The Midas Rex Legend EHS System Instructions for Use PDF download

Instructions for Use 175036EN D

The Midas Rex™ Legend EHS™ System Legend EHSTM and Legend EHS StylusTM

Customer service For further information regarding the use of this product or to report any problems, 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) 335-9557 or (800) 874-5797 [email protected] International Service: International Customers should contact their local Medtronic representative. 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.

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Contents Glossary�� 1 General information�� 1 Legend EHS™ system description�� 1 Electric motors�� 1 Attachments�� 1 Surgical dissecting tools�� 1 System accessories�� 1 Indications for use �� 1 Target population�� 1 Intended use�� 1 Clinical benefits�� 1 Contraindications�� 1 Special Notices �� 2 Warnings �� 2 Precautions�� 3 Training requirements�� 3 Residual risks�� 3 Possible adverse events�� 3 Material composition�� 3 System motors�� 4 Motor cable�� 4 Aligning the motor collet�� 5 Attachment assembly�� 5 Integrated Power Console (IPCTM) system set up�� 5 Connect to the IPCTM system�� 5 IPCTM system pump detection�� 6 IPCTM system touchscreen controls�� 6 Speed�� 6 Irrigation�� 6 Acceleration and deceleration�� 6 Rotation (FWD and REV)�� 6 Multifunction FCU�� 7 Technical specifications and performance characteristics�� 7 Guidance and manufacturer’s declaration - electrical safety EMC (electromagnetic compatibility)�� 8 Legend EHSTM and Legend EHS StylusTM attachments��10 Dissecting tool nomenclature��10 General guidelines for attachments and tool applications��11 Legend EHSTM and Legend EHS StylusTM attachment assembly and disassembly��15 Straight attachment ��15 Angled attachment ��16 Fixed footed attachment��16 Rotating footed attachment��17 Contra-angle and right-angle attachments��17 Metal cutting attachment��18 Variable exposure straight and angled attachment��18 Telescoping tube and telescoping tube base attachment straight (AT10) and angled (AT10A)��19

Telescoping curved bur and telescoping base attachment straight (AT10) and angled (AT10A) ��20 Perforator (AD01 & AD03) attachment��21 Jacobs Chuck attachment ��21 Angled double lock (DK) attachment��22 J-latch attachment ��22 Irrigation tubing set��23 System set-up check��23 Troubleshooting��23 Post-operative instructions��25 Disconnect accessory cable from console��25 Sterility��26 Legend EHS™ and Legend EHS Stylus™ system reprocessing instructions��26 Motors��26 Attachments/tubes��29 Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE) ��30 Refurbishing or repairs��30 Planned maintenance��31 Scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, 11��31 Scheduled maintenance intervals 4, 8, 12��33 Storage��33 Disposal��33 Midas Rex™ Legend EHS™ system Limited Warranty* (U.S. customers only)��34 Symbols��35

The Midas RexTM Legend EHSTM system

Glossary The following words and acronyms may be used in this manual: EHS FCU FWD ISM IPC REV RF Vrms

Electric High-Speed Foot Control Unit Forward - Rotation is clockwise Industrial, scientific, and medical Integrated Power Console Reverse - Rotation is counter-clockwise Radio Frequency Root mean square voltage

PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings, and precautions given in this document to the patient.

General information Read and understand this manual before using the Legend EHS™ system. The Legend EHS™ system is designed for use by medical professionals familiar with powered surgical instrumentation. The surgeon is responsible for learning the proper techniques in the use of this system, as inappropriate use may potentially be harmful. It is strongly recommended that the surgeon and dedicated operating room personnel are knowledgeable with the use of this system by being trained in Medtronic Midas Rex™ Hands-On Workshops or by one of the local authorized representatives.

Legend EHS™ system description Electric motors Electric motors provide power to operate disposable surgical dissecting tools. These motors are designed to interface with a series of attachments and surgical dissecting tools using a standard quick-connect locking mechanism. Motors operate in the same manner controlled by an FCU.

Attachments Attachments are designed to align the surgical tools with the motor to provide support and stability during various surgical procedures. Attachment options, of various lengths, include regular (straight, and angled), variable exposure (straight and angled), footed (craniotomes), and telescoping attachments and tubes. There are a variety of specialty attachments, such as the perforator, Jacobs chuck, J-latch, and metal cutting that are also available. This allows flexibility with the length and style of attachment for surgeries.

