Johnson & Johnson DePuy Synthes Battery Power Line II User manual

Battery-driven power tool system
for orthopedics and traumatology
Battery Power Line II
User’s Manual

Table of Contents
DePuy Synthes Power Tools Battery Power Line II User’s Manual
Introduction General Information 2
Drive Units 8
Operating Instructions Universal Battery Charger II 12
Battery Pack 13
(battery casing with inserted battery)
Battery Reamer/ Drill II 19
Attachments for Battery Reamer/ Drill II 20
Battery Oscillator II 35
Battery Reciprocator II 37
Care and Maintenance General Information 39
Preparation Prior to Cleaning 40
Manual Cleaning Instructions 41
Automated Cleaning Instructions 44
With Manual Precleaning
Lubrication 50
Inspection and Function Test 56
Packaging, Sterilization, and Storage 57
Battery Sterilization using STERRAD®and
V-PRO®Systems Sterilization 60
Repairs and Technical Service 63
Disposal of Waste 64

Battery Power Line II User’s Manual DePuy Synthes Power Tools
Table of Contents
Troubleshooting 65
System Specifications 70
Electromagnetic Compatibility 74
Ordering Information 78
Warning:
This description alone does not provide sufficient background for the direct
use of the product. Instruction by a surgeon experienced in handling this
product is highly recommended.

2 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Intended Use
The Battery Power Line II is a heavy duty battery-driven
system intended for orthopedic and trauma applications
including:
•Drilling
•Reaming
•Inserting/removing Kirschner wires and pins
•Cutting bone
Battery Reamer/Drill II
Drilling
Kirschner wire insertion
Reaming
Fixing of cutting block with a pin
Introduction
General Information

Battery Power Line II User’s Manual DePuy Synthes Power Tools 3
Battery Oscillator II
Battery Reciprocator II
Oscillating sawing
Reciprocating sawing
Introduction
General Information

4 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Safety Instructions
The Battery Power Line II (BPL II) is only to be used
for patient treatment after careful consultation of the
instructions for use. It is recommended that an alternative
system is available to use during application, as technical
problems can never be completely ruled out.
The Battery Power Line II is designed for use only by
physicians and trained medical personnel.
DO NOT use any component if damage is apparent.
DO NOT use any component if the packaging is damaged.
DO NOT use this equipment in the presence of oxygen,
nitrous oxide, or a mixture consisting of flammable
anesthetic and air.
To ensure proper operation of the tool, only use
DePuy Synthes original accessories.
Before first and every use and prior to returning for service,
power tools and their accessories/attachments, excluding
the battery, have to be run through the complete
reprocessing procedure. Protective covers and films must
be fully removed before sterilization.
For the tool to function properly, DePuy Synthes
recommends that it is cleaned and serviced after each
use in accordance with the process recommended in the
“Care and Maintenance” section. Compliance with these
specifications can considerably extend the service life
of the tool. Only use Synthes Special Oil (519.97) to
lubricate the tool.
We recommend using new DePuy Synthes cutting tools
for every surgical procedure. Efficiently working cutting
tools are the basis for successful surgery. Therefore, check
used cutting tools after every use for wear and/or damage
and replace them if necessary.
Cutting tools must be cooled with irrigation fluid to
prevent heat necrosis.
The user of the product is responsible for proper use
of the equipment during surgery.
Check proper operation of the tool before using it on
the patient.
To prevent overheating, always respect the specified duty
cycles on page 71.
If the Battery Power Line II is used in conjunction with an
implant system, make sure to consult the corresponding
Technique Guide.
For important information regarding electromagnetic
compatibility (EMC) please refer to the “Electromagnetic
Compatibility” section in this manual.
The tool is classified as type BF against electrical shock and
leakage current. The tool is suitable for use on patients in
accordance with IEC 60601-1.
Note: To ensure proper operation of the tool, annual
maintenance by a DePuy Synthes service center is
necessary. The manufacturer shall assume no
responsibility for damage resulting from improper
operation, and neglected or unauthorized
maintenance of the tool.
Introduction
General Information

Battery Power Line II User’s Manual DePuy Synthes Power Tools 5
Notes
• Always wear personal protective equipment (PPE)
including safety goggles when handling the BPL II
system.
• To avoid injuries, the locking mechanism of the
tool has to be activated before every manipulation
and when laying the tool down (i.e. the mode
switch has to be in the off position).
• Only place the tool in an upright position
when changing attachments or cutting tools
intraoperatively. The handpiece must be laid on
its side when not in use to avoid the risk of being
dropped or contaminating other instruments.
• If the machine has been dropped, it should be
checked carefully for damage. In the event that
any damage is visible, do not use it anymore and
send it to the DePuy Synthes service center.
• The tool may only be operated with a fully charged
battery. Therefore, ensure that the battery is
charged in good time. We recommend that the
battery is placed into the charger immediately
after surgery.
• The batteries must never be sterilized, washed,
rinsed, or dropped. This would destroy the battery
with possible secondary damage (explosion
hazard!). Only use original DePuy Synthes
batteries. Further information can be found on
page 17.
• Never place the BPL II in a magnetic environment
since the machine might start unintentionally.
Introduction
General Information

6 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Accessories/Scope of Delivery
The Battery Power Line II consists of three different
handpieces, a battery casing, a battery, and a range of
attachments designed for the system.
To charge the batteries, only use the corresponding
DePuy Synthes Universal Battery Charger II (05.001.204).
To reach the specified performance, only DePuy Synthes
cutting tools should be used. These are optimized to meet
the specific requirements of the tool. Non-DePuy Synthes
saw blades can considerably reduce the lifetime of
the system.
Special auxiliaries such as cleaning brushes (516.101) and
Synthes Special Oil (519.97) are available for cleaning and
servicing the system.
No oils from other manufacturers may be used. Only
Synthes Special Oil (519.97) must be used to lubricate the
power tools and attachments.
Lubricants with other compositions may cause jamming,
have a toxic effect, or have a negative impact on the
sterilization results. Only lubricate the power tool, the
battery casing, and the attachments when clean.
DePuy Synthes recommends the use of the specifically
designed DePuy Synthes Washing Basket (68.001.620,
68.001.625) to sterilize and store the system. Further-
more, the Washing Basket (68.001.620, 68.001.625) can
be used for the automated cleaning procedure. Further in-
formation can be found on page 47.
Please refer to the “Ordering Information” section on
page 78 for an overview of the components of the system.
Storage and Transport
Only use the original packaging for dispatch and transport
as otherwise damage may occur. If this is not possible,
please contact your local DePuy Synthes office.
For storage and transport environmental conditions,
please refer to the “Packaging, Sterilization, and Storage”
section on page 58.
Warranty
The warranty for the tools and accessories does not cover
damage of any kind resulting from wear, improper use,
damaged seal, use of non-DePuy Synthes cutting tools
and lubricants, or improper storage and transport.
The manufacturer shall assume no responsibility for
damage resulting from improper operation, and
neglected or unauthorized maintenance of the tool.
For further information on the warranty, please contact
your local DePuy Synthes office.
Introduction
General Information

Battery Power Line II User’s Manual DePuy Synthes Power Tools 7
10PB
0123
S9
IP X4
This symbol indicates that this battery
contains rechargeable lithium-ion cells.
The battery is rechargeable.
Duty cycle type according to IEC 60034-1.
Ingress protection rating according to
IEC 60529.
Locked symbol. Drive Unit is off for safety.
Date of manufacture
Non-sterile
Temperature
Relative humidity
Atmospheric pressure
Do not use if package is damaged.
Explanation of Symbols
The following symbols are applied to the device or
individual components.
CUTTER
RUN
ADJUST
TUBE
SAFE
F
R
0
0
.
.
5
5
3
3
.
.
2
2
4
4
.
.
8
8
6
6
.
.
4
4
8
8
.
.
0
0
2
2
.
.
4
4
1
1
.
.
6
6
non sterile
Caution
Consult the provided instructions for use
before operating the device.
The device is classified as type BF against
electrical shock and leakage current. The
device is suitable for use on patients
according to the standards defined by IEC
60601-1: 2005 + CORR. 1 (2006) + CORR.
2 (2007) ANSI/AAMI ES60601-1:2005,
Dated December 2005 and CAN/CSA-C22.2
No. 60601-1:08, Dated February 2008.
Do not immerse device in liquids.
Accredited test house for IEC 60601
The device meets the requirements of
directive 93/42/EEC for medical devices.
It is authorized by an independent notified
body for which it bears the CE symbol.
The European Battery Directive 2006/66/
EC applies to this device.
See section “Disposal” on page 64.
This device contains lithium-ion batteries
that should be disposed of in accordance
with environment protection requirements.
Introduction
General Information

8 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Battery Reamer/Drill II (530.705)
Speed (without attachment) 0–340 rpm (maximum speed varies with attachment)
Torque (without attachment) 0–15 Nm (maximum torque varies with attachment)
Weight of handpiece (including battery pack) 1565 g/3.4 lb
Cannulation 4.0 mm diameter
Protection against electric shock BF
Protection against water ingress IP X 4
Technical data is subject to tolerances.
Attachment release ring
Facilitates one-handed
removal of attachments
Variable-speed trigger
Controls rotational speed
Release buttons
Both release buttons must be
pressed simultaneously to remove
battery casing
Battery casing
Protects sterile environment from
contamination by unsterile battery
Battery casing locks
To open and close the lid of the battery casing and
prevent the casing from opening during surgery. Both
battery casing locks must be pressed simultaneously to
open and close the lid
Locked symbol
Drive unit is off
for safety
FWD
Clockwise rotation
REV
Counterclockwise
rotation
Mode switch
Introduction
Drive Units