Medtronic ES110 Instructions for Use

Instructions for Use 175037EN B

The Midas Rex™ Microsaw and Triton™ System

Microsaws and Triton Electric High-Torque Handpiece

Customer service

For further information regarding the use of this product or to report any problems, please contact Medtronic Customer Service or contact your local distributor:

Medtronic Powered Surgical Solutions

4620 North Beach Street

Fort Worth, Texas 76137 USA

US Help Line (800 468 9710)

www.medtronic.com

International Service: International Customers should contact their local Medtronic representative.

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The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.

The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Intelliow™ IPC™, Legend™, Legend EHS™, Legend EHS Stylus™, Midas Rex™, Mednext™, Stylus Touch™, and Triton™. All other trademarks, service marks, registered trademarks or registered service marks are the property of their respective owners in the United States and other countries.

Contents

Glossary .......................................................................................................................................................................................... 1

Indications for use ...................................................................................................................................................................... 1

Device description ......................................................................................................................................................................1

Contraindications .......................................................................................................................................................................1

No latex policy ............................................................................................................................................................................. 1

Warnings ....................................................................................................................................................................................... 1

Precautions ...................................................................................................................................................................................2

Handpiece systems ....................................................................................................................................................................3

Attachment assembly ............................................................................................................................................................... 3

IPC set up ....................................................................................................................................................................................... 3

IPC touchscreen controls .........................................................................................................................................................4

Manual safe mode ...................................................................................................................................................................... 4

Multifunction foot pedal controls .........................................................................................................................................5

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ..............................................................5

Technical specications ............................................................................................................................................................ 5

Midas Rex microsaw blade and rasp nomenclature ......................................................................................................6

Installation and removal of the Midas Rex microsaw attachments .......................................................................... 7

Triton electric high-torque handpiece attachments ...................................................................................................... 8

Installing, activating, and removing an attachment in the Triton electric high-torque handpiece .............8

Installation and removal of cutting tools, wires, and pins in Triton electric high-torque attachments ......9

Cleaning and sterilization ......................................................................................................................................................11

The Midas Rex microsaws and Triton electric high-torque handpiece system Limited Warranty*

(U.S. customers only) ...............................................................................................................................................................14

Symbols ........................................................................................................................................................................................15

System warnings ...................................................................................................................................................................1

Component warnings .......................................................................................................................................................... 2

Tools and disposable components warnings .............................................................................................................. 2

Connect to the IPC ................................................................................................................................................................ 3

IPC pump detection ............................................................................................................................................................. 4

Speed ......................................................................................................................................................................................... 4

Irrigation ................................................................................................................................................................................... 4

Safe mode (SAFE) ..................................................................................................................................................................4

Mode select switch ............................................................................................................................................................... 4

Foot and nger-control ...................................................................................................................................................... 4

Reverse pedal ..........................................................................................................................................................................5

Microsaw reciprocating saw attachment ....................................................................................................................7

Microsaw sagittal saw attachment ................................................................................................................................7

Microsaw oscillating saw attachment ...........................................................................................................................7

Microsaw irrigation and tubing clips attachment .................................................................................................... 8

Triton sagital saw attachment .......................................................................................................................................... 9

Triton reciprocating saw attachment ............................................................................................................................. 9

Triton AO/Synthes Chuck and Trinkle Chuck attachment ...................................................................................... 9

Triton Jacobs Chuck attachment ..................................................................................................................................... 9

Triton Hudson Chuck and Zimmer Chuck attachment .......................................................................................... 10

Triton wire collet and pin collet attachment ...........................................................................................................10

Midas Rex microsaw reprocessing instructions ......................................................................................................11

Triton electric high-torque handpiece reprocessing instructions ....................................................................12

The Midas Rex Microsaw and Triton system

Glossary

The following words and acronyms may be used in this manual:

EHS Electric High-Speed

FCU Foot Control Unit

FWD Forward - Rotation is clockwise

IPC Integrated Power Console

REV Reverse - Rotation is counter-clockwise

Indications for use

The Electric Drill System is an electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Electric Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy

• Lumbar Stenosis Decompression

• Posterior Lumbar lnterbody Fusion (PLIF)

• Transforaminal Lumbar Interbody Fusion (TLIF)

• Anterior Lumbar lnterbody Fusion (ALIF)

• Direct Lateral lnterbody Fusion (DLIF)

Device description

The Midas Rex microsaw is a powered saw system that is used to remove soft tissue, hard tissue, and bone during surgical procedures. The Triton electric high-torque

handpiece is a powered system that is used to drive screws, wires, and pins, drill pilot holes, and remove soft tissue, hard tissue, and bone during surgical procedures.

The devices are intended for use by physicians trained in the procedures described.

Contraindications

None

No latex policy

Medtronic Powered Surgical Solutions guarantees that all Legend equipment and products identied in this manual manufactured by and/or for Medtronic Powered Surgical Solutions do not contain latex.

Medtronic Powered Surgical Solutions’ packaging materials, labels, pouches, package inserts, or similar items do not contain latex.

Warnings

System warnings

W1 The Midas Rex microsaw and Trition electric high-torque handpiece system operator must be familiar with this Instructions for Use, the IPC User’s Guide, their

precautions, procedures and safety issues.

W2 The Midas Rex microsaw and Trition electric high-torque handpiece system and its associated equipment should be used only by qualied medical

professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.

W3 Do not place the Midas Rex microsaw and Trition electric high-torque handpiece systems in the proximity of a magnetic eld, such as magnetic drape or

Magnetic Resonance Imaging (MRI) equipment to avoid inadvertent handpiece activation. W4 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic or replaced. W5 Heavy side loads and/or long operating periods may cause the device to overheat. W6 The Midas Rex microsaw and Trition electric high-torque handpiece systems are precision surgical instruments. With precision instruments, excessive force,

beyond the design strength of the instruments, can be caused by even simple manual overloading. W7 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. W8 Carefully inspect dissecting tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities, or other defects. Replace any

suspicious dissecting tools with a new one prior to use. W9 Use only dissecting tools specically designed for use with the Midas Rex microsaw and Trition electric high-torque handpiece systems. Match the

nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. W10 Do not use the Midas Rex microsaw and Trition electric high-torque handpiece systems without proper cleaning and sterilization. W11 Refer to the IPC Instructions for Use for additional instructions, warnings, and cautions. W12 Refer IPC User’s Guide for warnings related to IPC. W13 The Midas Rex microsaw and Trition electric high-torque handpiece system complies with EN60601-1-2 safety standard for electromagnetic compatibility

(EMC), requirements, and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive

equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference.

