Mako System User Guide Rev 01 July 2015

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MAKO System User Guide

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Mako System User Guide

INTRODUCTION

User Manual Terms of Use

This manual is provided by MAKO Surgical Corp. (Stryker) and should be used for informational

purposes only. Terms and Conditions related to the use of the Stryker Robotic Arm System (Mako/RIO)

can be found in the placement agreement with the system user.

About This Manual

The content of this manual is the Original Instructions for setting up, transporting and cleaning the RIO.

Indications for Use

The RIO is intended to assist the surgeon in providing software defined spatial boundaries for

orientation and reference information to anatomical structures during orthopedic procedures.

The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery

may be appropriate, and where reference to rigid anatomical bony structures can be identified relative

to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement and/or

patellofemoral knee replacement and Total Hip Arthroplasty (THA).

This user guide supports RIO Model 3.0.

Manufacturer Support/Feedback

MAKO Surgical Corp.

2555 Davie Rd.Ft. Lauderdale, FL 33317

Customer Service Phone (855) 303-6256

Corporate Office Fax

(954) 927-0446

makosurgical.com

Patents

Reference: U.S. Patents http://patents.makosurgical.com/15.

Medical and Product Information

This manual is informational only and is not intended as medical advice or a substitute for medical

advice. As a manufacturer of medical devices in the field of orthopedics, Stryker does not practice

medicine and does not recommend the surgical techniques referenced or discussed in this manual or

any other surgical techniques for use on a particular patient. Stryker is not responsible for selection of

the appropriate surgical technique to be utilized for an individual patient.

Copyrights and Trademarks

The content of this manual is protected under applicable copyright and trademark laws. You agree that

you will not copy, distribute, republish, display, post, transmit or modify any content in this manual

without Stryker’s prior permission. Any images displayed in this manual are the property of their

respective copyright owners. Any reproduction, replication, modification or distribution of any art images

in this manual is prohibited. The third-party trademarks in this manual are proprietary to their respective

owners. These companies or their agents have granted Stryker the right to use their trademarks.

Governing Law

Any legal action or proceeding related to this manual or the information contained in it shall be brought

exclusively in a court in Bergen County, New Jersey, and shall be governed by the laws of the State of

New Jersey, without regard to conflicts of laws principles.

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General Warnings and Consideration

There are no user serviceable parts in the RIO, refer to your Stryker authorized personnel for service.

Do not use the RIO for any purpose other than its intended use or with an unsupported implant system.

Failure to comply may result in serious and/or fatal injury.

For detailed information on a specific software application work flow, consult the appropriate

Application User Guide.

The main system components are suitable for use within the patient environment as long as each is

prepared for surgery in accordance with the respective cleaning and/or sterilization instructions.

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RIO COMPONENTS

The main components of the RIO are the Robotic Arm, Guidance Module, Camera Stand, Foot Pedal,

and cutting system.

Robotic Arm

The term 'Robotic Arm' is used throughout this manual to refer to all components shown below, not

just the 'arm' portion. Sub-components will be identified by another descriptor (e.g., Robotic Arm

Base, Robotic Arm Articulating Arm, etc.).

Figure 1. Stryker Robotic Arm Components (Mako/RIO)

Item

A

Description

Left Pedal (Raise) - A foot pump to raise Robotic Arm off of fixed feet onto rolling casters.

Several (5 or 6) pumps are required to fully lift the Robotic Arm.

Right Pedal (Lower) - Depressing this pedal will lower the Robotic Arm onto its stationary

feet for storage and during operative use. Depress and hold for 3 - 4 seconds to lower

Robotic Arm onto its support feet. Be sure to check for obstructions before lowering the

system.

The RIO Robotic Arm must be in the holster position before lowering it onto the stationary feet for

storage or during operative use.

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Item

B

Description

Secondary Storage and User Panel (Lower)

A second user panel on the RIO, located inside a locked compartment to prevent

unauthorized access, houses the power cord connection, the ON/OFF switches, and other

peripheral connections

The control panel may differ depending on whether you have a RIO Knee System or a RIO Common

Hardware System.

Figure 2 Secondary Storage and Lower User Panel (RIO System)

1. Guidance Module Connection - The termination point of the Guidance Module connection

cord.

2. Power Switch/ Circuit Breaker - A circuit breaker for the Guidance Module (and Camera

Stand, if connected).

3. System Serial # Label- The identification label for the Robotic Arm. The serial number label

contains the system serial number, model number, part number, date of manufacture, voltage,

amperage, frequency, and any applicable standards (Figure 2).

