Stryker System 8, 8205-000-000 Manual

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.
• 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 Dual Trigger Rotary Battery Powered Heavy Duty System is intended for use in the drilling, reaming, and decorticating of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement of screws, wires, pins, and other fixation devices.

Contraindications
None known.

Safety Directives

• 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.
• Only healthcare professionals trained and experienced in the use of this medical device should operate 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, as a manufacturer, does not recommend surgical procedure or technique.
• 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 triggers before installing or removing attachments or accessories.

Accessories

• 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.

NOTES:

• A variety of attachments are available for use with this handpiece. Each attachment has a specialized retainer for wires, pins, tools and/ or cutting accessories. See the instructions for use supplied with the attachment.
• For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

The following Stryker-approved accessories are sold separately:

Attachments

Drill Bits

• 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.

Battery Packs

Features

NOTE: The Stryker System 8 Dual Trigger Rotary Handpiece (handpiece) is a component of the Stryker System 8 Battery Powered Heavy Duty System.

Handpiece
The System 8 Dual Trigger Rotary Handpiece is battery powered and has two triggers and a function switch.

1. Function Switch – Locks one or both of the triggers. See the Function Switch section.
2. Shift Collar – Sets the speed and torque. See the Shift Collar section.
3. Attachment Collar – Retains the attachment in the handpiece.
4. Reverse Trigger – Controls the variable speed operation of the handpiece in a counterclockwise direction.
5. Forward Trigger – Controls the variable speed operation of the handpiece in a clockwise direction.

NOTE: Press both triggers simultaneously to operate the handpiece in oscillate mode.

Function Switch

	Forward Mode – Only the forward trigger is functional. The reverse trigger is locked to prevent inadvertent operation of the handpiece in a counterclockwise direction.
	Forward/Reverse/Oscillate Mode – Both triggers are functional.
	Safe Mode – Both triggers are locked to prevent inadvertent operation of the handpiece.

Shift Collar

	Drill Mode – Fast speed, low torque operation
	Ream Mode – Slow speed, high torque operation

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
	Drill Mode
	Ream Mode
F/R 1 min / 4 min x 3 OSC 15s/15s x 5	Duty Cycle – See the Specifications section.

Instructions

To Install the Attachment and Accessory

1. Lock the handpiece triggers.
2. Insert the attachment into the handpiece until the attachment snaps into place.
   
   NOTE: If the attachment has notches, align one of the notches with a tab under the attachment collar before insertion.
   
3. Gently tug the attachment to make sure the attachment is securely locked in the handpiece.
4. Install a wire, pin, tool, or cutting accessory as required. See the instructions for use supplied with the attachment.

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 triggers.
2. Slide a fully charged battery pack into the handpiece until the battery pack snaps into place.
   
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.

To Operate the Handpiece

• ALWAYS lock the handpiece triggers 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 grasp or touch any rotating component while the handpiece is operating.
• DO NOT change the position of the function switch while the handpiece is operating.
• DO NOT change the position of the shift collar while the handpiece is operating.
• DO NOT operate the handpiece in the drill mode position when a reamer attachment and/or accessory is installed in the handpiece.
• ALWAYS operate the equipment within the specified environmental condition values. See theSpecifications section.
• ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See theSpecifications section and/or the instructions for use supplied with the attachment.
• 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.
• A wobbling attachment and/or accessory may cause bone or tissue damage or inaccurate wire or pin placement. If wobbling occurs, take corrective action as indicated in theTroubleshooting section.

• 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.
  NOTE: See the Features section for mode descriptions.
  1. Rotate the shift collar to the drill mode or ream mode position.
  2. Slide the function switch to the forward or forward/reverse/oscillate position.
  3. Depress one of the pressure-sensitive triggers to operate the handpiece.

To Remove the Battery Pack

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

To Remove the Attachment and Accessory

1. Lock the handpiece triggers.
2. Remove the accessory from the attachment.
3. Pull the attachment collar back and remove the attachment from the handpiece.
   

Care Instructions

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

Troubleshooting

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	ACTION
The handpiece does not operate or operates at a reduced speed.	The battery pack is discharged.	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 handpiece is damaged.	Return the equipment to Stryker for repair.
The handpiece operates but the cutting accessory does not move.	The attachment is not fully installed in the handpiece.	Remove and install the attachment. Make sure the attachment is securely locked in the handpiece.
	The shift collar is positioned between the drill and ream mode positions.	Fully rotate the shift collar to either the drill mode or ream mode position.
	Excessive pressure is being applied to the cutting accessory.	Release the pressure and allow the cutting accessory to do the cutting.
	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.
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 and/or the instructions for use supplied with the attachment.
	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 attachment will not fit or cannot be secured in the handpiece.	The attachment and/or the distal end of the handpiece contains debris.	See the care instructions manual supplied with the handpiece.
	The attachment is damaged.	Return the equipment to Stryker for repair.
	The handpiece is damaged.	Return the equipment to Stryker for repair.
The pin accessory cannot be removed from the collet attachment.	The collet mechanism is jammed.	Gently tap the side of the pin to dislodge it from the collet. DO NOT attempt to force the pin back through the collet.
	The collet is damaged.	Return the equipment to Stryker for repair.
The attachment and/or accessory wobbles in the handpiece.	The accessory is damaged.	Inspect the accessory for damage and replace the accessory as required.
	The accessory is the wrong size for the attachment.	Install a different accessory or attachment as required.
	The accessory extends too far from the distal end of the attachment, or is not properly centered in the attachment.	Remove and properly install the accessory. If wobble persists, return the handpiece and attachment to Stryker for repair.
	A reamer attachment and/or accessory is installed in the handpiece and the shift collar is in the drill mode position.	Rotate the shift collar to the ream mode position.
The handpiece is noisy and/or vibrates	The handpiece is damaged.	Return the equipment to Stryker for repair.
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.

Specifications

ALWAYS consult any documentation that accompanies attachments and/or accessories for product-specific duty cycles and instructions for use.

ALWAYS store the equipment within the specified environmental condition values throughout its useful life.

Model:	System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000)
Dimensions:	150 mm [5.9 inch] height, 39 mm [1.5 inch] width, 154 mm [6.1 inch] length
Mass:	1.04 kg [2.3 lb]
Speed:	1200 rpm (drill mode), 270 rpm (ream mode)
	Forward and Reverse Modes	Oscillate Mode
Mode of Operation:	Non-continuous	Non-continuous
Duty Cycle:	1 minute on/4 minutes off, 3 times	15 seconds on/15 seconds off, 5 times
Rest Between Cycles:	3 hours	1.5 hours
Applied Part(s):	The distal end of the handpiece and the attachment as defined by the manufacturer
Maximum Temperature of Applied Part(s):	Less than 51°C [124°F] as tested to the Product Safety Certification 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
Environmental Conditions:	Operation	Storage and Transportation
Temperature Limitation:
Humidity Limitation:
Atmospheric Pressure Limitation: