Medtronic AF02R Instructions for Use

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Instructions for Use 175036EN C

The Midas Rex™ Legend EHS™ System

Legend EHS, Legend EHS StylusTM, and Stylus Touch

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: Clearview™ , Intelliow™, IPC™, Legend™, Legend EHS™, Legend EHS Stylus™, Midas Rex™, Mednext™, and Stylus Touch™. 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 ...................................................................................................................................................................................3

System motors ............................................................................................................................................................................. 3

Attachment assembly ............................................................................................................................................................... 4

IPC set up ....................................................................................................................................................................................... 4

IPC touchscreen controls .........................................................................................................................................................5

Multifunction foot pedal controls .........................................................................................................................................6

Technical specications ............................................................................................................................................................ 6

EMC Guidance ..............................................................................................................................................................................6

Legend EHS, Legend EHS Stylus, and Stylus Touch attachments .............................................................................. 7

General guidelines for attachments and tool applications ......................................................................................... 8

Legend EHS, Legend EHS Stylus, and Stylus Touch attachment assembly and disassembly........................11

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

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

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

Motor cable .............................................................................................................................................................................4

Motor nger lever ................................................................................................................................................................4

Connect to the IPC ................................................................................................................................................................ 4

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

Speed ......................................................................................................................................................................................... 5

Irrigation ................................................................................................................................................................................... 5

Acceleration and deceleration ..........................................................................................................................................5

Rotation (FWD and REV) ..................................................................................................................................................... 5

Safe mode (SAFE) ..................................................................................................................................................................5

Dissecting tool nomenclature ..........................................................................................................................................7

Aligning the motor collet ................................................................................................................................................... 7

Straight attachment ..........................................................................................................................................................11

Angled attachment ............................................................................................................................................................11

Fixed footed attachment ..................................................................................................................................................12

Rotating footed attachment............................................................................................................................................12

Contra-angle attachment AC-16 ....................................................................................................................................13

Metal cutting attachment ................................................................................................................................................13

Variable exposure straight and angled attachment ...............................................................................................13

Telescoping tube and telescoping tube base attachment straight (AT10) and angled (AT10A) ............ 14

Telescoping curved bur and telescoping base attachment straight (AT10) and angled (AT10A) .........14

Perforator (AD01 & AD03) attachment ........................................................................................................................15

Jacobs Chuck attachment ...............................................................................................................................................15

Angled double lock (DK) attachment ..........................................................................................................................15

J-latch attachment .............................................................................................................................................................16

Irrigation tubing set............................................................................................................................................................16

Trans-nasal and Clearview skull base bur attachment ..........................................................................................16

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ............................................................17

Troubleshooting ........................................................................................................................................................................17

Post-operative instructions ...................................................................................................................................................19

Disconnect accessory cable from console .................................................................................................................19

Cleaning and sterilization ......................................................................................................................................................19

Legend EHS, Legend EHS Stylus, and Stylus Touch reprocessing instructions .............................................19

Legend attachments/tubes reprocessing instructions ........................................................................................21

Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE) ..........................22

Refurbishing or repairs ...........................................................................................................................................................22

Midas Rex Legend EHS system Limited Warranty* (U.S. customers only) ............................................................23

Preventive maintenance ........................................................................................................................................................24

Dening maintenance level ............................................................................................................................................24

Section 1: Preventive maintenance/service schedule:12 maintenance intervals .............................................24

Section 2: Instructions for completing preventive maintenance steps ................................................................25

Scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, 11 ....................................................................................25

Symbols ........................................................................................................................................................................................26

The Midas Rex Legend EHS 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

IV Intravenous

OSC Oscillate

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 Legend EHS, Legend EHS Stylus, and Stylus Touch systems are powered drills that are used to remove soft tissue, hard tissue, and bone during surgical procedures. Each system consists of a motor that powers/rotates the cutting media, attachments that are used to provide support and stability to the dissecting tools, and dissecting tools that perform the task of removing soft and hard tissue and bone. Note that the attachments and dissecting tools are common to all systems.

Unless specically referenced, the Legend EHS Stylus when referenced, will also encompass the Stylus Touch.

These 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 Legend EHS and/or Legend EHS Stylus system operator must be familiar with this Instructions for Use, the IPC User’s Guide, their precautions, procedures

and safety issues.

W2 The Legend EHS and/or Legend EHS Stylus 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 Legend EHS and/or Legend EHS Stylus handpiece 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 Legend EHS and/or Legend EHS Stylus motors should only be operated when the attachment is in the locked position. W7 The Legend EHS and/or Legend EHS Stylus motors are precision surgical instruments. With precision instruments, excessive force, beyond the design strength

of the instruments, can be caused by even simple manual overloading. W8 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. W9 Use only dissecting tools specically designed for use with this drill system. 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 Legend EHS and/or Legend EHS Stylus system without proper cleaning and sterilization. W11 Refer to the IPC Instructions for Use and Clearview Insert for additional instructions, warnings, and cautions. W12 Refer IPC User’s Guide for warnings related to IPC. W13 The Legend EHS and/or Legend EHS Stylus 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.

The Midas Rex Legend EHS system

W15 Portable and mobile radio frequency (RF) communications equipment can aect medical electrical equipment. W16 Do not operate the Legend EHS and/or Legend EHS Stylus motors 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 For metal transection, observe the following safety precautions:

W18a Wear eye protection. W18b Irrigate well to cool cutting surfaces. W18c Protect wound site from metal debris. W18d Use a clamp or grasping device to control loose fragments during transection of any metal component.

W19 All service must be performed by Medtronic qualied personnel only.

Component warnings

W20 Do not use any parts other than Medtronic system components as damage or substandard performance could result. W21 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.

W22 Employ visualization, including use of imaging techniques (for example, uoroscopy, image guided surgery) when using rotating powered accessories.

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

W23 When using Midas Rex variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should

explore the eect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.

W24 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. W25 Electrical contacts must be dry prior to use. W26 Do not use an overheated device, as it may cause thermal injury to the patient or operator. W27 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. Depending

on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50°C. W28 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. W29 Do not immerse the system components, except as noted. W30 Do not place motor, attachment, or tool on the patient or in an unsecured location during surgery. W31 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. W32 Match the nomenclature and color code on the tool packaging to the nomenclature and color code on the attachment. W33 When using Midas Rex variable exposure attachments, ensure that the attachment is still in the locked position after each adjustment of the tool exposure.

Attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked. W34 The Legend EHS motors will not run properly unless the attachment is in the locked position. W35 Midas Rex Legend EHS motor and Midas Rex Legend EHS Stylus motor should only be operated when the attachment is in the fully locked position. Smoke

and/or excessive heat may be generated if attachment is not in the fully locked position. This may result in thermal injury to the user or sta. W36 Do not change an accessory with the handpiece running to prevent laceration of user and/or cross-contamination through compromised glove. W37 Remove Legend footed attachments cautiously and slowly as per instructions to avoid injury to the operator. W38 Do not modify accessories used with the handpiece. Performance could be diminished with modied accessories. W39 Verify reusable device was cleaned and/or sterilized prior to use. If not, do not use. W40 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. W41 Place Stylus Touch in Safe mode while not in use. W42 Do not place Stylus Touch handpiece in the proximity of magnetic eld, such as a magnetic drape and MRI equipment, to avoid inadvertent handpiece activation. W43 Excessive side loading could cause angled attachments to unlock accidentally from motor. W44 Ensure proper installation of tool in footed attachment. Failure to follow instructions may result in the tool tip contacting the foot of the attachment causing

damage to the attachment and/or harm to patient. W45 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization. W46 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

W47 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. W48 Tool utes are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. Use methods at the

operative site to control bleeding that do not compromise patient safety during surgery. W49 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination through compromised glove. W50 Operate the tool only after appropriate anatomical landmarks at the intended surgical site have been conrmed. W51 Use care in application of the rotating cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories. W52 Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be dicult to remove,

causing irritation, inammation, and foreign-body response at surgical site. W53 Bending or prying may break the accessory, causing harm to patient or user. W54 Do not use excessive force to pry or push bone with the attachment or tool during dissection. W55 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. W56 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. W57 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. W58 Eccentricity of the tool can cause tool vibration and may result in excess tissue destruction, bone destruction, and hearing damage. W59 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. W60 Consult the cranial perforator device labeling for recommended speed specications. W61 Tools with “L” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect dissection stability.