Surgical dissecting tools Surgical dissecting tools are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterials, and metals during various surgical procedures. The surgical dissecting tools vary in length and the distal tips of the tools vary in shape and style. The tip designs include the following universal shapes: acorn, match head, ball or round, cylinder, oval, and tapered or side-cutting. Specialized tools such as metal cutters, twist drills, hole-makers, hole saws, and reverse tapered tools are also available.

System accessories System accessories enable the Legend EHS™ system to carry out the system’s intended use. Accessories include the motor wrench, cleaning brushes, instrument trays, irrigation tubing sets, electric control switch, electrical power cables, and tool rack. All of these are considered medical devices except for the tool rack and electric power cables.

Indications for use The Midas Rex™ Legend EHS™ 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 Midas Rex™ Legend EHS™ 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)

Target population

Candidates for surgical applications stated in the Indications for use.

Intended use

The Midas Rex™ Legend EHS™ Electric Drill system is intended to be used to perform the task of removing soft and hard tissue and bone as stated in the indications for use.

Clinical benefits

Clinical Benefits of the Legend EHS™ High-Speed Drill Systems include optimized visibility and maneuverability in the surgical site, sufficient power to cut bone and biomaterials, ergonomic grip that allows precise control, sensory feedback while cutting, the ability to adjust/configure the system efficiently, and a portfolio of attachments and tools that meet different surgical needs.

Contraindications None.

1

The Midas RexTM Legend EHSTM system

Special notices

The words warning, precaution, and note have special meanings in this manual and should be carefully reviewed: Warning: A warning indicates that the personal safety of the patient or user may be involved. Disregarding this information could result in injury to the patient or user. Precaution: A precaution indicates that there is a risk of damaging equipment. Note: A note is intended to provide additional information, which may be useful but is not essential to complete the procedure.

Warnings W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21 W22 W23 W24 W25 W26 W27

W28 W29 W30 W31 W32 W33 W34 W35 W36 W37 W38 W39 W40 W41 W42 W43 W44 W45 2

The system user must be familiar with this Instructions for Use (IFU) and the Intergrated Power Console (IPC™) System User’s Guide, their precautions, procedures, and safety issues. The system and its associated accessories should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic powered surgery systems. Always inspect the device before and after use for any damage. If damage is observed, do not use damaged device. Use adequate irrigation during dissection to prevent thermal necrosis. Do not use an overheated device, as it may cause thermal injury to the patient or user. Heavy side loads and/or long operating periods may cause the device to overheat. Never place an overheated device on the patient or draping during the surgery. 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 dissecting tool packaging to the same nomenclature and color band on the attachment. Do not use the reusable devices without proper cleaning and sterilization. Sterilize and dry the reusable device before storing. All service must be performed by Medtronic qualified personnel only. Discontinue the use of device if visualization to the surgical site is lost. Do not attempt to remove a dissecting tool or attachment while the motor is running to prevent laceration of the user and/or cross contamination through a compromised glove. Do not immerse the device, except when recommended by the cleaning instructions in this IFU. The motors should only be operated when the attachment/tool is in the fully locked position. Do not use the system if the motor continues to run after releasing the foot pedal. Do not place the device on the patient or in an unsecured location during surgery. Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration. Do not use the reusable device immediately after steam sterilization. Allow an adequate cooling period after steam sterilization. Do not place motor in the proximity of a magnetic field, such as magnetic drape or Magnetic Resonance Imaging (MRI) equipment, to avoid inadvertent motor activation. The system complies with IEC/EN 60601-1-2, ed. 3.0 and ed. 4.0 safety standard for electromagnetic compatibility (EMC), requirements and test. However, if the system 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. 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 system’s IFU. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Use of accessories other than those specified and sold by Medtronic may result in increased emissions and decreased Electromagnetic (EM) immunity of this unit. Do not use metal-cutting attachment or metal-cutter tools to cut/resect bone. For metal transection, observe the following safety guidelines: W27a Wear eye protection. W27b Irrigate well to cool the cutting surfaces. W27c Protect the wound site from metal debris. When using 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. Failure to follow prescribed maintenance schedule on motors and attachments may result in device(s) detaching and falling from the motor or attachment which may cause patient injury. To avoid this, motors and attachments should be serviced periodically at intervals recommended by Medtronic. Electrical contacts must be dry prior to use. When using the non-DK 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. Remove footed attachments cautiously and slowly, as per instructions to avoid injury to the user. Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for Cleaning step. Do not load more than one motor inside the instrument tray per sterilization cycle. The system devices must be cleaned separate from the instrument trays. Do not load system devices into instrument trays until the devices are clean. Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning. Do not use any parts other than Medtronic device unless as noted, as damage or substandard performance could result. Do not use cables or power cables with cracks, tears, or corrosion as use may cause injury to patient, user, or operating room staff. Tool flutes are sharp and may perforate surgical gloves. Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of the user and cross-contamination through a compromised glove. 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. A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease pressure supplied to the motor to prevent vibration. If vibration persists, change to a different tool size or geometry to prevent unintended tissue damage. Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage. Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent contamination, use only once.

