Steeper Espire Elbow Pro & Hybrid User manual

EspireTM Elbow
Pro & Hybrid
User’s Guide -
For Users
Distributeur

EN
Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users 3
Contents
1. Welcome .....................................................................................................................................4
1.1 Intended Use ........................................................................................................................ 4
1.2 Intended Use Statement ..................................................................................................... 4
1.3 What’s Included with Your Device ...................................................................................... 4
1.4 Technical Specications ...................................................................................................... 5
1.5 Powering on the Espire Elbow ............................................................................................ 6
1.6 LED Indicator ........................................................................................................................7
2. Batteries and Charging ...........................................................................................................9
2.1 The Battery ........................................................................................................................... 9
2.2 Battery Installation and Removal ....................................................................................... 9
2.3 Battery Charger ..................................................................................................................10
2.4 ChargingtheBattery..........................................................................................................11
3. Recalibration Using the Reset Button ..............................................................................12
3.1 Recalibration Overview ..................................................................................................... 12
3.2 Howto Recalibrate .............................................................................................................12
4. Counterbalance Adjustment (Hybrid Elbow Only) .......................................................14
4.1 Counterbalance Overview ................................................................................................ 14
4.2 Counterbalance Adjustment ............................................................................................ 14
5. Maintenance and Troubleshooting ..................................................................................15
5.1 Troubleshooting ................................................................................................................ 15
6. IntendedUse andSafety ......................................................................................................16
6.1 Intended Use ......................................................................................................................16
6.2 IntendedUsers ...................................................................................................................16
6.3 Indications and Contraindications ...................................................................................16
6.4 Safety .................................................................................................................................. 17

EN
Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users4
Welcome
1
The Espire Elbow system is only to be purchased, congured and tted by a qualied
prosthetist.
The operations contained in this document are intended for the end user.
1.2 Intended Use Statement
The Espire Elbow is to be used exclusively for external prosthetic ttings of the upper
limbs. The Espire Elbow Pro and Hybrid models process the user’s input signals to
activate and control powered elbow movement.
1.1 Intended Use
1.3 What’s Included with Your Device
Espire Elbow System (2) 10.8 V Smart
Lithium Ion
Batteries
Espire Elbow
Battery Charger

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Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users 5
Welcome
1
1.4 Technical Specications
Specications
Weight Limit 11.3kg/25lb
Maximum Lifting Force 4.5kg/10lb
Flexion Angle (preset control) -5 - 135°
Speed (preset control) 135°/sec
Mode of Operation Continuous
Device Operation – Internally Powered
Battery (Removable) Smart Li-Ion
10.8 V, 3,000 mAh, 32 WI
Time to Full Charge 3.5 hours
Charger 100-250 VAC, 24 V, 2,5A DC
Environmental Use Conditions
Charging (Temperature) 0°C to +45°C (32°F to 113°F)
Operating (Temperature) 5°C to 40°C (41°F to 104°F)
Storage & Transport (Temperature) -20°C to +60°C (-4°F to 140°F)*
Operating Relative Humidity 15% to 90%
Note: If storing device above or below operating temperature, allow the device to
return to within operating temperature range and leave the device to sit for 15
minutes before using.
IP Rating
IP22 Protected from touch by fingers and objects greater than 12mm. Protected from
water spray less than 15° from vertical.

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Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users6
Welcome
1
1.5 Powering on the Espire Elbow
Thepower button is located on the undersideof theEspire Elbow. To turn the device
on or o, press and hold the power button for 4 seconds. When the device is
powered on or o, a multi-coloured light on the LED indicator will ash for 1 second.
The system may also be congured with an external switch for turning the Espire
Elbow on and o. Pressing the switch will also turn the system on or o.

EN
Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users 7
Welcome
1
Feature Description
Power Button Press and hold for 4 seconds to turn Espire ON or OFF
Elbow LED Indication - Power
Colour Indicator Status
Multi-Colour Blink Power ON or OFF
The Espire Elbow features a single, multi-coloured LED Indicator located on the
centre of the forearm near the elbow joint. This LED is used to display information
such as battery life, calibration start and stop times, and system errors. The chart
below outlines each LED pattern.
Press the power button for 1-second to activate the LED indicator light on the
forearm. This indicator tells the user how much life is left in their current battery.
The Espire must be powered on to use this feature.
1.6 LED Indicator
Feature Description
Power Button Press and hold for 1 second to indicate the battery status

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Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users8
Welcome
1
Espire Elbow All LED Indications
Colour Indicator Status
4 Green Blinks Battery 100% Charged
3 Green Blinks Battery Less Than 75%
2 Green Blinks Battery Less Than 50%
1 Green Blink Battery Less Than 25%
Yellow Solid Critically Low - Charge Battery
Red Blinking Minor System Error (Battery
Overpowered, Object Too Heavy)
Red Solid Critical Error (Contact your Prosthetic Provider/Clinician who will contact
Loth Fabenim)
Blue Solid Bluetooth Connection

