Stryker System 7 - User Manual

2018-11 7205-001-700 Rev-AA www.stryker.com
Instructions For Use
ENGLISH (EN)
System 7
Dual Trigger Rotary Handpiece
REF
7205-000-000

Summary

Introduction and Safety Information

User;Patient Safety

Crucial safety information for using the handpiece and system components.

Indications for Use

Specifies the intended uses of the Stryker System 7 Battery Powered Heavy Duty System.

Contraindications

Lists any known conditions where the system should not be used.

Accessories

Handpiece Features

Component Identification

Identifies main parts: Function Switch, Shift Collar, Attachment Collar.

Attachment Details

Information on available attachments and their specialized retainers.

Handpiece Controls and Modes

Part Descriptions

Explains Applied Part, Reverse Trigger, and Forward Trigger functionalities.

Shift Collar Modes

Details the Drill Mode and Ream Mode operations of the shift collar.

Function Switch Modes

Describes Forward, Forward/Reverse/Oscillate, and Safe Mode operations.

Operating Instructions

Installing Attachments

Steps for inserting and securing attachments into the handpiece.

Installing Battery Pack

Procedure for correctly installing the battery pack into the handpiece.

Operating the Handpiece

Guidance on how to operate the handpiece, including trigger and switch usage.

Removal Procedures

Instructions for safely removing accessories and the battery pack from the handpiece.

Troubleshooting

Handpiece Operation Issues

Addresses problems like no operation, reduced speed, or trigger malfunctions.

Accessory and Noise Issues

Solves problems with attachment fit, wobbling, noise, vibration, and electrical interference.

Specifications Overview

Technical Specifications

Details model, dimensions, mass, speed, duty cycle, power, and ingress protection.

Product Safety Compliance

Lists product safety certifications and compliance standards like CSA, ANSI, IEC, CENELEC.

Environmental Conditions

Specifies operating and storage/transportation temperature, humidity, and pressure limits.

Electromagnetic Emissions

Declaration on RF emissions, harmonic emissions, and voltage fluctuations.

Electromagnetic Immunity

Guidance on immunity to ESD, fast transients, surge, voltage dips, and magnetic fields.

RF Equipment Separation

Recommended separation distances for RF equipment to prevent interference.

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Stryker System 7 Dual Trigger Rotary Handpiece is a component of the Stryker System 7 Battery Powered Heavy Duty System, designed for use in various surgical procedures involving bone and bone-related tissue. Its primary functions include cutting, drilling, decorticating, and smoothing bone, as well as facilitating the placement of screws, wires, pins, and other fixation devices.

Function Description

The handpiece operates with a dual-trigger mechanism, allowing for variable speed control in both clockwise (forward) and counterclockwise (reverse) directions. Pressing both triggers simultaneously activates an oscillate mode. A function switch provides three operational modes:

• Forward Mode: Only the forward trigger is functional, with the reverse trigger locked to prevent inadvertent counterclockwise operation.
• Forward/Reverse/Oscillate Mode: Both triggers are functional, enabling forward, reverse, and oscillate operations.
• Safe Mode: Both triggers are locked, preventing any inadvertent operation of the handpiece.

A shift collar on the handpiece allows users to select between two speed and torque settings:

• Drill Mode: Provides fast speed and low torque operation.
• Ream Mode: Offers slow speed and high torque operation.

The handpiece is designed to be used with a variety of attachments, each featuring specialized retainers for different accessories such as wires, pins, tools, and cutting accessories. The distal end of the handpiece and the attachment form the applied part as defined by product safety certification standards.

Usage Features

Before each use, the handpiece and its components must be cleaned and sterilized according to the Heavy Duty Care Instructions manual. Users should always inspect the equipment for damage upon initial receipt and before each use, and refrain from using any damaged components.

To install an attachment, the function switch must first be slid to the safe mode position. The attachment is then inserted into the handpiece until it snaps into place. If the attachment has notches, one must be aligned with a tab under the attachment collar. After installation, a gentle tug on the attachment confirms it is securely locked. Wires, pins, tools, or cutting accessories can then be installed as required.

