Stryker 4126-000-000 User manual

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Instructions For Use
4126-120-700 L
0000003946, Rev. L Effective Date: Jun 14, 2016 10:36:00 AM
Print Date: Jun 14, 2016 11:18:38 AM

2016-03 4126-120-700 Rev-L www.stryker.com
Instructions For Use
ENGLISH (EN)
ESPAÑOL (ES)
DEUTSCH (DE)
FRANÇAIS (FR)
ITALIANO (IT)
NEDERLANDS (NL)
SVENSKA (SV)
DANSK (DA)
SUOMI (FI)
PORTUGUÊS (PT)
NORSK (NO)
POLSKI (PL)
ΕΛΛΗΝΙΚΑ (EL)
TÜRKÇE (TR)
Battery Protector Kits
REF
4126-000-000
4222-000-000
4226-000-000
6127-000-000
0000003946, Rev. L Effective Date: Jun 14, 2016 10:36:00 AM
Print Date: Jun 14, 2016 11:18:38 AM

2 www.stryker.com
EN 4126-120-700 Rev-L
Introduction
This Instructions For Use manual is the most
comprehensive source of information for the
safe and effective use of your product. This
manual may be used by in-service trainers,
physicians, nurses, surgical technologists, and
biomedical equipment technicians. Keep and
consult this reference manual during the life
of the product.
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.
If additional information or in-service training
is required, contact your Stryker sales
representative or call Stryker customer
service. Outside the US, contact your nearest
Stryker subsidiary.
Indications For Use
Battery Protector Kits provide a sterile
enclosure for Stryker Non-sterile Batteries.
After a Non-sterile Battery is charged, it is
placed in a sterilized Aseptic Housing that is
loaded into a Stryker handpiece. See the For
Use With section.
Contraindications
None known.
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EN 4126-120-700 Rev-L 4126-120-700 Rev-L EN
For Use With
Stryker Battery Protector Kits contain the following components and are intended for use with
the following Stryker handpieces:
KIT CONTENTS
FOR USE WITH HANDPIECESKIT
Non-sterile
Battery
Aseptic
Housing
Transfer
Shield
Cordless Driver
Small Battery
Protector Kit (REF
4222-000-000)
REF 4222-
110-000
REF 4222-
120-000
REF 4222-
130-000
Cordless Driver (REF 4100-000-000),
Cordless Driver 2 (REF 4200-000-000),
Recip/Sternum Saw (REF 4107-000-
000 and REF 4207-000-000)
Cordless Driver
Large Battery
Protector Kit (REF
4226-000-000)
REF 4126-
110-000
REF 4226-
120-000
REF 4126-
130-000
Cordless Driver (REF 4100-000-000),
Cordless Driver 2 (REF 4200-000-000),
Recip/Sternum Saw (REF 4107-000-
000 and REF 4207-000-000)
System 5 Battery
Protector Kit (REF
4126-000-000)
REF 4126-
110-000
REF 4126-
120-000
REF 4126-
130-000
Rotary (REF 4103-000-000 and 4203-
000-000), Dual Trigger (REF 4205-
000-000), Reciprocating Saw (REF
4106-000-000 and REF 4206-000-
000), Sagittal Saw (REF 4108-000-000
and REF 4208-000-000)
System 6 Small
Battery Protector
Kit (REF 6127-
000-000)
REF 4222-
110-000
REF 6127-
120-000
REF 4222-
130-000
Cordless Driver 3 (REF 4300-000-000),
Single Trigger Rotary (REF 6203-000-
000), Dual Trigger Rotary (REF 6205-
000-000), Sternum Saw (REF 6207-
000-000), Sabo®Sagittal Saw (REF
4300-034-000), System 7 Handpieces
(REF 720X-XXX-XXX series)
0000003946, Rev. L Effective Date: Jun 14, 2016 10:36:00 AM
Print Date: Jun 14, 2016 11:18:38 AM

User/Patient Safety
WARNINGS:
• Only trained and experienced healthcare
professionals should use this equipment.
Before using any system component
or any component compatible with
this system, read and understand the
instructions. Pay particular attention to
WARNING information. Become familiar
with the system components prior to use.
• Upon initial receipt and before each
use, inspect non-sterile batteries for
damage. DO NOT charge or use if there
is evidence of damage. Electrolytes may
leak from damaged batteries and cause
serious chemical burns to the surgical
site, skin and/or eyes.
• DO NOT modify any system component or
accessory.
• DO NOT use this equipment in areas in
which flammable anesthetics or flammable
agents are mixed with air, oxygen or
nitrous oxide.
• See the instructions supplied with the non-
sterile battery and the System 5 or System
6 Charger used to recharge the batteries.
Instructions contain important safety
information and charging instructions.
• ALWAYS remove the non-sterile battery
from the aseptic housing before charging
the battery. Failure to comply may result in
product damage.
• Sterilize the aseptic housings and transfer
shields before first and every use. See the
care instructions manual supplied with the
handpiece.
• DO NOT sterilize the non-sterile batteries.
After charging, a non-sterile battery is
placed in a sterilized aseptic housing, then
loaded into a handpiece.
4 www.stryker.com
EN 4126-120-700 Rev-L
0000003946, Rev. L Effective Date: Jun 14, 2016 10:36:00 AM
Print Date: Jun 14, 2016 11:18:38 AM

SYMBOL DEFINITION
Lock
Unlock
Alignment marker
SYMBOL DEFINITION
Refer to instruction manual/
booklet
General warning sign
This rechargeable battery
pack contains Nickel-Cadmium
material.
To comply with European
Community Batteries Directive
2006/66/EC, this device
has been designed for safe
removal of the batteries
by the end user using the
instructions provided. Infected
units and batteries should be
decontaminated before they
are sent for recycling.
Ni-Cd
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.
www.stryker.com 5
EN 4126-120-700 Rev-L 4126-120-700 Rev-L EN
0000003946, Rev. L Effective Date: Jun 14, 2016 10:36:00 AM
Print Date: Jun 14, 2016 11:18:38 AM

6 www.stryker.com
EN 4126-120-700 Rev-L
Instructions
To Install Non-sterile Battery
WARNING: DO NOT use the aseptic
housing, transfer shield, or non-sterile
battery unless they are dry.
CAUTION: DO NOT allow the battery contact
terminals to touch metal objects.
NOTE: Ensure more than one sterilized
battery protector kit is available in case a
second battery installation is necessary.
Sterile Assistant Action
1. Open the lid (Figure 1).
Figure 1 – Open Lid
2. With the aseptic housing chamber open,
place the transfer shield onto the aseptic
housing and over its chamber (Figure 2).
Figure 2 – Place Transfer Shield
3. Present the chamber to the circulating
assistant.
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EN 4126-120-700 Rev-L 4126-120-700 Rev-L EN
Circulating Assistant Action
CAUTION: DO NOT contaminate the aseptic
housing. The transfer shield guards the
aseptic housing from contamination during
battery installation.
4. Hold the non-sterile battery by the handle.
5. While aligning the battery’s housing profile
with the transfer shield and chamber
opening, place the non-sterile battery into
the chamber (Figure 3).
Figure 3 – Install Battery
6. Remove the contaminated transfer shield
and set it aside.
WARNING: Sterilize the contaminated
transfer shield before using it again.
See the care instructions manual
supplied with the handpiece.
Sterile Assistant Action
7. Close the aseptic housing lid and rotate its
latch clockwise 90° until the detent clicks
into place. Ensure the marker aligns with
the lock symbol (Figure 4).
Figure 4 – Lock Lid
WARNING: Failure to turn the latch
completely to the lock symbol may
result in the lid opening, exposing the
non-sterile battery.
8. Slide the aseptic housing containing the
installed non-sterile battery firmly into the
handpiece until it snaps into place.
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8 www.stryker.com
EN 4126-120-700 Rev-L
To Replace Battery
WARNING: After installation, DO NOT
remove a non-sterile battery from
a sterile housing. If a new battery
is required, use another sterile
battery protector kit and perform the
installation procedure.
NOTE: It is important to keep non-sterile
batteries as clean as possible because they
cannot be sterilized.
1. Wipe debris from the aseptic housing.
2. Rotate the latch counterclockwise 90° to
the unlocked position. Open the lid.
3. Using the battery handle, lift the non-
sterile battery out of the aseptic housing
chamber.
Care Instructions
For processing instructions and disposal/
recycle information, see the care instructions
manual supplied with the handpiece.
0000003946, Rev. L Effective Date: Jun 14, 2016 10:36:00 AM
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www.stryker.com 9
EN 4126-120-700 Rev-L 4126-120-700 Rev-L EN
Specifications
NOTE: Specifications are approximate and may vary between devices.
Non-sterile Batteries
Model: Non-sterile Large Battery
(REF 4126-110-000)
Non-sterile Small Battery
(REF 4222-110-000)
Dimensions: 47 mm [1.9 inch] height
73 mm [2.9 inch] width
91 mm [3.6 inch] length
40 mm [1.6 inch] height
57 mm [2.2 inch] width
71 mm [2.8 inch] length
Mass: 0.36 kg [0.79 lb] 0.16 kg [0.35 lb]
Electrical: 1.75 A charge
9.6 V (Direct Current) output
1.0 A charge
9.6 V output
Aseptic Housings
Model: System 5
Aseptic Housing
(REF 4126-120-
000)
Cordless Driver
Small Aseptic
Housing (REF
4222-120-000)
Cordless Driver
Large Aseptic
Housing (REF
4226-120-000)
System 6 Small
Aseptic Housing
(REF 6127-120-
000)
Dimensions: 76 mm [3.0 inch]
height, 83 mm
[3.3 inch] width,
108 mm [4.3
inch] length
147 mm [5.8
inch] height, 67
mm [2.6 inch]
width, 90 mm
[3.5 inch] length
156 mm [6.1
inch] height, 83
mm [3.3 inch]
width, 108 mm
[4.3 inch] length
69 mm [2.7 inch]
height, 67 mm
[2.6 inch] width,
90 mm [3.5 inch]
length
Mass: 0.30 kg [0.66 lb] 0.26 kg [0.57 lb] 0.29 kg [0.64 lb] 0.25 kg [0.54 lb]
0000003946, Rev. L Effective Date: Jun 14, 2016 10:36:00 AM
Print Date: Jun 14, 2016 11:18:38 AM