Synthes Air Power Line II User manual

Battery Driven Power Tool System for Orthopedics and Traumatology
Battery Power Line II
Instructions for Use

Battery Power Line II Surgical Technique DePuy Synthes 1
Table of Contents
Introduction General Information 3
Drive Units 8
Universal Battery ChargerII 13
Operating Instructions Battery Pack
(battery casing with inserted battery) 14
Battery Reamer/DrillII (530.705) 22
Attachments for Battery Reamer/DrillII 23
Battery OscillatorII (530.710) 39
Battery ReciprocatorII (530.715) 42
Care and Maintenance General Information 45
Cleaning and Disinfection 47
• Preparation prior to Reprocessing 47
• Manual Cleaning Instructions 48
• Automated Cleaning Instructions
with Manual Pre-cleaning 51
Maintenance and Lubrication 57
Inspection and Function Test 63
Packaging, Sterilization and Storage 64
Repairs and Technical Service 67
Disposal of Waste 68

2 DePuy Synthes Battery Power Line II Surgical Technique
Table of Contents
Troubleshooting 69
System Specifications 75
Electromagnetic Compatibility 79
Ordering Information 84

Battery Power Line II Surgical Technique DePuy Synthes 3
Introduction
General Information
Intended use
The Battery Power Line II is a battery-powered system to
be used for treatment in orthopedic and traumatology
surgery, i.e. drilling, reaming, cutting, placing of
Kirschner Wires on bone of human skeleton.
Battery Reamer/DrillII
Drilling
Kirschner wire insertion
Reaming
Fixing of cutting block with a pin
Battery OscillatorII Battery ReciprocatorII
Oscillating sawing Reciprocating sawing

4 DePuy Synthes Battery Power Line II Surgical Technique
Safety instructions
The surgeon has to evaluate if the machine is suitable
for an application, based on power limitation of the
machine, attachment and cutting tool regarding bone
strength/anatomical situation as well as handling of the
machine, attachment and cutting tool regarding bone
size. In addition, the contraindications of the implant
have to be respected. Please refer to the corresponding
surgical techniques of the implant system used.
The Battery Power Line II system is only to be used for
patient treatment after careful consultation of the in-
structions 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 apparently damaged components.
DO NOT use any component if the packaging is dam-
aged.
DO NOT use this equipment in the presence of oxygen,
nitrous oxide or a mixture consisting of ammable anes-
thetic and air.
To ensure proper operation of the tool, only use Synthes
original accessories.
Before rst and every use and prior returning for service
power tools and their accessories/attachments, excluding
the battery, have to be run through the complete repro-
cessing procedure. Protective covers and lms must be
fully removed before sterilization.
For the tool to function properly, Synthes recommends
that it is cleaned, disinfected and serviced after each use
in accordance with the process dened in the “Care and
Maintenance” section. Compliance with these specica-
tions can considerably extend the service life of the tool
and reduce the risk of malfunction or harm to the user
and patient. Only use Synthes Special Oil (519.970) to lu-
bricate the tool.
Introduction
General Information
We recommend using new Synthes cutting tools for
every surgical procedure. Efciently 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 uid 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.
Unusual Transmissible Pathogens
Surgical patients identied as at risk for Creutzfeldt-
Jakob disease (CJD) and related infections should be
treated with single-use instruments. Dispose of the
instruments used or suspected of use on a patient with
CJD after surgery and/or follow the current national
recommendations.
To prevent overheating, always respect the specied
duty cycles on page 76. High torque of the powerful
Reamer/Drill (530.705) must always be observed.
For important information regarding electromagnetic
compatibility (EMC) please refer to the “Electromagnetic
Compatibility” section in this manual.
The tool is classied as type BF against electrical shock
and leakage current. The tool is suitable for use on
patients in accordance with IEC 60601-1.
Servicing
This system requires regular maintenance service, at least
once a year, in order to maintain its functionality. This
service has to be performed by the original manufacturer
or an authorized site.
The manufacturer assumes no responsibility for damage
resulting from improper operation, neglected or unau-
thorized maintenance of the tool.

