Microsaw and Triton System High Electric High Torque Handpiece Instructions for Use RevB Feb 2019 PDF download

Instructions for Use 175037EN B

The Midas Rex™ Microsaw and Triton™ System Microsaws and Triton Electric High-Torque Handpiece

Customer service For further information regarding the use of this product or to report any problems, please contact Medtronic Customer Service or contact your local distributor: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137 USA US Help Line (800 468 9710) www.medtronic.com International Service: International Customers should contact their local Medtronic representative.

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The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version. The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Intelliflow™ IPC™, Legend™, Legend EHS™, Legend EHS Stylus™, Midas Rex™, Mednext™, Stylus Touch™, and Triton™. All other trademarks, service marks, registered trademarks or registered service marks are the property of their respective owners in the United States and other countries.

Contents Glossary�� 1 Indications for use�� 1 Device description�� 1 Contraindications�� 1 No latex policy�� 1 Warnings �� 1 System warnings�� 1 Component warnings�� 2 Tools and disposable components warnings�� 2 Precautions�� 2 Handpiece systems�� 3 Attachment assembly�� 3 IPC set up�� 3 Connect to the IPC�� 3 IPC pump detection�� 4 IPC touchscreen controls�� 4 Speed�� 4 Irrigation�� 4 Safe mode (SAFE)�� 4 Mode select switch�� 4 Foot and finger-control �� 4 Manual safe mode�� 4 Multifunction foot pedal controls�� 5 Reverse pedal�� 5 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity�� 5 Technical specifications�� 5 Midas Rex microsaw blade and rasp nomenclature�� 6 Installation and removal of the Midas Rex microsaw attachments�� 7 Microsaw reciprocating saw attachment �� 7 Microsaw sagittal saw attachment �� 7 Microsaw oscillating saw attachment �� 7 Microsaw irrigation and tubing clips attachment �� 8 Triton electric high-torque handpiece attachments�� 8 Installing, activating, and removing an attachment in the Triton electric high-torque handpiece�� 8 Installation and removal of cutting tools, wires, and pins in Triton electric high-torque attachments�� 9 Triton sagital saw attachment�� 9 Triton reciprocating saw attachment�� 9 Triton AO/Synthes Chuck and Trinkle Chuck attachment�� 9 Triton Jacobs Chuck attachment�� 9 Triton Hudson Chuck and Zimmer Chuck attachment��10 Triton wire collet and pin collet attachment ��10 Cleaning and sterilization��11 Midas Rex microsaw reprocessing instructions ��11 Triton electric high-torque handpiece reprocessing instructions ��12 The Midas Rex microsaws and Triton electric high-torque handpiece system Limited Warranty* (U.S. customers only)��14 Symbols��15

The Midas Rex Microsaw and Triton system

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

Electric High-Speed

FCU

Foot Control Unit

FWD

Forward - Rotation is clockwise

IPC

Integrated Power Console

REV

Reverse - Rotation is counter-clockwise

Indications for use The Electric Drill System is an electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Electric Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: • Lumbar Microdiscectomy • Lumbar Stenosis Decompression • Posterior Lumbar lnterbody Fusion (PLIF) • Transforaminal Lumbar Interbody Fusion (TLIF) • Anterior Lumbar lnterbody Fusion (ALIF) • Direct Lateral lnterbody Fusion (DLIF)

Device description The Midas Rex microsaw is a powered saw system that is used to remove soft tissue, hard tissue, and bone during surgical procedures. The Triton electric high-torque handpiece is a powered system that is used to drive screws, wires, and pins, drill pilot holes, and remove soft tissue, hard tissue, and bone during surgical procedures. The devices are intended for use by physicians trained in the procedures described.

Contraindications None

No latex policy Medtronic Powered Surgical Solutions guarantees that all Legend equipment and products 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 W15 W16 W17 W18

The Midas Rex microsaw and Trition electric high-torque handpiece system operator must be familiar with this Instructions for Use, the IPC User’s Guide, their precautions, procedures and safety issues. The Midas Rex microsaw and Trition electric high-torque handpiece 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 the Midas Rex microsaw and Trition electric high-torque handpiece systems 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 Midas Rex microsaw and Trition electric high-torque handpiece systems are precision surgical instruments. With precision instruments, excessive force, beyond the design strength of the instruments, can be caused by even simple manual overloading. Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. 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. Use only dissecting tools specifically designed for use with the Midas Rex microsaw and Trition electric high-torque handpiece systems. Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. Do not use the Midas Rex microsaw and Trition electric high-torque handpiece systems without proper cleaning and sterilization. Refer to the IPC Instructions for Use for additional instructions, warnings, and cautions. Refer IPC User’s Guide for warnings related to IPC. The Midas Rex microsaw and Trition electric high-torque handpiece system complies with EN60601-1-2 safety standard for electromagnetic compatibility (EMC), requirements, and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient. 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. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Do not operate the Midas Rex microsaw and Trition electric high-torque handpiece systems 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. All service must be performed by Medtronic qualified personnel only.

1

The Midas Rex Microsaw and Triton system

Component warnings W19 Do not use any parts other than Medtronic system components as damage or substandard performance could result. W20 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic qualified personnel or replaced. Damaged parts may deposit metal shavings on surgical site, or may cause injury. W21 Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site. W22 Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment, causing patient injury. To avoid this, motors and attachments should be serviced periodically at intervals recommended by Medtronic. W23 Electrical contacts must be dry prior to use. W24 Do not use an overheated device, as it may cause thermal injury to the patient or operator. W25 Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. W26 Do not attempt to change a dissecting tool, or attachment while the motor is running or when the motor or attachment is in an overheated state. W27 Do not immerse the system components, except as noted. W28 Do not place the Midas Rex microsaw, Triton electric high-torque handpiece, attachment or tool on the patient or in an unsecured location during surgery. W29 A device that is not functioning properly should not be used until the unit is repaired and tested by Medtronic to ensure that it is functioning in accordance with Medtronic specifications. W30 Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. W31 Do not change an accessory with the handpiece running to prevent laceration of user and/or cross-contamination through compromised glove. W32 Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories. W33 Verify reusable device was sterilized prior to use. If not sterilized, do not use. W34 Sterilize and dry reusable device before storing. Decrease likelihood of cross-contamination with timely sterilization. After each procedure, properly clean and sterilize all reusable system components. W35 Place the finger-control of the Midas Rex microsaws in Safe Mode while not in use. W36 Any device that has not been used in a four year period should be serviced by Medtronic to ensure its performance.

Tools and disposable components warnings W37 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharpcutting powered tools induce bleeding and removal of significant tissue and bone. W38 Use methods at the operative site to control bleeding that do not compromise patient safety during surgery. W39 Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of user and cross-contamination through compromised glove. W40 Operate the tool only after appropriate anatomical landmarks at the intended surgical site have been confirmed. W41 Use care in application of the rotating cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories. W42 Bending or prying may break the accessory, causing harm to patient or user. W43 Do not use excessive force to pry or push bone with the attachment or tool during dissection. W44 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed of the motor to prevent vibration. Change to a new tool to prevent unintended tissue removal from patient. W45 Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient. W46 Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage. W47 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. W48 Cutting edges of the tool flutes or blades are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. W49 Do not re-sharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control. W50 Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use. W51 Excessive pressure applied to the tool may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. W52 Use only tools specifically designed for use with the Midas Rex microsaw and Triton electric high-torque handpiece systems. W53 Do not sterilize disposable devices. They are terminally sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once. W54 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization. W55 Do not use an accessory if its packaging is opened or damaged. A broken seal offers no protection against cross-contamination. W56 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. W57 Do not use dull, damaged, or bent tools. Use of dull tools can reduce cutting effectiveness and can cause the handpiece temperature to increase. W58 Always ensure that the attachment is securely engaged into the handpiece prior to operating the system. Always examine operation of each tool in a handpiece prior to use. W59 Powered burs and drills should be operated in the forward mode only. W60 Exposure of tool packaging to light for extended periods of time may cause damage to packaging.

Precautions P1 P2 P3 P4 P5 P6

2

Do not attempt to disconnect the cable from the Midas Rex microsaw. Do not kink cables. Inspect cables and pins for cracks, tears, or corrosion. 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.

The Midas Rex Microsaw and Triton system

Handpiece systems The Midas Rex microsaw and the Triton electric high-torque handpiece systems are powered by the IPC. The following instructions are in addition to Set up the IPC general assembly instructions provided in the IPC manual. Complete the IPC setup, then continue to the instructions below. Clean and sterilize the handpiece systems, prior to first use. Refer to the reprocessing instructions contained in this manual for additional information. The Midas Rex microsaw systems are foot (Figure 1-1) and finger-controlled (Figure 1-2) saws. Operation of the foot-controlled saws is via the multifunction foot pedal and that of the finger-controlled saws by pressing the finger lever. The Triton electric high-torque handpiece system (Figure 2) does not require the multi-function foot pedal to operate the handpiece, but it may be used to change control settings. 1-1

1-2

Foot-controlled microsaw handpieces

Finger-controlled microsaw handpieces

7 6 1

1 5

2

3

1. 2. 3.

4

5

3

Reciprocating saw collet Sagittal saw blade release button Oscillating saw head

2

4. 5.

Oscillating saw collet Color band

Triton electric high-torque handpiece

1

1. 2. 3.

4

Reciprocating saw collet Sagittal saw blade release button Oscillating saw head

4. 5. 6. 7.

Oscillating saw collet Color band Finger lever safe mode switch Finger lever

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

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

2

Connect to the IPC

3

Locate the Midas Rex microsaw or the Triton electric high-torque handpiece, and Foot Control Unit (FCU) ports on the IPC connector panel (Figure 3) and insert the connector. Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the console, then insert the connector. 3

IPC connector panel connection ports

4 1. 2. 3. 4.

Quick-release button Variable speed trigger Safe mode trigger Mode select switch

1 1. 2. 3.

2

3

Midas Rex microsaws or Triton electric high-torque handpiece connection port Intelliflow irrigation remote control Foot control unit

3

The Midas Rex Microsaw and Triton system

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

IPC touchscreen controls

4-1 IPC Midas Rex microsaws touchscreen

To set or adjust the Midas Rex microsaws (Figure 4-1) or Triton electric high-torque handpiece (Figure 4-2) controls, on the IPC touchscreen, in the control box, do the following: Important: When using the microsaw handpiece the IPC touchscreen recognizes the connected saw, then displays the appropriate name and color ring (Figure 4-1).

