Specifications

15
TP202 Rev. A © Midmark Corporation 2013
Guidelines for Loading
Types of Items
BeforeplacinganyinstrumentintheM9orM11,checkwiththeinstrumentmanufacturertobesurethe
materialsarecompatiblewithsteamsterilization,andtoverifytheacceptabilityofsterilization
parameters.TheM9andM11aredesignedtosterilizethefollowing:
 • Metalinstruments
 • Rubber/plasticdevices(ex. suction cannulas, impression trays, etc.)
 • Wrapping/bundlingmaterials(ex. CSR wrap, instrument pouches, etc.)
 • Cassettes
 • High/lowspeedhandpieces
 • Surgicalinstruments(ex. opthalmologic instruments)
Equipment Alert
Do not sterilize items composed of any of the following materials in the M9 or M11.
• Corrosion sensitive metal (ex. carbon steel, iron, etc.)
• Fragile items susceptible to breaking under pressure / high temperature
• Biomedical waste
• Plastics that may break down or produce residue when exposed to steam / high
temperatures.
Examples
 Polyethylene,Styrene,Cellulosics,ABS,PVC,Acrylic(Plexiglass™),PPO(Noryl™),
 Latex,andNeoprene
Qualication Testing
Aftersterilizerinstallation,relocation,majorrepairs,andsterilizationprocessfailuresqualicationtesting
usingBIchallengetestpacksortraysshouldbeperformedpriortoplacingthesterilizerinservice.Ifmultiple
cycletypesareused,e.g.“Pouches”and“Packs”eachcycletypeshouldbequalied.TheBIchallengetest
packortrayshouldcontainitemsroutinelyprocessedandconsideredtobethemostdifcultto
sterilizealongwithatleastoneBIandoneCI.Additionalitemsshouldbeplacedinthechamberalongwith
the test pack or tray so the chamber is fully loaded (don’t exceed the maximum capacities listed in the tables
under “Guidelines for Loading” in this manual).Threeconsecutivetestruns,foreachcycletypetested,with
negativeresultsfromtheBIs,andappropriatereadingsfromallphysicalmonitorsandCIsdemonstrating
completesterilization,providevericationthatthesterilizerhasbeenproperlyinstalled(or reinstalled after
relocation) orrepairedtothemanufactures’sspecicationsandthatitwillfunctioneffectivelyinthefacilityin
whichitisinstalled.Allitemsprocessedduringqualicationtestingshouldbequarantineduntiltheresultsof
theBItestingforallthreetestrunsareavailable.