Olympus OFP-2, Инструкция по эксплуатации

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Chapter 9 Specification
FLUSHING PUMP OFP-2
51
Chapter 9 Specification
Items Specifications
Product name Olympus Flushing Pump OFP-2
Classification
(electromedical
equipment)
Standards
compliance
This symbol on the OFP-2 indicates it is listed and
classified by Intertek Testing Services as meeting the
requirements of AAMI ES60601-1, and is certified to CSA
C22.2 No. 60601-1
Electro–magnetic
compatibility
This product complies with the requirements of EN IEC 60601-1-
2:2014 Edition 4 for emissions and immunity, and as such, its
operation is unlikely to be affected by, or cause interference with,
equipment meeting appropriate EMC standards. As a precaution,
equipment which may be sensitive to interference outside the limits
specified by EN IEC 60601-1-2:2014 Edition 4 should not be placed
in close proximity to the OFP-2.
Type of protection
against electrical
shock
Classification according to:
IEC 60601-1:2005 + A1:2012 Edition 3.1
EN 60601-1:2006 + A1:2013
ANSI/AAMI ES 60601-1:2005/(R)2012 - Class I
Degree of
protection against
electrical shock
In accordance with IEC 60601-1:2005 + A1:2012 Edition 3.1, EN
60601-1:2006 + A1:2013 and UL 60601-1:2003, the OFP-2 provides
an adequate degree of protection against electrical shock as if it has
an applied part isolated from all other parts of the equipment.
The endoscope is the applied part. The OFP-2 is an accessory to the
applied part.
Degree of
protection against
explosion
None: the Olympus OFP-2 must NOT be used in the zone of risk of
flammable anaesthetic gases.
Mode of operation Continuous
Regulatory
status
European
Economic Area
(EEA)
This mark on the product indicates compliance with
Medical Device Regulation 2017/745, as amended
relating to medical devices, Class IIa. The year of
manufacture is given in the second and third digits
of the serial number.
End of life In accordance with European Directive 2002/96/EC on
Waste Electrical and Electronic Equipment, this
symbol indicates that the product must not be
disposed of as unsorted municipal waste, but should
be collected separately. Refer to your local Olympus
distributor for return and/or collection systems
available in your country.
Year of manufacture
Displays the last two digits of the year of manufacture.
The year of manufacture is shown on the packaging
label, combined with the ‘MANUFACTURER’ symbol.
Dimensions
and weight
Dimensions Height: 166 mm (220mm with water container)
Width: 244 mm
Depth: 385 mm
Weight 4kg (with empty water container)
ETL CLASSIFIED
21501234
2015