4-2

1

TRITON

2 3

Speed

FWD Speed

+ 100 %

4

REV Speed

+ 100 %

• To adjust the Midas Rex microsaws speed in the Speed control box (Figure 4-1), press the plus button to increase maximum speed or the minus button to decrease maximum speed. • The Midas Rex microsaws variable speed adjustment ranges from 0% to 100%. Note: When the finger-controlled Midas Rex microsaw is in safe mode, the speed control box displays SAFE (Figure 5). Refer to the Safe mode (SAFE) topic for additional information.

IPC Triton touchscreen

1. 2. 3. 4.

Name and color ring of the connected saw Speed control box Pump control box Control box

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

Irrigation To adjust the Midas Rex microsaw 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. The default flow rate is 0cc per minute in Forward or Reverse mode. The maximum flow rate is 50cc per minute. Note: To adjust flow rate, you can use the touchscreen or the IntelliFlow irrigation remote control.

Safe mode (SAFE) • When the Midas Rex microsaw finger-control handpiece is in safe mode, it is inoperable until the safety is turned off. The Speed control box on the microsaw touchscreen displays SAFE when the handpiece is the active handpiece and in safe mode (Figure 5). • Switch the Midas Rex microsaw finger-control handpiece to safe mode any time it is attached to the console, but not currently being used. • When more than one handpiece is attached to the console, use the safety switch of an inactive handpiece to activate that handpiece and make it ready for use.

5

Midas Rex microsaw finger-control handpiece IPC screen safe mode Speed

SAFE + RPM

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

Foot and finger-control To switch the Midas Rex microsaws between foot and finger control, or to use both, select the appropriate option in the Control box. Finger-controlled saws can be operated via the lever on the handpiece, or the foot pedal. Note: This option is only available when using a Midas Rex microsaw finger-controlled handpiece.

Manual safe mode • When the Triton electric high-torque handpiece trigger is placed in the safe mode, it cannot be activated. The handpiece trigger has two safe positions. To activate the safe mode, rotate the trigger either clockwise or counter-clockwise until it stops (Figure 6-1). To activate the handpiece in the run position, rotate the trigger to the vertical position (Figure 6-2) and then squeeze it. • It is recommended that the trigger be set to safe mode when setting up the device, changing attachments, blades, tools or accessories. 6-1 Triton electric high-torque handpiece safe mode positions

6-2

Triton electric high-torque handpiece run position

L L

L

M

4

M

L

The Midas Rex Microsaw and Triton 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 7-1) to control the handpiece, do the following: • To start or adjust the speed of a handpiece in variable mode, press the foot pedal. • To toggle between the start/stop mode and variable speed mode, press the control button. Note: Functionality of the control button may be changed in the handpiece Defaults menu to pause irrigation. Refer to Change System Settings in the Pre-Operating Instructions section of the IPC User’s Guide. • To change the handpiece, press the handpiece button. Note: You can switch between finger-controlled handpieces by pressing the finger lever on the Midas Rex microsaw handpiece. Multifunction foot pedal & y-splitter

7-1

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

Reverse pedal When using the Triton electric high-torque handpiece you can connect the optional foot pedal to the IPC console. The pedal can be used as an alternative method of activating Reverse mode (without manipulating the Mode select switch at the bottom of the handpiece). When the pedal is connected, the Reverse Pedal control box appears on the screen (Figure 7-2). Note: By default, pedal functionality is turned OFF. 1. To use the pedal, press ON in the Reverse Pedal control box on the IPC touch screen. 2. With the pedal turned on, step on the foot pedal to put the handpiece into Reverse mode (regardless of what position the Mode select switch is in). NOTE: The trigger control must be pressed to activate the handpiece, even when you are stepping on the foot pedal. 3. Remove your foot from the pedal to return the handpiece to the mode currently defined by the Mode select switch on the handpiece.

7-2 Reverse pedal control box Reverse Pedal REV REV

ON OFF

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

Technical specifications Table 1: Triton electric high-torque handpiece technical specifications Triton electric high-torque handpiece ED500 Size

Weight

Speed

Duty cycle for applied part

3.5 inches length x 5.4 inches height x 1.1 inches width

2.1 lbs

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

Cycle time: 20 seconds on maximum / 20 seconds off minimum Maximum number of cycles before resting handpiece: 6 Maximum number of cycles before resting attachment: 3 Minimum rest period: 25 minutes

5

The Midas Rex Microsaw and Triton system Table 2: Midas Rex microsaw technical specifications Microsaw number

Microsaw type

Size

Weight

Speed

Duty cycle ≤ 20°C ambient (one cut period = 20 seconds on / 20 seconds off )

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

ES200

Reciprocating

20.3 cm length x 2.3 cm width

300 g

1400-14000 cpm

≤ 15 cut periods1

≤ 5 cut periods4

ES300

Sagittal

17.3 cm length x 2.3 cm width

250 g

2000-20000 cpm

≤ 6 cut periods2

≤ 6 cut periods5

ES100

Oscillating

19.8 cm length x 2.3 cm width

300 g

1600-16000 cpm

≤ 4 cut periods3

≤ 3 cut periods6

ES210

Finger-controlled reciprocating

20.3 cm length x 3.2 cm height x 2.3 cm width

320 g

1400-14000 cpm

≤ 15 cut periods1

≤ 5 cut periods4

ES310

Finger-controlled sagittal

17.8 cm length x 3.2 cm height x 2.3 cm width

300 g

2000-20000 cpm

≤ 6 cut periods2

≤ 6 cut periods5

ES110

Finger-controlled oscillating

21.0 cm length x 3.2 cm height x 2.3 cm width

320 g

1600-16000 cpm

≤ 4 cut periods3

≤ 3 cut periods6

Time for cool down after maximum number of cut periods listed above: 25 minutes. 5 periods with light force (0.8 Lbf ), 5 periods with medium force (2.1 Lbf ), 5 periods with heavy force (3.9 Lbf )

1

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

2

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

3

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

4

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

5

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

6

Midas Rex microsaw blade and rasp nomenclature Important: You can only use reciprocating blades and rasps with the reciprocating saw. You can use sagittal and oscillating blades interchangeably. Part numbers for microsaw blades follow a standard naming convention (Figure 8). 8

Microsaw blade part number naming convention

1. Cut limit depth XX.X millimeters (Ex.: 120 = 12.0 mm)

120S97-03F

Note: Blade depth markings are approximate and should be used for reference only. 2. Saw type S

Sagittal/Oscillating

R

Reciprocating

3. Cut width/length

1 9

2

3

4

Microsaw blade part number naming convention

5

X.X millimeters (Ex.: 97 = 9.7 mm) Note: Width for sagittal/oscillating blades and length for reciprocating blades 4. Blade thickness X.X millimeters (Ex.: 03 = 0.3 mm) 5. Other identifiers

6

F

Fine Teeth

PT

Pointed Blade

ARC

Rounded Blade

ST

Straight Rasp

BAY

Bayoneted Blade

CC

Crosscut Rasp

The Midas Rex Microsaw and Triton system

Installation and removal of the Midas Rex microsaw attachments Microsaw reciprocating saw attachment Important: Verify that the color code on the blade package matches the color band on the handpiece (Figures 1-1 and 1-2). Installation: 1. Rotate the collet knob to the unlocked position (Figure 10). 2. Insert the reciprocating blade or rasp into the collet. 3. Rotate the collet knob 90° to the locked position to secure the blade. 4. Ensure the blade is secure by gently pulling on it and verify it does not detach. Removal: 1. To remove the microsaw reciprocating saw blade, rotate the collet knob to the unlocked position. Remove blade and discard per local regulations.

Microsaw sagittal saw attachment Important: Verify that the color code on the blade package matches the color band on the handpiece (Figures 1-1 and 1-2). Installation: 1. Press the blade release button (Figure 11-1) and insert a blade at the desired angle (Figure 11-2). 2. Release the blade release button to secure the blade. 3. Ensure the blade is secure by gently moving it from side to side and verify it does not detach. Removal: 1. To remove the microsaw sagital saw blade, press the blade release button. Remove blade and discard per local regulations.

11-1

Microsaw reciprocating saw attachment installation

10

1. 2.

1

Rotate the collet knob to the unlocked position Rotate the collet knob 90° to the locked position

2

Microsaw sagital saw attachment installation

11-2

Microsaw sagital saw blade installation angles

1 2 1. 2.

Blade release button Blade

Microsaw oscillating saw attachment

Important: Verify that the color code on the blade package matches the color band on the handpiece (Figures 1a and 1b). Installation: 1. Rotate collet to the unlocked position (Figure 12-1). 2. Insert the blade into the collet until it “clicks” into place. Note: The blade can be inserted in 8 different orientations to facilitate surgical access (Figure 12-2). 3. Rotate the collet to the locked position (Figure 12-1). 4. Ensure the blade is secure by gently moving it from side to side and verify that it does not detach. Removal: 1. To remove the microsaw oscillating saw blade, rotate the collet to the unlocked position. Remove blade and discard per local regulations. 12-1

12-2

Microsaw oscillating saw attachment installation

Microsaw installation oscillating pin alignment

3 2

4 1

1. 2. 3. 4.

Rotate collet to the unlocked position Insert the blade into the collet Rotate the collet The locked position

7

The Midas Rex Microsaw and Triton system

Microsaw irrigation and tubing clips attachment Note: Use of irrigation with the microsaws is optional. Note: Refer to IPC manual for instructions on how to install tubing to the pump. Installation: 1. Snap the rear portion of the irrigation clip on to the handpiece (Figures 13-1 and 13-2). Note: On finger-controlled handpieces, attach the rear portion of the irrigation clip to the rotatable finger lever base (Figure 13-2). 2. Adjust the irrigation tube tip location by moving the metal irrigation dispensing tip in or out. 3. Snap the front of the tubing clip on to the handpiece. 4. To readjust the irrigation dispening tip location, disengage just the front of the irrigation clip, and follow steps 2 and 3 above. Removal: 1. Remove irrigation tubing set from attachment by pulling on the clip to detach it. 2. Similarly detatch all clips. 3. Discard of the irrigation tubing set per local regulations. 13-1

Foot-controlled microsaw irrigation and tubing clip installation

13-2

Finger-controlled microsaw irrigation and tubing clip installation

Triton electric high-torque handpiece attachments The following attachments are available for use with the Triton electric high-torque handpiece. • Sagittal saw attachment – Converts the Triton electric high-torque handpiece into a sagittal saw • Reciprocating saw attachment – Converts the Triton electric high-torque handpiece into a reciprocating saw • Oscillating saw attachment – Converts the Triton electric high-torque handpiece into a oscillating saw • A/O Synthesis Chuck attachment – Used to drive tools with an A/O Synthesis shank • Trinkle Chuck attachment - Used to drive tools with an Trinkle shank • Jacob’s Chuck attachment – This attachment is available is 5/32” and 1/4” sizes and uses a key to lock and unlock the chuck. It is used to drive drill bits, wires and pins up to 0.156” (3.9 mm) or 0.25” (6.4 mm) in diameter • Hudson Chuck attachment – Used to drive tools with a Hudson shank • Zimmer Chuck attachment – Used to drive tools with a Zimmer shank • Wire collet – Used to drive K-wire of diameter 0.028” (0.7 mm) thru 0.062” (1.5 mm) • Pin collet – Used to drive pins of diameter 0.078” (2.0 mm) thru 0.125” (3.2 mm) • Keyless Chuck attachment - This attachment is available is 5/32” and 1/4” sizes. It is used to drive drill bits, wires and pins up to 0.156” (3.9 mm) or 0.25” (6.4 mm) in diameter. • Extension handle - The extension handle is an accessory that screws into the back of the handpiece. This provides balance and two-handed control for various drilling and cutting applications.

Installing, activating, and removing an attachment in the Triton electric high-torque handpiece The following procedure applies to all Triton high-torque handpiece attachments. Attachments may be preload with the tool/blade before insertion into the Triton handpiece. For installing tools/blades onto specific attachments, refer the sections below. Caution: Insert all attachments into the handpiece with the handpiece trigger in the SAFE position (Figure 5b). 1. Installing and attachment: • Rotate handpiece trigger to SAFE position (Figure 5b). • Insert an attachment while depressing the quick-release button on top of the handpiece. Snap the attachment into the handpiece with a slight twisting motion until it is seated. • Place the handpiece in the RUN position by rotating the trigger control to the vertical position. 2. Actuating the attachment: • Rotate handpiece trigger to RUN position (Figure 5c) • Rotate Mode select switch at the base of the handle to the FORWARD position. • Actuate the attachment via squeezing the trigger 3. Detaching the attachment: • After use, return the trigger control to the SAFE position. • Remove the attachment by simultaneously pressing the quick-release button on top of the handpiece and pulling the attachment out of the Triton handpiece. 8

The Midas Rex Microsaw and Triton system

Installation and removal of cutting tools, wires, and pins in Triton electric high-torque attachments Triton sagital saw attachment Warning: Triton saw attachments should only be used with Medtronic Triton saw blades. Refer to the Triton Quick Reference Saw Blade Guide (LIT200017) for additional information on Triton saw blades. Installation: 1. The attachment can be installed in 12 different orientations to facilitate surgical access. Insert the sagittal saw attachment into the handpiece in a position to allow easy insertion of the sagittal saw key (Figure 14). 2. Insert the sagittal saw key into the attachment and turn counterclockwise until there is slight resistance. 3. Insert the blade into the space between the two jaws, ensuring that the blade is fully seated. 4. Reinsert the sagittal saw key and rotate it clockwise to lock the blade. Run briefly, then retighten blade. Caution: Do not over-tighten. 5. Reposition attachment as necessary to facilitate surgical access. 14

Triton sagital saw installation

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

Triton reciprocating saw attachment

15 Triton reciprocating saw attachment installation

Warning: Triton saw attachments should only be used with Medtronic Triton saw blades. Refer to the Triton Quick Reference Saw Blade Guide (LIT200017) for additional information on Triton saw blades. Installation: 1. Loosen the collet nut then insert the blade until it is fully seated (Figure 15). Note: You can install the attachment in different positions to facilitate surgical access. 2. Finger-tighten the collet nut. Run briefly, then retighten collet nut. Removal: 1. To remove the Triton reciprocating saw blade, unscrew the collet nut. Remove blade and discard per local regulations.

Triton AO/Synthes Chuck and Trinkle Chuck attachment Installation: 1. To install a drill bit, pull back on the attachment collar (Figure 16). 2. Insert the drill bit and release the attachment collar. Removal: 1. To remove a drill bit, pull back on the attachment collar. 2. Remove the drill bit and release the attachment collar. 3. Discard the drill bit per local regulations. 4. Remove the attachment per the instructions provided in the Installing, activating, and removing an attachment in the Triton electric high-torque handpiece section.

16

Triton AO/Synthes Chuck and Trinkle Chuck installation

17

Triton Jacobs Chuck Attachment installation

Triton Jacobs Chuck attachment Installation: 1. To install a drill bit, turn the key to open the chuck (or spin the collar if using a keyless chuck attachment) (Figure 17). 2. Insert the drill bit. 3. Secure the drill bit by inserting the key into the collet and turning it (or spin the collar if using a keyless chuck attachment). Removal: 1. To remove a drill bit, turn the key to open the chuck (or spin the collar if using a keyless chuck attachment). 2. Remove the drill bit and discard per local regulations.