The Midas Rex Legend EHS system

W62 Do not re-sharpen used tools. Worn tools should be frequently replaced with new ones to ensure eective cutting and control. W63 Excessive pressure applied to bur 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. W64 Do not use metal-cutting tools to cut/resect bone. W65 Use only rotary tools specically designed for use with this drill system. W66 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. W67 Do not use an accessory if its packaging is opened or damaged. Sterility may be compromised if packaging is opened or damaged. W68 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. W69 Do not use dull tools. Use of dull tools can reduce cutting eectiveness and can cause the handpiece temperature to increase. W70 Always ensure that the tool is secured in the handpiece prior to operating the system. Always examine operation of each tool in a handpiece prior to use. W71 Powered burs and drills should be operated in the forward mode only. W72 Exposure of tool packaging to light for extended periods of time may cause damage to packaging.

Precautions

P1 To prevent damage to curved tools, disconnect suction tube prior to changing tool during procedure. P2 When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen from the handpiece. P3 Do not run the AC-16 attachment above 62,000 rpm. This may cause overheating and damage to internal gears of attachment. P4 Do not use twist drill or contra-angle tool at an operating speed over 62,000 rpm. P5 Do not attempt to disconnect the cable from the Midas Rex Legend EHS Stylus or EHS Stylus Touch motor. P6 Do not kink cables. Inspect cables and pins for cracks, tears or corrosion. P7 Disconnect cable from Midas Rex Legend EHS motor prior to sterilization. P8 The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. P9 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. P10 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. P11 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. P12 Remove and discard accessories following local regulations for disposal of contaminated materials. P13 Clean the EHS motor and cable while still connected together. This will help to reduce debris ingress. Use only recommended cleaning agents.

System motors

The Midas Rex Legend EHS system motors are high-speed, high-torque, reversible electric motors used to dissect bone and biomaterials at selectable speeds from 200 to 75,000 rpm.

The Legend EHS Stylus motor (Figure 1) is a smaller and more compact version of the Legend EHS motor (Figure 2). The Stylus Touch motor (Figure 3) is a small, compact motor that includes a rotating nger lever.

Legend EHS Stylus motor Legend EHS motor

1. Rotating collet 2. Stationary collet 3. 4-pin cable connection

Stylus Touch motor

1. Stationary collet

2. Rotating collet

3. Ground connector

4. 4-pin cable connection

5. Locking sleeve

1. Telescoping nger rest

2. Finger lever

3. Finger lever safe mode switch

4. Control lever ring

5. Stationary collet

6. Rotating collet

The Midas Rex Legend EHS system

15323 4

Motor cable

The Legend EHS motor cable is separate from the handpiece, allowing it to connect and disconnect from the motor.

• To connect the Legend EHS cable to the Legend EHS motor, align the mark on the cable to the red mark on the motor (Figure 4-1) and connect the two pieces.

• To remove the Legend EHS cable from the Legend EHS motor, (1) push the cable towards the motor, then (2) pull out the cable by the locking ring only (Figure 4-2).

The Legend EHS Stylus and Stylus Touch motor cable is integrated in the handpiece and cannot be removed from the motor.

4-1

Connect Legend EHS cable to motor Disconnect Legend EHS cable from motor

Motor nger lever

The Stylus Touch motor includes a rotating nger lever. To rotate the nger lever, (1) press the control lever ring forward, then (2) Rotate the lever clockwise or counter clockwise until the lever locks in a new position (Figure 5)

4-2

Stylus Touch nger level rotation

Attachment assembly

Refer to the Legend EHS, Legend EHS Stylus, and Stylus Touch attachments for attachment Assembly instructions.

IPC set up

The following instructions for the Legend EHS, Legend EHS Stylus, and Stylus Touch 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 Legend EHS, Legend EHS Stylus, Stylus Touch, and Foot Control Unit (FCU) ports on the IPC connector panel (Figure 6) 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.

IPC connector panel connection ports

1. Legend EHS motor

2. Legend EHS Stylus motor

3. Stylus Touch motor

4. Intelliow irrigation remote control

5. Foot control unit

IPC pump detection

The IPC incorporates the Legend EHS, Legend EHS Stylus, and Stylus Touch irrigation at Pump 1. If you do not use irrigation for the Stylus Touch, manually change the Pump 1 to None. Refer to the IPC User’s Guide, Set up and Prime Pumps for more information.

When the system detects the Legend EHS or Legend EHS Stylus, Pump 2 defaults to None.

When the IPC detects both the Legend EHS and Legend EHS Stylus handpieces, the system defaults Pump 2 to the Shared conguration. Use the pumps screen to override the Shared default by selecting the Legend EHS Stylus for Pump 1. Refer to the IPC User’s Guide, Set up and Prime Pumps for more information.

Control operation of the Legend EHS, Legend EHS Stylus, and the Stylus Touch with the IPC touchscreen and the multifunction foot pedal.

The Midas Rex Legend EHS system

IPC touchscreen controls

To set or adjust the Legend EHS and Legend EHS Stylus (Figure 7-1) or Stylus Touch (Figure 7-2) controls, on the IPC touchscreen, in the control box, do the following:

7-1

IPC Stylus touchscreen IPC Stylus Touch touchscreen

7-2

Speed

• To adjust speed in Forward (FWD) or Reverse (REV) mode, in the Speed control box, press the plus button to increase speed or the minus button to decrease speed.

• The Legend EHS Stylus and Stylus Touch: Default speed, 60,000 rpm; variable speed adjustment from 200 to 75,000 rpm. Note: When the handpiece is in safe mode, the Speed control box displays SAFE (Figure 9). Refer to the Safe mode (SAFE) topic for additional information.

• The Legend EHS: Default speed, 70,000 rpm; variable speed adjustment from 200 to 75,000 rpm.

Irrigation

• To adjust the 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.

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

• Default, 0cc per minute in Forward or Reverse mode.

Acceleration and deceleration

• To adjust acceleration and deceleration, on the Defaults menu (Figure 7-1 and 7-2), press the corresponding plus or minus button. Acceleration is the rate at which the motor speeds up to reach the target speed. Deceleration is the rate at which the motor slows down to reach the target speed or stop.

Note: While in the default menu, the motor will not be active to demonstrate the selected acceleration and deceleration. In order to determine the desired values, adjust the acceleration and deceleration during motor operation and note the preferred values.

• To enable adjustment of acceleration or deceleration during handpiece operation and to display the acceleration and deceleration adjustment options on the motor operational screen; On the Defaults menu, select Show On Screen and then press [OK]. To hide the acceleration and deceleration during handpiece operation, on the Defaults menu, deselect Show On Screen.

Rotation (FWD and REV)

• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse).

Important: System conguration may be dierent from the default. If the REV (reverse) button appears raised (Figure 8-1) and does not have a selectable radio button, you cannot select the Reverse mode. If the REV button appears concave (Figure 8-2) and has a selectable radio button, you can select the Reverse mode via the touchscreen or the multifunction foot pedal.

Safe mode (SAFE)

• The Stylus Touch handpiece comes with a safe mode option. When the handpiece is in safe mode, it is inoperable until the safety is turned o. The Speed control box on the Stylus Touch touchscreen displays SAFE when the handpiece is the active handpiece and in safe mode (Figure 9).

• Switch the device to safe mode any time it is attached to the console, but not currently being used. To set the Stylus Touch to safe mode, on the Stylus Touch handpiece, switch the safe mode nger lever (Figure 3) to on.

• 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.

8-1

IPC touchscreen

REV button raised

Mode

FWD

REV

IPC Stylus Touch safe mode

touchscreen

Speed

8-2

IPC touchscreen

REV button concave

Mode

FWD

REV

SAFE

RPM

The Midas Rex Legend EHS system

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 10) to control the handpiece, do the following:

• To select Forward or Reverse mode, press the mode button.

• 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.

Multifunction foot pedal and y-splitter

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

Technical specications

Table 1: Legend EHS technical specications

Legend EHS EM100-A

Size Weight Speed Duty cycle for applied part

9.02 cm length x 2.03 cm diameter 180 g 75,000 rpm forward/reverse For use in operating room temperatures up to 40°C (104°F), the Legend EHS motor is rated for a cutting time of 3 minutes at 70,000 rpm.

For normal operating room temperatures (typically 20°C/68°F), the Legend EHS motor is rated for cutting time of 10 minutes followed by 25 minutes or rest.

The Legend EHS motor is rated for intermittent use of 20 seconds ON / 20 seconds OFF, indenitely at 70,000 rpm.

