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

Battery Power Line II User’s Manual DePuy Synthes Power Tools 9
Battery Oscillator II (530.710)
Speed 0–12,000 oscillations per minute
Deflection 4.5° (0° +/-2.25°)
Weight of handpiece (including battery pack) 1685 g/3.7 lb
Protection against electric shock BF
Protection against water ingress IP X 4
Technical data is subject to tolerances.
Saw blade coupling
To insert or remove saw blade
Sliding sleeve
Allows sawing plane to be adjusted
through 360°, in 45° increments
Variable-speed trigger
Controls oscillating frequency
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
ON
Drive unit is on
for sawing
Saw head Mode switch
Locking knob
Allows keyless assembly
and removal of saw blades
Introduction
Drive Units

10 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Battery Reciprocator II (530.715)
Speed 0–14,000 oscillations per minute
Stroke 4 mm
Weight of handpiece (including battery pack) 1675 g/3.6 lb
Protection against electric shock BF
Protection against water ingress IP X 4
Technical data is subject to tolerances.
Saw blade coupling
To insert or remove
saw blade
Release knob
Ejects saw blade
Sliding sleeve
Allows sawing plane to be adjusted
through 360°, in 45° increments
Variable-speed trigger
Controls reciprocating frequency
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
ON
Drive unit is on
for sawing
Saw head
Mode switch
Introduction
Drive Units

Battery Power Line II User’s Manual DePuy Synthes Power Tools 11
Battery for Battery Power Line II (530.630)
Type Li-Ion (lithium ion)
Voltage 14.8 V
Capacity 1.5 Ah/22.2 Wh
Charging time Typically <60 minutes
Technical data is subject to tolerances.
Note: For further information on the correct method
of charging, storing and using the battery, please
refer to page 17.
Introduction
Drive Units

12 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Operating Instructions
Universal Battery Charger II
The Universal Battery Charger II (05.001.204) includes
four independent charging bays. Each charging bay has
three slots; the Battery Power Line II battery (530.630)
fits into the top slot.
Note: For the BPL II battery to be recognized
and charged by the UBC II, firmware version 14.0*
is required. If necessary, send the charger to a
DePuy Synthes representative for a firmware update.
For further information on the Universal Battery Charger II,
please consult the relevant Instructions for Use or contact
your local DePuy Synthes office.
The BPL II battery cannot be charged with the Universal
Battery Charger (item number 530.600 or 530.601).
1 Charging bays (4)
2 Symbols for battery type
3 ON/OFF display
4 Control display for each charging bay
5 Ventilation holes
6 Ventilation holes
7 Power switch
8 Fuses: 2 x 5 AT/250 V
9 Power cord connection
10 Symbol for BPL and II batteries
(530.620 or 530.630)
* Sticker as shown on the underside of the charger with firmware version 14.0:
Front View
1
2
3
4
5
10
6
7
8
9
Rear View
SW-Rev. 14.0
2013/01/09

Battery Power Line II User’s Manual DePuy Synthes Power Tools 13
DePuy Synthes non-sterile batteries and advanced charging
technology optimize intraoperative battery capacity,
maximize battery lifespan, and shorten turnaround time.
One Universal Battery Charger II (05.001.204) for multiple
DePuy Synthes battery-driven systems simplifies the
charging process. Simple aseptic technique preserves the
sterile field when assembling the battery pack.
Instruments
530.630 Battery for Battery Power Line II
530.660 Insertion Shield for Battery Power Line II
530.690 Battery Casing for Battery Power Line II
Assembling and Inserting the Battery Pack
For instructions on Assembling and Inserting a battery
sterilized in Sterrad®or V-PRO®systems, please refer to
page 61.
Scrubbed Person
Open the lid of the battery casing (Figure 1).
Ensure the lid of the battery casing is fully open (Figure 2).
Ensure that the lid of the battery casing is facing towards
the scrubbed person (Figure 3).
Position the insertion shield securely on top of the battery
casing (Figure 4).
Notes
• The insertion shield helps to guide the battery into
the battery casing and prevents contamination
of the sterile casing by the non-sterile battery.
• Sterilize the insertion shield after each use to
ensure aseptic conditions when inserting the
non-sterile battery into the sterile battery casing.
Precautions
• If the non-sterile battery contacts the outside
of the battery casing, the battery casing must be
cleaned and resterilized before being used in the
operating room.
• Do not insert the non-sterile battery into the
battery casing whilst a handpiece is attached.
Operating Instructions
Battery Pack
(battery casing with inserted battery)
Figure 1
Figure 2
Figure 3
Figure 4

14 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Operating Instructions
Battery Pack
Circulating Person
Insert the non-sterile battery through the insertion shield
into the battery casing (Figure 5a). Press down on the
battery to ensure it is fully seated (Figure 5b).
Note: The shape of the battery ensures that it is
inserted with the correct pole alignment. The
circulating person must not touch the outside of
the battery casing.
Remove the insertion shield from the battery casing
(Figure 6).
Precaution: Avoid all contact with the outside of the
battery casing to prevent contamination. Should the
non-sterile battery or the circulating person’s hand
come into contact with the outside of the battery
casing, it must be cleaned and resterilized before
being used in the operating room.
Figure 5a
Figure 5b
Figure 6
Circulating person
Scrubbed person
Circulating person
Scrubbed person
Circulating person
Scrubbed person

