensor kit is stored at
–25°C (–13°F) or 65°C (149°F) and then moved to a place
at 20°C (68°F).
Atmospheric compensation:
Automatic
Lifetime of the optional items:
The optional items are disposable.
Their lifetime is 36 months from the
month of manufacture.
Safety standard:
IEC 60601-1:2005+Amendment 1:2012
IEC 60601-1-2:2007
IEC 60601-1-2:2014 1
IEC 60601-1-12:2014 1
ISO 80601-2-55:2011
1 Only when the connected instrument
complies with the standard
Electromagnetic Compatibility:
IEC 60601-1-2:2007
or IEC 60601-1-2:2014 1
1
Depends on the instrument to which
the CO2 sensor kit is connected.
For details on “EMC Reated Caution”,
“Electromagnetic Emissions”,
“Electromagnetic Immunity” and
“System Composition for EMC Test”,
refer to the instrument manual.
Measurement Principle
The mainstream CO2 measurement principle is based on the
fact that CO2 absorbs 4.3 μm wavelength infrared light well.
Infrared light is emitted from the emitter on the CO2 sensor,
passes through the CO2 sensor cell where some is absorbed
by CO2 in the cell, then the unabsorbed light is detected
by the detector. The CO2 concentration in the respiration is
calculated from the ratio of unabsorbed infrared light that
passed through the CO2 sensor cell and reference infrared
light that does not go through the CO2 sensor cell (single
wave spectroscopic method).
Use with Volatile Anesthetic Agents
When using volatile anesthetic agents, the displayed value is
off by the following amount (at 1 atmospheric pressure and
gas mixtures of 5% CO2 (5.1 kPa (38 mmHg)) and balance
N2, dry gas).
Anesthetic Gas Concentration Difference
Halothane 4% +0.04 kPa (+0.3 mmHg)
Enurane 5% +0.12 kPa (+0.9 mmHg)
Isourane 5% +0.22 kPa (+1.7 mmHg)
Sevourane 6% +0.28 kPa (+2.1 mmHg)
Desurane 15% +0.39 kPa (+2.9 mmHg)