Legend EHS System EHS, EHS Stylus and Stylus Touch Instructions For Use May 2019 PDF download

Instructions for Use 175036EN C

The Midas Rex™ Legend EHS™ System Legend EHS, Legend EHS StylusTM, and Stylus TouchTM

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™ , Intelliflow™, 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 System warnings�� 1 Component warnings�� 2 Tools and disposable components warnings�� 2 Precautions�� 3 System motors�� 3 Motor cable�� 4 Motor finger lever �� 4 Attachment assembly�� 4 IPC set up�� 4 Connect to the IPC�� 4 IPC pump detection�� 4 IPC touchscreen controls�� 5 Speed�� 5 Irrigation�� 5 Acceleration and deceleration�� 5 Rotation (FWD and REV)�� 5 Safe mode (SAFE)�� 5 Multifunction foot pedal controls�� 6 Technical specifications�� 6 EMC Guidance�� 6 Legend EHS, Legend EHS Stylus, and Stylus Touch attachments�� 7 Dissecting tool nomenclature�� 7 Aligning the motor collet�� 7 General guidelines for attachments and tool applications�� 8 Legend EHS, Legend EHS Stylus, and Stylus Touch attachment assembly and disassembly��11 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 Defining 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 specifically 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 identified 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 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 W13

W14

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. The Legend EHS and/or Legend EHS Stylus system and its associated equipment should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems. Do not place Legend EHS and/or Legend EHS Stylus handpiece in the proximity of a magnetic field, such as magnetic drape or Magnetic Resonance Imaging (MRI) equipment to avoid inadvertent handpiece activation. 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. Heavy side loads and/or long operating periods may cause the device to overheat. The Legend EHS and/or Legend EHS Stylus motors should only be operated when the attachment is in the locked position. 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. Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. Use only dissecting tools specifically 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. Do not use the Legend EHS and/or Legend EHS Stylus system without proper cleaning and sterilization. Refer to the IPC Instructions for Use and Clearview Insert for additional instructions, warnings, and cautions. Refer IPC User’s Guide for warnings related to IPC. 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. 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.

1

The Midas Rex Legend EHS system W15 W16 W17 W18

Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Do not operate the Legend EHS and/or Legend EHS Stylus motors in the presence of (MRI) devices. Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit. 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 qualified 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 qualified 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, fluoroscopy, 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 effect 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 specifications. 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 staff. 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 modified 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 field, 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. Sharpcutting powered tools induce bleeding and removal of significant tissue and bone. W48 Tool flutes 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 fingers 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 confirmed. 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 difficult to remove, causing irritation, inflammation, 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 specifications. W61 Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. 2

The Midas Rex Legend EHS system W62 Do not re-sharpen used tools. Worn tools should be frequently replaced with new ones to ensure effective 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 specifically 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 effectiveness 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 P2 P3 P4 P5 P6 P7 P8 P9

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

P10 P11 P12 P13

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 finger lever. 1

Legend EHS Stylus motor

2

Legend EHS motor

3

1 2

1 1.

Rotating collet

2 2.

3

Stationary collet

3.

4-pin cable connection

Stylus Touch motor

1

2

3

4

5. 6.

Stationary collet Rotating collet

3 4 5 1. 2. 3.

Stationary collet Rotating collet Ground connector

5 6 4. 5.

4-pin cable connection Locking sleeve

1. 2.

Telescoping finger rest Finger lever

3. 4.

Finger lever safe mode switch Control lever ring

3

The Midas Rex Legend EHS system

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.

4-2

Connect Legend EHS cable to motor

4-1

Disconnect Legend EHS cable from motor

2

Motor finger lever The Stylus Touch motor includes a rotating finger lever. To rotate the finger 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)

5

1

Stylus Touch finger level rotation

2

1

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. 6

IPC connector panel connection ports 1. 2. 3. 4.

1

2

3

4

5

5.

Legend EHS motor Legend EHS Stylus motor Stylus Touch motor Intelliflow irrigation remote control 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 configuration. 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.

