Warranty - Codman HAKIM Handbuch

Specifications
Electrical
Supply Voltage Range: 100–240 VAC autodetected
Supply Frequency: 50/60 Hz
Supply Fuses: T5AL 250 VAC (100/120 VAC)
T2AL 250 VAC (220/240 VAC)
Rated Input: 100–120 VAC, 0.26A/3A
220–240 VAC, 0.43A/6A
Mode of Operation: Continuous with intermittent loading
Environmental
Operating Temperature
Range: +10°C to +30°C
Operating Humidity
Range: 30% to 75% relative humidity, non-condensing
Operating Pressure
Range: 700 hPa to 1060 hPa
Transport & Storage
Temperature Range: –40°C to +60°C
Transport & Storage
Humidity Range: 10% to 85% relative humidity, non-condensing
Transport & Storage
Pressure Range: 500 hPa to 1060 hPa
Note: A storage/carrying case is provided for protection of the programmer
and transmitter when not in use or when transporting from one location
to another.
Preventive Maintenance and Cleaning
With general care and handling, the programmer and transmitter are virtually
maintenance free. The user must observe the following:
1. Before each use, check the integrity of the equipment covers and
interconnecting leads. If either the covers or the leads are damaged, do not
use; return the equipment for service (see Service and Repair).
2. If the equipment fails to operate, return the programmer and transmitter for
service (see Service and Repair).
3. Clean the equipment after each use and before storing. Disconnect the
programmer from the power (mains) supply and clean the programmer and
transmitter using a clean cloth dampened with 70% isopropyl alcohol or mild
hospital cleaning detergent/bactericide. Dry with a clean cloth.
4. Never immerse the programmer or transmitter in liquid.
5. Do not sterilize. Use a sterile drape to protect the patient if programming
the valve during the implantation procedure.
Replacing the External Fuse
1. The programmer's fuse holder is located adjacent to the power switch on the
rear of the unit (Figure 8). With a fingernail or tool such as a screwdriver, press
the release to the left and pull the fuse holder out of the chassis.
2. Remove the fuse by pulling it from its socket. Replace with a new fuse of
the appropriate specifications.
3. Push the new fuse into the socket. Replace the fuse holder into
the programmer. Push the fuse holder in until the release snaps back
into position.
WARNING: Replace the fuse with one of the correct specifications, as
listed in the Specifications section. Disconnect HAKIM Programmer
from external power sources before changing fuses.
Technical Maintenance
There is no preventive maintenance for this device. The programmer
checks all critical systems each time the power is turned on. Failure of
this test will result in an error message on the display: "PROGRAMMER
FAILURE – NEED SERVICE". Contact Codman Customer Service or your
Codman sales representative.
Responsibility of the Manufacturer
Codman & Shurtleff, Inc. accepts responsibility for the effects of safety,
reliability and performance of the equipment only if:
• Adjustments, modifications and repairs are carried out by
authorized personnel;
• The electrical installation of the relevant room complies with
local regulations;
• The equipment is used in accordance with these instructions for use.
205181-001-E.indd 5 205181-001-E.indd 5
Safety Information
Internally Powered Equipment
The equipment is a Class II device with a floating applied part, Type BF. The
programmer and transmitter comply with the requirements of the standards
listed below:
Medical Electrical Equipment-Part 1: General Requirements for Safety
CAN/CSA C22.2 No. 60601-1 (2008), EN 60601-1 (2006), IEC 60601-1 (2005)
EN 60601-1-2 (2001), Medical Electrical Equipment, Part 1-2: General
Requirements for Safety—Collateral Standard: Electromagnetic
Compatibility Requirements and Tests
IEC 60601-1-6 (2010) 3rd edition, Medical Equipment, Part 1-6: General
Requirements for Safety—Collateral Standard: Application of Usability
Engineering to Medical Devices
Equipment not suitable for use in the presence of FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE.
Service and Repair
Send the programmer and the transmitter for service or repair to:
Medos International Sàrl
Chemin-Blanc 38
CH 2400 Le Locle
Switzerland
End of Life
The programmer contains electrical components. Consider recycling at the
end of service life. The product can be returned to Codman for recycling.
Dispose of the equipment in accordance with local ordinances.

Warranty

Codman & Shurtleff, Inc. warrants that this medical device is free from
defects in both materials and workmanship for one (1) year from the date of
purchase. Any other express or implied warranties, including warranties
of merchantability or fitness, are hereby disclaimed. Suitability for use
of this medical device for any particular surgical procedure should
be determined by the user in conformance with the manufacturer's
instructions for use. There are no warranties that extend beyond
the description on the face hereof.
® CODMAN is a registered trademark of Codman & Shurtleff, Inc.
® HAKIM is a registered trademark of Hakim USA, LLC and is used under license by
Codman & Shurtleff, Inc.
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