The Midas RexTM Legend EHSTM system W46 Excessive pressure applied to a tool may cause tool fracture. Should a tool fracture in use, exercise extreme care to ensure all the fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. W47 Do not use a dissecting tool if its packaging is damaged or opened outside the sterile field. Sterility is compromised if packaging is opened or damaged. W48 Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the system temperature to increase. Use of a dull tool may lead to heat at the cutting site. W49 Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging. W50 The system user should ensure sensitive anatomy is protected during drilling and use of the system. Failure to do so could cause injury to the patient. W51 When using a non‐DK angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor. W52 After each procedure, properly clean and sterilize all reusable devices.

Precautions P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15 P16 P17 P18 P19 P20 P21 P22 P23

Do not use a twist drill dissecting tool at an operating speed over 62,000 rpm. Powered burs and drills should be operated in the forward mode only. Do not run the AC-16 attachment above 62,000 rpm. This may cause overheating and damage to internal gears of attachment. Clean the Legend EHSTM motor and cable while still connected together. This will help to reduce debris ingress. Use only recommended cleaning agents. Disconnect cable from Legend EHSTM motor prior to sterilization. Do not attempt to disconnect the cable from the Legend EHS StylusTM motor. 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. Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite, sodium hydroxide, formic acid, or solutions containing glutaraldehyde. Remove and discard tools and accessories following local regulations for disposal of contaminated materials. Do not soak or submerge system devices. Do not use ultrasonic cleaners for system devices. Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor. Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the performance of the device and also the efficacy of the sterilization cycle. Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility. Do not modify device; performance could be diminished. When not operating the motor, eliminate accidental foot control activation. Do not operate the system without eye protection. Use the instrument tray for sterilizing the reusable devices only. Do not use the instrument tray for cleaning or disinfection of the reusable devices. Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. It is recommended that devices should be cleaned as soon as possible, preferably within 30 minutes following use to limit fixation of contaminants. The use of a washer-disinfector for cleaning may cause a degradation in performance.

Training requirements This device is intended for use by physicians, or appropriate staff, trained in the procedures described in the indications for use.

Residual risks Residual risks related to the use of the Medtronic Midas Rex™ Legend EHS™ electric system are: General surgical complications, Thermal injury, Tissue or bone damage, Nervous system injury, Cerebrospinal fluid leakage, Infection, Hearing damage, and Electric shock.

Possible adverse events In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic and the competent authorities.

Material composition Material contained in product that can cause an allergic reaction: nickel. Patients can be exposed to the following material in the dissecting tool with carbide ( Tool CFN with “C” in suffix), which are carcinogenic, mutagenic, and toxic for reproduction (CMR): Material

CAS number

Cobalt

7440‐48‐4.

For additional material of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.

3

The Midas RexTM Legend EHSTM system

System motors The Legend EHSTM 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 StylusTM motor (Figure 1) is a smaller and more compact version of the Legend EHSTM motor (Figure 2). 1

2

Legend EHS StylusTM motor

Legend EHSTM motor

3

1 2

1 1.

Motor collet Rotating

2 2.

Motor collet Stationary

3.

6

3 4 5 1. 2. 3.

Motor collet - Stationary Motor collet - Rotating Ground connector

4. 5. 6.

4-pin cable connection Locking sleeve Cable

Motor cable The Legend EHSTM motor cable can be separated from the handpiece, allowing it to connect and disconnect from the motor. • To connect the cable to the motor, align the mark on the cable to the red mark on the motor (Figure 3-1) and connect the two pieces. • To remove the cable from the motor, (1) push the cable towards the motor, then (2) pull out the cable by the locking ring only (Figure 3-2). The Legend EHS StylusTM motor cable is integrated in the handpiece and cannot be removed from the motor.