4

The Midas Rex Legend EHS system

IPC touchscreen controls

7-1

IPC Stylus touchscreen

IPC Stylus Touch touchscreen

7-2

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:

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 flow rate, in the Pump control box, press the plus button to increase flow rate or the minus button to decrease flow rate. If intermittent flow is available, pressing the plus or minus button progresses the system through intermittent and continuous flow. The system displays Intermittent when in intermittent flow mode. Note: To adjust flow 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 configuration may be different 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.

8-1 IPC touchscreen REV button raised

Mode

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 off. 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 finger 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.

8-2 IPC touchscreen REV button concave

9

FWD

REV

IPC Stylus Touch safe mode touchscreen Speed

SAFE + RPM

5

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

10

2

1

1. 2. 3. 4. 5. 6. 7. 8.

1 6

3

5

4

7

Mode button Handpiece button Control button Slip-resistant food pad Foot pedal Y-splitter Port 1 Port 2

8

Technical specifications Table 1: Legend EHS technical specifications 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, indefinitely at 70,000 rpm.

Table 2: Legend EHS Stylus technical specifications 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 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 indefinitely at 60,000 rpm.

Table 3: Stylus Touch technical specifications 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 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 indefinitely at 60,000 rpm.

EMC Guidance See the IPC User’s Guide for the EMC guidance. 6

The Midas Rex Legend EHS system

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 five characters, representing the associated attachment length, the tool-head shape, and the tool-head diameter. Part numbers can also include a variety of prefixes to identify specific attachment types, as well as a variety of suffixes to provide additional information about the dissecting tool. Tools that use a design taken from the Mednext line are designated by an additional “-MN” suffix. 11

Dissecting tool nomenclature naming convention

9 MH30 1 1. 2. 3.

2

3

4

Optional prefix Attachment length, x centimeters (Ex. 9 = 9 cm) Tool head shape, xx form/function (Ex. MH = Match Head)

5 4.

6

Tool head diameter, x.x millimeters (Ex. 30 = 3.0 mm) Optional suffix Optional “-MN” suffix

5. 6.

Tool number prefixes

Tool number suffixes

Note: A single part number will use only one prefix.

Note: More than one suffix may be combined in a single part number.

Prefix

Tool attatchments

Suffix

Tool head shape modifiers

CB

Curved Burr

B

Ball end

F

Footed attachments

BR

Barrel

SD

Spinal with Distal bend

M

2-Flute Match style

SP

Spinal with Proximal bend

PR

Pear shaped

T

Telescoping tube

S

Spiral flutes

TN

Trans-Nasal

T

3-Flute or SymmeTRI

Tool head shape (form/function)

Suffix

Tool head cutting modifiers

Suffix

Tool length modifiers

AC

Acorn

C

Carbide

L

Long

BA

Ball

D

Diamond

SH

Short

CY

Cylinder

DC

Diamond Coarse

Pxx

HM

Hole Maker

DF

Diamond Fine

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

HS

Hole Saw

DX

Diamond Extra Coarse

Mxx

Minus ‘xx’ mm

MC

Metal Cutting

DXF

Diamond Extra Fine

MH

Match Head

F

Fine

OV

Oval

-MN

MedNext style

RT

Reverse Taper

X

Coarse

TA

Tapered or side cutter

XF

Extra Fine

TD

Twist Drill

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 flats are not aligned. Verify alignment of arrows on motor collet flats. Prior to installation of an attachment and dissecting tool on motor, ensure that arrows on the motor collet flats 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

12-2

Incorrect alignment

1

1.

13

Motor wrench

2

Stationary collet

2.