For battery installation, the function switch must also be in the safe mode position. A fully charged battery pack is slid into the handpiece until it snaps into place, and a gentle tug verifies secure locking. The handpiece's operation should be tested by sliding the function switch to the forward or forward/reverse/oscillate mode and depressing the trigger.

When operating the handpiece, the shift collar should be rotated to either the drill or ream mode position. The function switch is then slid to the desired operational mode (forward or forward/reverse/oscillate), and the pressure-sensitive trigger is depressed for variable speed control.

Safety precautions during use include:

• Always sliding the function switch to the safe mode when the handpiece is idle or being passed to another person.
• Never changing the position of the function switch while the handpiece is operating.
• Avoiding operation in drill mode when a reamer attachment or accessory is installed.
• Always gently tugging the attachment and accessory to ensure they are securely locked before operation.
• Not changing the shift collar position while the handpiece is operating.
• Avoiding grasping or touching any rotating component during operation.
• Operating the equipment within specified environmental conditions and following recommended duty cycles to prevent overheating.
• Avoiding excessive pressure on accessories, which could cause damage, tissue injury, or accessory ejection.
• Addressing any wobbling attachments or accessories immediately to prevent damage or inaccurate placement.
• Avoiding stalling the handpiece, as this can damage the motor or battery pack. If the handpiece jams, the trigger should be released immediately and any obstructions removed.
• Replacing the battery pack with a fully charged one if any power loss is experienced during use to prevent damage and shortened battery life.

To remove an accessory, it should first be taken out of the attachment. Then, the attachment collar is pulled back, and the attachment is removed from the handpiece. For battery removal, the battery latch is depressed, and the battery pack is slid out of the handpiece, ensuring the function switch is in the safe mode.

Maintenance Features

The handpiece is designed for professional healthcare facility environments. For processing instructions, including cleaning and sterilization, and disposal/recycle information, users should refer to the care instructions manual supplied with the equipment.

Troubleshooting guidance is provided for common issues:

• Handpiece not operating or operating at reduced speed: This could be due to a discharged or expended battery pack, the function switch being in safe mode, or a malfunctioning drivetrain. Solutions include recharging/replacing the battery, changing the function switch position, or returning the handpiece for repair.
• Handpiece operates but accessory does not move: Possible causes include an improperly installed attachment, the shift collar being positioned between modes, or excessive pressure on the cutting accessory. Solutions involve reinstalling the attachment, rotating the shift collar to a defined mode, or releasing pressure.
• Handpiece continues to operate after trigger release: This indicates a malfunctioning trigger, requiring the handpiece to be returned for repair.
• Battery pack becomes unusually hot: This suggests malfunctioning circuitry, requiring the battery pack to be checked with a Stryker battery charger and replaced if necessary.
• Attachment not fitting or securing: Debris in the attachment or handpiece, or a damaged attachment or handpiece, can cause this. Cleaning, or returning damaged components for repair, is recommended.
• Attachment/accessory wobbles: This could be due to a damaged accessory, an incorrect size accessory, or improper installation. Solutions include inspecting/replacing the accessory, installing a different accessory, or re-installing the accessory. If wobbling persists, both the handpiece and attachment should be returned for repair.
• Handpiece is noisy/vibrates: A malfunctioning drivetrain is the likely cause, requiring the handpiece to be returned for repair.
• Sporadic electrical interference: This may be due to electrical noise in the operating room. Solutions include turning off unused electrical equipment, relocating equipment, increasing spatial distance, or plugging equipment into different outlets.

The device is not intended for disassembly or servicing by the user; for service, the Stryker sales representative or customer service should be contacted. Only Stryker-approved system components and accessories should be used, and no modifications should be made to any system component or accessory. The product is not suitable for use in MRI environments or areas with flammable anesthetics or agents. Special precautions regarding electromagnetic compatibility (EMC) must be observed, and the equipment should not be stacked or placed adjacent to other products if it degrades performance. The device is intended for multiple uses and should not be reused, reprocessed, or repackaged if intended for single use.

Stryker System 7 Specifications