Diminished performance may lengthen operating time for anesthetized patient. W14 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information

provided in this Instructions for Use. W15 Portable and mobile radio frequency (RF) communications equipment can aect medical electrical equipment. W16 Do not operate the Midas Rex microsaw and Trition electric high-torque handpiece systems in the presence of (MRI) devices. W17 Use of accessories and cables other than those specied and sold by Medtronic may result in increased emissions and decreased immunity of this unit. W18 All service must be performed by Medtronic qualied personnel only.

The Midas Rex Microsaw and Triton system

Component warnings

W19 Do not use any parts other than Medtronic system components as damage or substandard performance could result. W20 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic

qualied personnel or replaced. Damaged parts may deposit metal shavings on surgical site, or may cause injury.

W21 Employ visualization, including use of imaging techniques (e.g., uoroscopy, image guided surgery) when using rotating powered accessories. Discontinue

powered application in the event of lack of visualization of surgical site.

W22 Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment, causing patient injury.

To avoid this, motors and attachments should be serviced periodically at intervals recommended by Medtronic. W23 Electrical contacts must be dry prior to use. W24 Do not use an overheated device, as it may cause thermal injury to the patient or operator. W25 Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. W26 Do not attempt to change a dissecting tool, or attachment while the motor is running or when the motor or attachment is in an overheated state. W27 Do not immerse the system components, except as noted. W28 Do not place the Midas Rex microsaw, Triton electric high-torque handpiece, attachment or tool on the patient or in an unsecured location during surgery. W29 A device that is not functioning properly should not be used until the unit is repaired and tested by Medtronic to ensure that it is functioning in accordance

with Medtronic specications. W30 Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. W31 Do not change an accessory with the handpiece running to prevent laceration of user and/or cross-contamination through compromised glove. W32 Do not modify accessories used with the handpiece. Performance could be diminished with modied accessories. W33 Verify reusable device was sterilized prior to use. If not sterilized, do not use. W34 Sterilize and dry reusable device before storing. Decrease likelihood of cross-contamination with timely sterilization. After each procedure, properly clean and

sterilize all reusable system components. W35 Place the nger-control of the Midas Rex microsaws in Safe Mode while not in use. W36 Any device that has not been used in a four year period should be serviced by Medtronic to ensure its performance.

Tools and disposable components warnings

W37 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-

cutting powered tools induce bleeding and removal of signicant tissue and bone. W38 Use methods at the operative site to control bleeding that do not compromise patient safety during surgery. W39 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination through compromised glove. W40 Operate the tool only after appropriate anatomical landmarks at the intended surgical site have been conrmed. W41 Use care in application of the rotating cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories. W42 Bending or prying may break the accessory, causing harm to patient or user. W43 Do not use excessive force to pry or push bone with the attachment or tool during dissection. W44 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed of the motor to prevent vibration. Change to a new tool

to prevent unintended tissue removal from patient. W45 Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal

from patient. W46 Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage. W47 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. W48 Cutting edges of the tool utes or blades are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. W49 Do not re-sharpen used tools. Worn tools should be replaced with new ones frequently to ensure eective cutting and control. W50 Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious

tools with a new one prior to use. W51 Excessive pressure applied to the tool may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the

tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. W52 Use only tools specically designed for use with the Midas Rex microsaw and Triton electric high-torque handpiece systems. W53 Do not sterilize disposable devices. They are terminally sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once. W54 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization. W55 Do not use an accessory if its packaging is opened or damaged. A broken seal oers no protection against cross-contamination. W56 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. W57 Do not use dull, damaged, or bent tools. Use of dull tools can reduce cutting eectiveness and can cause the handpiece temperature to increase. W58 Always ensure that the attachment is securely engaged into the handpiece prior to operating the system. Always examine operation of each tool in a

handpiece prior to use. W59 Powered burs and drills should be operated in the forward mode only. W60 Exposure of tool packaging to light for extended periods of time may cause damage to packaging.

Precautions

P1 Do not attempt to disconnect the cable from the Midas Rex microsaw. Do not kink cables. Inspect cables and pins for cracks, tears, or corrosion. P2 The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. P3 Remove devices from instrument case before placing into washer disinfector and allow devices to drain. Orient devices in the washer-disinfector by following

manufacturer recommendations. P4 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. P5 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. P6 Remove and discard accessories following local regulations for disposal of contaminated materials.

The Midas Rex Microsaw and Triton system

Handpiece systems

The Midas Rex microsaw and the Triton electric high-torque handpiece systems are powered by the IPC. The following instructions are in addition to Set up the IPC general assembly instructions provided in the IPC manual. Complete the IPC setup, then continue to the instructions below.

Clean and sterilize the handpiece systems, prior to rst use. Refer to the reprocessing instructions contained in this manual for additional information.

The Midas Rex microsaw systems are foot (Figure 1-1) and nger-controlled (Figure 1-2) saws. Operation of the foot-controlled saws is via the multifunction foot pedal and that of the nger-controlled saws by pressing the nger lever.

The Triton electric high-torque handpiece system (Figure 2) does not require the multi-function foot pedal to operate the handpiece, but it may be used to change control settings.

1-1

Foot-controlled microsaw handpieces Finger-controlled microsaw handpieces

1. Reciprocating saw collet

2. Sagittal saw blade release button

3. Oscillating saw head

Triton electric high-torque handpiece

4. Oscillating saw collet

5. Color band

Attachment assembly

Refer to the Midas Rex microsaw and Triton electric high-torque handpiece attachments installation and removal sections for attachment instructions.