3-1

Connect Legend EHSTM cable to motor

3-2

Disconnect Legend EHSTM cable from motor

2

4

1

4-pin cable connection

The Midas RexTM Legend EHSTM system

Aligning the motor collet Note: An attachment will not seat on the Legend EHS and Legend EHS Stylus motor if the arrows on the collet flats are not aligned. Verify alignment of motor collet arrows. Prior to installation of an attachment and dissecting tool on motor, ensure that the motor collet arrows are in proper alignment. (Figure 4-1). If the arrows are not aligned (Figure 4-2), use the motor wrench (Figure 4-3) 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. 4-1

Correct alignment

4-2

Incorrect alignment

1

1.

4-3

Motor wrench

2

Motor collet Stationary

2.

Motor collet Rotational

Attachment assembly Note: Refer to the Legend EHSTM and Legend EHSTM Stylus attachments for attachment Assembly instructions.

Integrated Power Console (IPCTM) system set up The following instructions for the Legend EHSTM and Legend EHS StylusTM are in addition to the general assembly instructions found in the Integrated Power Console (IPC™) System User’s Guide. To obtain a copy of the user’s guide, please contact Medtronic or your local distributor.

Connect to the IPCTM system Locate the Legend EHSTM, Legend EHS StylusTM, and FCU ports on the IPC connector panel (Figure 5) and insert the connector. Note: Prior to use, check for bent or missing pins in the cable connectors. 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. 5

IPC™ system connector panel connection ports

1. 2. 3. 4.

1

2

3

Legend EHS motor Legend EHS Stylus motor Intelliflow irrigation remote control FCU

4

5

The Midas RexTM Legend EHSTM system

IPCTM system pump detection The IPC™ system incorporates the Legend EHSTM and Legend EHS StylusTM irrigation tubing sets at Pump 1. Refer to the IPC™ System User’s Guide section on Set up and Prime Pumps for more information. When the IPC detects the Legend EHSTM or Legend EHS StylusTM, Pump 2 defaults to None. When the IPC detects both the Legend EHSTM and Legend EHS StylusTM motors, 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 and Legend EHS Stylus with the IPC™ system touchscreen and the multifunction foot pedal.

IPCTM system touchscreen controls

6

IPCTM Stylus touchscreen

To set or adjust the Legend EHSTM and Legend EHS StylusTM (Figure 6) controls, on the IPCTM system touchscreen, in the control box, adjust or set motor speed, irrigation flow rate, motor acceleration/ deceleration, and motor rotation option:

Speed • To adjust speed in FWD or REV mode (Figures 7-1 and 7-2), in the Speed control box, press the plus button to increase speed or the minus button to decrease speed. + • The Legend EHS StylusTM has a default speed, 60,000 rpm and a variable speed adjustment from 200 to 75,000 rpm. • The Legend EHSTM has a default speed, 70,000 rpm and a 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, 0 cc per minute in FWD or REV mode. • For additional instructions see the IPC™ System User’s Guide.

Acceleration and deceleration • To adjust acceleration and deceleration, on the Defaults menu (Figure 7-1), 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. 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 motor 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 motor operation, on the Defaults menu, deselect Show On Screen.

Rotation (FWD and REV) • To change rotation mode, in the Mode control box, select FWD or REV. Important: System configuration may be different from the default. If the REV button appears raised (Figure 7-1) and does not have a selectable radio button, you cannot select the REV mode. If the REV button appears concave (Figure 7-2) and has a selectable radio button, you can select the REV mode via the touchscreen or the multifunction foot pedal.

6

7-1

IPCTM touchscreen REV button raised Mode

7-2

IPCTM touchscreen REV button concave Mode

FWD

REV

The Midas RexTM Legend EHSTM system

Multifunction FCU Important: By default, press each button on the FCU for at least 100 milliseconds (mS) for the selection to become active. Use the IPC™ system touch screen settings screen to change the default value. To use the multifunction foot pedal (Figure 8) to control the motor, do the following: • To select FWD or REV mode, press the mode button. • To change the handpiece, press the handpiece button. • 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 IPCTM User’s Guide. • To start or adjust the speed of a motor in variable mode, press the foot pedal. 8

IPCTM Multifunction FCUs

2

1

1. 2. 3. 4. 5.

