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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:
100–127 VAC, 0.17A/6.3A 50/60 Hz
220–240 VAC, 0.11A/3.3A 50/60 Hz
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 your local
Integra representative.
Responsibility of the Manufacturer
Integra LifeSciences 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.
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
Please contact the nearest Service and Repair facility:
USA & Central/South America
Integra LifeSciences
5965 Pacific Center Blvd
Suite 705
San Diego, California 92121
Tel: 800-815-1115 Option 5
Fax: 858-455-5874
Email: sdservicerepair@integralife.com
Canada
Integra Canada ULC – An Integra LifeSciences Company
2590 Bristol Circle, Unit 1
Oakville Ontario, Canada L6H 6Z7
Tel: 905-618-1616
Fax: 905-632-7938
Email: Canada.Repair@integralife.com
Europe, Middle East and Africa Service Center
Integra Neurosciences GmbH
Halskestrasse 9
Ratingen 40880, Germany
Tel: +49 2102 5535 6150
Fax: +49 2102 942 4872
Email: emea.techservice@integralife.com
Asia Pacific Service Center
Integra NeuroSciences Pty. Ltd.
Unit 3, 24-30 Winterton Road
Clayton, Vic. 3168, Australia
Tel: +613 85400400
Fax: +613 95400004
Email: service@integralife.com.au
End of Life
The programmer 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.
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