Table 2: Legend EHS Stylus technical specications

Legend EHS Stylus EM200

Size Weight Speed Duty cycle for applied part

7.77 cm length x 1.65 cm diameter 90 g 75,000 rpm forward/reverse For use in operating room temperatures up to 40°C (104°F), the Legend EHS

Table 3: Stylus Touch technical specications

Stylus Touch EM210

Size Weight Speed Duty cycle for applied part

15.26 cm length x 1.65 cm diameter 130 g 75,000 rpm forward/reverse For use in operating room temperatures up to 40°C (104°F), the Stylus Touch motor

Stylus motor is rated for 3 minutes at 60,000 rpm followed by 25 minutes or rest.

For normal operating room temperatures (typically 20°C/68°F), the Legend EHS Stylus motor is rated for cutting indenitely at 60,000 rpm.

is rated for 3 minutes at 60,000 rpm followed by 25 minutes of rest.

For normal operating room temperatures (typically 20°C/68°F), the Stylus Touch motor is rated for cutting indenitely at 60,000 rpm.

EMC Guidance

See the IPC User’s Guide for the EMC guidance.

The Midas Rex Legend EHS system

1234 56

Legend EHS, Legend EHS Stylus, and Stylus Touch attachments

Dissecting tool nomenclature

Note: Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color code on the attachment.

Part numbers for dissecting tools follow a standard naming convention (Figure 11). A basic part number consists of ve characters, representing the associated attachment length, the tool-head shape, and the tool-head diameter. Part numbers can also include a variety of prexes to identify specic attachment types, as well as a variety of suxes to provide additional information about the dissecting tool. Tools that use a design taken from the Mednext line are designated by an additional “-MN” sux.

Dissecting tool nomenclature naming convention

9 M H 3 0

1. Optional prex

2. Attachment length, x centimeters (Ex. 9 = 9 cm)

3. Tool head shape, xx form/function (Ex. MH = Match Head)

Tool number prexes Tool number suxes

Note: A single part number will use only one prex. Note: More than one sux may be combined in a

Prex Tool attatchments Sux Tool head shape modiers

Tool head shape (form/function) Sux Tool head cutting modiers Sux Tool length modiers

Curved Burr

Footed attachments

Spinal with Distal bend

Spinal with Proximal bend

Telescoping tube

Trans-Nasal

Acorn

Ball

Cylinder

Hole Maker

Hole Saw

Metal Cutting

Match Head

Oval

Reverse Taper

Tapered or side cutter

Twist Drill

4. Tool head diameter, x.x millimeters (Ex. 30 = 3.0 mm)

5. Optional sux

6. Optional “-MN” sux

single part number.

Ball end

Barrel

2-Flute Match style

Pear shaped

Spiral utes

3-Flute or SymmeTRI

Carbide

Diamond

Diamond Coarse

Diamond Fine

Diamond Extra Coarse

DXF

Diamond Extra Fine

Fine

-MN

MedNext style

Coarse

Extra Fine

Pxx

Mxx

Long

Short

Plus ‘xx’ mm (for example, P15 = Plus 15mm)

Minus ‘xx’ mm

Aligning the motor collet

Note: An attachment will not seat on the Legend EHS, Legend EHS Stylus, or Stylus Touch motor if the arrows on the collet ats are not aligned.

Verify alignment of arrows on motor collet ats. Prior to installation of an attachment and dissecting tool on motor, ensure that arrows on the motor collet ats are in proper alignment. (Figure 12-1).

If the arrows are not aligned (Figure 12-2), use the motor wrench (Figure 13) to turn the rotational collet until its arrow is aligned with the arrow on the stationary collet.

Note: Do not use any other components except for the motor wrench to align arrows on motor collet.

12-1

Correct alignment Incorrect alignment Motor wrench

12-2

1. Stationary collet 2. Rotational collet

The Midas Rex Legend EHS system

General guidelines for attachments and tool applications

These are general guidelines for dissecting tool applications and are not an all-inclusive listing.

Surgical

application

Spine 8-B, 9-M, 14-AM straight or angled,

Commonly used

attachments

15-A straight or angled

Commonly used

dissecting tools

Match head

Elongated spherical design allows controlled, delicate dissection. For laminotomy, foramenotomy, entry hole, nerve decompression, osteophyte removal, etc.

Ball

Helical cutting utes dissect bone from a variety of approach angles. For debridement, decortication, corpectomy, osteophyte removal, etc.

Oval

Helical cutting utes and curved design blend acorn and ball styles to vary dissection eciency with approach angle. For decortication, laminotomy, entry hole, nerve decompression, osteophyte removal, etc.

Hole maker and hole saw

Matched sets of hole makers and hole saws are ecient and eective for interbody fusion.

Cylinder

Eective bone sculpturing and planing. For graft shaping, debridement corpectomy, decortication, interbody fusion, fusion takedown, etc.

Acorn

Curved designs varies dissection eciency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etc.

Telescoping Match head

Footed Tapered

Neurosurgical–Cranial 7-6ST straight or angled, 8-B, 9-M,

10-9ST straight or angled, 14-AM straight or angled, 15-A straight or angled

Telescoping Match head

Elongated spherical design allows controlled, delicate dissection. For laminotomy, foramenotomy, entry hole, nerve decompression, osteophyte removal, etc.

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, laminectomy, etc.

Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, mastoidectomy, acoustic neuroma, skull base, etc.

Ball

Helical cutting utes dissect bone from a variety of approach angles. For debridement, decortication, entry hole, nerve decompression, mastoidectomy, acoustic neuroma, etc.

Twist drill

Helical design with stop produces a hole with a precise depth. Ideal for plating.

Acorn

Curved design varies dissection eciency with varied approach angles. For entry hole, bone shaping, debridement, etc.

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, mastoidectomy, acoustic neuroma, skull base, etc.

Footed Tapered

Slender design for precise dissection with minimal bone loss. For craniotomy, transection, osteotomy, etc.

The Midas Rex Legend EHS system

Surgical

application

General surgery and plastic surgery (craniofacial/ maxillofacial/ sternotomy)

Ear, nose, and throat (otology, neurootology)

Orthopaedics 8-B, 9-M, 14-AM straight or angled,

Commonly used

attachments

7-6ST straight or angled, 8-B, 9-M, 10-9ST straight or angled, 14-AM straight or angled

7-6ST straight or angled, 10-9ST straight or angled

21-TU, 26-R, footed, telescoping

Commonly used

dissecting tools

Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etc.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etc.

Tapered

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, entry hole, suture hole, midface advancement, etc.

Twist drill

Helical design with stop produces a hole with a precise depth. Ideal for plating.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, mastoidectomy, facial recess, cochlear implant bed, ossiculoplasty, labyrinthectomy, middle fossa approach, acoustic neuroma, etc.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, cement removal, acetabular revision, etc.

Biometals/ bioceramics/ biomaterials

Tapered

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, suture hole, etc.

Acorn

Curved designs varies dissection eciency with varied approach angles. For bone shaping, debridement, decortication, cement removal, acetabular revision, etc.

Cylinder

Eective bone sculpturing and planing. For graft shaping, debridement, decortication, cement removal, acetabular revision, etc.

Footed Tapered

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, etc.

MC Metal cutter

Cutting utes or diamond wheel design remove metals, ceramics and other biomaterials eectively from a variety of approach angles. For cutting rods, pins, plates, implants, screws, etc.

The Midas Rex Legend EHS system

Warning: Match the nomenclature and color code on the Legend dissecting tool packaging to the same nomenclature and color code on the Legend attachment.

Note: These are general guidelines for surgical dissecting tool applications and are not an all-inclusive listing.

Table 4: Glossary

Surgical procedures Tool head designs

LM Lumbar Microdiscectomy PH Pilot Hole MH

Lumbar Stenosis

LSD

Decompression

Posterior Lumbar Interbody Fusion (PLIF)

Transforaminal Lumbar Interbody Fusion (TLIF)

LIF

Anterior Lumbar Interbody Fusion (ALIF)

Direct Lateral Interbody Fusion (DLIF)

ND Nerve Decompression BA

OR Osteophyte Removal AC

DB Debridement CY Cylinder dissecting tool eective in bone sculpturing and planning.

DC Decortication HM/S

CT Corpectomy OV

Match Head dissecting tool with an elongated spherical design allows controlled, delicate dissection.

Ball dissecting tool, cutting utes to dissect bone or cement eectively from a wide variety of approach angles.

Acorn dissecting tool, curved design varies dissection eciency with varied approach angles and eective in bone shaping.

Hole Maker/Hole Saw dissecting tool, matched sets of hole makers and hole saws are ecient and eective.

Oval dissecting tool with helical cutting utes and curved design blend acorn and ball styles to vary dissection eciency with approach angle.