IPC set up

The following instructions for the Midas Rex microsaw and the Triton electric high-torque handpiece systems are in addition to the general assembly instructions found in the Integrated Power Console User’s Guide. To obtain a copy of the IPC User’s Guide, please contact Medtronic or your local distributor.

Connect to the IPC

Locate the Midas Rex microsaw or the Triton electric high-torque handpiece, and Foot Control Unit (FCU) ports on the IPC connector panel (Figure 3) and insert the connector.

Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the console, then insert the connector.

1-2

3 4

1. Reciprocating saw collet

2. Sagittal saw blade release button

3. Oscillating saw head

4. Oscillating saw collet

5. Color band

6. Finger lever safe mode switch

7. Finger lever

1. Quick-release button

2. Variable speed trigger

3. Safe mode trigger

4. Mode select switch

IPC connector panel connection ports

1. Midas Rex microsaws or Triton electric high-torque handpiece connection port

2. Intelliow irrigation remote control

3. Foot control unit

The Midas Rex Microsaw and Triton system

Speed

IPC pump detection

Irrigation for the Midas Rex microsaw is provided by Pump 2 on the IPC. If irrigation is not required, select None for Pump 2 via the IPC touch screen (see IPC manual for detailed instructions). For irrigation and tubing clips installation, see the microsaw handpiece attachments installation and removal section.

Note: Use of irrigation with the Midas Rex microsaws is optional.

IPC touchscreen controls

To set or adjust the Midas Rex microsaws (Figure 4-1) or Triton electric high-torque handpiece (Figure 4-2) controls, on the IPC touchscreen, in the control box, do the following:

Important: When using the microsaw handpiece the IPC touchscreen recognizes the connected saw, then displays the appropriate name and color ring (Figure 4-1).

Speed

• To adjust the Midas Rex microsaws speed in the Speed control box (Figure 4-1), press the plus button to increase maximum speed or the minus button to decrease maximum speed.

• The Midas Rex microsaws variable speed adjustment ranges from 0% to 100%. Note: When the nger-controlled Midas Rex microsaw is in safe mode, the speed control box displays SAFE (Figure 5). Refer to the Safe mode (SAFE) topic for additional information.

• To adjust the Triton handpieces variable speed in Forward (FWD) or Reverse (REV) mode, in the Speed control box, press the plus button to increase variable speed or the minus button to decrease variable speed (Figure 4-2).

4-1

IPC Midas Rex microsaws touchscreen IPC Triton touchscreen

3 4

1. Name and color ring of the connected saw

2. Speed control box

3. Pump control box

4. Control box

4-2

FWD Speed

REV Speed

100

TRITON

Irrigation

To adjust the Midas Rex microsaw irrigation ow rate, in the Pump control box, press the plus button to increase ow rate or the minus button to decrease ow rate. If intermittent ow is available, pressing the plus or minus button progresses the system through intermittent and continuous ow. The system displays Intermittent when in intermittent ow mode. The default ow rate is 0cc per minute in Forward or Reverse mode. The maximum ow rate is 50cc per minute.

Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow irrigation remote control.

Safe mode (SAFE)

• When the Midas Rex microsaw nger-control handpiece is in safe mode, it is inoperable until the safety is turned o. The Speed control box on the microsaw touchscreen displays SAFE when the handpiece is the active handpiece and in safe mode (Figure 5).

• Switch the Midas Rex microsaw nger-control handpiece to safe mode any time it is attached to the console, but not currently being used.

• When more than one handpiece is attached to the console, use the safety switch of an inactive handpiece to activate that handpiece and make it ready for use.

Midas Rex microsaw nger-control

handpiece IPC screen safe mode

SAFE

RPM

Mode select switch

Use the mode select switch (Figure 2) to change the Triton electric high-torque handpiece from Forward to Reverse when the handpiece is the active handpiece.

Foot and nger-control

To switch the Midas Rex microsaws between foot and nger control, or to use both, select the appropriate option in the Control box. Finger-controlled saws can be operated via the lever on the handpiece, or the foot pedal.

Note: This option is only available when using a Midas Rex microsaw nger-controlled handpiece.

Manual safe mode

• When the Triton electric high-torque handpiece trigger is placed in the safe mode, it cannot be activated. The handpiece trigger has two safe positions. To activate the safe mode, rotate the trigger either clockwise or counter-clockwise until it stops (Figure 6-1). To activate the handpiece in the run position, rotate the trigger to the vertical position (Figure 6-2) and then squeeze it.

• It is recommended that the trigger be set to safe mode when setting up the device, changing attachments, blades, tools or accessories.

6-1

Triton electric high-torque handpiece

safe mode positions

6-2

Triton electric high-torque handpiece

run position

The Midas Rex Microsaw and Triton system

Reverse Pedal

Multifunction foot pedal controls

Important: By default, press each button on the foot pedal for at least 100 mS for the selection to become active. Use the IPC touch screen Settings screen to change

the default value.

To use the multifunction foot pedal (Figure 7-1) to control the handpiece, do the following:

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

• To toggle between the start/stop mode and variable speed mode, press the control button.

Note: Functionality of the control button may be changed in the handpiece Defaults menu to pause irrigation. Refer to Change System Settings in the Pre-Operating Instructions section of the IPC User’s Guide.

• To change the handpiece, press the handpiece button.

Note: You can switch between nger-controlled handpieces by pressing the nger lever on the Midas Rex microsaw handpiece.

7-1

Multifunction foot pedal & y-splitter

Reverse pedal

When using the Triton electric high-torque handpiece you can connect the optional foot pedal to the IPC console. The pedal can be used as an alternative method of activating Reverse mode (without manipulating the Mode select switch at the bottom of the handpiece). When the pedal is connected, the Reverse Pedal control box appears on the screen (Figure 7-2). Note: By default, pedal functionality is turned OFF.

1. To use the pedal, press ON in the Reverse Pedal control box on the IPC touch screen.

2. With the pedal turned on, step on the foot pedal to put the handpiece into Reverse mode (regardless of what position the Mode select switch is in). NOTE: The trigger control must be pressed to activate the handpiece, even when you are stepping on the foot pedal.