Battery Power Line II User’s Manual DePuy Synthes Power Tools 15
Scrubbed Person
Close the battery casing (Figures 7a and 7b).
Note: Ensure that both battery casing locks engage
and that the lid of the battery casing is closed
properly. Always ensure that the lid of the battery
casing is totally closed before using the system.
Precaution: Do not contact the non-sterile battery
or the inside of the battery casing to avoid
contamination. Should the scrubbed person
come into contact with either the non-sterile battery
or the inside of the battery casing, they must be
scrubbed again. Should the battery casing be
contaminated, it must be cleaned and resterilized
before being used in the operating room.
Notes
• Normally, one fully charged battery has sufficient
capacity for an entire operation. As a precaution,
a second battery pack (battery casing with inserted
battery) should be kept ready, so that the battery
pack can be quickly exchanged under sterile
conditions during surgery if necessary.
• Never open a battery casing intraoperatively to
insert a new battery. Always replace the whole
battery pack by another battery pack prepared
before the start of the surgery.
Insert the battery pack into the drive unit, ensuring the
contacts on the battery pack align with the contacts in
the recess of the drive unit (Figure 8). Press firmly to
ensure the battery pack is engaged correctly, and check
by pulling lightly downward on the battery pack.
Notes
• For safety reasons, the battery pack can only be
inserted fully when it is in the correct orientation.
• To prevent injuries, the mode switch of the drive
unit should always be in the off position when
inserting or removing the battery pack.
• Installing the battery pack just before use prevents
unwanted discharge of battery capacity.
Operating Instructions
Battery Pack
Figure 7a
Figure 7b
Figure 8

16 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Operating Instructions
Battery Pack
Removing and Disassembling the Battery Pack
Press both release buttons simultaneously on the drive
unit to remove the battery pack (Figure 9).
Open the casing by pressing both battery casing locks and
remove the battery or hold open the battery casing to allow
another person to remove the battery (Figure 10).
Ensure that the battery does not touch the exterior of
the battery casing to avoid contaminating the battery. If
this occurs, follow the information in the “Care and
Maintenance” section starting on page 40.
Store battery in Universal Battery Charger II (05.001.204)
when not in use (Figure 11).
Precaution: Do not wash, rinse, drop, or apply force
to the battery (530.630). This will destroy it with
possible secondary damage.
Figure 9
Figure 10
Figure 11
Circulating person
Scrubbed person

Battery Power Line II User’s Manual DePuy Synthes Power Tools 17
Charging, Storing, and Using Batteries
Charging
Only use the DePuy Synthes Universal Battery Charger II
(05.001.204) to charge the battery. Using a charger that
does not originate from DePuy Synthes can damage
the battery.
For the BPL II battery to be recognized and charged by the
Universal Battery Charger II, a minimum firmware version
of 14.0 is required.
If necessary, send the charger to a DePuy Synthes
representative for a firmware update.
The BPL II battery cannot be charged with the Universal
Battery Charger (item number 530.600 or 530.601).
The batteries should always be charged before use.
Place the battery into the charger immediately after surgery.
Charge the batteries within an ambient temperature
range of 10 °C/50 °F to max. 40 °C/104 °F.
Keep the charger and the batteries clean and in a cool
and dry place.
Detailed information on the Universal Battery Charger II
can be found in the relevant User’s Manual (J8895).
Storage
Always recharge the Li-Ion Battery for Battery Power Line
II (530.630) after each use. Do not store an empty battery
as this will shorten the life span and will not be covered
by warranty.
When the battery is not in use, store it in the
DePuy Synthes Universal Battery Charger II (05.001.204).
This will guarantee that the battery is always fully charged
and ready to use.
The Universal Battery Charger II should always be turned
on when a battery is in the charging bay. This ensures
availability of charged batteries.
Operating Instructions
Battery Pack
Do not expose batteries to heat or fire. Avoid storage in
direct sunlight.
Keep the charger and the batteries clean and in a cool
and dry place.
Use
Do not remove battery from its original packaging until
required for use.
Do not drop or apply force to the battery. This will destroy
it with possible secondary damage.
Do not use any battery which is not designed for use with
the equipment.
Do not use a faulty or damaged battery, as this may damage
the power tool.
Do not short circuit a battery.
Do not store or transport batteries haphazardly in a box
or drawer where they may short circuit each other or be
short circuited by other metal objects. This can damage
the batteries and generate heat, which can cause burns.
Batteries give their best performance when they are operated
at normal room temperature (20 °C/68 °F +/- 5 °C/9 °F).
The power tool may only be operated with a fully charged
battery. Therefore the batteries should always be charged
before use.
Place the battery into the charger immediately after surgery.
Only insert the battery pack directly before using the
power tool. This saves battery energy and prevents having
to change it during surgery.
Follow the information in the “Care and Maintenance”
section starting on page 40 as well as the User’s Manual
of the DePuy Synthes Universal Battery Charger II (J8895).

18 DePuy Synthes Power Tools Battery Power Line II User’s Manual
Operating Instructions
Battery Pack
Notes
• Generally, medical power tools can heat up if in
constant use. The cool down times should be
observed; see “Duty Cycle” section on page 71, to
prevent the power tool from exceeding its acceptable
surface temperature.
• In case of cell leakage, do not allow the leaking
fluid to come into contact with skin or eyes. In
case of contact, wash the affected area with
copious amounts of water and seek medical advice.
• Faulty batteries may not be reused and should be
disposed of in an environmentally friendly manner
and in accordance with national regulations.
Warnings
• Never expose batteries to temperatures over
60 °C/140 °F. The maximum exposure time at
60 °C/140 °F is 72 hours.
• Do not dismantle, open, or shred batteries.