Stryker

System 8 Sternum Saw Instructions for Use Rev AA Sept 2019

Instructions for Use

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File Name: Stryker - 8207-001-700 - System 8 Sternum Saw Instructions for Use Rev AA Sept 2019 - 2019-09.pdf

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Page 1

System 8 Sternum Saw REF

8207-000-000

Instructions For Use

ENGLISH (EN) 2019-09

8207-001-700 Rev-AA

www.stryker.com

8207-001-700 Rev-AA

Contents

Definitions... 8

Introduction... 3

Instructions... 8

Audience... 3

To Install the Blade... 8

Conventions... 3

To Install the Blade Guard... 9

Contact Information... 3

To Install the Battery Pack... 11

Indications For Use... 3

To Operate the Handpiece... 11

Contraindications... 3

To Remove the Battery Pack... 12

Safety Directives... 4

To Remove the Blade Guard... 13

For Use With... 4

To Remove the Blade... 13

Accessories... 5

Care Instructions... 13

Short Blade Guard and Blades... 6

Troubleshooting... 14

Long Blade Guard and Blade... 6

Specifications... 18

Battery Packs... 6

Product Safety Certification... 19

Insert Trays... 6

Product Safety Compliance... 20

Features... 7

Electromagnetic Compatibility... 21

Handpiece... 7 Function Switch... 7

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8207-001-700 Rev-AA

Introduction This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product. Keep and consult this reference manual during the life of the product. NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

Audience This manual is intended for in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians.

Conventions The following conventions are used in this manual: ▪▪ A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury.

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

Contact Information For additional information, including safety information, in-service 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.

Indications For Use The Stryker System 8 Sternum Battery Powered Heavy Duty System is intended for use in the cutting of bone and other bone related tissue, including the sternum.

Contraindications None known.

8207-001-700 Rev-AA

Safety Directives WARNINGS: ▪▪ Before using this equipment, or any component compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. ▪▪ The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. ▪▪ Only healthcare professionals trained and experienced in the use of this medical device should operate this equipment. ▪▪ Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. See the care instructions manual supplied with the handpiece.

▪▪ Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece. ▪▪ 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 medical electrical equipment. Place this 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. ▪▪ ALWAYS lock the handpiece trigger before installing or removing attachments or accessories.

For Use With A sternum blade guard must be used with the handpiece to create a safe and effective system. The following sternum blade guards are sold separately: DESCRIPTION

REF

Sternum Blade Guards

7207-003-000 7207-002-000 www.stryker.com

8207-001-700 Rev-AA

Accessories WARNINGS: ▪▪ Use only Stryker-approved electronic components and accessories. Failure to comply may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. ▪▪ DO NOT modify any equipment without the authorization of the manufacturer. ▪▪ Using non-Stryker blades may result in fragmentation or ejection of the blade during use. ▪▪ Upon initial receipt and before use, visually inspect the package for damage to confirm the integrity of the sterile barrier. Do not use the product if damage is apparent, the sterile barrier is compromised, or the package is unintentionally opened.

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▪▪ DO NOT reuse, reprocess, or repackage a device that is intended for single use only. -- A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. -- Design features may make cleaning difficult. -- Reuse may create a contamination risk and compromise structural integrity resulting in operational failure. -- Critical product information may be lost during repackaging. Failure to comply may lead to infection or cross infection and result in patient and/or healthcare staff injury. NOTES: ▪▪ Sterile cutting accessories are sterilized by irradiation. ▪▪ For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

8207-001-700 Rev-AA

The following Stryker-approved accessories are sold separately:

Short Blade Guard and Blades DESCRIPTION Sternum Blade Guard Sternum Blades

REF 7207-003-000 0296-097-102 0298-097-100 0298-097-101 0298-097-104 6207-097-101

Long Blade Guard and Blade DESCRIPTION Long Sternum Blade Guard

REF 7207-002-000

Sternum Blade

0298-097-101S5

Battery Packs DESCRIPTION

REF

System 8 Battery Packs

8212-000-000 8215-000-000

SmartLife® Battery Packs

7212-000-000 7215-000-000

SmartLife Non-sterile Batteries

7126-110-000 7222-110-000

SmartLife Aseptic Housings

7126-120-000 7222-120-000

SmartLife Transfer Shields

7126-130-000 7222-130-000

System 6 Battery Packs

6212-000-000 6215-000-000

System 6 Aseptic Battery Kits

6126-000-000 6127-000-000

Insert Trays

DESCRIPTION

REF

Insert Trays

7102-450-010 7102-452-010 7102-453-010 7102-454-010 7102-458-010

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8207-001-700 Rev-AA

Features

NOTE: The Stryker System 8 Sternum Saw (handpiece) is a component of the Stryker System 8 Battery Powered Heavy Duty System.

Function Switch – Sets the speed or locks the trigger. See the Function Switch section.

Guard Collar – Retains the blade guard in the handpiece.

Handpiece

The System 8 Sternum Saw is battery powered and has a trigger and a function switch.

Blade Collar – Retains the blade in the handpiece.

Guard Collar Lever – Facilitates rotation of the guard collar.

Trigger – Controls the variable speed operation of the handpiece.

Function Switch A

Fast Mode – The handpiece will operate at high speed when the trigger is depressed.

C D E

Standard Mode – The handpiece will operate at standard speed when the trigger is depressed. Safe Mode – The trigger is locked to prevent inadvertent operation of the handpiece.

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8207-001-700 Rev-AA

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

DEFINITION General warning sign Fast Mode

1 min / 4 min x5

Instructions To Install the Blade WARNINGS: ▪▪ ALWAYS install the blade in a vertical orientation. ▪▪ ALWAYS make sure the blade collar springs back to its original position and the blade is securely locked in the blade collar after installation.

Standard Mode

1. Lock the handpiece trigger.

Duty Cycle – See the Specifications section.

2. Rotate the spring-loaded blade collar to align the slots in the distal end of the collar, and then fully insert the blade into the blade collar in a vertical orientation.

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8207-001-700 Rev-AA

CORRECT

INCORRECT

To Install the Blade Guard WARNINGS: ▪▪ ALWAYS make sure the blade is properly installed before installing the blade guard.

3. Release the blade collar. Make sure the blade collar springs back to its original position and the blade is securely locked in the blade collar.

▪▪ Use only Stryker blades. ALWAYS select and install the appropriate blade guard for the specific blade used. See the instructions for use supplied with the blade guard. ▪▪ DO NOT attempt to straighten and reuse a bent blade guard. ▪▪ ALWAYS install the blade guard in a vertical orientation to match the blade. The teeth of the blade must point away from the guard.

CORRECT

INCORRECT

▪▪ ALWAYS make sure the guard collar returns to its original position and the blade guard is securely locked in the guard collar after installation. ▪▪ ALWAYS make sure the blade does not touch or retract from the end of the blade guard after installation.

4. Gently tug the blade to make sure the blade is securely locked in the blade collar.

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1. Push the guard collar lever to rotate the guard collar, and then fully insert the blade guard into the guard collar.

8207-001-700 Rev-AA

3. Make sure the blade does not touch or retract from the end of the blade guard. CORRECT

INCORRECT

4. Gently tug the blade guard to make sure the blade guard is securely locked in the guard collar. 2. Release the guard collar lever. Make sure the guard collar returns to its original position and the blade guard is securely locked in the guard collar.

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8207-001-700 Rev-AA

To Install the Battery Pack NOTE: See the instructions for use supplied with the battery pack and/or battery charger for charging instructions and specifications. 1. Lock the handpiece trigger. 2. Slide a fully charged battery pack into the handpiece until the battery pack snaps into place.

To Operate the Handpiece WARNINGS: ▪▪ ALWAYS lock the handpiece trigger when the handpiece is idle or when passing the handpiece to another person. ▪▪ Before operating the handpiece, ALWAYS gently tug the attachment and accessory to make sure the attachment is securely locked in the handpiece and the accessory is securely locked in the attachment. ▪▪ DO NOT change the position of the function switch while the handpiece is operating. ▪▪ DO NOT operate the handpiece until after the blade is in contact with bone or tissue. Failure to comply may fracture the blade or eject the blade from the handpiece.

3. Gently tug the battery pack to make sure the battery pack is securely locked in the handpiece. 4. Test the operation of the handpiece by unlocking and then depressing the trigger.

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▪▪ When operating the handpiece, DO NOT grasp the handpiece near the guard collar lever or cause the guard collar lever to move. Failure to comply may cause the blade guard to disengage from the handpiece. ▪▪ ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section.

▪▪ ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section. ▪▪ DO NOT apply excessive pressure, such as bending or prying, with the accessory. Excessive pressure may bend or fracture the accessory and result in tissue damage, loss of tactile control, and/or the ejection of accessory fragments at a high velocity.

8207-001-700 Rev-AA

NOTE: See the Features section for mode descriptions. 1. Slide the function switch to the fast or standard position. 2. Depress the pressure-sensitive trigger to operate the handpiece.

To Remove the Battery Pack

CAUTIONS:

1. Lock the handpiece trigger.

▪▪ When operating the handpiece, let the accessory do the cutting. DO NOT apply excessive pressure with the accessory. Excessive pressure may bend the blade and reduce the cutting quality.

2. Depress the battery latch and slide the battery pack out of the handpiece.

▪▪ DO NOT stall the handpiece. Failure to comply may damage the electric motor and/or battery pack. If the handpiece jams, release the trigger immediately. Remove any obstructions before continuing to operate the handpiece. ▪▪ If any power loss is experienced while using the handpiece, ALWAYS replace the battery pack with a fully charged battery pack. Failure to comply may result in a drained or damaged battery pack with a shortened life.

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8207-001-700 Rev-AA

To Remove the Blade Guard 1. Lock the handpiece trigger. 2. Push the guard collar lever to rotate the guard collar, and then remove the blade guard from the handpiece.

To Remove the Blade 1. Lock the handpiece trigger. 2. Rotate the blade collar to align the slots in the distal end of the collar, and then remove the blade from the handpiece.

Care Instructions For processing instructions and disposal/recycle information, see the care instructions manual supplied with the equipment.

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8207-001-700 Rev-AA

Troubleshooting WARNING: DO NOT disassemble or service this equipment without the authorization of the manufacturer. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

CAUSE

The handpiece does not operate The battery pack is discharged. or operates at a reduced speed.

ACTION Use a Stryker battery charger to recharge the battery pack.

The battery pack is expended.

Replace the battery pack.

The handpiece trigger is locked.

Unlock the handpiece trigger. See the Features section.

The function switch is in the standard position.

Set the function switch to the fast position.

The handpiece is damaged.

Return the equipment to Stryker for repair.

The handpiece operates but the cutting accessory does not move.

The handpiece is damaged.

Return the equipment to Stryker for repair.

The handpiece continues to operate after the trigger is released.

The handpiece is damaged.

Depress the battery latch and slide the battery pack out of the handpiece. Return the equipment to Stryker for repair.

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8207-001-700 Rev-AA

PROBLEM

CAUSE

ACTION

The equipment becomes unusually hot during use.

The duty cycle has been exceeded.

ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section.

The handpiece is damaged.

Return the equipment to Stryker for repair.

The battery pack is damaged.

Use a Stryker battery charger to check the integrity of the battery pack. See the instructions for use supplied with the battery charger for more information. Replace the battery pack if required.

The distal end of the handpiece contains debris.

See the care instructions manual supplied with the handpiece.

The cutting accessory is not a Stryker product.

Use a Stryker cutting accessory.

The cutting accessory is damaged.

Replace the cutting accessory.

The handpiece is damaged.

Return the equipment to Stryker for repair.

The cutting accessory will not fit or cannot be secured in the handpiece.

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8207-001-700 Rev-AA

PROBLEM

CAUSE

The blade collar does not spring back to its original position to securely lock the blade in the blade collar.

The blade collar contains debris. See the care instructions manual supplied with the handpiece. Actuate the collar several times to obtain smooth operation.

The blade guard will not fit or cannot be secured in the guard collar.

The wrong blade guard has been selected for the specific blade used.

Select the appropriate blade guard for the specific blade used. See the instructions for use supplied with the blade guard.

The guard collar contains debris.

See the care instructions manual supplied with the handpiece.

The blade guard is damaged.

Replace the blade guard.

The cutting accessory is not properly installed in the handpiece.

Remove and properly install the cutting accessory. Make sure the cutting accessory is securely locked in the handpiece.

The cutting accessory is not a Stryker product.

Use a Stryker cutting accessory.

The cutting accessory is damaged.

Replace the cutting accessory.

The handpiece is damaged.

Return the equipment to Stryker for repair.

The handpiece is noisy and/or vibrates.

ACTION

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8207-001-700 Rev-AA

PROBLEM

CAUSE

ACTION

The handpiece experiences sporadic electrical interference.

Electrical noise is present.

Turn off all electrical equipment not in use in the operating room. Relocate electrical equipment and/or increase spatial distance between electrical equipment. Plug operating room equipment into different operating room outlets.

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8207-001-700 Rev-AA

Specifications WARNING: ALWAYS consult any documentation that accompanies attachments and/or accessories for product-specific duty cycles and instructions for use. CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. Model:

System 8 Sternum Saw (REF 8207-000-000)

Dimensions:

150 mm [5.9 inch] height, 36 mm [1.4 inch] width, 184 mm [7.2 inch] length

Mass:

1.0 kg [2.2 lb]

Speed:

14000 cpm (fast mode), 11000 cpm (standard mode)

Excursion:

3.9 mm [0.154 inch]

Mode of Operation:

Non-continuous

Duty Cycle:

1 minute on/4 minutes off, 5 times

Rest Between Cycles:

3 hours

Applied Part(s):

The distal end of the handpiece and the sternum blade guard as defined by the manufacturer

Maximum Temperature Less than 51 °C [124 °F] as tested to the Product Safety Certification of Applied Part(s): standards Power Supply:

Internally powered. Refer to battery housing for voltage rating.

Ingress Protection:

IPX9 during cleaning and sterilization

Equipment Type:

Type BF Applied Part

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8207-001-700 Rev-AA

Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation: 75 %

Humidity Limitation: 10 %

Atmospheric Pressure Limitation:

Product Safety Certification Canadian Standards Association (CSA) International Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:14, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009/(R) 2012); Amendment 2 (2010/(R) 2012); Amendment 1 (2012)

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8207-001-700 Rev-AA

Product Safety Compliance International Electrotechnical Commission (IEC) IEC 60601-1:2005, Ed: 3.1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Corrigendum 1 (2006); Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-2:2014 Ed: 4, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Electromagnetic Disturbances IEC 60601-1-2:2007 Ed: 3, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Electromagnetic Compatibility IEC 60601-1-6:2010+ A1:2013 Ed. 3.1, Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Usability IEC 62366-1:2007+ A1:2014 Ed 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); CENELEC Corrigendum (2010); CENELEC Amendment A11 (2011); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014)

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