3. Remove your foot from the pedal to return the handpiece to the mode currently dened by the Mode select switch on the handpiece.

1. Mode button

2. Handpiece button

3. Control button

4. Slip-resistant food pad

5. Foot pedal

6. Y-splitter

7. Port 1

8. Port 2

Reverse pedal

7-2

control box

Reverse Pedal

OFF

REV REV

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Refer to the Guidance and Manufacturer’s Declaration – Electromagnetic Immunity section of the IPC User’s Guide.

Technical specications

Table 1: Triton electric high-torque handpiece technical specications

Triton electric high-torque handpiece ED500

Size Weight Speed Duty cycle for applied part

3.5 inches length x 5.4 inches height x 1.1 inches width

2.1 lbs 180-1800 rpm (actual speed depends on attachment used)

Cycle time: 20 seconds on maximum / 20 seconds o minimum

Maximum number of cycles before resting handpiece: 6

Maximum number of cycles before resting attachment: 3

Minimum rest period: 25 minutes

The Midas Rex Microsaw and Triton system

Table 2: Midas Rex microsaw technical specications

Microsaw number

Microsaw type Size Weight Speed Duty cycle ≤ 20°C ambient

(one cut period = 20 seconds on / 20 seconds o)

ES200 Reciprocating 20.3 cm length x 2.3 cm

300 g 1400-14000 cpm ≤ 15 cut periods

width

ES300 Sagittal 17.3 cm length x 2.3 cm

250 g 2000-20000 cpm ≤ 6 cut periods2 ≤ 6 cut periods

width

ES100 Oscillating 19.8 cm length x 2.3 cm

300 g 1600-16000 cpm ≤ 4 cut periods

width

ES210 Finger-controlled

reciprocating

ES310 Finger-controlled

sagittal

ES110 Finger-controlled

oscillating

20.3 cm length x 3.2 cm height x 2.3 cm width

17.8 cm length x 3.2 cm height x 2.3 cm width

21.0 cm length x 3.2 cm height x 2.3 cm width

320 g 1400-14000 cpm ≤ 15 cut periods

300 g 2000-20000 cpm ≤ 6 cut periods

320 g 1600-16000 cpm ≤ 4 cut periods

Time for cool down after maximum number of cut periods listed above: 25 minutes.

5 periods with light force (0.8 Lbf), 5 periods with medium force (2.1 Lbf ), 5 periods with heavy force (3.9 Lbf)

2 periods with light force (0.8 Lbf), 2 periods with medium force (1.5 Lbf ), 2 periods with heavy force (3.0 Lbf)

1 period with light force (0.7 Lbf), 2 periods with medium force (1.5 Lbf ), 1 period with heavy force (2.6 Lbf)

1 period with light force (0.8 Lbf), 2 periods with medium force (2.1 Lbf ), 2 periods with heavy force (3.9 Lbf)

2 periods with light force (0.8 Lbf), 2 periods with medium force (1.5 Lbf ), 2 periods with heavy force (3.0 Lbf)

1 period with light force (0.7 Lbf), 1 period with medium force (1.5 Lbf ), 1 period with heavy force (2.6 Lbf)

Duty cycle > 20°C ambient (one cut period = 20 seconds on / 40 seconds o)

≤ 5 cut periods

≤ 3 cut periods

≤ 5 cut periods

≤ 6 cut periods

≤ 3 cut periods

Midas Rex microsaw blade and rasp nomenclature

Important: You can only use reciprocating blades and rasps with the reciprocating saw. You can use sagittal and oscillating blades interchangeably.

Part numbers for microsaw blades follow a standard naming convention (Figure 8).

1 2 0 S 9 7 - 0 3 F

Microsaw blade part number naming convention 1. Cut limit depth

XX.X millimeters (Ex.: 120 = 12.0 mm)

Note: Blade depth markings are approximate and should be used for reference only.

2. Saw type

S Sagittal/Oscillating R Reciprocating

3. Cut width/length

X.X millimeters (Ex.: 97 = 9.7 mm)

Note: Width for sagittal/oscillating blades and length for reciprocating blades

Microsaw blade part number naming convention 4. Blade thickness

X.X millimeters (Ex.: 03 = 0.3 mm)

5. Other identiers

F Fine Teeth PT Pointed Blade

ARC Rounded Blade ST Straight Rasp

BAY Bayoneted Blade CC Crosscut Rasp

Installation and removal of the Midas Rex microsaw attachments

Microsaw reciprocating saw attachment

Important: Verify that the color code on the blade package matches the

color band on the handpiece (Figures 1-1 and 1-2).

Installation:

1. Rotate the collet knob to the unlocked position (Figure 10).

2. Insert the reciprocating blade or rasp into the collet.

3. Rotate the collet knob 90° to the locked position to secure the blade.

4. Ensure the blade is secure by gently pulling on it and verify it does not detach.

Removal:

1. To remove the microsaw reciprocating saw blade, rotate the collet knob to the unlocked position. Remove blade and discard per local regulations.

Microsaw reciprocating saw attachment installation

The Midas Rex Microsaw and Triton system

1. Rotate the collet knob to the unlocked position

2. Rotate the collet knob 90° to the locked position

Microsaw sagittal saw attachment

Important: Verify that the color code on the blade package matches the color band on the handpiece (Figures 1-1 and 1-2).

Installation:

1. Press the blade release button (Figure 11-1) and insert a blade at the desired angle (Figure 11-2).

2. Release the blade release button to secure the blade.

3. Ensure the blade is secure by gently moving it from side to side and verify it does not detach.

Removal:

1. To remove the microsaw sagital saw blade, press the blade release button. Remove blade and discard per local regulations.

11-1

Microsaw sagital saw attachment installation Microsaw sagital saw blade

1. Blade release button

2. Blade

11-2

installation angles

Microsaw oscillating saw attachment

Important: Verify that the color code on the blade package matches the color band on the handpiece (Figures 1a and 1b).

