User Manual

Medtronic MiniMed
®
2007
Implantable Pump System
Limited Warranty
The Medtronic MiniMed 2007 Implantable Pump and Personal Pump
Communicator are components of the Medtronic MiniMed Implantable
Pump System designed for the long-term, intraperitoneal infusion of
insulin in the intensive treatment of insulin dependent diabetes
mellitus (IDDM) with the use of a peritoneal catheter, also a
component of the system. Pumps include an exhaustible power
source which will ultimately cease to function, requiring replacement
of the entire pump. No representation is made regarding the longevity
of the power supply. Causes of pump or catheter failure include but
are not limited to: premature battery failure; changes in product
performance characteristics; medical complications; catheter
occlusion. The improper handling or filling of pumps, the use of drugs
other than special U-400, or other intervening acts may also result in
pump or catheter failure, despite all due care in design, manufacture
and testing prior to sale. Therefore, no representation or warranty is
made that cessation of pump or catheter function will not occur.
Moreover, because the implantation of any device is always subject to
inherent risks, no representation can be made that the human body
will not react adversely to the implantation or presence of the pump
and/or catheter.
Medtronic MiniMed hereby warrants solely to the original purchaser of
the Pump and Personal Pump Communicator the following:
1. Should the pump fail to function within normal tolerances due to
a defect in materials or workmanship within a period of six (6) years,
commencing with the date of the implant of the pump, Medtronic
MiniMed will issue a credit equal to the percentage purchase price, as
defined below, against the purchase of another pump requested as
its replacement, or, at the option of Medtronic MiniMed, provide a
replacement pump at no charge. The percentage shall be 100% for
pumps that fail within four (4) years of implant. The percentage shall
be reduced by either (i) 4% for each month beyond the forty-eighth
month that the pump functions within normal tolerances, or (ii) 1% for
each 1 ml of medication delivered beyond 200 ml of medication,
whichever percentage is greater.
2. The credit issued hereunder shall be provided to purchaser of
the replacement pump. As used herein, “Purchase Price” shall mean
the lesser of the original or replacement pump purchase price, as
evidenced by the Medtronic MiniMed invoice, or the purchase price of
the currently functionally comparable Medtronic MiniMed pump. In no
way shall the Purchase Price include any VAT, sales or other tax paid
in relation to the pump.
3. To qualify for this limited warranty, the pump must be implanted
before its “use before” date contained in its packaging; replaced
pumps must be returned to Medtronic MiniMed and shall be the sole
property of Medtronic MiniMed and the use of the pump, including the
medication infused thereby, must be in accordance with the manuals
shipped with the pump. All explanted pumps returned to Medtronic
MiniMed must be prepared and shipped in the manner described in
the Physician Manual. Proper preservation of the pump is required
for accurate post-implant analysis.
4. Should the Personal Pump Communicator fail to function within
normal tolerances due to a defect in materials or workmanship within
a period of three (3) years, commencing with the date of implant,
Medtronic MiniMed will either repair or replace the Personal Pump
Communicator, at the sole discretion of Medtronic MiniMed. For
Personal Pump Communicators that have been damaged as a result
of abuse or neglect, the owner will be charged for repair or
replacement.
The Limited Warranty is limited by its express terms. THE
REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE
EXCLUSIVE REMEDIES AND THIS WARRANTY IS EXPRESSLY IN
LIEU OF ALL OTHER WARRANTIES. NEITHER MEDTRONIC
MINIMED NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE
LIABLE FOR ANY GENERAL, SPECIAL OR CONSEQUENTIAL
DAMAGES ARISING OUT OF THE SALE, MANUFACTURE OR USE
OF THE PRODUCT SOLD HEREUNDER. MEDTRONIC MINIMED
MAKES NO WARRANTIES, EXPRESS OR IMPLIED (INCUDING,
BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTIBILITY
OR FITNESS OF THE PRODUCTS FOR ANY PURPOSE OR
REASON) WITH RESPECT TO THE PUMP SOLD UNDER THIS
WARRANTY, EXCEPT AS CONTAINED IN THIS LIMITED
WARRANTY. NO PERSON HAS ANY AUTHORITY TO BIND
MEDTRONIC MINIMED TO ANY REPRESENTATION, CONDITION
OR WARRANTY, EXCEPT AS SPECIFICALLY SET FORTH
HEREIN.
In no event shall this Limited Warranty apply to any Pump or Personal
Pump Communicator replaced after the end of the period specified in
Paragraphs 1 and 4 above. This Limited Warranty is not applicable to
catheters, side ports or other accessories used with the Pump.
Some jurisdictions do not allow the exclusion or limitation of incidental
or consequential damages, so the limitations or exclusions herein
may not apply. This Limited Warranty gives you specific legal rights,
and you may have other rights which vary from jurisdiction to
jurisdiction.
Products covered by the Warranty include:
MMT-2007C Implantable Pump
MMT-3150 Personal Pump Communicator
USA
Northridge, CA
(818) 362-5859
To order supplies
(818) 843-6687 FAX (818) 364-0968
EUROPE
Medtronic MiniMed S.A.
63, Rue Marius Autan
92300 Levallois-Perret, France
Tel: (33)-(01)-47-59-76-60
FAX (33)-(01)-47-59-76-77
www.minimed.com
These products are covered by one or more of the following U.S.
patents:
[U.S.]4,373,527; [U.S.]4,395,259; [U.S.]4,525,165;
[U.S.]4,568,250; [U.S.]4,569,641; [U.S.]4,573,994;
[U.S.]4,619,653; [U.S.]4,636,150; [U.S.]4,731,051;
[U.S.]4,776,842; [U.S.]5,167,633; [U.S.]5,176,644;
[U.S.]5,197,322; [U.S.]5,217,442; [U.S.]5,257,971;
[U.S.]5,460,618; [U.S.]5,466,218; [U.S.]5,514,103;
[U.S.]5,527,307; [U.S.]5,559,828; [U.S.]5,797,733;
[U.S.]5,915,929
Patents also exist in a number of foreign countries and other U.S.,
international, and foreign patent applications are pending.
SYMBOL
MEANING
DO NOT RE-USE
READ INSTRUCTIONS FOR USE
STERILIZED WITH ETHYLENE OXIDE
REF
REFERENCE/RECORD NUMBER
STORAGE TEMPERATURE RANGE
FRAGILE PRODUCT
0459
MARKING AUTHORIZED
TYPE CF
OPEN HERE