Return/Repair/Warranty; Warnings And Cautions - Gyrus Acmi Berkeley VC-10 Mode D'emploi

80807 REV KA
Berkeley VC-10 Vacuum Curettage System • Instructions for Use and Technical Manual

Return/Repair/Warranty

Return/Repair
All returns must have prior authorization. To comply with OSHA Bloodborne Pathogen Standard 29
CFR 1910.1030 regulations and U.S. Postal and Transportation law, all used medical devices returned
for repair or replacement must be properly cleaned and decontaminated with a chemical germicide that
has been cleared for use as a "Hospital Disinfectant." To ensure that the product has been properly
decontaminated, a signed Decontamination Certificate should be enclosed in the package.
All medical devices returned to Gyrus ACMI for any reason must be shipped in accordance with Gyrus
ACMI's return procedures (available upon request) and all applicable regulations. To obtain a return
authorization number (RMA), return address, and instructions, please call Gyrus ACMI Customer Service
at 1-888-524-7266 or 1-763-416-3000.
Please provide the product part number and lot/serial number. Product should be returned in its original
packaging (when possible) and marked with the RMA number on the exterior of the package.
Limited Express Warranty
SHOULD THE PRODUCT BECOME INOPERABLE DURING NORMAL AND PROPER USE IN ACCORDANCE
WITH APPLICABLE INSTRUCTIONS AND WITHIN THE TIME FRAME SPECIFIED BELOW FROM THE DATE
OF SHIPMENT, GYRUS ACMI WILL REPAIR OR REPLACE THE PRODUCT, AT ITS SOLE OPTION, AT NO
CHARGE. GYRUS ACMI MAKES NO OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND
EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AS TO MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER. IN NO EVENT SHALL GYRUS ACMI BE
LIABLE FOR ANY CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL GYRUS ACMI BE LIABLE FOR ANY
BREACH OF WARRANTY IN ANY AMOUNT EXCEEDING THE PURCHASE PRICE OF THE PRODUCT.
This warranty applies only to the original purchaser and will be voided if the product(s) are serviced or
repaired by anyone other than Gyrus ACMI or an organization duly authorized by Gyrus ACMI for such
purpose.
Vacuum Curettage Systems................................................................................... 1 year

Warnings and Cautions

The following warnings and cautions apply to the use, care, and/or maintenance of the Gyrus ACMI
Berkeley VC -10 Vacuum Curettage System.
Warnings
(indicate that a danger to life or health can result from misusing the equipment)
1. Other than user/operator accessible and replaceable components identified and described within this
document, there are NO serviceable parts or assemblies in the VC-10 Vacuum Curettage System.
For technical support, contact the Gyrus ACMI Technical Support Hotline at 1-800-331-2264
1-763-416-3000
.
2. Study this manual and other labeling thoroughly for safe handling and storage. Misuse of instruments
can cause injury to the patient and could have an adverse effect on the procedure being performed. Do
not drop instruments or allow them to be struck by other objects.
3. Procedures should be performed only by persons with adequate training and preparation. Consult the
medical literature regarding techniques, complications, and hazards prior to any vacuum curettage
procedure.
4. This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or
with nitrous oxide (N O).
2
5. This equipment is not suitable for use in hazardous atmospheric conditions.
6. Grounding reliability can only be achieved when the unit is connected to equivalent receptacle marked
"Hospital Grade".
7. Do not use an instrument that fails to meet the criteria stated in the labeling, or that has been damaged.
8. Follow the labeling instructions regarding the disposal or reuse of accessories. Reuse of disposable
accessories could compromise patient safety.
9. Use only those replacement parts specified in the labeling.
®
or
3