AIR POWER LINE II
AIR POWER LINE II
Air driven power tool system for
orthopedics and traumatology
Instruments and implants approved by the AO Foundation.
This publication is not intended for distribution in the USA.
INSTRUCTIONS FOR USE
Contents
Introduction
Air Reamer/Drill II
Air Oscillator Air Reciprocator General Information
3
Startup of the Air Power Line system
6
Working with the Air Power Line system
7
Power Tool
8
Attachments for the Air Reamer/Drill II
9
Power Tool
18
Attaching the Saw Blades
19
Positioning the Saw Head
20
Power Tool
21
Attaching the Saw Blades
22
Positioning the Saw Head
23
Air Power Line II Instructions for Use DePuy Synthes 1
Contents
Care and Maintenance
General Information
24
Preparation prior to Cleaning
26
Manual Cleaning Instructions
27
Automated Cleaning Instructions with
Manual Pre-cleaning
29
Maintenance and Lubrication
33
Inspection and Function Test
35
Packaging, Sterilization and Storage
36
Repairs and Technical Service
38
Disposal of Waste
39
Troubleshooting
40
System Specifications
42
Ordering Information 46
2 DePuy Synthes Air Power Line II Instructions for Use
Introduction
General Information
Intended use
The Air Power Line II is a compressed air 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.
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 Air Power Line System 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 Air Power Line System is designed for use by physicians
and trained medical personnel.
DO NOT use any apparently damaged components.
DO NOT use any component if the packaging is damaged.
To ensure correct operation of the Air Power Line, use only
Synthes original accessories.
For the tool to function properly, Synthes recommends that
it is cleaned and serviced after each use in accordance with
the process defined in the “Care and Maintenance” section.
Compliance with these specifications 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 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.
Unusual Transmissible Pathogens
Surgical patients identified 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.
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 unauthorized
maintenance of the tool.
Recommended operating pressure: 6–7 bar (max 10 bar).
Only use original Synthes hoses for compressed air.
Before the first and every use and prior returning for service,
power tools and their accessories/attachments have to run
through the complete reprocessing procedure. Protective
covers and films must be fully removed before sterilization.
The user of the product is responsible for proper user of the
equipment during surgery.
Check correct operation of the tools before using it on the
patient.
High torque of the powerful Reamer/Drill (511.606) must
always be observed.
Air Power Line II Instructions for Use DePuy Synthes 3
Introduction
Accessories/Scope of delivery
The Air Power Line consists of three different handpieces, air
hoses and a range of attachments and accessories designed
for the system. Please refer to the “Ordering Information”
section for an overview of the components of the system.
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 and the attachments when clean.
Precautions:
–– Always wear personal protective equipment (PPE) including safety goggles when handling with the Air Power Line
system.
–– DO NOT use this equipment in presence of oxygen, nitrous oxide or a mixture consisting of flammable anesthetic and air (danger of explosion). Only use compressed
air or nitrogen for this equipment.
–– 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 trigger has to be in the LOCK
position (refer to page 7, Safety system).
–– Should the machine drop on the floor and have visible defects, do not use it anymore and send it to the Synthes
Service Center.
–– If a product drops on the floor, 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 field or hit the
patient.
–– Should the system have corroded parts, do not use it anymore and send it to the Synthes Service Center.
4 DePuy Synthes Air Power Line II Instructions for Use
Locating of the instrument or fragments of
instruments
Synthes instruments are designed and manufactured to perform within the scope of their intended use. However, if a
Power Tool or accessory/attachment breaks during use, a visual inspection or a medical imagine device (e.g. CT, Radiation Devices, etc.) can aid in locating the fragments and/or
components of the instrument.
Storage and transport
Only use the original packaging for dispatch and transport as
otherwise damage may occur. If the packing material is no
longer available, please contact your local Synthes office.
For storage and transport environmental conditions please
refer to the section “System specification”.
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 maintenance
or servicing of the tool.
For further information on the warranty please contact your
local Synthes office.
Explanation of symbols used
The following symbols are applied to the device or individual
components. Information on additional symbols is given in
the relevant sections of this document.
Caution
Read the provided Instructions for Use before
operating the device.
Do not reuse
Products intended for single use must not be
reused.
Reuse or reprocessing (e.g. cleaning and resterilization) may compromise the structural integrity
of the device and / or lead to device failure,
which may result in patient injury, illness or
death. Furthermore, reuse or reprocessing of single use devices may create a risk of contamination e.g. due to the transmission of infectious
material from one patient to another. This could
result in the injury or death of the patient or
user.
Date of manufacture and manufacturer
Date of manufacture
non stérile Non sterile
Non sterile
The marked device shall only be used within ­
a specified temperature range.
Relative humidity
Synthes does not recommend reprocessing contaminated products. Any Synthes product that
has been contaminated by blood, tissue and / or
bodily fluids / matter should never be used again
and should be handled according to hospital
protocol. Even though they may appear undamaged, the products may have small defects and
internal stress patterns that may cause material
fatigue.
Atmospheric pressure
Do not use if package is damaged.
This symbol indicates that the corresponding
device may not be immersed in liquids.
0123
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.
Air Power Line II Instructions for Use DePuy Synthes 5
Introduction
Startup of the
Air Power Line system
Connecting the compressed air hose to the handpiece
Attach the hose coupling over the air inlet nipple on the unit
up to the stop. The coupling will lock by itself with an
­audible click.
Attach the other end of the air hose to the compressed air or
nitrogen source. Ensure that the coupling geometry of the
air hose is compatible with the geometry of the wall coupling.
If the operating room does not have an exhaust air system
then use the Air Diffusor (519.950) to diffuse the air. The Air
Diffusor is connected between the source and the air hose.
Removing the compressed air hose
Disconnect the hose by pulling back the hose coupling
sleeve.
Remove the air hose from the compressed air or nitrogen
source.
Precaution: The air hose has to be connected properly and
should never be squeezed or obstructed by any loads.
Non-respect might lead to bursting of the outer hose.
6 DePuy Synthes Air Power Line II Instructions for Use
Working with
the Air Power Line system
Operating the trigger
The trigger smoothly regulates the speed of the Air Reamer/
Drill II (511.606) and the frequency of the Air Oscillator
(511.610) and the Air Reciprocator (511.615).
Safety system
Air Power Line power tools have a safety system that prevents unintentional operation.
To lock the trigger, pull it forward according to the marking
on the handle and then turn it. To unlock the trigger, twist it
in the opposite direction and then push it back.
Air Power Line II Instructions for Use DePuy Synthes 7
Air Reamer/Drill II
Power Tool
1 Attachment coupling
2 Unlocking ring for attachment coupling
3 Trigger and safety device
4 Air inlet
5 Knob for forward and reverse
5
1
2
3
Reverse operation of the Air Reamer/Drill II
The Air Reamer/Drill is equipped with a knob for forward
and backward 5.
By turning the knob in the indicated direction, the tool
­switches from forward to reverse or vice versa.
