5025 and 5020 Electric Instrument Control Console Instructions for Use Rev F May 2020

Instrument Manual Translation Information The following additional languages are available online at www.microaire.com/resources: Dansk (Danish) Danske oversættelser af denne brugsanvisning er tilgængelig online på www.microaire.com/resources. Nederlands (Dutch) Nederlandse vertalingen van deze handleiding zijn online beschikbaar op www.microaire.com/resources. Suomalainen (Finnish) Suomen käännökset tämän käyttöohjeen löytyvät osoitteesta www.microaire.com/resources. Française (French) Des traductions françaises de ce manuel d’instructions sont disponibles en ligne à www.microaire.com/resources. Deutsch (German) Deutsch Übersetzungen dieser Bedienungsanleitung sind online verfügbar unter www.microaire.com/resources. Italiano (Italian) Traduzioni italiane di questo manuale sono disponibili online all’indirizzo www.microaire.com/resources. Português (Portuguese) Tradução para português deste manual de instruções estão disponíveis online em www.microaire.com/resources. Español (Spanish) Traducciones al español de este manual de instrucciones están disponibles en línea en www.microaire.com/resources. Svenska (Swedish) Svenska översättningar av denna bruksanvisning finns tillgängliga online på www.microaire.com/resources. Türk (Turkish) Bu kullanım kılavuzu Türkçe tercümeleri sitesinde online olarak mevcuttur www.microaire.com/resources. 中文(Chinese) 本 明 的中文 本可在网上 www.microaire.com/resources. Русский (Russian) Русские переводы этого руководства можно ознакомиться на сайте www.microaire.com/resources. Português do Brasil (Brazilian) As traduções dinamarquesas deste manual estão disponíveis on-line em www.microaire.com/resources. 日本語 (Japanese) このマニュアルのデンマーク語の翻訳は、www.microaire.com/resources からオンラインで入手できます。.

IM-5025 REV F 2020-05

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Table of Contents

Instrument Manual Translation Information Symbol Definition

1 3-5

Intended Use

5

Compatible Instruments

5

Warning, Caution and Note Definitions

5-8

System Setup

8-12

REF 5020 / REF 5025 Instrument Control Console Features

8

Connecting the Instruments

9

Loading Irrigation tubing

10

Tube holder repositioning

11

Connecting Foot Pedal Control

11-12

REF 5020 / REF 5025 Operation

13-22

Technical Description

23-24

Cleaning and Sterilization Guidelines

24

Environmental Parameters

24

Troubleshooting Guidelines

25

Maintenance Information

26

Proper Shipping, Storage and Handling

26

Essential Performance Statement

26

Electromagnetic Compatibility (EMC)

26-28

Warranty, Service, Repair and Disposal

29-30

2

IM-5025 REV F 2020-05

Symbol Definition Name

Ref#

(ISO 7000)2

Symbol

Description

Use Standard

Refer to Instruction Manual / Booklet

ISO-7010 M002

• Indicates a MANDATORY action for the user to consult the Instructions For Use (IFU). • Symbol must be blue, as shown.

Consult Instructions For Use (IFU)

1641

Indicates the need for the user to consult the Instructions For Use (IFU). Not required in conjunction with the Caution symbol, if applicable.

ISO 15223-1:20121

5333

Indicates a medical device complying with the specified requirements of IEC 60601-1 to provide a higher degree of protection against electric shock than that provided by Type B Applied Parts.

IEC 60601-1:2005

REF (Catalog #)

2493

• Indicates the manufacturer’s catalog number so that the medical device can be identified. • Per EN980:2008, the REF symbol may be used without surrounding box.

Authorized Representative in the European Community

N/A

Indicates the authorized representative in the European Community. This symbol shall be accompanied by the name and address of the authorized representative, adjacent to the symbol.

Serial #

2498

• Indicates the manufacturer’s serial number so that a specific medical device can be identified. • Per EN980:2008, the SN symbol may be used without surrounding box.

Lot / Batch Code

2492

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO 15223-1:20121

Do Not Immerse in any Liquid

5995

Indicates a medical device that is not to be immersed in any liquid.

IEC 60335-2-15

Do Not Lubricate

N/A

Indicates a medical device that is not to be lubricated.