FT Fusion Takedown MI Minimally Invasive procedure T Fluted dissecting tool, cutting utes to allow faster, and ecient bone removal.

Laminotomy TA

FRT

Foramenotomy MC Metal Cutting dissecting tool to facilitate the cutting and shaping of metal.

Tapered dissecting tool with slender design for precise dissection with minimal bone loss.

Table 4: General guidelines for attachment and tool applications

Surgical application - Spine

Incision/cutting, removal, drilling, and sawing of soft and hard tissue,

Tools

bone, and biomaterials.

Commonly used attachments

MH BA AC CY HM/S OV T TA MC

LM LSD LIF FT LT FRT PH ND OR DB DC CT MI

X X X X X X X X X X X X X

X X X  X X X X X X X X X

X X X X X X X X X X X X X

X X X  X X X X X X X X X

Straight

Angled

Base Tube

Straight Straight Angled Curved

Angled

Footed

Curved burs

Contra angle

X X X X X X X X 

X X X   X X  

       X 

X X     X  

X       X 

X X X X X X X X X X X X X

ASMC

        X

The Midas Rex Legend EHS system

Legend EHS, Legend EHS Stylus, and Stylus Touch attachment assembly and disassembly

Warnings: W4, W34, W35, W50, W52, W53, and W54 apply to all Legend attachments.

Straight attachment

Caution: Match the nomenclature and color code on the tool

packaging to the nomenclature and color code on the attachment.

Notes:

• An attachment will not seat on the motor if the arrows on the collet ats are not in alignment.

• The Legend EHS motors will not run properly unless the attachment is in the locked position.

Assembly:

1. Slide a straight attachment over the motor collet aligning the triangular arrows on the attachment and the motor case (Figure 14-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Insert the tool into the attachment with a slight rotational motion (Figure 14-2). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

3. Rotate the attachment in the direction indicated by arrow on the attachment until the attachment alignment mark is directly in line with the locked symbol (Figure 14-3). You will hear two clicks as the attachment is rotated. Note: Only when the second click is heard is the attachment fully seated and the collet brake fully released.

4. Gently pull on the tool to ensure that it is locked into the handpiece. Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

Disassembly:

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up as in Figure 14-2.

2. Remove the dissecting tool from the attachment and discard the tool.

3. Use thumb and index nger to lift the attachment o of the motor.

14-1

14-2

14-3

Straight attachment assembly

Angled attachment

Warnings: Refer to warning W43.

Caution: When using an angled attachment, hold the handpiece assembly

by the attachment so that the attachment does not inadvertently loosen from the handpiece.

Notes:

• A dissecting tool may be installed and locked in the attachment before the angled attachment is installed onto the motor.

• Angled and straight attachments with the same length, marking, and color band share the same dissecting tools.

Assembly:

1. With the tool lock in the unlocked position, insert a tool into the angled attachment with a slight rotational motion (Figure 15-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Rotate the tool lock/unlock sleeve in the direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 15-2).

3. Gently pull on the tool to ensure that it is locked into the handpiece. Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

4. Slide the angled attachment over the motor collet aligning the triangular arrows on the attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

5. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two clicks as the attachment is rotated. Note: Only when the second click is heard is the attachment fully seated and the collet brake fully released.

6. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbols (Figure 15-3).

Disassembly:

1. Rotate the tool lock to the unlocked position to remove the tool from the attachment.

2. Rotate the attachment to the unlocked position and lift attachment o of the motor.

15-1

Angled attachment assembly

15-2

1. Tool lock/unlock sleeve

15-3

Angled attachment assembly

The Midas Rex Legend EHS system

Fixed footed attachment

Warnings: Refer to warning W44 .

Assembly:

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 16-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Slide the xed footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case (Figure 16-2).

3. Pull the xed footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 16-3).

4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment as shown in Figure 16-4. This will prevent damage to the attachment and/or injury to patient.

16-1

16-3

Disassembly:

1. To remove the xed footed attachment, hold the motor in the palm of your hand. Push the sleeve on the xed footed attachment distally while rotating the attachment to the unlocked position on the motor case and then release the sleeve (Figure 16-5).

2. To avoid injury from the dissecting tool, use thumb and index nger to cautiously and slowly lift the attachment o of the motor and away from the dissecting tool (Figure 16-6).

3. Pull the dissecting tool out of the motor collet and discard the tool (Figure 16-7).

16-5

16-7

Fixed footed attachment assembly Fixed footed attachment assembly

Fixed footed attachment assembly

Fixed footed attachment disassembly Fixed footed attachment disassembly

Fixed footed attachment disassembly

16-2

16-4

16-6

Rotating footed attachment

Warnings: Refer to Warning W44.

Notes:

• Rotating and xed footed attachments with the same length, marking and color band share the same dissecting tools.

• The footed end of the attachment has 360° of unrestricted rotation.

Assembly:

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 17-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Slide the rotating footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case (Figure 17-2).

3. Pull the rotating footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 17-3).

4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment as shown in Figure 17-4. This will prevent damage to the attachment and/or injury to patient.

17-1

17-3

Rotating footed attachment assembly Rotating footed attachment assembly

Rotating footed attachment assembly

17-2

17-4

The Midas Rex Legend EHS system

Disassembly:

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up.

2. Use thumb and index nger to lift the attachment o of the motor.

3. Remove the dissecting tool from the motor collet and discard the tool.

Contra-angle attachment AC-16

Assembly:

Note: The input speed of the AC-16 should be no more than

62,000 rpm. Set speed on the IPC Console to be 62,000 rpm or less.

1. Slide the contra-angle attachment over the motor collet aligning triangular arrows on the attachment and the motor case.

2. Rotate the attachment to the locked position on the motor case (Figure 18-1).

3. Rotate the attachment head’s lever laterally to the open position and insert a dissecting tool (Figure 18-2).

4. Align the at in the tool with the corresponding at in the attachment and fully insert tool into the attachment.

5. Close lever (Figure 18-3) to lock tool in the attachment.

6. Gently pull on the dissecting tool shaft to ensure it is locked in the attachment.

Disassembly:

1. Rotate the lever on the attachment head laterally to unlock the tool and then remove the dissecting tool.

2. Discard the dissecting tool.

3. Rotate the AC-16 attachment to the unlocked position and lift the attachment o of the motor.

18-1

18-2

Contra-angle attachment AC-16 assembly

Attachment assembly Attachment assembly

18-3

Metal cutting attachment

Warning: Refer to Warning W18.

Important: The metal cutting attachment uses the tungsten carbide or diamond wheel dissecting tools.

All metal cutting dissecting tools have an “MC” attachment prex in their nomenclature (for example, MC254 and MC30). Metal cutting dissecting tools cannot be installed into any other attachment.

Assembly:

1. Slide the metal cutting attachment over the motor collet aligning triangular marks on the attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Rotate the attachment to the locked position on the motor case.

3. Unscrew tool lock sleeve several turns and while holding the attachment upright, insert a dissecting tool into the attachment (Figure 19).

4. Rotate the dissecting tool until it drops into position and is fully seated (Figure 19).

5. Lock the tool in the attachment by rotating the locking sleeve in the direction shown on the attachment until the tool is secured.

6. Gently pull on the tool to ensure that it is secured in the attachment.

Disassembly:

1. Unscrew the tool lock with several turns, then withdraw the dissecting tool. Note: Do not rotate past the point where resistance is felt.

2. Discard tool.

3. Rotate the attachment to the locked position on the motor case and lift attachment o of the motor.

Variable exposure straight and angled attachment

Warning: Refer to Warning W23 and W33.

Note: The variable exposure attachments can be distinguished from standard attachments by the dual color

bands on the attachment. Match the color band on the attachment to the color code on the dissecting tool packaging.

Assembly:

1. Assemble the variable exposure straight attachment using the Straight attachment Assembly instructions and the variable exposure angled attachments using the Angled attachment Assembly instructions.

2. After assembly, use the tube adjustment ring to adjust the exposure of the dissecting tool (Figure 20). With the tool pointing away from you, turn the ring to the right to increase the length of the tube, thereby decreasing the exposure of the tool. Turn the ring to the left to decrease the length of the tube, thereby increasing the exposure of the tool.

Disassembly:

Remove the variable exposure straight attachment using the Straight attachment Disassembly instructions and the variable exposure angled attachments using the Angled attachment Disassembly instructions.

Metal cutting attachment

Variable exposure attachment assembly

The Midas Rex Legend EHS system

Telescoping tube and telescoping tube base attachment straight (AT10) and angled (AT10A)

Assembly:

1. Assemble the telescoping base attachment straight (AT10), or angled (AT10A) to the motor using the Straight attachment Assembly instructions.

