Owner's manual
3.RecommendedSterilizationParameters:
Returned Goods Policy
Productsmustbereturnedinunopenedpackageswithmanufacturer’sseals
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
INTEGRAANDITSSUBSIDIARIES(“INTEGRA”)ANDMANUFACTUREREXCLUDEALL
WARRANTIES,EXCEPTINTEGRA’SAPPLICABLESTANDARDWARRANTYWHETHER
EXPRESSEDORIMPLIED,INCLUDINGBUTNOTLIMITEDTO,ANYIMPLIED
WARRANTIESOFMERCHANTABILITYORFITNESSFORAPARTICULARPURPOSE.
NEITHERINTEGRANORMANUFACTURERSHALLBELIABLEFORANYINCIDENTAL
ORCONSEQUENTIALLOSS,DAMAGE,OREXPENSE,DIRECTLYORINDIRECTLY
ARISINGFROMUSEOFTHISPRODUCT.NEITHERINTEGRANORMANUFACTURER
ASSUMENORAUTHORIZEANYPERSONTOASSUMEFORTHEMANYOTHER
ORADDITIONALLIABILITYORRESPONSIBILITYINCONNECTIONWITHTHESE
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 -
GravitySteam 121°C(250°F) 30 minutes 30 minutes
GravitySteam 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/
EECformedicaldevices
Manufacturer
1
EuropeanAuthorized
Representative
Catalog number
LotNumber
Caution! See Warnings
and Precautions
1
Companyresponsibleforadevicemarketedunderitsownnameregardlessof
whether“manufacturedfor”or“manufacturedby”thecompany.
EC REP
REF
LOT
EURepresentative
WellkangLtd SuiteB,29HarleyStreet LONDON,W1G9QR,U.K.
Manufactured for
IntegraYorkPA,Inc.
589DaviesDrive,York,PA17402
866-854-8300USA +1 717-840-2763outsideUSA +1 717-840-9347 fax
integralife.com/integra-miltex
Integra,theIntegralogo,andMiltexareregisteredtrademarksofIntegraLifeSciencesCorporation
oritssubsidiariesintheUnitedStatesand/orothercountries.Allothertrademarksareproperty
oftheirrespectiveowners.©2012IntegraLifeSciencesCorporation.AllRightsReserved.
SURGOSDILSETDFU Rev. - 04/13
Manufacturer
Panpac Medical Corporation
6F-2,No.202,Sec.3,Ta-TongRd.,
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