S5505A_STERRAD-100NX.pdf
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- Attached to
- Y1DA--Project No. 580-17-121 Upgrade/Renovate/Relocate Sterile Processing Services (SPS)
- Solicitation number
- 36C25621R0014
About this file
This document provides product specifications for the STERRAD 100NX Sterilization System with ALLClear Technology. Key details include that the system uses hydrogen peroxide gas plasma sterilization in standard, flex, express, and duo cycles ranging from 24 to 60 minutes. It has a single or double door configuration, touchscreen control interface, and connectivity options. Installation, space, and environmental requirements are specified. Related federal contract opportunity 36C25621R0014 seeks proposals to upgrade, renovate, and relocate approximately 16,500 square feet of sterile processing services at the Michael E. DeBakey Veterans Affairs Medical Center, including adherence to latest standards and performance without medical center operations disruption.
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THE STERRAD® 100NX SYSTEM
with ALLClear™ Technology
Productive
Reduces workflow interruptions
Connected
Enhances compliance, automatically*
Easy
Designed with simplicity in mind to reduce the potential for human error
*STERRAD® Systems with ALLClear™ Technology have features that may enhance compliance, including greater adherence to device IFUs and improved record handling.
JUST LOAD AND GO
Cycle temperature 47°C-56°C
Sterilant Hydrogen peroxide
Sterilant delivery Delivered in closed system in cassettes with automatic detection of expiration date:
Standard/Express/Flex: 10.8 mL per cycle (double kill) (2 ampules, each ampule is 5.4 mL) Duo: 3.1 mL per cycle
Used cassette disposal Automatic and touchless ejection into cassette disposal container
Peroxide residual breakdown
Gas plasma technology breaks down H2O2 to safe elements of water and oxygen
Configurations Single and double doors
System dimensions (maximum)
Height: 1800 mm Width: 775 mm Depth: single door: 1055 mm; double door: 1095 mm
Chamber total volume 152 L
Chamber dimensions Height: 410 mm Width: 510 mm Depth: 735 mm
Chamber shape Rectangular
Shelf info Two-tiered shelf: Width: 444 mm Depth: 643 mm
Mobility 4 casters (2 locking)
System weight 1 door: 382 kg 2 door: 408 kg
User interface Touchscreen technology: projected capacitive touch Resolution: 800 x 600 pixels
Supported USB devices
• Barcode reader • External drives: USB that allows data upload and download
• External printer connection (PCL3 compatible or equivalent)
Standards/Compliance ISO 14937
TECHNICAL SPECIFICATIONS
Cycles Standard: sterilizes most general surgical instruments Flex: sterilizes up to 2 single-channel flexible endoscopes Express: sterilizes da Vinci® 3-D endoscopes and other delicate instruments without lumens Duo: sterilizes cameras and up to 2 single-channel flexible endoscopes
Time Standard: 47 minutes Flex: 42 minutes Express: 24 minutes Duo: 60 minutes
Lumen claims Standard: diameter: ≥0.7 mm; length: ≤500 mm Flex: diameter: ≥1 mm; length: ≤850 mm Express: nonlumen sterilization only Duo: diameter: ≥1 mm; length: ≤875 mm
CYCLE SPECIFICATIONS*
Sterilization process Terminal-sterilization, double-kill cycle to provide a Sterility Assurance Level (SAL) of 10-6; 2 injections and identical plasma phases
Delivered sterilant concentration
58%-59.6%
Sterilization cycle monitoring
Critical system parameters monitored with on-board sensors, biological indicators, and chemical indicators; IMS (independent monitoring system) available
H2O2 concentration continuous monitoring
Monitoring using UV sensor within the chamber
STERILIZATION SPECIFICATIONS
FOR MORE INFORMATION
Visit www.emea.aspjj.com or contact your local ASP representative
*Always refer to the STERRAD® Sterility Guide (www.sterradsterilityguide.com) for the latest updates on instruments’ validations and cycles and systems’ compatibility.