2. Insert the base end of the telescoping tube into the AT10, or AT10A attachment until the hub is fully seated. To secure the tube, turn the tube locking ring on the AT10, or AT10A attachment until nger tight (Figure21-1). Note: Do not over tighten.

3. Verify that the telescoping tube is secure by gently pulling on the tube.

4. Rotate the tool locking ring to the unlocked position.

5. Insert the tool into the telescoping tube. Apply a slight amount of inward pressure on the tool (Figure 21-2). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

6. Turn the tool locking ring to the locked position (Figure 21-3).

7. Verify that the tool is secured by gently pulling on the tool.

8. To vary the tube position/tool exposure, rotate the tube locking ring toward the unlocked position, re-position the tube, then rotate the tube locking ring toward locked position until nger tight. Note: Do not over tighten.

9. Gently pull on the dissecting tool, then the tube, to ensure they are secure.

Disassembly:

1. Rotate the tube locking ring towards the unlocked position.

2. Rotate the tool locking ring to the unlocked position.

3. Remove the tool and then the telescoping tube from the AT10, or A10A attachment.

4. Discard the tool.

5. Rotate the AT10, or AT10A attachment to the unlocked position on the motor case and lift the attachment o the motor.

Telescoping curved bur and telescoping base attachment straight (AT10) and angled (AT10A)

Assembly:

1. Assemble the attachment straight (AT10), or angled (AT10A) using the Straight attachment Assembly instructions.

2. Insert the base end of the curved bur into the AT10, or AT10A attachment until the hub is fully seated. To lock in place, turn the tube locking ring until nger tight (Figure 22-1). Note: Do not over tighten.

3. Verify that the hub is in place by gently pulling on the tool.

4. Seat the tool in the AT10, or AT10A attachment by gently pushing on the bur (Figure 22-2). An audible click, heard and perceptible by touch, conrms that the tool is fully seated. Verify tool is seated by checking the bur head exposure as shown in Figure 22-2.

5. Rotate the tool locking ring until the tool lock alignment mark is directly in line with the locked symbol (Figure 22-3).

6. Verify that the bur is secured by gently pulling on the bur.

7. Prior to initial use, soak the cooling sleeve by dipping it into a cup of saline or deionized (DI) water (Figure 22-4).

8. During use, copiously irrigate the cooling sleeve and bur by dribbling saline or DI water along the entire length of the cooling sleeve.

Disassembly:

1. Rotate the tube locking ring towards the unlocked position.

2. Rotate the tool locking ring to the unlocked position.

3. Remove the curved bur from the AT10, or AT10A attachment.

4. Discard the curved bur.

5. Rotate the AT10, or AT10A attachment to the unlocked position on the motor case and lift the attachment o the motor.

21-1

1. Tube locking ring

2. Tool locking ring

21-2

21-3

22-1

Telescoping tube and telescoping tube base

attachment (AT10) or angled (AT10A) assembly

12 3

3. Base

Attachment assembly

Telescoping curved bur and telescoping base

attachment straight (AT10) and angled (AT10A) assembly

1. Cooling sleeve

22-2

22-3

22-4

Curved bur cooling

Attachment assembly

Perforator (AD01 & AD03) attachment

Warnings: Refer to warning W56.

Note: A cranial perforator device may be installed in the attachment before the perforator

attachment is installed on the motor.

Assembly:

1. Assemble the attachment onto the motor using the Straight attachment Assembly Instructions.

2. To install a cranial perforator device with a hudson shank, pull back proximally on the collar of the perforator attachment. Insert a device and release the collar to its original position (Figure 23).

3. The speeds achievable by the AD01 and AD02 attachments are provided in Table 5.

Disassembly:

Pull back proximally on the collar of the perforator attachment and then remove the cranial perforator device. Rotate the perforator attachment to the unlocked position and lift the attachment o of the motor.

Table 5: Maximum output speed

Console setting AD1 AD03

60000 rpm 645 rpm 830 rpm

70000 rpm 745 rpm 965 rpm

72000 rpm 770 rpm 995 rpm

74000 rpm 790 rpm 1020 rpm

75000 rpm 805 rpm 1035 rpm

The Midas Rex Legend EHS system

Perforator attachment assembly

Jacobs Chuck attachment

Assembly:

1. Assemble the attachment onto the motor using the Straight attachment Assembly instructions.

2. Install the Jacobs Chuck key as shown in Figure 24 and rotate it counterclockwise to open the ridged collar. Insert drill bit and tighten collar by turning the Jacob’s Chuck key clockwise (Figure 24) until the tool is secure.

Disassembly:

Using the Jacobs key, open the collar. Remove and discard the drill bit. Rotate the Jacobs Chuck attachment to the unlocked position and lift the attachment o of the motor.

Angled double lock (DK) attachment

Notes:

• Angled attachments with the same length, marking, and color band share the same dissecting tools.

• You can insert and lock a tool in the attachment before the angled attachment is installed on the motor.

Assembly:

1. Assemble the attachment onto the motor using the Angled attachment Assembly instructions.

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully seated (Figure 25-1).

3. Rotate the tool lock in direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 25-2).

4. Pull on the tool to ensure that it is secured in the attachment.

5. The tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

6. Verify that both the attachment to motor and the tool-lock alignment mark is directly in line with the corresponding locked symbol.

Disassembly:

1. To remove the attachment, hold the motor in the palm of your hand, and push the sleeve on the attachment distally while turning the attachment to the unlocked position (Figure 25-3).

2. Release the sleeve and remove the attachment.

25-1

25-2

25-3

Angled double lock (DK) attachment assembly

Angled double lock (DK) attachment disassembly

Jacobs Chuck attachment assembly

The Midas Rex Legend EHS system

J-latch attachment

This attachment is designed for use with industry standard J-latch dissecting tools. Refer to the dissecting tool’s labeling for information on specic operating requirements and limitations.

Assembly:

1. Assemble and secure the attachment onto the motor using the Straight attachment Assembly instructions (Figure 26-1).

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully seated (Figure 26-2).

3. Turn the tool lock sleeve in the direction shown on the attachment to lock the tool (Figure 26-3). Pull on the shaft of the dissecting tool to verify tool is secure

Disassembly:

1. Turn the tool lock sleeve in the direction shown on the attachment to unlock the tool (Figure 26-3).

2. Remove the dissecting tool from the attachment and discard it.

3. Rotate the attachment on motor to the unlocked position.

4. Lift the attachment o of the motor.

26-1

26-3

J-latch attachment assembly J-latch attachment assembly

J-latch attachment assembly

26-2

Irrigation tubing set

Refer to the IPC manual for instructions to attach the tubing set to the IPC.

Note: Clip may not fasten to small bore attachment after having been used on large bore attachment.

Note: Not for use with the curved bur or trans-nasal bur.

Assembly:

1. Adjust the location of plastic clip on the stainless-steel irrigation tube (Figure 27).

2. Bend the irrigation tube to the desired angle.

3. Snap the clip onto the distal end of attachment (near the tool).

Disassembly:

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.

Trans-nasal and Clearview skull base bur attachment

Assembly:

1. Assemble and secure the attachment onto the motor using the Straight attachment Assembly instructions. Rotate the attachment to the locked position on the motor case (Figure 28-1).

2. Attach irrigation tubing to the port on the attachment (Figure 28-2).

Disassembly:

1. Remove irrigation tubing.

2. Rotate the attachment to the unlocked position on the motor case.

3. Remove the attachment from the motor and discard.

28-1

28-2

Irrigation tubing set assembly

Trans-nasal and Clearview skull base bur attachment assembly

1. Irrigation tubing connection

1. Stainless steel irrigation tube

2. Plastic clip

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

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

Troubleshooting

For any troubleshooting items not corrected by the actions below, contact Customer Service.

Problem Possible cause Recommendations

Legend EHS, Legend EHS Stylus, and Stylus Touch

The Midas Rex Legend EHS system

Motor is too hot to touch/ hold.

Tool is dicult to remove from attachment.

Attachment will not seat properly on the motor.

Motor does not run. Cables not properly connected. Ensure motor and foot control cables are properly connected.

Motor with attachment rotates, but an abnormal noise is heard.

Inadequate cool down period following sterilization. Motor must be allowed to cool down following steam sterilization.

Attachment transferring heat to the motor. Switch attachments to determine whether the heat is being generated by

Heavy side loading during dissection. Discontinue use and rest the motor by using it intermittently or wrap the

Inadequate irrigation. Ensure adequate irrigation to surgical site during bone dissection.