Rotational collet 7

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

Commonly used attachments

Commonly used dissecting tools

Spine

8-B, 9-M, 14-AM straight or angled, 15-A straight or angled

Match head Elongated spherical design allows controlled, delicate dissection. For laminotomy, foramenotomy, entry hole, nerve decompression, osteophyte removal, etc. Ball Helical cutting flutes dissect bone from a variety of approach angles. For debridement, decortication, corpectomy, osteophyte removal, etc. Oval Helical cutting flutes and curved design blend acorn and ball styles to vary dissection efficiency 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 efficient and effective for interbody fusion. Cylinder Effective bone sculpturing and planing. For graft shaping, debridement corpectomy, decortication, interbody fusion, fusion takedown, etc. Acorn Curved designs varies dissection efficiency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etc.

Neurosurgical–Cranial

Telescoping

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

Footed

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

7-6ST straight or angled, 8-B, 9-M, 10-9ST straight or angled, 14-AM straight or angled, 15-A straight or angled

Match head Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, mastoidectomy, acoustic neuroma, skull base, etc. Ball Helical cutting flutes 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 efficiency with varied approach angles. For entry hole, bone shaping, debridement, etc.

8

Telescoping

Match head 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

Commonly used attachments

Commonly used dissecting tools

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

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

Match head Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etc. Ball Helical cutting flutes dissect bone or cement effectively 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.

Ear, nose, and throat (otology, neurootology)

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

Ball Helical cutting flutes dissect bone or cement effectively from a wide variety of approach angles. For debridement, decortication, mastoidectomy, facial recess, cochlear implant bed, ossiculoplasty, labyrinthectomy, middle fossa approach, acoustic neuroma, etc.

Orthopaedics

8-B, 9-M, 14‑AM straight or angled, 21-TU, 26-R, footed, telescoping

Ball Helical cutting flutes dissect bone or cement effectively from a wide variety of approach angles. For debridement, decortication, cement removal, acetabular revision, etc. 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 efficiency with varied approach angles. For bone shaping, debridement, decortication, cement removal, acetabular revision, etc. Cylinder Effective bone sculpturing and planing. For graft shaping, debridement, decortication, cement removal, acetabular revision, etc.

Biometals/ bioceramics/ biomaterials

Footed

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

MC

Metal cutter Cutting flutes or diamond wheel design remove metals, ceramics and other biomaterials effectively from a variety of approach angles. For cutting rods, pins, plates, implants, screws, etc.

9

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

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

LSD

Lumbar Stenosis Decompression

ND

Nerve Decompression

BA

Ball dissecting tool, cutting flutes to dissect bone or cement effectively from a wide variety of approach angles.

Posterior Lumbar Interbody Fusion (PLIF)

OR

Osteophyte Removal

AC

Acorn dissecting tool, curved design varies dissection efficiency with varied approach angles and effective in bone shaping.

Transforaminal Lumbar Interbody Fusion (TLIF)

DB

Debridement

CY

Cylinder dissecting tool effective in bone sculpturing and planning.

Anterior Lumbar Interbody Fusion (ALIF)

DC

Decortication

HM/S

Hole Maker/Hole Saw dissecting tool, matched sets of hole makers and hole saws are efficient and effective.

Direct Lateral Interbody Fusion (DLIF)

CT

Corpectomy

OV

Oval dissecting tool with helical cutting flutes and curved design blend acorn and ball styles to vary dissection efficiency with approach angle.

FT

Fusion Takedown

MI

Minimally Invasive procedure

T

Fluted dissecting tool, cutting flutes to allow faster, and efficient bone removal.

LT

Laminotomy

TA

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

FRT

Foramenotomy

MC

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

LIF

Table 4: General guidelines for attachment and tool applications Surgical application - Spine Incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials. LM LSD LIF FT

LT FRT PH ND OR DB DC CT MI

X

Tools Commonly used attachments

MH

BA

AC

CY

HM/S

OV

T

TA

MC

X

-

X

-

X

-

X

-

X

-

X

-

X

-

X

-

X

-

X

-

X

-

X

Straight X

X

X Angled

X

-

X

Base

Tube

Straight

Straight Angled Curved

Angled

Footed

Curved burs X

X

-

X

Contra angle

ASMC

10

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 flats 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, confirms 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, confirms 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.

14-1

Straight attachment assembly

14-2

Straight attachment assembly

14-3

Straight attachment assembly

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 finger to lift the attachment off of the motor.

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.

15-1

Angled attachment assembly

Assembly: 15-2 Angled attachment 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, confirms 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). 1 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 1. Tool lock/unlock sleeve the motor case. An audible click, heard and perceptible by touch, confirms that the tool is fully seated. 15-3 Angled attachment assembly 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 off of the motor.

11

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, confirms that the tool is fully seated. 2. Slide the fixed 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 fixed 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

Fixed footed attachment assembly

16-2

16-3

Fixed footed attachment assembly

16-4

Fixed footed attachment assembly

Disassembly: 1. To remove the fixed footed attachment, hold the motor in the palm of your hand. Push the sleeve on the fixed footed attachment distally while rotating the attachment to the unlocked position on the motor case and then release the sleeve (Figure 16-5). 2. 3.

To avoid injury from the dissecting tool, use thumb and index finger to cautiously and slowly lift the attachment off of the motor and away from the dissecting tool (Figure 16-6). Pull the dissecting tool out of the motor collet and discard the tool (Figure 16-7).

16-5

Fixed footed attachment disassembly

16-7

Fixed footed attachment disassembly

16-6

Fixed footed attachment disassembly

Rotating footed attachment Warnings: Refer to Warning W44. Notes: • Rotating and fixed 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, confirms 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

Rotating footed attachment assembly

17-2

17-3

Rotating footed attachment assembly

17-4

12

Rotating footed attachment assembly

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 finger to lift the attachment off of the motor. 3. Remove the dissecting tool from the motor collet and discard the tool.

Contra-angle attachment AC-16 18-1 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). 18-2 3. Rotate the attachment head’s lever laterally to the open position and insert a dissecting tool (Figure 18-2). 4. Align the flat in the tool with the corresponding flat 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 off of the motor.

Contra-angle attachment AC-16 assembly

Attachment assembly

18-3

Attachment assembly

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 prefix 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, confirms 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. 2. 3.

19

Metal cutting attachment

20

Variable exposure attachment assembly

Unscrew the tool lock with several turns, then withdraw the dissecting tool. Note: Do not rotate past the point where resistance is felt. Discard tool. Rotate the attachment to the locked position on the motor case and lift attachment off 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.

13

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 finger 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, confirms 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 finger 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 off 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 finger 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, confirms 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 off the motor.

21-1

1

1. 2.

Tube locking ring Tool locking ring

3.

Attachment assembly

21-3

Attachment assembly

22-1

3

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

1 1.

2

Base

21-2

Cooling sleeve

22-2

Attachment assembly

22-3

Attachment assembly

22-4

14

Telescoping tube and telescoping tube base attachment (AT10) or angled (AT10A) assembly

Curved bur cooling

The Midas Rex Legend EHS system

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 off of the motor.

23

Perforator attachment assembly

Table 5: Maximum output speed Console setting

AD01

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

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 off of the motor.

24

Jacobs Chuck attachment assembly

Angled double lock (DK) attachment 25-1 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 25-2 Assembly instructions. 2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, confirms 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). 25-3 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.

Angled double lock (DK) attachment assembly

Angled double lock (DK) attachment disassembly

15

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 specific 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, confirms 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

26-1

J-latch attachment assembly

26-3

J-latch attachment assembly

26-2

J-latch attachment assembly

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 off of the motor.

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.

27

Irrigation tubing set assembly 1.

1

2.

Stainless steel irrigation tube Plastic clip

2

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.

16

28-1

Trans-nasal and Clearview skull base bur attachment assembly

28-2

Trans-nasal and Clearview skull base bur attachment assembly

1

1.

Irrigation tubing connection

medtronic

Medtronic MIDAS Series Systems

Legend EHS System EHS, EHS Stylus and Stylus Touch Instructions For Use May 2019