Installation:

1. Rotate collet to the unlocked position (Figure 12-1).

2. Insert the blade into the collet until it “clicks” into place. Note: The blade can be inserted in 8 dierent orientations to facilitate surgical access (Figure 12-2).

3. Rotate the collet to the locked position (Figure 12-1).

4. Ensure the blade is secure by gently moving it from side to side and verify that it does not detach.

Removal:

1. To remove the microsaw oscillating saw blade, rotate the collet to the unlocked position. Remove blade and discard per local regulations.

12-1

Microsaw oscillating saw attachment installation Microsaw installation oscillating pin alignment

12-2

1. Rotate collet to the unlocked position

2. Insert the blade into the collet

3. Rotate the collet

4. The locked position

The Midas Rex Microsaw and Triton system

Microsaw irrigation and tubing clips attachment

Note: Use of irrigation with the microsaws is optional.

Note: Refer to IPC manual for instructions on how to install tubing to the pump.

Installation:

1. Snap the rear portion of the irrigation clip on to the handpiece (Figures 13-1 and 13-2). Note: On nger-controlled handpieces, attach the rear portion of the irrigation clip to the rotatable nger lever base (Figure 13-2).

2. Adjust the irrigation tube tip location by moving the metal irrigation dispensing tip in or out.

3. Snap the front of the tubing clip on to the handpiece.

4. To readjust the irrigation dispening tip location, disengage just the front of the irrigation clip, and follow steps 2 and 3 above.

Removal:

1. Remove irrigation tubing set from attachment by pulling on the clip to detach it.

2. Similarly detatch all clips.

3. Discard of the irrigation tubing set per local regulations.

13-1

13-2

Foot-controlled microsaw irrigation and tubing clip installation

Finger-controlled microsaw irrigation and tubing clip installation

Triton electric high-torque handpiece attachments

The following attachments are available for use with the Triton electric high-torque handpiece.

• Sagittal saw attachment – Converts the Triton electric high-torque handpiece into a sagittal saw

• Reciprocating saw attachment – Converts the Triton electric high-torque handpiece into a reciprocating saw

• Oscillating saw attachment – Converts the Triton electric high-torque handpiece into a oscillating saw

• A/O Synthesis Chuck attachment – Used to drive tools with an A/O Synthesis shank

• Trinkle Chuck attachment - Used to drive tools with an Trinkle shank

• Jacob’s Chuck attachment – This attachment is available is 5/32” and 1/4” sizes and uses a key to lock and unlock the chuck. It is used to drive drill bits, wires and pins up to 0.156” (3.9 mm) or 0.25” (6.4 mm) in diameter

• Hudson Chuck attachment – Used to drive tools with a Hudson shank

• Zimmer Chuck attachment – Used to drive tools with a Zimmer shank

• Wire collet – Used to drive K-wire of diameter 0.028” (0.7 mm) thru 0.062” (1.5 mm)

• Pin collet – Used to drive pins of diameter 0.078” (2.0 mm) thru 0.125” (3.2 mm)

• Keyless Chuck attachment - This attachment is available is 5/32” and 1/4” sizes. It is used to drive drill bits, wires and pins up to 0.156” (3.9 mm) or 0.25” (6.4 mm) in diameter.

• Extension handle - The extension handle is an accessory that screws into the back of the handpiece. This provides balance and two-handed control for various drilling and cutting applications.

Installing, activating, and removing an attachment in the Triton electric high-torque handpiece

The following procedure applies to all Triton high-torque handpiece attachments. Attachments may be preload with the tool/blade before insertion into the Triton handpiece. For installing tools/blades onto specic attachments, refer the sections below.

Caution: Insert all attachments into the handpiece with the handpiece trigger in the SAFE position (Figure 5b).

1. Installing and attachment:

• Rotate handpiece trigger to SAFE position (Figure 5b).

• Insert an attachment while depressing the quick-release button on top of the handpiece. Snap the attachment into the handpiece with a slight twisting

motion until it is seated.

• Place the handpiece in the RUN position by rotating the trigger control to the vertical position.

2. Actuating the attachment:

• Rotate handpiece trigger to RUN position (Figure 5c)

• Rotate Mode select switch at the base of the handle to the FORWARD position.

• Actuate the attachment via squeezing the trigger

3. Detaching the attachment:

• After use, return the trigger control to the SAFE position.

• Remove the attachment by simultaneously pressing the quick-release button on top of the handpiece and pulling the attachment out of the Triton handpiece.

The Midas Rex Microsaw and Triton system

Installation and removal of cutting tools, wires, and pins in Triton electric high-torque attachments

Triton sagital saw attachment

Warning:

Triton saw attachments should only be used with Medtronic Triton saw blades. Refer to the Triton Quick Reference Saw Blade Guide (LIT200017) for additional information on Triton saw blades.

Installation:

1. The attachment can be installed in 12 dierent orientations to facilitate surgical access. Insert the sagittal saw attachment into the handpiece in a position to allow easy insertion of the sagittal saw key (Figure 14).

2. Insert the sagittal saw key into the attachment and turn counterclockwise until there is slight resistance.

3. Insert the blade into the space between the two jaws, ensuring that the blade is fully seated.

4. Reinsert the sagittal saw key and rotate it clockwise to lock the blade. Run briey, then retighten blade. Caution: Do not over-tighten.

5. Reposition attachment as necessary to facilitate surgical access.

Triton sagital saw installation

Removal:

1. To remove the Triton sagital saw blade, insert the sagittal saw key into the attachment and turn counterclockwise. Remove blade and discard per local regulations.

Triton reciprocating saw attachment

Warning:

Triton saw attachments should only be used with Medtronic Triton saw blades. Refer to the Triton Quick Reference Saw Blade Guide (LIT200017) for additional information on Triton saw blades.

Installation:

1. Loosen the collet nut then insert the blade until it is fully seated (Figure 15). Note: You can install the attachment in dierent positions to facilitate surgical access.

