Synthes Electric pen drive User manual

This publication is not intended for
distribution in the USA.
Instruments and implants
approved by the AO Foundation
Instructions
for Use
Electric Pen Drive. Compact drive
with specific attachments for
a wide spectrum of applications.

Electric Pen Drive Instructions for Use DePuy Synthes 1
Table of Contents
Introduction
Consoles
Electric Pen Drive System
Attachments
General Information 3
Explanation of Symbols 5
Standard Consoles 6
Basic Console 7
Set-up of Consoles 8
Speed Regulation 10
Torque Limiting 11
Irrigation 13
Light Adapter for Colibri (05.001.108) 15
Electric Pen Drive 60,000 rpm (05.001.010) 16
Electric Pen Drive 90,000 rpm (05.001.011) 18
Hand Switch (05.001.012) 19
Foot Switch,1 Pedal (05.001.016) 20
Foot Switch, 2 Pedals (05.001.017) 21
General Information 22
Drill Attachments 23
Screw Attachments 25
Kirschner Wire Attachment 26
Saw Attachments 27
Burr Attachments 29
Adapter for Intra Coupling 31
Perforators 32
Craniotome Attachment 34

2 DePuySynthes Electric Pen Drive Instructions for Use
Table of Contents
Cutting Tools
Care and Maintenance
Troubleshooting
System Specifications
Electromagnetic Compatibility
Ordering Information
General Information 35
General Information 36
Preparation for Cleaning and Disinfection 37
Cleaning and Disinfection 38
Maintenance and Lubrication 40
Inspection, Packaging, Sterilization and Storage 43
Repairs and Technical Service 44
Disposal 45
46
49
Accompanying Documents 55
59
Warning
This description alone does not provide sufficient background for direct use of
the product. Instruction by a surgeon experienced in handling this product is
highly recommended.

Electric Pen Drive Instructions for Use DePuy Synthes 3
Efficiently working cutting tools are the basis for successful
surgery. Therefore, it is mandatory to check used cutting
tools after every use for wear and / or damage and to re-
place them if necessary. We recommend using new Synthes
cutting tools for every surgery. Cutting tools must be cooled
with irrigation liquid to prevent heat necrosis.
The user of the product is responsible for proper use of the
equipment during surgery.
If the Electric Pen Drive System is used in conjunction with an
implant system make sure to consult the corresponding
“Technique Guide”.
For important information regarding electromagnetic com-
patibility (EMC) please refer to the chapter “System Specifi-
cations” 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, Synthes recommends
annual maintenance by a Synthes service center. The manu-
facturer shall assume no responsibility for damage resulting
from improper operation or unauthorized maintenance of
the tool.
Precaution: To avoid injuries, the locking mechanism of the
tool has to be activated before every manipulation and be-
fore placing the tool back down, i.e. the mode switch has to
be in the LOCK position ( ).
Introduction
General Information
Intended use
The Electric Pen Drive is an electrically-powered system to be
used for treatment in general traumatology, as well as for
surgery in the hand, foot, spine and maxillofacial regions and
neurosurgery. Only use Synthes accessories to guarantee
operational reliability of the Electric Pen Drive.
Safety instructions
The Electric Pen Drive 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 Electric Pen Drive System is designed for use by physi-
cians and trained medical personnel.
DO NOT use any component if damage is apparent.
DO NOT use this equipment in presence of oxygen, nitrous
oxide or a mixture consisting of flammable anesthetic and air.
To ensure proper operation of the tool, use only Synthes
original accessories.
Before first and every use, power tools and their acces-
sories/attachments have to run through the complete repro-
cessing procedure. Protective covers and foils must be fully
removed before sterilization.
Check proper operation of the tools before using it on the
patient.
To prevent overheating, always respect the duty cycles for
each attachment listed on page 52.
For the tool to function properly, Synthes recommends that it
is cleaned and serviced after each use in accordance with the
process recommended in the chapter “Care and Mainte-
nance”.
Compliance with these specifications can considerably ex-
tend the service life of the tool. Only use Synthes oil to lubri-
cate the tool.

4 DePuySynthes Electric Pen Drive Instructions for Use
Accessories/Scope of delivery
The main components of the Electric Pen Drive (EPD) System
are the handpiece, hand switch, foot switch, console, electric
cables as well as attachments and accessories. An overview
of all components belonging to the Electric Pen Drive System
can be found in the chapter “Ordering Information”.
For using the EPD System the following components are a
must:
– Electric Pen Drive (05.001.010)
– Hand Switch (05.001.012) or Foot Switch (05.001.016)
with the Cable Foot Switch-Console (05.001.022)
– Console (05.001.000, 05.001.006 or 05.001.002)
– Cable Electric Pen Drive – Console (05.001.021 or
05.001.025)
– At least one attachment belonging to the system and a
cutting tool fitting to the attachment.
For an optimal function of the system only Synthes cutting
tools shall be used.
For sterilization and storage two system-specific Vario Cases
are recommended and available.
For care and maintenance special tools are available, such as
cleaning brushes, Synthes Maintenance Oil for EPD and APD,
Maintenance Spray and a Maintenance Unit. No oils from
other manufacturers may be used. Only Synthes oil may
be used.
Storage and Transport
Please use the original packaging for dispatch and transport.
If this is no longer available, please contact the Synthes office.
The same environmental conditions apply for transport as for
storage, see page 51.
Warranty
The warranty for the tools and accessories does not cover
damage of any kind resulting from improper use, damaged
seal and improper storage and transport. The manufacturer
does not accept liability for damage resulting from repairs
or maintenance carried out by unauthorized sites.
Introduction
General Information

Do not reuse
Products intended for single use must not be
re-used.
Reuse or reprocessing (e.g. cleaning and resteril-
ization) 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
injury or death of the patient or user.
Synthes does not recommend reprocessing con-
taminated 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.
Electric Pen Drive Instructions for Use DePuy Synthes 5
Introduction
Explanation of Symbols
2
Caution.
Read the provided instructions for use before
operating the device.
Indicates that the device complies with the classifi-
cation type B against electrical shock and electrical
leakage current. The device is suitable for use
on patients as defined by CSA 601.1, IEC 60601-1
and UL 60601
Do not immerse device in liquids.
The marked device shall only be used within a
specified temperature range.
The marked device shall be re-calibrated.
Electric Pen Drive
With regard to electrical shock, fire, mechanical
hazards, only in accordance with UL 60601-1
and CAN/CSA C22.2 No. 601.1
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 directive 2002/96/EC on waste elec-
trical and electronic equipment (WEEE) applies
to this device. This device contains materials that
should be disposed of in accordance with environ-
ment protection requirements. Please observe
national and local regulations.
0123
10PB

21 3 4
21 11 4
75 6 8 9 10
75 6 8 9 10
6 DePuySynthes Electric Pen Drive Instructions for Use
Consoles
Standard Consoles
The Electric Pen Drive (05.01.010 and 05.001.011) can be
supplied with the Standard Console, or as an alternative with
the Basic Console (without torque limiting function and irri-
gation). The Standard Console can alternatively be ordered
without the torque limiting function.
Standard Console with irrigation (05.001.000)
1Slide control for adjusting the maximum speed
for 1
2Slide control for adjusting the maximum speed
for 2
3Selection switch for torque limiting
4Selection switch for irrigation
5Connection for Adapter for Colibri
6Connection for Electric Pen Drive and
Small Electric Drive 1
7Connection for Electric Pen Drive and
Small Electric Drive 2
8Connection for Foot Switch
9Twist lock for irrigation pump
10 Adjustment knob for irrigation flow rate
Standard Console with irrigation,
without torque limiting (05.001.006)
1Slide control for adjusting the maximum speed
for 1
2Slide control for adjusting the maximum speed
for 2
4Selection switch for irrigation
5Connection for Adapter for Colibri
6Connection for Electric Pen Drive and
Small Electric Drive 1
7Connection for Electric Pen Drive and
Small Electric Drive 2
8Connection for Foot Switch
9Twist lock for irrigation pump
10 Adjustment knob for irrigation flow rate
11 LED Irrigation Ready (Activation with Foot Switch)

1
5 6 8
Consoles
Basic Console
Electric Pen Drive Instructions for Use DePuy Synthes 7
Basic Console (05.001.002)
1Slide control for adjusting the maximum speed for 1
5 Connection for Adapter for Colibri
6Connection for Electric Pen Drive and
Small Electric Drive 1
8Connection for Foot Switch
Notes:
– When returning the console for repair or maintenance,
always send back the power cord.
– For more details on the Small Electric Drive please refer to
the separate manual and contact your Synthes represen-
tative for more information.

12
13
14
15
8 DePuySynthes Electric Pen Drive Instructions for Use
Color Coding Set (60038602)
A color coding set is supplied with every console. Each set
contains 3 text stickers, 8 silicone rings in 3 colors (red, blue
and white) and 8 stickers of the colored rings. The stickers
and silicone rings can be used to indicate on the console and
the cables how the system has to be assembled.
Note: The silicone rings fixed to the cables have to be
removed (moved backwards on the cable) before washing
and fixed again before sterilization.
Content of Set No. 60038602
Set-up
Before the initial operation of the device, make sure that the
power switch (12) is set to position 0. Only connect the con-
sole to the power supply with the cable provided via the
power plug socket (13) and set the power switch to position
1 (ON). The LED marked with on the front of the console
signals the proper operation of the console. If the LED
flashes, the console must be sent in for maintenance.
A potential equilization connector (14) for an equipotential
earth plug is integrated in the console. Existing equipotential
earth plugs can be connected there.
(15) Fuses: 2⳯3 AF / 250 VA Breaking Capacity 1500 A
Consoles
Set-up of Consoles

Electric Pen Drive Instructions for Use DePuy Synthes 9
Removing cables
To remove the plug, grasp the release sleeve, pull back
and remove.
The connections 5–8(page 6) are used to connect the
following devices:
(5): Connection for a Colibri/Small Battery
Drive handpiece
(6 and 7): Connection for an Electric Pen
Drive and Small Electric Drive
(8): Connection for the Foot Switch
Connections not used can be sealed off with the protective
caps provided.
Precautions:
– Do not place consoles directly against a wall, as console
ventilation will be impaired. Maintain a distance of at least
3cm.
– Only place consoles on smooth surfaces.
– Do not lay textiles or objects under the console. These can
be sucked up and block the ventilation inlet.
– Do not hang the irrigation liquid directly above the con-
sole to prevent liquid from dripping on the console.
– Do not pull on the cable! Always activate the release
sleeve.
– The use of HF (= high frequency) equipment for tissue
coagulation can cause electromagnetic disturbances – in
this case the cables should be separated as far as possible.
Mounting cables on consoles
To mount the respective cables on the consoles, position the
nose on the plugs flush with the groove on the plug sockets
and insert the plugs. For improved orientation, red dots
are provided on the plug and socket that must face upward
when connecting the cable.

10 DePuySynthes Electric Pen Drive Instructions for Use
Functions of the Standard Consoles (05.001.000 and
05.001.006) and the Basic Console (05.001.002)
Adjustment of the maximum speed (1, 2)
The speed is automatically optimally adjusted for each at-
tachment; however the maximum achievable speed of the
connected handpiece (incl. attachment) can be reduced in
increments of 25% with the slide controls for adjusting the
maximum speed (1, 2). This is above all very helpful when
using the high-speed burr attachments to adjust the maxi-
mum speed given by Synthes for each burr. A letter code on
the burrs indicates the maximum speed recommended for
the respective burr.
Marking Console Setting Console Setting
Pen 60k Pen 90k
A 100% 100%
B 100% 75%
C 75% 50%
D 50% 25%
E 25% 25%
This is also explained by symbols on the supplied adhesive
foil. The adhesive foil can be applied to the console as a ref-
erence aid.
Consoles
Speed Regulation

ab
cd3.23.1 3.3
Consoles
Torque Limiting
Electric Pen Drive Instructions for Use DePuy Synthes 11
Function of the Standard Console (05.001.000)
The function of the Standard Console (05.001.000) de-
scribed in the following is not available on the Standard
Console without torque limiting (05.001.006) or on the
Basic Console.
Torque limiting (3)
The Electric Pen Drive System enables screws to be directly
implanted and tightened with the unit. This function is
particularly advantageous with angularly stable screws which
must be locked in the plate with a specified torque
(e.g. Synthes LCP System).
For this purpose the torque must be calibrated
in advance as follows:
Connect a handpiece (05.001.010) with a cable to connec-
tion 2, picture a, and insert a Screw Attachment
(05.001.028, 05.001.029, or 05.001.034; picture b). Guide
the handpiece with the Screw Attachment into the Torque
Calibration Unit (05.001.060–05.001.061) (see picture c)
and set the torque limiting selection switch (3), picture d, to
the calibration position (3.3). The handpiece now begins the
calibration process as soon as either the Hand or Foot Switch
is activated. Do not release the switch until the process has
been completed.
Remove the handpiece and set the torque limiting selection
switch to the torque limiting ON position (3.2) to work with
this function. The LED for torque limiting lights up when the
calibration has been successfully carried out and the system
is ready. To work without torque limiting again, set the se-
lection switch to the torque limiting OFF position (3.1). The
calibrated value is stored and can be reactivated in the ON
position until the calibration has been carried out again, until
the console is switched off or until the handpiece is removed
from connection 2.
3.1 Torque limiting OFF
3.2 Torque limiting ON
3.3 Calibration torque CAL

ef
25° C
77° F
18° C
64° F
calibrate
annually
12 DePuySynthes Electric Pen Drive Instructions for Use
Precautions:
– To guarantee a correct calibrated value, the Torque Cali-
bration Units (05.001.060 and 05.001.061) shall only be
used when their temperature is between 18°C–25°C
(64°F–77°F) as showed on the symbol in picture e.
– In case a calibration unit has been sterilized more than 10
times without being used, proceed with a test calibration
before the first calibration.
– The Torque Calibration Units have to be sent for re-cali-
bration once a year (see picture f).
– The calibration function is only possible with an Electric
Pen Drive 60,000 rpm (05.001.010) on the pen connec-
tion 2 in the forward position .
Note: Please ensure that the switch for the torque limiting
function is set to the OFF position when it is not used.
A wrong setting can lead to a malfunctioning of the system.
To insert the screw, insert the screwdriver insert in the screw
attachment and pick up the screw. Position the screw and
activate the Foot or Hand Switch. In the torque limitation ON
mode, the speed automatically only increases slowly to a pre-
defined speed even with the Hand/Foot Switch completely
pressed down. This enables perfect guidance of the screw.
When locking the screw head in the plate, the Electric Pen
Drive limits the torque to the previously calibrated torque
and stops automatically.
Precautions:
– The torque must be recalibrated before each operation.
– Do not release the calibration unit during the calibration
process.
– If the LED for torque limiting flashes, consult the corre-
sponding points in the troubleshooting section on
page 47.
– The Torque Calibration Units shall only be used when they
have reached room temperature (18°–25°C,
64°–77°F).
Do not use the calibration units directly after sterilisation,
when they are still hot. Otherwise the calibration result
can be altered.
– In case a calibration unit has been sterilized more than 10
times without being used, proceed with a test calibration
before the first calibration.
Consoles
Torque Limiting

4.14.3 4.54.2 4.4
11
Consoles
Irrigation
Electric Pen Drive Instructions for Use DePuy Synthes 13
4.1 Irrigation OFF
4.2 Variable irrigation for Pen 1 VAR
4.3 Constant irrigation for Pen 1 CON
4.4 Variable irrigation for Pen 2 VAR
4.5 Constant irrigation for Pen 2 CON
Function of the Standard Consoles (05.001.000 and
05.001.006)
The function of the Standard Consoles described in the
following is not available on the Basic Console.
Irrigation (4)
With the integrated irrigation system, tools can be cooled to
prevent necrosis due to excess heat. Irrigation nozzles for the
attachments and sterile irrigation tubes are available for the
irrigation system. In addition to the OFF position (4.1), there
are also 2 operating positions each for Pen 1 and Pen 2.
In the positions 4.3/4.5 (constant irrigation for Pen 1/Pen 2),
a constant quantity of irrigation liquid is given off for
Pen 1/Pen 2. This constant flow rate can be adjusted be-
tween 10 and 100 ml/min (0.34 and 3.4 fl oz/min) with the
adjustment knob for the irrigation flow rate (5).
In the positions 4.2/4.4 (variable irrigation for Pen 1/Pen 2),
the flow rate is directly proportional to the speed selected on
the Hand or Foot Switch, i.e the faster the Electric Pen Drive
runs, the higher the irrigation flow rate. The maximum
achievable flow rate can be set between 10 and 100 ml / min
(0.34 and 3.4 oz/min) with the adjustment knob for the
irrigation flow rate (5).
The LED lights up if the irrigation is activated (11) on the foot
switch. Please refer to the chapter of the Foot Switch for a
detailed explanation on how to activate or deactivate the irri-
gation.
A Bottle Holder for Irrigation Fluid (05.001.007) is available
for the standard consoles (05.001.000 and 05.001.006).
It makes is possible to hang a bottle with irrigation fluid near
the console.
Bottle Holder

14 DePuySynthes Electric Pen Drive Instructions for Use
Fig. 2
Irrigation Tube Set (05.001.069.01S and 05.001.069.05S
– clips included),
Irrigation Tube Set (05.001.178.01S and 05.001.178.05S)
and Clips for Irrigation Tube Set (05.001.179.05S),
Inserting Irrigation Tube
1. Remove the sterile Irrigation Tube from the sterile package.
2. Secure the Irrigation Nozzle on the attachment used.
3. Fit the irrigation tube on the Irrigation Nozzle used first
and then secure it with the clips on the cable.
4. Route the Irrigation Tube end into the non-sterile area and
open the twist lock for the irrigation pump in the direction
of the arrow.
5. Insert the Irrigation Tube in the pump in accordance with
the marking (see Fig.2) and close the twist lock.
6. Remove the protective cap from the cannula and connect
cannula to irrigation bag. When doing so, make sure that
the connection nipple of the cannula is not touched by
non-sterile persons while securing irrigation nozzle to the
attachment.
Push the Irrigation Nozzles for the Burr Attachments, Oscil-
lating Saw Attachment and Reciprocating Saw Attachment
as far as necessary over the attachment from the front.
Push the Irrigation Nozzle for the Sagittal Saw Attachment
onto the attachment from the rear (from the attachment
coupling side) before mounting the attachment on the hand-
piece.
Note: The vent of the spike has to be open when the irriga-
tion is used.
2
2
Fig. 1
Consoles
Irrigation

Consoles
Light Adapter for Colibri (05.001.108)
Electric Pen Drive Instructions for Use DePuy Synthes 15
The Light Adapter for Colibri (05.001.108) is used to enable
the use of the Colibri with the Electric Pen Drive Consoles
(05.001.000, 05.001.006 and 05.001.002)
Inserting Light Adapter for Colibri in drive unit
Push the Adapter into the mounting shaft of the handpiece
from below until it engages (Fig.1). The shape of the
Adapter prevents incorrect connection. Check the correct
seating of the Adapter by pulling slightly on it.
Removing Light Adapter for Colibri from drive unit
Press the release buttons on the Colibri simultaneously with
one hand and pull the Adapter out of the handpiece with
the other hand (Fig. 2).
Connecting Adapter Cable to Console
To connect the Adapter Cable to the Console, position the
nose on the plug flush with the groove on the connection
for the Colibri (see page 6) and insert the plug. For improved
orientation, red dots are provided on the plug and socket
which must face upward when connecting the cable.
Fig. 1 Fig. 2

65
12
43
7
16 DePuySynthes Electric Pen Drive Instructions for Use
Electric Pen Drive System
Electric Pen Drive 60,000 rpm
(05.001.010)
1Adjustment sleeve
2Release sleeve for attachment
3Cable IN/OUT position
4LOCK position
5Forward position (clockwise)
6Reverse position (anti-clockwise)
7Lock slide for adjustment sleeve
Turning the adjustment sleeve
To avoid an unintentional change of the operating mode the
lock slide for adjustment sleeve (7) locks the adjustment
sleeve automatically. To be able to move the adjustment
sleeve the lock slide has to be pushed in the direction indi-
cated by the arrow. After having reached the desired position
release the lock slide (7) and the adjustment sleeve (1) is
locked in the desired position.
Mounting cable on handpiece
Move the adjustment sleeve (1) on the handpiece into the
position cable IN/OUT (3). Align the groove on the plug
with the notch in the sleeve and insert the plug. Turn the ad-
justment sleeve into the LOCK position (4). The cable is
now firmly locked in the handpiece and the handpiece is in
locked mode. To remove, move the adjustment sleeve (1)
into the cable IN/OUT position (3) and remove the cable.
FWD/REV switchover
By turning the adjustment sleeve into the forward position
(5), the handpiece can be switched into a clockwise run-
ning direction. In the reverse position (6) the handpiece
can be operated in an anti-clockwise direction.
In addition to locking the cable, the LOCK position (4) is
also used for safety switch-off when changing attachments
and tools. This prevents accidental start-up of the unit while
performing these activities.
For instructions on mounting the attachments see page 22.
Either a Hand Switch (page 19) or a Foot Switch (page 20/ 21)
can be used for speed control.

Electric Pen Drive Instructions for Use DePuy Synthes 17
Precautions:
– Do not lay the handpiece on magnetic sterile covers or in
the immediate vicinity of other magnetic objects. This
could activate the handpiece.
– When two Electric Pen Drive handpieces are connected
and the speed is controlled with the Foot Switch, one
handpiece must be switched to LOCK . Otherwise
neither of the handpieces will function for safety reasons.
– In all other cases, the first speed control device to be
activated functions. As long as this device is activated, all
others are deactivated (incl. Colibri).
– When an Electric Pen Drive 90,000 rpm (05.001.011) and
an Electric Pen Drive 60,000 rpm (05.001.010) are con-
nected simultaneously, the Electric Pen Drive 90,000 rpm
only works if the Electric Pen Drive 60,000 rpm is set to
the LOCK position on the adjustment sleeve (1). Other-
wise the Electric Pen Drive 60,000 rpm works.
– HF (= high frequency) equipment for tissue coagulation
can cause electromagnetic disturbances and inadvertently
activate the Electric Pen Drive – cables should be sepa-
rated as far as possible.

18 DePuySynthes Electric Pen Drive Instructions for Use
The Electric Pen Drive (05.001.011) can only be operated
with a Foot Switch. The FWD/REV changeover has to be
done with the Foot Switch (05.001.017). The cable is perma-
nently fixed to the pen.
Precautions:
– Only high-speed attachments such as Burr Attachments
(05.001.045–05.001.050, 05.001.055), Craniotome
(05.001.059) and Perforator (05.001.054) are compatible
with this handpiece.
– The Hand Switch (05.001.012) cannot be used.
– It is not possible to use two Electric Pen Drives,
90,000 rpm (05.001.011). If two of them are plugged in,
neither of them will work for safety reasons.
– When an Electric Pen Drive 90,000 rpm (05.001.011) and
an Electric Pen Drive 60,000 rpm (05.001.010) are con-
nected simultaneously, the Electric Pen Drive 90,000 rpm
only works if the Electric Pen Drive 60,000 rpm is set to
the LOCK position on the adjustment sleeve. Otherwise
the Electric Pen Drive 60,000 rpm works.
Electric Pen Drive System
Electric Pen Drive 90,000 rpm
(05.001.011)