Johnson & Johnson DePuy Synthes Battery Power Line II, BPL II Instructions For Use Manual
Instructions
for Use
Battery Power Line II (BPL II).
Battery driven power tool system for
orthopedics and traumatology.
This publication is not intended for
distribution in the USA.
Instruments and Implants
approved by the AO Foundation
Content
Introduction
Operating Instructions
Care and Maintenance
General Information
Drive Units
Battery Pack
Battery Reamer/Drill II
Attachments for Battery Reamer/Drill II
Battery Oscillator II
Battery Reciprocator II
General Information
Preparation prior to Cleaning
Manual Cleaning Instructions
Automated Cleaning Instructions with Manual
Pre-cleaning
Lubrication
Inspection and Function Test
Packaging, Sterilization and Storage
3
8
14
20
21
35
37
39
40
41
44
48
54
55
Troubleshooting
System Specifications
Electromagnetic Compatibility
Ordering Information
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.
Repairs and Technical Service
Disposal of Waste
Accompanying Documents
58
59
60
63
67
71
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 batterydriven system intended for orthopedic and trauma
applications including:
– Drilling
– Reaming
– Inserting / removing Kirschner wires and pins
– Cutting bone
Battery Reamer/Drill II
Drilling
Reaming
Kirschner wire insertion
Battery Oscillator II
Oscillating sawing
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
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 Synthes original accessories.
Before first and every use and prior 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
(519.970) 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 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.
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, neglected or unauthorized
maintenance of the tool.
4 DePuy Synthes Battery Power Line II Instructions for Use
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 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 in order 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 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 unintentionally.
Battery Power Line II Instructions for Use DePuy Synthes 5
Introduction
General Information
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 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 Synthes Washing Baskets
(68.001.620, 68.001.625) or Synthes Vario Case
(689.202) to sterilize and store the system. Furthermore, 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
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 55ff.
original packaging for dispatch and
Warranty
The wa
cover damage of any kind resulting from wear, improper use, damaged seal, use of non Synthes cutting 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 contact your local DePuy Synthes office.
rranty for the tools and accessories does not
6 DePuy Synthes Battery Power Line II Instructions for Use
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.
Accredited test house for IEC 60601
10PB
0123
Li-Ion
S9
IP X4
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 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.
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
Battery Power Line II Instructions for Use DePuy Synthes 7
Introduction
Drive Units
Battery Reamer/Drill II (530.705)
Speed
(without attachment)
Torque
(without attachment)
Weight of handpiece
(including battery pack)
Cannulation Ø 4.0 mm
Protection against
electric shock
Protection against
water ingress
Cleaning brush (516.101) and Synthes Special Oil
(519.970) included
0 – 340 rpm
(maximum speed varies
with attachment)
0 –15 Nm
(maximum torque varies
with attachment)
1565 g / 3.4 lbs
BF
IP X4
Technical data is subject to tolerances.
8 DePuy Synthes Battery Power Line II Instructions for Use
Battery Oscillator II (530.710)
Speed 0 – 12’000 oscillations per
minute
Deflection 4.5° (0° +/ - 2.25°)
Weight of handpiece
(including battery pack)
Protection against
electric shock
Protection against water ingress
Synthes Special Oil (519.970) included
1685 g / 3.7 lbs
BF
IP X4
Technical data is subject to tolerances.
Battery Power Line II Instructions for Use DePuy Synthes 9
Introduction
Drive Units
Battery Reciprocator II (530.715)
Speed 0 –14’000 oscillations
per minute
Stroke 4 mm
Weight of handpiece
(including battery pack)
Protection against
electric shock
Protection against
water ingress
Synthes Special Oil (519.970) included
1675 g / 3.6 lbs
BF
IP X4
Technical data is subject to tolerances.
10 DePuy Synthes Battery Power Line II Instructions for Use
Battery for Battery Power Line II
Art. no.
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.
530.630
Battery Power Line II Instructions for Use DePuy Synthes 11
Introduction
Drive Units
Compatibility between BPL and BPL II batteries
Existing BP
BPL II batteries
The existing
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.
