Johnson & Johnson DePuy Synthes Battery Power Line II User manual

Battery Power Line II (BPL II).
Battery driven power tool system for
orthopedics and traumatology.
Instructions
for Use
This publication is not intended for
distribution in the USA.
Instruments and Implants
approved by the AO Foundation

Content
Introduction General Information 3
Drive Units 8
Operating Instructions Battery Pack 14
Battery Reamer/Drill II 20
Attachments for Battery Reamer/Drill II 21
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 with Manual
Pre-cleaning 44
Lubrication 48
Inspection and Function Test 54
Packaging, Sterilization and Storage 55
Repairs and Technical Service 58
Disposal of Waste 59
Troubleshooting 60
System Specifications 63
Electromagnetic Compatibility Accompanying Documents 67
Ordering Information 71
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.
Battery Power Line II Instructions for Use DePuy Synthes 1

2 DePuy Synthes Battery Power Line II Instructions for Use

Introduction
General Information
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
Battery Oscillator II
Oscillating sawing
Reaming
Fixing of cutting block with a pin
Battery Reciprocator II
Reciprocating sawing
Battery Power Line II Instructions for Use DePuy Synthes 3

Introduction
General Information
4 DePuy Synthes Battery Power Line II Instructions for Use
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 alter-
native 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 oxy-
gen, nitrous oxide or a mixture consisting of flamma-
ble anesthetic and air.
To ensure proper operation of the tool, only use Syn-
thes original accessories.
Before first and every use and prior returning for ser-
vice 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 rec-
ommends 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
(519.970) to lubricate the tool.
We recommend using new 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 64.
If the Battery Power Line II is used in conjunction
with an implant system make sure to consult the cor-
responding Technique Guide.
For important information regarding electromagnetic
compatibility (EMC) please refer to the “Electromag-
netic 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.
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 im-
proper operation, neglected or unauthorized
maintenance of the tool.

Battery Power Line II Instructions for Use DePuy Synthes 5
Notes:
–Always wear personal protective equipment
(PPE) including safety goggles when handling
with the BPL II system.
–To avoid injuries, the locking mechanism of the
tool has to be activated before every manipula-
tion 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 intraopera-
tively. The handpiece must be laid on its side
when not in use in order to avoid the risk of be-
ing 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 bat-
tery is charged in good time. We recommend
that the battery is placed into the charger imme-
diately 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 Synthes batteries.
Further information can be found on page 18ff.
–Never place the BPL II in a magnetic environ-
ment since the machine might start unintention-
ally.

Introduction
General Information
6 DePuy Synthes Battery Power Line II Instructions for Use
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
Synthes Universal Battery Charger II (05.001.204).
To reach the specified performance only Synthes
cutting tools should be used. These are optimized to
meet the specific requirements of the tool.
Non Synthes saw blades can considerably reduce
the lifetime of the system
Special auxiliaries such as cleaning brushes
(516.101) and Synthes Special Oil (519.970) are
available for cleaning and servicing the system.
No oils from other manufacturers may be used. Only
Synthes Special Oil (519.970) must be used to lubri-
cate the power tools and attachments.
Lubricants with other compositions may cause jam-
ming, 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 specifi-
cally designed Synthes Washing Baskets
(68.001.620, 68.001.625) or Synthes Vario Case
(689.202) to sterilize and store the system. Further-
more, the Washing Baskets (68.001.620,
68.001.625) can be used for the automated cleaning
procedure. Further information can be found on page
46ff.
Please refer to the “Ordering Information” section on
page 71ff 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 Syn-
thes office.
For storage and transport environmental conditions
please refer to the “Packaging, Sterilization and
Storage” section on page 55ff.
Warranty
The warranty for the tools and accessories does not
cover damage of any kind resulting from wear, im-
proper use, damaged seal, use of non Synthes cut-
ting tools and lubricants or improper storage and
transport.
The manufacturer shall assume no responsibility for
damage resulting from improper operation, neglected
or unauthorized maintenance of the tool.
For further information on the warranty please con-
tact your local DePuy Synthes office.

Battery Power Line II Instructions for Use DePuy Synthes 7
Explanation of symbols used
The following symbols are applied to the device or
individual components.
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.
10PB
Accredited test house for IEC 60601
0123
The device meets the requirements of
directive 93/42/EEC for medical de-
vices. It is authorized by an independ-
ent notified body for which it bears the
CE symbol.
Li-Ion
The European Battery Directive
2006/66/EC applies to this device.
See section “Disposal” on page 60.
This device contains Lithium-Ion
batteries that should be disposed of in
accordance with environment protection
requirements.
This symbol indicates that this battery
contains rechargeable Lithium-Ion cells.
The battery is rechargeable.
S9 Duty cycle type according to
IEC 60034-1.
IP X4 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

Introduction
Drive Units
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 lbs
Cannulation Ø 4.0 mm
Protection against
electric shock BF
Protection against
water ingress
IP X4
Cleaning brush (516.101) and Synthes Special Oil
(519.970) included
Technical data is subject to tolerances.
8 DePuy Synthes Battery Power Line II Instructions for Use

Battery Power Line II Instructions for Use DePuy Synthes 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 lbs
Protection against
electric shock BF
Protection against wa-
ter ingress
IP X4
Synthes Special Oil (519.970) included
Technical data is subject to tolerances.

Introduction
Drive Units
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 lbs
Protection against
electric shock BF
Protection against
water ingress
IP X4
Synthes Special Oil (519.970) included
Technical data is subject to tolerances.
10 DePuy Synthes Battery Power Line II Instructions for Use

Battery Power Line II Instructions for Use DePuy Synthes 11
Battery for Battery Power Line II
Art. no. 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 18ff.

Introduction
Drive Units
Compatibility between BPL and BPL II batteries
Existing BPL handpieces are compatible with
BPL II batteries
12 DePuy Synthes Battery Power Line II Instructions for Use
The existing BPL handpieces (530.605, 530.610,
530.615) can be used with the new BPL II battery
(530.630), battery casing (530.690) and sterile cover
(530.660) as seen in Fig. 1.
Existing BPL batteries are compatible with BPL II
handpieces
The existing BPL battery (530.620), battery casing
(530.680) and sterile cover (530.650) can be used
with the new BPL II handpieces (530.705, 530.710,
530.715) as seen in Fig. 2.
Note:
Technical data is subject to tolerances and may vary
when combining the two systems.
Figure 1
530.605
530.690
530.705
530.680
Figure 2

Introduction
Universal Battery Charger II
Battery Power Line II Instructions for Use DePuy Synthes 13
The Universal Battery Charger II (05.001.204) in-
cludes four independent charging bays. Each charg-
ing bay has three slots; the Battery Power Line II
battery (530.630) fits into the top slot.
Note:
In order that the BPL II battery can 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.
*Sticker as shown on the underside of the charger
with firmware version 14.0:
For further information on the Universal Battery
Charger II please consult the relevant Instructions for
Use (036.000.500) or contact your local DePuy Syn-
thes office.
The BPL II battery cannot be charged with the Uni-
versal Battery Charger (item number 530.600 or
530.601).
1Charging bays (4)
2Symbols for battery type
3ON/OFF display
4Control display for each charging bay
5Ventilation holes
6 Ventilation holes
7Power switch
8Fuses: 2 x 5 AT / 250 V
9Power cord connection
10 Symbol for BPL I and II batteries (530.620 or
530.630)
10
SW-Rev. 14.0
2013/01/09

