Fillauer ML Motion Arm User Manual

: June 3, 2024
: fillauer

Motion Arm™
ML & EL
Users Manual

Introduction

The Motion Arm is the first waterproof elbow for use with myoelectric devices. Rated at IP67 dustproof/waterproof certification, with a waterproof terminal device (electric hook or hand) and waterproof wrist attached, the entire prostheses can now be submersed up to the first opening in the prosthetic socket.
*No longer fear rainy days, washing the car or even vigorously washing your hands.
Power comes from an internal 3000 mAhr battery, adequate for a full day’s charge in most situations. Five LED lights on the front of the arm indicate the level of charge left in the batteries with low battery warnings at 20% and 15% of capacity remaining. No more guessing if you need to charge your battery!
Please read through this User Guide. It contains important precautions and information to get the highest performance from your prosthesis.

When used in conjunction with a waterproof terminal device and waterproof quick disconnect wrist.

Special Precautions

Use caution when using this device in situations where injury to yourself or others may occur. These include but are not limited to activities such as driving, operating heavy machinery, or any activity where injury may occur. Conditions such as a low or dead battery, loss of electrode contact, or mechanical/electrical malfunction (and others) may cause the device to behave differently than expected. Device poses a spark risk if used around volatile gases.
Risk Management : To minimize the risk of device damage or injury to the user while maximizing the functions of this device, follow the instructions for installation, and use this device as described in this manual.
A waterproof terminal device with a waterproof quick disconnect wrist must be installed to make the elbow waterproof. Exposing the elbow to water without a waterproof wrist installed will likely cause damage to the elbow.
Use the battery charger supplied with the elbow ONLY. Do not use generic or other manufacturer’s chargers.
Do not remove any covers, screws, plates or any part of the elbow not described in this manual. There are no user serviceable components within the elbow. Removal of these covers will compromise the waterproof seal and void the warranty.
Do not charge the elbow while wearing the prosthesis. Remove the prosthesis before charging the device.
A Low Battery Warning will activate when the battery reaches 20% of full capacity. The wearer should charge the elbow at this point. Once the charge is depleted from the battery, the device will no longer function. Non-Motion Control terminal devices may not be able to release their grasp on an object.
The Motion Arm will support 50 ft-lbs/65 Nm (22.6 kg) with the elbow in the locked position. Forces greater than 50 lbs could damage the elbow and are considered beyond the capabilities of the elbow. This could include but is not limited to lifting heavy loads and/or falls onto the elbow.
**** In the unlikely event a serious incident occurs in relation to the use of the device, users should seek immediate medical help and contact their prosthetist at the earliest possible convenience. Clinicians should contact Motion Control immediately in the event of any device failure.

Charging

When you receive the Motion Arm elbow it likely will not have a full charge. Upon receiving the device, it should be charged to a full charge. The charger comes with multiple wall plugs for various inter-national power outlets. Choose the correct one for your area and slide it into place. Plug the charger into the outlet and the light on the charger will glow green.
The charge port for the elbow is found on the back of the elbow. It is a simple magnetic connection. Once the connection is made the charger light will change to red as the elbow charges. Once the battery is fully charged, the light will return to green. From full discharge to full charge is usually about 3 hours.
If the charger light glows green but the elbow is not fully charged, check the connection between the charger and the elbow. If it continues to show green (see the battery level indicator image below), there is a fault in the charging system.

Power On/Off

The on/off button is located next to the silver screw on the front of the elbow. To turn the power on/off, press and hold the button for about 2 seconds. When the elbow powers “on” it will beep or buzz and the 5 LEDs will sequentially flash green, then flash green to indicate the level of charge in the battery. When the on/off button is pressed again for 2 seconds, the LEDs will light red and then sequentially flash red. Once the last red LED is extinguished, the elbow will beep/buzz and the power is now off.

The charge port is located on the back of the elbow and connects with a break- away magnetic charging plug.| The power button and red/green LED indicator lights are located on the front of the elbow.

Battery Level Indicator

The 5 LEDs on the front of the elbow indicate the charge level of the battery. To activate the indicator, the arm must be turned on, the on/ off button is pressed momentarily, and the LEDs will light showing the remaining charge. Each light represents 20% remaining charge. The lights will go out in a few seconds.

Low Battery Warning

When the battery charge level drops to 20% of capacity 1 LED will blink and the elbow will beep/buzz 3 times every 5 minutes. This warning can be disabled by pressing the on/off switch momentarily. If the elbow is turned off, and then back on, the warning will reactivate.
A critical Low Battery Warning will notify the user when the Battery is at 15% of capacity. The elbow will beep/buzz 3 times and the LEDs will flash red. When the battery is completely depleted the terminal device and all components will not function.
When the Low Battery Warning goes off, the wearer should actively begin seeking a charge for the battery. Non-Motion Control terminal devices may not be able to release their grasp on an object when the battery is depleted.

Adjusting Automatic Forearm Balance

The Motion Arm ML and EL have a self-contained automatic forearm balance mechanism. This allows adjustment of the forearm lift force to counteract the weight of the terminal device and/or an electric wrist rotator.
The forearm adjustment is found on the backside of the forearm. To increase the lift assist for heavier terminal devices or the addition of an electric wrist rotator, open the two wings of the adjustment screw and turn it clockwise as if looking directly at the adjustment screw. To decrease the forearm lift, (for example, going from a multi-articulating hand to an ETD) turn the screw counterclockwise. A total of 10 revolutions are possible. The screw will not turn after it reaches its limit. Do not force it further as damage will occur. Once the adjustment has been made, be sure to return the adjustment screw wings to their flattened, locked position

The Automatic Forearm Balance (AFB) mechanism is on the bottom of the arm. Lift the tabs and twist to adjust. A total of 10 revolutions is possible.
Elbow Electronic Adjustments

Motion Arm ML

The Motion Arm Manual Lock is designed to be a simple, lightweight, low-cost elbow. As such, set up of the elbow is performed by a series long and short depressions of the on/off switch. See the section, Settings Mode (p.8) for the setting codes.
Motion Arm EL
The Motion Arm Electric Lock elbow has sophisticated electronics including Bluetooth for communication with the iOS User Interface. For information on downloading the Motion Arm User Interface (MAUI), see the MAUI for iOS section (p.16). After downloading the App, you will be prompted to view a tutorial. It is highly suggested you follow this tutorial as it only takes 10-15 minutes.
MAUI adjustments affect only the elbow settings. Adjustment of these settings are necessary for ease of lock/unlock of the elbow. Adjustment of the electric wrist rotator and/or terminal device are made in each component’s specific user interface.
Manual Lock/Unlock Override
Motion Arm EL only
The Motion Arm EL has a manual lock/ unlock override for those situations where you may not be able to hit an unlock trigger, or the battery is depleted, and the elbow is locked. Behind the elbow axis, slightly below the friction band, a slide will lock/unlock the elbow. By pushing on the right side and sliding it to the left, (from the patient’s perspective) the elbow will unlock. Sliding from the left toward the right, the elbow will lock.

Mode Adjustments

Elbow Unlock: Wrist/Terminal Device Disable
The Motion Arm can be set so the Terminal Device and wrist rotator (if installed) is disabled upon elbow unlock. This allows the wearer to flex and extend the elbow without the fear of inadvertent opening (or closing) of the terminal device or wrist rotation. It can also be set to allow motion of the TD and wrist rotator while simultaneously flexing and extending the elbow.
Feedback
The elbow will beep or buzz to inform the wearer of several events. The wearer can choose between a beep, buzz, or none by turning off the feedback for these events.
Settings Mode—Motion Arm ML
Lacking Bluetooth communications, settings for the manual locking elbow are made with the power switch. To enter the settings mode, with the arm powered on, press the on/off button twice, quickly and then hold the button on the third press. The LEDs will now dance green. Pushing the power button once, the settings will now cycle
through as follows. Quickly pressing the power button twice enables or disables a setting.

SETTING	RED LED	GREEN LED
Disable Wrist/TD Elbow Unlocked	Wrist/TD Enabled when elbow is unlocked

Wrist/TD Disabled when elbow is unlocked
Buzz| Disabled| Enabled
Beep| Disabled| Enabled

*Note, all Buzzers and Beepers, including low battery buzzers, are disabled when both buzz and beep are turned off.
Exit Settings Mode the same way as entering it, push the power switch twice quickly and hold on the third push. The LEDs will now dance red. The settings mode will time out and exit after 5 minutes of no activity.

Feedback Indicators

Many events will trigger a beep or buzz and flashing lights. See the below chart for an indication of those events.

EVENT	FEEDBACK
Power On	One long buzz or beep
Lock/Unlock	One quick buzz or beep
Low Battery Indication	1 Green LED ramp-up (20% battery remaining). Three

quick buzzes or three quick beeps
Critical Battery Level| 1 Red LED ramp-up (15% battery remaining). Three quick buzzes or three quick beeps
Enter Settings Mode| LEDs dance green
Exit Settings Mode| LEDs dance red

MAUI App for iOS
Quick Setup for Motion Arm User Interface for Apple® iOS (MAUI)

From the Apple® App Store download the MAUI app .
Open the App and follow the Tutorial.
Go to the Connect screen and tap Scan .
Input the Pairing Key that came with the device. This key should be kept in the Patient’s record.
The device is now connected to the MAUI.
To disconnect, tap the Connect icon in the lower left corner , then tap Disconnect .

