stryker_system_8_ezout_system_series_instructions_f.pdf
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System 8
EZout™ System
EZout System
REF
8202-999-000
EZout Blades
REF
7812-0XX-001K
Series
Instructions For Use
EZout Blades
REF 7812-0XX-001K Series
ENGLISH (EN)
2017-09
8202-001-700 Rev-C
Print Date: Oct 06, 2017 02:15:42 PM
0000226103, Rev. C Effective Date: Oct 6, 2017 12:49:49 PM
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EN
8202-001-700 Rev-C
Contents
Instructions . . . . . . . . . . . . . . . . 11
Introduction . . . . . . . . . . . . . . . . . 3
To Select the Plug . . . . . . . . . . . 11
Audience . . . . . . . . . . . . . . . . . 3
To Select the Blade . . . . . . . . . . . 12
Conventions. . . . . . . . . . . . . . . . 3
To Install the Attachment and Accessories 13
Contact Information . . . . . . . . . . . . 3
To Install the Battery Pack . . . . . . . . 16
Indications For Use. . . . . . . . . . . . . . 3
To Operate the Handpiece . . . . . . . . 16
Contraindications. . . . . . . . . . . . . . . 3
To Remove the Battery Pack. . . . . . . 19
To Remove the Attachment and Accessories . 19
Safety Directives . . . . . . . . . . . . . . . 4
Definitions . . . . . . . . . . . . . . . . . . 6
Care Instructions
. . . . . . . . . . . . . 20
System Overview. . . . . . . . . . . . . . . 6
Troubleshooting . . . . . . . . . . . . . . 21
Handpiece . . . . . . . . . . . . . . . . 6
Specifications . . . . . . . . . . . . . . . 24
Attachment and Accessories . . . . . . . . 8
Handpiece . . . . . . . . . . . . . . . 24
Sizing Tools. . . . . . . . . . . . . . . . 9
Accessories. . . . . . . . . . . . . . . 25
Battery Packs . . . . . . . . . . . . . . 10
Product Safety Certification . . . . . . . 26
Insert Trays and Sterilization Cases . . . 10
Product Safety Compliance . . . . . . . 27
Electromagnetic Compatibility . . . . . . 28
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8202-001-700 Rev-C
EN
Introduction
Contact Information
This instructions for use manual contains
information intended to ensure the safe, effective,
and compliant use of your product.
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.
Keep and consult this reference manual during
the life of the product.
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.
▪
Indications For Use
The Stryker System 8 EZout Acetabular Cup
Removal System is intended to cut bone and
hard tissue around the bone-to-cup interface. The
system incorporates a power tool (handpiece),
attachment, plugs, riser rings, sizing equipment,
and a variety of blades to aid in the removal of a
hemispherical acetabular cup during revision of
hip arthroplasty.
Contraindications
None known.
A NOTE supplements and/or clarifies
procedural information.
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EN
8202-001-700 Rev-C
Safety Directives
▪
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.
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.
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.
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8202-001-700 Rev-C
▪
DO NOT use this device to remove
non-hemispherical cups. Attempting to
remove a non-hemispherical cup could
cause burns to soft tissue, bone loss, and/
or contamination of the surgical site by metal
debris.
▪
DO NOT use this device to remove
cemented acetabular cups. Attempting to
remove cemented acetabular cups could
cause overheating, burns to soft tissue,
contamination of the surgical site by metal
debris, and/or the ejection of metal fragments
at a high velocity.
▪
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.
▪
ALWAYS lock the handpiece trigger before
installing or removing attachments or
accessories.
EN
▪
All cutting accessories are intended for single
use only. Reuse significantly increases wear
on the handpiece and attachment.
▪
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.
▪
Once the blade packaging is opened, discard
any unused blades. Unused blades cannot
be reused, reprocessed, resterilized, or
repackaged.
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8202-001-700 Rev-C
Definitions
System Overview
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.
NOTE: The Stryker System 8 EZout System is
a component of the Stryker System 8 Battery
Powered Heavy Duty System. The System 8
EZout System includes a saw (handpiece),
attachment, centering plugs, riser rings, sizing
equipment, and a variety of blades.
SYMBOL
DEFINITION
Fast Mode
NOTE: For a complete list of accessories, contact
your Stryker sales representative or call Stryker
customer service. Outside the US, contact your
nearest Stryker subsidiary.
Standard Mode
Handpiece
Duty Cycle – See the
Specifications section.
The EZout Saw is battery powered and has a
trigger and a function switch.
General warning sign
2 min / 1 min
/ 1 min
DESCRIPTION
REF
System 8 EZout Saw
8202-000-000
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8202-001-700 Rev-C
EN
Function Switch
B
C
A
D
A
Function Switch – Sets the speed
or locks the trigger. See the Function
Switch section.
