Arthrex DrillSaw Sports 400 User manual

Universal DrillSaw™Battery
Charger
User’s Guide
The Arthrex Universal DrillSaw Battery Charger User’s Guide
provides safety operation information for all components of
the Arthrex Universal DrillSaw Battery Charger, 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-0256-1
Revision 0
© 2016 Arthrex, Inc. All rights reserved
DFU-0256-1, Rev. 0 English
AR-400UBC

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Table of contents
DFU-0256-1 Rev. 0 Page i
1.0 General Warnings and Safety Notices - Read This First.....................1
1.1 Important Safety Conventions............................................................................1
1.2 Symbols Definition .............................................................................................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 Product Features................................................................................................8
2
2. .4 4. .1 1AR-400UBC Universal DrillSaw Battery Charger – Front View.............................. 8
2
2. .4 4. .2 2AR-400UBC Universal DrillSaw Battery Charger – Rear View.............................. 9
2
2. .4 4. .3 3AR-400UBC Display Messages ..........................................................................10
2
2. .4 4. .4 4AR-400UBC-4 Charging bay for AR-400UB Batteries..........................................11
2
2. .4 4. .5 5AR-400UBC-3 Charging bay for AR-300 and AR-600 Batteries...........................12
3
3. .0 0Technical Specifications...................................................................13
3.1 Charger............................................................................................................13
3.2 Safety, EMC, and Regulatory Requirements ...................................................14
3.3 Electromagnetic Compatibility (EMC)...............................................................15
3.4 Risks due to electromagnetic fields:.................................................................15
4
4. .0 0Setup................................................................................................16
4.1 AC Power Safety Considerations.....................................................................16
4.2 Basic Setup Procedure for the AR-400UBC Charger.......................................17
4.3 Setup - Installing a charging bay......................................................................18
4.4 Setup – Battery Installation and Removal........................................................19
5
5. .0 0Operation and frequently used functions ..........................................21
5.1 Main Screen.....................................................................................................21
5.2 Options Screen Display....................................................................................22
5.3 Cycle Screen Display (Only available for AR-400 Batteries)............................23
5.4 Error Code Screen Display...............................................................................23
6
6. .0 0Cleaning and Disinfecting.................................................................24
7
7. .0 0Sterilization.......................................................................................25
7.1 Transmissible Spongiform Encephalopathy Agents.........................................25

Table of contents
DFU-0256-1 Rev. 0 Page ii
8
8. .0 0Maintenance.....................................................................................26
8.1 Periodic Maintenance.......................................................................................26
9
9. .0 0Technical Support.............................................................................27
9.1 Additional Technical Information......................................................................27
1
10 0. .0 0Troubleshooting................................................................................28
1
11 1. .0 0Repair Policy....................................................................................30
1
12 2. .0 0End of Life, Environmental Directives...............................................31
1
13 3. .0 0Electromagnetic Emissions...............................................................32
List of Figures
Figure 1 Front Panel of the Charger....................................................................................................8
Figure 2 Rear Panel of the Charger ..................................................................................................... 9
Figure 3 Charging bay for AR-400UB Batteries............................................................................... 11
Figure 4 Charging bay for AR-300 and AR-600 Batteries ..............................................................12
Figure 5 Install a charging bay........................................................................................................... 18
Figure 6 Battery Attachment and Removal:.....................................................................................19

Table of contents
DFU-0256-1 Rev. 0 Page iii
List of Tables
Table 1 Front Panel of the Charger....................................................................................................8
Table 2 Rear Panel of the Charger ..................................................................................................... 9
Table 3 AR-400UBC Display Messages...........................................................................................10
Table 4 Elements of the Charging bay for AR-400UB Batteries ..................................................11
Table 5 Elements of the Charging bay for AR-300L & AR-600L Batteries................................. 12
Table 6 AR-400UBC Charger............................................................................................................ 13
Table 7 Ambient conditions for operation .....................................................................................13
Table 8 Ambient conditions for storage.......................................................................................... 13
Table 9 Safety, EMC, and Regulatory Requirements....................................................................14
Table 10 Install a charging bay........................................................................................................... 18
Table 11 Battery Attachment and Removal......................................................................................20
Table 12 Touch Screen Display Elements....................................................................................... 21
Table 13 Options Screen Display ....................................................................................................... 22
Table 14 Options Screen Display ....................................................................................................... 23
Table 15 Error Code Screen Display.................................................................................................. 23
Table 16 Troubleshooting: Faults, their Causes, and Solutions.....................................................28
Table 17 Guidance and Manufacturer's Declaration - Electromagnetic Emissions.................... 32
Table 18 Guidance and Manufacturer's Statement - Electromagnetic Immunity....................... 33
Table 19 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ........34
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.

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1.0 General Warnings and Safety Notices - Read This First
It is imperative that the symbols and conventions listed below be clearly understood. The
Universal DrillSaw Battery Charger 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. No modification of the charger (AR-400UBC) or accessories are allowed.
3. DO NOT open or attempt to service this system, as this may void your warranty.
There are no user-serviceable parts inside. Removing the cover may introduce an
electric shock hazard by exposing you to dangerously high voltages or other
risks. If the system malfunctions, return it for service immediately.
4. Misuse, unauthorized assembly and modifications or repairs to the AR-400UBC
system, or non-compliance with these instructions relieves Arthrex of all liability
for claims under warranty or other claims.
5. 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.
6. 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.
7. Only use accessories which are in proper working order. Damaged or improperly
functioning components must be sent in for service before use.
8. Before using the AR-400UBC for the first time, store it at room temperature for 24
hours.

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DFU-0256-1 Rev. 0 Page 2 of 35
9. The equipment is NOT suitable for use in potentially explosive atmospheres or
with potentially explosive mixtures of anesthetic substances containing oxygen or
nitrous oxide.
10. DO NOT use the system without a blank shipping cover or a charger cup present
over each of the four charging bays, as this could introduce an electric shock
hazard by exposing you to dangerously high voltages or other risks.
The PRECAUTION! symbol identifies methods and procedures that
must be followed to avoid damaging the device or causing it to
malfunction.
1. DO NOT – under any condition, or for any reason – open the charger, any
system component, or any other system accessory.
2. Only use replacement power cords that meet medical grade standards
according to IEC 60320-1 Subclause 3.21, Detachable Power Supply Cords or
electrical standards for the designated country where the AR-400UBC is being
used. Contact your Arthrex representative for further information.
3. 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.
4. DO NOT clean the device with abrasive cleaning or disinfectant compounds,
solvents, or other materials that could scratch or damage the device.
5. Always comply with the instructions issued by the manufacturer of disinfectant.
6. NEVER use liquid to clean the accessory device connector contacts. Remove
dust regularly with dry compressed air.

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NOTE: This identifies information and training that can simplify the setup and operation of this
device.
1. Read this User’s Guide thoroughly before operating the device and save it for
future reference. For additional information and training, contact your local
Arthrex representative.
2. The AR-400UBC charger incorporates a universal AC input power supply. A
voltage selection switch is not required.
3. AR-400UBC has been designed to accept EMC from other devices within the
limitations as described in section 13.0

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DFU-0256-1 Rev. 0 Page 4 of 35
1.2 Symbols Definition
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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DFU-0256-1 Rev. 0 Page 5 of 35
Catalog number
The product meets
the essential
requirements of
Medical Device
Directive 93/42/EEC
Quantity
Do not use if package
is damaged
Onn/Off Symbol
Protective Earth
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 any 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. Refer also to our General Terms of Business.
Please visit Arthrex.com for warranty information.

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2
2. .0 0 Product Description and Intended Use
2.1 Product Description
The Arthrex Universal DrillSaw Battery Charger is classified as a FDA Class I medical
device.
The Arthrex Universal DrillSaw Battery Charger is designed to charge the following
Arthrex batteries
•AR-300L
•AR-400UB
•AR-400SB
•AR-600L
A detachable power cord is used to provide power to the charger.
The charger is activated by a switch.
The front panel display is a touch screen, back lit LCD display that is used to select
and provides a means for charging status of the battery, and status/warning/caution
indicators of batterie health status.
The AR-400UBC Universal DrillSaw Battery Charger, Applied Parts and Accessories:
• AR-400UBC Universal DrillSaw Battery Charger
• Charging bays (Sold separately):
•AR-400UBC-U4 – Charging Bay for AR-400UB batteries
•AR-400UBC-S4 – Charging Bay for AR-400SB batteries
•AR-400UBC-3 – Charging Bayfor AR-300L & AR-600L batteries
• Power Cord
2.2 Intended Use
The Universal DrillSaw Battery Charger is intended exclusively for charging AR-
300L, AR-600L, AR400SB and AR-400UB rechargeable batteries.
2.3 Contraindications
The AR-400UBC is contraindicated in any procedure where a conductive solution is
used.
Specifically:
•use by unskilled/untrained personnel
•disregarding the intended use

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Only use Arthrex accessories described in this User’s Guide.
WARNING!
Misuse may damage the AR-400UBC 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.

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2.4 Product Features
2
2. .4 4. .1 1 AR-400UBC Universal DrillSaw Battery Charger – Front View
Figure 1 shows the front panel of the AR-400UBC. The features are identified in Table
1 below.
Figure 1 Front Panel of the Charger
Table 1 Front Panel of the Charger
1.
Charging Bay No.1
2.
Charging Bay No.2
3.
Charging Bay No.3
4.
Charging Bay No.4
5.
Touch Screen Display
1
4
5
2 3

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2
2. .4 4. .2 2 AR-400UBC Universal DrillSaw Battery Charger – Rear View
Figure 2 shows the rear panel of the AR-400UBC. The features are identified in Table
2 below.
Figure 2Rear Panel of the Charger
Table 2 Rear Panel of the Charger
6.
ON/ OFF Power Switch
7.
Supply main input Plug
8.
Supply main output to connect a second charger to an existing
charger
9.
Hex-wrench
87
9 6

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2
2. .4 4. .3 3 AR-400UBC Display Messages
The Touch Screen Display [Figure 1] provides information about the status of the
AR-400UBC charging status in real time. A list of informational and error messages
is shown in Table 3 below. Messages shaded in gray denote that Arthrex technical
support should be contacted for further instructions.
Table 3AR-400UBC Display Messages
Charger
Error Codes
Cause Solution AR-300L
AR-600L
AR-400UB
AR-400SB
01 Open Charge Power
Path or Short Circuit
Power Path
Recommend retry charging
the battery.
If the fault repeats, the
battery needs to be
replaced.
x
x
02 Battery failed to
communicate
Recommend retry charging
the battery.
If the fault repeats, replace
the battery.
x
03 Charge time out
exceeded (120
minutes)
Make not of the fault and
retry charging the battery.
If the fault repeats replace
the battery.
xx
04 Battery Identification
incorrect or Battery
severely discharge
Battery should not be used.
Replace the battery.
xx
05 Battery to cold or hot Wait until the battery
temperature adjusts and
recommend retry charging
the battery
xx
06 Charger
communication to
the battery has
repeatedly failed
Recommend retry charging
the battery.
If the fault repeats, replace
the battery.
x
07 Battery has a
permanent fault
Battery should not be used.
Replace the battery.
x
08 Battery health below
70% of design
capacity
Battery will not charge, and
needs to be replaced.
x

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2
2. .4 4. .4 4 AR-400UBC-4 Charging bay for AR-400UB Batteries
Figure 3.shows the Charging bay for the AR-400UB Battery Pack. The features are
identified in Table 4 below.
Figure 3Charging bay for AR-400UB Batteries
Table 4 Elements of the Charging bay for AR-400UB Batteries
1.
Battery contact
2.
Alignment tabs for connecting to the charger
3.
Alligment arrow for the AR-400 battery pack
1
2
3

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2
2. .4 4. .5 5 AR-400UBC-3 Charging bay for AR-300 and AR-600 Batteries
Figure 4.shows the Charging bay for AR-300L and AR-600L Battery Packs. The
features and symbols are identified in Table 5 below.
Figure 4Charging bay for AR-300 and AR-600 Batteries
Table 5 Elements of the Charging bay for AR-300L & AR-600L Batteries
1.
Battery contact
2.
Alignment arrow for AR-300L and AR-600L battery packs
3.
Alignment tabs for connecting to the charger
1
2
3

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3
3. .0 0 Technical Specifications
3.1 Charger
Table 6 AR-400UBC Charger
Width
330 mm (13 in.)
Height
100 mm (4 in.)
Depth
280 mm (11 in.)
Weight
2.65 kg (5.9 lbs.)
Water protection
IP30
AC Input
100-240V~, 50/60Hz, 3 A, Class I
Mains Fuse
5A (Non-Replaceable)
Power
250W
Pollution Level
2
Altitude
4,500 m (15,000 ft)
Overvoltage Category
II
Table 7 Ambient conditions for operation
Temperature
0° to 35 °C (32° to 95 °F)
Relative Humidity
0% to 85% (relative), non-condensing
Air Pressure
700 hPa to 1020 hPa (21 in. Hg to 30.12 in. Hg)
Table 8 Ambient conditions for storage
Temperature
-20° to +60°C (-4° to 140°F)
Relative Humidity
10% to 85% (relative), non-condensing
Air Pressure
500 hPa to 1020 hPa (15 in. Hg to 30.12 in. Hg)

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3.2 Safety, EMC, and Regulatory Requirements
Table 9 Safety, EMC, and Regulatory Requirements
Parameter Parameter Value
System Classification IEC 60601-1 Class I
(protection against electric
shock)
FDA class Class I medical device (non-
sterile)
EU class Class IIa
Health Canada Class Class II
Safety Certifications Domestic Certificaton ANSI/AAMI ES60601-1
(2005+C2+A2)
Canadian Certification CSA C22.2 No 60601.1 (2008)
EU Certification EN/IEC 60601-1: 2005 +
A1:2012
EMC Certifications EMC Certification IEC 60601-1-2: 2007
Safety Certification Marking UL
CE Classification
MDD93/42/EEC
Annex IX Rule 9 Class IIa
For all other accessories refer to accompanying DFUs for more information.Refer to Section
13.0 Electromagnetic Emissions for further details on EMC certification.

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3.3 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.
The AR-400UBC has been designed to accept EMC from other devices within the
limitations as described in section 13.0.
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.
3.4 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.