Aging of attachment. Contact Customer Service.

Use of reprocessed tools. Do not use reprocessed tools. Use only new tools.

Device refurbished by a non-Medtronic service center. For optimal performance, devices must be refurbished only by Medtronic.

Improper cleaning. Clean the attachment thoroughly according to the instructions in this

Motor collet ats are not aligned. Use the Legend motor wrench to rotate the at closest to the motor case

Speed setting is too low. Ensure that a speed greater than 10,000 rpm (EHS) or 3,000 rpm (Stylus) is

Attachment not properly installed and locked onto the motor.

Internal failure of motor and/or console. Replace motor or console to isolate the problem.

Foot control not properly functioning. Check for obstruction under the foot pedal.

Cables damaged. Check cables for cracks, splits, or bent connector pins.

Bearings are worn. Change the attachment to isolate the location of the problem.

Poor electrical connection. Check all connections from electrical source to console.

Internal failure of motor, console, or cable. Change motor, console, or cable to isolate the failing component.

the motor or the attachment.

motor with a moist sterile towel.

manual.

until its marker is aligned with the marker on the at farthest away from the motor case.

selected.

Remove and reinstall the attachment and dissecting tool to ensure proper installation.

Replace foot control to isolate problem.

Ensure motor and foot control cables are properly connected.

Problem Possible cause Recommendations

Stylus Touch motors

Motor does not run. Motor not reaching maximum speed. Check that the control lever ring is properly seated in one of the four

possible positions.

Finger switch not responding. Place the nger switch in run mode and the safety switch in safe mode.

Finger control damaged. Contact Customer Service.

The Midas Rex Legend EHS system

Problem Possible cause Recommendations

Legend attachments, and telescoping tubes

Attachment or telescoping tube has uncomfortable temperature to touch/ hold.

Attachment/telescoping tube is bent, loose, damaged or missing a component.

Color band on attachment/telescoping tube fades or discolors.

Attachment has excess lubrication.

Footed attachment has a component missing from leg/foot area or foot is bent.

AC-16 contra-angle attachment is overheating.

Smoke is generated by the attachment or motor.

When using a footed or rotating footed attachment, a gap does not exist between the tip of the tool and the foot of the attachment.

Heat from worn attachment/tube bearings. Do not use. Try another attachment/tube.

Telescoping tubes are multi-use disposable. If problem is resolved with a new Telescoping tube, discard the over-heated tube.

Attachment/tube unclean due to improper cleaning procedures.

Heavy side loading during dissection. Discontinue use and rest the attachment by using intermittently, try

Attachment mishandled, failed due to extended use or excessive force applied during use.

Incorrect cleaning or sterilization method. Use nomenclature markings on the attachment to match with a

Use of chlorine based or corrosive agents. Use recommended cleaning agents.

Aging. Telescoping tubes are multi-use disposable.

Over lubrication during cleaning process. Visually inspect and wipe excess lubrication.

Attachment damaged by dissecting tool drilling out part or all of leg/foot area.

Bend caused by incorrect use. Use proper technique when using attachment.

The contra-angle attachment operates by a set of internal gears to engage the drive shaft. It is normal for some heat to be generated approximately 2 cm from the distal end of the attachment and at the right of the angle head.

Attachment is not in the locked position. Ensure the attachment is in the locked position.

Improper installation of tool. Remove attachment and tool and reinstall per instructions. Ensure the tool

Debris in collet. Check motor collet for debris. If conrmed, contact Customer Service.

Check that appropriate cleaning procedures are being followed.

another identical attachment or wrap the attachment interface with a moist sterile towel.

Do not use. Dispose of telescoping tube. Telescoping tubes are multi-use disposable. Contact Customer Service.

corresponding dissecting tool or contact Customer Service.

Avoid over lubrication.

Do not use. Contact Customer Service.

Check motor collet for debris. If conrmed, contact Customer Service.

Check for proper installation of tool in collet prior to installation of footed attachment.

If heat continues or is excessive, contact Customer Service.

Ensure the tool is locked in the angled attachment.

is fully seated in collet by verifying tactile click when installing the tool.

Problem Possible cause Recommendations

Legend surgical dissecting tools

Tool wobbles. A non-Legend tool is being used. Replace with a Legend tool.

Worn attachment or tube bearings. Replace attachment or tube to isolate the location of the problem.

If the attachment is failing, Contact Customer Service.

If the telescoping tube is failing, dispose of it and use a new telescoping tube.

Attachment/telescoping tube and tool are not compatible.

Motor may be damaged. Contact Customer Service.

Match color code on the tool packaging to the color code on the attachment/telescoping tube.

Problem Possible cause Recommendations

Legend surgical dissecting tools

The Midas Rex Legend EHS system

Tool’s size and geometry may contribute to wobbling at certain speeds.

Tool vibrates excessively. Tool’s size and geometry may create excessive

Tool dull. Extended use of tool. Change to a new tool.

Tool will not seat properly in the motor or attachment collet.

vibration at certain speeds.

Reprocessed tool was used. Use only new tools from Medtronic.

Incorrect geometry. Contact Customer Service.

Debris in collet of attachment or motor. Clean the attachment or motor thoroughly according to the instructions in

A non-Legend tool is being used. Replace with a Legend tool.

Adjust the speed by changing the speed setting or foot/nger control. Do not use if wobbling persists. Change tool.

Adjust the speed.

Change tools.

this manual.

If cleaning does not correct the problem, Contact Customer Service.

Post-operative instructions

Disconnect accessory cable from console

To disconnect non-silicone multi-pin cables from the console, push the cable toward the console and then pull out by the lock ring.

Note: Silicone insulated multi-pin and single pin cable connectors do not have a lock ring (Figure 29). Remove these types of cable connectors straight from the connector panel.

Note: After disconnecting insulated connectors from the console, connectors that have debris under the insulator must be cleaned according to Cleaning and sterilization instructions. If debris is still present after cleaning and sterilization, return for warranty servicing.

Legend electrical connector

1. Lock ring

Cleaning and sterilization

Devices should be cleaned and then sterilized per the instructions below:

Reprocessing Instructions are subject to change. Refer to manuals.medtronic.com for current Reprocessing Instructions.

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 AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

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

Legend EHS, Legend EHS Stylus, and Stylus Touch 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.

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.

The Midas Rex Legend EHS system

Legend EHS, Legend EHS Stylus, and Stylus Touch reprocessing instructions

Containment and transportation

Preparation for decontamination

Preclean instructions prior to use in an automated washer

Cleaning: Automated Caution: Do not use ultrasonic cleaner. Review the washer-disinfector warning above, before using this cleaning method.

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

Detach attachment from Legend EHS and Legend EHS Stylus motor. Remove and discard tool. Do not soak devices.

Rinse devices under running tap water with collet pointed down until no visible soil is noticed.

A nylon brush may be used to aid in cleaning.

Remove devices from instrument trays before placing into washer.

Verify devices are visually clean prior to placing in instrument washer.

Orient devices in the washer to ensure maximum exposure to the cleaning agents.

Clean per recommended washer cycle below.

Legend EHS, Legend EHS Stylus, and Stylus Touch 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

Legend EHS and Legend EHS Stylus automated wash cycle using an alkaline detergent (pH 8.0 -10.5)

Phase Recirculation time Water temperature Detergent type

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

Wash 5 minutes (05:00) 43°C (109°F) (set point) Alkaline detergent with pH 8.0 - 10.5

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

Thermal rinse 1 minute (01:00) 90°C (194°F) (set point) Not applicable

Puried water rinse

1 minute 30 seconds (01:30) 66°C (151°F) (set point) Not applicable

Cleaning: Manual Wipe all external surfaces of the motor and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0.

Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent.

Rinse motor thoroughly under running water, collet end pointed down. Dry collet and motor with lint-free towel.

Verify that devices are visually clean after manual cleaning.

Rinse thoroughly with tap water

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.

Legend EHS, Legend EHS Stylus, and Stylus Touch 100% Ethylene Oxide (EtO) sterilization parameters

Preconditioning

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

Legend EHS, Legend EHS Stylus, and Stylus Touch steam sterilization

Cycle Pre-vac Gravity Pre-vac Pre-vac

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

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

Drying 15 minutes (15:00) 15 minutes (15:00) 10 minutes (10:00) 20 minutes (20:00)

STERRAD Not validated for use with low temperature hydrogen peroxide gas plasma sterilization.

Sterilization temperature

51-59 °C (124-138 °F)

Relative humidity

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

EtO concentration

Gas exposure (full-cycle)

Aeration

18 hours

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.

