Stryker System 6 6208 Bedienungsanleitung

2007/09 6208-001-701 Rev-B www.stryker.com

Instructions For Use

System 6

Sagittal Saw

REF 6208

US Patents: 5,263,972; 5,747,953; 6,013,991

2 www.stryker.com

2007/09 6208-001-701 Rev-B

Intended Use

The Stryker System 6 Battery Powered Heavy Duty Sag-

ittal Saw is an oscillating cutting device used for cutting

bone and bone related tissue.

DESCRIPTION REF

Large Battery Pack ................................................... 6215

Accessory Information*

*Contact your Stryker sales representative for a com-

plete list of additional accessories.

WARNINGS:

• Use only Stryker-approved components and acces-

sories, unless otherwise specified. Other accessories

may result in increased electromagnetic emissions or

decreased electromagnetic immunity of the system.

DO NOT modify any component or accessory. Failure

to comply may result in patient and/or health care

staff injury.

• ALWAYS use Stryker sagittal saw blades with this

handpiece. Failure to comply may result in patient

and/or health care staff injury.

Important Information

The words WARNING, CAUTION and NOTE have special

meaning and should be reviewed.

WARNING: Disregarding WARNING information

may compromise the safety of the

patient and/or health care staff and

may result in injury.

CAUTION: Disregarding CAUTION information

may compromise product reliability

and may result in damage.

NOTE: NOTE information supplements and/

or clarifies procedural information.

A triangle with an exclamation point

alerts the health care professional to

read and understand the accom-

panying instructions, especially the

operating, maintenance, and safety

information.

6208-001-701 Rev-B 2007/09

www.stryker.com 3

User/Patient Safety*

WARNINGS:

• Only trained and experienced health care profes-

sionals should use this equipment. Before using any

system component or any component compatible

with this system, read and understand the instruc-

tions. Pay special attention to WARNING information.

Become familiar with the system components prior

to use. Failure to comply may result in patient and/or

health care staff injury.

• Upon initial receipt and before each use, operate the

equipment and inspect each component for damage.

DO NOT use any component if damage is apparent.

Failure to comply may result in patient and/or health

care staff injury.

• Perform recommended periodic maintenance as

indicated in the instructions for use. Only trained

and experienced health care professionals should

maintain this equipment.

• Clean and sterilize handpieces and batteries before

first and every use.

• DO NOT use this equipment in the presence of a

mixture consisting of flammable anesthetic and air or

with oxygen or nitrous oxide.

• Take special precautions regarding electromagnetic

compatibility (EMC) when using medical electri-

cal equipment like the handpiece. Install and place

the handpiece into service according to the EMC

information in this manual. Portable and mobile RF

communications equipment can affect the function of

the handpiece.

• ALWAYS place the handpiece in the safe mode while

the handpiece is idle, before installing or removing

any accessory, or when passing the handpiece to an-

other person. Failure to comply may result in patient

and/or health care staff injury.

• DO NOT apply excessive pressure, such as bending

or prying, with a cutting accessory to prevent fractur-

ing the accessory. Failure to comply may result in

patient and/or health care staff injury.

• DO NOT reuse single use cutting accessories. Failure

to comply may result in patient and/or health care

staff injury.

*If you need more information, contact your Stryker sales representative or call Stryker customer service at 1-800-253-3210. Outside

the US, contact your nearest Stryker subsidiary.

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2007/09 6208-001-701 Rev-B

Features

• Battery Latch - To release the battery pack from the handpiece, depress the battery latch.

• Battery Pack - Rechargeable battery pack that provides power to the handpiece.

• Index Button - To allow the indexing of the sagittal head, push the index button.

• Blade Mount Lever- Rotate the lever to the LOAD or RUN position to install or lock the blade into place.

• Blade Retainer - The retainer holds the blade.

• Sagittal Head - The sagittal head may be indexed in 45° increments and can turn in a complete 360° rotation to

achieve the desired cutting angle.

• Trigger Switch - The trigger is pressure sensitive for variable speed operation.

• FAST/STD/Safe Control - Based on its position, allows the handpiece to operate in the FAST or STD mode; the

safe mode prevents operation of the handpiece.

• Accessory Interface - Connector provides power and communication for future accessories.

Symbol Definitions

Slide the FAST/STD/Safe control to the

FAST position to allow the handpiece to

operate at high torque and high speed

when the trigger is depressed.

Slide the FAST/STD/Safe control to the

STD (standard) position to allow the

handpiece to operate at high torque and

standard speed when the trigger switch

is depressed.