Battery Power Line II Surgical Technique DePuy Synthes 5
Precautions :
• 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 before placing the tool back 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 being
dropped or contaminating other instruments.
• Should the machine drop on the oor and have
visible defects, do not use it anymore and send it to
the Synthes Service Center.
• If a product drops on the oor, fragments may split
off. This represents a danger for the patient and
user as:
–these fragments may be sharp.
–unsterile fragments may enter the sterile eld or
hit the patient.
• The tool must only be operated with a fully
charged battery. Therefore, ensure that the battery
is charged in good time. We recommend to install
the battery pack just before use in order to prevent
unwanted discharge of battery capacity. Further-
more, it is recommended that the battery is placed
into the charger immediately after surgery.
• The aseptic transfer is detailed on page 14ff. Alter-
natively please follow the guidelines provided in
the STERRAD/V-PRO sterilization guide
(DSEM/PWT/0615/0068). No other sterilization
methods are allowed.
• The battery must never be washed, rinsed or
dropped. This would destroy the battery with pos-
sible secondary damage (explosion hazard!). Only
use original Synthes batteries. Further informa-
tion can be found on page 20ff.
• Never place the BPLII in a magnetic environment
since the machine might start unintentionally.
• Should the system have corroded parts, do not use
it anymore and send it to the Synthes Service
Center.
Locating of the instrument or fragments of
instruments
Synthes instruments are designed and manufactured to
perform within the scope of their intended use. How-
ever, if a Power Tool or accessory/attachment breaks
during use, a visual inspection or a medical imaging de-
vice (e.g. CT, Radiation Devices, etc.) can aid in locating
the fragments and/or components of the instrument.

6 DePuy Synthes Battery Power Line II Surgical Technique
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.
Please refer to the “Ordering Information” section on
page 84ff for an overview of the components of the
system.
To charge the batteries only use the corresponding
Synthes Universal Battery ChargerII (05.001.204).
To reach the specied performance only Synthes cutting
tools should be used. These are optimized to meet the
specic 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 must 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 at-
tachments when clean.
Synthes recommends the use of the specically 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
51ff.
Storage and transport
Only use the original packaging for dispatch and trans-
port as otherwise damage may occur. If the packing
material is no longer available, please contact your local
Synthes ofce.
Please refer to the guidelines for transporting Li-Ion
batteries when returning them to the Synthes Service
Center.
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.
For storage and transport environmental conditions
please refer to the section “System Specication” on
page 75.
Warranty/Liability
The warranty for the tools and accessories does not
cover damage of any kind resulting from wear, improper
use, improper reprocessing and maintenance, damaged
seal, use of non Synthes cutting tools and lubricants or
improper storage and transport.
The manufacturer excludes liability for damage resulting
from improper use, neglected or unauthorized mainte-
nance or servicing of the tool.
For further information on the warranty please contact
your local Synthes ofce.
Introduction
General Information

Battery Power Line II Surgical Technique DePuy Synthes 7
Explanation of symbols used
The following symbols are applied to the device or
individual components. Information on additional sym-
bols is given in the relevant sections of this document.
S9
IP X4
Caution
Consult the provided instructions for use
before operating the device.
The device is classied as type BF against
electrical shock and leakage current.
The device is suitable for use on patients
according to the standards dened by
IEC60601-1.
Indicates Environment Friendly Use Period
of 5 years in China.
Indicates Environment Friendly Use Period
of 10 years in China.
Do not immerse device in liquids.
Product is UL Classied to the require-
ments of both the United States and
Canada
The device meets the requirements of
directive 93/42/EEC for medical devices. It
is authorized by an independent notied
body for which it bears the CE symbol.
The European Battery Directive 2006/66/
EC applies to this device. See section
“Disposal of Waste” on page 68. This
device contains Lithium-Ion batteries that
should be disposed of in accordance with
environment protection requirements.
Please observe national regulations. See
section entitled "Disposal of Waste" on
page 68.
The European directive 2012/19/EC on
waste electrical and electronic equipment
(WEEE) applies to this device. This device
contains materials that should be dis-
posed of in accordance with environment
protection require ments. Please observe
national regulations. See section entitled
“Disposal of Waste” on page 68.
Duty cycle type according to
IEC60034-1.
Ingress protection rating according to
IEC60529.
Locked symbol. Drive Unit is off for safety.
Manufacturer
Date of manufacture
Non sterile
Temperature
Relative humidity
Atmospheric pressure
Do not use if package is damaged.
Cd MH
Li-Ion
Cd MH
0123

8 DePuy Synthes Battery Power Line II Surgical Technique
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 B 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.
Introduction
Drive Units
Attachment release ring
Facilitates one-handed
removal of attachments
Battery casing
Protects sterile environment from
contamination by non-sterile 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.
Variable-speed trigger
Controls rotational speed
Release buttons
Both release buttons must be pressed
simultaneously to remove battery casing
Mode switch
Locked symbol
Drive unit is off
for safety
FWD
Clockwise rotation
REV
Counterclockwise
rotation