4
Caution:
–– Do not switch the direction of rotation while the tool is
­operating.
–– Use reverse only with tools that are approved for such
use. Otherwise the tool may break and cause damage.
Technical data
Rpm, without attachment:
0–340 rpm
Weight:
1,100 g
Air consumption at 6 bar:
max. 380 l/min
Recommended operating pressure:
6­–7 bar (max. 10 bar)
Cannulation:
B 4.0 mm
Technical data is subject to tolerances.
8 DePuy Synthes Air Power Line II Instructions for Use
Attachments for the Air Reamer/Drill II
Please observe the safety instructions and warnings on the
relevant pages when working with attachments.
Mounting the attachments
Insert the attachment into the front of the attachment coupling and turn until the positioning pins lock into the grooves
of the unlocking ring. Applying slight pressure, turn the attachment clockwise until it has completely locked into position. Check that it is fitted properly by lightly pulling
the attachment.
Removing the attachments
Turn the unlocking ring for the attachment coupling 2
(see page 8) clockwise and remove the attachment.
Precautions: To prevent injury, the tool must be locked with
the safety system (see page 7) during each manipulation.
Make sure not to press the triggers when mounting and removing the attachments.
Only use original attachments and tools from Synthes.
Damage that might arise from using attachments and tools
of other manufacturers is not covered by the war­ranty.
Properly functioning attachments are essential to the success
of an operation.
For this reason, used attachments must be checked for wear
and/or damage after each use and replaced if necessary.
Precaution: During reaming procedure, high torque values
must be provided by the power tool to the reaming head to
allow efficient bone removal. In cases where the reaming
head suddenly is blocked, these high torque values can be
transferred onto the user’s hand, wrist and/or the patient’s
body. In order to prevent injuries it therefore is essential that:
–– The power tool is held in an ergonomic position with a
firm grip.
–– If the reamer head blocks, the speed trigger is released
immediately.
–– The correct function of the speed trigger (immediate stop
of the system when the trigger is released) is checked before the reaming process.
Air Power Line II Instructions for Use DePuy Synthes 9
Air Reamer/Drill II
Color marking on the attachments
Some rotating attachments are available in two different
speeds for drilling and reaming, respectively. The attach­
ments are marked accordingly (Figs. 1 and 2):
Figure 1: Chuck with drilling speed (text DRILL and blue color marking)
Drill attachments:
Blue color marking and inscribed with DRILL
All drilling speed attachments are geared to increase the
maximum drive speed to 930 rpm while reducing the maximum torque to 8.0 Nm.
Ream attachments:
Red color marking and inscribed with REAM
All reaming speed attachments transfer the speed and
torque of the drive unit with a maximum speed of 340 rpm
and a maximum torque of 20 Nm.
Technical data is subject to tolerances.
11 DePuy Synthes Air Power Line II Instructions for Use
Figure 2: Chuck with reaming speed (text REAM and red color marking)
AO/ASIF Quick Coupling (530.750)
(Speed: 0–930 rpm)
Quick Coupling for DHS/DCS Triple Reamers (530.760)
(Speed: 0–930 rpm)
AO/ASIF Quick Coupling for Reamer (530.780)
(Speed: 0–340 rpm)
Hudson Quick Coupling (530.782)
(Speed: 0–340 rpm)
Hudson Quick Coupling (530.792)
(Speed: 0–930 rpm)
Trinkle Quick Coupling, modified (530.783)
(Speed: 0–340 rpm)
Trinkle Quick Coupling, modified (530.793)
(Speed: 0–930 rpm)
Trinkle Quick Coupling (530.784)
(Speed: 0–340 rpm)
Trinkle Quick Coupling (530.794)
(Speed: 0–930 rpm)
Trinkle Quick Coupling XXL, modified (530.795)
(Speed: 0–340 rpm)
Technical data is subject to tolerances.
Air Power Line II
Instructions for Use
DePuy Synthes
11
Air Reamer/Drill II
Inserting the tools in the attachments
(on page 9)
Attaching cutting tools
Pull the unlocking sleeve on the attachment backwards (forwards for the DHS/DCS Quick Coupling, 530.760) and completely insert the tool (e.g. drill bit) by lightly turning it.
Once the tool is completely locked in place, release the unlocking sleeve. Turn slightly to ensure that the tool is properly
locked into the coupling.
For the AO/ASIF Quick Coupling (530.750/530.780) the tool
can be inserted without moving the unlocking sleeve
(“click-in”).
Removing cutting tools
Pull the unlocking sleeve on the attachment backwards
­(forwards for the DHS/DCS Quick Coupling, 530.760) and
­remove the tool.
Caution: Properly operating 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 should be replaced if necessary.
11 DePuy Synthes Air Power Line II Instructions for Use
Quick Coupling for Guide Pins B 1.5 to 4.0 mm
(510.790)
(Speed: 0–930 rpm)
Load the guide pin and insert into the bone
1.Adjust the adjusting sleeve 3 to fit the diameter of the
guide pin to be used. Slightly press the adjusting sleeve
­axially against the tool and rotate the sleeve.
2.Apply a slight amount of pressure to insert the guide pin
from the front or back into the cannulation 1. The guide
pin is held automatically.
3.Adjust the working length by pulling on the guide pin.
4.To fit the guide pin pull the tension lever 2 against the
tool. Only pull the tension lever against the tool as much
as necessary. The clamping force can be varied by pulling
and releasing the clamping lever.
5.Insert the guide pin into the bone. Apply the clamping
force as long as the guide pin is advanced.
6.To regrip the guide pin, reduce the clamping force and
move the tool to the desired length. Reclamp the guide
pin by pulling on the tension lever.
1
3
2
The guide pin is removed from the bone analogue as
­described above.
Technical data is subject to tolerances.
Air Power Line II Instructions for Use DePuy Synthes 11
Air Reamer/Drill II
Drill Chuck with key (530.732)
(Speed: 0–340 rpm)
Drill Chuck (530.732)
Drill Chuck with key (530.730)
(Speed: 0–930 rpm)
Drill Chuck (530.730)
Drill Chuck, keyless (530.731)
(Speed: 0–930 rpm)
Drill Chuck (530.731)
Accept round and triangular shafts up to B 7.3 mm
Loading tools into the chuck
Drill chuck with key (530.730, 530.732)
Open the clamps of the drill chuck with the key provided
(510.191): Insert the key into the suitable shaft and turn anticlockwise. Insert the shaft of the tool into the centre of the
opened chuck.
Close the chuck in reverse order.
Ensure that the shaft of the tool is fitted between the centre
of the three clamps of the chuck. Turn the key clockwise to
tighten. The teeth of the key must be properly seated in the
gear of the drill chuck. The teeth of the chuck and of the key
must not be worn.
Drill Chuck, keyless (530.731)
Open the clamps manually be holding the retaining ring and
turning the securing ring clockwise. Insert the shaft of the
tool into the centre of the opened chuck. Lock and tighten
the chuck by holding the retaining ring and turning the
securing ring clockwise. Ensure that the shaft of the tool is
loaded between the centre of the three clamps of the chuck.
