System G Sagittal Saw Instructions for Use Rev AA

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7308-001-700 Rev-AA

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.

▪

A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage.

▪

A NOTE supplements and/or clarifies procedural information.

Features . . . . . . . . . . . . . . . . . . . . . . . 4 Sagittal Saw . . . . . . . . . . . . . . . . . . . 4 Safety Switch . . . . . . . . . . . . . . . . . . 4 Definitions . . . . . . . . . . . . . . . . . . . . . . 4 Instructions . . . . . . . . . . . . . . . . . . . . . 5 To Process the Equipment . . . . . . . . . . . . 5 To Charge a Power Module . . . . . . . . . . . . 5 To Install a Power Module . . . . . . . . . . . . 5 Sterile Assistant . . . . . . . . . . . . . . . 5 Circulating Assistant . . . . . . . . . . . . . 6 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 . . . . . . . . . . . . . 8 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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7308-001-700 Rev-AA

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Indications For Use

For Use With

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

▪

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

Contraindications 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 2108-XXX-XXX series

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7308-001-700 Rev-AA

Features

Safety Switch

Sagittal Saw Run Mode – The trigger is functional.

B C A

Safe Mode – The trigger is locked to prevent inadvertent operation of the handpiece.

D

E

F

Definitions

A B C

D E F

Safety Switch – Locks the trigger. Blade Lock Button – Releases the cutting tool from the handpiece. Blade Mount – Retains the cutting tool in the handpiece and allows the tool to be indexed in 45-degree increments to achieve the desired cutting angle. 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 Full Insert

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7308-001-700 Rev-AA

Instructions

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

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.

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

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

4. Present the compartment to the Circulating Assistant.

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7308-001-700 Rev-AA

Circulating Assistant WARNING: DO NOT contaminate the handpiece. The transfer shield guards the sterile handpiece from contamination during power module installation.

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

1. Hold the power module by the handle. 2. Insert the power module through the transfer shield into the open compartment.

Sterile Assistant WARNINGS:

3. Push the handle down.

▪

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.

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.

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7308-001-700 Rev-AA

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.

EN

3. Release the blade lock button.

4. Gently pull on the blade to verify it is secure. 5. If desired, pull and rotate the blade mount to a new position.

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.

To Install and Remove a Cutting Tool 1. Push the blade lock button and fully insert the blade into the blade mount.

2. Verify the FULL INSERT line disappears inside the blade mount indicating the blade is properly positioned.

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6. Snap the blade mount back into place.

7. Attempt to rotate the blade mount to verify it is secure. 8. To remove the blade, push the blade lock button again.

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To Operate a Handpiece WARNINGS:

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.

▪

DO NOT open the handpiece housing during surgery as the inside of the device is not sterile.

▪

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.

▪

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.

1. Wipe all debris from the external surfaces of the handpiece.

ALWAYS operate the equipment within the specified environmental condition values:

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

▪

Temperature Limitation

Humidity Limitation

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.

To Remove a Power Module NOTE: Keep the power module as clean as possible because it cannot be sterilized.

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

Atmospheric Pressure Limitation

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. 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.

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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 Sagittal Saw 7308-001-000 204.98 mm 83.82 mm 235.75 mm 1.24 kg 11500 cycles per minute 5 degree arc 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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7308-001-700 Rev-AA

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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 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 Sagittal Saw (REF 7308-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) 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 A

The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

CISPR 11 RF emissions CISPR 11 Harmonic emissions

N/A

IEC 61000-3-2 Voltage fluctuations/flicker emissions

N/A

WARNING: This equipment/system is intended for use in a professional healthcare facility environment. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) or shielding the location.

IEC 61000-3-3

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Guidance and manufacturer’s declaration - electromagnetic immunity NOTE: The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD)

±2 kV, ±4 kV, ±6 kV, ±8 kV contact

±2 kV, ±4 kV, ±6 kV, ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

±2 kV, ±4 kV, ±8 kV, ±15 kV air

±2 kV at 100 kHz repetition frequency for power supply lines

N/A

±1 kV at 100 kHz repetition frequency for input/output lines

N/A

IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge

±0.5, ±1 kV line(s) to line(s)

N/A

IEC 61000-4-5

±0.5, ±1, ±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

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

N/A

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

N/A

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

N/A

70% UT (30% dip in UT) for 25 & 30 cycles at 0°

N/A

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

N/A

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

N/A

30 A/m at 50 and 60 Hz

30 A/m at 50 and 60 Hz

IEC 61000-4-11

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

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 20%.

N/A

N/A

N/A

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

NOTE: UT is the alternating current mains voltage prior to application of the test level.

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7308-001-700 Rev-AA

Guidance and manufacturer’s declaration - electromagnetic immunity NOTE: The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) should assure that it is used in such an environment. IEC 60601 test level

Immunity test

3 Vrms 150 kHz to 80 MHz outside ISM bands 80% AM at 1 kHz

Conducted RF IEC 61000-4-6

Compliance level

Electromagnetic environment - guidance IEC 60601-1-2 3rd Edition: Portable and mobile RF equipment should be used no closer to any part of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

N/A

6 Vrms 150 kHz to 80 MHz in ISM bands 80% AM at 1 kHz

Recommended separation distance d=1.2√P d=1.2√P 80 MHz to 800 MHz d=2.3√P 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). IEC 60601-1-2 4th Edition:

3 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz

WARNING: Portable RF equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the STRYKER SYSTEM G Sagittal Saw (REF 7308001-000) specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 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 Sagittal Saw (REF 7308-001-000) is used exceeds the applicable RF compliance level above, the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) 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 Sagittal Saw (REF 7308-001-000).

a

b

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

IEC 60601-1-2 3rd Edition: Recommended separation distances between portable and mobile RF equipment and the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) 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 Sagittal Saw (REF 7308-001-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF equipment (transmitters) and the STRYKER SYSTEM G Sagittal Saw (REF 7308-001000) as recommended below, according to the maximum output power of the equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz d=2.3√P

d=1.2√P

d=1.2√P

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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产品安全认证 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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 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

电磁兼容性 指引及制造商声明 - 电磁辐射 STRYKER SYSTEM G 矢状锯（REF 7308-001-000）应在下列指定的电磁环境中使用。STRYKER SYSTEM G 矢状锯（REF 7308-001-000） 的客户或用户应确保其用于此环境下。 辐射测试

合规性

电磁环境 - 使用指南

射频辐射

第1组

STRYKER SYSTEM G 矢状锯（REF 7308-001-000）的射频能量仅用于其内部功能。因此，其射频辐射 很低，不大可能对附近的电子设备造成任何干扰。

A类

STRYKER SYSTEM G 矢状锯 (REF 7308-001-000) 适用于除民用以外的所有建筑物，且可用于民用建筑 以及那些直接连接于为民用建筑供电的公共低压供电网的建筑，但应注意以下警告：

不适用

警告：本设备/系统适用于专业医疗机构环境。本设备/系统可能导致射线干扰或干扰 附近设备的运行。可能有必要采取减轻措施，例如调整 STRYKER SYSTEM G 矢状锯 (REF 7308-001-000) 的方向和位置，或者屏蔽安置场所。

CISPR 11 射频辐射 CISPR 11 谐波发射 IEC 61000-3-2 电压波动/闪变 辐射

不适用

IEC 61000-3-3

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Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210

2021-07

7308-001-700 Rev-AA

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