4. Ethernet Port (RIO Knee System)- For Stryker use only. Not used intra-operatively.

5. Foot Pedal Connector - Receptacle for the optional foot pedal control.

6. System Power Button -A single button which powers all of the RIO components (if connected).

See the ‘Powering the RIO’ section of this manual for details.

7. System Power Switch - A switch controlling main power to the Robotic Arm (includes

Guidance Module and Camera, if connected). Must be in the ON position for the Robotic Arm to

function.

8. Power Cord Connection - Outlet for the Robotic Arm power cord with a fastener to hold the

cord in place. The power cord should not be removed.

9. Type B Device Label and Patent Protect Label.

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Item

Description

C

Upper User Panel - The upper user panel of the RIO allows manual locking and release of

the Robotic Arm brakes. Pressing the EMERGENCY stop (E-Stop) while the Robotic Arm is

active will lock the Robotic Arm brakes and prevent motion in the Articulating Arm. The Mako

Product Specialist can enable the system after an E-Stop.

The control panel may differ depending on whether you have a RIO Knee System or a RIO Common

Hardware System.

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4

5

7

6

2

1

8

9

Figure 3 Control Panel

1. Emergency Stop - Pressing this button (E-Stop) at any time while the Articulating Arm is in use

will lock the Robotic Arm joint brakes and prevent any Robotic Arm motion. To release the EStop, rotate the button clockwise. This will activate the enable button. Press and hold the

enable button until the Robotic Arm brakes disengage.

2. Power – (RIO Common Hardware System Only) Indicates power is on.

3.

Fault Light - (yellow LED) - When lit, indicates a system fault.

When not in use, the Robotic Arm should be placed in the transportation position and the Emergency

Stop should be engaged.

4.

Enable Button - (and green ring LED) - Pressing this button while the LED ring is

blinking will disengage the joint brakes of the Articulating Arm. This button is used during

Robotic Arm setup and to enable the Articulating Arm after releasing the emergency stop or

switching between hip and knee applications.

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Enabling the Robotic Arm can cause the Robotic Arm to move. Hold the Robotic Arm when pressing

the enable button.

5. Burr Motor Connection-A socket where the Anspach cable is connected.

6. MICS Motor Connection- (RIO Common Hardware System Only). A socket where the MICS

handpiece cable is connected.

7. Irrigation Pump - Used during the surgery to pump irrigation. When ejected, the lid may be

opened and irrigation tubing clicked into place. The direction of irrigation flow is indicated.

When not in use, the pump can be stored inside the Robotic Arm by closing the lid and pressing

it into the Robotic Arm. The pump will click into place

8.

Brake Release Button - (RIO Knee System Only) Pressing this button will release the Robotic

Arm brakes and allow the Articulating Arm to be moved, if necessary.

9.

Override Button- This button is a manual override for the MICS handpiece or Anspach control,

which allows the MICS handpiece to be used freehand (in conjunction with the foot pedal) in the

case of a Robotic Arm failure. Lift the button cover and depress the override button to use.

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Item

D

Description

Transport Handle

Used for pushing, pulling, or turning the Robotic Arm when in transport position.

E

Storage Bin

The storage bin on the back of the Robotic Arm contains space for the following:

• Calibration End Effector

• DVD-ROM Drive and Calibration data CDs for all End Effectors, Calibration End Effectors

and Ball Bars included with the system

• Socket wrench and hex keys

• Socket Array (located under the Calibration End Effector

• MICS Holder

• User Manual (if required)

Figure 4. Stryker Robotic Arm Storage Bin (Mako/RIO)

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Item

F

Description

Base Array Tracking Arm- The Base Tracker Arm supports the Base Array during surgery.

The Large Tracker Arm Knob on the lower portion of the Base Tracker Arm allows for

positioning, this knob must be secured to hold the Base Array in place.

For optimal setup, the Base Tracker Arm should be set and locked into position immediately

following draping. Any further adjustments required for the base array may be done using the

Large Tracker Arm Knob.

Loosening the larger Base Tracker Arm Knob will release three joints at once. Support the Tracker Arm

before loosening.

Base Array

Connector

Figure 5. Base Tracker Arm Lower Arm (left) and Upper Arm (right)

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Figure 5a. Quick Connect Base Array Connector*

Figure 5b. Quick Connect Base Array Assembly

* The Base Array Tracking Arm shall be configured with either the Base Array Connector with Thumb Screw or the

Quick Connect Base Array Connector.

Item

G

Description

Articulating Arm

Each of the six joints in the arm has a different range of motion.

Control of the Articulating Arm is handled by software and the user.

H

Calibration Slide and Locking Knobs

To free the Calibration Slide, loosen both knobs by turning counter clockwise. The slide can be

extended toward the right or left sides of the Robotic Arm and locked into place.

Both the Calibration Slide and the locking knobs are only used for Robotic Arm calibration (performed

by Stryker customer service personnel) and for pre-surgery check (performed by the Mako Product

Specialist). These items are not used intra-operatively.

Knobs

Slide

Turnclockwise

Turnclockwise

Figure 6. Kinematic Calibration Slide and Locking Knobs.

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Guidance Module

The Guidance Module acts as a computer workstation for the Mako Product Specialist, and houses one

of the two system computers.

Figure 7. Guidance Module Components

Item

Description

A

LCD Monitor - This monitor can be viewed by the Mako Product Specialist during the

procedure and may also act as backup monitor if the surgeon monitor fails.

B

USB Ports - Used for data import /export and portable DVD drive connection.

C

Transport Handle - Used for pushing, pulling or turning the Guidance Module.

D

Computer Housing - Houses the computer which runs the application software.

E

Camera Stand Connection - Connection socket for the Camera Stand cord.

F

Cord Wrap - Used to bundle the Guidance Module cord.

G

Reset / Power Button - Used to reset the computer inside the Guidance Module.

Fully power down the system before disconnecting any cabling to avoid a potential electrical shock

hazard.

To prevent damage to the Camera Stand connection, the cable connection cover on the Guidance

Module must be attached at all times when not in use.

During normal use, power to the Guidance Module is provided automatically when the Robotic Arm is

powered. The Reset Button (Item G) should only be used to power the Guidance Module to recover

from a failure.

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Figure 8. Guidance Module

Figure 9. Serial Number

Do not transport the Guidance Module unless the unit is in the storage position. The maximum

threshold transition that the Guidance Module can be pushed over is 10 mm.

Item

Description

H

Keyboard - A sealed keyboard for use during the pre-surgery check and surgery.

I

Mouse - A sealed, three button mouse used to navigate through the application software.

J

Storage Compartment - Stores the system Ball Bar used for system calibration and the presurgery check.

K

Wheel Brakes - Brakes on two of the four wheels can be used to secure the Guidance

Module.

L

Serial Number - Serial number is located on the back of the base of the Guidance Module.

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Camera Stand

Figure 10. Camera Stand

Figure 11. Warning Symbol on Camera Stand Arm

Ensure the camera does not move while the Robotic Arm is in the stereotactic boundary. Movement of

the camera may cause the Robotic Arm to move outside of the incision.

To avoid a potential tipping hazard, do not transport the Camera Stand unless the unit is in storage

position. The maximum threshold transition that the Camera Stand can be pushed over is 10 mm.

Item

A

Description

Camera -Used for tracking MAKOplasty instruments and arrays. The camera is composed

of two sensor/illuminators which provide and detect infra-red light and a central user panel

described in Figure 10.

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Figure 12. Camera User Panel.

1. Warm up Sensor – 2 minutes are required for camera warm up with a maximum warm up time

of 10 minutes. The LED will blink while booting and turn green when ready.

2. Power Indicator – This LED will turn green when power is supplied. This LED may flash blue

during system boot. This is part of the normal warm up process.

3. Bump Sensor – This LED will turn orange if a major bump is detected. Notify Stryker customer

service if this light is illuminated.

4. Laser Aperture – Source of the laser alignment guide.

Do not look directly into the laser-emitting aperture. The Class 2 laser module on the Position Sensor

emits radiation that is visible and may be harmful to the human eye. Direct viewing of the laser diode

emission at close range may cause eye damage. A warning label related to laser radiation is affixed to

the back of the camera.

Figure 13. Laser radiation warning and serial number label

5. Laser Alignment Button – This button produces a red laser light which may be used for

alignment of the camera field of view. The light will remain on only as long as the button is

pressed.

Item

B

Description

Surgeon Monitor - An LCD monitor used for surgeon view which can be translated and

rotated to achieve proper viewing angle.

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Item

C

Description

Camera Adjustment Mount - The position of the camera can be adjusted using any of the

knobs outlined below.

1. To adjust the camera, activate the trigger and

rotate to the desired position.

