System G Reciprocating Saw Instructions for Use Rev A May 2016

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7306-001-700 Rev-A

Contents

Introduction

Introduction... 2

This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product.

Audience... 2 Conventions... 2 Contact Information... 2 Intellectual Property... 2 Indications For Use... 3 Contraindications... 3

Audience This manual is intended for in-service trainers, physicians, nurses, and surgical technologists. Keep and consult this reference manual during the life of the product.

Safety Directives... 3 For Use With... 3

Conventions

Power and Care Components... 3

The following conventions are used in this manual:

Cutting Tools... 3

▪▪ A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury.

Features... 4 Handpiece... 4 Safety Switch... 4 Definitions... 4 Instructions... 5 To Process the Equipment... 5

▪▪ A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. ▪▪ A NOTE supplements and/or clarifies procedural information.

To Charge a Power Module... 5 To Install a Power Module... 5 Sterile Assistant... 5 Circulating Assistant... 5 Sterile Assistant... 6 To Install and Remove a Cutting Tool... 7

Contact Information For additional information, including safety information, inservice training, or current literature, contact your Stryker sales representative or call Stryker customer service at 1-269-323-7700 or 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary.

To Operate a Handpiece... 7 To Remove a Power Module... 8 Specifications... 9 Handpiece... 9

Intellectual Property Trademarks not the property of Stryker Corporation are the property of their respective owners.

Transfer Shield... 9 Product Safety Compliance... 10 Electromagnetic Compatibility... 10

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7306-001-700 Rev-A

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Indications For Use

For Use With

The STRYKER SYSTEM G Reciprocating Saw (handpiece) is a surgical battery-powered instrument intended for use during variety of orthopedic and trauma procedures to provide power to operate saw blades.

This section identifies components intended to be used with the equipment to obtain a safe combination.

This handpiece is designed for surgical procedures where hard tissue and/or bone must be cut and/or decorticated.

▪▪ Use only Stryker-approved equipment, unless otherwise specified.

Contraindications

▪▪ Use of unapproved electrical equipment may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system.

None known.

Safety Directives WARNINGS: ▪▪ Before using this equipment, read and understand the instructions for use. Pay particular attention to safety information. ▪▪ Only trained and experienced healthcare professionals should use this equipment. ▪▪ The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker does not recommend surgical procedure or technique.

WARNINGS:

NOTE: For a complete list of components or ordering information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary.

Power and Care Components Description STRYKER SYSTEM G Transfer Shield STRYKER SYSTEM G Power Module STRYKER SYSTEM G Charger, 2-Bay STRYKER SYSTEM G Sterilization Cases

REF 7304-120-000 7309-120-000 7310-120-000 7302-120-000 7302-130-000

Cutting Tools WARNING: All cutting tools are intended for single use only. Description Blades

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REF 0277-096-XXX series

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7306-001-700 Rev-A

Features

Safety Switch

Handpiece Run Mode – The trigger is functional. B A Safe Mode – The trigger is locked to prevent inadvertent operation of the handpiece.

C

D

E

Definitions

A B C D E

Safety Switch – Locks the trigger. Blade Chuck – Retains the cutting tool in the handpiece. Trigger – Controls the variable speed operation of the handpiece. Door – Opens to allow installation of a power module. Latch – Secures the door.

The symbols located on the equipment and/or labeling are defined in this section and/or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. Symbol

Definition General Warning Sign Run Mode Run Mode

1 min/ 4 min X 5

Duty Cycle (See the Specifications section.) Lock Unlock Direction of Rotation Alignment Mark

USE ONLY STRYKER Use only Stryker power module. POWER MODULE STERILIZE WITH DOOR Sterilize with door fully open. FULLY OPEN

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7306-001-700 Rev-A

Instructions

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3. Place the sterile transfer shield over the open compartment.

To Process the Equipment WARNING: Upon initial receipt and before each use, process the equipment as indicated in the care instructions manual supplied with the equipment.

To Charge a Power Module Fully charge the power module before first and every use. NOTES: ▪▪ For charging instructions, see the instructions for use supplied with the battery charger. ▪▪ For additional information, including safety information, see the instructions for use supplied with the power module. 4. Present the compartment to the Circulating Assistant.

To Install a Power Module Sterile Assistant 1. Set the safety switch to the safe mode position.

Circulating Assistant WARNING: DO NOT contaminate the handpiece. The transfer shield guards the sterile handpiece from contamination during power module installation. 1. Hold the power module by the handle. 2. Insert the power module through the transfer shield into the open compartment.

2. Turn the latch to the unlock position and open the door.

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3. Push the handle down.

1. Holding the door by the latch, use the door to push the power module handle down until it locks into position against the power module.

WARNING: ALWAYS sterilize the contaminated transfer shield before using it again. 4. Remove the contaminated transfer shield.

2. Close the door and turn the latch to the lock position. Verify the mark on the latch aligns with the lock symbol and the door is securely closed.

Sterile Assistant WARNINGS: ▪▪ When closing the door, hold the door by the latch. DO NOT touch the edges of the door or the internal surface of the door that faces the power module. ▪▪ ALWAYS verify the door is securely closed to prevent exposing the power module to the sterile field.

6

NOTE: Although one power module is usually sufficient for one operation, Stryker recommends preparing a second handpiece with power module to ensure quick intraoperative exchange of handpieces under sterile conditions.

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To Install and Remove a Cutting Tool 1. Rotate the spring-loaded blade chuck to align the slots and fully insert the blade. NOTE: The blade teeth may be directed in any of four positions.

To Operate a Handpiece WARNINGS: ▪▪ ALWAYS be alert for blade whip when operating the handpiece below the maximum speed. Blade whip may cause the blade to fracture. ▪▪ When the Short Reciprocating Blade (REF 0277096-250) is installed, DO NOT operate the handpiece unless the blade is in contact with bone or tissue. Failure to comply may cause the blade to fracture or eject from the handpiece. ▪▪ DO NOT open the handpiece housing during surgery as the inside of the device is not sterile.

2. Release the blade chuck. Verify the chuck springs back into its original position indicating the blade is properly seated.

▪▪ ALWAYS follow the specified duty cycle to prevent the equipment from overheating. See the Specifications section. ▪▪ ALWAYS consult attachment and tool labeling for product-specific duty cycles and instructions for use. ▪▪ DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide. ▪▪ Take special precautions regarding electromagnetic compatibility (EMC) when using this equipment. Place the equipment into service according to the EMC information contained in this manual.

Correct

Incorrect

▪▪ Portable and mobile radio frequency (RF) communications equipment can affect the function of this equipment. ▪▪ This equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, ALWAYS verify normal operation in the configuration in which it will be used. ▪▪ ALWAYS operate the equipment within the specified environmental condition values:

3. Gently pull on the blade to verify it is secure. 4. To remove the blade, rotate the spring-loaded blade chuck again.

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Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

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1. Before operating the equipment, verify the following: ▪▪ You are using Stryker-approved equipment. ▪▪ The equipment is not damaged. ▪▪ The equipment is clean and sterile. ▪▪ You have properly assembled the equipment. ▪▪ You have installed a fully-charged power module.

To Remove a Power Module

NOTE: If you experience difficulty during operation, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary.

2. Turn the latch to the unlock position and open the door.

NOTE: Keep the power module as clean as possible because it cannot be sterilized. 1. Wipe all debris from the external surfaces of the handpiece.

3. Use the handle to remove the power module from the handpiece.

2. Set the safety switch to the run mode position. NOTE: Set the safety switch back to the safe mode position when the handpiece is idle or when passing the handpiece to another person. CAUTION: DO NOT apply excessive pressure or restrict the motion of the cutting tool during operation. An excessive load on the system may cause the power module to temporarily shut down. If this happens, release the trigger to resume operation or allow the power module to cool for 20 to 40 minutes. 3. Pull the trigger to control the variable speed operation of the handpiece. NOTE: Typical power module run time is 5 minutes or longer, depending on surgical procedure and technique.

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Specifications Handpiece Model: Catalog Number: Dimensions: Length: Width: Height: Mass: Nominal Speed: Excursion: Mode of Operation: Duty Cycle: Rest Between Cycles: Applied Part: Maximum Temperature of Applied Part: Power Supply: Ingress Protection (IP): Equipment Type:

STRYKER SYSTEM G Reciprocating Saw 7306-001-000 212.10 mm 83.82 mm 228.40 mm 1.08 kg 11500 cycles per minute 3.9 mm Non-continuous 1 minute on/4 minutes off, 5 times 3 hours The handpiece and cutting tool as defined by the manufacturer Less than 43 °C, as tested to the Product Safety Compliance standards at a maximum ambient temperature of 30 °C. Internally Powered IPX0 Type BF Applied Part

European Conformity:

Transfer Shield Model: Catalog Number: Dimensions: Length: Width: Height: Mass: European Conformity:

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STRYKER SYSTEM G Transfer Shield 7304-120-000 150.9 mm 103.5 mm 37.0 mm 77 g

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Product Safety Compliance International Electrotechnical Commission (IEC) IEC 60601-1 A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability – Edition 3.1 Consolidated Reprint. IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical devices - Edition 1.1 Consolidated Reprint. IEC 60601-1-2: 2010: EMC (Version 3.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 3.0 IEC 62133: 2012/12/06 Edition: 2.0: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications, Corrigendum 1:2013 European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for basic safety and essential performance – Incorporates Amendment A12: 2014

Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic emissions The STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) 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.

Class B

The STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 RF emissions CISPR 11 Harmonic emissions

N/A

IEC 61000-3-2 Voltage fluctuations/flicker emissions

N/A

IEC 61000-3-3

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Guidance and manufacturer’s declaration - electromagnetic immunity The STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

IEC 61000-4-2

±8 kV air

±8 kV air

Electrical fast transient/burst

±2 kV for power supply lines

N/A

IEC 61000-4-4

±1 kV for input/output lines

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

N/A Surge

±1 kV line(s) to line(s)

N/A

IEC 61000-4-5

±2 kV line(s) to earth

N/A

Voltage dips, short interruptions and voltage variations on power supply input lines

<5% UT (>95% dip in UT) for 0,5 cycle

N/A

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

N/A

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

N/A

<5% UT (>95% dip in UT) for 5 seconds

N/A

3 A/m

3 A/m

IEC 61000-4-11

Power frequency (50/ 60 Hz) magnetic field

N/A

N/A

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

IEC 61000-4-8 NOTE: UT is the alternating current mains voltage prior to application of the test level. Guidance and manufacturer’s declaration - electromagnetic immunity

The STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

N/A 150 kHz to 80 MHz 80 MHz to 800 MHz

[E1] = 3 V/m

800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: (Non-ionizing electromagnetic radiation)

NOTE 1: At 80 MHz and 800MHz the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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 STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) is used exceeds the applicable RF compliance level above, the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000).

a

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended separation distances between portable and mobile RF communications equipment and the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) The STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the STRYKER SYSTEM G Reciprocating Saw (REF 7306-001-000) as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m

Rated maximum output power of transmitter W

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

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. NOTE 1: At 80 MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2: 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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Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210

2016-05

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