10509251Tech Form.pdf

INNOWAVE™ PRO SONIC IRRIGATOR

(Typical only - some details may vary.)

Item ________________________ Location(s)___________________

10509251 (Rev B)

The Selections Checked Below Apply To This Equipment

INSTALLATION REQUIREMENTS

❑ Eliminizer Combo Dryer/Filter (MED1496) ❑ Seismic Anchoring Kit (IW1047)

ACCESSORIES

❑ 2.5 Gallon Pickup Tube (IW1073)

Qty: 1 ❑ Elbow Connector (MED3088)

Qty: 1

FLUSH NOZZLE SET

❑ Si - Standard - Flush Nozzle Set (IW1057) ❑ S/Si - Single Site - Flush Nozzle Set (IW1058) ❑ Si - Stapler- Flush Nozzle Set (IW1059)

BASKETS AND TUBING

❑ Standard Instrument (IW1049) ❑ Xi - Standard (IW1053)

Qty: 6 Standard ❑ Xi - Multi-Basket (IW1051)

Qty: 4 Standard / 2 Stapler ❑ Si - Multi-Basket (IW1055)

Qty: 8 Standard / 2 Stapler

BASKET ONLY

❑ Standard Instrument (IW1040)

TUBING ONLY

❑ Standard Instrument (IW1050) ❑ Xi - Standard (IW1052) ❑ Si - Multi-Basket (IW1056)

ULTRASONIC INDICATORS

❑ VERIFY Ultrasonic Indicator (U501) ❑ VERIFY Ultrasonic Indicator Holder (U505) ❑ VERIFY Ultrasonic Indicator Log Form (RK058) ❑ Wash Check H Indicator (V3503935) ❑ Wash Check H Indicator Holder (V3503940)

• Data Capture/Export Capabilities

APPLICATION

The STERIS InnoWave PRO Sonic Irrigator is designed to thoroughly clean (remove tissue, blood and other contaminants) a variety of reusable surgical instruments. The InnoWave PRO provides Sonic Irrigation (ultrasonic cavitation) to both the interior and exterior of lumened instruments. The system also uses Power Flush (approximately 44 psi) when instruments are connected to remove debris from the inside channels. This unit is equipped with intermediate level thermal disinfection to ensure instruments are safe for the staff to handle at the end of the cycle.

DESCRIPTION

The InnoWave PRO Sonic Irrigator is a freestanding high-pressure washer disinfector in a compact stainless-steel cabinet. The InnoWave PRO contains all needed components to effectively clean 60 lumens or 66 lb (30 kg) of reusable general surgical instruments prior to sterilization.

Cleaning and intermediate-level thermal disinfection is achieved through a combination of ultrasonics and flushing action with heated water to remove debris from both outside and inside (hollow instruments only) of items placed in wash tank.

The InnoWave PRO is equipped with:

• Sonic Irrigation

• Power Flush

• Deluge Wash

• Thermal Disinfection

• Auto Lid-Locking

• Foot Pedal

• Touch Screen

STANDARDS

The InnoWave PRO Sonic Irrigator meets the applicable requirements of the following standards:

• EMC Requirements EN 61326:2013

• Medical Electrical Equipment IEC 60601-1-6:2010+A1:2015, IEC 60601-1-2:2007 and IEC 60601-1:2006+A12:2014

• Medical Devices ANSI/AAMI/IEC 62336-1:2015

• Washer-Disinfectors ANSI/AAMI ST15883-2:2013(R)2015

• Electrical Equipment Safety Requirements IEC 61010-1:2010

• CAN/CSA-C22.2 No. 61010-1:2015 (ed. 3)

• ISO 15883-1 A0 3000 International Standards for Time and Temperature to Meet Thermal Disinfection

SIZE (W X H X D)

Overall dimensions of a fully equipped ultrasonic:

• 49.6 x 43.5 - 65 x 33.7" (1260 x 1105 - 1651 x 856 mm)

Service Access Clearance:

• Minimum 6" (150 mm) sides; 8" (200 mm) rear

Basket/Tray Compatibility:

• Three trays hold instruments with dimensions up to

13.5 x 3 x 26.3" (343 x 76 x 668 mm)

• 20 Lumen Instruments per basket (three baskets)

• 22 lb (10 kg) Maximum Load Weight per Carrier (total 66 lb)

FEATURES

The InnoWave PRO Sonic Irrigator is wired for operation on 200-230 V (60 Hz, three phase + PE). STERIS supplies all components necessary to obtain a complete working unit ready for installation and connection to facility service lines. Unit includes the following features:

Auto-Tuning Frequencies is ensured by constant power output generators typically operating at 38 kHz.

Reflectasonic Technology to improve the life of the tank by reducing pitting (which can occur from ultrasonic activity over time).

Easy-To-Use Touch Screen Control to aid user interaction with the unit.

Two Pick-Up Tubes provided for a 2.5 gallon bottles of detergent or bottle of lubricant. Both center doors allow access to chemical storage compartment, where pickup connection is located. Unit weighs chemical bottle to detect when there is insufficient chemical to run a cycle, then prompts user to replace bottle before cycle begins.

Integrated USB Port comes standard and is accessed through left-hand chemical storage door.

Operator PINs help to ensure User safety and facility security.

Optional user code is available to require user to enter a four-digit PIN number to unlock the user control panel. A valid PIN entry identifies the user and the operator’s number is shown on the cycle printout. There are 80 predefined operator numbers available.

Cycle Monitoring ensures recording of successful cycles and any abnormalities for documentation purposes. During cycle, parameters are reported at key stages of process. On-board cycle log can be download via a USB flash drive. Control is also designed to perform cycle within strict and carefully controlled tolerances. If an unexpected condition occurs during a wash cycle, system aborts cycle and reports an error.

Front Doors and Side Service Access Panels are supplied on unit for ease of any maintenance procedures. Access doors are scratch and dent resistant.

Emergency Stop Pushbutton is supplied to cut power to Carrier Lift and other critical outputs. Cycle is aborted. Normal operation is resumed once pushbutton is pulled out.

CYCLE DESCRIPTION

The InnoWave PRO Sonic Irrigator has ability to wash up to 60 lumened instruments or up to 66 lb (30 kg) of general surgical instruments. There are three pre-programmed cycles and three open cycles available for customization. Some of these cycles are equipped with Prewash, Wash, Rinse and Disinfection phases tailored to clean a multitude of different loads. During cycle, remaining time for each stage and temperature/pump pressure are shown on the display.

Load Instruments

User loads instruments into basket(s), presses foot pedal to raise carrier from unit wash chamber, places loaded basket(s) into carrier (space for up to three baskets), then presses foot pedal again to lower carrier and start automated cleaning process.

Prewash

Cycle begins with a cold-water fill to mid-level. Spray and irrigation functions operate alternately with pump running for specified time. Water is drained.

Wash

At main wash stage, tank is filled to top level with a cold and hot water mix to attain set temperature. Detergent is also added at this point. To even out temperature, fill all cavities and to mix chemical thoroughly, pump is pulsed on and off. Once tank is full, ultrasonics degas tank by pulsing on and off to remove any dissolved air. A period of irrigation follows to flush any material from inside instruments. Ultrasonics then alternate with irrigation for set period of time. Water is drained.

Rinse

Tank is filled to mid-level. Unit then alternates between spray and irrigation for pre-defined time. Water is drained.

For some programs this stage is repeated.

Disinfection

If thermal disinfection is required, machine is then filled to minimum level with hot water and heated to pre-set temperature (91°C / 196°F) then spray and irrigation functions operate alternately for three minutes. Water is drained.

Cooling

To disperse chamber vapor, unit opens drain valve and fills with cold water for several minutes.

Drying

To remove excess water from irrigation and spray channels, Unit alternately injects compressed air for several minutes.

Unload

User presses foot switch to raise carrier and basket(s) is removed.