Troubleshooting

Make sure the battery on the device is fully charged
Confirm the device is turned on
Verify that you are not in “Simulation Mode” by double tapping the Home key, then swiping MAUI off the screen, and reopening the app
Bluetooth® must be turned on in Settings on the iOS device
The Information icon provides information about a function
To repeat the tutorial, go to and tap on Reset Guided Tutorial Reset

System Requirements

iOS 11 minimum
iPad® (5th gen and later)
iPad mini ® (2nd gen and later)
iPad Air®
iPad Pro®
iPod Touch® (6th gen and later)
iPhone® 5s and later

Declarations

Single Patient Use

Each amputee is unique. The shape of their residual limb, the control signals each generates and the tasks an amputee performs during the day require specialized design and adjustment of the prosthesis. Fillauer Motion Control products are manufactured to be fit to one individual.

Disposal/Waste Handling

This device, including any associated electronics and batteries should be disposed of in accordance with applicable local laws and regulations. This includes laws and regulations regarding bacterial or infectious agents, if necessary.

Serious Incidents

In the unlikely event a serious incident occurs in relation to the use of the device, users should seek immediate medical help and contact their prosthetist, local competent authority and Fillauer at the earliest possible convenience. Clinicians should at any time contact their local Fillauer representative and local competent authority immediately in
the event of any device failure.

Limited Warranty

The Motion Arm is warranted for 24 months from the date of shipment from Motion Control. Extended warranties are available and must be purchased within 6 months of elbow purchase. Items under warranty will be repaired or replaced (at Motion Control’s discretion) at no charge. The warranty will be void if the Motion Arm has been fabricated or installed outside Fillauer Motion Control’s recommendations, or altered mechanically, electronically, or structurally in any way. The warranty is void if the arm has been exposed a corrosive environment. This warranty does not include any prosthetic fitting or clinical expenses.

Rental Program

Fillauer Motion Control offers a rental program for trial fittings up to six months. A product is rented with Fillauer Motion Control’s signed rental agreement, and a portion of the rent is applicable towards purchase using a sliding formula. Contact us for details.

Return Policy

In all cases, if reconditioning or repairs are required, costs for returning the product to resalable condition will be charged. Products returned within 30 days after sale, in resalable condition, are credited the full value without a restocking fee. Products received 31-60 days after sale will be charged a 10% restocking fee. Products received 61-90 days after sale will be charged a 15% restocking fee. Products returned over 90 days after sale will not be exchanged or credited.

Microprocessor Software Information

Copyright (c) 2009-2015 Atmel Corporation. All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.
Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.
The name of Atmel may not be used to endorse or promote products derived from this software without specific prior written permission.
This software may only be redistributed and used in connection with an Atmel microcontroller product.

THIS SOFTWARE IS PROVIDED BY ATMEL “AS IS” AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT ARE EXPRESSLY AND SPECIFICALLY DISCLAIMED. IN NO EVENT SHALL ATMEL BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

Technical Specifications

Operating temperature: 0° to 44° C (32° to 110° F)
Transport & storage temperature: -18° to 60° C (0° to 140° F)
Load limit (elbow locked): 50 ft-lbs/65 Nm, all directions (+/- 10%)
Range of motion: 0° to 145°
Humeral rotation: 360 degrees, adjustable friction resistance
Weight: 1.7 lbs / 771 grams
Weight with lamination collar/friction band: 1.8 lbs / 816 grams
Build height: 1.75 in / 45 mm
Dimensions (from elbow center of rotation)
Maximum length: 12 in / 305 mm
Standard length: 10 in / 254 mm
Minimum length: 8 in / 203 mm

Optional Features

MC Electric ProWrist Rotator
MC ETD or ETD2, MC Hand
Compatible with TASKA® , i-limb® and bebionic® hands, and other manufacturers’ terminal devices

Battery Pack Specifications

Nominal Voltage:	7.2 V
Rated Capacity:	3000 mAhr
Charge Time:	3 Hours
Ingress Protection Rating:	IP67

Declaration of Conformity

The product herewith complies with Medical Device Regulation 2017/745 and is registered with the United States Food and Drug Administration. (Registration No. 1723997)

Customer Support

Americas, Oceania, Japan
Fillauer Motion Control
115 N. Wright Brothers Dr.
Salt Lake City, UT 84116
801.326.3434
Fax 801.978.0848
motioninfo@fillauer.com| Europe, Africa, Asia
Fillauer Europe
Kung Hans väg 2
192 68 Sollentuna, Sweden
+46 (0)8 505 332 00
support@fillauer.com
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Fillauer LLC
2710 Amnicola Highway
Chattanooga, TN 37406
423.624.0946
customerservice@fillauer.com| Fillauer Europe
Kung Hans väg 2
192 68 Sollentuna, Sweden
+46 (0)8 505 332 00
support@fillauer.com