Arthrex DrillSaw Mini 300 System User manual

DrillSaw Mini 300™ System
User’s Guide
The Arthrex DrillSaw Mini 300™ System User’s Guide provides
safety operation information for all components of the
Arthrex DrillSaw Mini 300™ System, including accessories.
All operating personnel must read this User’s Guide
thoroughly, prior to using this system and follow all safety
warnings, cautions, and precautions.
0086
Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Toll Free: 1-[phone]
www.arthrex.com
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: [phone]
Fax: [phone]
www.arthrex.de
DFU-0223-2
Revision 0
© 1/2019 Arthrex, Inc. All rights reserved
AR-300

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Table of contents
DFU-0223-2 Rev. 0 Page i
1
1. .0 0General Warnings and Safety Notices - Read This First ....................1
1.1 Important Safety Conventions............................................................................ 1
1.2 Symbol Definitions ............................................................................................. 4
1.3 Shipping, Unpacking, and Warranty Information................................................ 5
2
2. .0 0Product Description and Intended Use ..............................................6
2.1 Product Description............................................................................................ 6
2.2 Intended Use...................................................................................................... 6
2.3 Contraindications ............................................................................................... 6
2.4 Set Composition................................................................................................. 7
2.5 Product Functions .............................................................................................. 8
2
2. .5 5. .1 1AR-300 Handpiece ............................................................................................... 8
2
2. .5 5. .2 2AR-300L Battery Pack, Li-Ion................................................................................ 9
2
2. .5 5. .3 3AR-3000LBH Battery Housing .............................................................................10
3
3. .0 0Technical Specifications ..................................................................11
3.1 Handpiece........................................................................................................ 11
3.2 Attachments ..................................................................................................... 12
3.3 Safety, EMC, and Regulatory Requirements ................................................... 13
3.4 Electromagnetic Compatibility (EMC)............................................................... 13
3.5 Risks due to electromagnetic fields:................................................................. 14
4
4. .0 0Setup ...............................................................................................15
4.1 How to Set Up the Handpiece.......................................................................... 15
4.2 Setup - Connecting and removing an attachment to the handpiece................. 15
4.3 Setup - Connecting a battery housing to the handpiece................................... 16
4.4 Setup - Removing the battery housing from the handpiece ............................. 17
4.5 Setup - Quick Connect of Drilling and Reaming Attachments .......................... 18
4.6 Setup - Drilling and Reaming Attachments, Keyed Jacobs Chuck................... 19
4.7 Setup - Drilling and Reaming Attachments, Keyless Chuck............................. 20
4.8 Setup - Saw Attachment .................................................................................. 21
4.9 Setup – Burr / Drill Attachments ....................................................................... 22
4.10 Setup - Wire/Pin Driver Attachment ................................................................. 23
4.11 Battery Housing/Battery Pack/Transfer Plate................................................... 24
5
5. .0 0Cleaning and Disinfecting ................................................................25

Table of contents
DFU-0223-2 Rev. 0 Page ii
5.1 Battery Pack..................................................................................................... 25
5.2 Preliminary Cleaning ........................................................................................ 26
5
5. .2 2. .1 1Handpieces and Battery Housings .......................................................................26
5
5. .2 2. .2 2Attachments and Transfer Plates.........................................................................26
5.3 Automated Cleaning and Thermal Disinfection ................................................ 27
6
6. .0 0Sterilization ......................................................................................28
6.1 Approved Sterilization ...................................................................................... 28
6.1Transmissible Spongiform Encephalopathy Agents......................................... 29
7
7. .0 0Maintenance ....................................................................................30
7.1 Periodic Maintenance....................................................................................... 30
8
8. .0 0Technical Support............................................................................31
8.1 Additional Technical Information ...................................................................... 31
9
9. .0 0Repair Policy ...................................................................................32
1
10 0. .0 0End of Life, Environmental Directives ..............................................33
1
11 1. .0 0Electromagnetic Emissions..............................................................34

Table of contents
DFU-0223-2 Rev. 0 Page iii
List of Figures
Figure 1 Handpiece ...............................................................................................................................8
Figure 2 AR-300L Battery Pack............................................................................................................9
Figure 3 Battery Housing....................................................................................................................10
Figure 4 Connecting and removing an attachment ........................................................................15
Figure 5 Connecting a battery housing ............................................................................................16
Figure 6 Removing the battery housing ..........................................................................................17
Figure 7 Insert a drill bit ..................................................................................................................... 18
Figure 8 Insert a drill bit into a Jacobs Chuck..................................................................................19
Figure 9 Insert a drill bit into a Keyless Chuck ............................................................................... 20
Figure 10 Insert a sawblade.............................................................................................................. 21
Figure 11 Insert a drill / burr bit ......................................................................................................22
Figure 12 Insert a pin / wire ............................................................................................................. 23
Figure 13 Insert drop-in battery to the Battery Housing..............................................................24

Table of contents
DFU-0223-2 Rev. 0 Page iv
List of Tables
Table 1 Handpiece ...............................................................................................................................8
Table 2 Battery Pack ............................................................................................................................9
Table 3 Battery Housing....................................................................................................................10
Table 4 Handpiece AR-300 ...............................................................................................................11
Table 5 Ambient conditions for operation ..................................................................................... 11
Table 6 Ambient conditions for storage (in shipping packaging)...............................................11
Table 7 Attachments..........................................................................................................................12
Table 8 Safety, EMC, and Regulatory Requirements................................................................... 13
Table 9 Connecting and removing an attachment ........................................................................15
Table 10 Connecting a battery housing ............................................................................................16
Table 11 Removing the battery housing ..........................................................................................17
Table 12 Insert a drill bit ..................................................................................................................... 18
Table 13 Insert a drill bit into a Jacobs Chuck..................................................................................19
Table 14 Insert a drill bit into a Keyless Chuck ............................................................................... 20
Table 15 Insert a sawblade.................................................................................................................. 21
Table 16 Insert a burr / drill bit ..........................................................................................................22
Table 17 Insert a pin / wire .................................................................................................................23
Table 18 Drop-in battery.....................................................................................................................24
Table 19 Guidance and Manufacturer's Declaration - Electromagnetic Emissions.................... 34
Table 20 Guidance and Manufacturer's Statement - Electromagnetic Immunity...................... 35
Table 21 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d)........36
Table 22 Accessories for DrillSaw Mini 300 System™ ...................................................................38
This is not a warranty document. For all warranty information, including disclaimers, exclusions,
terms, conditions and related provisions refer to the "Arthrex U.S. Product Warranty" section of the
Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by
reference.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 1
1
1. .0 0 General Warnings and Safety Notices - Read This First
It is imperative that the symbols and conventions listed below be clearly understood. The
DrillSaw Mini 300 System User’s Guide identifies critical, important, and useful information
using these symbols and conventions.
1.1 Important Safety Conventions
Users of this device are encouraged to contact their Arthrex representative if they
require a more comprehensive surgical technique.
WARNING!
The WARNING! label is the most important safety symbol. It identifies critical
information that must be followed precisely to avoid injury or death.
1. Use this device only for purposes described in the User’s Guide, under the
supervision of a trained and licensed physician. This device should not be used
by untrained personnel or used for indications other than those described in this
User’s Guide.
2. Before using the DrillSaw Mini 300 System for the first time, store it at room
temperature for 24 hours.
3. Charge batteries before every use. Follow instructions for charging batteries
before use.
4. The device is intended to apply mechanical force/rotational energy to the patient.
5. Before each use, check the handpiece and the attachments for damage and/or
loose parts. Do not use any part that is damaged.
6. Prior to each use, press the trigger mechanism to ensure proper function.
7. Never touch the chuck mechanism of the handpiece while the motor is still in
motion.
8. Avoid overheating at the treatment site by following the duty cycle and using
sharp cutting and drilling accessories.
9. No modification of the AR-300 or the accessories is allowed.
10. Unauthorized attempts to open or service this system will void the warranty.
Removing the cover may introduce an electric shock hazard by exposing the
user to dangerously high voltages or other risks. If the system malfunctions, it
should be returned for service immediately.
11. Misuse, unauthorized assembly and modifications or repairs to the AR-300
system, or non-compliance with these instructions relieves Arthrex of all liability
for claims under warranty or other claims.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 2
12. Use only Arthrex approved accessories. Other accessories may result in
increased emissions or decreased immunity of the system. Contact your Arthrex
representative for a complete list of accessories. DO NOT modify any accessory.
Failure to comply may result in injury to the patient and/or operating room staff.
13. Do not use in the presence of flammable anesthetics or oxidizing gases such as
nitrous oxide, oxygen, or endogenous gases. All oxygen connections must be
leak free for the duration of the surgical procedure.
14. After autoclaving, the accessory devices are VERY HOT. Handle with care to
avoid burns.
15. The equipment is NOT suitable for use in potentially explosive atmospheres or
with potentially explosive mixtures of anesthetic substances containing oxygen
or nitrous oxide.
16. Zone M is defined as a “medical environment” and constitutes the part of a room
in which potentially explosive atmospheres may form due to the use of
anesthetics or medical antiseptics and antibacterial soaps; such atmospheres
are typically localized and temporary. Zone M comprises a truncated pyramid
below the operating table which is tilted outwards at a 30° angle.
17. Zone G, also known as an “enclosed medical gas system”, does not necessarily
include areas enclosed around all sides, in which explosive mixtures are
continuously or temporarily generated, directed or used in small quantities.
18. Only fit an attachment/accessory when the handpiece is at a complete stop and
in safe position. Safe position is annotated by the “S” on the mode switch.
19. Do not interfere with the rotary instruments or saws while they are in motion.
20. Never touch an attachment or press the release mechanism of the collet while
the device is in motion.
21. To avoid potential injury, never allow a rotary or saw attachment to make contact
with the surrounding soft tissues and vessels.
22. Never use the Arthrex DrillSaw Mini 300 System in areas near strong magnetic
fields.
23. Do not place the handpiece on the patient.
24. Disconnect the rechargeable battery immediately after using the handpiece.
25. Only use accessories which are in proper working order. Damaged or improperly
functioning accessories must be sent in for service.
26. It is recommended to have a backup system available should the need arise.
The PRECAUTION! symbol identifies methods and procedures that
must be followed to avoid damaging the device or causing it to
malfunction.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 3
1. DO NOT – under any condition, or for any reason – open the handpiece, any
system component, or any other system accessory.
2. This device has passed testing for EMI/RFI radiation and susceptibility, and
EMC compatibility. This device may cause interference with other devices in the
near vicinity if not set up, and used as instructed by Arthrex.
3. Do not attach accessories to the handpiece unless the handpiece is in the safe
mode.
4. Only use batteries approved by Arthrex.
5. Do NOT clean the device with abrasive cleaning or disinfectant compounds,
solvents, or other materials that could scratch or damage the device.
6. The battery packs are NOT to be cleaned and disinfected in a thermo washer
disinfector.
7. NEVER place the handpiece or accessories in Cidex or other aldehyde
disinfectant solutions.
8. After sterilization in the autoclave, let the accessory device cool down slowly.
NEVER use cold water to cool the handpieces. This will damage the electronic
components and seals.
9. Liquid on the battery and handpiece contacts may damage the device. Before
connecting the battery housing, ensure the receptacles are clean and dry.
10. Always comply with the instructions issued by the manufacturer of the cleaning
disinfectant regarding concentration, exposure times, temperature, and material
compatibility.
11. Remove all accessories, including attachments, battery pack, and accessories
before sterilizing a handpiece.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 4
1.2 Symbol Definitions
Safety Sign
Follow operating
instructions
Caution: Federal law
restricts this device to
sale by or on the order
of a physician.
Non sterile
Fragile, handle with
care
Caution
This side up
Keep dry
Temperature limits for
storage and transport
Electrical Hazard,
dangerous voltages
are present. Never
attempt to repair the
equipment. Only
trainer service
personnel may remove
the cover, or obtain
access to system
components
Atmospheric pressure
limitation for storage
and transport
Type B Device – Not
suitable for
intracardiac
applications
Humidity limits for
storage and transport
Authorized
representative in the
European Community
Manufacturer
Serial number
Date of manufacture;
year and month.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 5
Electrical waste
The product meets the
essential
requirements of
Medical Device
Directive 93/42/EEC
Catalog number
Do not use if package
is damaged
Quantity
RF symbol. Non-
ionizing
electromagnetic
radiation
1.3 Shipping, Unpacking, and Warranty Information
Carefully unpack and inspect all components for shipping damage.
Any damage could compromise patient safety and should be reported immediately
to Arthrex or an authorized Arthrex distributor. The warranty could be voided if
shipping or first-installation damage is not reported within seven business days of
receiving the device. Please visit Arthrex.com for warranty information.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 6
2
2. .0 0 Product Description and Intended Use
2.1 Product Description
The Arthrex DrillSaw Mini 300 System is a battery powered surgical instrument. The
handpiece contains a microprocessor and is powered by a Lithium Ion battery.
Activation of the handpiece is achieved by pressing a hand switch.
The handpiece utilizes a drop-in style battery that does not go through the
sterilization process, which provides longer life from the battery pack. The battery
pack is used in conjunction with a sterile battery case that holds the battery and
prevents contact with the sterile surgical field.
2.2 Intended Use
The DrillSaw Mini 300™ System is a modular electric system, consisting of a
handpiece drive, various accessories, and a charging station for machining bones.
It can be used for small bone orthopedic and sports medicine applications to make
osteotomies, drill holes, and drive pins and wires.
2.3 Contraindications
The DrillSaw Mini 300 System is contraindicated in any non-orthopedic surgery
procedure and procedure disregarding the intended use.
Specifically:
•use by unskilled/untrained personnel
•disregarding the intended use
•non-compliance with the operation mode
•usage of improper accessories
Only use Arthrex accessories.
WARNING!
Misuse may damage the DrillSaw Mini 300 System and cause risks and hazards for
patients, users and third parties.
WARNING!
This device is only for use under the supervision of a trained and licensed physician.
This device should not be used by untrained personnel or used for indications other
than those described in this User’s Guide.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 7
2.4 Set Composition
Arthrex DrillSaw Mini 300 System parts and accessories:
•Handpiece
•Attachments (See Table 22)
•Battery pack
•Battery housing (aseptic battery only)
•Battery transfer plate (aseptic battery only)
•Battery Charger (see DFU-0256-XX)
•Instrument Tray(s)
•Elongation handle (optional device)

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 8
2.5 Product Functions
2
2. .5 5. .1 1 AR-300 Handpiece
The handpiece functions are identified and defined below.
Figure 1 Handpiece
Table 1 Handpiece
1.
Chuck mechanism
2.
Speed regulator
3.
Battery housing
4.
R/S/F Switch
5.
Forward drive (F)
6.
Safe position (S)
7.
Reverse drive (R)
1
2
3
6
7
4
5

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 9
2
2. .5 5. .2 2 AR-300L Battery Pack, Li-Ion
The main elements of the AR-300L battery pack are identified and defined below.
Figure 2 Battery Pack
Table 2 Battery Pack
1.
Battery contacts
2.
Handle
1
2

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 10
2
2. .5 5. .3 3 AR-3000LBH Battery Housing
The main elements of the Battery Housing are identified and defined below.
Figure 3 Battery Housing
Table 3 Battery Housing
1.
Battery contacts
2.
Battery housing door
3.
Release tab to remove battery housing from handpiece
1
2
3

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 11
3
3. .0 0 Technical Specifications
3.1 Handpiece
Table 4 Handpiece AR-300
Width
94 mm (3.7”)
Height
47 mm (1.85”)
Depth
175 mm (6.889”)
Weight
550 g (1.21 lbs.)
Cannulation
2.4 mm (0.0945”)
Protection
IPX0
Speed
See Section 3.2 Table 7 Attachments
Torque
See Section 3.2 Table 7 Attachments
Applied part type
B
Pollution level
2
Overvoltage category
II
Altitude
Up to 3,000 m [9,842 ft.] above sea level
Duty Cycle*
Operating Type S3 per IEC 60034-1
At 25°C (77°F) Ambient Temperature:
30 sec on / 30 sec off for 5 cycles, then wait 48 minutes
*Following the duty cycle is an important part of maintaining the Arthrex Mini 300
Power System. The duty cycle times have been determined under average load,
using the Sagittal Saw attachment and at ambient air temperature of 25° C (77° F).
Operating the device above of these prescribed parameters can lead to user and
patient injury, as well as a shortened life span of the device itself. The recommended
environmental operating temperature is 25° C (77° F) or lower. Operating in
environments above 25° C (77° F) can shorten the above prescribed duty cycles. The
environment temperature, surgical attachment type and time need to be considered
by the user, when planning its use in surgical interventions. Additionally, please
read the General Warnings and Safety Notices that start on Page 1 of this User’s Guide.
Table 5 Ambient conditions for operation
Temperature
10° to 40 °C (50° to 104 °F)
Relative Humidity
15% to 80% (relative), non-condensing
Table 6 Ambient conditions for storage (in shipping packaging)
Temperature
-40° to +70°C (-40° to +158°F)
Relative Humidity
8% to 80% (relative), non-condensing

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 12
3.2 Attachments
Table 7 Attachments
Drill Speed
2.750 rpm
1.300 rpm
Drill Torque
24 Ncm (2.12 inch pounds)
45 Ncm ( 3.98 inch pounds)
Reamer Speed
500 rpm
Reamer Torque
1.15 Nm ( 10.17 inch pounds)
Cutting
15,000 cpm
Sterilization
YES

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 13
3.3 Safety, EMC, and Regulatory Requirements
Table 8 Safety, EMC, and Regulatory Requirements
Parameter Parameter Value
System Classification IEC 60601-1 Class I
(protection against electric
shock)
FDA class Class I
EU class Class IIa
Health Canada Class Class II
Safety Certifications Domestic Certification ANSI/AAMI ES60601-1
Canadian Certification CSA C22.2 No 60601.1 (
EU Certification EN/IEC 60601-1
EMC Certifications EMC Certification EN/IEC 60601-1-2
Safety Certification Marking UL
CE Classification
MDD 93/42/EEC
Annex IX Rule 9 Class IIa
For all other accessories refer to accompanying DFUs for more information. Refer to Section
11.0 Electromagnetic Emissions for further details on EMC certification.
3.4 Electromagnetic Compatibility (EMC)
This device has passed testing for EMI/RFI radiation and susceptibility
and EMC compatibility. This device may cause interference with other
devices in the near vicinity if not set up and used as instructed by
Arthrex.

DrillSaw Mini 300™ System User’s Guide
DFU-0223-2 Rev. 0 Page 14
The DrillSaw Mini 300 System has been designed to accept EMC from other devices
within the limitations as described in section 11.0.
Try to correct the interference by following one or more of these measures:
1. Reorient or relocate the receiving device.
2. Increase the distance between the devices.
3. Connect the device to an outlet on a different circuit than the other
device(s) are connected to.
4. Consult the manufacturer or field service technician for the receiving
device for guidance.
3.5 Risks due to electromagnetic fields:
The functionality of implantable systems, such as cardiac pacemakers and ICD
(implantable cardioverter defibrillator) can be affected by electric, magnetic and
electromagnetic fields.
1. Consider the application and find out if patient or user has any of these
devices, before using the product.
2. Weigh the risks and benefits.
3. Keep the product away from any of these devices.
4. Make appropriate emergency provisions and take immediate action upon
any signs of health issues.
5. Symptoms such as raised heartbeat, irregular pulse and dizziness can be
signs of a problem with a cardiac pacemaker or ICD.