Description

InnoWave™ Ultra+

Sonic Irrigator

APPLICATION

The STERIS InnoWave Ultra+ Sonic Irrigator is designed to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The InnoWave Ultra+ provides Sonic Irrigation to both the interior and exterior of lumened instruments. The system also uses Lumen Flush when instruments are connected to further assist remove debris from the inside of channels (e.g., lumen devices, MIS instruments, etc.). The InnoWave Ultra+ Sonic Irrigator automatically fills, doses chemistry, and drains.

This datasheet also applies to all Medisafe SISA S Sonic Irrigators.

DESCRIPTION

The InnoWave Ultra+ Sonic Irrigator is a flexible unit available in either a countertop or freestanding floor configuration. The InnoWave Ultra+ contains all needed components to effectively clean and reusable surgical instruments prior to sterilization.

The InnoWave Ultra+ is equipped with

 Sonic Irrigation                                                                                           Touch Screen 

Interlocking Lid Sensor                                                                               Data Capture/Export Capabilities

This unit is meant to be used only in areas inaccessible to patients.

DIMENSIONS AND CAPACITY

Overall Dimensions, Lid Closed: 29.5” x 15.6” x 21.0″ (748 mm x 379 mm x 534 mm)

Overall Dimensions, Lid Open: 29.5” x 29.0” x 21.0″ (748 mm x 739 mm x 534 mm)

Service Access Clearance: Minimum 2″ (51 mm) sides; 3″ (76 mm) rear

Basket Dimensions: 19.0” x 10.0″ x 3.0” (484 mm x 253 mm x 76 mm) 

Capacity of Connected Instruments: 12 LumenInstruments 

Maximum Load Weight: 11.0 lb (5.0 kg)

UTILITY REQUIREMENTS

Refer to Operator Manual for installation details and specifications.

Electrical ─ Units must be ordered specifying required power configuration.

Drain: 3/4″ hose tail outlet from unit. Facility drain must be fitted with suitable traps. Drain hose supplied with Unit. Overflow: 1.9” (48 mm) OD outlet from machine in same as drain. Overflow hose connection to main drainage system must not be airtight. Note: Drain entry and entire drain hose must be below machine drain outlet, measured from Unit rear. Facility Drainpipe ID must be at least 2″ (50 mm).

Drain Flow Rate: >8 US gal/min. (>30 L/min.)

Hot Water: 3/4″ BSP Connection; 30 psi to 70 psi (2 bar to 5 bar); +122 °F to +176 °F (+50 °C to +80 °C)

Cold Water: 3/4″ BSP Connection; 30 psi to 70 psi (2 bar to 5 bar); +41 °F to +86 °F (+5 °C to +30 °C)

Flow Rate: 3 US gal/min. to 8 US gal/min. (11 L/min. to 30 L/min.)

Heating Rate: 0.9 °F/min. (0.5 °C/min.)

STANDARDS

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

•  ISO 20417:2021

•  EN 1717:2000

•  ISO 13485:2016

• ISO 14971:2019

• ISO 15223-1:2021

• ISO 15883-1:2006+AMD1:2014

•  IEC 61010-1:2010+AMD1:2016

•  IEC 61010-2-040:2020

• IEC 62304:2006+AMD1:2015

• EN 61326-1:2020

• BS EN/IEC 61326-1:2021

•  IEC 62366-1:2015+AMD1:2020 ANSI C63.4 – 20141

• CAN/CSA-C22.2 No 61010-1-12:2015

• UL 61010-1, 3rd Edition May 11 2012, Revised July 19 2019

FEATURES

The InnoWave Ultra+ Sonic Irrigator is wired for operation on any of the listed electrical configurations. STERIS supplies all components necessary to obtain a complete working unit ready for installation and connection to facility service lines. The unit includes the following features:

Basket/Tray can hold up to 12 lumen instruments and up to 11.0 lb (5.0 kg) load weight.

Integrated USB Port comes standard and is accessed at rear of unit.

Operator PINs help to ensure operator 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.

Auto-Tuning Frequencies is ensured by constant power output generators operating between between 38 kHz and 40 kHz (dependent on load).

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

One Chemistry Inlet provided on back of unit for chemical connection.

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.

CYCLE DESCRIPTION

There are three pre-programmed cycles and three open cycles available for customization**. Some of these cycles are equipped with Prewash, Wash and Rinse 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.

** cycle programs may vary for Medisafe SISA S Sonic Irrigators.

Load Instruments

User loads instruments into basket, places it into Unit and presses touch screen to start cycle.

Prewash

Cycle begins with a cold-water fill. Ultrasonic and irrigation functions operate alternately with pump running for specified time. Tank drains.

Wash

At main wash stage, tank is filled with a cold and hot water mix. Detergent is also added at this point.

Solution is heated to setpoint. 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 port for set time. Water is then drained.

Rinse

Tank is filled with a cold and hot water mix and heated to setpoint. Unit then alternates between spray and irrigation for pre-defined time. Water is then drained.

Final Rinse

Tank is filled with a cold and hot water mix and heated to setpoint. Unit then alternates between spray and irrigation for pre-defined time. Water is then drained.

Unload

User touches screen to acknowledge cycle completion. Open lid and remove basket.

CHEMISTRY

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

Recommended Chemicals (North America only)

Note: Certain products may not be available in your area. Contact your local supplier for product availability and ordering information.

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 weights:

a.    Operating: 121 lb (55 kg).

b.    Shipping: 110 lb (50 kg).

4.    Unit must be mounted on a stable, level, non-combustible worktop.

5. STERIS recommends a drain system capable of handling greater than 4 gpm flow rate, such as a floor sink. Overflow hose connection to drain must not be airtight.