Slide the FAST/STD/Safe control to

the safe position to lock the trigger and

prevent inadvertent operation of the hand-

piece; the handpiece cannot be operated.

The LOAD position allows the insertion of

the blade into the handpiece.

The RUN position locks the blade in the

handpiece.

Battery Pack

Sagittal Head

Blade Retainer

Index Button

Trigger Switch

Battery Latch Blade Mount Lever

FAST/STD/Safe Control

Accessory Interface

6208-001-701 Rev-B 2007/09

www.stryker.com 5

To Install Cutting Accessory

Figure 1 To Install Blade Rotate the Lever

Instructions

Figure 2 To Index Head Push the Button

To Index Sagittal Head

NOTE: The sagittal head has eight possible cutting

angle positions (45° increments).

Push and hold the index button; rotate the sagittal

head to the desired cutting angle (see figure 2).

Slide the FAST/STD/Safe control to the safe position.

Rotate the blade mount lever to the LOAD position.

Hold the handpiece in a vertical orientation with the

sagittal head and blade entry slot facing up. (see

figure 1).

Insert the blade into the slot. Ensure the full insert

line of the blade disappears in the blade retainer

indicating the blade is positioned properly.

Once the sagittal head is positioned, release the

index button, and gently turn the sagittal head to

ensure it is locked into position.

WARNING: To prevent the inadvertent

running of the handpiece, ALWAYS place

the FAST/STD/safe control in the safe

position before installing or removing any

accessory.

Rotate the blade mount lever to the RUN position

while maintaining the vertical orientation of the hand-

piece to lock the blade.

Gently tug the blade to ensure it is secure.

CAUTION: Before operating the handpiece, ensure

the sagittal head is locked into position. Failure to

comply may result in product damage.

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2007/09 6208-001-701 Rev-B

Instructions (cont’d)

To Install Battery Pack To Operate Handpiece

Slide a fully charged battery pack firmly into the

handpiece until the battery latch snaps, indicating the

battery pack is secure (see figure 3).

Figure 3 Install Battery Pack

Test the operation of the handpiece by sliding the

FAST/STD/Safe control to the FAST or STD positions

and squeezing the trigger.

Slide FAST/STD/Safe control to the safe position

until you are ready to use the handpiece.

NOTES:

• This handpiece is designed to accept the Stryker

Large Battery Pack REF 6215 only. This battery

pack can be charged in the Stryker System 6 Battery

Charger REF 6110-120 configured with the appropri-

ate battery charger module.

• See the instructions supplied with the battery charger

and/or battery pack for charging details and specifi-

cations.

WARNING: ALWAYS place the FAST/

STD/Safe control in the safe position while

the handpiece is idle, before installing or

removing an accessory, or when passing

the handpiece to another person. Failure to

comply may result in patient and/or health

care staff injury.

CAUTIONS:

• When operating the handpiece, let the blade do the

cutting. Applying too much pressure will bend the

blade and reduce the cutting quality.

• 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 the pro-

cedure.

• If any power loss is experienced while using a hand-

piece, 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.

Slide the FAST/STD/Safe control to the FAST or STD

position to allow the handpiece to operate.

Squeeze the pressure sensitive trigger for variable

speed operation.

Slide the FAST/STD/Safe control to the safe position

when you are finished operating the handpiece.

6208-001-701 Rev-B 2007/09

www.stryker.com 7

To Remove Battery Pack

Depress the battery latch and pull the battery pack out.

To Remove Cutting Accessory

Rotate the blade mount lever to the LOAD position and

remove the blade.

Periodic Maintenance

INTERVAL ACTIVITY

Prior to each use. Inspect, operate and test the hand-

piece to ensure that it is working

properly. Ensure that there are no

loose or missing components. Check

all moving parts for free movement.

Be alert for unusual sounds or vibra-

tions and note the operating speed.

Storage and Handling

To ensure the longevity, performance and safety of this

equipment, use the original packaging materials when

storing or transporting this equipment.

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2007/09 6208-001-701 Rev-B

Troubleshooting Guide*

PROBLEM CAUSE ACTION

Handpiece does not run or

oscillates at a reduced speed

making cutting difficult.

Battery pack is discharged. Recharge the battery pack in Stryker charger.

FAST/STD/Safe control is in STD

position.

Set the FAST/STD/Safe control to the FAST position.

Battery pack is expended. Replace the battery pack.

FAST/STD/Safe control is in the

safe position.

Set the FAST/STD/Safe control to the FAST or STD

position.