PREVENTIVE MAINTENANCE

Customers are encouraged to contact STERIS concerning our annual maintenance program. Under the terms of the program, preventive maintenance, adjustments and replacement of worn parts are provided on a scheduled basis to help ensure optimal equipment performance and help minimize untimely or costly schedule interruptions. STERIS maintains a worldwide staff of well-equipped, factory-trained technicians to provide these services, as well as on-site installation, training and expert repair services. Contact STERIS for details.

NOTES

1. Pipe sizes shown indicate terminal outlets only. Building service lines (not provided by STERIS) must supply the specified pressures and flow rates.

2. STERIS recommends a dedicated, grounded electrical circuit be provided for each unit. Do NOT use extension cord and plug.

3. Approximate operating weight:

» Operational (dry) 905 lb (411 kg).

» Shipping 1135 lb (515 kg).

4. Unit must be mounted on a hard, level, non-combustible surface.

5. STERIS recommends as a minimum a 6 x 6" deep floor sink.

CHEMISTRY

The following STERIS Chemistries are recommended for use in this unit:

Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner, 4 x 1.0 Gallon (1C3308)

Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner, 2.5 Gallon (1C3310)

Prolystica® 2X Concentrate Neutral Detergent, 4 x 1.0 Gallon (1C3208)

Prolystica® 2X Concentrate Neutral Detergent, 2.5 Gallon (1C3210)

Prolystica® 2X Concentrate Enzymatic Automated Detergent, 2.5 Gallon (1C2210)

Prolystica® 2X Concentrate Neutral automated Detergent,

2.5 Gallon (1C2110)

ULTRASONIC PERFORMANCE

Ultrasonic Performance: >48 Watts/gal

Ultrasonic Frequency: Typically 38 kHz

Ultrasonic Bath Size: Large enough to submerge devices with at least 1" (25 mm) clearance around all ultrasonic edges.

UTILITY REQUIREMENTS

Refer to Operator Manual for installation details and specifications.

Electrical* Voltage: 200-230 Vac, 60 Hz, 3-Phase + PE.

Power: 18 kW.

Facility Current Capacity: > 48A per Phase.

Facility MCB and Disconnect Switch Current Rating: 63A.

Drain Type: Gravity.

Connection: 2.125" OD outlet from unit. Drain pipe must be at least 4" ID.

Traps: Drain must be fitted with suitable traps.

Capacity: Greater than 47.5 gal/min.

Overflow: Internally connected (within unit) to drain pipe downstream of drain valve.

NOTE: Drain entry and entire drain hose must be below unit drain outlet. A floor sink or floor drain is required. Drain can be extended up to 1.0 meter from unit drain outlet.

Hot Water 3/4" Stainless-Steel BSP; 30 - 70 psi (2-5 bar); 122-140°F (50-60°C).

Cold Water 3/4" Stainless-Steel BSP;30 - 70 psi (2-5 bar); 41-86°F (5- 30°C).

RO/DI Water (Optional) 3/4" Stainless-Steel BSP;30 - 70 psi (2-5 bar); 41-140°F (5- 60°C).

Flow Rate 3 - 8 gal/min

Heating Rate 4°C/min (9°F/min)

Air Quality Requirement If medical grade** compressed air is not used, an Elimizer Combo Dryer/Filter (MED1496) must be included at time of order.

* Units must be ordered specifying required voltage and phase.

** Medical grade air is defined as no detectable liquids, hydrocarbons, waters or solvents. It shall have < 25 ppm gaseous hydrocarbons, and filtered to

0.3 microns.

The base language of this document is ENGLISH. Any translations must be made from the base language document.

CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH

APPLICABLE LOCAL AND NATIONAL CODES AND

REGULATIONS.

For Further Information, contact:

STERIS Corporation 5960 Heisley Road Mentor, OH 44060-1834 • USA 440-354-2600 • 800-548-4873 www.steris.com

This document is intended for the exclusive use of STERIS Customers, including architects or designers. Reproduction in whole or in part by any party other than a Customer is prohibited.

©2019, STERIS Corporation. All rights reserved. 10509251 Rev B