2497

• Indicates the date when the medical device was manufactured. The date is expressed as YYYY-MM (e.g. 2015-11) or YYYY-MM-DD (e.g. 2015-11-29). • If the symbol is filled (see Manufacturer symbol), both the date of manufacture and the name/address of the manufacturer may be combined in one symbol.

ISO 15223-1:20121

3082

• Indicates the medical device manufacturer. This symbol shall be accompanied by the name and address of the manufacturer. The date of manufacture may be combined with this symbol. • When using MicroAire as the manufacturer, use the MicroAire LLC symbol.

ISO 15223-1:20121

Use-By Date

2607

Indicates the date after which the medical device is not to be used. This symbol shall be accompanied by a date to indicate that the medical device should not be used after the end of the month shown. The date is expressed as YYYY-MM (e.g. 2015-11) or YYYYMM-DD (e.g. 2015-11-29).

ISO 15223-1:20121

CE Mark (with Notified Body #

N/A

Indicates the European Conformity Mark with Notified Body Number. 0086 is the BSI-UK-registered Notified Body. This product received CE Certification in 2013.

Council Directive 93/42/EEC

CE Mark (with Notified Body #

N/A

Indicates the European Conformity Mark with Notified Body Number. 2797 is the BSI-UK-registered Notified Body. This product received CE Certification in 2013.

Council Directive 93/42/EEC

CE Mark

N/A

Indicates the European Conformity Mark

Council Directive 93/42/EEC

Type BF Applied Part

Date of Manufacture

Manufacturer

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0086

2797

3

IEC 60601-1:20051

ISO 15223-1:20121

ISO 15223-1:20121

ISO 15223-1:20121

N/A

Name

Ref#

Description

Use Standard

2620

Indicates the range of humidity to which the medical device can be safely exposed. The humidity limitations shall be indicated adjacent to the upper and lower horizontal lines.

ISO 15223-1:20121

Temperature Limitation

0632

Indicates the temperature limits to which the medical device can be safely exposed. The upper and lower limits to temperature shall be indicated adjacent to the upper and lower horizontal lines.

ISO 15223-1:20121

Do Not Expose to Stray Magnetic Fields

N/A

Indicates a medical device that is not to be exposed to stray magnetic fields.

N/A

N/A

N/A

Potential Equalization Terminal

N/A

N/A

N/A

Do not allow fingers to contact moving parts.

N/A

Prescription

N/A

Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

FDA Title 21, Chapter 1, Subchapter H, Part 801.15(F)

Dispose of per WEEE Directive 2012/19/EU

N/A

Indicates a medical device that is not to be disposed of as unsorted municipal waste. Medical device is to be disposed of per WEEE Directive 2012/19/EU.

Council Directive 2012/19/EU

N/A

Indicates a medical device that is not to be disposed of as unsorted municipal waste. Medical device is to be disposed of per WEEE Directive 2012/19/EU. This symbol is used in place of the above symbol if the product entered the market after 13 August, 2005.

Council Directive 2012/19/EU (Symbol: European Standard EN 50419)

N/A

MEDICAL-GENERAL MEDICAL EQUIPMENT AS TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY. IN ACCORDANCE WITH ANSI/AAMI ES 60601-1 (2005) + A1 (2012) + CAN/CSA C22.2 No. 60601-1 (2014) | Control Number: E494242

UL

Indicates Irrigation Pump Function

N/A

Irrigation Pump Pause/Run (Normal Run)

N/A

Indicates Surgical Instrument Function

N/A

Humidity Limitation

Dispose of per WEEE Directive 2012/19/EU

UL symbol

(ISO 7000)2

Symbol

>

E494242

Irrigation Pump

N/A

Irrigation Pause/Run

N/A

Surgical Instrument

N/A

Normal Run

5107B

p

Run Direction (Run in Forward or Reverse as Indicated)

N/A

Standby

5009

X

Switches Unit In and Out of Standby Mode

N/A

Instrument Speed Adjustment

N/A

Press to Adjust Instrument Speed (Variable in Steps)

N/A

Irrigation Flow Adjustment

N/A

Press to Adjust Irrigation Flow Rate (Variable in Steps)

N/A

Direction of Rotation

0941

Indicates Direction of Rotation

N/A

Foot Control

N/A

Indicates Foot Control Related Function

N/A

Tube Holder Adjustment

N/A

Irrigation Pump Tube Holder Adjustment for Large and Small Size Irrigation Tubing

N/A

CSA Mark

N/A

Canadian Standards Association Mark for Canada and U.S.

