STERRAD® 101

Learning the basics

 Topics
• Critical instrumentation
• Process flow
• Sterilization modalities
• Stakeholders
• ASP mission & innovation
• STERRAD basics, including gas plasma
• MDM validation

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Spaulding’s Classification
In 1968 Dr. Earle Spaulding devised a rational approach to disinfection and sterilization. This is now referred to as
Spaulding's Classification and it has been refined and retained over the years because it is so clear and logical.
Spaulding believed that instruments and equipment should be cleaned and reprocessed according to the level of
risk associated with their intended use.

Body Contact Disinfection Requirements FDA Device Class

Intact skin Low level Non-critical
Mucous membranes High level Semi-critical
Sterile body cavity Sterilization Critical

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Critical
Enter sterile tissue or body cavities
• Example: Choledochoscope

Breaks mucosal barrier

• Example: Biopsy Forceps

Enters Vascular System

• Example: Angioscope

Critical devices requires sterilization

Sterilization kills all microorganisms including bacterial spores, which
are the most difficult to kill

Recognized as a SAL of 10 to the minus 6, a 12 log reduction

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 4
 Sterilization
• Sterilization destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated
with the use of that item
• “Sterile” is measured as a probability of sterility
• Sterility Assurance Level (SAL) defined as the probability of a single viable microorganism occurring on a product after sterilization.
• If the probability of a spore surviving were one in one million, the SAL would be 10−6
• Sterilization options
• Steam Sterilization
• Low-temperature sterilization (e.g., ethylene oxide, hydrogen peroxide gas plasma, peracetic acid)

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Sterilization modalities
Steam
Low-temp sterilization
ETO
Peracetic
Hydrogen peroxide gas plasma

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
12533
 Methods of Sterilization
High Temperature Low Temperature

Moist Heat Dry Heat Formaldehyde Ethylene Oxide Hydrogen Peroxide

121-134oC Up to 50-55oC

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 7
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 Steam Sterilization
• moist heat in the form of saturated steam under pressure is the most widely used and the most dependable
• nontoxic, inexpensive, rapidly microbicidal, sporicidal, and rapidly heats and penetrates fabrics
• has some deleterious effects on some materials, including corrosion and combustion of lubricants associated with dental
handpieces; reduction in ability to transmit light associated with laryngoscopes; and increased hardening time (5.6 fold) with
plaster-cast
• four parameters of steam sterilization: steam, pressure, temperature, and time
• cycle is monitored by mechanical, chemical, and biological monitors
• typically, chemical indicators are affixed to the outside and incorporated into the pack to monitor the temperature or time and
temperature.
• effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus
stearothermophilus
• flash sterilization is a modification of conventional steam sterilization (either gravity, prevacuum, or steam-flush pressure-
pulse) in which the flashed item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow
for rapid penetration of steam
• the longer a sterile item is exposed to air, the greater the number of microorganisms that will settle on it

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Low Temp Sterilization: Ethylene Oxide "Gas" Sterilization
• use of ETO evolved when few alternatives existed for sterilizing heat- and moisture-sensitive medical devices
• colorless gas that is flammable and explosive
• four essential parameters (operational ranges) are: gas concentration (450 to 1200 mg/l); temperature (37 to 63°C); relative
humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure time (1 to 6 hours)
• main disadvantages associated with ETO are the lengthy cycle time, the cost, and its potential hazards to patients and staff
• sterilization cycle consists of five stages
• preconditioning and humidification, gas introduction, exposure, evacuation, and air washes
• takes approximately 2 1/2 hrs excluding aeration time.
• mechanical aeration for 8 to 12 hours at 50 to 60°C allows desorption of the toxic ETO residual contained in exposed
absorbent materials
• most modern ETO sterilizers combine sterilization and aeration in the same chamber as a continuous process
• these ETO models minimize potential ETO exposure during door opening and load transfer to the aerator.
• there are no federal regulations for ETO sterilizer emission; however, many states have promulgated emission-control
regulations
• exposure can cause eye pain, sore throat, difficulty breathing and blurred vision, dizziness, nausea, headache, convulsions,
blisters and vomiting and coughing.
• ETO has been demonstrated to be carcinogenic, linked to spontaneous abortion, genetic damage, nerve damage, peripheral
paralysis, muscle weakness, and impaired thinking and memory
• Injuries (e.g., tissue burns) to patients have been associated with ETO residues in implants used in surgical procedures