Operating Instructions
Battery Pack (battery casing with inserted battery)
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 Synthes battery-driven systems simplifies
the charging process. Simple aseptic technique pre-
serves the sterile field when assembling the battery
pack.
Instruments
530.630 Battery for Battery Power Line II
530.660 Sterile Cover for Battery Power Line II
530.690 Battery Casing for Battery Power Line II
Assembling and inserting the battery pack
Scrubbed person
Open the lid of the battery casing as shown in Fig. 1.
Ensure the lid of the battery casing is fully open
(Fig. 2). Ensure that the lid of the battery casing is
facing towards the scrubbed person (Fig. 3).
Position the sterile cover securely on top of the bat-
tery casing (Fig. 4).
Notes:
–The sterile cover helps to guide the battery into
the battery casing and prevents contamination of
the sterile casing by the non-sterile battery.
–Sterilize the sterile cover after each use to en-
sure aseptic conditions when inserting the un-
sterile battery into the sterile battery casing.
–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 bat-
tery casing whilst a handpiece is attached.
Figure 1
Figure 2
Figure 3
530.690
Scrubbed person
Scrubbed person
Scrubbed person
Scrubbed person
530.660
530.690
Figure 4
14 DePuy Synthes Battery Power Line II Instructions for Use

Circulating person
Insert the non-sterile battery through the sterile cover
into the battery casing (Fig. 5a). Press down on the
battery to ensure it is fully seated (Fig. 5b).
Note:
The shape of the battery ensures that it is inserted
with the correct pole alignment. The circulating per-
son must not touch the outside of the battery casing.
Remove the sterile cover from the battery casing
(Fig. 6).
Precaution:
Avoid all contact with the outside of the battery
casing in order not to contaminate it. 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.
Circulating person
Figure 5a
Figure 5b
Figure 6
Circulating person
Circulating person
530.630
530.660
530.690
Scrubbed person
Scrubbed person
Scrubbed person
Battery Power Line II Instructions for Use DePuy Synthes 15

Operating Instructions
Battery Pack (battery casing with inserted battery)
16 DePuy Synthes Battery Power Line II Instructions for Use
Scrubbed person
Close the battery casing (Figs. 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 in order to avoid con-
tamination. Should the scrubbed person come into
contact with either the non-sterile battery or the in-
side 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 in-
serted 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 con-
tacts in the recess of the drive unit (Fig. 8). Press
firmly to ensure the battery pack is engaged cor-
rectly, 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 in-
serting or removing the battery pack.
–Installing the battery pack just before use pre-
vents unwanted discharge of battery capacity.
Figure 7a
Figure 7b
Figure 8
Scrubbed person
530.705
530.690
Scrubbed person
Scrubbed person

Removing and disassembling the battery pack
Press both release buttons simultaneously on the
drive unit to remove the battery pack (Fig. 9).
Open the casing by pressing both battery casing
locks and remove the battery or hold open the bat-
tery casing to allow another person to remove the
battery (Fig. 10).
Ensure that the battery does not touch the exterior of
the battery casing in order to avoid contaminating the
battery. If this occurs follow the information in the
“Care and Maintenance” section starting on page 39.
Store battery in Universal Battery Charger II
(05.001.204) when not in use (Fig. 11).
Precaution:
Do not wash, rinse, sterilize, drop or apply force to
the battery (530.630). This will destroy it with possi-
ble secondary damage.
Figure 9
Scrubbed person
Scrubbed person
Circulating person
Figure 10
Figure 11
Battery Power Line II Instructions for Use DePuy Synthes 17

Operating Instructions
Battery Pack (battery casing with inserted battery)
18 DePuy Synthes Battery Power Line II Instructions for Use
Charging, storing and using batteries
Charging
Only use the Synthes Universal Battery Charger II
(05.001.204) to charge the battery. Using a charger
that does not originate from Synthes can damage the
battery.
In order that the BPL II battery can 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.
The BPL II battery cannot be charged with the Uni-
versal 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 Instructions for Use
(036.000.500).
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 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.
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 al-
ways 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 Mainte-
nance” section starting on page 39 as well as the
Instructions for Use of the Synthes Universal Battery
Charger II (036.000.500).