2. Finger-tighten the collet nut. Run briey, then retighten collet nut.

Removal:

1. To remove the Triton reciprocating saw blade, unscrew the collet nut. Remove blade and discard per local regulations.

Triton reciprocating saw attachment installation

Triton AO/Synthes Chuck and Trinkle Chuck attachment

Installation:

1. To install a drill bit, pull back on the attachment collar (Figure 16).

2. Insert the drill bit and release the attachment collar.

Removal:

1. To remove a drill bit, pull back on the attachment collar.

2. Remove the drill bit and release the attachment collar.

3. Discard the drill bit per local regulations.

4. Remove the attachment per the instructions provided in the Installing, activating, and removing an attachment in the Triton electric high-torque handpiece section.

Triton AO/Synthes Chuck and Trinkle Chuck installation

Triton Jacobs Chuck attachment

Installation:

1. To install a drill bit, turn the key to open the chuck (or spin the collar if using a keyless chuck attachment) (Figure 17).

2. Insert the drill bit.

3. Secure the drill bit by inserting the key into the collet and turning it (or spin the collar if using a keyless chuck attachment).

Removal:

1. To remove a drill bit, turn the key to open the chuck (or spin the collar if using a keyless chuck attachment).

2. Remove the drill bit and discard per local regulations.

Triton Jacobs Chuck Attachment installation

The Midas Rex Microsaw and Triton system

Triton Hudson Chuck and Zimmer Chuck attachment

Installation:

1. To install an instrument, pull back on the attachment collar, then insert the tang end of the instrument into the chuck (Figure 18).

2. Release the collar to secure the tool.

Triton Hudson Chuck and Zimmer

Chuck attachment installation

Removal:

1. To remove an instrument, pull back on the attachment collar, then remove the instrument from the chuck and discard per local regulations.

Triton wire collet and pin collet attachment

The wire collet accepts wires up to 1.6 mm (.062 inches) in diameter. The pin collet accepts pins up to 3.2 mm (.125 inches) in di am e ter.

Installation:

1. Insert the wire or pin collet (Figure 19) into the handpiece.

2. Screw the cannulated extension to the back of the handpiece to protect the op er a tor from the end of the wire or pin.

3. Insert the wire or pin from the front or back of the handpiece.

4. Switch the device to the RUN position by po si tion ing the trigger control vertically.

5. Turn the Mode select switch at the base of the handle to the FORWARD position.

6. While squeeze the wire or pin advance lever and holding it, press the trigger control to drive the wire or pin. The pressure-sensitive trigger allows variable speed operation.

7. To obtain additional wire or pin length, release the wire or pin, squeeze only the wire or pin advance lever and pull the device back.

8. Squeeze the wire/pin advance lever and trigger control to drive the additional length of the wire or pin.

Triton wire and pin collet attachment installation

Removal:

1. To remove threaded wire/pin, put the Mode select switch in REVERSE, squeeze the wire/pin advance lever and press the trigger control.

2. Remove the attachment per the instructions provided in the Installing, activating, and removing an attachment in the Triton electric high-torque handpiece section..

The Midas Rex Microsaw and Triton system

Cleaning and sterilization

Cleaning and sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com.

Note: The reprocessing instructions provided below have been validated by the manufacturer as being capable of preparing the product for re-use. It remains the responsibility of the processor to ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Note: The Pre-Vac (FR/WHO) and Pre-Vac (UK) sterilization cycles are not considered by the United States Food and Drug Administration (US FDA) to be standard sterilization cycles. Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the selected sterilization cycle specications (time and temperature).

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ Creutzfeldt-Jakob disease (CJD) diagnosis.

Midas Rex microsaw reprocessing instructions

WARNINGS Do not soak/submerge devices.

Do not use ultrasound to clean devices.

Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.

The use of a washer-disinfector for cleaning may cause a degradation in performance.

Allow an adequate cooling period after steam sterilization.

Limitations on reprocessing

Point of use Follow hospital procedures.

Containment and transportation

Preparation for decontamination

Preclean instructions prior to use in an automated washer

Cleaning: Automated Caution: Do not use ultrasonic cleaner.

The product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

Verify functionality prior to re-use.

It is recommended that devices are reprocessed as soon as is practical following use.

Disconnect handpiece from console.

Remove irrigation tubing/clips, saw blade, and cable management clamps.

Prior to placing the saws in the automated washer, manually rinse the saw body with the distal end pointed down under tap water, until no visible soil is noticed.

Move any movable parts back and forth to allow water to reach hard-to-rinse areas.

Transfer the devices into the washer for processing, making sure that the oscillating saw collet is open. Place the devices in the washer to facilitate drainage.

Verify that devices are visually clean after automated cleaning.

Midas Rex microsaw automated wash cycle using a neutral enzymatic detergent (pH 6.0-8.0)

Phase Recirculation time Water temperature Detergent type

Pre-wash 2 minutes (02:00) Cold water Not applicable

Wash 5 minutes (05:00) 66°C (151°F) (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute (01:00) Hot tap water Not applicable

Cleaning: Manual Rinse the device thoroughly under running water, with the collet end pointed down.

Wipe the saw body and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 (henceforth referred to as “cleaning solution”).

With the blade collet end pointed down, brush saw body, blade-release button, and extended lever tip (if applicable) with a nylon brush that has been dipped in cleaning solution.

Sagittal only:

1. Dip the distal end of the saw in cleaning solution and agitate for 10-15 seconds.

2. Press and hold the blade-release button, then repeat step 1.

3. With the blade-release button pressed, ush approximately 15 mL of cleaning solution from a syringe into the blade opening.

4. Flush all ports with 15 mL of cleaning solution.

5. Repeat steps 1-4 using water instead of cleaning solution. Reciprocating only:

1. With the distal end facing up, squeeze 30 mL of cleaning solution from a syringe into the distal end of the device so that the solution thoroughly reaches the inside of the collet.

2. While the device is in the vertical position, rotate the collet knob back and forth three times.

3. Dump the solution from the device.

4. Repeat steps 1-3 a second time with cleaning solution.

5. Repeat steps 1-3 a third time with water.

Rinse the device under running water, ensuring that water enters all ports/openings. Move any moveable parts to allow the solution to reach all areas. Rinse until there is no visible evidence of soil or debris.