CSA

/p

R

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Ref#

Name

(ISO 7000)2

USB Port 1 2

Symbol

N/A

Description

Use Standard

Universal Serial Bus Port

USB 2.0

ISO 15223-1:2012 – “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements” ISO 7000/IEC 60417 – “Graphical symbols for use on equipment – Registered symbols”

Intended Use The MicroAire REF 5025 or REF 5020 Electric Instrument Control Console (“the Console”) is an electronic control system designed to drive small power instrumentation in a wide variety of surgical applications. Intended users are surgeons, physician’s assistants, orthopaedic operating room nurses and circulating nurses. Indications for use and contraindications will be provided in the IFU for the instruments that are powered by the REF 5020 and REF 5025. See the Compatible Instruments section below.

Compatible Instruments PRODUCT CATALOG NUMBER (REF) DESCRIPTION

INSTRUCTIONS FOR USE WITH COMPLETE LIST OF ACCESSORIES AND TYPE BF APPLIED PARTS

REF PAL-650

PAL Powered Handpiece

IM-PAL-650

REF 5006-PAL

PAL Instrument Cable

IM-PAL-650

REF 5000E

Series 5000 Electric Motor Module, Throttle-less

IM-5000E

REF 5000ET

Series 5000 Electric Motor Module, With Throttle

IM-5000E

REF 5641

Series 5000 SmartDriver DUO®e Dual Trigger Electric

IM-5641

REF 5995U

Series 5000 Solo™ Driver Handpiece

IM-5995U

REF 5006-5000

Series 5000 Instrument Cable

IM-5000E, IM-5641, IM-5995U

REF 5401

Series 5000 Electric Foot Pedal

IM-5025

REF 5025-5401

Series 5000 Foot Pedal Cable

IM-5025

REF 1000ET

Series 1000 Electric Motor Module, With Throttle

IM-1000 (IEC 60601-1 2nd Edition)

REF 5006-1000

Series 1000 Instrument Cable

IM-1000

Instruments and their accessories are sold separately. Contact your MicroAire® Sales representative or MicroAire® Customer Service at 1-800-722-0822 for a complete list of accessories and instruments available. Outside the USA, contact your nearest MicroAire authorized distributor.

DEFINITIONS: WARNING – CAUTION – NOTE

Please read this manual and follow its instructions carefully. The words WARNING, CAUTION and NOTE carry special meanings and should be carefully reviewed. WARNING: Used to indicate that the safety of the patient and hospital personnel could be involved. CAUTION: Used to indicate special procedures or precautions that must be followed to avoid damaging the system and instruments. NOTE: Used to indicate the easiest means of carrying out techniques.

GENERAL WARNINGS WARNING:

Upon receipt and before each use, you should inspect the system and its components for visible damage. Do not use if there is apparent damage to any component. Perform recommended maintenance as indicated in the Instructions for Use. Failure to comply may result in healthcare professional and/or patient injury.

WARNING:

The healthcare provider performing any procedure is responsible for determining whether this is the appropriate equipment/instrument for the specific procedure that is being performed for each patient. As the manufacturer, MicroAire does not recommend surgical procedures or offer any guidance in such procedures.

WARNING:

Only trained and experienced healthcare providers/professionals should use this medical equipment. Before using any system component or any component that is compatible with this system read and understand the Instructions for Use. Pay special attention to the WARNING information and familiarize yourself with the system components prior to use. Failure to comply may result in patient and/or healthcare professional injury.

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WARNING: Consult and follow the appropriate Instructions for Use for the instrument to be used. See the table under Compatible Instruments. WARNING:

Do not use this equipment or components in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

WARNING:

AC mains disconnect must be achieved by removing cord from wall outlet. Ensure that the Console is positioned so that the power cord can be unplugged.

WARNING: Use personal protective equipment as required. Failure to comply may result in patient and/or healthcare professional injury. WARNING:

Cleaning and Sterilization of all system components used inside the sterile field are required before each use. See MicroAire’s Cleaning and Sterilization Procedures in the appropriate instrument Instructions for Use.

WARNING:

Use only MicroAire approved accessories. Use of unapproved accessories may result in increased electromagnetic emissions or decreased immunity of the system and will void the warranty. Do not modify any accessory. Failure to comply may result in patient and/or healthcare professional injury.

WARNING: Do not place instruments, components or handpieces on the patient. Failure to comply may result in patient injury. WARNING:

Do not place handpieces near or on magnetic pads or trays. Magnetic fields can create throttle output of a Foot Pedal or handpiece switch and may cause the instrument or component to operate inadvertently. Failure to comply may result in patient and/or healthcare professional injury.

WARNING:

Do not allow fingers to contact moving parts.

WARNING:

This product does not comply with the ATEX directive and must not be used with explosive atmospheres.

WARNING:

Irrigation must be used when cutting bone in order to ensure that the temperature at the cutting accessory does not exceed 41°C / 105.8°F.

WARNING:

Use only with a medically approved type SJT or equivalent three wire (protective earth) grounded power cord rated for 125V or 250V AC, 10A, constructed with 18/3 AWG wires and an IEC 320 appliance connector.

WARNING:

DO NOT modify the ground connection or any portion of the Console power cord. Failure to comply may result in healthcare professional injury.

WARNING:

Grounding reliability can only be achieved when the equipment is connected to an equipment receptacle marked as “Hospital Grade”.

WARNING:

Anyone who connects additional equipment to the contact closure connector configures a medical system, and is therefore responsible that the system complies with the requirements of clause 16 of ANSI/AAMI/IEC ES60601-1:2005 + Am1 (2012).

WARNING:

The USB port is to be used only for diagnostics and/or software upgrade by MicroAire approved technicians only. The USB port must not be connected to any cable or device while in operation.

WARNING:

If the Console reboots due to instrument overload or loss of electrical power, the Irrigation Pump will be disabled when the Console restarts. The Irrigation Pump must be re-enabled via the touchscreen before resuming use of the instrument. Failure to comply may result in patient injury.

WARNING:

Do not use this equipment in the presence of flammable anesthetics.

WARNING:

Modification of this equipment is not allowed.

WARNING:

Electric Shock. Do not remove cover. Refer servicing to authorized MicroAire personnel only.

WARNING:

Take special precautions with electromagnetic compatibility (EMC) when using the MicroAire Electric Instrument Console. Ensure that the Console is installed and placed into service according to the EMC information contained in the Instructions for Use.

WARNING: The 5020/5025 Electric Instrument Control Console and associated instruments have been tested for use in the vicinity of High Frequency Electrosurgical/ Electrocoagulation equipment. Use of such equipment in close proximity to the MicroAire instruments or instrument cables may cause unintended interruptions or unintended motion of durations up to 1 second. Place MicroAire Instruments on a safe surface when not in use. Do not place MicroAire Instruments on the patient when not in use. Avoid entwining HF surgical cables with MicroAire Instrument Cables. WARNING:

Portable RF communications equipment should be used no closer than 30 cm (12 inches) away from any part of the 5020/5025 Console, its associated cables or the handpieces it is controlling. Otherwise degradation of the performance of the PAL-650 or series 5000 instruments could result. 6

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WARNING:

Use of the 5020/5025 Console adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the 5020/5025 and the adjacent equipment should be observed to verify that they are operating normally.

WARNING: The following items should be periodically inspected for signs of damage and repaired or replaced as needed to ensure continued safety with regard to electromagnetic disturbances over the life of the system: • 5020/5025 Electric Instrument Control Console: - Proper Fit of the top cover to the chassis. - Damage to the LCD Display - Test that the Protective Earth Connection meets ES60601-1 requirements. • Inspect the 5006-PAL instrument cables for signs of physical damage to the cable. WARNING:

The 5020 & PAL-650 Liposuction handpiece and the 5025 & Series 5000 Instrument System are suitable for use in hospitals and surgery centers. These systems should not be used near Magnetic Resonance Imaging equipment.

CAUTION: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). CAUTION:

Do not thread or twist the push/pull connectors on the cable(s) during installation or removal.

CAUTION:

When connecting or disconnecting a cable(s) to the front of the Console, always hold the cable by its connector. Failure to comply may result in damage to the cable or Console.

CAUTION:

Cables that are connected to the front of the Console have keyed, push/pull type connectors that lock into place. Do not force a connector into a Console port. Each connector and port has an alignment mark to indicate proper cable orientation.

CAUTION:

DO NOT sterilize the 5020/5025 Console or its power cord, or the 5401 Foot Pedal - They may be wiped down with a germicidal cleaner. Take precautions to avoid allowing any moisture inside of any Console opening and power cord.

CAUTION:

DO NOT use aerosol sprays of any kind directly on the screen display of the Console. Clean by wiping with a soft, damp cloth and drying with a soft dry cloth.

CAUTION: Use only a MicroAire REF 5401 Foot Control Pedal and REF 5025-5401 Cable with the REF 5025 and REF 5020 Electric Instrument Console. Use of other Foot Pedal controllers will void warranty and may damage instrument Console. NOTE: When the Instrument Slider Bar is being adjusted, the number shows the desired maximum speed. When the instrument is in use (rotating), it will show the commanded speed of the instrument as a percentage of its rated speed. NOTE: If the Console screen is touched in more than one place at the same time, an unintended button activation may occur. Please make sure the settings are adjusted as required before operating the accessories/ instruments. NOTE: The Instrument Direction icon only changes direction of the pencil grip instruments. For all other instruments this icon serves as an indicator to the user of which direction the instrument is currently running. Pressing the direction icon when these instruments are connected results in an error tone and will not change the direction of that instrument. NOTE: Connection of the Potential Equalization Connector is not required for compliance with IEC 60601-1 or IEC 60601-1-2. NOTE: The emissions characteristics of this product make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 Class B is normally required) this equipment might not offer adequate protection to radio frequency communication services. The user might be required to take mitigation measures, such as relocating or re-orienting the equipment. NOTE: Repairs or alterations to MicroAire® products made by anyone other than MicroAire® or an Authorized MicroAire® Repair Facility will void that product’s warranty, and the customer will be responsible for any costs related to returning the product to working condition. NOTE: The Irrigation Pump is not intended for use with the PAL-650. NOTE:

If using the Console Irrigation Pump, install the Irrigation Pole (supplied with the 5025 Console) to the mounting bracket on the back of the Console. Hang the irrigation bag from the pole and follow the irrigation instructions as stated below.

NOTE:

The Foot Pedal icon is only visible for instruments that are able to be run by the Foot Pedal. If the icon is not present Foot Pedal control is not available for that instrument.

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NOTE:

Foot Pedal can only control one instrument at a time. If the Foot Pedal is active for Instrument 1 and you wish to change to Instrument 2, make sure that neither connected instrument is running, then press the Foot Pedal icon on the instrument of your choice to activate the Foot Pedal for that instrument.

NOTE:

MicroAire® mailing address information is located on the back cover of this Instructions for Use document.

NOTE:

DO NOT return equipment without an RMA number. Doing so could cause delays in service, and/or problems tracking your equipment.

Sytem Setup REF 5020 / REF 5025 Instrument Control Console Features Irrigation Pump (Not used with PAL-650)

Color Touch Screen Touch screen to control settings Standby Button Blinking when in stand by , must press and hold to power up

USB Serial Port Communication port used for software upgrade(s)

Foot Pedal Connector (Not used with PAL-650)

Handpiece connectors Allows connection and running of handpieces simultaneously

FIGURE 1

Irrigation Bag Pole-Mounting Bracket (Not used with PAL-650)

Contact Closure Used for control of MicroAirecompatible suction pumps

Potential Equalization Connector Used for common ground among multiple instruments in procedure

Power Receptacle Connect Console power cord and connect to facility power outlet

FIGURE 2

8

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Connecting the Instruments WARNING: Do not place instruments, components or handpieces on the patient. Failure to comply may result in patient injury. WARNING:

Do not place handpieces near or on magnetic pads or trays. Magnetic fields can create throttle output of a Foot Pedal or handpiece switch and may cause the instrument or component to operate inadvertently. Failure to comply may result in patient and/or healthcare professional injury.

1. Place the Console on a sturdy, flat surface near a hospital-grade outlet. 2. Install the power cord plug into the power receptacle on the Console. 3. Install the other end of the power cord into a hospital wall outlet. 4. Wait for the Console to initialize, then press and hold the blinking standby button to turn on the Console. 5. If using a Foot Pedal, plug the Foot Pedal cable into the port marked with a Foot Pedal symbol. Align the marks and gently push the connectors together. Once correctly plugged in, the blue led light around the connector will light up. Only one Foot Pedal may be connected to the Console at a time, but can be selected to operate either of the Foot Pedal-compatible instruments. 6. Plug the handpiece cable(s) into the Console port(s) marked with a HANDPIECE symbol. Align the marks and gently push the connectors together. Once correctly plugged in, the blue led light around the connector will light up. Two handpieces may be connected to the Console and operated simultaneously. 7. Plug the other end of the handpiece cable(s) into the instrument(s). See Instructions For Use supplied with each handpiece for connection information. 8. Attach the cutting accessory to the handpiece(s). See the Instructions for Use supplied with each handpiece or attachment for cutting accessory installation information. 9. If required, install the irrigation tubing into the Console Irrigation Pump by following the instructions in the “Irrigation Settings” section in the Instructions for Use manual.

Instrument Duty Cycles • The REF 5020 & REF 5025 Electric Instrument Control Consoles are designed for Continuous Operation. Each Instrument has its own Duty Cycle. • The REF PAL-650 has an operating duty cycle of 2 hours ON, 2 hours OFF. • The REF 5000E, 5000ET, 5641 and 5995-U instruments have an operating duty cycle of 1 minute ON, 1 minute OFF, for 6 cycles maximum. • The REF 1000E and 1000ET instruments are designed to operate for 1 minute of continuous use and should be allowed to cool to room temperature. (IEC 60601-1 2nd Edition) WARNING:

Irrigation must be used when cutting bone in order to ensure that the temperature at the cutting accessory does not exceed 41°C / 105.8°F.

NOTE:

If using the Console Irrigation Pump, install the Irrigation Pole (supplied with the 5025 Console) to the mounting bracket on the back of the Console. Hang the irrigation bag from the pole and follow the irrigation instructions as stated below.

CAUTIONS: • Do not thread or twist the push/pull connectors on the cable(s) during installation or removal. • When connecting or disconnecting a cable(s) to the front of the Console, always hold the cable by its connector. Failure to comply may result in damage to the cable or Console. • Cables that are connected to the front of the Console have keyed, push/pull type connectors that lock into place. Do not force a connector into a Console port. Each connector and port has an alignment mark to indicate proper cable orientation. IM-5025 REV F 2020-05

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Loading irrigation Tubing NOTE:

The Irrigation Pump is not intended for use with the PAL-650.

1.

Open the irrigation area door.

2.

Open irrigator pump door by lifting/clicking up on the beige indicated area of the irrigator cover to allow ample room to install irrigation tubing. (NOTE: Irrigation Pump runs in the counterclockwise direction).

3.

Verify that the pump tube holder is set to the small tube position. If adjustment is required, see instructions under “Tube Holder Repositioning”. Load irrigation tubing by placing the tubing inside the Irrigation Pump. Make sure that the end of the tubing to be attached to the instrument is positioned on the proper side as noted below. When loading the Tubing, make sure to load only the proper section of tubing into the Irrigation Pump as shown below in Figure 3.

4.

Once irrigation tubing is properly loaded, close the irrigator pump door by pushing down until the door locks into place, securing the tubing.

5.

Insert spike into the irrigation bag with the bag spike-end of the Tubing as shown below in Figure 3.

6.

Place Irrigation tubing into the instrument irrigation clip as instructed in the Instructions for Use supplied with each handpiece or attachment-for-cutting accessory installation information.

7.

To prime the Irrigation Pump, follow the instructions in Figures 3 and 4.

WARNING:

Do not allow fingers to contact moving parts.

WARNING:

This product does not comply with the ATEX directive and must not be used with explosive atmospheres.

4 To close Irrigator Pump

door, push down on the door until it snaps into place

2 Open Irrigator Pump

door by lifting the door as shown

Irrigation Bag

NOTE: This end of the irrigation tubing will be connected to the irrigation bag

1 Open irrigation area door

3 Load Irrigation tubing making note of the pump direction (See notes 1-3)

6 This end of the irrigation tubing will disperse the irrigation fluid

FIGURE 3 Tube Loading Area Between two arrows

æ

Insert spike into bag by 5 slightly twisting the bag spike while penetrating the irrigation bag as shown

å

FIGURE 4 Load the section of tubing between the two connectors into the Irrigation Pump to prevent tubing from advancing inadvertently 10

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Tube holder repositioning for use with Irrigation Pump To change from the large tube to the small tube setting Switch off the pump before changing the tube holder position. Use a pointed device such as a ball-point pen to reposition the lower tube holders on both sides of the pumphead. • Lift the flip top until fully open. • Place the pointed device pointing down into the small depression pictured here.

• Press down and slightly away from the front of the pumphead, as shown in the first picture above. • Maintain the angled downward pressure and push away from the front of the pumphead. The jaw clicks into a new position. • Release the pressure. The jaw rises into its correct alignment. If it does not rise, repeat the procedure, being sure to maintain downward pressure until release. • Adjust the tube holder on the other side of the pumphead in the same way.

Connecting a Foot Pedal Control CAUTION: Use only a MicroAire REF 5401 Foot Control Pedal and REF 5025-5401 Cable with the REF 5025 and REF 5020 Electric Instrument Console. Use of other Foot Pedal controllers will void warranty and may damage instrument Console. Plug the Foot Pedal Cable into the Foot Control Pedal and then plug the other end into the Console port marked with the Foot Pedal symbol as shown in Figure 5. To activate the Foot Pedal, press the Foot Pedal Control icon. Press again to inactivate the Foot Pedal as shown in Figure 6. The Foot Pedal icon does not respond if pressed while the instrument is running. NOTE: The Foot Pedal icon is only visible for instruments that are able to be run by the Foot Pedal. If the icon is not present Foot Pedal control is not available for that instrument. NOTE: Foot Pedal can only control one instrument at a time. If the Foot Pedal is active for Instrument 1 and you wish to change to Instrument 2, make sure that neither connected instrument is running, then press the Foot Pedal icon on the instrument of your choice to activate the Foot Pedal for that instrument.

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11

á

á FIGURE 5

á

To activate the Foot Pedal control, press the dim Foot Pedal icon. To inactivate, press again.

The bright Foot Pedal icon indicates that the Foot Pedal is active.

FIGURE 6

Foot Pedal Control Definition See Figure 7 below for guidelines on the button and pedal configurations of your Foot Pedal control. This button controls the irrigation flow. Press to increase the flow rate in increments of 10%.

This button controls the Irrigation Pump and acts as a pause and run switch. Press once to pause irrigation and then again to resume irrigation.

This button controls the instrument speed. Press to increase the speed rate in increments of 10%.

This Foot Pedal is depressed to run the instrument in reverse (counterclockwise) direction.

This Foot Pedal is depressed to run the instrument in forward (clockwise) direction.

FIGURE 7

12

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REF 5020 / REF 5025 Operation Press the blinking standby button and this screen is momentarily displayed while the Console powers up.

FIGURE 8 - Power Up Screen If there is a failure of the operating system on your Console, Error 12 will be displayed. If no handpieces are connected to the Console during the initial power up, the following screen will appear:

Press this button to access the Settings area

Press this button to access the Help area

FIGURE 9 - Plug in Handpiece Cable Screen To access the instrument control screen, you must connect an instrument to the Console. From this screen you may access the HELP screen/menu or the SETTINGS screen/menu. IM-5025 REV F 2020-05

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FIGURE 10 Alert Help: All Alert pop-ups will contain the Help Icon. Pressing the Help Icon will bring up and Alert Help Screen. See the Troubleshooting Guide on page 25 for details on each alert message.

FIGURE 11

14

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FIGURE 12

FIGURE 13

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Adjusting Language Settings The manufacturer’s default language is set to English. If you wish to change your language settings, please follow the instructions below. To access the Settings area press the “user settings” icon:

To access the Languages menu press the “language settings” icon:

The following screen opens and allows you to pick your language. The current active language icon will be bright, and all other languages available will be shown, but will be dimly lit. To select another language, press the appropriate language icon. To confirm your language change, press the “confirm action/ok” button. To return to the Settings screen and leave the language choice unchanged, press the “take no action/back” button as noted below.

Current active language setting

Other languages available

FIGURE 14 To return to the Settings menu without making a language change

To confirm your language choice

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Icon Definitions ICON

NAME

DEFINITIONS

ENGLISH

Select English Help Screens

CHINESE

Select Chinese Help Screens

DANISH

Select Danish Help Screens

GERMAN

Select German Help Screens

SPANISH

Select Spanish Help Screens

FRENCH

Select French Help Screens

ITALIAN

Select Italian Help Screens

TURKISH

Select Turkish Help Screens

DUTCH

Select Dutch Help Screens

PORTUGUESE

Select Portuguese Help Screens

SWEDISH

Select Swedish Help Screens

FINNISH

Select Finnish Help Screens

RUSSIAN

Select Russian Help Screens

PORTUGUESE (BRAZIL)

Select Brazilian Portuguese Help Screens

JAPANESE

Select Japanese Help Screens

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Icon Definitions - Continued This section provides a complete list of the icons as they appear on the screens within the graphical user interface. All icons can appear in one of three states as outlined: (1) brightly lit icon identifies that the icon is active, (2) dimly lit icon identifies that the icon is not active at this time, (3) brightly lit icon with a halo around it identifies that you are currently pressing that icon.

ICON

NAME

DEFINITIONS

OFF

ICON

NAME

DEFINITIONS

Turn off selected feature

HOME

Returns to the home screen from any window

ON

Turn on selected feature

UP

Scroll up one page in the help screens

TAKE NO ACTION/ GO BACK

Cancel and close window

DOWN

Scroll down a page in the help screen

CONFIRM ACTION/OK

Select and confirm action

FORWARD

Move to next screen

Foot Pedal CONTROLS

Adjust Foot Pedal settings

GO BACK

Go back to previous screen

OSCILLATE

Set handpiece to oscillate (rotate back and forth)

HELP

View Console help screen and settings

FORWARD

Set handpiece to forward (rotate in clockwise direction)

USER SETTINGS Return from user settings RETURN screen

REVERSE

Set handpiece to reverse (rotate in counterclockwise direction)

USER SETTINGS

View and adjust Console user settings

HANDPIECE INDICATOR

Pencil-Style handpiece

LANGUAGE SETTING

Change current language setting to new language

HANDPIECE INDICATOR

SmartDriver DUOe™ handpiece

MICROAIRE® SERVICE

Restricted access - password protected for MicroAire approved Service Centers only

HANDPIECE INDICATOR

SmartDriver™ Single Trigger handpiece

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Icon Definitions - Continued ICON

NAME

DEFINITIONS

IRRIGATOR SETTINGS

NAME

DEFINITIONS

Adjust irrigator settings

SOFTWARE UPGRADE

Software Upgrade (MicroAire Authorized Service Only)

Console SETTINGS

View and adjust Console display settings

DISCONNECT

Disconnect all instruments & Foot Pedal from Console

ADJUST BRIGHTNESS

View and adjust Console brightness

Foot Pedal

Icon for Foot Pedal information

ADJUST SOUNDS

View and adjust Console sounds

INSTRUMENT A

Icon for Instrument A information

MUTE

Mute Reverse Audio

INSTRUMENT B

Icon for Instrument B information

REVERSE DIRECTION AUDIO

Reverse Audio set up icon

IRRIGATOR

Icon for irrigator pump information

ONE TIME

Play reverse audio one time only

CONTINUOUS PLAY

Continuous play of reverse audio

HANDPIECE INDICATOR

Solo™ handpiece

LOCK INDICATOR

Indicates that handpiece is locked and in safe position

HANDPIECE INDICATOR

PAL® handpiece

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ICON

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