1 3

3 5

Mode button Motor button Control button Slip-resistant foot pad Foot pedal

5 4

4

Technical specifications and performance characteristics Table 1: Legend EHSTM technical specifications and performance characteristics Legend EHSTM (EM100-A) Size

Weight

Speed

Duty cycle for applied part

9.02 cm length x 2.03 cm diameter

180 g

75,000 rpm FWD/REV, variable speed of 200– 75,000 rpm

For use in operating room temperatures up to 40°C (104°F), the 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 motor is rated for cutting time of 10 minutes followed by 25 minutes or rest. The motor is rated for intermittent use of 20 seconds ON / 20 seconds OFF, indefinitely at 70,000 rpm.

Table 2: Legend EHSTM Stylus technical specifications and performance characteristics Legend EHS Stylus (EM200) TM

Size

Weight

Speed

Duty cycle for applied part

7.77 cm length x 1.65 cm diameter

90 g

75,000 rpm FWD/REV, variable speed of 200– 75,000 rpm

For use in operating room temperatures up to 40°C (104°F), the 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 motor is rated for cutting indefinitely at 60,000 rpm.

7

The Midas RexTM Legend EHSTM system

Guidance and manufacturer’s declaration - electrical safety EMC (electromagnetic compatibility) Functional standards for electrical systems ANSI/AAMI ES60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005, CORR. 1:2009, AMMEND. 1:2012

IEC 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005, CORR. 1:2006, CORR. 2:2007, AMMEND. 1:2012

EN 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2006, AMMEND. 12:2014

IEC 60601-1-4

Medical electrical equipment - Part 1: General requirements for safety, Part 4: Programmable electrical medical systems 1996, AMMEND. 1:1999

IEC 60601-1-2

Medical electrical equipment - Part 1-2: General requirements for safety, collateral standard: electromagnetic compatibility - requirements and tests ED. 3.0:2007, ED. 4.0:2014

CAN/CSA C22.2#60601-1

Medical electrical equipment - Part 1: General requirements for safety ED. 3.0:2014

Environment of intended use: • Professional healthcare facility environment

Part-1: Electromagnetic immunity The Legend™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the Legend™ system should assure that it is used in such an environment. Immunity test

Test level (IEC/EN 60601-1-2)

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 8 kV contact

The relative humidity should be at least 5%.

± 15 kV air

Note 1 and 3

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV line to line ±2 kV line to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

0 % UT (100 % dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0 % UT (100 % dip in UT) for 1 cycle at 0°

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Legend™ system requires continued operation during power mains interruptions, it is recommended that the Legend™ system be powered from a uninterruptible power supply or a battery.

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 0.5 sec

0 % UT (100 % dip in UT) for 5 sec

30 A/m

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Note 1 and 3

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

Note: 1. UT is the mains voltage prior to application of the test level. 2. When the console is powered and connected to the FCU, application of -15KV air discharge onto the buttons may cause the console to freeze. Power cycle the console to re-establish normal operation. 3. All electric motors are compliant with IEC/EN 60601-1-2, ed. 3.0 and ed. 4.0 standards. Refer to the IPC™ System User’s Guide to determine specific standard compliance for the IPC™ system.

8

The Midas RexTM Legend EHSTM system

Part-1: Electromagnetic emissions The Legend™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the Legend™ system should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment – guidance

RF emission CISPR 11

Group 1

The Legend™ system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The Legend™ system is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purpose.

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

Recommended separation distances between portable and mobile RF communications equipment and the Legend™ system The Legend™ system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Legend™ system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Legend™ system as recommended below, according to the maximum output power of the communications equipment. Rated maximum power of transmitter

Separation distance (in meters) according to frequency of transmitter

W

380MHz-390MHz d = 0.22√P

430MHz-470MHz d = 0.22√P

704MHz-787MHz d = 0.67√P

800MHz-960MHz d = 0.22√P

1.7GHz-1.99GHz d = 0.22√P

2.4GHz-2.57GHz d = 0.22√P

5.1GHz-5.8GHz d = 0.67√P

0.01

0.03

0.07

0.03

0.07

0.1

0.07

0.21

0.07

0.21

1

0.22

0.67

0.22

0.67

10

0.7

2.12

0.7

2.12

100

2.2

6.7

2.2

6.7

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Part-2: Guidance and manufacturer’s declaration – electromagnetic immunities The Legend™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the Legend™ system should assure that it is used in such an environment. Immunity test

Test level (IEC/EN 60601-1-2)

Compliance level

Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

6 Vrms 150 kHz to 80 MHz in ISM bands

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Legend™ system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment may result.

