Integra Codman 901001CBL1 Handbuch Seite 5

Troubleshooting
If the service indicator is illuminated and flashing, the pump will cease operation.
To troubleshoot, power off the Irrigator by depressing the Power button, check
all connections and then power the unit back on by depressing the Power button
again.
If the service indicator is still illuminated, contact your local Integra representative.
Power Cord
To remove power from the device, unplug the power cord from the power receptacle
or wall socket. Do not use extension cords with three-prong to two-prong power plug
adaptors, or extra-length Power Cords with the Irrigator. Before each use, visually
inspect the Power Cord and plug for frayed or broken insulation. If necessary, replace
the Power Cord with the same type, length, gauge, and insulation.
Safety Information
Internally Powered Equipment
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and
Essential Performance
IEC 60601-1 ed.3.0 (2005-12), am1 (2012-07)
CAN/CSA-C22.2 NO. 60601-1:14
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/
(R)2012
EN 60601 1:2006+A12:2014
Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety
and Essential Performance – Collateral Standard: Electromagnetic Disturbances –
Requirements and Tests
IEC 60601-1-2 ed.3.0 (2007-03) and ed.4.0 (2014-02)
Service and Repair
The manufacturer will provide schematics, parts list, and other technical
information to authorized service centers. The Irrigator has no user serviceable
parts. For service, repair or replacements, contact your local Integra representative.
End of Useful Life
The Irrigator contains electrical components. Consider recycling at the end of
service life. The product can be returned to Integra for recycling. Dispose of the
equipment in accordance with local ordinances.
PRODUCT INFORMATION DISCLOSURE
INTEGRA LIFESCIENCES CORPORATION ("INTEGRA") HAS EXERCISED REASONABLE
CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE
PRODUCTS. INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO
THE PRODUCT LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR
APPLICABLE PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE, AND INTEGRA
DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED,
INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR
ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR
INDIRECTLY ARISING FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES
NOR AUTHORIZES ANY PERSON TO ASSUME ANY OTHER OR ADDITIONAL LIABILITY
OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.
Technical Specifications and Environmental Requirements
Supply Voltage
60 VA at 100–240 VAC
Supply Frequency
50/60 Hz
Supply Current
1.0 A
Fuses
5 x 20 mm, F 2H, 250 V (fast blow)
WARNING: Never touch the patient and external fuse simultaneously.
Environmental: Operational:
Temperature 10 to 40°C
Relative Humidity 20% to 80%
(non-condensing)
Atmospheric 700 hPa to
Pressure 1050 hPa
Guidance and Manufacturer's Declaration
Medical electrical equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided in
the tables below.
NOTE: Portable and mobile RF communications equipment can affect medical
electrical equipment.
Table I—Guidance and Manufacturer's Declaration—Emissions
All ME Equipment and ME Systems
Guidance and Manufacturer's Declaration-Emissions
The Codman Irrigator is intended for use in the electromagnetic environment
specified below. The customer or user of the Irrigator should ensure that it is used
in such an environment.
IEC 60601-1-2,
Emissions 3rd edition
Test Compliance
Level
RF Emissions
Group 1
CISPR 11
RF Emissions
Class A
CISPR 11
Harmonics
Class A
IEC 61000-3-2
Flicker
Complies
IEC 61000-3-3
WARNING: The Irrigator should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the System should be observed
to verify normal operation in the configuration in which it is used.
NOTE: The EMISSIONS characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 Class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency communication services. The
user might need to take mitigation measures, such as relocating or re-orienting the
equipment."
4
Transport: Storage:
-40 to 50°C -40 to 50°C
20% to 80% 20% to 80%
500 hPa to 500 hPa to
1050 hPa 1050 hPa
IEC 60601-1-
Electromagnetic
2, 4th edition
Environment-Guidance
Compliance
Level
The Codman Irrigator
creates/uses electromagnetic
energy for its internal
functioning only; therefore, its
electromagnetic interferences
and disturbances are very low
and are not likely to cause
any interference in nearby
electronic equipment.
The Codman Irrigator
is suitable for use in all
establishments, other than
domestic and those directly
connected to the public low
voltage power supply network
that supplies buildings used
for domestic purposes.
EN – ENGLISH