Owner's manual

3.RecommendedSterilizationParameters:
Returned Goods Policy
Productsmustbereturnedinunopenedpackageswithmanufacturer’sseals
intact to be accepted for replacement or credit unless returned due to a complaint
of product defect. Determination of a product defect will be made by Integra.
Products will not be accepted for replacement if they have been in the possession
of the customer for more than 90 days.
Product Information Disclosure
INTEGRAANDITSSUBSIDIARIES(“INTEGRA”)ANDMANUFACTUREREXCLUDEALL
WARRANTIES,EXCEPTINTEGRA’SAPPLICABLESTANDARDWARRANTYWHETHER
EXPRESSEDORIMPLIED,INCLUDINGBUTNOTLIMITEDTO,ANYIMPLIED
WARRANTIESOFMERCHANTABILITYORFITNESSFORAPARTICULARPURPOSE.
NEITHERINTEGRANORMANUFACTURERSHALLBELIABLEFORANYINCIDENTAL
ORCONSEQUENTIALLOSS,DAMAGE,OREXPENSE,DIRECTLYORINDIRECTLY
ARISINGFROMUSEOFTHISPRODUCT.NEITHERINTEGRANORMANUFACTURER
ASSUMENORAUTHORIZEANYPERSONTOASSUMEFORTHEMANYOTHER
ORADDITIONALLIABILITYORRESPONSIBILITYINCONNECTIONWITHTHESE
PRODUCTS.
Sterilizer
Exposure
Temperature
Exposure
Time
Minimum
Dry Time
Pre-Vacuum
(Wrapped)
132°C(270°F) 4 minutes 20 minutes
Pre-Vacuum
(Un-wrapped)
132°C(270°F) 4 minutes -
GravitySteam 121°C(250°F) 30 minutes 30 minutes
GravitySteam 132°C ~ 135°C
(270°F~275°F)
10 minutes 30 minutes
Consult Instruction for Use
CAUTION:Federal(USA)law
restricts this device to sale by or
on the order of a physician
Not made with natural
rubber latex
Product complies with
requirements of directive 93/42/
EECformedicaldevices
Manufacturer
1
EuropeanAuthorized
Representative
Catalog number
LotNumber
Caution! See Warnings
and Precautions
1
Companyresponsibleforadevicemarketedunderitsownnameregardlessof
whether“manufacturedfor”or“manufacturedby”thecompany.
EC REP
REF
LOT
EURepresentative
WellkangLtdSuiteB,29HarleyStreetLONDON,W1G9QR,U.K.
Manufactured for
IntegraYorkPA,Inc.
589DaviesDrive,York,PA17402
866-854-8300USA +1 717-840-2763outsideUSA +1 717-840-9347 fax
integralife.com/integra-miltex
Integra,theIntegralogo,andMiltexareregisteredtrademarksofIntegraLifeSciencesCorporation
oritssubsidiariesintheUnitedStatesand/orothercountries.Allothertrademarksareproperty
oftheirrespectiveowners.©2012IntegraLifeSciencesCorporation.AllRightsReserved.
SURGOSDILSETDFU Rev. - 04/13
Manufacturer
Panpac Medical Corporation
6F-2,No.202,Sec.3,Ta-TongRd.,
Shi-Chih Dist., New Taipei City TAIWAN,R.O.C. Phone: 886-2-8647-2242
Fax:(886)28647-2770
EC REP
Symbols used on labeling
0434