ASP Sterrad 100S Sterilizer System

The Sterrad 100S System offers a rapid 55-minute cycle time
to deliver increased instrument utilization and measurable cost efficiencies.
Using ASP’s proven gas plasma technology,
the STERRAD 100S System provides dry, low-temperature sterilization
of both heat-stable and heat- and moisture-sensitive instruments
in a single system—allowing you to have critical instruments available when you need them.
The STERRAD 100S System not only increases productivity and capacity,
but also eliminates the costs associated with resterilization, ventilation,
and instrument repair, thereby turning speed into money.

Fast turnaround means increased instrument utilization.
Rapid 55-minute cycle time facilitates processing of 14 loads of critical
and noncritical medical devices in the time it takes to complete one cycle of EtO.
Safety features protect both users and the environment.
Process by-products are water and oxygen, eliminating the need for aeration or ventilation.
Hydrogen peroxide residuals are nontoxic and noncarcinogenic.
Multiple cost efficiencies enhance overall cost-effectiveness.
Processed instruments can be inventoried or used immediately, enabling greater utilization of product inventory.
Gentle system prolongs the useful life of instruments, minimizing damage
and reducing costly instrument repair.
Maximized instrument use reduces expensive inventories and eliminates the need
for outsourcing.
Quick installation reduces costs further still.
System installation requires nothing more than a dedicated 3 phase 208V outlet.
No costly plumbing, ventilation, or monitors are required.
button operation increases user productivity.
Simplified cycle start requires just one button.
User-friendly display indicates cycle stage and elapsed time.
Minimized training requirements enhance ease-of-use.

Indications for Use

The following text briefly describes the materials and devices that can be sterilized
by the Sterrad 100S Sterilizer. It also provides information on how to prepare items
for sterilization. The Sterrad 100S Sterilizer can process many
of the items you commonly sterilize as well as instruments that are sensitive
to heat and moisture. However, there are a few important exceptions.

The Sterrad 100S Sterilizer is designed for sterilization of both metal
and nonmetal medical devices at low temperatures.
Because the cycle operates within a dry environment and at low temperatures,
it is especially suitable for instruments sensitive to heat and moisture.
The Sterrad 100S Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Metal and nonmetal lumened instruments with inside diameters
of 6 mm (1/4 inch) or larger and lengths of 310 mm (12 inches)
or shorter can be processed in the Sterrad 100S Sterilizer.
Additionally, medical devices with only a single stainless steel lumen which
has an inside diameter of 3 mm (1/8 inch) or larger
and a length of 400 mm (15-3/4 inches) or shorter can be processed
in the Sterrad 100S Sterilizer.

Recommended Materials
Many devices made of the following materials can be loaded into the Sterrad 100S Sterilizer:
Aluminum
Ethyl vinyl acetate (EVA)
Kraton
Latex
Polyethylene (high density and low density)
Polycarbonate
Polymethyl methacrylate (PMMA)
Polyolefin
Polypropylene
Polyurethane
Polyvinyl chloride (PVC)
Silicone
Stainless steel
Teflon

Typical Items Sterilized
Examples of devices that can be sterilized in the STERRAD 100S Sterilizer
are listed below. All medical devices should be processed in accordance
with the medical device manufacturer's recommendations.
Check the manufacturer's instructions before loading any device into
the Sterrad 100S Sterilizer.
Stereotactic equipment
Defibrillator paddles
Electrocautery instruments
Esophageal dilators
Laryngoscope blades
Metal instruments
Cryoprobes
Dopplers
Endoscopic instruments
Fiberoptic light cables
Laser hand pieces, fibers, and accessories
Radiation therapy equipment
Rigid endoscopes
Cranial pressure transducer cables
Trocar sheaths
Video cameras and couplers
Pigmentation hand pieces
Resectoscope/working elements and sheaths
Shaver hand pieces
Surgical power equipment and batteries
Ultrasound probes
Ophthalmic lenses
Patient lead cables

Specifications:
Total Cycle Time: Approximately 74 minutes

Size:
Width: 765 mm (30 in)
Height: 1660 mm (65.5 in)
Depth: 1020 mm (40 in)
Weight: 350 kg (770 lbs)
Cycle Temperature: 40o to 55oC (104o to 131oF)

Installation and Operating Requirements:
Connections (50-60 Hz, 5 wires, 3 phase WYE configuration):
200 - 208 VAC, 10A, 50/60Hz
380 VAC, 10A, 50Hz
400 VAC, 10A, 50Hz
415 VAC, 10A, 50Hz
Cord Length: 3 meters (10 feet)
Placement: Built-in wheels provide mobility.

Operational Environment:
Temperature: 10o to 40oC (50o to 104oF)
Humidity: 10 to 95% relative humidity (non-condensing)
Installation Space:
Minimum area: 87 x 107 cm (32 x 42 in)
Surface: Flat = 5 mm/M (3/16 in / 3 feet)
Minimum Distance from Wall: 50 mm (2 in)
Minimum Service Access: 1 meter (3 feet) on all sides (Unit can be moved for service)
Preventative Maintenance Schedule: 750/1500 cycles

Sterilization Chamber:
Usable Volume: 100 liters (3.5 cubic feet)
Shelf Strength: 25 kg (55 lb) per shelf
Shelf Dimensions:
Upper shelf: 700 x 425 mm (28 x 17 in)
Lower shelf: 760 x 325 mm (30 x 13 in)
Maximum Extension of Upper Shelf: Approximately 350 mm (14 in)
Certification Interval: 1,500 cycles

Regulatory Approvals:
CAN/CSA-C22.2 No. 0-M91; General Requirements - Canadian Electrical Code, Part II
0.4-M1982; bonding and Grounding of Electrical Equipment (Protective Grounding)
151-M1986; Laboratory Equipment
EN 61010; Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
EN 60601-1 (1990) Medical Equipment Safety
EN 55011, Group II Class A limits, based on CISPR 11; Emissions
FCC 47 Part 18; FCC Requirements for Industrial, Scientific, and Medical Equipment
EN 60601-1-2 (1993); Medical Electrical Equipment, Collateral Standard, Electromagnetic Compatibility CE
a mark of conformity for the European Community