The Midas Rex Legend EHS system

Legend attachments/tubes 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. Review the washer-disinfector warning above, before using this cleaning method.

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.

Detach attachment from motor. Remove and discard tool. Do not soak devices.

Rinse attachments/tubes under running tap water, until no visible soil is noticed.

Attachments with moving parts must be actuated through their full range of motion under running tap water.

While rinsing under running tap water, an appropriately sized nylon brush must be used internally (for straight, footed attachments and telescoping tubes only) and/or externally to aid in cleaning attachments.

Remove devices from instrument trays before placing into washer.

Variable exposure attachments (AVAXX, AVAXXDK, AVSXX) must be placed in the washer with their tube in the fully extended position.

Verify devices are visually clean prior to placing in instrument washer.

Orient devices in the washer to ensure maximum exposure to the cleaning agents.

Clean per recommended washer cycle below.

Legend attachments/tubes automated cleaning - 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

Legend attachments/tubes automated cleaning - alkaline detergent (pH 8.0 -10.5)

Phase Recirculation time Water temperature Detergent type

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

Wash 5 minutes (05:00) 43°C (109°F) (set point) Alkaline detergent with pH 8.0 - 10.5

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

Thermal rinse 1 minute (01:00) 90°C (194°F) (set point) Not applicable

Puried water rinse

Cleaning: Manual Wipe all attachments and telescoping tubes with a cloth, dampened with a surgical instrument cleaning solution.

Immerse the head of contra-angle attachments in surgical instrument cleaning solution and run the motor for 1 minute.

Other attachments and tubes may be mechanically agitated in cleaning solution, but not soaked or immersed.

A nylon brush dampened with a surgical instrument cleaning solution may be used to clean the external surfaces and internal connecting surfaces of the attachments and tubes.

Straight attachments, footed attachments and telescoping straight tubes have special cleaning brushes sized to the attachment’s or telescoping tube’s internal diameter. Push the brush wet with surgical instrument cleaning solution through the attachment or telescoping tube from rear to front to loosen and remove debris trapped inside.

Move any moveable parts back and forth to allow solution to thoroughly clean attachment, for example, sleeve on footed attachment, perforator attachment.

Clean variable exposure attachments without adjusting the tube length rst, then with the tube fully extended, and nally with the tube fully retracted.

Rinse thoroughly with tap water.

1 minute 30 seconds (01:30) 66°C (151°F) (set point) Not applicable

The Midas Rex Legend EHS system

Legend attachments/tubes 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.

Thoroughly dry attachments. An air gun may be used to blow moisture out from rear to front of attachment. Note: Medtronic no longer recommends using the Legend attachment cleaning nozzle (PA120), as this may cause some attachments to overheat.

Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments:

Holding the can approximately 10-15 cm (3-6 inches) away from the attachment, spray all components that move, rotate, or slide with three quick squirts.

Articulate movable components to ensure proper lubrication.

Remove excess lubricant with a clean cloth.

wrap.

Legend attachments/tubes 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 15 minutes (15:00) 15 minutes (15:00) 20 minutes (20:00) 10 minutes (10:00)

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.

Legend attachments/tubes 100% Ethylene Oxide (EtO) sterilization parameters

Preconditioning

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

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.

Sterilization temperature

51-59 °C (124-138 °F)

Relative humidity

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

EtO Cconcentration

Gas exposure (full-cycle)

Aeration

18 hours

Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE)

Reusable devices that have been used on patients with suspected Creutzfeldt-Jakob Disease (CJD) or other Transmissible Spongiform Encephalopathies (TSE) should be quarantined and not reused until a diagnosis is conrmed or excluded. Medtronic Powered Surgical Solutions (MPSS) will not authorize or accept the return of MPSS products that directly contacted a patient or are contaminated with a patient’s body uids that is suspected or conrmed with TSE or CJD diagnosis. Furthermore, MPSS recommends that all MPSS product used on a patient conrmed with or suspected of a TSE/CJD diagnosis be incinerated. If TSE/CJD is excluded as a diagnosis, the quarantined reusuable equipment may be returned for use after appropriate cleaning, decontamination and sterilization. Hospital personnel should contact their infection control personnel for current procedures and policy for reusable equipment processing. Contact your Sales Representative for temporary equipment while original equipment is quarantined or for replacement of product incinerated under this policy. Contact MPSS Regulatory Aairs Department for additional information regarding TSE/CJD contamination.

Refurbishing or repairs

When the Legend EHS System requires servicing or refurbishing, contact Medtronic Powered Surgical Solutions Repair Services for a return authorization and instructions for returning the equipment. Medtronic Powered Surgical Solutions provides quality assured service by factory-trained personnel who will utilize genuine Midas Rex Legend parts as required. All items being returned for servicing or refurbishing should be properly cleaned and sterilized prior to shipping.

US Customers Contact:

Refurbishing or repairs:

Medtronic Powered Surgical Solutions Repair Services

(800) 335-9557 or (817) 788-6440

mmrcustomerservice@medtronic.com

Purchasing additional or replacement products:

(800) 433-7080 or (817) 788-6400

Customers Outside the US:

Contact your Medtronic Sales Representative

The Midas Rex Legend EHS system

Peak performance, reliability and maximum service life from your Legend EHS system may be assured by using only those Midas Rex Legend products for your Legend EHS system that are manufactured by and sold through Medtronic Powered Surgical Solutions, Fort Worth, Texas. While Medtronic Powered Surgical Solutions guarantees complete compatibility among its products within a specic product line, the dissecting tools are designed for single-use only, and Medtronic disclaims any responsibility when reprocessed dissecting tools are used. If you would like more information about the patient and product risks associated with reprocessed tools, please contact the number or e-mail address listed above. Due to safety and environmental concerns, Medtronic Powered Surgical Solutions requests the return of electric high-speed motors for proper disposal at the end of the product life cycles.

Midas Rex Legend EHS system Limited Warranty* (U.S. customers only)

A. This Limited Warranty provides the following assurance to the purchaser of a Medtronic Midas Rex® Legend EHS System. This Limited Warranty is extended only

to the buyer purchasing the Legend EHS System directly from Medtronic or from its aliate or its authorized distributor or representative. The Midas Rex® Legend EHS System includes the motor, instrumentation cases and trays (hereafter referred to as System Components), motor attachments (hereinafter referred to as “Attachments”), telescoping tubes (hereinafter referred to as Semi-reusable Components) and dissecting tools and other accessories not listed above and jointly referred to as Legend EHS System, 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 Motor 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 Semi-reusable Component fail to function to Medtronic’s published specications during the term of this Limited Warranty (30 days from the date of sale of a new Semi-reusable Component), Medtronic will replace the Semi-reusable Component or any portion thereof.

4. 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 Legend EHS 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.

The Midas Rex Legend EHS system

Preventive maintenance

Dening maintenance level

The scheduled maintenance information is provided as a guide to assist the customer in getting the greatest ownership value from their Midas Rex Legend EHS system, while helping to maximize its performance, safety, and reliability. This scheduled maintenance program is in addition to the required routine cleaning after each use. (The scheduled maintenance program is one of three programs, Limited Warranty and Extended Maintenance Agreement are the other two, intended to help you keep your system in good condition.)

The maintenance information is divided into two sections.

Section 1 contains the preventive maintenance/service schedule. How much scheduled maintenance a Midas Rex Legend EHS system requires depends upon how often it is used and the conditions to which it is subjected, such as cleaning and sterilization. The demands on these systems can vary greatly from facility to facility. Twelve maintenance intervals have been dened. The time interval is determined by tool usage per year per motor and has been identied as levels A, B, C, or D as determined in Table 6.

Table 6: Maintenance level

Maintenance level

A 150–200 12–16* 3 months

B 100–149 8–11 4 months

C 50–99 4–7 5 months

D <50 <4 6 months

*A motor with usage rates greater than 16 uses per month should be returned for factory maintenance at a 6-month interval.

WARNING: Failure to follow recommended service and preventive maintenance schedules for attachments may prevent tool from being secured properly.

Identifying and following the scheduled maintenance intervals for the Midas Rex Legend EHS system will assist in reducing the potential for unanticipated down time as a result of wear.

The preventive maintenance schedule found in Section 1 details the specic checkpoints that are recommended and its associated interval.

It also provides a convenient place to document your system’s maintenance history. If any of these checkpoints indicate wear or damage, do not use. Return the respective product to Medtronic Powered Surgical Solutions (MPSS) for service.