Drivetrain is malfunctioning. Return the handpiece for repair.

Motor runs but blade does not

move.

Drivetrain is malfunctioning. Return the handpiece for repair.

Battery pack becomes unusu-

ally hot during use.

Circuitry is malfunctioning. Check the battery pack on the charger. Replace the bat-

tery pack if required. See the instructions supplied with

the battery charger.

Blade will not fit into the blade

retainer or cannot be secured.

Debris is inside the end of the

blade retainer.

Clean the handpiece with a small brush.

Blade is not a Stryker product. Use a Stryker blade.

Blade retainer is damaged. Return the handpiece for repair.

Handpiece has become noisy

and vibrates.

Blade is not a Stryker product. Use a Stryker blade.

Drivetrain is malfunctioning. Return the handpiece for repair.

Sporadic electrical interference

is experienced.

Electrical noise is present. Turn off all electrical equipment not in use in the operat-

ing room.

Relocate electrical equipment; increase spatial distance.

Plug operating room equipment into different operating

room outlets.

*DO NOT service this equipment. If you require service, contact your Stryker sales representative or call Stryker customer service

at 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary.

6208-001-701 Rev-B 2007/09

www.stryker.com 9

To Drain Water From Handpiece

Remove the battery pack and cutting accessory from

the handpiece.

Using a brush with stiff, non-metallic bristles and

hospital enzymatic cleaner, scrub the debris from the

handpiece. Pay special attention to crevices and hard

to reach areas such as seams, joints, and details

around the blade retainer, trigger, and connector

areas.

Rinse all external surfaces of the handpiece under

running water. Hold the handpiece upright to prevent

water from running into the battery contact area.

If water leaks into the handpiece, tip the handpiece

back as shown to allow drainage from a small open-

ing in the battery contact area.

To Clean Handpiece

Visually inspect the handpiece for any remaining

debris; if any debris is present, repeat the cleaning

and rinsing procedure using fresh hospital enzymatic

cleaner.

Dry the handpiece with a lint-free towel.

After cleaning, sterilize as directed. See Sterilization

Recommendations.

To Clean Battery Packs and Accessories

See the care instructions supplied with the battery

packs, battery pack modules and battery charger.

Cleaning Recommendations

WARNINGS:

• Clean and sterilize handpieces, and batteries before

first and every use.

• Prior to cleaning and sterilization, remove all acces-

sories from the handpieces.

• DO NOT use solvents, lubricants, or other chemicals

unless otherwise specified.

CAUTIONS:

• DO NOT immerse a handpiece or battery pack in

liquid. Moisture may enter the equipment, cause cor-

rosion, and damage the electrical and/or mechanical

components.

• DO NOT allow liquid to run directly into any electrical

connection. Moisture may cause corrosion to electri-

cal and/or mechanical components.

10 www.stryker.com

2007/09 6208-001-701 Rev-B

Sterilization Recommendations*

WARNINGS:

• Clean and sterilize handpieces and batteries before

first and every use.

• Prior to cleaning and sterilization, remove all acces-

sories from the handpieces.

To obtain optimal performance and prevent damage,

perform one of the following sterilization procedures:

“Flash” Autoclave:

• Gravity displacement sterilizer

• 270-272 °F (132-134 °C)

• Unwrapped in an instrument tray

• 10-minute minimum exposure time

Hi Vac:

• Pre-vacuumed sterilizer

• 270-272 °F (132-134 °C)

• Wrapped or unwrapped

• 4-minute minimum exposure time

• 8-minute minimum dry time

To Sterilize Battery Packs

See the care instructions supplied with the battery

packs.

ETO:

• 100% ETO

• 120-135 °F (49-57 °C)

• Wrapped in an instrument tray or fully perforated

sterilization box

• 2-hour 30-minute exposure time, 8-hour minimum

aeration time

250 °F Gravity:

• Gravity displacement sterilizer

• 250-254 °F (121-123 °C)

• Wrapped in an instrument tray or fully perforated

sterilization box

• 50-minute exposure time

• 8-minute minimum drying time

270 °F Gravity:

• Gravity displacement sterilizer

• 270-272 °F (132-134 °C)

• Wrapped in an instrument tray or fully perforated

sterilization box

• 35-minute minimum exposure time

• 8-minute minimum dry time

*Validation is based on the Association for the Advancement of

Medical Instrumentation (AAMI) protocol.

To Sterilize Handpieces

NOTE: After sterilization, allow the equipment to cool

to room temperature to ensure a comfortable operating

temperature.

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