B
Locking Sleeve – Retains the
attachment in the handpiece.
C
Flats – Align with the attachment flats
during assembly.
D
Trigger – Controls the variable speed
operation of the handpiece.
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Fast Mode – The
handpiece will operate
at high speed when the
trigger is depressed.
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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EN
8202-001-700 Rev-C
Attachment and Accessories
To obtain a safe combination, the EZout Saw
must be used with the following Stryker-approved
attachment, alignment tools, and cutting
accessories.
DESCRIPTION
REF
EZout Attachment
7202-100-000
EZout Centering Plugs
7202-200-0XX series
EZout Riser Rings
7202-200-1XX series
EZout Blades
7812-0XX-001K
series
A
B
C
D
E
F
G
H
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8202-001-700 Rev-C
EN
Sizing Tools
A
Flats – Align with the handpiece flats
during assembly.
B
Green Ring – Indicates the amount of
blade engagement while cutting.
C
Handle – Allows for blade control (up/
down and rotation) during use.
DESCRIPTION
D
Lower Rod – Rotates attachment flats
for alignment during assembly.
EZout Trial Rod
7202-300-100
E
Blade – Cuts bone and hard tissue
around the bone-to-cup interface.
EZout Plug Sizing
Templates
7202-300-1XX series
F
Blade Latch Button – Retains the blade
to the attachment.
G
Centering Plug (plug) (20) – Provides
proper alignment between the
attachment and the implanted cup.
H
Riser Ring (8) – Allows the plug to sit
flush with the top of the implanted cup,
if needed.
I
Plug Sizing Template (2) – Measures
the cup liner to determine plug size.
J
Blade Sizing Tool (4) – Measures the
outside diameter of the implanted cup
to determine blade size.
K
The system includes several sizing tools which
are used to determine the appropriate plug and
blade sizes.
REF
EZout Blade Sizing Tools 7202-300-0XX series
I
J
K
Trial Rod – Rotates the blade sizing tool
inside the cup to determine blade size.
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EN
8202-001-700 Rev-C
Battery Packs
The handpiece accepts the following Stryker
battery packs:
DESCRIPTION
REF
System 8 Battery Packs
8212-000-000
8215-000-000
Stryker SmartLifeTM Battery
Packs
7212-000-000
7215-000-000
Insert Trays and Sterilization
Cases
Upon initial receipt and before each use, the
system is intended to be processed using the
EZout Insert Tray.
DESCRIPTION
REF
Insert Trays
7102-450-010
7102-452-010
7102-454-010
7102-458-010
7102-459-010
Stryker SmartLife Non-sterile 7126-110-000
Batteries
7222-110-000
SmartLife Aseptic Housings
7126-120-000
7222-120-000
EZout Insert Tray and Case
7102-459-000
SmartLife Transfer Shields
7126-130-000
7222-130-000
EZout Insert Tray and
Container
7102-559-000
System 6 Battery Packs
6212-000-000
6215-000-000
EZout Insert Tray and Solid
Bottom Container
7102-659-000
System 6 Aseptic Battery
Kits
6126-000-000
6127-000-000
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8202-001-700 Rev-C
EN
Instructions
CORRECT
INCORRECT
To Select the Plug
34
36
36
38
2. Center the bottom of the liner into each
cutout on the plug sizing template until the
closest match is found. The number below
the selected cutout on the template indicates
the appropriate plug size.
40
1. Remove the cup liner from the implanted cup.
45
43
38
44
WARNING: Ensure that the plug size
is correct for the cup to be removed.
Impingement caused by incorrectly sized
plugs could cause burns to soft tissue,
bone loss, contamination of the surgical
site by metal debris, and/or the ejection of
metal fragments at a high velocity.
NOTES:
▪
The correctly sized cutout will show the least
amount of gap between the cup liner and the
plug sizing template.
▪
Make sure the bottom of the cup liner is
centered on the plug sizing template cutout.
3. Place the selected plug into the implanted
cup to verify fit.
Cup Liner
Plug
43
34
36
38
45
40
Plug Sizing
Template
46
41
47
42
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Cup
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8202-001-700 Rev-C
NOTES:
▪
Plug stability can be improved by trying one
plug size larger or smaller, or by utilizing a
riser ring.
▪
The final plug size should not be more than
one size away from that initially identified by
the plug sizing template unless a resurfacing
cup is being removed as noted below.
▪
If a resurfacing cup is being removed, the
starting plug size should be four sizes smaller
than that initially indicated by the plug sizing
template (e.g., if a 42 plug size was initially
identified by the plug sizing template, a 38
plug size should be used).
▪
Use the femoral head component to
determine plug size for implants without a
liner.
To Select the Blade
WARNING: Ensure that the blade size
is correct for the cup to be removed.
Impingement caused by incorrectly sized
blades could cause burns to soft tissue,
bone loss, contamination of the surgical
site by metal debris, and/or the ejection of
metal fragments at a high velocity.
