Specifications; Replacing The External Fuses; Responsibility Of The Manufacturer; Safety Information - Integra Codman VPV System Manual

Specifications

Electrical
Supply Voltage: 100–240 VAC
Range: 90–264 VAC (Autodetected)
Supply Frequency: 50/60 Hz
Supply Fuses: T5AL 250 VAC
Rated Input: 100–240 VAC 6.5 A
Mode of Operation: Continuous with intermittent loading 30% maximum duty cycle
Environmental
Operating Temperature Range: +10 °C to +35 °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

Replacing the External Fuses

1. Turn the program unit power switch off.
2.
Disconnect the program unit from the power supply.
3. The program unit's fuse holder is located adjacent to the power switch on the rear of the top panel. Use a small
flat-head screwdriver to lift the lid of the fuse holder and pull the fuse holder from the chassis.
4. Remove each fuse by pulling it from its socket. Replace each fuse with a new fuse of the
appropriate specifications.
5. Reinsert the fuse holder in the program unit. Push the lid of the fuse holder in until the release snaps back into
position.
CAUTION: Replace each fuse with one of the correct specifications, as listed in

Responsibility of the Manufacturer

Integra LifeSciences Corporation 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

The CODMAN VPV System (catalog no. 823192R) complies with the requirements of
ANSI/AAMI ES60601-1:2005
CAN/CSA-C22.2 No. 60601-1:2008
IEC 60601-1 (2005) 3rd Edition
EN 60601-1 (2006) 3rd Edition
WARNING: 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 VPV System for service or repair to:
Always include a repair purchase order number and a written description of the problem.

End of Useful Life

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.

Appendix A: Confirming Valve Adjustment: Visually or by X-ray

Adjustment of the packaged valve can be confirmed visually or by x-ray. Adjustment of the implanted valve can be
confirmed by x-ray.
Figure 7 shows an x-ray of a CODMAN HAKIM valve. The white marker on the valve indicates the right hand side of the
Specifications
.
valve. The pressure indicator on the white ring indicates the chosen setting. If the valve were inverted, the white marker
would appear on the left side.
The positions of the setting selection keys on the program unit's front panel also correlate with the positions of the
pressure indicator on the valve, as seen when x-rayed (Figure 8). The figure shows the location of the pressure indicator
for each setting (30 through 200). When the valve is adjusted to 70, 120, or 170, the pressure indicator aligns with the
"X" in the center of the valve.
The position of the pressure indicator of a packaged valve can also be observed visually. Figure 9 shows a magnified
view.
X-raying an Implanted Valve
Use an x-ray with intensifying TV screen, or an x-ray plate. Take care when positioning the patient's head so that:
•
•
9
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
the nonimplanted side of the head rests on the plate (the implanted side is uppermost from the plate), and,
the inlet valve is parallel to the x-ray plate.
EN – ENGLISH