Trigger

Figure 14. Camera Adjustment Mount

When adjusting the camera, always make sure the trigger is depressed. Failure to adjust the camera

with the trigger depressed will damage the camera mount.

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Item

Description

D

Camera Stand Base and Wheel Brakes - The Camera Stand should be locked into position

when in use or in storage by applying the two wheel brakes. A 'NO STEP' label is affixed to the

top of the Camera Stand base.

Figure 15. No Step Label Location

A MAKO serial number label with the part number, serial

number, manufacture date, and certification information can

be found on the rear of the Camera Stand Base as shown in

Figure 16. A secondary label is also affixed to the left of the

MAKO logo showing serial number and certifications for the

original equipment manufacturer.

Figure 16. Serial Number Location

To avoid a potential tipping hazard, do not step on the base of the Camera Stand.

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TRANSPORTING THE RIO

Transporting the Robotic Arm

The Robotic Arm should only be transported when all the following conditions are met:

• Robotic Arm is in home position (Robotic Arm folded at elbow, centered above the Robotic Arm

base) with covers attached as shown.

• E-Stop switch is pressed (to engage Robotic Arm brakes).

• Power is off and all cords are disconnected.

• Stationary leveling legs are lifted completely off the floor (using the left foot pump).

To prevent potential damage to the self-leveling feet of the RIO, please follow these

recommendations before moving the system:

1. Ensure that the RIO is fully raised off the self-leveling feet and onto the casters by pumping the

Lift Pedal until it will not pump anymore.

2. Pump the Lift Pedal slowly and with even strokes to provide adequate hydraulic lifting.

Use the front handle to maneuver the Robotic Arm to the desired location; it takes two people to move

the RIO.

Figure 17. Transport Configuration of the Robotic Arm

Do not transport the system while the Robotic Arm is in use. The Robotic Arm must not be

transported unless the lift mechanism is in the fully up, transport position. Ensure the Robotic Arm

has been fully lifted using the foot pump.

To avoid a potential tipping hazard, do not transport the Robotic Arm unless the unit is in the storage

position. The maximum threshold transition that the Robotic Arm can be pushed over is 10 mm.

The Robotic Arm has limited ground clearance and the user should not attempt to push it over cables

or other obstacles. Always transport the Robotic Arm with the lift mechanism fully engaged (i.e., the

stationary support legs fully retracted).

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Transporting the Guidance Module

To move the Guidance Module, unlock the two wheel

brakes and use the handle as a grip.

Figure 18. Transport Configuration of the

Guidance Module

Transporting the Camera Stand

To move the Camera Stand, unlock the brakes on the stand

wheels, ensure the primary monitor and camera arms are

retracted toward the center of the stand, and cover the unit

with the supplied covers.

Use the exposed handle to push the Camera Stand.

Do not bump the Camera Stand while moving. It

could cause damage to the system.

Figure 19. Transport Configuration of

the Camera Stand (new pix)

The Camera Stand may tip over if transported on an incline of more than 10°. Always transport the

Camera Stand in transport position (i.e., with the monitor and camera fully stowed).

When in storage position, the upper segment of the Camera Stand may be too tall to fit through the

doorway in the upright position. It may be necessary to lower the upper segment of the arm to avoid

damage to the Camera Stand.

Important RIO Concepts

Passive Navigation

In addition to the Robotic Arm, the RIO utilizes instrumentation for wireless navigation. Unlike traditional

surgical tools, these instruments are affixed with VIZADISC which reflect infrared light produced and

collected by the camera system. Software in the RIO uses the information gathered by the camera to

determine tip position and tool orientation of a given navigated instrument as it moves through the

camera’s field of view. Additionally, bone mounted arrays are used as a reference to register the position

and orientation of other objects (e.g., bones).

Instruments and reference arrays equipped with passive VIZADISC must have an unobstructed line-ofsight path to the camera in order to be tracked.

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Other sources of infrared energy (certain OR lights, direct sunlight) or highly reflective surfaces in the

operating room can interfere with instrument and array tracking.

Stereotactic Boundaries

Stereotactic boundaries are virtual walls created by the software and implemented through the Robotic

Arm hardware to restrict the cutting tip to within a pre-defined resection volume. If a surgeon attempts to

move the cutting system past the predefined volume in cutting mode, the Robotic Arm applies a force

simulating contact with a rigid wall, thereby confining the tip to the correct region in space. When the

stereotactic boundaries are not in place, (i.e., during calibration, setup, etc.) resection is disabled and the

Robotic Arm may be manipulated freely.

Virtual Arm Holster

Do not use excessive force or speed when moving the Robotic Arm.

The Virtual Arm Holster is a particular position (upright) in which the Robotic Arm rests when not in use.

The Virtual Arm Holster prevents the Robotic Arm from drifting downward.

Failure to place the Robotic Arm at the center of the Virtual Arm Holster may result in the Robotic

Arm moving when the Robotic Arm is enabled. Hold the Robotic Arm when pressing the enable

button.

To place the Robotic Arm in the Virtual Arm Holster, grasp the Robotic Arm and with a gentle force, lift

and push the Robotic Arm to an upward position. Once the Robotic Arm is within 15 degrees of center

the RIO software will take over and automatically hold the Robotic Arm in the Virtual Arm Holster

position.

To release the Robotic Arm from the Virtual Arm Holster, use gentle force to place the Robotic Arm in

the desired position. The RIO software automatically releases the Robotic Arm from the Virtual Arm

Holster position when the Robotic Arm is moved 30 degrees away from the center.

15°

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CABLE CONNECTIONS

Ensure RIO cables are placed in “low-traffic” areas to prevent inadvertent disconnection or damage

due to OR traffic during a procedure.To avoid cable damage during OR bed movement, clear a path

around the cables or attach cord sweepers.

1. Ensure the red ON/OFF circuit breaker switch on the Robotic Arm lower user panel is in the ‘OFF’

position and the system is not powered.

2. Guidance Module to Robotic Arm (orange end) - Remove the cable cover and align the

connector to the outlet marked ‘Guidance Module’. This connection is keyed and can only be made

in one orientation. Slowly insert the cable straight into the connector and tighten the outer cable ring

until it cannot be tightened further.

3. Foot Pedal - If desired, connect the Cutting System foot pedal cable to the outlet marked ‘foot

switch’ on the lower user panel.

4. Camera Stand to Guidance Module (purple end) - Remove the cable cover and align the

connector to the outlet marked ‘Camera Stand’. This connection is keyed and can only be made in

one orientation. Slowly insert the cable straight into the connector and tighten the outer ring until

the red indicator band is no longer visible.

5. RIO Power - Ensure the power cable is connected to the port in the Robotic Arm and connect the

male end into the wall power outlet.

Guidance Module

Camera Stand

Robotic Arm

Foot Pedal

Figure 20. Cable Connections

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Power

Cutting System

Motor

(Initially Sterile)

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POWERING THE RIO

To prevent under powering or damaging the unit, do not connect the RIO power into a surge protector

or extension cord. The RIO must be powered directly from a hospital outlet using the Stryker supplied

cord.

Do not boot the system with the circuit breaker switch (A) turned off. If the switch is toggled after the

system begins initial boot up, the camera may not function correctly.

The RIO is equipped with a Uninterruptible Power Supply (UPS) which can temporarily power the

system in case of a power outage. Should a power outage occur, plug the system back into an

appropriate power source as soon as possible to avoid draining the UPS or losing system function.

The back panel may slightly differ depending on your RIO configuration.

1. Ensure the red ON/OFF circuit breaker

switch on the Robotic Arm lower user

panel is in the 'OFF' position and the

system is not powered.

2. Turn the Guidance Module/Camera

Stand circuit breaker switch (A) and

Main Power switch (C) to ON/1. These

switches can be selected in any order.

3. Press and hold the POWER ON/OFF

button (B) on the Robotic Arm connector

panel for 2-3 seconds. The system will

emit a continuous beep. When a beep

ceases, release the button and the

system will boot.

If a short, weak beep is heard during boot up and the system does not power, repeat Step 3.

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MAKOplasty STARTUP SCREEN

Startup Page

When the system is powered, the software will automatically load the application startup page. The

functionality of the features available on this page are described below.

1. Registered MAKOplasty procedure.

2. Registered MAKO logo.

3. Patent information.

4. Control panel.

See the appropriate Application Guide for instructions on the clinical implementation of a MAKOplasty

procedure using the RIO, also referred to as a robotic-arm assisted surgery.

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VIZADISC ASSEMBLY

Sterile Staff Member

1. Remove VIZADISC from the box and remove sterile top

sheet.

2. The VIZADISC is arranged in patterns that exactly match the

geometry of the arrays and the probes.

3. Place the chosen array over the appropriate layout.

Sterile Staff Member

4. With the VIZADISC tray on a stable platform, press the array

onto the VIZADISC.

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