Sealed Sterilization Container

Why ONE TRAY®?

Regulatory ComplianceFDA Clearance: the patented ONE TRAY® Sealed Container system is 510(k) cleared, and complies with both AORN and AAMI recommendations for the safe handling, transport and delivery. CE marked according to the Directive 93/42 / EEC on medical devices.

SafetyONE TRAY® containers enable the “Rapid” sterilization of surgical instrumentation with the safety and assurance of CE Marked and FDA regulatory clearance and 510(k) validated protocol.

ConvenienceONE TRAY® utilizes the same familiar assembly and convenient preparation protocols that are widely used for traditional filtered vent containers.

ValueMedical journals contain articles which state the clinical need for the rapid sterile processing of surgical instrument sets using convenient, safe, and 510(k) cleared methods.

FlexibilityONE TRAY® allows for user-defined capacities with various base and lid height options as well as footprint sizes. The ONE TRAY® System is validated for a 30-day event related shelf life.

InnovativeThe innovative SterObexPM barrier technology assures long term sealing capabilities and increases sterility maintenance of the container.

Go GREENThis Innovative “Rapid” Sterilization Technology eliminates waste associated with the wrapping of surgical instrumentation and loaner/consignment sets.

Surgical facilities are experiencing unprecedented demands for cost controls and improved efficiency. The challenge is managing instrumentation in coor-dination with the surgical case load within a rapidly changing environment; especially where emergency cases are common.

The ONE TRAY® processing system optimizes the utilization of limited surgical assets and supplies by offering quantifiable time and cost savings that are immediate and ongoing.

Environmental benefits

• Reduces Energy Use• Reduces Waste• Reduces Carbon Footprint• Tamper Evident Protection• Green Environmental Initiatives

Value benefits

• Reduce Capital Investments• Improve Service Levels• Enhance Productivity• Increase Service Capacity and

Velocity• Reduce Cost, Time, and Effort

ONE TRAY®’s breakthrough rapid processing capability is accomplished by innovative design features and unique performance benefits that eliminate drying/cool times.

Features and Benefitsto ASC/Hospital

Disposal of wraps “Greener Technology”

Decreases labor to wrap/manage loads

Cost of goods to sterilize:Blue wraps, towels/laundry, corner bumpers/extra trays to protect, tape

Unused trays wrapped (allows intra-op decisions/eliminates wrapping everything)

Wet/torn wraps re-sterilization/flashing

Case cancels/schedule change

No redundant back up trays need to be wrapped for case

Utilities - lower sterilizer energy needed (Greener Pathway):Water/Steam, Electric, and Gas use decreases

Training Staff/eliminate human error in sterilization (one protocol)

Sterilization quality increases patient safety

Standardize policies and sterilization guidelines for SPD/OR

Conforms to AORN 25lbs/11.3kg standards - allows SPD to mandate

Rapid processing advantages:• Decrease OR wait time ($75 - $200 per minute) • Eliminate IUS paperwork, eliminate joint commission scrutiny on

flashing

Case cancelled/moved due to unsterile equipment or lack of sets

Consistent sterilization outcomes

Decrease infection rates due to higher than required FDA Fo values

Eliminates long term storage (Is it sterilized or not?)

Containers are sturdy and durable

Thirty day event related shelf life

Increase Efficiency Save You Money Save Time

Three areas of opportunity to affect any facility

1. Solutions for headaches in SPD/OR

2. Solution for the mountain of loaner and consignment trays processed in SPD departments daily

3. Replace IUSS/”Flash” the day trays are delivered

ONE TRAY® accepts surgical instrumen-tation protected in their modular organizing trays for the rapid processing of entire instrument sets for increased efficiency.

ONE TRAY® system

FDA cleared sealed terminal filtered vent sterilization container:

• 4 minute pre-vac (standard 3 pulse cycle)• Validated for 0 minutes minimum dry/cool time• Thirty day event related shelf life

Industry leading compression force cam locking design

The innovative SterObexPM barrier assures long term sealing capabilities and increases sterility maintenance of the ONE TRAY® line of containers

Deck plate elevates instruments off bottom of the tray

Unique lip design helps prevent nicks tothe top edge of base

Unique container design enhancesthermodynamic steam flow

Up close view of “SterObexPM Barrier Technology”

Stackability foreasy storage

Unique characteristics of the ONE TRAY® filter combined with container design, achieve terminal sterility and sterility maintenance.

The proprietary non-woven filters are required as part of the ONE TRAY® system.

How it works• Proprietary non-woven material• Optimal barrier protection

– Micro-particulate barrier– Hydrophobic barrier

• Filters and filter cover design create a “sealed” container• A unique balance of airflow and fluid barrier technology

Advantages• Greater confidence preventing bacterial contamination following

processing• Patent protected• Highest filtration and microbial barrier efficiencies• Utilizes the same protocol for standard autoclaving• Provides safe transport in a sealed container• Filter designed for easy installation, eliminating user errors

Processing KitsONE TRAY® processing kits are required for use with the ONE TRAY® system.

Each kit contains the following items:

• Three proprietary filters ensure correct alignment and use• Two load ID cards• One class 5 integrator• Two One LockPM tamper evident seals with indicator dots

ONE TRAY® processing kits (shown above) can be conveniently ordered by contacting Innovative Sterilization Technologies.

Filter Design

ONE TRAY® utilizes a proprietary set of three non-woven filters. These filters act not only as particulate barriers, but also as fluid barriers. The design of the filters ensure proper alignment and use.

Tray Models and DescriptionsPre-Vaccum

Temperature 270°F/132°C

Exposure Time 4 minutes

Cycle Dry Time Not required

Cycle Cool Time Not required

Gravity

Temperature 270°F/132°C

Exposure Time 34 minutes

Cycle Dry Time Not required

Cycle Cool Time Not required

Steam Sterilization CyclesModel Description/Dimensions

M2104 21” (53.3cm) long I.D. x 12” (30.5cm) wide I.D. - 4” (10.2cm) working height with 21”(53.3cm) deck plate

M2106 21” (53.3cm) long I.D. x 12” (30.5cm) wide I.D. - 6” (15.2cm) working height with 21”(53.3cm) deck plate

M2108 21” (53.3cm) long I.D. x 12” (30.5cm) wide I.D. - 8” (20.3cm) working height with 21”(53.3cm) deck plate

M2404 24” (61.0cm) long I.D. x 12” (30.5cm) wide I.D. - 4” (10.2cm) working height with 24”(61.0cm) deck plate

M2406 24” (61.0cm) long I.D. x 12” (30.5cm) wide I.D. - 6” (15.2cm) working height with 24”(61.0cm) deck plate

M2408 24” (61.0cm) long I.D. x 12” (30.5cm) wide I.D. - 8” (20.3cm) working height with 24”(61.0cm) deck plate

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Innovative Sterilization Technologies7625 Paragon Road, Suite A · Dayton, OH 45459, USTel. 00 1 937.619.0138 · www.iststerilization.com

www.medcomtech.es