Battery Power Line II Surgical Technique 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 water ingress IP X4
Synthes Special Oil (519.970) included
Technical data is subject to tolerances.
Saw blade coupling
To insert or remove saw blade
Locking knob
Allows keyless assembly and
removal of saw blades
Battery casing
Protects sterile environment from
contamination by non-sterile 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.
Sliding sleeve
Allows sawing plane to be adjusted
through 360°, in 45° increments
Release buttons
Both release buttons must be pressed
simultaneously to remove battery casing
Variable-speed trigger
Controls oscillating frequency
Mode switch
Saw head
Locked symbol
Drive unit is off
for safety
ON
Drive unit is on
for sawing

10 DePuy Synthes Battery Power Line II Surgical Technique
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.
Saw blade coupling
To insert or remove
saw blade
Release knob
Ejects saw blade
Battery casing
Protects sterile environment from
contamination by non-sterile 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.
Sliding sleeve
Allows sawing plane to be adjusted
through 360°, in 45° increments
Release buttons
Both release buttons must be pressed
simultaneously to remove battery casing
Variable-speed trigger
Controls reciprocating frequency
Mode switch
Locked symbol
Drive unit is off
for safety
ON
Drive unit is on
for sawing
Saw head

Battery Power Line II Surgical Technique 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 20ff.

12 DePuy Synthes Battery Power Line II Surgical Technique
Introduction
Drive Units
Compatibility between BPL and BPLII batteries
Existing BPL handpieces are compatible with BPLII
batteries
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.
Note: All BPL/BPL II attachments are fully
compatible with the BPL/BPL II handpieces
(530.605/530.705).
530.605
530.690
530.705
530.680
Figure 1
Figure 2

Battery Power Line II Surgical Technique DePuy Synthes 13
Introduction
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)
ts into the top slot.
Note: In order that the BPLII battery can be recog-
nized and charged by the UBCII, a minimum of
rmware version 14.0* is required. If necessary,
send the charger to a Synthes representative for a
rmware update.
For further information on the Universal Battery
ChargerII please consult the relevant Instructions for Use
(DSEM/PWT/1114/0050) or contact your local Synthes
o f  c e .
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 × 5 AT/250 V
9 Power cord connection
10 Symbol for BPL andBPL II batteries
(530.620 or 530.630)
Front view
Rear view
1
2
3
4
5
6
7
8
9
10
* Sticker as shown on the underside of the charger with firmware
version 14.0:
SW-Rev.14.0
2013/01/09

14 DePuy Synthes Battery Power Line II Surgical Technique
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 multi-
ple Synthes battery-driven systems simpli es the charg-
ing process. Simple aseptic technique preserves the ster-
ile  eld when assembling the battery pack.
The aseptic transfer is detailed below. Alternatively use
the STERRAD/V-PRO sterilization guide if preferred
(DSEM/PWT/0615/0068).
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).
Figure 1
Figure 2

Battery Power Line II Surgical Technique DePuy Synthes 15
Figure 3
Figure 4
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 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 bat-
tery casing whilst a handpiece is attached.

16 DePuy Synthes Battery Power Line II Surgical Technique
Operating Instructions
Battery Pack
(battery casing with inserted battery)
Circulating person
Insert the non-sterile battery through the sterile cover
into the battery casing (Fig. 5a). Press down on the bat-
tery to ensure it is fully seated (Fig. 5b).
Note: The shape of the battery ensures that it is in-
serted with the correct pole alignment. The circulat-
ing 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 non-sterile battery or the circulating person’s
hand come into contact with the outside of the bat-
tery casing, it must be cleaned and resterilized be-
fore being used in the operating room.
Figure 5a
Scrubbed person
Circulating
person
Circulating
person
Circulating
person
Figure 5b
Figure 6
Scrubbed person
Scrubbed person

Battery Power Line II Surgical Technique DePuy Synthes 17
Scrubbed person
Close the battery casing (Figs. 7a and 7b).
Both battery casing locks must be pressed simultane-
ously to close the lid of the battery casing (Fig. 7a).
Note: Ensure that both battery casing locks engage
and that the lid of the battery casing is closed pro-
perly. Always ensure that the lid of the battery cas-
ing 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 suf cient
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 con-
ditions during surgery if necessary.
• Never open a battery casing intraoperatively to
insert a new battery. Always replace the whole
battery pack with another battery pack prepared
before the start of the surgery.
Figure 7a
Figure 7b

18 DePuy Synthes Battery Power Line II Surgical Technique
Operating Instructions
Battery Pack
(battery casing with inserted battery)
Figure 8
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  rmly to ensure
the battery pack is engaged correctly, and check by pull-
ing lightly downward on the battery pack.
Precautions:
• 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.