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Low Temp Sterilization: peracetic acid
• automated machine using peracetic acid to sterilize medical, surgical, and dental instruments introduced in 1988
• Example: System 1E liquid sterilization
• the sterilant, 35% peracetic acid, and an anticorrosive agent are supplied in a single-dose container
• container is punctured at the time of use, immediately prior to closing the lid and initiating the cycle
• concentrated peracetic acid is diluted to 0.2% with filtered water (0.2 mm) at a temperature of approximately 50°C.
• diluted peracetic acid is circulated within the chamber of the machine and pumped through the channels of the endoscope for
12 minutes, decontaminating exterior surfaces, lumens, and accessories.
• interchangeable trays are available to permit the processing of up to three rigid endoscopes or one flexible endoscope
• connectors are available for most types of flexible endoscopes for the irrigation of all channels by directed flow
• rigid endoscopes are placed within a lidded container, and the sterilant fills the lumens either by immersion in the circulating
sterilant or by use of channel connectors to direct flow into the lumen(s)
• the peracetic acid is discarded via the sewer and the instrument rinsed four times with filtered water
• Possible concerns
• filtered water may be inadequate to maintain
• the system can only sterilize surfaces that can be contacted by the sterilant
− bronchoscopy-related infections occurred when bronchoscopes were processed using the wrong connector

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Low Temp Sterilization: Hydrogen Peroxide Gas Plasma
• new sterilization technology based on plasma was patented in 1987 and marketed in the United States in 1993
• materials and devices that cannot tolerate high temperatures and humidity, such as some plastics, electrical devices, and
corrosion-susceptible metal alloys, can be sterilized by hydrogen peroxide gas plasma
• gas plasmas have been referred to as the fourth state of matter (i.e., liquids, solids, gases, and gas plasmas)
• gas plasmas are generated in an enclosed chamber under deep vacuum using radio frequency or microwave energy to excite
the gas molecules and produce charged particles, many of which are in the form of free radicals
• free radicals within a plasma field are capable of interacting with essential cell components (e.g., enzymes, nucleic acids) and
thereby disrupt the metabolism of microorganisms
• sterilization chamber is evacuated and hydrogen peroxide solution is injected from a cassette and is vaporized in the
sterilization chamber to a concentration of 6 mg/l.
• hydrogen peroxide vapor diffuses through the chamber, exposes all surfaces of the load to the sterilant, and initiates the
inactivation of microorganisms
• an electrical field created by a radio frequency is applied to the chamber to create a gas plasma.
• excess gas is removed and in the final stage (i.e., vent) of the process the sterilization chamber is returned to atmospheric
pressure by introduction of high-efficiency filtered air.
• by-products of the cycle (e.g., water vapor, oxygen) are nontoxic and eliminate the need for aeration
• sterilized materials can be handled safely, either for immediate use or storage
• moisture on the objects will cancel the cycle because the vacuum will not be achieved the vacuum will not be achieved

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
11
 Instrument Life Time
• Instrument life -- Surface studies

Control
Adson Ganglion Scissors

0.5
mm

STEAM Sterilizer STERRAD Sterilizer

is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 30
510(k)Cycles
STERRAD VELOCITY™
30 Cycles clearance.
 • Instrument life -- Cutting edge
Control

Adson Ganglion Scissors

0.1
mm

STEAM Sterilizer STERRAD Sterilizer

STERRAD VELOCITY™ is pending 510(k) clearance.30 Cycle
Not available 30clearance.
for sale or distribution in the US. For training prior to 510(k) Cycles
 ASP
Mission & innovation

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 ASP Mission
To protect our patients during their most critical moments

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 ASP Innovation
Terminal Sterilization

Start Start

EXPRESS DUO
Cycle Cycle

STERRAD®
H2O2 Systems with
as Gas Plasma STERRAD® 200 STERRAD STERRAD® STERRAD® ALLClear®
Precursor STERRAD® 100 STERRAD® 50 GMP STERRAD NX® 100NX® EXPRESS Cycle DUO cycle Technology

1980s 1993 1994 1999 2002 2003 2005 2007 2008 2011 2013 2017 2019
High Level Disinfection

 1960s
CIDEX® patents

1970s
CIDEX® and ENZOL® CIDEX® OPA ADAPTASCOPE™ EVOTECH® ENDOCLENS- AEROFLEX™
CIDEXPLUS® Enzymatic Solution System + NSX™ AER AER with
market release Detergent CIDEX® OPA-C AUTOSURE™
MRC Monitor
+
AERO-OPA

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
16
 Gas Plasma Technology

1993 1999 2003 2005 2007 2016 2017

STERRAD® 100 System STERRAD® 50 System STERRAD® 200 System STERRAD NX® System STERRAD® 100NX System STERRAD® 100NX STERRAD NX®
with ALLClear® Technology with ALLClear ® Technology

Gas Plasma Technology

NX Technology

ALLClear® Technology

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
17
 Market Presence
Asp is the World Leader in Low Temperature Sterilization
INSTALLED BASE
> 20.000 installed systems worldwide
> 4.000 installed systems in Europe

IFU ENDORSEMENTS
> 24.000 Medical Device Manufacturer Endorsements

COMPLIANCE
• ISO Standards and EN Norms

INNOVATION
• Pre-conditioning cycle eliminating cycle cancellations
• Fully integrated sterilization ecosystem with seamless information sharing
• Fastest in the world BI readout, result in 30 minutes

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 18
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 STERRAD® History
Hydrogen peroxide (H2O2) is the simplest peroxide (a compound with an
oxygen-oxygen single bond) It is also a strong oxidant.

Hydrogen peroxide is a clear liquid slightly more viscous than water. In dilute
solution, it appears colorless.

Due to its oxidizing properties, hydrogen peroxide is often used as a bleach or

cleaning agent. The oxidizing capacity of hydrogen peroxide is so strong that it
is considered a highly reactive oxygen species.

PH: 2-4 (20°C)

Density: 1,11g/cm³

Melting Temperature: -58°C ( 1atm,59%)

Boiling point: 118°C (1atm,59%)

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 19
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 ASP Strategic Framework

Elevate Standard of Care

Make it safer for patients

Enhance Compliance
Make it simple so the job is done right,
every time….and provide proof

Drive Operational Efficiency

Make it predictable and on-time while
extending device life

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD basics
Hydrogen peroxide gas plasma

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
12533
 Flexibility – Updates Available ((NEW SLIDE)
3 Systems, 7 cycles to process a wide range of devices
As the expandable platform, STERRAD ® 100NX ® System has broadest processing capabilities of all STERRAD ®
System models

54 SHORT 28 STANDARD 24 EXPRESS

minutes
rigid devices minutes
rigid devices minutes
non-lumen devices
72 LONG 38 ADVANCED 42 FLEX
minutes minutes minutes
flexible scopes flexible scopes flexible scopes

47 STANDARD
minutes
rigid devices

60 DUO
minutes
flexible scopes

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
22
 Why are there so many STERRAD® Cycles?

For rigid lumened devices:

For rigid lumened devices: For rigid lumened devices:
• ≥ 1 mm and <2 mm ID x ≤ 125 mm length STD
STD • ≥ 1 mm ID x ≤ 150 mm length stainless steel • ≥ 0.7 mm ID x ≤ 500 mm length stainless steel
stainless steel
• ≥ 2 mm ID x ≤ 400 mm length stainless steel
• ≥ 2 mm and <3 mm ID x ≤ 250 mm length For flexible endoscopes:
stainless steel FLEX
For rigid lumened devices: • ≥ 1 mm ID x ≤ 850 mm length PTFE1 or PE2
• ≥ 3 mm inner diameter (ID) x ≤ 400 mm • ≥ 1 mm ID x ≤ 500 mm length stainless steel
length stainless steel ADV For flexible endoscopes:
For flexible endoscopes: DUO
• ≥ 1 mm ID x 850 mm PTFE1 or PE2 • ≥ 1 mm ID x ≤ 875 mm length PTFE1 or PE2
N/A (no lumened devices, surface sterilization
EXP
only)

Diffusion-restricted Spaces = Greatest Challenge for H2O 2 Sterilization

Each STERRAD® Cycle has optimized parameters for specific “lumen claims”

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
Data Sources: STERRAD® 100S Sterilization System User’s Guide; STERRAD NX® Sterilization System User’s Guide; STERRAD® 100NX Sterilization System User’s Guide 23
 STERRAD 100S
Hydrogen peroxide gas plasma

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
12533
 STERRAD® 100S® – the beginning
Proven performance for cost-effective sterilization
New look in 2010
54-minute and 72-minute cycle
• Most general surgical instruments
• Flexible scopes with use of boosters
• Cameras, light cables, batteries, micro surgical
• Ease of use: one-button operation

Value proposition:
Customer’s cost-effective choice for dry, low- temperature sterilization

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 25
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 Changing the cassette collection box

• Follow the display panel prompts

• Must use gloves
• Remove filled box and close it.
Seal ends with tape.
• Know the location of new boxes
• Assemble correctly -Fold down lids
and insert it into sterilizer.
Ensure the instructions face
the door - Close side panel
door.
• Refer to Routine Maintenance in
User’s Guide

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD® 100S® diagram

SHORT Cycle = 54min.

LONG Cycle = 72min.

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 27
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 STERRAD® 100S Sterilization System Cassette
Collection Box Placement

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Maintaining Vaporizer dish (100S & 50)

• Always wear gloves when handling vapour plate

• Replace vapour plate with new one every 30 days or 145
cycles

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Replacing the printer ribbon rolls or
cartridge (STERRAD® 100S, 50 & 200)

• Change printer cartridge when ink on printout starts to fade

• Refer to chapter 5 of User’s Guide for instructions specific
to your STERRAD model

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 • Replace paper when red ‘tram tracks’ appear

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD 100NX / 100NX ALL CLEAR
Hydrogen peroxide gas plasma

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
12533
 STERRAD® 100NX® System
The most advanced performer
Designed to enhance the features and capabilities of the STERRAD® 100S
NX® technology in a larger system
Four cycle options for productivity

• Standard: 47 minutes for most general surgical instruments

• Flex: 42 minutes for single-channel flexible scopes
• Express: 24 minutes for da Vinci* endoscopes, rigid telescopes, rechargeable
batteries and general metal medical devices without lumens - Surface sterilization
• DUO: 60 minute for compatible Olympus scopes

Advanced features for ease of use and quality control

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 33
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 100S Vs. 100NX

Upgradable Full color touch Network

Cycle history
platform screen Capability

Easy load thermal UV Sensor Higher

Ergonomic design
paper Concentration

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 UV Sensor for H2O2 Concentration

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 100NX Technology

– Vaporization system concentrates hydrogen peroxide by removing most of

the water
– Increased ability to penetrate lumens, including single-channel flexible
endoscopes and other difficult to sterilize locations
– Overall sterilization cycle times are reduced

H2O2 H2 O H2O2 H2 O H2O2 H2O2

H2O2 H2O2
H2O2 H2O2
H2O2
H2O2 H2O2
H2 O H2O2
H2 O
H2 O
H2 O
H2O2 H2O2

H2O2 H2O2 H2O2 H2O2

H2O2 H2O2
H2 O
H2 O H2 O
H2 O H2O2 H2O2
H2O2 H2O2

100S: LONG and SHORT Cycle 100NX: STANDARD and

100NX: DUO and EXPRESS Cycle FLEX Cycle

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Replacing STERRAD® 100NX Printer Paper

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Analysis Report

History Search

Manuel
Operation

Auto Backup

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
42
 STERRAD System Sterilization Process
• Warms Instrument Loads to Minimize Cancelled Cycles
• Moisture Detection & Correction of Load Issues
• A vacuum is created inside the chamber
• Hydrogen peroxide sterilant is injected into the chamber and allowed to
surround and interact with devices to be sterilized
• Applying a strong electrical field creates plasma
• Plasma breaks down the peroxide into a “cloud” of highly energized
particles
• The primary purpose of plasma is to efficiently eliminate residual
hydrogen peroxide

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD 100NX: Instrumentation

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD: Instrument processing guidelines

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD NX / NX ALL CLEAR
Hydrogen peroxide gas plasma

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
12533
 STERRAD® NX® System
A Sterilizer for all your department’s needs
NX® technology
Compact and mobile
28-minute and 38-minute cycle
• Most general surgical instruments
• Single channel flexible scopes (no boosters)

Value proposition:
Fast, safe terminal sterilization of packaged instruments at points of use*

* When local regulations allow placement of sterilizer outside of CSSD

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 47
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 1. Touch Screen

2. Advanced & Standard cycle

3. Advanced cycle; 38 minutes

 Lumens Device
 One Flex Endoscopy
per cycle

4. Standard cycle; 28 minutes

 Non-Lumens

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD® NX® Cycle

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 50
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 Plasma
STERRAD Technology

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
12533
 What is Plasma?
Plasma is the 4th State of Matter .
SOLID

Energy = LIQUID

Energy =
GAS

Energy = PLASMA
(RF or LFPS II)

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 The Plasma — the 4th stage of the matter

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance. 53
THE NEW RHYTHM OF REPROCESSING • CONFIDENTIAL • FOR INTERNATIONAL USE ONLY • NOT FOR DISTRIBUTION OR DISSEMINATION
 What is Gas Plasma?
Gas plasmas are highly ionized gases, composed of ions, electrons and neutral
particles, that produce a visible glow

Plasma is often called “the fourth state of matter,” along with solid, liquid and gas. Just as a
liquid will boil, changing into a gas when energy is added, heating a gas will form a plasma
– a soup of positively charged particles (ions) and negatively charged particles (electrons).

Plasma consists of a collection of free moving electrons and ions - atoms that have lost electrons. Energy is
needed to strip electrons from atoms to make plasma. The energy can be of various origins: thermal, electrical, or
light (ultraviolet light or intense visible light from a laser). With insufficient sustaining power, plasmas recombine
into neutral gas.Plasma can be accelerated and steered by electric and magnetic fields, which allows it to be
controlled and applied.

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 How is Plasma Created?
• An electrical field created by a radio frequency is applied to the chamber to create a gas plasma.

• Plasma is created when energy is applied to a gas with enough force to strip electrons from atoms
- In STERRAD, An electrical field created by a radio frequency is applied to the chamber of hydrogen peroxide gas to create a gas plasma
• The resulting mixture of free radicals, ultraviolet light, and positive and negatively charged particles is known as plasma

Plasma TV Neon Lights

Aurora Borealis

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 How Long Does Plasma Last?
• Plasma and free radicals exist only while the electrode is turned on
• When the electrode is turned off, free radicals recombine to form water vapor and oxygen
• No toxic residual, converter or special ventilation is required

The divided hydrogen

peroxide (H2O2)….

…Recombine to simple water

(H2O) and oxygen (O2)

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Why is plasma beneficial??
The benefit of low-temperature gas plasma sterilization is that it has the ability to efficiently eliminate residual hydrogen
peroxide from materials and devices
−No toxic residue on instruments
−Safe for patients

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Low Frequency Plasma System in STERRAD Systems
Inside the chamber, surrounding the shelves is a metal screen (the electrode) that helps generate plasma during operation.