NOTE: The blade size corresponds to the outer
diameter of the implanted cup. Not all cup sizes
indicated by the cup manufacturer correspond to
the actual outer diameter of the cup.
1. Place the selected plug (and riser ring, if
needed) into the implanted cup. (See the To
Select the Plug section.)
2. Select a blade sizing tool that is marked with
sizes closest to that of the implanted cup’s
outer diameter.
3. Place the blade sizing tool onto either end of
the trial rod.
4. Place the blade sizing tool into the plug.
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8202-001-700 Rev-C
EN
5. Looking down on the blade sizing tool, select
the section of the tool that meets or exceeds
the outer edge of the implanted cup. The
number on the selected section indicates the
appropriate blade size.
NOTE: The trial rod can be rotated to turn the
blade sizing tool.
To Install the Attachment and
Accessories
1. Lock the handpiece trigger.
2. Pull back the handpiece locking sleeve, and
place the attachment into the handpiece.
Trial
Rod
Blade
Sizing
Tool
44
46
48
50
52
Plug
NOTE: Compare the blade
sizing tool to the edge of the
implanted cup, not the plug.
Cup
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EN
3. Rotate the attachment lower rod until the flats
on the attachment align with the flats on the
handpiece. Release the locking sleeve.
8202-001-700 Rev-C
5. Slide the attachment handle down to expose
the blade latch button.
6. Press down on the blade latch button and
slide the selected short blade into the
attachment. Then release the blade latch
button.
4. Gently tug the attachment to make sure
the attachment is securely locked in the
handpiece.
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8202-001-700 Rev-C
7. Make sure the horizontal mark at the base
of the blade aligns with the attachment,
indicating that the blade is loaded correctly.
EN
9. Place the selected plug into the cup.
10. Place the attachment end into the plug.
Attachment
Blade
Plug
Cup
8. Gently tug the blade to make sure the blade
is securely locked in the attachment.
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EN
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.
8202-001-700 Rev-C
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 grasp or touch any oscillating
component while the handpiece is operating.
▪
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.
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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8202-001-700 Rev-C
▪
Ensure that the plug and blade sizes
are correct for the cup to be removed.
Impingement caused by incorrectly sized
plugs or blades could cause burns to soft
tissue, bone loss, contamination of the
surgical site by metal debris, and/or the
ejection of metal fragments at a high velocity.
EN
▪
ALWAYS keep the device in line with the
implanted cup axis and engaged with the plug
while cutting. Cutting at an excessive angle
may result in blade impingement, which may
cause bone loss and/or contamination of the
surgical site by metal debris.
CAUTIONS:
▪
DO NOT use the blade to cut through fins,
spikes, or screws on the cup. Attempting
to cut through these items could cause
contamination of the surgical site by metal
debris, and/or the ejection of metal fragments
at a high velocity.
▪
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.
▪
ALWAYS pre-lubricate the attachment/plug
connection with saline prior to use, and
irrigate throughout the cutting process to
prevent overheating.
▪
▪
DO NOT apply excessive pressure, such as
bending, prying, or excessive twisting, with the
device. Excessive pressure or twisting may
bend or fracture the blade or attachment and
result in tissue damage, loss of tactile control,
and/or the ejection of metal fragments at a
high velocity.
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.
1. Remove any screws from the implanted cup.
2. Pre-lubricate the attachment/plug connection
with saline.
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EN
8202-001-700 Rev-C
NOTE: See the Function Switch section for mode
descriptions.
WARNINGS:
3. Slide the handpiece function switch to the
desired mode position.
▪
ALWAYS use care when removing the blade
as it may be hot.
4. Depress the pressure-sensitive trigger to
operate the handpiece.
▪
DO NOT bend, pry, or break bone to remove
the cup.
5. While irrigating, continually rotate the
attachment handle back and forth while
engaging the blade. Do not plunge the blade
into the bone without rotating the attachment
handle.
NOTES:
▪
Ensure full cutting with the short blade prior
to cutting with the long blade.
▪
If the cup is still attached after cutting with
the long blade, use other methods to cut the
final portion of bone.
NOTE: It is not necessary to rotate the handpiece
along with the attachment.
6. The blade is fully extended when the green
ring is flush with the top of the attachment
handle.
CORRECT
INCORRECT
7. When you are ready to switch to the long
blade, lock the handpiece trigger.
8. Press down on the blade latch button and
remove the short blade from the attachment.
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8202-001-700 Rev-C
9. Slide the selected long blade into the
attachment. Then release the blade latch
button.
EN
To Remove the Attachment and
Accessories
WARNING: ALWAYS use care when
removing the blade as it may be hot.
10. Gently tug the blade to make sure the blade
is securely locked in the attachment.