14
DePuy Synthes Air Power Line II
Instructions for Use
Spare key (510.191)
Caution: Do not allow the tools fitted in the keyless Drill
Chuck to­­rotate backwards, as the Drill Chuck can otherwise
open.
Use the Drill Chuck with Key for reverse mode (530.730,
530.732).
Precaution: To ensure secure fixation of the instrument,
make sure the toothed rims on the drill chuck and key are
not worn.
Replace damaged or worn components. Only use original
Synthes key.
Removing cutting tools
Drill Chuck with key (530.730, 530.732)
Release the chuck by turning the key (510.190) anticlockwise
and remove the tool. The teeth of the chuck and of the key
must not be worn.
Universal Drill Chuck, Keyless (530.731)
Hold the Drill Chuck on the retaining ring and release the
­securing ring by turning anticlockwise. Remove the tool from
the Drill Chuck.
Technical data is subject to tolerances.
Air Power Line II Instructions for Use DePuy Synthes 11
Air Reamer/Drill II
Radiolucent Drive (511.300)
Adapter for Radiolucent Drive (530.741)
Coupling the Radiolucent Drive to the power tool
Attach the Adapter for Radiolucent Drive (530.741) to the Air
Reamer/Drill II (for information please refer to page 9,
Mounting the attachments). Push the Radiolucent Drive as
far as it will go over the quick coupling and the adapter, and
rotate it into the desired working position. Support the drive
with your free hand.
For removal, follow the same procedure in reverse.
Inserting the drill
Pull the ring on the attachment forward, and push the drill
into the coupling as far as it can go while rotating it slightly
(Fig. 1). Push the ring on the attachment back to fix the drill.
Check if the drill is seated correctly by gently pulling on it.
For removal, follow the same procedure in reverse.
Figure 1
16
DePuy Synthes Air Power Line II
Instructions for Use
Using the Radiolucent Drive
Before positioning the Radiolucent Drive, align the image
­intensifier until the distal locking hole of the medullary nail is
round and easily visible.
After the incision, position the Radiolucent Drive and center
the drill bit tip over the locking hole. On the monitor of the
image intensifier, you can see both the drill bit and the target rings of the drive.
Swing the drive up and center it precisely so that the drill bit
appears as a round point and the locking hole is visible
around it. The target rings also assist centring. The locking
hole can now be drilled directly.
For further information on the Radiolucent Drive and on
the special 3-flute spiral drill bits please consult the relevant
Instructions for Use (036.000.150) or your local Synthes
office.
Notes: Grip the coupled Radiolucent Drive tightly when
switching on the power tool, particularly if the power tool is
held face down.
–– Only special 3-flute spiral drill bits can be used. Your
Synthes representative will pro­vide you with additional
information on which drill bits can be used.
–– Handle the Radiolucent Drive with great care. Do not
allow contact between the drill bit and the medullary nail.
–– Depending on the setting of the image intensifier, a zone
may appear in the rear of the Radiolucent Drive that is not
radiolucent. However, this does not inhibit aiming and
working with the device.
–– To protect the gears, the Radiolucent Drive is equipped
with a slip clutch that disengages in case of an overload
and emits an audible rattling noise.
–– The following procedures can cause an overload:
– Correcting the drilling angle when the cutting edge
of the drill bit are completely in the bone.
– Hitting the nail with the drill bit.
–– Drilling can continue after making the following
corrections:
– Correcting the drilling angle: Remove the drill bit until
the flutes are visible and then restart the drilling.
– Hitting a nail: Remove the drill bit until the flutes are
visible, and reaim the drill bit or ex­change the drill bit
if necessary.
Air Power Line II Instructions for Use DePuy Synthes 11
Air Oscillator
Power Tool
1 Locking knob for the saw blade quick coupling
2 Sliding sleeve for positioning the saw head
3 Trigger and safety device
4 Air inlet
2
3
Technical data
Continuously adjustable frequency:
0–14000 1/min
Weight:
1,260 g
Air consumption at 6 bar:
max. 380 l/min
Recommended operating pressure:
6–7 bar (max. 10 bar)
Saw blade deflection:
4.5°
Technical data is subject to tolerances.
11 DePuy Synthes Air Power Line II Instructions for Use
4
1
Attaching the Saw Blades
The single variable-speed trigger allows control of the oscillating frequency from 0 to 14 000 oscillations per minute.
When the trigger is released, the power tool stops immediately. Ensure the drive unit is running prior to contacting the
bone. Optimal sawing performance is achieved by gently
moving back and forth in the plane of the saw blade, allowing the blade to oscillate freely slightly beyond the bone.
Mounting the saw blades
Open the quick coupling for saw blades by turning the locking knob 1 (Fig. page 18) counter clockwise. Use a slight
amount of pressure to slide the saw blade against the screw
head and turn it to the desired position. Lock the saw blade
coupling by tightening the locking knob clockwise.
Removing the saw blade
Open the quick coupling for saw blades by turning the
­locking knob 1 (Fig. page 18) counter clockwise, and
­remove the saw blade.
Precautions: Make sure that the locking knob for the saw
blade quick coupling is firmly tightened. Otherwise the screw
can loosen during use causing the saw blade to vibrate.
To prevent injuries, the trigger should always be in the lock
position when inserting or removing saw blades, or adjusting
the sawing plane.
Air Power Line II Instructions for Use DePuy Synthes 11
Air Oscillator
Positioning the Saw Head
The saw head can be locked in eight operating positions
(8 2 45°).
To choose the operating working position, pull the sliding
sleeve backwards and rotate the saw head into the required
position. Release the sliding sleeve. It will lock automatically
as soon as the correct position is reached.
Instructions for handling saw blades
Synthes recommends using a new saw blade for each operation to ensure that the saw blade is optimally sharpened
and clean.
The following risks are associated with used saw blades:
–– Thermal necrosis caused by excessive heat build-up
–– Infection caused by residues
–– Extended cutting time due to poor sawing performance
–– Potentially, splintering of the teeth or the saw blade
The use of irrigation fluid is recommended to cool the cutting tools and prevent heat necrosis.
Check the cutting tools for wear and/or damage after each
use, and replace if necessary. For optimal performance only
use Synthes saw blades. These are optimized to meet the
specific requirements of the tool. Non Synthes saw blades
can considerably reduce the lifetime of the system.
Detailed ordering information on saw blades for the
Air Power Line II system can be found in the brochure
“Large Bone Saw Blades” (036.001.681).
22 DePuy Synthes Air Power Line II Instructions for Use
Air Reciprocator
Power Tool
1 “Click-in” saw blade coupling
2 Sliding sleeve for positioning the saw blade
3 Trigger and safety device
4 Air inlet
1
2
3
Technical data
Continuously adjustable frequency:
0–14000 1/min
Weight:
1,060 g
Air consumption at 6 bar:
max. 380 l/min
Recommended operating pressure:
6–7 bar (max. 10 bar)
Stroke:
4 mm
4
Technical data is subject to tolerances.