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
Shintani et al. (2010). Gas Plasma Sterilization of Microorganisms and Mechanisms of Action (Review). Experimental and Therapeutic Medicine, 1, 731-738. 58
 STERRAD: Inside the chamber

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
12533
 Points to Consider Prior to Processing
• Implants
• Cellulosic (paper, towels, foam, gauze)
• 510(k) cleared closed rigid containers
• Liquids and Powders

• Lumen considerations
−Size/length
−Dead end

• Flexible scopes
−Single channel
−1 flexible scope (ADVANCED Cycle) /2 independently wrapped flexible scopes (FLEX Cycle)
−DUO cycle for flexible scopes
−Placement of vent cap prior to processing

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 What happens when you press start in the STERRAD with ALLClear System?

H2O2 is delivered to the vaporizer/condenser and

• Plasma and free radicals exist only while the evacuation begins
electrode is turned on

Pressure is reduced and H2O is removed from the H2O2

• When the electrode is turned off, free radicals
solution
recombine to form water vapor and oxygen

Pressure is further reduced and the H2O2 is transferred into

• No toxic residual, converter or special ventilation is
the chamber
required

Diffusion throughout the chamber

Energy is applied creating a Plasma

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Hydrogen Peroxide (H2O2)
STERRAD® System Killing Mechanism
Hydrogen Peroxide: a strong oxidizing agent is used to kill microorganisms
via the hydroxyl free radical. The hydroxyl free radical, being highly reactive,
attacks membrane lipids, DNA, and other essential cell components, resulting
in microbial death.

Geobacillus stearothermophilus
spores are highly resistant to
the STERRAD® Sterilization
Process and are used for cycle
development and validation
Shintani et al. (2010). Gas Plasma Sterilization of Microorganisms and Mechanisms of Action
(Review). Experimental and Therapeutic Medicine, 1, 731-738. TEM image of cross section of G. stearothermophilus spore
Linley et al. (2012). Use of hydrogen peroxide as a biocide: new consideration of its mechanisms of biocidal Photograph by Comm Tech Lab and the Center for Microbial Ecology at Michigan State University.
action

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
62
 Peroxide Concentration
The STERRAD NX® Systems and Illustrative Only
STERRAD® 100NX Systems have the
capability to remove water from the
hydrogen peroxide solution to enhance
efficacy.

Why?
 Allows for processing of longer-
lumened devices without the use of a
booster. Typical STERRAD® Vapor Mixture after
 Allows for reduced cycle times. Vapor Mixture Concentration

The concentration process does not add more

peroxide to the chamber but does remove water.

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
63
 Peroxide Concentration
Transition Valve Trim Valve Peroxide Monitor
Vent valve

Press.
Transducer
Press.
Transducer Pump

Chamber
Orifice

Cassette Vacuum Valve

Condenser

Vaporizer

1) 59% H2O2 delivered from the cassette and vaporized

2) 59% H2O2 concentrated to 90% and water removed from the condenser
3) 90% H2O2 vaporized from the condenser and delivered to the chamber
4) Sterilization cycle proceeds to completion

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
64
 Diffusion of Water and Peroxide into Lumens
Example of an open-ended lumen:

Note: this figure is

illustrative, not
necessarily reflective
of actual H2O:H2O2
Lumen ratios or distributions
BI

H2O H2O2

The inside of a lumen is an example of a diffusion restricted space.

Sterilization efficacy is tested with a biological indicator (BI) at the midpoint of an open-
ended lumen for testing worst-case lumen claims.

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
65
 ALLClear Technology
Optional Process that occurs prior to the sterilization cycle being initiated
Moisture detection &
Instrument warming System checks
removal

Plasma removes
Excess moisture and gases moisture and warms
automatically detected instruments

Automatic pre-cycle system diagnostics and load conditioning designed to reduce cycle cancelations

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
66
 Drying Devices Prior to Placing in the STERRAD® with ALLClear® System
What’s the importance of having instruments dry before processing?

•While ALLClear aids in detecting moisture ...

•Instrumentation processed in the STERRAD  NX  System must be dry

•Options for drying include:

−Towel drying
−Medical grade compressed air
−Drying cabinet

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 STERRAD® System Monitoring and Cancellations

−STERRAD® Systems measure multiple parameters, such as pressure,

peroxide concentration (NX/100NX) and temperature to ensure that the cycle is
being executed correctly
These parameters will vary –within validated cancellation limits– between systems and cycles
depending on the types of loads being run, load temperature, moisture, etc.

−As long as the system is operating within the cancellation limits, and with
compatible loads, it is achieving sterility (SAL<10-6)

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
68
 Sterility Assurance Level (SAL) & Overkill Method
Sterility Assurance Level (SAL) is defined as:
Microbiological Inactivation Kinetics
Probability of a single viable microorganism (Log-Linear Scale)
occurring on an item after sterilization. 106

Number of surviving
microorganisms
105
[Definition from ISO 11139:2018] 104
103
102
101
Cycle Phase I
100
10-1

Probability of surviving
SAL is normally expressed as 10-x. SAL of 10-6 10-2

microorganisms
10-3
is most often used for sterile devices. 10-4
10-5
10-6
Cycle Phase II

Time or Dose

Adapted from ISO 11138-7:2019 Annex A

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
69
 Biological Models
These lumen claims are then used to develop a proprietary Biological Model,
which is unique for each cycle
•Ex. A series of the longest claimed lumens, inoculated with > 1 million Geobacillus spores in the
hardest to reach locations, tested under “worst-case” conditions for sterilization:
Heaviest chamber loading
Low chamber/vaporizer temperatures
Low peroxide concentration

Simulates the “worst-case” load, processed under “worst-case” conditions

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
70
 Medical Device Manufacturer Program

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Sterility Assurance- MDM Program
Best-in-Class MDM Partnership:

• Broad range of MDM IFU endorsements from many key

device manufacturers

• 100% of device listings on STERRAD® Sterility Guide

supported by MDM documentation

• ASP runs 10,000+ cycles annually to support MDM

validations

• Devices are verified for device compatibility and

functionality

• ASP MDM Program follows ISO and AAMI guidelines

• MDM is responsible for verifying functional compatibility

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Validation Testing
Partial list of studies:

Efficacy Testing Compatibility Testing

In-Use Test • H2O2 Residuals
Simulated Use Test • Device / Material Compatibility
Surface Sterilization • Biocompatibility
Mated Surfaces Test
Lumen Test
Half-Cycle / Endpoint Validation
AOAC Sporicidal Test

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
page
73
 Differentiators

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 ASP Strategic Framework, STERRAD® F&Bs

• Direct H2O2 measurement

Elevate Standard of Care • UV lamp • X67 lower H2O2 emissions compared to
Make it safer for patients • Gas plasma V-PRO
• Greater margin of safety / efficacy

Enhance Compliance • Integrated quality control features • Enhance compliance of technicians

Make it simple so the job is done right, • SSG database • Ensure critical instruments are endorsed
every time….and provide proof • ASP ACCESS / ecosystem by MDMs
• Making data audit ready

• ALLClear Technology • Minimize load issues prior to

Drive Operational Efficiency
Make it predictable and on-time while • 23,000 MDM endorsements sterilization
extending device life • Upgradable platform • Industry leading device compatibility
with STERRAD
• Future proof existing system for system
enhancements via SW upgrades

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Supporting Marketing Collateral

H2O2 Emissions
Elevate Standard of Care

Rutala Sell Sheet

Make it safer for patients

Sanford ecosystem

ALLClear Overall
Enhance Compliance

ALLClear Tech
ACCESS

Dossier
Make it simple so the job is done right,
every time….and provide proof

Drive Operational Efficiency

Upgrade
SSG

Make it predictable and on-time while

extending device life

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.
 Thank you!
Q&A

STERRAD VELOCITY™ is pending 510(k) clearance. Not available for sale or distribution in the US. For training prior to 510(k) clearance.