11. Repeat steps 1-6.
To Remove the Battery Pack
1. Lock the handpiece trigger.
2. Press down on the blade latch button and
remove the blade from the attachment.
1. Lock the handpiece trigger.
2. Depress the battery latch and slide the
battery pack out of the handpiece.
3. Remove the plug from the removed cup.
4. If a riser ring has been installed, pull to
remove it from the base of the plug.
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EN
5. Pull back the handpiece locking sleeve, and
remove the attachment from the handpiece.
8202-001-700 Rev-C
Care Instructions
For processing instructions and disposal/recycle
information, see the care instructions manual
supplied with the equipment.
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8202-001-700 Rev-C
EN
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.
The handpiece operates but the
blade does not move.
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 Function Switch
section.
The handpiece is damaged.
Return the equipment to Stryker
for repair.
The attachment is not fully
installed in the handpiece.
Remove and install the
attachment. Make sure the
attachment is securely locked in
the handpiece.
Excessive pressure is being
applied to the blade.
Release the pressure and allow
the blade to do the cutting.
The handpiece is damaged.
Return the equipment to Stryker
for repair.
The attachment is damaged.
Return the equipment to Stryker
for repair.
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8202-001-700 Rev-C
PROBLEM
CAUSE
ACTION
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.
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 See the care instructions
end of the handpiece contains
manual supplied with the
debris.
handpiece.
The attachment is damaged.
Return the equipment to Stryker
for repair.
The handpiece is damaged.
Return the equipment to Stryker
for repair.
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8202-001-700 Rev-C
EN
PROBLEM
CAUSE
ACTION
The attachment wobbles in the
handpiece.
The attachment and/or
handpiece is damaged.
Return the equipment to Stryker
for repair.
The handpiece is noisy and/or
vibrates excessively.
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.
The attachment handle and/
or blade will not move up and
down.
The attachment is damaged.
Return the equipment to Stryker
for repair.
The attachment handle and/or
blade will not rotate.
The attachment is damaged.
Return the equipment to Stryker
for repair.
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8202-001-700 Rev-C
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.
Handpiece
Model:
System 8 EZout Saw (REF 8202-000-000)
Dimensions:
150 mm [5.9 inch] height, 37 mm [1.4 inch] width, 164 mm [6.5 inch] length
European Conformity:
Mass:
1.04 kg [2.3 lb]
Speed:
9000 rpm (fast mode), 8000 rpm (standard mode)
Mode of Operation:
Non-continuous
Duty Cycle:
2 minutes on/1 minute off/1 minute on
Rest Between Cycles:
1 hour
Applied Part(s):
The distal end of the attachment and the accessories 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
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Print Date: Oct 06, 2017 02:15:42 PM
0000226103, Rev. C Effective Date: Oct 6, 2017 12:49:49 PM
www.stryker.com
Page 25
8202-001-700 Rev-C
EN
Accessories
Model:
Dimensions:
Mass:
European
Conformity:
Model:
Dimensions:
Mass:
European
Conformity:
Model:
Dimensions:
Mass:
European
Conformity:
EZout Attachment
(REF 7202-100-000)
41 mm [1.6 inch] height
41 mm [1.5 inch] width
326 mm [12.8 inch] length
0.6 kg [1.1 lb]
Model:
Dimensions:
Mass:
European
Conformity:
Model:
EZout Centering Plugs
(REF 7202-200-0XX series)
38 to 66 mm [1.5 to 2.6 inch]
outer diameter
18.5 mm [0.73 inch] height
0.04 to 0.12 kg [0.09 to 0.26 lb]
Dimensions:
Mass:
European
Conformity:
Model:
EZout Riser Rings
(REF 7202-200-1XX series)
40.6 to 63.5 mm [1.6 to 2.5 inch]
outer diameter
3 mm [0.12 inch] height
0.01 to 0.02 kg [0.02 to 0.04 lb]
Dimensions:
Mass:
European
Conformity:
Model:
EZout Blade Sizing Tools
(REF 7202-300-0XX series)
25.4 to 38.1 mm [1.0 to 1.5 inch]
width
38.1 mm [1.5 inch] height
0.05 to 0.06 kg [0.12 to 0.14 lb]
EZout Trial Rod
(REF 7202-300-100)
228.6 mm [9.0 inch] length
17 mm [0.67 inch] outer diameter
0.11 kg [0.25 lb]
EZout Plug Sizing Templates
(REF 7202-300-1XX series)
292 mm [11.5 inch] length
61 mm [2.4 inch] width
2.8 mm [0.11 inch] height
0.05 kg [0.1 lb]
EZout Blades
(REF 7812-0XX-001K series)
European
Conformity:
www.stryker.com
Print Date: Oct 06, 2017 02:15:42 PM
0000226103, Rev. C Effective Date: Oct 6, 2017 12:49:49 PM
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