3 V/m 80 MHz to 2.7 GHz

9 – 28 V/m Spot frequencies 385MHz to 5.785 GHz Pulse modulation

Radiated RF IEC 61000-4-3

Portable and mobile RF communications equipment should be used no closer to any part of the Legend™ system including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 6 d P E Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, E is the immunity test levels in volt per meter (V/m), and d is the recommended separation distance in meters (m). Interference may occur in the vicinity of equipment marked with the following symbol:

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

9

The Midas RexTM Legend EHSTM system

Legend EHSTM and Legend EHS StylusTM attachments Dissecting tool nomenclature Note: Match the nomenclature and color code on the dissecting tool packaging to the corresponding nomenclature and color code on the attachment. Part numbers for dissecting tools follow a nomenclature, which is described in the diagram below (Figure 9). Standard tool part numbers consist of the associated attachment length, the tool family identifier, 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. 9

LegendTM surgical dissecting tool nomenclature

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. 5. 6.

6

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

Tool number prefixes (not all inclusive)

Tool number suffixes (not all inclusive)

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 attachments

Suffix

Tool head shape modifiers

CB F T

Curved Bur Footed attachments Telescoping tube

B BR M S T W

Ball end Barrel 2-Flute Match style Spiral flutes 3-Flute or SymmeTRI Wing flute

Tool head shape (form/function)

Suffix

Tool head cutting modifiers

Suffix

Tool length modifiers

AC BA CY HM HS MC MH OV RT TA TD

C D DC DF DX DXF F -MN X XF

Carbide Diamond Diamond Coarse Diamond Fine Diamond Extra Coarse Diamond Extra Fine Fine MedNext style Coarse Extra Fine

L SH Pxx

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

10

Acorn Ball Cylinder Hole Maker Hole Saw Metal Cutting Match Head Oval Reverse Taper Tapered or side cutter Twist Drill

Mxx

The Midas RexTM Legend EHSTM 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

Spine

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

11

The Midas RexTM Legend EHSTM system Surgical application

Commonly used attachments

Commonly used dissecting tools

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

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. 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.

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)

12

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.

The Midas RexTM Legend EHSTM system Surgical application

Commonly used attachments

Orthopaedics

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

Commonly used dissecting tools

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

Biometals/ bioceramics/ biomaterials

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.

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 3: 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

13

The Midas RexTM Legend EHSTM system 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

Angled

X

Base

Tube

Straight

Straight Angled Curved

Angled X

X

-

X

-

X

Footed

Curved bur

Contra angle

ASMC

14

The Midas RexTM Legend EHSTM system

Legend EHSTM and Legend EHS StylusTM attachment assembly and disassembly Warnings: • Always inspect the device before and after use for any damage. If damage is observed, do not use damaged device. • The motors should only be operated when the attachment/tool is in the fully locked position. • Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. • 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.

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 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 10‑1). 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 10-2). 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 10-3). 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 motor. Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

10-1

Straight attachment assembly

10-2

Straight attachment assembly

10-3

Straight attachment assembly

Disassembly: 1. Hold the motor in the palm of your hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up (Figure 10-2). 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.

15

The Midas RexTM Legend EHSTM system

Angled attachment 11-1 Warning: Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. Precaution: When using an angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor. 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.

Angled attachment assembly

Assembly: 11-2 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 11-1). 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 11-2). 1 3. Gently pull on the tool to ensure that it is locked into the motor. 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. 11-3 Angled attachment assembly 5. Rotate the attachment in the direction indicated by the arrow until the 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 11-3). 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 the attachment off of the motor.

Fixed footed attachment Warning: 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. Note: Fixed and rotated footed attachments with the same length, marking and color band share the same dissecting tools. Assembly: 1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 12-1). 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 12-2). 3. Pull the fixed footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 12-3). 4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment (Figure 12-4). This will prevent damage to the attachment and/or injury to patient. 12-1

Fixed footed attachment assembly

12-2

12-3

Fixed footed attachment assembly

12-4 Tool Gap

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 12-5). 2. 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 12-6). 3. Pull the dissecting tool out of the motor collet and discard the tool (Figure 12-7).

16

medtronic

10 cm Variable Exposure, Small Bore Attachment, Straight, 10 mm Adjustment

The Midas Rex Legend EHS System Instructions for Use