S5505C_STERRAD-NX.pdf

Installation Requirements and Product Specifications

Model The STERRAD® NX® System is an advanced hydrogen peroxide gas plasma system that offers fast terminal sterilization with a standard 28-minute cycle time and an advanced 38-minute cycle time.* The system can sterilize a wide range of instruments, including single-channel flexible endoscopes, semi-rigid ureteroscopes, power drills, batteries, cameras, light cords, rigid scopes, general surgical instruments, and more. The system provides the flexibility of having dry, packaged, sterile instruments ready when needed. The STERRAD® NX® System offers several unique features, including network connectivity, a diagnostics program, and an easy-to-read touch screen. Its compact size and simple plug-in make it ideal for placement in a variety of locations such as OR Substerile Rooms, OR Surgical Cores, Ambulatory Surgery Centers, Sterile Processing Departments and Specialty Departments, (e.g., Urology). Only the STERRAD® NX® System provides all of this, enabling healthcare facilities to handle more caseloads, without delays, to keep the OR on schedule.

Voltage/ Frequency/Power

Hydrogen Peroxide gas PlasMa Process serVice requireMents

* Standard 28-minute cycle time for most surgical instruments, with an advanced 38-minute cycle time for single-channel flexible endoscopes. For more detailed instrument processing information, please refer to the "What Can I Sterilize In The STERRAD® NX® System."

† Please refer to the STERRAD® NX® System User's Guide for more detailed processing instructions.

S T E R R A D® N X® S T E R I l I z A T I O N S y S T E m

In operation, the STERRAD® NX® System should not be placed closer than 1 inch (25 mm) to a wall at the rear. The sterilizer should be installed in a space of sufficient size to permit access to all four sides of the system. Service access requires a minimum clearance of 24 inches (61 cm) above the top and 24 inches (61 cm) to the right of the system. The power receptacle should be positioned 12 inches to 24 inches (30.5 cm to 61 cm) above the floor.

The STERRAD® NX® System requires a single-phase dedicated circuit with dedicated hot and neutral wires, a NEmA 5-20 receptacle with a 20-amp circuit.

Wire gauge to be of sufficient size to maintain 108-132 VAC with the following load conditions: 16 amps – continuous current and 40 amps – momentary current.

The STERRAD® NX® Sterilizer has a vacuum pump which will cause the sterilizer to draw up to 40 amps of current for 1 to 2 seconds when the pump starts. If the wire gauge is too small, when the vacuum pump starts the line voltage at the outlet will drop to a level which can cause the sterilizer to reboot. Have the electrician use a voltage drop calculator to ensure the line voltage at the outlet does not drop below 108 Volts AC during the 1 to 2 seconds of 40 amps current draw.

The STERRAD® NX® System involves the combined use of hydrogen peroxide and low-temperature gas plasma to safely and rapidly sterilize medical devices and materials without leaving any toxic residues.

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 that produce a visible glow. A solution of hydrogen peroxide and water (59% nominal peroxide by weight) is delivered to the sterilizer, concentrated to approximately 90%, 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.

ImPORTANT DETAIl wHere Marketed Worldwide

Fda clearance yes liquid cHeMical agent Hydrogen Peroxide (59% nominal weight) agent deliVery systeM Cassette ionized sPecies Hydrogen Peroxide total cycle tiMe Standard Cycle: 28 minutes Advanced Cycle: 38 minutes

PriMary ByProducts Water Vapor and Oxygen

Biological indicators Self-Contained Biological Indicator. Incubate for time specified on the STERRAD® CyClESURE® 24 Biological Indicator IFU.

cHeMical indicators Chemical indicator tapes, strips & peel pouches tyPes oF PoucHes/wraPs Tyvek®/ mylar Pouches and Polypropylene CSR Wrap teMPerature range °c < 55°C aPProVed deVices metal, non-metal, heat- and moisture-sensitive instruments, single-channel flexible endoscopes (see User’s Guide) cHaMBer

Shape Rectangular

Dimensions (HxWxD) 6.2 in x 12.6 in x 23.6 in (15.7 cm x 32 cm x 60 cm)

Usable Volume 30 liters

Two-Tiered Shelf 12.3 in x 23.6 in (31.2 cm x 60 cm) installation ASP recommends mounting the STERRAD® NX® System on the specially designed cart, product code 10300. ASP will not install on any other cart. The STERRAD® NX® System may be mounted on a countertop meeting the specifications on page 4.

Required Countertop Space 57 in x 48.4 in x 34 in (145 cm x 123 cm x 85 cm)

Required Cart-mounted Space 63 in x 32 in x 70 in (160 cm x 81.3 cm x 177.8 cm)

Venting Requirements None required

Gas Tank Requirements None required

Electrical Requirements 8.2 ft./2.5m power cord (included)

Weight 275 lbs. (125 kg)

Weight with cart 411 lbs. (187 kg)

Ethernet Port (optional) Should be located near STERRAD® NX® Systems that will be connected to servers or networks.

electrical oPeration (Also see voltage/frequency/power on previous page)

Requirements 108-132 VAC 20A dedicated NEmA 5-20 receptacle to supply 16A continuous and 40A momentary current. Sharing current-carrying conductors (hot and/or neutral) is not allowed. Please see voltage/ frequency/power section on previous page for additional requirements regarding the size of wire supplying the dedicated outlet.

enVironMental conditions

Air Exchanges minimum 10/hour

Altitude up to 10,000 ft. (3048 m)

Ambient Temperature 64°F to 95°F (18°C to 35°C)

Heat Generation 1366 BTU / Hour

Relative Humidity 10% to 85% up to 86°F ambient and linearly decreasing from 85% at 86°F to 70% at 95°F.

warranty

Term 1 year parts and labor

Tyvek® is a registered trademark of DuPont Corporation.

S y S T E m I N F O R m A T I O N

S P A C E P l A N N I N G I N F O R m A T I O N

ImPORTANT DETAIl

33 Technology Drive, Irvine, California 92618 1-888-783-7723 www.aspjj.com© Ethicon, Inc. 2012. All rights reserved. AD-53417-01-US_F

Front View Right Side View cart-Mounted

Top View Front View

28”

9.61”

23” MIN

1“ MIN

8.5”

2.4” MIN

(22”) 24” MIN

BACK WALL

COUNTER TOP/TABLE

SERVICE ACCESS AREA

SI

D

E W

A

LL

SI

D

E W

37.37” MIN

USER OPERATING AREA

(KEEP CLEAR)

24” MIN 8.5” MIN

SI

D

E W

OVERHEAD CLEARANCE

COUNTERTOP/TABLE

SURFACE

34” MAX

countertoP shown with recommended cart, product code 10300.

I N S T A l l A T I O N D I A G R A m