2 x 1080 [42.5]
2 x 1000 [39.4]
[30.4]
110º 2 x 1080
[42.5]
2 x 1000 [39.4]
[30.4]
110º
[30.4]
[39.4]
[30.4]
LIMIT TO
90º
SPACE PLANNING DIMENSIONS
TOP VIEWS
ONE-DOOR CONFIGURATION
TOP VIEW
TWO-DOOR CONFIGURATION
Legend
Millimeters
[Inches]
[41.5]
[30.5] 25
[1.0]
[70.9]
[43.1]
STERILIZER
FOOTPRINT
[39.4]
1084 MAX.
[42.7]
[39.4]
[39.4]
[39.4]
865.0 +/- 6.4 [34.1 +/- 0.25]
1842 +/- 6.4 [72.5 +/- 0.25]
STERILIZER
[69.9]
STERILIZER
FOOTPRINT
[39.4]
1084 MAX.
[42.7]
[39.4]
[39.4]
[39.4]
865.0 +/- 6.4 [34.1 +/- 0.25]
1842 +/- 6.4 [72.5 +/- 0.25]
STERILIZER
[69.9]
LEFT SIDE
SYSTEM LAYOUT
TWO-DOOR CONFIGURATION
For recessed system, clearance should be ~1.8” on each side:
(865-775)/2 = 45 mm (~1.8”)
LEFT SIDE INPUT SIDE
SYSTEM LAYOUT
ONE-DOOR CONFIGURATION
Clearance on each side of the system should be ~39.4”
SYSTEM DIMENSIONS
WALL OPENING
IN-WALL INSTALLATION
INPUT OR OUTPUT SIDE
SERVICE CLEARANCE
CODE PRODUCT DESCRIPTION
10104-005 STERRAD® 100NX Sterilization System with ALLClear™ Technology, single-door unit, STANDARD & FLEX cycles, includes installation
10104-006 STERRAD® 100NX Sterilization System with ALLClear™ Technology, double-door unit, STANDARD & FLEX cycles, includes installation
10104-007 STERRAD® 100NX Sterilization System with ALLClear™ Technology, single-door unit, STANDARD, FLEX and DUO cycles, includes installation
10104-008 STERRAD® 100NX Sterilization System with ALLClear™ Technology, double-door unit, STANDARD, FLEX and DUO cycles, includes installation
10144 STERRAD® 100NX System Cassette (2 cassettes/case)
20227 Cassette Disposal Box (10 boxes/case)
10135 STERRAD® 100NX System EXPRESS Cycle Kit
10137 STERRAD® 100NX System DUO Cycle Kit
10305 Thermal Printer Paper (12 rolls/case)
113617-01 STERRAD® Systems Bar Code Scanner Kit
SYSTEM ORDERING INFORMATION
Heat generation Idle: 4574 BTU/hour Maximum: 6187 BTU/hour
Electrical power specifications
• US/Canada: 208 VAC, 60 Hz, NEMA L21-30 5-wire grounding twist-lock outlet attached to a dedicated 30-amp, 3-phase wye configuration circuit with separate neutral and ground conductors
• International: 380-415 VAC, 50/60 Hz, 5-wire grounding outlet attached to a dedicated 30-amp, 3-phase wye configuration circuit with separate neutral and ground conductors
• Japan: 200 VAC, 50/60 Hz: 4-wire grounding outlet attached to a dedicated 30-amp, 3-phase delta configuration with separate ground conductors
Installation space requirements
In operation, the STERRAD® 100NX System with ALLClear™ Technology should not be placed closer than 50.8 mm from the rear wall. The power receptacle should be positioned 30.5 to 61 cm above the floor. For recessed systems, a clearance of 25 mm from the top of the system and 45 mm on each side of the system is required.
Service space requirements
Service access requires a minimum clearance of 610 mm above the top and approximately 991 mm in on all sides of the system (can be less if the system can be moved for servicing).
System performance data and reports
Cycle history, full 1-second data files, and reports available via ASP ACCESS™ Technology
Network connectivity Communication protocol for Instrument Tracking Systems (ITS) available via ASP ACCESS™ Technology
Data recording • Electronic data storage up to 200 cycles • Internal printer for manual recordkeeping
• Full electronic cycle data and reports via ASP ACCESS™ Technology
Temperature 18°C-35°C
Humidity 10%-85% RH (noncondensing)
INSTALLATION AND ELECTRICAL REQUIREMENTS
NETWORKING AND DATA RECORDING
OPERATIONAL ENVIRONMENT
STERRAD® is a registered trademark of Advanced Sterilization Products, division of Cilag GmbH International, a Johnson & Johnson company.
STERRAD ALLClear™ and ASP ACCESS™ are trademarks of Advanced Sterilization Products, division of Cilag GmbH International, a Johnson & Johnson company.
Advanced Sterilization Products, Gubelstrasse 34, 6300 Zug www.emea.aspjj.com
© All rights reserved. 2017 AD-160028-01-CT_B
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