The maintenance checkpoints have been designed for a facility’s Biomedical Department or equivalent to perform. servicing the Midas Rex Legend EHS system in accordance with the maintenance levels.

Number of tools used per motor per year

Usage rate uses per month per motor Time interval

Section 2 contains the detailed instructions for

Section 1: Preventive maintenance/service schedule:12 maintenance intervals

Date of system purchase:__________________ Maintenance level:__________________

Scheduled maintenance (See Section 2 for details)

Scheduled maintenance

1st

2nd

3rd

4th

5th

6th

7th

8th

9th

10th

11th

12th

Attachments: Straight, footed, perforator, Jacobs Chuck, and telescoping Attachments: Angled, contra, and metal cutting

□ Etching and color ring remain legible and distinguishable. □ Attachment tube and base are clean and free of debris. □ Attachment has no loose components. □ (Straight/footed) Attachment tip shows no signs of wear or deformation. □ Footed attachment foot is not bent. □ Collet on perforator or Jacobs Chuck drive attachment shows no signs of

wear or deformation.

□ Connect the attachment to the motor and run for 3 minutes. Motor case,

attachment base and tip do not become uncomfortably hot to the touch.

□ Repeat for each straight, footed, telescoping, perforator, and Jacobs Chuck

drive attachment in this system.

□ Note: Telescoping tubes are multi-use disposable. Discard if excessive heat

or vibration is present.

If any damage, excessive rust/corrosion, or wear is observed with the product, or if action is required beyond cleaning, do not use the product and return to MPSS for service.

Level A months

 3  4  5  6

 6  8  10  12

 9  12  15  18

 12  16  20  24

 15  20  25  30

 18  24  30  36

 21  28  35  42

 24  32  40  48

 27  36  45  54

 30  40  50  60

 33  44  55  66

 36  48  60  72

Level B months

Level C months

Level D months

Date performed Performed by

Factory service recommended - contact Medtronic

□ Etching and color ring remain legible and distinguishable. □ Attachment tube and base are clean and free of debris. □ Attachment has no loose components. □ Attachment tip shows no signs of wear or deformation. □ Connect the angled or metal cutting attachment to the motor and run for

3 minutes. Motor case, attachment base, knuckle and tip do not become

uncomfortably hot to the touch. □ Head to tube joint for the contra-angled attachment is stable, that is, no play. □ Connect the contra-angled attachment to the motor and run for 1 minute at

62,000rpm. Motor case, contra-angled attachment base, knuckle and tip do

not become uncomfortably hot to the touch □ Repeat for each angled, contra-angled or metal cutting attachment in this

system.

The Midas Rex Legend EHS system

Section 2: Instructions for completing preventive maintenance steps

Scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, 11

Console, motor, foot control, and cables

1. Visually inspect the power cord to verify that it does not have any damage to the insulation or to the blade of the connector and that there is no debris evident. Replace if damage is apparent.

2. Turn the rotational collet of the motor as shown in Figure 30-1 using motor wrench PA130 to the position shown in Figure 30-2.

3. Run the motor and verify that the pedal smoothly controls the motor speed.

4. If the display shows any errors, then the motor is not properly connected or the motor cable may need servicing or the connectors of the motor or motor cable are dirty, or the motor or console may need servicing.

5. Press the Reverse button on the foot control several times and verify that the console display toggles between << REVERSE and FORWARD >>. Leave the console in the << REVERSE mode. Press the foot pedal to start the motor in reverse and listen for 3 beeps when the motor starts in reverse.

6. Run motor for 3 minutes at 70,000 rpm for EHS or 5 minutes at 60,000 rpm for EHS Stylus. Verify that the motor case, attachment base and tip do not become uncomfortably hot to the touch.

7. Verify that when the foot pedal is released the motor stops and does not continue to run. If the motor continues to run when the foot pedal is released, do not use and return system to MPSS for service.

8. Using the motor wrench, turn the rotational collet such that it aligns with stationary collet as shown in Figure 30-3.

30-1

Turn the rotational collet Rotational collet turned and ready for testing Rotational collet aligned with the stationary collet

30-2

1. Stationary collet

2. Rotational collet

30-3

Attachments: Straight, footed, perforator, Jacobs Chuck, and telescoping

Telescoping tubes are multi-use disposable and do not receive scheduled maintenance.

1. Visually inspect the etching and color ring to ensure it remains legible and the color is distinguishable.

2. Visually inspect the attachment tube and base for any signs of debris or damage.

3. Connect an attachment to the motor and verify a tactile and audible click when the attachment is locked on the motor.

4. Visually and physically inspect (pulling and twisting by hand) the attachment for any loose or loosening components. If any components return the attachment to MPSS for service.

5. (Straight/footed) Visually inspect the attachment tip for any signs of wear. The tip should remain round with no evidence of deformation.

6. (Footed) Visually inspect the foot. The foot and/or leg of the attachment should not be bent, or damaged.

7. (Perforator and Jacobs Chuck) Visually inspect the perforator collet for any signs of wear or deformation.

8. Heat check

• For telescoping attachment, insert an appropriate telescoping tube into the base.

• Attach and lock the attachment onto the motor. Check to ensure that there is a tactile and an audible click when the attachment is locked on the motor.

• Connect the motor to a console with foot control attached.

• Turn console on.

• Run the motor for 3 minutes.

• Feel the motor case, the attachment base, and the attachment tip (except telescoping) to ensure they are not uncomfortably hot to the touch.

9. Repeat steps 1-7 for each straight/footed/telescoping/perforator/Jacobs Chuck drive attachment in this system.

Attachments: Angled, contra, and metal cutting

1. Visually inspect the etching and color ring to ensure it remains legible and the color is distinguishable.

2. Visually inspect the attachment tube and base for any signs of debris or damage.

3. Connect an attachment to the motor and verify a tactile and audible click when the attachment is locked on the motor.

4. Visually and physically inspect (pulling and twisting by hand) the attachment for any loose or loosening components. If any components are loose, do not use and return the attachment to MPSS for service.

5. Visually inspect the attachment tip for any signs of wear. The tip should remain round with no evidence of deformation.

6. Heat check angled and metal cutting attachment

• Attach and lock the attachment onto the motor. Check to ensure that there is a tactile and an audible click when the attachment is locked on the motor. Turn the tool locking ring to the locked position on the angled attachment.

• Connect the motor to a console with foot control attached.

• Turn console on and run motor for 3 minutes.

• Feel the motor case, the attachment base, the knuckle (angled area for angled attachment only), and the attachment tip to ensure they are not uncomfortably hot to the touch. Turn the tool locking ring to the unlocked position on conclusion of the inspection.

7. Visually inspect the head to tube joint for the contra-angled attachment for stability, that is, there is no loosening of this joint.

8. Heat check contra-angled attachment

• Attach and lock the contra-angled attachment onto the motor. Check to ensure that there is a tactile and an audible click when the attachment is locked on the motor.

• Connect the motor to a console with foot control attached.

• Set speed to 62,000 rpm using the speed down button for EHS or the speed up button for EHS Stylus.

• Turn console on and run the motor for 1 minute.

• Feel the motor case, the attachment base, the knuckle (contra-angled area), and the attachment tip to ensure they are not uncomfortably hot to the touch.

are loose, do not use and

The Midas Rex Legend EHS system

EC REP

EUR · USA · JPN · AUS

105345

STERILE

IPX1

DEHP

Dissecting Tool

EHS

Refurbished

Symbols

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

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

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

Is Approximately Equal To

Use With

ACC

Left Foot Control Unit Button / Mode Button

Right Foot Control Unit Button

Fine Irrigant Adjustment

Output

Accessory

Adapter

Attachment

Brush

Dissecting Tool

Electrical High Speed Handpiece Connector

Instrument Case

STERILE EO

+ XX °C

+ XX °F + XX °C + XX °F

PHT

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 Vertical Water Drops

Contains DEHP (di-2-ethyl hexyl phthalate)

AC Power

Protective Earth

<120s

Applied Part Duty Cycle

OFF

>180s

On/O Button

Start/Stop

! USA

Unlocked

Motor

Refurbished

Multi-Use Disposable Attachment

Part Number

USA Only

Do not use if package is open or damaged

Locked

Package Quantity

Forward

Reverse

Pump Head 1

Pump Head 2

Handpiece

Top Foot Control Unit Button / Handpiece Button

Foot Pedal Connector

May be covered by U.S. Patents:

EC REP

2019-05

Medtronic.com/patents

Made in USA. Printed in USA.

Medtronic Powered Surgical Solutions

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Fort Worth, Texas 76137 USA

+1 800-433-7080

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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 AF02R Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual