5025 and 5020 Electric Instrument Control Console Instructions for Use Rev D

Table of Contents Instrument Manual Translation Information

1

Symbol Definition

3

Intended Use

4

Equipment Description

4

Warning, Caution and Note Definitions

4

Compatible Instruments

5

System Setup

5

REF 5020 / REF 5025 Instrument Control Console Features

6

Connecting the Instruments

7

Loading Irrigation Tubing

8

Connecting Foot Pedal Control

9 –10

REF 5020 / REF 5025 Operation

11–18

Technical Description

19 – 20

Cleaning and Sterilization Guidelines

20

Environmental Parameters

20

Troubleshooting Guidelines

21

Maintenance Information

21 – 22

Proper Shipping, Storage and Handling

22

Essential Performance Statement

22

Electromagnetic Compatibility (EMC)

22 – 25

Warranty, Service, Repair and Disposal

25 – 26

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IM-5025 REV D

Safety Information MARKINGS

DEFINITION Refer to Instruction Manual/Booklet Consult Instructions for Use (IFU). IEC60601-1 TYPE BF Applied Part Product Catalog Number Authorized European Representative

>

Product Serial Number

Lot Number Example (1010175891)

Humidity Limitations

Atmospheric Pressure Limitation

Temperature Limitations DO NOT Immerse

DO NOT Lubricate

Date of Manufacture YYYY-MM

Manufacturer

Expiration Date YYYY-MM

0086

European Conformity Mark DO NOT expose to stray magnetic fields Potential Equalization Terminal DO NOT place fingers between irrigator gears/wheels Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Waste Electrical and Electronic Equipment (WEEE) European Community Symbol. Regarding Electrical Equipment European Union end of life of product, indicating separate collection for electrical and electronic equipment. ALWAYS follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its usual life. Non-Ionizing Electromagnetic Radiation

E494242

IM-5025 REV D

!!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

3

Intended Use The MicroAire REF 5025 or REF5020 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 of this IFU.

Equipment Description The MicroAire REF 5025 or REF5020 Instrument Control Console is an electronic control system for operating surgical instruments, such as drills, saws, wire drivers and power assisted liposuction instruments. The color touch screen display provides an intuitive graphical user interface that allows users to view system status and set parameters with a touch of the screen. Changes may be made easily, with little to no interruption during the surgical procedure. The console allows the operator to control the speed and direction of the surgical instrument motor. The speed is adjusted by a throttle actuator on the instrument or by an optional foot pedal unit. Instrument speed and direction are displayed on the front of the console. The maximum speed of the instrument may be adjusted via the touchscreen display. The console also provides an irrigation system for cooling cutting accessories while in use. The irrigation pump speed is adjustable from 5% to 100%, and when enabled the irrigation will operate any time the associated instrument is running. This condition is also shown on the display. When the console is in the Standby condition, the accessories are not powered and will not operate. The display is not operational and will not provide any information to the user. Likewise, the irrigation pump and contact closure are not powered and will not operate. In the ON condition, the accessories are powered on and will respond to user input. The display will show the status of each subsystem (instrument, foot pedal and irrigation system). If an abnormal condition is detected, the display will advise the user with a message.

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 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:

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

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 and 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. 4

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Compatible Instruments WARNING:

Before using any of the instruments listed below, Consult and Follow the appropriate Instructions for Use.

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.

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 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 5601-IT

Series 5000 Irrigation Tubing

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.

System Setup 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.

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REF 5020 / REF 5025 Instrument Control Console Features Irrigation Door opens to allow installation of irrigation tubing

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 Connect Foot Pedal here

Handpiece connectors Allows connection and running of handpieces simultaneously

FIGURE 2

Contact Closure Used for control of MicroAirecompatible suction pumps

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

Irrigation Bag Pole-Mounting Bracket Allows connection of pole to hold irrigation bag (Maximum Irrigation Bag Size of 3 Liters)

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

FIGURE 3

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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 stand by 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 REF5020 & REF 5025 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 D

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Loading Irrigation Tubing 1.

Open the irrigation 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.

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 12.

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 13.

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 14 and 15. Irrigation Bag

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

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 11

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 13

FIGURE 12 Load the section of tubing between the two connectors into the irrigation pump to prevent tubing from advancing inadvertently

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Connecting a Foot Pedal Control WARNING:

Use only a MicroAire REF 5401 Foot Control Pedal with a REF 5025-5401 Cable, with the REF 5025 and REF 5020 Electric Instrument Console. Failure to comply may result in healthcare professional and/or patient injury. Use of other foot pedal controllers will void warranty and may damage instrument console. Foot Pedal can only control one instrument at a time.

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 14. To activate the Foot Pedal, press the Foot Pedal Control icon. Press again to inactivate the Foot Pedal as shown in Figure 15. 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. 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.

á

á á FIGURE 14

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 15

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9

Foot Pedal Control Definition See Figure 16 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 resume switch. Press once to pause irrigation and then again to resume irrigation.

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

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

FIGURE 16

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

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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 4 - 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 6 - 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 D

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Adjusting Language Settings The manufacturer’s default language is set to English. If after powering up the Console 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 7 To return to the Settings menu without making a language change

To confirm your language choice

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Icon Definitions ICON

IM-5025 REV D

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

13

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 settings

LANGUAGE SETTING

Change current language setting to new language

HANDPIECE INDICATOR

SmartDriver DUOe™ handpiece settings

MICROAIRE® SERVICE

Restricted access - password protected for MicroAire approved Service Centers only

HANDPIECE INDICATOR

SmartDriver™ Single Trigger handpiece settings

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Icon Definitions - Continued ICON

IM-5025 REV D

NAME

DEFINITIONS

IRRIGATOR SETTINGS

ICON

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 settings

LOCK INDICATOR

Indicates that handpiece is locked and in safe position

HANDPIECE INDICATOR

PAL® handpiece settings

15

Selecting Settings (One handpiece connected) Once you have connected a handpiece to the Console, the instrument screen is where most of the user interaction will take place. When the Console is first turned on, the settings will default to factory settings until such time as the settings are manually modified by the user. 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.

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:

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.

The instrument type that is connected will display here

The Instrument Slider Bar allows the user to set the maximum instrument speed setting. Use the touch screen to adjust speed by sliding to or tapping area of desired maximum speed on bar. Maximum speed is 100%.

This icon is a display icon for the type of instrument connected

The Wrench icon is used to access the Settings menu screen

The Foot Pedal icon is either dim (the Foot Pedal is not currently active), or bright (Foot Pedal is active.) If no Foot Pedal is connected, then this icon will not be present on the screen.

The Help icon is used to access the Help menu FIGURE 8 The Irrigation icon is either dim (irrigation pump is not activated), or bright (to let you know it is currently active.)

The Irrigation Slider Bar allows the user to set the maximum desired flow rate of the irrigation pump. use the touch screen to adjust rate by sliding to or tapping area of desired maximum flow rate on bar. Maximum flow rate is 100%.

16

The Direction icon indicates the direction in which the instrument is currently set. Forward (F) (clockwise) motion, Reverse (R) (counterclockwise) motion or Oscillate (O) motion.

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Selecting Settings (Two handpieces connected) Once you have connected both handpieces to the Console, the instrument screen is where most of the user interaction will take place. When connecting two handpieces to the Console, they will be displayed separately on the screen as shown below in Figure 9. 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.

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.

The two instrument types that you have connected will display here The Instrument Slider Bar allows the user to set the maximum instrument speed setting. Use the touch screen to adjust speed by sliding to or tapping area of desired maximum speed on bar. Maximum speed is 100%.

This icon is a display icon that signifies that the instrument is set to the lock/safe position. This icon signifies what direction the instrument is currently set to run in Forward (F) (clockwise) motion, Reverse (R) (counterclockwise) motion or Oscillate (O).

This icon is used to access the Help menu

This icon is a display icon for the type of instrument you have connected

FIGURE 9

The Foot Pedal icon is either dim (foot pedal is not activated), or bright (Foot Pedal is active.) This icon will not appear if there is no Foot Pedal connected or if the instrument connected does not run with a foot pedal. IM-5025 REV D

This icon is used to access the Setting menu screen

The Irrigation icon is either dim (irrigation pump is not activated), or bright (irrigation pump is active.)

17

Change Running Direction of a Connected Instrument To change a pencil grip instrument from running in Forward direction to run in Reverse or Oscillate direction, follow the instructions noted below. Press the Instrument Direction icon to toggle between instrument directions available for the instrument you are running as seen in Figure 10. The currently active instrument direction will be displayed on the screen. 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.

Press the Instrument Direction icon to change the direction of a pencil grip instrument

FIGURE 10

Alerts Definitions This section provides a complete list of the Alert banners as they appear on the screens within the graphical user interface.

ALERT BANNERS Instrument Alert - Accompanies graphics or text showing the condition of either the instrument or the Foot Pedal.

Irrigation Pump Alert - Accompanies graphics or text showing the condition of the irrigation pump or pump head.

System Alert - Accompanies graphics or text showing the internal condition of the Console.

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Technical Description The MicroAire REF 5025 or REF5020 Instrument Control Console is an electronic control system for operating surgical instruments, such as drills, saws, wire drivers and power assisted liposuction instruments. The color touch screen display provides an intuitive graphical user interface that allows users to view system status and set parameters with a touch of the screen. Changes may be made easily, with little to no interruption during the surgical procedure. The console allows the operator to control the speed and direction of the surgical instrument motor. The speed is adjusted by a throttle actuator on the instrument or by an optional foot pedal unit. Instrument speed and direction are displayed on the front of the console. The maximum speed of the instrument may be adjusted via the touchscreen display. The console also provides an irrigation system for cooling cutting accessories while in use. The irrigation pump speed is adjustable from 5% to 100%, and when enabled the irrigation will operate any time the associated instrument is running. This condition is also shown on the display. 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.

When the console is in the Standby condition, the accessories are not powered and will not operate. The display is not operational and will not provide any information to the user. Likewise, the irrigation pump and contact closure are not powered and will not operate. In the ON condition, the accessories are powered on and will respond to user input. The display will show the status of each subsystem (instrument, foot pedal and irrigation system). If an abnormal condition is detected, the display will advise the user with a message.

IEC60601-1 EQUIPMENT CLASSIFICATION: •

CLASS 1 • Degree of electrical isolation: Type BF • The Ingress Protection Rating: IPX1 • The console is rated for use up to 3000 meters (9842 feet).

FIGURE 1 - System Block Diagram

The Console accepts input power of 100VAC – 240VAC 50/60Hz. 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 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”.

Intended devices for use with instrument input connectors: Series 5000 Instruments, 1000ET and PAL-650 Instruments. Intended device for use with foot pedal input connector: REF 5401 Foot Pedal Controller. The SIP/SOP rating for this applied part is: 8VDC. Intended device for use with Contact Closure output connector: For use only with a MicroAire IEC 60601-1 compliant suction pump for use with the PAL-650.

IM-5025 REV D

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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).

Intended device for Irrigation Pump: REF 5601-IT Irrigation Tubing Set. Intended devices for use with a USB Flash Drive. The SIP/SOP rating for this connector is: 5VDC. 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.

Cleaning and Sterilization Guidelines MicroAire’s powered surgical instruments (ie. handpieces, handpiece cable, etc.) are normally sterilized by steam, using dynamic air removal steam sterilizer. For specific sterilization instructions for handpieces, see their respective Instructions for Use. CAUTION:

DO NOT sterilize the 5025/5020 Console, power cord or 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.

Environmental Parameters Operating Operations

Devices have been tested and proven to operate within the following conditions: 75.2° F/24° C

70kPa

10%

50° F/10° C

106kPa

91%

Humidity

Temperature

Atmospheric

Shipping and Storage Conditions

Devices have been tested and proven to operate after repeated exposure to the following conditions: 140° F/60° C

-4° F/-20° C

70kPa

10%

Temperature

106kPa

91%

Humidity

Atmospheric

The materials and components used in the construction of this device were selected to ensure that the device could be shipped by any standard commercial method without special handling conditions.

WARNING:

DO NOT use this equipment in the presence of flammable anesthetics..

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