The Midas Rex Microsaw and Triton system

Midas Rex microsaw reprocessing instructions

Drying and lubrication

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene

Sterilization Note: The temperatures and times for sterilization are the minimum required.

Dry the entire device with a lint-free towel.

Reciprocating and oscillating only: If desired, complete the following steps using Pana Spray to lubricate the saw collet:

1. Holding the can approximately 10-15 cm (4-6 inches) away from the saw collet, spray into the hole of the shaft (reciprocating saw) or onto the proximal/bottom portion of the collet near the locked/unlocked indicators (oscillating saw) with three quick squirts.

2. Articulate the collet to ensure proper lubrication.

3. Remove excess lubricant with a clean cloth.

wrap..

Midas Rex microsaw steam sterilization

Cycle Pre-vac Pre-vac (FR/WHO) Pre-vac (UK)

Temperature 132°C (270°F) 134°C (273°F) 134°C (273°F)

Time 4 minutes (04:00) 18 minutes (18:00) 3 minutes (03:00)

Drying 20 minutes (20:00) 30 minutes (30:00) 22 minutes (22:00)

STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter

and length restrictions.

STERIS Do not use liquid peracetic acid sterilization due to immersion procedure.

Maintenance, inspection and testing

Storage Store with other sterile devices.

Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.

Verify functionality prior to re-use.

Triton electric high-torque handpiece reprocessing instructions

WARNINGS Do not soak/submerge devices.

Do not use ultrasound to clean Triton electric high-torque handpiece.

Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.

Allow an adequate cooling period after steam sterilization.

The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

Limitations on reprocessing

Point of use Disconnect device from the IPC. Remove and discard disposables.

Containment and transportation

Preparation for decontamination

Preclean instructions prior to use in an automated washer

Cleaning: Automated Caution: Do not use ultrasonic cleaner.

The product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

Verify functionality prior to re-use, by connecting the handpiece to the IPC and pressing the trigger. Verify that the drive shaft rotates.

It is recommended that devices are reprocessed as soon as is practical following use.

Disconnect device from the IPC. Remove and discard disposables.

Handpiece and attachments:

Prior to placing devices in the automated washer, manually rinse under tap water, until no visible soil is noticed.

Move any movable parts back and forth to allow water to reach hard-to-rinse areas.

Transfer the devices into the washer for processing. Place the devices in the washer to facilitate drainage.

Verify that devices are visually clean after automated cleaning.

Triton electric high-torque handpiece attachments automated wash cycle using a neutral enzymatic detergent (pH 6.0-8.0)

Phase Recirculation time Water temperature Detergent type and concentration

Pre-wash 2 minutes (02:00) Cold tap water Not applicable

Wash 5 minutes (05:00) 66°C (151°F) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute (01:00) Hot tap water Not applicable

The Midas Rex Microsaw and Triton system

Triton electric high-torque handpiece reprocessing instructions

Cleaning: Manual Handpiece and attachments:

1. Rinse the entire device, including cable, thoroughly under running water.

2. Wipe all external surfaces of the device and cable with a cloth dampened with a neutral enzymatic detergent pH 6.0-8.0 (henceforth referred to as “cleaning solution”).

3. Scrub the device thoroughly with a soft bristled brush that has been dampened with the cleaning solution, paying close attention to rough surfaces, crevices, and dicult to reach areas. Move any moveable parts to allow the solution to reach all areas.

4. Clean central cannulation shaft of the handpiece with a cleaning brush (P/N 120-028-1 or equivalent) dampened with the cleaning solution.

5. Insert the cleaning brush into the cannulation from the front and make at least 6 passes with the brush. If residual soil is seen on the cleaning brush in between strokes, rinse it o in the cleaning solution.

6. Repeat the step above from the back side of the handpiece.

7. Flush approximately 30 mL of cleaning solution from a syringe into the central cannulation shaft.

8. Flush approximately 30 mL of cleaning solution from a syringe into the trigger and Forward/Reverse switch, while moving moveable parts.

9. Repeat the ushing in steps 7 and 8, using water instead of cleaning solution.

10. Rinse the entire device under running water. Move any moveable parts, to allow the water to reach all areas. Also, allow water to thoroughly clean the central cannulation shaft. Rinse until there is no visible evidence of soil or debris.

11. Dry the entire device with a towel.

Sagittal and reciprocating saw attachments:

1. Rinse the entire device thoroughly under running water.

2. Wipe all external surfaces of the device with a cloth dampened with a neutral enzymatic detergent pH 6.0-8.0 (henceforth referred to as “cleaning solution”).

3. Scrub the device thoroughly with a soft bristled brush that has been dampened with the cleaning solution, paying close attention to rough surfaces, crevices, and dicult to reach areas. Ensure to brush the blade opening, the gaps/details between and around the blade jaws.

4. Dip the distal end of the saw body (up to approximately 1.25 inches from the distal end) into cleaning solution and agitate it for 1015 seconds.

5. Flush approximately 30 mL of cleaning solution from a syringe into the blade opening and the gaps and details between and around two jaws. Repeat the ushing using water, instead of cleaning solution.

6. Repeat the previous step one more time.

7. Rinse the device under running water. Allow water to thoroughly rinse the gaps and details between and around blade jaws. Rinse until there is no visible evidence of soil or debris.

8. Dry the device with a towel.

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene

Sterilization Note: The temperatures and times for sterilization are the minimum required.

wrap.

Triton electric high-torque handpiece steam sterilization

Cycle Gravity Pre-vac Pre-vac (FR/WHO) Pre-vac (UK)

Temperature 132°C (270°F) 132°C (270°F) 134°C (273°F) 134°C (273°F)

Time 25 minutes (25:00) 4 minutes (04:00) 18 minutes (18:00) 3 minutes (03:00)

Drying 30 minutes (30:00) 20 minutes (20:00) 30 minutes (30:00) 22 minutes (22:00)

STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and

STERIS Not applicable.