L handpieces are compatible with
BPL handpieces (530.605, 530.610,
Figure 1
Figure 2
530.605
530.690
530.705
530.680
12 DePuy Synthes Battery Power Line II Instructions for Use
Introduction
Universal Battery Charger II
The Universal Battery Charger II (05.001.204) includ
es four independent charging bays. Each charging 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:
SW-Rev. 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 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 I and II batteries (530.620 or
2013/01/09
530.630)
10
Battery Power Line II Instructions for Use DePuy Synthes 13
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 preserves 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 p
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 battery 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 unsterile 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.
erson
Figure 1
Figure 2
Figure 3
Scrubbed person
530.690
Scrubbed person
Scrubbed person
Scrubbed person
530.660
14 DePuy Synthes Battery Power Line II Instructions for Use
Figure 4
530.690
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 person 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 nonsterile 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
Circulating person
530.630
530.660
530.690
Scrubbed person
Scrubbed person
Figure 5b
Circulating person
Figure 6
Battery Power Line II Instructions for Use DePuy Synthes 15
Scrubbed person
Operating Instructions
Battery Pack (battery casing with inserted battery)
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 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 (Fig. 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 pre-
vents unwanted discharge of battery capacity.
Figure 7a
Figure 7b
Figure 8
Scrubbed person
Scrubbed person
Scrubbed person
530.705
530.690
16 DePuy Synthes Battery Power Line II Instructions for Use
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 battery 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 possible secondary damage.
Figure 9
Circulating person
Scrubbed person
Scrubbed person
Figure 10
Figure 11
Battery Power Line II Instructions for Use DePuy Synthes 17
Operating Instructions
Battery Pack (battery casing with inserted battery)
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 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 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 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 39 as well as the
Instructions for Use of the Synthes Universal Battery
Charger II (036.000.500).
18 DePuy Synthes Battery Power Line II Instructions for Use
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 64,
in order to prevent the power tool from exceed-
ing 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 co-
pious amounts of water and seek medical ad-
vice.
– Faulty batteries may not be reused and should
be disposed of in an environmentally friendly
manner and in accordance with national regula-
tions.
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.
Battery Power Line II Instructions for Use DePuy Synthes 19
Operating Instructions
Battery Reamer/Drill II (530.705)
For clockwise rotation, turn the mode switch to the
“FWD” position.
For counterclockwise rotation, turn the mode switch
to the “REV” position.
The single variable-speed trigger allows control of
the speed from 0 to the maximum rpm. Maximum
torque and speed vary, depending on the attachment
(see pages 21 ff). Ensure that the correct attachment
is used for each operation in terms of speed and
torque.
For further information on the System Specifications
and Duty Cycle please refer to page 63f.
For safety, turn the
mode switch to the OFF
position.
For clockwise rotation,
turn the mode switch to
the FWD position.
For counterclockwise
rotation turn the mode
switch to the REV
position.
20 DePuy Synthes Battery Power Line II Instructions for Use
Operating Instructions
Attachments for Battery Reamer/Drill II
Instrument
530.705 Battery Reamer/Drill II
Precaution:
To prevent injuries, the mode switch of the drive unit
should always be in the “OFF” position when inserting
or removing attachments and cutting tools.
Please observe the safety instructions and warnings
stated in the instructions when working with attachments. Only use original Synthes attachments.
Damage resulting from the use of attachments from
other manufacturers is not covered by the warranty.
Insert attachment
Insert the attachment into the coupling of the Battery
Reamer/Drill II, aligning the positioning pins of the attachment with the grooves on the attachment release
ring (Fig. 1).
Turn the attachment release ring in the direction of the
arrow and push the attachment until it engages in
place (Fig. 2). If the attachment does not engage
properly then rotate the attachment gently until the
drive shaft engages.
Check that the attachment coupling is closed properly
by lightly pulling the attachment.
Remove attachment
Turn the attachment release ring in the direction of the
arrow and remove the attachment.
Note:
Properly functioning tools are essential to the success
of an operation. For this reason, used tools must be
checked for wear and/or damage after each use and
replaced if necessary.
Figure 1
Figure 2
Battery Power Line II Instructions for Use DePuy Synthes 21
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