Mako Technical User Guide Rev 01 July 2015

Mako Technical User Guide

Unless qualified by Stryker, healthcare facility Biomedical Engineering departments should limit system repair/maintenance to electrical safety testing as outlined in the Preventive Maintenance section of this manual.

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

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Mako Technical User Guide

INTRODUCTION About This Manual This manual provides information regarding hardware components of the Stryker Robotic Arm System (Mako/RIO) for use as a reference. Manufacturer Support / Feedback MAKO Surgical Corp. 2555 Davie Rd. Ft. Lauderdale, FL 33317 Customer Service Phone (855) 303-6256 makosurgical.com 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. This user guide supports RIO Model 3.0. 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. Manufacturer MAKO Surgical Corp. 2555 Davie Rd. Ft. Lauderdale, FL 33317 Responsibility Under the terms of the service contract, maintenance and repair of the RIO is the responsibility of Stryker.

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Mako Technical User Guide

STRYKER ROBOTIC ARM SYSTEM The main components of the Stryker Robotic Arm System (Mako/RIO) are the Robotic Arm, Guidance Module, and Camera Stand. Other instrumentation and accessories are available for use with the system, but are not discussed in this manual. Robotic Arm The Robotic Arm facilitates controlled bone resection by applying stereotactic boundaries to a cutting burr. The upper portion of the arm articulates, allowing motion with six Degrees of Freedom (DOF). The lower base houses the computer and power components, cable panel, user panel, and positioning lever. A smaller fixed arm is attached to the base and supports a reference array.

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

There are no user-serviceable parts on the Robotic Arm.

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Mako Technical User Guide

Guidance Module The Guidance Module acts as a computer workstation, houses one of the two system computers, and coordinates input from the various system components.

Figure 2. Guidance Module

There are no user-serviceable parts on the Guidance Module.

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Mako Technical User Guide

Camera Stand The camera or position sensor is used to track the location of passive tools. The camera is mounted on a mobile stand and can be positioned for height, angle, and rotation by adjusting the auto balance arm or the stand. The camera stand also includes a surgeon monitor display.

Figure 3. Camera Stand

There are no user-serviceable parts on the Camera Stand.

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Mako Technical User Guide

USER APPLICATION SOFTWARE The MAKOplasty software provides functionality to: •

Import or acquire patient CT DICOM data.

•

Display the patient data using 2D and/or 3D representations.

•

Register points in the patient data sets to the patient using various tracked instruments and tools.

•

Display locations of tracked instrumentation with respect to other tracked instrumentation, registered patient anatomy, or the RIO.

•

Communicate with the RIO and with the tool tracking system.

•

Manage the application pages and the screen layout.

Robotic Arm Software A separate software application runs on the Robotic Arm and is transparent (not accessible to the user). Functionally this application can be divided into 3 basic categories. •

Error/Safety monitoring.

•

RIO hardware control.

•

Peripheral connectivity.

Reporting Problems Hardware There are no internal user-serviceable parts in the RIO. Unless qualified by Stryker, do not open any system panels. Problems experienced during pre-operative, intra-operative, or post-operative use of the RIO should be reported to MAKO Surgical Corp. Software Software error reports are logged through the software and collected by Stryker Service Personnel during preventive maintenance.

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Mako Technical User Guide

RIO TECHNICAL INFORMATION Stryker makes available to Stryker-trained personnel circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the appropriate qualified technical personnel to repair parts of equipment designated by Stryker. Table 1 RIO Technical Information Guidance Module

Robotic Arm

Camera Stand

MICS Handpiece

Storage Dimensions (LxWxH)

31" x 27" x 63"

24" x 35" x 56"

42" x 27" x 79"

21” x 9” x 4”

Operating Dimensions (LxWxH)

31" x 27" x 63"

35" x 49" x 56"

56" x 27" x 79"

9” x 9” x 4”

Power Requirements

N/A

100 / 120 / 230 V, 1150 W, ~50/60 Hz

N/A

N/A

Weight

114 lbs (51.7 kg)

866 lbs (394 kg)

190 lbs (86.2 kg)

4.3 lbs (1.8 kg)

Footprint

27" x 31"

24" x 35"

27" x 31"

N/A

Physical

Environmental Humidity

20% to 80% (non-condensing)

Temperature

Operating: 10° to 32° Celsius Storage: -20 ºC to 50º Celsius

Barometric Pressure

Sea level 1060 hPa to max conditions (3000M) 700 hPa

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Mako Technical User Guide

Table 1 RIO Technical Information (continued) EMC Information RF emissions CISPR11

Class A

ESD Contact / Air EN61000-4-2

Class A / Class B

Radiated RF EN61000-4-3

3 V/m

Fast Transients (EFT) IEC61000-4-4

+/- 2 kV for power supply lines; +/- 1 kV for input/output lines

Line surge immunity IEC61000-4-5

+/- 1 kV differential; +/- 2 kV common mode

Conducted RF IEC61000-4-6

3 Volts

Power frequency (60 Hz) magnetic field EN61000-4-8

3 A/m

Voltage dip immunity IEC61000-4-11

Operated on 5%, 5%, 40%, and 70% of AC main power for 250 cycles, 0.5 cycles, 5 cycles, and 25 cycles, respectively.

Regulatory Compliance Safety approvals

TUV SUD NRTL certification to: UL 60601-1:2003 for the US CAN/CSA C22.2 No. 60601-1-08 for Canada EN 60601-1:2006 for EU

Applicable standards

UL 60601-1:2003 CAN/CSA C22.2 No. 60601-1-08 EN 60601-1:2006

Classifications Per IEC 60601-1, the RIO has been classified as: •

Continuous Operation, according to mode of operation.

•

Class I, according to type of protection against electric shock.

•

Type B Applied Part, according to degree of protection against electric shock.

•

IPX0 rating, according to degree of protection against the ingress of fluids.

Explanation of Labels For an explanation of all labels attached to the RIO system, reference the Mako System User Guide (PN 210711).

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Mako Technical User Guide

RIO Cabling Table 2 RIO Cabling Part Name

Length of Cable

RIO Guidance Module (external cable to RIO)

25 ft

Camera stand (external cable to Guidance Module)

25 ft

Anspach eMax2 Plus

12 ft 7 in

MICS Handpiece

12 ft

RIO Arm power

20 ft

RIO Foot Switch

12 ft

Electromagnetic Interference This device is tested to the requirements of IEC 60601-1-2 for electromagnetic compliance for Class A, Group 1 medical devices. It has been shown not to emit RF energy at a level that may interfere or affect surrounding equipment. It is also shown to not be susceptible to RF or Electrostatic discharge (ESD) to a level that interferes or affects its own operation. This is predicated on the fact that the installation and operation is done in accordance with all service and operator instructions. The RIO has special precautions regarding EMC and must be installed and put into service according to the EMC information provided in this Technical User Manual and the accompanying appendices. Portable and mobile RF communications equipment can affect the RIO.

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Mako Technical User Guide

Electromagnetic Emissions Table 3 Electromagnetic Emissions This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •

Reorient or relocate the receiving antenna.

•

Increase the separation between the equipment and receiver.

•

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

•

Consult the dealer or an experienced technician for help.

The user should not modify or change this device without written approval from Stryker. Modification could void authority to use this equipment.

The RIO is intended for use in the electromagnetic environment specified below. The customer or the user of the RIO should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment Guidance

RF emissions CISPR11 (RE-E)

Group 1, Class A

The RIO 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 emissions CISPR11 (RE-E)

Group 1, Class A

Harmonic emissions IEC 61000-3-2

Class A

The RIO 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 used for domestic purposes.

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

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Mako Technical User Guide

The RIO should not be used adjacent to or stacked with other equipment, but if adjacent or stacked use is necessary, the RIO should be observed to verify normal operation in the configuration in which it will be used.

Table 4 Electromagnetic Immunity The RIO is intended for use in the electromagnetic environment specified below. The customer or the user of the RIO should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Levelb

Electromagnetic Environment Guidance

Electrostatic discharge EN 61000-4-2

+/- 6 kV contact +/- 8 kV air

+/- 6 kV contact +/- 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

+/- 2 kV for power supply lines +/- 1 kV for input/ output lines

+/- 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 differential mode +/- 2 kV common mode

+/- 1 kV differential mode +/- 2 kV common mode

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

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

• <5% UT (>95% dip in UT) for 0.5 cycle

• <5% UT (>95% dip in UT) for 0.5 cycle

• 40% UT (60% dip in UT) for 5 cycles

• 40% UT (60% dip in UT) for 5 cycles

• 70% UT (30% dip in UT) for 25 cycles

• 70% UT (30% dip in UT) for 25 cycles

• <5% UT (>95% dip in UT) for 5 sec

• <5% UT (>95% dip in UT) for 250 cycle

Mains power quality should be that of a typical commercial or hospital environment. If the user of the RIO requires continued operation during power mains interruptions, it is recommended that the RIO be powered from an uninterruptible power source.

3 A/m

3 A/m

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

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

(a) UT is the AC mains voltage prior to application of the test level. (b) EN 61000-4-2 Class B pass criteria specifies that the Unit Under Test (UUT) may experience a selfrecovering temporary failure.

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Mako Technical User Guide

Table 5 Guidance and Declaration – Electromagnetic immunity The RIO is intended for use in the electromagnetic environment specified below. The customer or the user of the RIO should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Levelb

• Conducted RF IEC 61000-4-6

• 3 Vrms 150 kHz to 80 Hz

• 3 V RMS

• Radiated RF EN 61000-4-3

• 3 V/m 80 MHz to 2.5 GHz

• 3 V/M

Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the RIO, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 3.5 d = -------V1

P

3.5 d = -------E1

P 80 MHz to 800 MHz

7 d = -----E1

P 800 MHz to 2.5 GHz

d = recommended separation distance in meters (m). p = maximum output power rating of transmitter in watts (W) according to transmitter manufacturer. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than compliance level in each frequency range. Interference may occur in vicinity of equipment marked with following symbol:

a.)Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RIO is used exceeds the applicable RF compliance level above, the RIO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the RIO. b.)Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Mako Technical User Guide

The RIO is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RIO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RIO as recommended below, according to the maximum output power of the communications equipment. Table 6 Recommended separation distances between portable and mobile RF communications equipment and the RIO Separation Distance Based on Transmitter Frequency (m) Rated Maximum Output Power of Transmitter (W)

150 kHz to 80 MHz Outside ISM Bands

3.5 d = -------V1

150 kHz to 80 MHz In ISM Bands

12 d = -----V2

P

80 MHz to 800 MHz

12 d = -----E1

P

800 MHz to 2.5 GHz

23 d = -----E1

P

0.01

0.04

0.12

0.12

0.23

0.1

0.11

0.38

0.38

0.73

1

0.35

1.2

1.2

2.3

10

1.11

3.8

3.8

7.3

100

3.5

12

12

23

P

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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.

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Mako Technical User Guide

PREVENTIVE MAINTENANCE The RIO requires preventive maintenance (PM) performed by authorized service personnel to make reliable and consistent measurements of essential operational parameters. The PM session also provides the standard maintenance activities necessary to keep the system at its optimum level of performance. Preventive Maintenance is to be performed by Stryker-qualified service personnel only.

Preventive Maintenance will be initiated by Stryker and may include the following activities: •

Inspecting the system cables and connectors.

•

Inspecting and testing tracked tools and accessories (e.g., end effector, base tracker, end effector array).

•

Inspecting and cleaning the Robotic Arm system.

•

Inspecting all LED functions.

•

Testing RIO Robotic Arm calibration, homing, brakes.

•

Inspecting the UPS system on the Robotic Arm.

•

Inspecting and testing the Robotic Arm platform with tools including tool clamps, guides, mounts for accuracy.

•

Inspecting the mechanical cables in the arm.

•

Inspecting motor assemblies (encoders, motor phasing, etc.).

Cleaning, disinfection and electrical safety testing are to be considered preventive maintenance activities that are performed by the healthcare facility biomedical engineering department.

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Mako Technical User Guide

SYSTEM DISPOSAL Contact MAKO Surgical Corp. before disposing of any RIO equipment.

To dispose of RIO equipment, it is recommended that the following procedure be followed. This procedure helps ensure the safe disposal of the system. In addition, disposal must be consistent with any contractual obligations with Stryker regarding the RIO.

Procedure 1. Power down the equipment. 2. Inspect the equipment for signs of biohazard contamination. 3. De-contaminate the equipment. 4. Contact Customer Service for additional information required for removal of the system application software (as specified in the software license agreement) and disposal of any potentially hazardous materials. 5. Disassemble the equipment and dispose of it with a qualified salvage and disposal specialist.

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A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. The products depicted are CE marked according to the Medical Device Directive 93/42/EEC. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Mako, Mako Surgical Corp., MAKOplasty, RIO, and Stryker. All other trademarks are trademarks of their respective owners or holders. PN 210710 Rev 01 07/15 Copyright © 2015 Stryker Printed in USA

Stryker Australia Pty Ltd 8 Herbert Street St Leonards NSW 2065 Australia Ph: +61 2 9467 1000 www.stryker.com.au

Stryker New Zealand Limited 515 Mt. Wellington Highway Auckland 1060 New Zealand Ph: +64 9 573 1890 www.stryker.com