Triton electric high-torque handpiece 100% Ethylene Oxide (EtO) sterilization parameters

Preconditioning Sterilization

51-59 °C (124-138 °F), 70 % ±5 % relative humidity, time: 30 minutes (30:00)

Maintenance, inspection and testing

Storage Store in a clean, dry area.

Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.

Verify functionality prior to re-use.

length restrictions.

temperature

51-59 °C (124-138 °F), 70 +/- 5 % 725 +/- 25 mg/L 4 hours 51-59 °C (124-138 °F),

Relative humidity

EtO concentration

Gas exposure (full-cycle)

Aeration

18 hours

The Midas Rex Microsaw and Triton system

The Midas Rex microsaws and Triton electric high-torque handpiece system Limited Warranty* (U.S. customers only)

A. This Limited Warranty provides the following assurance to the purchaser who receives a Medtronic Midas Rex Microsaws and Triton Electric High-Torque

Handpiece System. The Midas Rex Microsaws and Triton Electric High-Torque Handpiece System includes the motor, high-torque hand piece and their cables and instrumentation cases and trays (hereafter referred to as System Components), the attachments (hereafter referred to as Attachments) and dissecting tools and other accessories not listed above, unless specically noted.

1. Should a System Component fail to function to Medtronic’s published specications during the term of this Limited Warranty (one year from the date of sale of a new System Component or 90 days from the date of sale of a refurbished or used System Component), Medtronic will either repair or replace the component or any portion thereof.

2. Should an Attachment fail to function to Medtronic’s published specications during the term of this Limited Warranty (90 days from the date of sale of a new Attachment), Medtronic will either repair or replace the Attachment or any portion thereof.

3. Should a Single Use Component fail to function to Medtronic’s published specications prior to its “use by” date Medtronic will replace the Single Use Component.

B. To qualify for this Limited Warranty, these conditions must be met:

1. The Product must be used on or before its “Use By” or “Use Before” date, if applicable.

2. The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling.

3. Medtronic must be notied in writing within thirty (30) days following discovery of a defect.

4. The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above.

5. Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was not repaired or altered by anyone other than Medtronic or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services, if applicable, have been performed on the Product.

6. Only Midas Rex Microsaws and Triton Electric High-Torque Handpiece System dissecting tools that are manufactured, authorized, and quality controlled by Medtronic may be used.

C. This Limited Warranty is limited to its express terms. In particular:

1. Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE LEGEND EHS SYSTEM TO FUNCTION WITHIN NORMAL TOLERANCES WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, NEGLIGENCE, STRICT LIABILITY, OR OTHER TORT OR OTHERWISE.

2. This Limited Warranty is made only to the purchaser. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NO SUCH EXPRESS OR IMPLIED WARRANTY TO THE PURCHASER SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.

3. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable or in conict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be aected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specic legal rights. The purchaser may also have other rights that vary from state to state.

4. No person has any authority to bind Medtronic to any representation, condition, or warranty, except this Limited Warranty.

*This Limited Warranty is provided by Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, Texas 76137-4116. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for terms of the warranty.

After the warranty period, any costs incurred for repair/refurbishing become the responsibility of the customer. This limited warranty does not include the cost associated with any of the factory level service requirements identied in the preventive maintenance schedule. Extended Maintenance Agreements are available.

EC REP

EUR · USA · JPN · AUS

105345

STERILE

IPX7

IPX1

DEHP

Dissecting Tool

EHS

Symbols

The following symbols can appear on this device and related packaging.

The Midas Rex Microsaw and Triton system

Compliant with European Council Directive MDD 93/42/EEC

Authorized Representative in the European Community

Compliance Mark EMC

Conforms to ANSI/AAMI ES60601-1, Certied to CAN/CSA-C22.2 No.606011, IEC/EN 60601-1

RoHS - Environmental friendly use period - China (SJ/T11364-2006)

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Consult Instructions for Use

Follow Instructions for Use

Caution

Do Not Immerse

Protected Against Vertical Water Drops

PHT

Contains DEHP (di-2-ethyl hexyl phthalate)

RF Transmitter (Interference May Occur)

Type BF Applied Part

Manufacturer

Date of Manufacture

Use By Date

Serial Number

Catalog Number

Lot Number

Package Contents

Quantity

ACC

Handpiece

Top Foot Control Unit Button / Handpiece Button

Foot Pedal Connector

Left Foot Control Unit Button / Mode Button

Right Foot Control Unit Button

Fine Irrigant Adjustment

Output

Accessory

Adapter

Attachment

Brush

STERILE EO

+ XX °C

+ XX °F + XX °C + XX °F

Do Not Oil

Do Not Dispose Of This Product In The Unsorted Municipal Waste Stream. Dispose Of This Product According to Local Regulations. See Recycling. Medtronic.com for Instructions On Proper Disposal Of This Product.

If the single use symbol is on the device label then this device is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

Non-Sterile

Sterilized using EO

Sterilized using Irradiation

Temperature Limitation

Protected Against The Eects Of Temporary Immersion In Water

Is Approximately Equal To

Use With

AC Power

Protective Earth

<120s

Applied Part Duty Cycle

OFF

>180s

Refurbished

On/O Button

Dissecting Tool

Electrical High Speed Handpiece Connector

Instrument Case

Motor

Refurbished

Part Number

Start/Stop

USA Only

Unlocked

! USA

Do not use if package is open or

Locked

damaged

Package Quantity

Forward

Reverse

Pump Head 1

Pump Head 2

May be covered by U.S. Patents:

EC REP

2019-02

Medtronic.com/patents

Made in USA. Printed in USA.

Medtronic Powered Surgical Solutions

4620 North Beach Street

Fort Worth, Texas 76137 USA

+1 800-433-7080

Medtronic B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen The Netherlands +31 45 566 8000

Medtronic Australian Sponsor:

Medtronic Australasia Pty Ltd

2 Alma Road

Macquarie Park, NSW 2113 Australia

medtronic.com

manuals.medtronic.com

Medtronic ES110 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual