Arthrex DrillSaw Sports 400 User manual

DrillSaw Sports 400™ System
User’s Guide
The Arthrex DrillSaw Sports 400™ System User’s Guide
provides safety operation information for all components of
the Arthrex DrillSaw Sports 400™ 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.
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-0253-4 Revision 0
06/2020
© 2020 Arthrex, Inc. All rights reserved
AR-400

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.

Table of contents
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1
1. .0 0General Warnings and Safety Notices - Read This First ....................1
Important Safety Conventions............................................................................ 1
Symbol Definitions ............................................................................................. 4
Shipping, Unpacking, and Warranty Information................................................ 6
2
2. .0 0Product Description and Intended Use ..............................................7
Product Description............................................................................................ 7
Intended Use...................................................................................................... 7
Contraindications ............................................................................................... 7
Set Composition................................................................................................. 7
Product Functions .............................................................................................. 9
2
2. .5 5. .1 1AR-400 Handpiece ............................................................................................... 9
2
2. .5 5. .2 2AR-400UB Aseptic Battery Pack..........................................................................10
2
2. .5 5. .3 3AR-400UBH-1 Aseptic Battery Housing ...............................................................11
3
3. .0 0Technical Specifications ..................................................................13
Handpiece........................................................................................................ 13
Attachments ..................................................................................................... 14
Safety, EMC, and Regulatory Requirements ................................................... 15
3.4 Electromagnetic Compatibility (EMC)............................................................... 16
3.5 Risks due to electromagnetic fields:................................................................. 16
4
4. .0 0Setup ...............................................................................................17
4.1 How to Set Up the Handpiece.......................................................................... 17
4.2 Setup - Connecting and Removing an Attachment to the Handpiece .............. 17
4.3 Setup - Connecting a Battery to the Handpiece ............................................... 18
4.4 Setup - Removing a battery from the Handpiece ............................................. 19
4.5 Setup - Quick Connect of Drilling and Reaming Attachments .......................... 20
4.6 Setup - Drilling and Reaming Attachments, Keyed Jacobs Chuck................... 21
4.7 Setup - Drilling and Reaming Attachments, Keyless Chuck............................. 22
4.8 Setup - Sagittal Saw Attachment...................................................................... 23
4.9 Setup – Burr and J-Latch Attachments ............................................................ 25
Setup - Wire/Pin Driver Attachment ................................................................. 26
Aseptic Battery Housing/Aseptic Battery Pack/Aseptic Transfer Kit................. 27
5
5. .0 0Cleaning and Disinfecting ................................................................29

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5.1 Aseptic Battery Pack ........................................................................................ 29
5.2 Detergent Selection.......................................................................................... 30
5.3 Preliminary Cleaning ........................................................................................ 31
5
5. .3 3. .1 1Handpiece, Aseptic Battery Housing, and Sterilizable Battery..............................31
5
5. .3 3. .2 2Attachments and Aseptic Transfer Kit ..................................................................31
5.4 Automated Cleaning and Thermal Disinfection ................................................ 31
6
6. .0 0Sterilization ......................................................................................34
6.1 Approved Sterilization - Handpiece, Attachments, Aseptic Battery Housing and
Aseptic Transfer Kit.................................................................................................... 34
6.2 Approved Sterilization – Sterilizable Battery .................................................... 35
Transmissible Spongiform Encephalopathy Agents......................................... 36
7
7. .0 0Maintenance ....................................................................................37
Periodic Maintenance....................................................................................... 37
8
8. .0 0Technical Support............................................................................38
Additional Technical Information ...................................................................... 38
9
9. .0 0Repair Policy ...................................................................................39
1
10 0. .0 0End of Life, Environmental Directives ..............................................40
Specific guidelines for the disposal of Li-Ion batteries...................................... 40
1
11 1. .0 0Electromagnetic Emissions..............................................................41

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List of Figures
Figure 1 Handpiece ...............................................................................................................................9
Figure 2 AR-400UB Aseptic Battery Pack ........................................................................................ 10
Figure 3 Aseptic Battery Housing ..................................................................................................... 11
Figure 4 AR-400SB Sterilizable Battery.............................................................................................12
Figure 5 Connecting and removing an attachment ........................................................................17
Figure 6 Connecting a battery............................................................................................................ 18
Figure 7 Removing a battery.............................................................................................................. 19
Figure 8 Insert a drill bit ..................................................................................................................... 20
Figure 9 Insert a drill bit into a Jacobs Chuck..................................................................................21
Figure 10 Insert a drill bit into a Keyless Chuck ............................................................................... 22
Figure 11 Insert a sawblade..................................................................................................................23
Figure 12 Indexing the saw head ........................................................................................................ 24
Figure 13 Inserting a rotary instrument (burr/drill bit)................................................................... 25
Figure 14 Inserting a wire /pin ............................................................................................................26
Figure 15 Aseptic Battery Pack Transfer ............................................................................................ 27

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List of Tables
Table 1 Handpiece ...............................................................................................................................9
Table 2 AR-400UB Aseptic Battery Pack ........................................................................................10
Table 3 Aseptic Battery Housing .....................................................................................................11
Table 4 AR-400SB Sterilizable Battery............................................................................................. 12
Table 5 Handpiece AR-400 ...............................................................................................................13
Table 6 Ambient conditions for operation .....................................................................................13
Table 7 Ambient conditions for storage (in shipping packaging)...............................................13
Table 8 Attachments.......................................................................................................................... 14
Table 9 Safety, EMC, and Regulatory Requirements.................................................................... 15
Table 10 Connecting and removing an attachment ........................................................................17
Table 11 Connecting a battery............................................................................................................ 18
Table 12 Removing a battery..............................................................................................................19
Table 13 Insert a drill bit .....................................................................................................................20
Table 14 Insert a drill bit into a Jacobs Chuck.................................................................................. 21
Table 15 Insert a drill bit into a Keyless Chuck ...............................................................................22
Table 16 Insert a sawblade.................................................................................................................. 23
Table 17 Indexing the saw head.........................................................................................................24
Table 18 Inserting a rotary instrument (burr/drill bit).................................................................... 25
Table 19 Inserting a wire/pin.............................................................................................................. 26
Table 20 Aseptic Battery Pack Transfer ............................................................................................27
Table 21 Guidance and Manufacturer's Declaration - Electromagnetic Emissions....................41
Table 22 Guidance and Manufacturer's Statement - Electromagnetic Immunity....................... 42
Table 23 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d)........ 42
Table 24 DrillSaw Sports 400 System™ ............................................................................................ 44

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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 Sports 400 System User’s Guide identifies critical, important, and useful information
using these symbols and conventions.
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 Sports 400 System for the first time, store it at room
temperature for 24 hours.
3. Charge batteries before every use. Follow the instructions for charging the
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, fully assemble the system and press the trigger mechanism to
ensure proper function. All couplings and mechanical connections need to be
fully secured or locked before the actuation of the system. Never touch the chuck
mechanism of the handpiece while the motor is still in motion.
7. Avoid overheating at the treatment site by following the duty cycle and using
sharp cutting and drilling accessories.
8. No modification of the AR-400 or the accessories is allowed.
9. 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.
10. Misuse, unauthorized assembly and modifications or repairs to the AR-400
system, or non-compliance with these instructions relieves Arthrex of all liability
for claims under warranty or other claims.

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11. 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.
12. 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.
13. After autoclaving, the accessory devices are VERY HOT. Handle with care to
avoid burns.
14. The equipment is NOT suitable for use in potentially explosive atmospheres or
with potentially explosive mixtures of anesthetic substances containing oxygen
or nitrous oxide.
15. 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.
16. 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.
17. 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.
18. Do not interfere with the rotary instruments or saws while they are in motion.
19. Never touch an attachment or press the release mechanism of the collet while
the device is in motion.
20. To avoid potential injury, never allow a rotary or saw attachment to make contact
with the surrounding soft tissues and vessels.
21. Never use the Arthrex DrillSaw Sports 400 System in areas near strong
magnetic fields.
22. Do not place the handpiece on the patient.
23. Disconnect the rechargeable battery immediately after using the handpiece.
24. Only use accessories which are in proper working order. Damaged or improperly
functioning accessories must be sent in for service.
25. 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.

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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 aseptic 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, 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 and battery before sterilizing a
handpiece.
12.
Caution: Federal law restricts this device to sale by or on the order of a
physician.
13.
This device is intended to be used by a trained medical professional
14.
Biohazard waste, such as explanted devices, needles and contaminated
surgical equipment, should be safely disposed of in accordance with the
institutions policy.
15.
Serious incidents should be reported to Arthrex Inc., or an in-country
representative, and to the health authority where the incident occurred.
•Surgeons are advised to review the product-specific surgical technique prior to performing
any surgery. Arthrex provides detailed surgical techniques in print, video, and electronic
formats. The Arthrex website also provides detailed surgical technique information and
demonstrations. Or, contact your Arthrex representative for an onsite demonstration.
•In CE accepting Countries:Procedures carried out using these devices may be used on
the general population.
•In CE accepting Countries: The clinical benefits associated with the use of these devices
outweigh the known clinical risks.
•In CE accepting Countries: There are no unacceptable residual risks or uncertainties
associated with the clinical use of these devices.

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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
trained service
personnel may remove
the cover, or obtain
access to system
components.
Atmospheric pressure
limitation for storage
and transport
Authorized
representative in the
European Community
Humidity limits for
storage and transport
Serial number Manufacturer
Electrical waste
Date of manufacture;
year and month.

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Catalog number
The product meets the
essential
requirements of
Medical Device
Directive 93/42/EEC
Quantity
Do not use if package
is damaged
Type B Device – Not
suitable for
intracardiac
applications
RF symbol. Non-
ionizing
electromagnetic
radiation
Consult Instructions
for Use
•All of the symbols used on the labeling along with the title, description and standard
designation number may be found on our website at www.arthrex.com/symbolsglossary.

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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.

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2
2. .0 0 Product Description and Intended Use
Product Description
The Arthrex DrillSaw Sports 400 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.
Intended Use
The DrillSaw Sports 400 System is a battery-driven power tool which uses a
multitude of attachments for cutting, drilling, reaming, and pin and wire driving.
This system is intended to be used in general orthopaedic surgical applications.
Contraindications
The DrillSaw Sports 400 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
•Not for use on spinal or neuro procedures
Only use Arthrex accessories.
WARNING!
Misuse may damage the DrillSaw Sports 400 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.
Set Composition

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Arthrex DrillSaw Sports 400 System parts and accessories: (See Table 24)
•Handpiece
•Attachments
•Aseptic Battery Pack
•Aseptic Battery Housing (aseptic battery only)
•Aseptic Transfer Kit (aseptic battery only)
•Sterilizable Battery
•Universal Battery Charger (see DFU-0256-XX)
•Charging Bays

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Product Functions
2
2. .5 5. .1 1 AR-400 Handpiece
The handpiece functions are identified and defined below.
Figure 1 Handpiece
Table 1 Handpiece
1.
Collet Release button
2.
Mode switch
3.
Battery connection
4.
Safe position
5.
Forward only (Reverse is locked out)
6.
All functions:
6a – Forward
6b – Reverse
6c - Oscillate
1
2
3
4
5
6
6a
6b
6c

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2
2. .5 5. .2 2 AR-400UB Aseptic Battery Pack
The main elements of the AR-400UB Aseptic Battery Pack are identified and defined
below.
Figure 2 AR-400UB Aseptic Battery Pack
Table 2 AR-400UB Aseptic Battery Pack
1.
Battery contacts
2.
Handle
1 2

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2
2. .5 5. .3 3 AR-400UBH-1 Aseptic Battery Housing
The main elements of the Aseptic Battery Housing are identified and defined below.
Figure 3 Aseptic Battery Housing
Table 3 Aseptic Battery Housing
1.
Battery contacts
2.
Battery housing door
3.
Release tab to remove battery housing from handpiece
4.
Lever to open and close battery housing door
5.
5a- Lever position when battery housing door closed
5b- Lever position when battery housing door open
1
2
3
4
5b
5a

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2.5.4 AR-400SB Sterilizable Battery
The main elements of the AR-400SB Sterilizable Battery are identified and defined
below.
Figure 4 AR-400SB Sterilizable Battery
Table 4 AR-400SB Sterilizable Battery
1.
Battery contacts
2.
Release tab to remove battery from handpiece
1 2

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3
3. .0 0 Technical Specifications
Handpiece
Table 5 Handpiece AR-400
Width
40 mm (1.574”)
Height
141.5 mm (5.57”)
Depth
121mm (4.764”)
Weight
630 g (1.3 lbs.)
Cannulation
3.2 mm (0.126”)
Protection
IPX0 for Handpiece and IPX4 for AR-400UBH-1
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 seconds on/off for 5 cycles, then wait 48 minutes
Worst Case Temperature Condition: At 40°C (104°F)
18 seconds on/off for 5 cycles, then wait 60 minutes
*Following the duty cycle is an important part of maintaining the Arthrex DrillSaw
Sports 400 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 6 Ambient conditions for operation
Temperature
10° to 40 °C (50° to 104 °F)
Relative Humidity
15% to 80% (relative), non-condensing
Table 7 Ambient conditions for storage (in shipping packaging)
Temperature
-40° to +70°C (-40° to +158°F)
Relative Humidity
8% to 80% (relative), non-condensing

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Attachments
Table 8 Attachments
Drill Speed
1,330 rpm
Drill Torque
3.2 Nm (28 inch pounds)
Reamer Speed
330 rpm
Reamer Torque
9 Nm (79 inch pounds)
Cutting
23,000 cpm
Sterilization
YES