Johnson & Johnson DePuy Synthes Electric Pen Drive User manual

Electric Pen Drive
Compact Drive With Specific Attachments
For A Wide Spectrum Of Applications
User‘s Manual

Introduction General Information 4
Explanation of Symbols 6
Consoles Standard and Basic Consoles 7
Set-up of Consoles 8
Speed Regulation 10
Irrigation 11
Electric Pen Drive System Electric Pen Drive 60,000 rpm (05.001.010) 13
Hand Switch (05.001.012) 14
Foot Switch, 1 Pedal (05.001.016) 15
Foot Switch, 2 Pedals (05.001.017) 16
Attachments General Information 17
Drill Attachments 18
Screw Attachments 20
Kirschner Wire Attachment 20
Saw Attachments 21
Burr Attachments 23
Adapter for Intra Coupling 25
Perforators 26
Craniotome Attachment 27
Table of Contents

User‘s Manual Electric Pen Drive DePuy Synthes 3
Table of Contents
Cutting Tools General Information 28
Cleaning and Disinfection General Information 29
Preparation Prior to Cleaning 30
Manual Cleaning Instructions 31
Automated Cleaning Instructions with
Manual Pre-Cleaning 33
Care and Maintenance Maintenance and Lubrication 36
Function Control 38
Packaging, Sterilization and Storage 39
Repairs and Technical Service 40
Disposal 41
Troubleshooting 42
System Specifications 44
Electromagnetic Compatibility Accompanying Documents According 50
to IEC 60601-1-2, 2014, ED. 4.0
Ordering Information 54

4 DePuy Synthes Electric Pen Drive User‘s Manual
Introduction
General Information
Indications:
The Electric Pen Drive (EPD) System is indicated for screw
insertion, pin and wire placement, cutting of bone and
metal, drilling, reaming, decorticating, shaping and
smoothing of bones and teeth in a wide variety of
surgical procedures, including but not limited to general
orthopedic trauma, foot, hand, maxillofacial,
neurosurgical, oral, otolaryngological, reconstructive and
spine surgery.
Safety Instructions
The surgeon has to evaluate if the machine is suitable
for an application based on several key factors, such as:
•Power capability of the machine, attachment and
cutting tool relative to the bone strength/anatomical
situation
•Handling of the machine, attachment and cutting tool
relative to bone size
In addition, contraindications of the implant must be
considered and respected. If the Electric Pen Drive
System is used in conjunction with an implant system
make sure to consult the corresponding “Surgical
Te chnique”.
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 a backup
EPD 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
physicians 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.
Never place the Electric Pen Drive in a magnetic
environment since the machine might start unintentionally.
To ensure proper operation of the tool, use only DePuy
Synthes original accessories.
Before first and every use, power tools and their
accessories / attachments have to run through the
complete reprocessing procedure. Protective covers and
foils must be fully removed before sterilization.
Check instruments for correct adjustment and
functioning prior to every use.
Always wear personal protective equipment (PPE) including
safety goggles when handling with the Electric Pen Drive.
To prevent overheating, always respect the duty cycles
for each attachment listed on page 45.
For the tool to function properly, DePuy Synthes
recommends that it is cleaned and serviced after each
use in accordance with the process recommended in the
Cleaning and Disinfection section of this manual. It is
mandatory to check used cutting tools after every use for
wear and/or damage and to replace them if necessary. We
recommend using new DePuy Synthes cutting tools for
every surgery.
Cutting tools must be cooled with irrigation liquid to
prevent bone necrosis due to heat.
The user of the product is responsible for proper use of
the equipment during surgery.
For important information regarding electromagnetic
compatibility (EMC) please refer to the chapter
“Electromagnetic Compatibility” in this manual.
The tool is classified as type B against electrical shock
and leakage current. The tool is suitable for use on
patients in accordance with IEC 60601-1.
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.
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 used
or suspected of use on a patient with CJD after surgery
and/ or follow current national recommendations.

User‘s Manual Electric Pen Drive DePuy Synthes 5
Introduction
such as cleaning brushes, DePuy Synthes Maintenance
Oil for EPD and APD (05.001.095), Maintenance Spray
(05.001.098), and a Maintenance Unit (05.001.099).
No oils from other manufacturers may be used. Only
DePuy Synthes oil may be used. Lubricants with other
compositions can 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.
Locating of the Instrument or Fragments of
Instruments
DePuy 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 imaging 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. If the packing material is no longer available,
please contact the DePuy Synthes office. For storage and
transport environmental conditions, see page 44.
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-DePuy Synthes cutting tools and lubricants or
improper storage and transport.
The manufacturer excludes liability for damage resulting from
repairs or maintenance carried out by unauthorized sites.
For further information on the warranty please contact
your local DePuy Synthes office.
Precautions:
• 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 LOCK position ( ).
• Should the machine drop on the floor and have visible
defects, do not use it anymore and send it to the
DePuy 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
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 (05.001.006 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, use only DePuy
Synthes cutting tools.
DePuy Synthes recommends the use of DePuy Synthes
Graphic Cases and Washing Basket (68.001.800), which
are designed specfically to sterilize and store the system.
For care and maintenance, special tools are available,

6 DePuy Synthes Electric Pen Drive User‘s Manual
Introduction
Explanation of Symbols
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 injury or death of the patient or user.
DePuy Synthes does not recommend reprocessing
contaminated products. Any DePuy 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.
IP X4 Ingress protection rating according to IEC 60529
Locked symbol. Drive Unit is off for safety
Manufacturer
Date of manufacture
Non-sterile
Temperature limit
Catalog Number
Lot number
Serial number
Packaging unit ISO 7000-2794 (2009-02)
Use-by-date
INMETRO Ord. 350 certified
Caution
Consult Instructions for Use
Indicates that the device complies with the
classification type B against electrical shock and
electrical leakage current. The device is suitable for
use on patients as defined by IEC 60601-1
Do not immerse device in liquids
calibrate
annually
The marked device shall be re-calibrated
10PB
Product is UL classified to the requirements of
both the United States and Canada
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.
The European directive 2012/19/EC on waste
electrical and electronic equipment (WEEE) applies
to this device. This device contains materials that
should be disposed of in accordance with
environment protection requirements. Please
observe national and local regulations.
Indicates Environment Friendly Use Period of 10
years in China
Indicates Environment Friendly Use Period of 50
years in China
Humidity limitation
Atmospheric pressure limitation
Do not use if package is damaged

User‘s Manual Electric Pen Drive DePuy Synthes 7
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 injury or death of the patient or user.
DePuy Synthes does not recommend reprocessing
contaminated products. Any DePuy 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.
IP X4 Ingress protection rating according to IEC 60529
Locked symbol. Drive Unit is off for safety
Manufacturer
Date of manufacture
Non-sterile
Temperature limit
Catalog Number
Lot number
Serial number
Packaging unit ISO 7000-2794 (2009-02)
Use-by-date
INMETRO Ord. 350 certified
Consoles
Standard and Basic Consoles
1 2 11 4
5 9876 10
1
6 85
The Electric Pen Drive (05.001.010) can be supplied with
the Standard Console (05.001.006), or the Basic Console
without irrigation (05.001.002).
Standard Console with Irrigation, without Torque
Limiting Function (05.001.006)
1. Slide control for adjusting the maximum speed for 1
Electric Pen Drive ( ) 1
2. Slide control for adjusting the maximum speed for a
second Electric Pen Drive 2
4. Selection switch for irrigation
5. Connection for Adapter for Small Battery Drive*( )
6. Connection for Electric Pen Drive and Small
Electric Drive**( )1
7. Connection for Electric Pen Drive and Small
Electric Drive** 2
8. Connection for Foot Switch
9. Twist lock for irrigation pump
10. Adjustment knob for irrigation flow rate
11. LED Irrigation Ready (Activation with Foot Switch)
1. Basic Console (05.001.002)
1. Slide control for adjustment of the maximum speed
for 1
5. Connection for Adapter for Small Battery Drive*
6. Connection for Electric Pen Drive and Small
Electric Drive ** 1
8. Connection for Foot Switch ( )
*This connection is not of use anymore since the Adapter for Small Battery Drive is no longer available.
**The Small Electric Drive is no longer available for purchase.

8 DePuy Synthes Electric Pen Drive User‘s Manual
Consoles
Set-up of Consoles
12
13
15
14
Color Coding Set
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.
Set-up
Before the initial operation of the device, make sure that
the power switch (12) is set to position 0 (OFF). Only
connect the console 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: 2x3AF/250V, Breaking Capacity 1500A

User‘s Manual Electric Pen Drive DePuy Synthes 9
Consoles
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.
Removing Cables
To remove the plug, grasp the release sleeve, pull back
and remove.
The connections 5–8 (page 8) are used to connect the
following devices:
Connections not used can be sealed off with the
protective caps provided.
Precautions:
•Do not lay textiles or objects under the console. These
can be sucked up and block the ventilation inlet.
•Do not block the ventilation opening on the back
of the console with any object.
•Only place consoles on smooth and flat surfaces.
•Do not place the console in the sterile field.
•Do not hang the irrigation liquid directly above
the console to prevent liquid from dripping on
the console.
•Do not pull the cable! Always activate the release
sleeve.
•The use of HF (= high frequency) equipment for
tissue coagulation can cause electromagnetic
interferences – in this case cables should be
separated as far as possible.
•Ensure that the power cord can always be
disconnected immediately from mains supply.
5Connection for a Small Battery Drive
handpiece*
6 & 7 Connection for an Electric Pen Drive
and Small Electric Drive**
8Connection for the Foot Switch
* This connection is not of use anymore since the Adapter
for Small Battery Drive is no longer available.
**The Small Electric Drive is no longer available for
purchase.

10 DePuy Synthes Electric Pen Drive User‘s Manual
Consoles
Speed Regulation
Functions of the Standard Console (05.001.006) and
the Basic Console (05.001.002)
Adjustment of the maximum speed (1, 2)
Speed is automatically optimized and adjusted for each
attachment; for certain attachments it is however
recommended that you reduce the maximum speed of the
connected handpiece. Adjustment can be performed in
increments of 25 % with the slide controls for adjustment
of maximum speed. It is recommended using this feature
for high speed burrs. A letter code on each burr indicates
the maximum speed specified by DePuy Synthes.
Marking Console Setting
Pen 60k
A100%
B100%
C75%
D50%
E25%
This is also explained by symbols on the supplied
adhesive foil. The adhesive foil can be applied to the
console as a reference aid.