S5505B_STERRAD-100S.pdf

Division of Ethicon, Inc.

33 Technology Drive Irvine, California 92618

1-888-STERRAD

www.sterrad.com© ASP 2004 AD-52363 Rev. A

U.S. Version

40 in (101.6 cm)

30.3 in (77 cm)

11.8 in (30 cm)

65.4 in (166 cm)

LINE CORD: 14 AWG

118 in (300 cm) LONG

SIDE FLOOR LEVEL FRONT

STERRAD® 100S Sterilization System Installation Diagram

40 in (101.5 cm)

30.3 in (77 cm)

39.4 in (100 cm)

ALL AROUND

FRONT

PLAN

STERRAD® 100S Sterilization System Installation Requirements and Product Specifications

Division of Ethicon, Inc.

Voltage/Frequency/ Power

Service Requirements

Model

STERRAD® 100S Sterilization System

The STERRAD® 100S System is a multi-purpose sterilizer intended for use in the sterile processing departments and ORs of hospitals and other medical facilities. The system employs the proprietary STERRAD Technology, a hydrogen peroxide gas plasma process to achieve at least a 10-6 Sterility Assurance Level in a 55-minute cycle. Various types of medical instruments and equipment can be sterilized in the system, with the exception of liquids, cellulosic materials (paper, linen, cotton, etc.), and medical instruments with restrictive labeling. The STERRAD 100S System is designed to be freestanding and self-contained, with no required connections other than an electrical power cord. It is also equipped with wheels, permitting it to be easily rolled from one location to another. In addition, the system has adjustable feet at the front of the unit to enable leveling, if required.

Hydrogen peroxide is an oxidizing agent that affects sterilization by oxidation of key cellular components.

Plasma is a state of matter distinguishable from a solid, liquid, or gas. Gas plasmas are highly ionized gases composed of ions, electrons and neutral particles. The cloud of plasma is composed of ions, electrons and neutral atomic particles that produce a visible glow.

A solution of hydrogen peroxide and water (59% nominal peroxide by weight) is vaporized and allowed to surround and interact with the devices to be sterilized.

Hydrogen peroxide is a bactericidal, virucidal, sporicidal and fungicidal agent, even at low concentration and temperature. Applying a strong electrical field then creates plasma. The plasma breaks down the peroxide into a “cloud” of highly energized species that recombine, turning the hydrogen peroxide into water and oxygen.

STERRAD® 100S System employs 208 VAC, 60 Hz power and requires a NEMA L 21-20 five wire grounding twist lock outlet attached to a dedicated 20 amp, 3 phase 208VAC circuit with separate neutral and ground conductors. The sterilizer requires a CBA phase rotation. The correct phase rotation must be present at installation.

In operation, the STERRAD® 100S System should not be placed closer than 2 inches (5 cm) to a wall at the rear and/or sides of the system. The sterilizer should be installed in a space of sufficient size to permit access to all four sides of the system when it is rolled from the rear and/or side walls a distance of 10 feet (3 meters), the extent of the power cord. Service access requires a minimum clearance of 3 feet (1 meter) on all sides of the system. The power receptacle should be positioned 12 inches to 24 inches (30.5 cm to 61 cm) above the floor.

Hydrogen Peroxide Gas Plasma Process

Where Marketed Worldwide FDA Clearance Yes

CE Mark Yes

Liquid Chemical Agent Hydrogen Peroxide (59% nominal by weight)

Agent Delivery System Cassette

Ionized Species Hydrogen Peroxide

Total Cycle Time 55 Minutes

Primary By-Products Water Vapor and Oxygen

Biological Indicators Self-contained Biological Indicator with 48-hour readout.

Chemical Indicators Chemical indicator tapes, strips & peel pouches.

Types of Pouches/Wraps Tyvek®/MYLAR Pouches and Polypropylene CSR Wrap

Temperature Range oC <55o C

Approved Devices Metal, non-metal, heat- and moisture-sensitive instruments.

(see User’s Guide)

Space Planning Information

System Information

Input/Output

Display LCD display Hard Copy Printer Control Interface Dedicated controls, touch panel Alarms Audible, Visual

Chamber

Shape Circular Dimensions (HxWxD) 20 in x 20 in x 32 in

(51.0 cm x 51.0 cm x 81.3 cm) Usable Volume 100 liters, 3.5 cu. ft.

Shelves Removable top shelf, fixed bottom shelf Shelf Dimensions Top: 28 in x 17 in (70 cm x 42.5 cm)

Bottom: 30 in x 13 in (76 cm x 33 cm)

Installation

Space Requirements 78 in x 34 in x 42 in (HxWxD) (166.4 cm x 86.4 cm x 106.7 cm) Mobility Movable Venting Requirements None required Gas Tank Requirements None required Electrical Requirements 3 m/10 ft. power cord Weight 349.3 kg/770 lbs.

Electrical Operation

Also see Voltage/Frequency/ 208 VAC, 60 Hz 3 phase WYE, 20 amps NEMA L21-20 receptacle, CBA phase rotation Power on previous page

Environmental Conditions

Air Exchanges Minimum 10/hour Altitude -100 m to 3000 m msl (-330 ft. to 10,000 ft. msl) Ambient Temperature 10o C to 40o C (50o F to 104o F) Heat Generation 1919 BTU/Cycle Relative Humidity 0% to 95%, noncondensing

Warranty

Term 1 year parts and labor Repairs/Service Manufacturer Service Network Regional with regional supply depots Response Time 24 hours 7 days/week, 365 days/year

Tyvek® is a registered trademark of DuPont Corporation.