Air Power Line II Instructions for Use DePuy Synthes 22
Air Reciprocator
Attaching the Saw Blades
The single variable-speed trigger allows control of the oscillating frequency from 0 to 14 000 oscillations per minute.
When the trigger is released, the power tool stops immediately. Ensure the drive unit is running prior to contacting the
bone. Optimal sawing performance is achieved by gently
moving back and forth in the plane of the saw blade, allowing the blade to oscillate freely slightly beyond the bone.
Mounting the saw blades
Insert the saw blade into the guide slot of the saw blade
coupling until the lock knob springs back into locked position with a click. Check the correct seating of the saw blade
by pulling it slightly forward in an axial direction.
Removing the saw blade
Turn the lock knob in the direction of the arrow until the
saw blade jumps forward approx. 1 mm. Remove the saw
blade from the holder.
Precautions:
–– Ensure that the saw blade is correctly clicked-in to the
saw blade coupling. Otherwise the saw blade could come
loose and begin to vibrate.
–– To prevent injuries, the trigger should always be in the
lock position when inserting or removing saw blades, or
adjusting the sawing plane.
22 DePuy Synthes Air Power Line II Instructions for Use
Positioning the Saw Head
The saw head can be locked in eight operating positions
(8 2 45°).
To choose the operating working position, pull the sliding
sleeve backwards and rotate the saw head into the required
position. Release the sliding sleeve. It will lock automatically
as soon as the correct position is reached.
Instructions for handling saw blades
Synthes recommends using a new saw blade for each operation to ensure that the saw blade is optimally sharpened
and clean.
The following risks are associated with used saw blades:
–– Thermal necrosis caused by excessive heat build-up
–– Infection caused by residues
–– Extended cutting time due to poor sawing performance
–– Potentially, splintering of the teeth or the saw blade
The use of irrigation fluid is recommended to cool the cutting tools and prevent heat necrosis.
Check the cutting tools for wear and/or damage after each
use, and replace if necessary. For optimal performance only
use Synthes saw blades. These are optimized to meet the
specific requirements of the tool. Non Synthes saw blades
can considerably reduce the lifetime of the system.
Detailed ordering information on saw blades for the Air
Power Line II system can be found in the brochure “Large
Bone Saw Blades” (036.001.681).
Air Power Line II Instructions for Use DePuy Synthes 22
Care and Maintenance
General Information
Power tool units and attachments are frequently exposed to
high mechanical loads and shocks during use and should not
be expected to last indefinitely. Proper handling and maintenance help extend the useful life of surgical instruments.
Gentle care and maintenance with proper lubrication can
substantially increase the reliability and life of the system
components and reduce the risk of malfunction or harm to
the user and patient.
Synthes power tools must be serviced and inspected annually by the original manufacturer or an authorized site. Yearly
maintenance will ensure that the equipment maintains the
highest standard of performance and will prolong the life of
the system. The manu­facturer assumes no warranty for damages arising from improper use, ­neglected or unauthorized
servicing of the tool.
For more information about Care and Maintenance, please
refer to the Air Power Line II Care and Maintenance Poster
(038.000.017).
22 DePuy Synthes Air Power Line II Instructions for Use
Precautions:
–– Reprocessing must be performed immediately ­after each
use.
–– Cannulations, unlocking sleeves and other narrow sites
require special attention during cleaning.
–– Cleaners with a pH of 7–9.5 are recommended. The use
of cleaners with higher pH-values can – d
­ epending on the
cleaner – cause dissolution of the surface of aluminum,
titanium and its alloys, ­plastics or compound materials.
The use of such cleaners should be subject to the data
regarding material compatibility in the corresponding data
sheet.
At pH values higher than 11, the surface of stainless steel
can be affected.
For detailed information about material compatibility,
refer to the document “Important Information” at
www.synthes.com/reprocessing. Please ­refer to the
chapter “Material Compatibility of ­Synthes Instruments in
Clinical Processing”. Concerning the clinical reprocessing
of the Air Power Line II ­system please refer to the following section of this document.
–– Follow the enzymatic cleaner instructions for use for
correct dilution/concentration, temperature and water
quality. Devices should be cleaned in a fresh, newly-made
solution.
–– Detergents used on the products will be in contact with
the following materials: stainless steel, aluminum, plastic,
and rubber seals.
–– Never immerse the handpiece or attachments in aqueous
solutions or in an ultrasonic bath. Do not use pressurized
water as this will cause damage to the system.
–– Synthes recommends using new sterile cutting tools for
each operation. Refer to “Clinical Processing of Cutting
Tools” (036.000.499) for ­detailed clinical processing instructions.
Unusual Transmissible Pathogens
Surgical patients identified as at-risk for Creutzfeldt-­Jakob
disease (CJD) and related infections should be treated with
single-use instruments. Dispose of instruments, power tools
and attachments used, or suspected to have been used, on a
patient with CJD after surgery by incineration and/or follow
current national recommendations.
Notes:
–– The clinical processing instructions provided have been
validated by Synthes for preparing a non-sterile ­Synthes
medical device; these instructions are provided in accordance with ISO 17664 and ANSI/AAMI ST81.
–– Consult national regulations and guidelines for additional
information. Furthermore, compliance with internal hospital policies and procedures and recommendations of manufacturers of detergents, disinfectants, and any clinical
processing equipment is additionally required.
–– Cleaning Agent Information: Synthes used the following
cleaning agents during validation of these reprocessing
recommendations. These cleaning agents are not listed in
preference to other available cleaning agents which may
perform satisfactorily – neutral pH enzymatic detergents
(e.g. Steris Prolystica 2X Concentrate Enzymatic Cleaner).
–– It remains the responsibility of the processor to ensure
that the processing performed achieves the desired result
using the appropriate, properly installed, maintained and
validated equipment, materials and personnel in the processing unit. Any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.
Air Power Line II Instructions for Use DePuy Synthes 22
Care and Maintenance
Preparation prior to Cleaning
In the operating room
Remove surface soiling with a disposable lint-free cloth. Reprocess an instrument directly after it is used so that blood
does not dry on it.
Preparation for cleaning
–– Reprocessing must be carried out immediately after
each use.
–– Before cleaning and disinfection, all attachments and
­instruments must be removed from the machine.
–– The unit and attachments may not be immersed.
–– Make sure that no cleaning solution enters the machine’s
air inlet (Fig. 4). Follow the procedure described in the
table below.
–– Do not use pointed objects for cleaning.
–– When cleaning the unit, do not insert objects into
the inlet and outlet holes for the air connector since
this would damage the microfilter (Fig. 4)
–– The unlocking ring (page 8), the trigger and sliding
sleeve (Fig. 1), the knob for forward and reverse (Fig. 2)
and the locking knob for the saw blade coupling (Fig. 3)
must all be free of residue so that they can move freely.
1
2
3
4
Handpieces, attachments and air hoses may be processed
using
–– manual cleaning
–– automated cleaning with manual pre-cleaning
Preparation for manual cleaning and automated cleaning
with manual pre-cleaning:
Article number
Procedure
Air Power Line II handpieces
Put the seal nipple (519.596) on the
machine’s air inlet.
511.606
511.610
511.615
Synthes Double Air Hoses
519.510
Seal the Synthes Double Air Hose by
joining the inlet and outlet.
Precaution: Clean all movable parts in opened or unlocked
position.
519.530
519.550
Dräger Double Air Hoses
519.610
Connect both sides of the Dräger Double
Air Hose with the seal nipple (519.596).
519.630
519.650
BOC/Schrader Double Air Hoses
519.511
Note: Before connecting the air inlet of the handpiece and
both sides of the air hose with the seal nipple, make sure
that the surfaces, which the seal nipple will cover, are not
contaminated. If they are, first wipe off or spray these
surfaces with alcohol-based disinfectant and then put the
seal nipple on. Make sure that no solution enters the hose.
Connect both sides of the BOC/Schrader
Air Hose with the seal nipple (519.591 or
519.592).
519.531
22 DePuy Synthes Air Power Line II Instructions for Use
Manual Cleaning Instructions
1. Remove debris
Rinse the device under running cold tap water for a minimum of 2 minutes. Make sure that no liquids enter the air inlet. Plug the air inlet with the seal nipple (519.596).
Use a sponge, soft lint-free cloth or soft-bristled brush to assist in removing gross soil. For cannulations of the handpiece
and attachments, the cleaning brush (516.101) shown below
should be used. (Fig. 5)
Precautions:
– Do not use pointed objects for cleaning.
– Brushes and other cleaning tools shall be either single-use
items or, if reusable, be decontaminated at least daily using a solution as detailed in section “3. Spray and wipe”.
– Brushes shall be inspected before daily use and discarded
if they have degraded to the point where they may
scratch instrument surfaces or be ineffective due to worn
or missing bristles.
– Make sure that no cleaning solution enters the machine’s
air inlet.
– Never immerse the handpiece or attachments in aqueous
solutions or in an ultrasonic bath. Do not use pressurized
water as this will cause damage to the system.
5
2. Manipulate moving parts
Manipulate all moving parts such as triggers, sliding sleeves,
attachment release rings, saw blade coupling, locking knob
for the saw blade quick coupling and switches under running
tap water to loosen and remove gross debris.
3. Spray and wipe
Spray and wipe the device using a neutral pH enzymatic
solution for a minimum of 2 minutes. Follow the enzymatic
detergent manufacturer’s directions for correct temperature,
water quality (i.e. pH, hardness) and concentration/dilution.
(78 mm)
(55 mm)
(B 4.7 mm)
(310 mm)
Cleaning brush (516.101)
Air Power Line II
Instructions for Use
DePuy Synthes
27
Care and Maintenance
4. Clean with detergent
Clean the device manually under running warm water using
an enzymatic cleaner or detergent for a minimum of 5 minutes. Manipulate all moving parts under running water. Use
a soft-bristled brush and/or soft lint-free cloth to remove all
visible soil and debris. Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct temperature, water quality and concentration/dilution.
5. Rinse with tap water
Rinse the device thoroughly using cool to lukewarm running
water for a minimum of 2 minutes. Use a syringe or pipette
to flush lumens and channels. Actuate joints, handles and
other movable device features in order to rinse thoroughly
under running water.
6. Visually inspect device
Inspect the cannulations, sliding sleeves, attachment release
rings, etc. for visible soil. Repeat steps 1–6 if visible soil remains.
7. Final rinse with deionized/purified water
Final rinse with deionized or purified water for a minimum of
2 minutes.
8. Dry
Dry device using a clean, soft lint-free cloth or medical grade
compressed air.
22 DePuy Synthes Air Power Line II Instructions for Use
Automated Cleaning Instructions
with Manual Pre-cleaning
Manual pre-cleaning prior to automated cleaning/disinfection is important to ensure cannulations and other difficult
to access areas are clean.
Alternative cleaning/disinfection procedures other than in the
procedure described below (including manual pre-cleaning)
have not been validated by Synthes.
Preparation for manual cleaning and automated cleaning
with manual pre-cleaning:
Article number
Procedure
Air Power Line II handpieces
Put the seal nipple (519.596) on the
machine’s air inlet.
511.606
511.610
511.615
Synthes Double Air Hoses
519.510
Seal the Synthes Double Air Hose by
joining the inlet and outlet.
519.530
519.550
Dräger Double Air Hoses
519.610
Connect both sides of the Dräger Double
Air Hose with the seal nipple (519.596).
519.630
519.650
BOC/Schrader Double Air Hoses
519.511
Connect both sides of the BOC/Schrader
Air Hose with the seal nipple (519.591 or
519.592).
519.531
Note: Before connecting the air inlet of the handpiece and
both sides of the air hose with the seal nipple, make sure
that the surfaces, which the seal nipple will cover, are not
contaminated. If they are, first wipe off or spray these
surfaces with alcohol-based disinfectant and then put the
seal nipple on. Make sure that no solution enters the hose.
Precaution: Clean all movable parts in opened or unlocked
position.
Air Power Line II Instructions for Use DePuy Synthes 22
Care and Maintenance
1. Remove debris
Rinse the device under running cold tap water for a minimum of 2 minutes. Make sure that no liquids enter the air inlet. Plug the air inlet with the seal nipple (519.596). Use a
sponge, soft lint-free cloth or soft-bristled brush to assist in
removing gross soil. For cannulations of the handpiece and
attachments, the cleaning brush (516.101) shown below
should be used.
Precautions:
– Do not use pointed objects for cleaning.
– Brushes and other cleaning tools shall be either single use
items or, if reusable, be decontaminated at least daily using a solution as detailed on page 31 in section “3. Spray
and wipe”.
– Brushes shall be inspected before daily use and discarded
if they have degraded to the point where they may
scratch instrument surfaces or be ineffective due to worn
or missing bristles.
– Make sure that no cleaning solution enters the machine’s
air inlet.
– Never immerse the handpiece or attachments in aqueous
solutions or in an ultrasonic bath. Do not use pressurized
water as this will cause damage to the system.
(78 mm)
(55 mm)
Cleaning brush (516.101)
30
DePuy Synthes
Air Power Line II
Instructions for Use
(B 4.7 mm)
(310 mm)
2. Manipulate moving parts
Manipulate all moving parts such as triggers, sliding sleeves,
attachment release rings, saw blade coupling , locking knob
for the saw blade quick coupling and switches under running
tap water to loosen and remove gross debris.
3. Spray and wipe
Spray and wipe the device using a neutral pH enzymatic
solution for a minimum of 2 minutes. Follow the enzymatic
detergent manufacturer’s directions for correct temperature,
water quality (i.e. pH, hardness) and concentration/dilution.
4. Clean with detergent
Clean the device manually under running warm water using
an enzymatic cleaner or detergent for a minimum of 5 minutes. Manipulate all moving parts under running water. Use
a soft-bristled brush and/or soft lint-free cloth to remove all
visible soil and debris. Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct temperature, water quality and concentration/dilution.
5. Rinse with tap water
Rinse the device thoroughly using cool to lukewarm running
water for a minimum of 2 minutes. Use a syringe or pipette
to flush lumens and channels. Actuate joints, handles and
other movable device features in order to rinse thoroughly
under running water.
6. Visually inspect device
Inspect the cannulations, sliding sleeves, attachment release
rings, etc. for visible soil. Repeat steps 1–6 if visible soil remains.
7. Load the washing tray
Place all articles in the washing tray in a way that an effective washing/disinfection can be performed. Ensure that the
attachments are positioned in an upright position and fully
opened. Ensure that the water can flow off any surface.
Damage due to improper reprocessing is not covered by the
warranty.
Air Power Line II Instructions for Use DePuy Synthes 33
Care and Maintenance
8. Automated cleaning cycle parameters
Note: The washer/disinfector should fulfill requirements
specified in ISO 15883.
Step
DurationCleaning
(minimum)Instructions
Rinse
2 minutes
Cold tap water
Pre-wash1 minute
Warm water
(≥ 40°C);
use detergent
Clean2 minutes
Warm water
(≥ 45°C);
use detergent
Rinse5 minutes
Rinse with
deionized
(DI) or purified
water
(PURW)
Thermal disinfection 5 minutes
processing
Hot DI water,
≥ 90°C
Dry
40 minutes
≥ 90°C
9. Inspect device
Remove all devices from the washing tray.
Remove the seal nipple on the machine’s air inlet and from
the Double Air Hose, inspect the cannulations, sliding
sleeves, etc. for visible soil. If necessary, repeat the manual
pre-cleaning/automated cleaning cycle. Confirm that all parts
are completely dry.
Precaution: Mechanical cleaning is an additional stress for
power equipment, especially for seals and bearings. Therefore, devices must be properly lubricated after automated
cleaning.
Furthermore, the device must be serviced at least once per
year as specified under the section “Repairs and Technical
Services” on page 38.
33 DePuy Synthes Air Power Line II Instructions for Use
Maintenance and Lubrication
Prior to maintenance refer to the following procedures:
Article number
Procedure
Air Power Line II handpieces
Remove the seal nipple (519.596) on the
machine’s air inlet.
511.606
511.610
511.615
Synthes Double Air Hoses
519.510
Ensure that the inlet and outlet of
the Synthes Double Air Hose are not
connected.
519.530
519.550
Dräger Double Air Hoses
519.610
Remove the seal nipple (519.596) from the
Dräger Double Air Hose and ensure that
the inlet and outlet are not connected.
1
519.630
519.650
BOC/Schrader Double Air Hoses
519.511
519.531
Remove the seal nipple (519.591 or
519.592) from the BOC/Schrader Double
Air Hose and ensure that the inlet and
outlet are not connected.
Oiling the power tools
–– After each use, apply around 5 drops of the Synthes
­special oil (oil dispenser 519.970) into the air inlet of the
cleaned power tool (Fig. 1).
–– Connect the power tool to a double hose using the lubrication adapter (519.790) (Fig. 2).
–– Wrap gauze or a cloth around the hose coupling to absorb the exiting oil.
–– Run the power tool for approximately 20 seconds.
–– If dirty oil exits, the process must be repeated.
2
Make sure that the unlocking ring (Page 8 2), the trigger
and sliding sleeve (Page 18 2,), the forward and reverse
knob (Page 8 ) and the saw blade coupling (Page 18 ,
top ­arrow) are lubricated after each use. After lubricating the
trigger shaft, press the trigger several times.
Oiling the attachments
After each use, oil the rings on all the cleaned attachments
and the jaws of the cleaned drill chuck with 1 drop of
Synthes special oil (Fig. 3).
3
Distribute the oil by moving the parts, and remove excess oil
with a cloth.
Air Power Line II Instructions for Use DePuy Synthes 33
Care and Maintenance
Precautions: To ensure long service life and reduce repairs,
it is necessary that the accessible moving parts of the
handpiece and attachment are lubricated after each use.
Failing to lubricate the parts will lead to damage and malfunction, increasing the risk of harm to the user and patient.
For further information on lubrication, please refer to the
Instruction for Use of the Synthes Special Oil 519.970
(60099544) and the APL II Care and Maintenance Poster
(038.000.017).
–– Power tools and accessories may only be lubricated with
Synthes special oil (519.970). The composition of the
­vapor-permeable and biocompatible oil is optimized for
the specific requirements of the power tools. Lubricants
with other compositions can cause the power tools to jam
and be toxic.
–– Only lubricate the power tools and attachments when
clean.
–– Oil should only be used on the air hose sleeve. Ensure that
no oil gets into the double air hose. When lubricating,
never use a double hose without the lubrication adapter
(519.790) since leaking oil could otherwise damage the
hose.
Warning: The Radiolucent Drive (511.300) does not require
lubrication.
33 DePuy Synthes Air Power Line II Instructions for Use
Inspection and Function Test
Visually inspect for damage and wear (e.g. unrecognizable
markings, missing or removed part numbers, corrosion, etc.).
Check the handpiece controls for smooth operation and
function.
All movable parts should be moving smoothly. Check that
the triggers do not remain blocked in the handpiece when
pressing on them. Check that no residuals prevent the movable parts from moving smoothly.
Check the release ring of the handpiece and attachments for
smooth operation, and check for function together with cutting tools.
Check instruments and cuttings tools for correct adjustment
and functioning prior to every use.
Do not use damaged, worn or corroded components but
send them instead to the Synthes Service Center.
Failing to follow these instructions will lead to damage and
malfunction, increasing the risk of harm to the user and patient. For further information on inspection and function
test, please refer to the APL II Care and Maintenance Poster
(038.000.017).
Air Power Line II Instructions for Use DePuy Synthes 33
Care and Maintenance
Packaging, Sterilization and Storage
Packaging
Put cleaned and dry products into their proper places in the
Synthes Air Power Line Vario Case (68.001.550). Additionally,
use an appropriate sterilization wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier System
according to ISO 11607.
Care should be taken to prevent pointed and sharp instruments from contact with other objects that may damage the
surface or the Sterile Barrier System.
Sterilization
Synthes Air Power Line II system may be resterilized using
validated steam sterilization methods (ISO 17665 or national
standards). Synthes recommendations for packed devices
and cases are as follows.
Cycle type
Saturated steam-forced air
­removal (pre-vacuum)
Sterilization
exposure time (minutes)
Sterilization
exposure temperature
Minimum 4
Minimum 132°C
Maximum 138°C
20–60
Minimum 3
Minimum 134°C
Maximum 138°C
20–60
Drying times generally range from 20 to 60 minutes due to
differences in packaging materials (Sterile Barrier System,
e.g., wraps or re-usable rigid container systems), steam quality, device materials, total mass, sterilizer performance and
varying cool-down time.
33 DePuy Synthes Air Power Line II Instructions for Use
Dry time (minutes)
Precautions:
–– The following maximum values may not be exceeded:
138°C over a maximum of 18 minutes. Higher values can
damage the sterilized products.
–– Observe the packages prior to storage for visual moisture
or dampness and if found on or within the pack, the
product should be repackaged and sterilized with an increased drying time.
–– Do not accelerate the cooling process as it will damage
the electronic components of the power tool and could
result in harm to the user and patient.
–– Hot air, ethylene oxide, plasma and formaldehyde sterilization are not recommended.
–– Ensure that the seal nipple (519.596) is removed from the
machine’s air inlet and that the air hose’s inlet and outlet
are disconnected prior to sterilization.
Storage
Storage conditions for products labeled “STERILE” are
printed on the packaging label.
Packaged and sterilized products should be stored in a dry,
clean environment, protected from direct sunlight, pests,
and extremes of temperature and humidity. Use products in
the order in which they are received (“first-in, first-out principle“), taking note of any expiration date on the label.
Air Power Line II Instructions for Use DePuy Synthes 33
Care and Maintenance
Repairs and Technical Service
The power tool should be sent to the Synthes office for repair if it is faulty or malfunctions.
Contaminated products have to run through the complete
reprocessing procedure before being sent to the Synthes office for repair or technical service.
To prevent damage during shipping use the original packaging to return devices back to Synthes. If the packing material
is no longer available, please contact the Synthes affiliate.
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.
Faulty devices may not be used. If it is no longer possible or
feasible to repair the power tool it should be disposed of, cf.
the following section “Disposal of waste”.
Other than the above-mentioned care and maintenance, no
further maintenance work may be carried out independently
or by third parties.
The manufacturer excludes liability for damage resulting
from improper use, neglected or unauthorized maintenance
or servicing of the tool.
33 DePuy Synthes Air Power Line II Instructions for Use
Disposal of Waste
In most cases, faulty power tools can be repaired (refer to
the previous section “Repairs and Technical Service”).
Please send devices that are no longer used to your local
Synthes representative. This ensures that they are disposed
of in accordance with the national application of the respective directive. The device may not be disposed of with household waste.
To prevent damage during shipping use the original packaging to return devices back to Synthes. If this is not possible,
please contact the Synthes affiliate.
Precaution: Contaminated products have to run through
the complete reprocessing procedure in order to rule out any
risk of infection in case of disposal.
Air Power Line II Instructions for Use DePuy Synthes 33
Troubleshooting
Problem
Possible causes
Solution
Power tools do not enough power.
Operating pressure is too low.
Set operating pressure on pressure
­regulator to 6–7 bar overpressure.
Microfilter is blocked.
Exchange microfilter in the central air
supply.
Air inlet is blocked.
Remove particles from the air inlet
with tweezers.
Do not use sharp objects for this.
Hose is too long.
Check that the entire length of the
hose does not exceed 8 m.
Hose coupling is defective.
Check wall and power tool hose
­couplings for leaks.
Central air system is blocked.
Have someone check the central air
system.
Power tool continues to operate
after releasing the trigger.
The trigger is blocked by deposits
of blood, etc.
Press trigger several times; clean and
oil according to instructions. Use only
­Synthes Special Oil (Oil Dispenser
519.970).
Trigger is blocked.
Safety system is activated.
Unlock the power tool by turning and
pushing the trigger according to the
markings on the power tool.
Air Reamer/Drill does not start.
Compressed air motor is blocked from
not operating for a long time.
Lock the power tool. Rotate the un­
locking sleeve by hand without
­pressing the trigger. Release the lock
and run the machine.
44 DePuy Synthes Air Power Line II Instructions for Use
Problem
Possible causes
Solution
Attachments cannot be coupled to
the Air Reamer/Drill.
Attachment coupling and/or unlocking
sleeve are blocked.
Lock the power tool. Remove particles
with a tweezer. Do not use sharp objects for this. If necessary, clean and oil
the power tool and move the moving
parts a few times.
Tool cannot be coupled.
Coupling geometry of the tool has
changed due to wear.
Exchange the tool, or send it to your
local Synthes Service Center.
Bone and tool heat up during surgery.
The tool blades are blunt.
Replace the tool.
Oscillating saw vibrates too much.
The saw blade has come loose.
Tighten the fixation knob for the saw
blade quick coupling more firmly.
Saw blade is difficult to couple or
cannot be coupled.
General wear and tear has affected
the connection geometry of the saw
blade.
Replace the saw blade.
If the recommended solutions do not work, send the power tool to your local
Synthes Service Center.
For further technical questions or information on our services, please contact
your Synthes representative.
Air Power Line II Instructions for Use DePuy Synthes 44
System Specifications
Environmental Conditions
Operation
Temperature
Storage
40 °C
104 °F
10 °C
50 °F
Relative humidity
90 %
30 %
90 %
30 %
1060 hPa
1.06 bar
Altitude
104 °F
10 °C
50 °F
Atmospheric pressure
40 °C
700 hPa
0.7 bar
700 hPa
0.7 bar
0 – 3000 m
0 – 3000 m
Transportation*
Temperature
Duration
Humidity
–29 °C; –20 °F
72 h
uncontrolled
38 °C; 100 °F
72 h
85 %
60 °C; 140 °F
6 h
30 %
*products have been tested according to ISTA 2A
Precaution: The machine must not be stored or operated in
explosive ­atmospheres.
44 DePuy Synthes Air Power Line II Instructions for Use
1060 hPa
1.06 bar
Duty Cycle
To prevent overheating, always follow the duty cycles for
each handpiece and attachment listed below.
Intermittent operation guidelines
X s on
Ys off
Cycles
Drilling and tapping threads
60 sec
60 sec
5
Kirschner wire and pin
setting
30 sec
90 sec
5
Reaming
60 sec
60 sec
5
Oscillating sawing
30 sec
90 sec
5
Reciprocating sawing
20 sec
120 sec
5
Precautions:
–– Carefully observe the above recommended duty cycles.
–– Always control the temperature of the system to prevent
overheating and possibly harming the patient or user.
–– Above mentioned duty cycles should be reduced if higher
loads are being applied and if the ambient temperature
is above 20 °C/68 °F. This needs to be taken into consideration during the planning of the surgical intervention.
–– Always use new cutting tools to prevent heating up of
the system due to reduced cutting performance.
–– Cutting tools must be cooled with irrigation fluid to
­prevent heat necrosis. For this purpose, irrigate manually.
–– Careful maintenance of the system will reduce heat
development in the handpiece and the attachments.
–– The Air Power Line II must not be stored or operated in
an explosive atmosphere.
Generally, Power Tools systems heat up if in constant use.
For this reason the handpiece and the attachments should
be allowed to cool for at least 60 seconds (Ys off ) following
the time of constant use (X s on) as outlined on the table
above. After a certain amount of cycles (defined in the above
table under “Cycles”) the handpiece and attachment should
be allowed to cool down. Observing these instructions
­prevents the system from overheating and possibly harming
the patient or user.
The user is responsible for the application and for turning
off the system as prescribed. If longer periods of constant
use are required, an additional handpiece and/or attachment
should be used.
Depending on the cutting tool used and the load applied,
the heat generated by the handpiece, attachment and/or
cutting tool can vary.
Air Power Line II Instructions for Use DePuy Synthes 44
System Specifications
Declaration of the emission sound pressure level and
the power level according to the EU Directive
2006/42/EG Annex I
Measurements of the sound pressure level [LpA] are carried
out in accordance with standard EN ISO 11202.
Measurements of the sound power level [LwA] are carried
out in accordance with standard EN ISO 3746.
Handpiece
Attachment
Cutting Tool
Sound
Pressure
Level (LpA)
in [dB(A)]
Sound
Power
Level (LwA)
in [dB(A)]
Max. daily
exposure time
without hearing
protection
Air Reamer/
Drill II* 511.606
Drill/Ream*
–
78
–
> 8 h
Air
Oscillator II**
511.610
–
Saw Blade (519.115)
83
94
> 8 h
–
Saw Blade (519.170)
83
94
> 8 h
–
Saw Blade
(05.002.105)
85
96
8 h
–
Saw Blade (511.905)
83
95
> 8 h
–
Saw Blade (511.912)
85
95
8 h
Air
Reciprocator
II*** 511.615
Operation condition:
* Handpiece
511.606 with 530.750 at idle speed (450 rpm) and with 6 bar.
Handpiece 511.610 at idle speed (14 000 Osc./min) and with 6 bar.
*** Handpiece 511.615 at idle speed (14 000 Osc./min) and with 6 bar.
**
Technical data is subject to tolerances.
The values are determined with Synthes saw blades.
44 DePuy Synthes Air Power Line II Instructions for Use
Declaration of vibration emission according to the EU
Directive 2006/42/EG Annex I
The assessment of the vibration emissions [m/s2] is to be
made to the hand-arm system according to EN ISO 8662.
Handpiece
Attachment
Cutting Tool
Vibration
emission
[m/s2]
Max. daily
exposure
Air Reamer/
Drill II* 511.606
Drill/Ream*
–
< 2.5
No limitation
Air
Oscillator II**
511.610
–
Saw Blade (519.115)
6.3
5h
–
Saw Blade (519.170)
4.7
No limitation
–
Saw Blade
(05.002.105)
5.2
7 h 28 min
–
Saw Blade (511.905)
11.6
1 h 28 min
–
Saw Blade (511.912)
11.5
1 h 32 min
Air
Reciprocator II***
511.615
Operation condition:
* Handpiece
511.606 with 530.750 at idle speed (450 rpm) and with 6 bar.
Handpiece 511.610 at idle speed (14 000 Osc./min) and with 6 bar.
*** Handpiece 511.615 at idle speed (14 000 Osc./min) and with 6 bar.
**
Technical data is subject to tolerances.
The values are determined with Synthes saw blades.
Air Power Line II Instructions for Use DePuy Synthes 44
Ordering Information
Power Tools
511.606
Air Reamer/Drill II
511.610
Air Oscillator
511.615
Air Reciprocator
Attachments
530.780
AO/ASIF Quick Coupling for Reamers, for Power Line
530.750
AO/ASIF Quick Coupling, for Power Line
530.760
Quick Coupling for DHS/DCS Triple Reamers, for Power Line
530.730 Drill Chuck (930 1/min), with Key, for Power Line
530.732
Drill Chuck (340 1/min), with Key, for Power Line
510.191
Spare Key for Drill Chuck, clamping range up to  7.3 mm
530.731
Drill Chuck, keyless, for Power Line
510.790
Quick Coupling for Guide Pins  1.5 to 4.0 mm
530.782
Hudson Quick Coupling (340 1/min), for Power Line
530.792
Hudson Quick Coupling (930 1/min), for Power Line
530.783Trinkle Quick Coupling (340 1/min), modified,
for Power Line
530.793Trinkle Quick Coupling (930 1/min), modified,
for Power Line
530.784
Trinkle Quick Coupling (340 1/min), for Power Line
530.794
Trinkle Quick Coupling (930 1/min), for Power Line
530.741
Adapter for RDL for Power Line
530.795Trinkle Quick Coupling XXL (340 1/min), modified,
for Power Line
511.300
Radiolucent Drive
44 DePuy Synthes Air Power Line II Instructions for Use
Air hoses
System SystemSystem
SynthesDrägerBOC/Schrader
Double Air Hose, length 3 m
519.510
519.610
519.511
Double Air Hose, length 5 m
519.530
519.630
519.531
Double Spiral Air Hose, length 2 m
519.550
519.650
Accessories
516.101
Cleaning brush for APL II / BPL / TRS
519.970
Oil dispenser with Synthes special oil
519.790
Lubrication adapter, for SYNTHES compressed air units
519.591
Seal Nipple for BOC/Schrader Double Air Hoses, silver
519.592
Seal Nipple for BOC/Schrader Double Air Hoses, beige
519.596Seal Nipple for Compact Air Drive and for Dräger
Double Air Hoses
(Can also be used to close the air intake of compressed
air-operated drive units during washing).
05.001.087
Adapter for Schrader/Synthes Coupling
05.001.088
Adapter for Dräger/Synthes Coupling
519.950
Exhaust Air Diffusor
520.500
Wall Coupling with Opposite Tubes
520.600
Wall Coupling with Parallel Tubes
68.001.550 Vario Case, size 1/1, height 88 mm, for Air Power Line II,
without lid, without contents
68.001.551 Insert, size 1/2 for Reciprocator,
for Vario Case No. 68.001.550
689.507 Lid (stainless steel), size 1/1, for Vario Case
For further information please contact your local Synthes representative.
Cutting tools
Detailed ordering information on saw blades for the Air Power Line II system can
be found in the brochure “Large Bone Saw Blades” (036.001.681).
Detailed ordering information on the special 3-flute drill bits for the Radiolucent
Drive can be found in the brochure “Working with the Radiolucent Drive”
(036.000.150).
Technical data is subject to tolerances.
Air Power Line II Instructions for Use DePuy Synthes 44
This publication is not intended for distribution in the USA.
0123
© DePuy Synthes Power Tools, a division of Synthes GmbH. 2016. All rights reserved. 036.000.136 DSEM/PWT/0715/0074(2) 04/16
Synthes GmbH
Eimattstrasse 3
4436 Oberdorf
Switzerland
Tel: +41 61 965 61 11
Fax: +41 61 965 66 00
www.depuysynthes.com
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