9

The Midas Rex Microsaw and Triton system

Triton Hudson Chuck and Zimmer Chuck attachment Installation: 1. To install an instrument, pull back on the attachment collar, then insert the tang end of the instrument into the chuck (Figure 18). 2. Release the collar to secure the tool. 18

Triton Hudson Chuck and Zimmer Chuck attachment installation

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

Triton wire collet and pin collet attachment The wire collet accepts wires up to 1.6 mm (.062 inches) in diameter. The pin collet accepts pins up to 3.2 mm (.125 inches) in diameter. Installation: 1. Insert the wire or pin collet (Figure 19) into the handpiece. 2. Screw the cannulated extension to the back of the handpiece to protect the operator from the end of the wire or pin. 3. Insert the wire or pin from the front or back of the handpiece. 4. Switch the device to the RUN position by positioning the trigger control vertically. 5. Turn the Mode select switch at the base of the handle to the FORWARD position. 6. While squeeze the wire or pin advance lever and holding it, press the trigger control to drive the wire or pin. The pressure-sensitive trigger allows variable speed operation. 7. To obtain additional wire or pin length, release the wire or pin, squeeze only the wire or pin advance lever and pull the device back. 8. Squeeze the wire/pin advance lever and trigger control to drive the additional length of the wire or pin. 19

Triton wire and pin collet attachment installation

Removal: 1. To remove threaded wire/pin, put the Mode select switch in REVERSE, squeeze the wire/pin advance lever and press the trigger control. 2. Remove the attachment per the instructions provided in the Installing, activating, and removing an attachment in the Triton electric high-torque handpiece section..

10

The Midas Rex Microsaw and Triton system

Cleaning and sterilization Cleaning and sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com. Note: The reprocessing instructions provided below have been validated by the manufacturer as being capable of preparing the product for re-use. It remains the responsibility of the processor to ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process. Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. Note: The Pre-Vac (FR/WHO) and Pre-Vac (UK) sterilization cycles are not considered by the United States Food and Drug Administration (US FDA) to be standard sterilization cycles. Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the selected sterilization cycle specifications (time and temperature). Medtronic recommends incineration of devices that have directly contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ Creutzfeldt-Jakob disease (CJD) diagnosis.

Midas Rex microsaw reprocessing instructions WARNINGS

Do not soak/submerge devices. Do not use ultrasound to clean devices. Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde. The use of a washer-disinfector for cleaning may cause a degradation in performance. Allow an adequate cooling period after steam sterilization.

Limitations on reprocessing

The product is provided non-sterile and must be cleaned and sterilized before the first use and any reuse. Verify functionality prior to re-use.

Point of use

Follow hospital procedures.

Containment and transportation

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

Preparation for decontamination

Disconnect handpiece from console. Remove irrigation tubing/clips, saw blade, and cable management clamps.

Preclean instructions prior to use in an automated washer

Prior to placing the saws in the automated washer, manually rinse the saw body with the distal end pointed down under tap water, until no visible soil is noticed. Move any movable parts back and forth to allow water to reach hard-to-rinse areas. Transfer the devices into the washer for processing, making sure that the oscillating saw collet is open. Place the devices in the washer to facilitate drainage. Verify that devices are visually clean after automated cleaning.

Cleaning: Automated

Caution: Do not use ultrasonic cleaner. Midas Rex microsaw automated wash cycle using a neutral enzymatic detergent (pH 6.0-8.0)

Cleaning: Manual

Phase

Recirculation time

Water temperature

Detergent type

Pre-wash

2 minutes (02:00)

Cold water

Not applicable

Wash

5 minutes (05:00)

66°C (151°F) (set point)

Neutral enzymatic detergent, pH 6.0-8.0

Rinse

1 minute (01:00)

Hot tap water

Not applicable

Rinse the device thoroughly under running water, with the collet end pointed down. Wipe the saw body and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 (henceforth referred to as “cleaning solution”). With the blade collet end pointed down, brush saw body, blade-release button, and extended lever tip (if applicable) with a nylon brush that has been dipped in cleaning solution. Sagittal only: 1. Dip the distal end of the saw in cleaning solution and agitate for 10-15 seconds. 2. Press and hold the blade-release button, then repeat step 1. 3. With the blade-release button pressed, flush approximately 15 mL of cleaning solution from a syringe into the blade opening. 4. Flush all ports with 15 mL of cleaning solution. 5. Repeat steps 1-4 using water instead of cleaning solution. Reciprocating only: 1. With the distal end facing up, squeeze 30 mL of cleaning solution from a syringe into the distal end of the device so that the solution thoroughly reaches the inside of the collet. 2. While the device is in the vertical position, rotate the collet knob back and forth three times. 3. Dump the solution from the device. 4. Repeat steps 1-3 a second time with cleaning solution. 5. Repeat steps 1-3 a third time with water. Rinse the device under running water, ensuring that water enters all ports/openings. Move any moveable parts to allow the solution to reach all areas. Rinse until there is no visible evidence of soil or debris. 11

The Midas Rex Microsaw and Triton system

Midas Rex microsaw reprocessing instructions Drying and lubrication

Dry the entire device with a lint-free towel. Reciprocating and oscillating only: If desired, complete the following steps using Pana Spray to lubricate the saw collet: 1. Holding the can approximately 10-15 cm (4-6 inches) away from the saw collet, spray into the hole of the shaft (reciprocating saw) or onto the proximal/bottom portion of the collet near the locked/unlocked indicators (oscillating saw) with three quick squirts. 2. Articulate the collet to ensure proper lubrication. 3. Remove excess lubricant with a clean cloth.

Disinfection

Follow hospital procedures.

Packaging

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

Sterilization

Note: The temperatures and times for sterilization are the minimum required. Midas Rex microsaw steam sterilization Cycle

Pre-vac

Pre-vac (FR/WHO)

Pre-vac (UK)

Temperature

132°C (270°F)

134°C (273°F)

Time

4 minutes (04:00)

18 minutes (18:00)

3 minutes (03:00)

Drying

20 minutes (20:00)

30 minutes (30:00)

22 minutes (22:00)

STERRAD

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

STERIS

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

Maintenance, inspection and testing

Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired. Verify functionality prior to re-use.

Storage

Store with other sterile devices.

Triton electric high-torque handpiece reprocessing instructions WARNINGS

Do not soak/submerge devices. Do not use ultrasound to clean Triton electric high-torque handpiece. Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hydroxide, formic acid, or solutions containing glutaraldehyde. Allow an adequate cooling period after steam sterilization. The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

Limitations on reprocessing

The product is provided non-sterile and must be cleaned and sterilized before the first use and any reuse. Verify functionality prior to re-use, by connecting the handpiece to the IPC and pressing the trigger. Verify that the drive shaft rotates.

Point of use

Disconnect device from the IPC. Remove and discard disposables.

Containment and transportation

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

Preparation for decontamination

Disconnect device from the IPC. Remove and discard disposables.

Preclean instructions prior to use in an automated washer

Handpiece and attachments: Prior to placing devices in the automated washer, manually rinse under tap water, until no visible soil is noticed. Move any movable parts back and forth to allow water to reach hard-to-rinse areas. Transfer the devices into the washer for processing. Place the devices in the washer to facilitate drainage. Verify that devices are visually clean after automated cleaning.

Cleaning: Automated

Caution: Do not use ultrasonic cleaner. Triton electric high-torque handpiece attachments automated wash cycle using a neutral enzymatic detergent (pH 6.0-8.0)

12

Phase

Recirculation time

Water temperature

Detergent type and concentration

Pre-wash

2 minutes (02:00)

Cold tap water

Not applicable

Wash

5 minutes (05:00)

66°C (151°F)

Neutral enzymatic detergent, pH 6.0-8.0

Rinse

1 minute (01:00)

Hot tap water

Not applicable

The Midas Rex Microsaw and Triton system

Triton electric high-torque handpiece reprocessing instructions Cleaning: Manual

Handpiece and attachments: 1. Rinse the entire device, including cable, thoroughly under running water. 2. Wipe all external surfaces of the device and cable with a cloth dampened with a neutral enzymatic detergent pH 6.0-8.0 (henceforth referred to as “cleaning solution”). 3. Scrub the device thoroughly with a soft bristled brush that has been dampened with the cleaning solution, paying close attention to rough surfaces, crevices, and difficult to reach areas. Move any moveable parts to allow the solution to reach all areas. 4. Clean central cannulation shaft of the handpiece with a cleaning brush (P/N 120-028-1 or equivalent) dampened with the cleaning solution. 5. Insert the cleaning brush into the cannulation from the front and make at least 6 passes with the brush. If residual soil is seen on the cleaning brush in between strokes, rinse it off in the cleaning solution. 6. Repeat the step above from the back side of the handpiece. 7. Flush approximately 30 mL of cleaning solution from a syringe into the central cannulation shaft. 8. Flush approximately 30 mL of cleaning solution from a syringe into the trigger and Forward/Reverse switch, while moving moveable parts. 9. Repeat the flushing in steps 7 and 8, using water instead of cleaning solution. 10. Rinse the entire device under running water. Move any moveable parts, to allow the water to reach all areas. Also, allow water to thoroughly clean the central cannulation shaft. Rinse until there is no visible evidence of soil or debris. 11. Dry the entire device with a towel. Sagittal and reciprocating saw attachments: 1. Rinse the entire device thoroughly under running water. 2. Wipe all external surfaces of the device with a cloth dampened with a neutral enzymatic detergent pH 6.0-8.0 (henceforth referred to as “cleaning solution”). 3. Scrub the device thoroughly with a soft bristled brush that has been dampened with the cleaning solution, paying close attention to rough surfaces, crevices, and difficult to reach areas. Ensure to brush the blade opening, the gaps/details between and around the blade jaws. 4. Dip the distal end of the saw body (up to approximately 1.25 inches from the distal end) into cleaning solution and agitate it for 1015 seconds. 5. Flush approximately 30 mL of cleaning solution from a syringe into the blade opening and the gaps and details between and around two jaws. Repeat the flushing using water, instead of cleaning solution. 6. Repeat the previous step one more time. 7. Rinse the device under running water. Allow water to thoroughly rinse the gaps and details between and around blade jaws. Rinse until there is no visible evidence of soil or debris. 8. Dry the device with a towel.

Disinfection

Follow hospital procedures.

Packaging

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

Sterilization

Note: The temperatures and times for sterilization are the minimum required. Triton electric high-torque handpiece steam sterilization Cycle

Gravity

Pre-vac

Pre-vac (FR/WHO)

Pre-vac (UK)

Temperature

132°C (270°F)

134°C (273°F)

Time

25 minutes (25:00)

4 minutes (04:00)

18 minutes (18:00)

3 minutes (03:00)

Drying

30 minutes (30:00)

20 minutes (20:00)

30 minutes (30:00)

22 minutes (22:00)

STERRAD

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

STERIS

Not applicable.

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

Sterilization temperature

Relative humidity

EtO concentration

Gas exposure (full-cycle)

Aeration

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

51-59 °C (124-138 °F),

70 +/- 5 %

725 +/- 25 mg/L

4 hours

51-59 °C (124-138 °F), 18 hours

Maintenance, inspection and testing

Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired. Verify functionality prior to re-use.

Storage

Store in a clean, dry area.

13

The Midas Rex Microsaw and Triton system

The Midas Rex microsaws and Triton electric high-torque handpiece system Limited Warranty* (U.S. customers only) A. This Limited Warranty provides the following assurance to the purchaser who receives a Medtronic Midas Rex Microsaws and Triton Electric High-Torque Handpiece System. The Midas Rex Microsaws and Triton Electric High-Torque Handpiece System includes the motor, high-torque hand piece and their cables and instrumentation cases and trays (hereafter referred to as System Components), the attachments (hereafter referred to as Attachments) and dissecting tools and other accessories not listed above, unless specifically noted. 1. Should a System Component fail to function to Medtronic’s published specifications during the term of this Limited Warranty (one year from the date of sale of a new System Component or 90 days from the date of sale of a refurbished or used System Component), Medtronic will either repair or replace the component or any portion thereof. 2. Should an Attachment fail to function to Medtronic’s published specifications during the term of this Limited Warranty (90 days from the date of sale of a new Attachment), Medtronic will either repair or replace the Attachment or any portion thereof. 3. Should a Single Use Component fail to function to Medtronic’s published specifications prior to its “use by” date Medtronic will replace the Single Use Component. B. To qualify for this Limited Warranty, these conditions must be met: 1. The Product must be used on or before its “Use By” or “Use Before” date, if applicable. 2. The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. 3. Medtronic must be notified in writing within thirty (30) days following discovery of a defect. 4. The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above. 5. Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was not repaired or altered by anyone other than Medtronic or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services, if applicable, have been performed on the Product. 6. Only Midas Rex Microsaws and Triton Electric High-Torque Handpiece System dissecting tools that are manufactured, authorized, and quality controlled by Medtronic may be used. C. This Limited Warranty is limited to its express terms. In particular: 1. Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE LEGEND EHS SYSTEM TO FUNCTION WITHIN NORMAL TOLERANCES WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, NEGLIGENCE, STRICT LIABILITY, OR OTHER TORT OR OTHERWISE. 2. This Limited Warranty is made only to the purchaser. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NO SUCH EXPRESS OR IMPLIED WARRANTY TO THE PURCHASER SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON. 3. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specific legal rights. The purchaser may also have other rights that vary from state to state. 4. No person has any authority to bind Medtronic to any representation, condition, or warranty, except this Limited Warranty. *This Limited Warranty is provided by Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, Texas 76137-4116. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for terms of the warranty. After the warranty period, any costs incurred for repair/refurbishing become the responsibility of the customer. This limited warranty does not include the cost associated with any of the factory level service requirements identified in the preventive maintenance schedule. Extended Maintenance Agreements are available.

14

The Midas Rex Microsaw and Triton system

Symbols The following symbols can appear on this device and related packaging. Compliant with European Council Directive MDD 93/42/EEC

IPX1 Protected Against Vertical Water Drops PHT DEHP

EC REP Authorized Representative in the European Community

Compliance Mark EMC

+ XX °C + XX °F

RF Transmitter (Interference May Occur)

Foot Pedal Connector

Type BF Applied Part

Left Foot Control Unit Button / Mode Button Right Foot Control Unit Button

Date of Manufacture

Fine Irrigant Adjustment

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

Use By Date

Output

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

Serial Number

Consult Instructions for Use

Catalog Number

Accessory

Follow Instructions for Use

Lot Number

Adapter

Caution

Package Contents

Attachment

Do Not Immerse

Quantity

Brush

Do Not Oil

Is Approximately Equal To

Dissecting Tool

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

Use With

EHS

Electrical High Speed Handpiece Connector

STERILE Non-Sterile

+ XX °C + XX °F

Top Foot Control Unit Button / Handpiece Button

Manufacturer

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

STERILE EO

Contains DEHP (di-2-ethyl hexyl phthalate)

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

EUR · USA · JPN · AUS

105345

M

Handpiece

ON <120s

OFF >180s

Accessory

AC Power

Instrument Case

Protective Earth

Motor

Applied Part Duty Cycle

Refurbished

On/Off Button

Unlocked Locked

Sterilized using EO

Forward

Sterilized using Irradiation

Reverse

Temperature Limitation

Pump Head 1

Refurbished

Part Number

Start/Stop

Non-Sterile

Against The Effects Of IPX7 Protected Temporary Immersion In Water

ACC

! USA

USA Only

Do not use if package is open or damaged Package Quantity

Pump Head 2

15

2019-02 May be covered by U.S. Patents: Medtronic.com/patents ©2019 Medtronic, Inc. Made in USA. Printed in USA. Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137 USA +1 800-433-7080 EC REP Medtronic B.V.

Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands +31 45 566 8000

Medtronic Australian Sponsor: Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park, NSW 2113 Australia medtronic.com manuals.medtronic.com