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users 9
Batteries and Charging
2
2.1 The Battery
The Espire Elbow system is supplied with two removable lithium-ion batteries. It is
advised to rotate use of these batteries, keeping one as a spare for backup power.
For most users, one battery will last an entire day*, depending on the prosthetic
components, condition of the battery and the frequency of use.
*Based on average use during an 8-hour period
Caution: Use only the Steeper Group manufactured Espire Elbow battery pack and
the provided battery charger with the Espire Pro and Hybrid systems. Always follow
the manufacturer’s instructions for proper removal of and replacement of battery
pack.
Note: If storing the Espire Elbow for an extended period without using, remove
battery pack from the elbow before storage.
Batteries can be removed and replaced as necessary. To remove the battery, simply
push the battery cover clip and gently lift it o the elbow. Use the pull tab to remove
the battery.
Installing a battery is the reverse process. Ensure that the battery connections are
facing the distal opening of the forearm and that the Steeper Group logo on the top
of the battery is visible. Insert the battery into the elbow, ensuring that the pull tab is
accessible for future removal. Then, angle battery cover to insert closest to elbow
rst and apply. The battery cover clip will “click” into place when seated.
2.2 Battery Installation and Removal

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Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users10
Batteries and Charging
2
2.3 Battery Charger
Espire Elbow systems are supplied with a Smart Charger for the lithium-ion battery.
Thechargerisrecommendedfordailyuseandwillassurethatthebatterywillreceive
a full charge and provide maximum running time. There are two charger types
(single-bay or dual-bay) and three power adapter options (US, UK, or European) to
match the needs of dierent regions. There is also a car charger available.
Caution: Using a different A/C adapter than the one provided with your battery
charger may cause damage to the Espire battery or battery charger.

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Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users 11
Batteries and Charging
2
Battery Charger LED Indications
Colour Indicator Battery Status
Green Blinking Charging
Green Solid Fully Charged
Red Solid Error
2.4 Charging the Battery
Charging the Espire Elbow Battery
1. Place the charger on a at, level surface away from sources of heat and
moisture. Plug the A/C connector from the power supply into the back of
the charger and connect the power supply to the main A/C supply using the
cable supplied.
2. If the battery you wish to charge is inside of the Espire Elbow, it must rst be
removed from the battery bay. Remove the battery cover using the clip and
remove the battery by using the pull tab.
3. Place the battery into the battery bay ensuring that the 5-way connector is
fully seated. The LEDs in the status window will provide status information
and the charger will automatically begin charging.
Recharge time from empty is approximately 3.5 hours.

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Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users12
Recalibration Using the Reset Button
3
3.1 Recalibration Overview – For Users with A/C Myoelectrodes
Only
Changes in volume of your residual limb may lead to decreased contact with the
myoelectrodes in your prosthetic socket. This decreased contact may cause your
Espire Elbow system to respond more slowly or erratically. If this occurs, it may help
to recalibrate the system.
3.2 How to Recalibrate
1. Press and hold the reset button for 1 second to begin “At
Rest” calibration.
2. A tone will play to signify the start of calibration.
3. While sitting or standing upright, relax your muscles
and hold the Espire Elbow straight down in an extended
position. If successful, a success tone (ascending tone)
will play to signify the end of the “At Rest” calibration. If
unsuccessful, a failure tone (descending tone) will play,
and you should repeat “At Rest” calibration.
Feature Description
Reset Button Press and hold for 1 second to begin
“At Rest” calibration
During At Rest Calibration:
During At Rest Calibration:
• You may sit or stand upright
• Allow the device to remain motionless at your side
• Avoid swaying or allowing the device to swing
• Do not ex any muscles at this time

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Espire Elbow Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.
EspireTM Elbow Pro & Hybrid User’s Guide - For Users 13
Recalibration Using the Reset Button
3
Feature Description
Reset Button Press and hold for 4 seconds to
begin “Strong Signal” calibration
During Strong Signal Calibration:
1. Press and hold the reset button for 4 seconds to begin “Strong Signal” calibration.
2. A tone will play to signify the start of calibration.
3. While standing upright, activate all myo signals used for device control (both
exion and extension) at a comfortable but deliberate level. If successful, a
success tone, (ascending tone) will play to signify the end of the “Strong Signal”
calibration. If unsuccessful, a failure tone, (descending tone) will play, and you
should repeat the “Strong Signal” calibration.
During Strong Signal Calibration:
• You may sit or stand upright
• Activate all myo signals used for device control throughout the duration of the
calibration
Note: Contracting your muscles too hard will set the device calibration at an
unrealistic level. Use an intensity that you will be comfortable using throughout
the day.
The Espire Elbow system has now been recalibrated.

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users14
4Counterbalance Adjustment (Hybrid Elbow Only)
4.1 Counterbalance Overview
The Counterbalance assists in exion and extension of the Espire Elbow. Dierent
amounts of tension are necessary based on the elbow’s overall length and the
weight of the terminal device.
Counterbalance Dial
4.2 Counterbalance Adjustment
Direction Adjustment Result
Turn the dial posteriorly
to increase the
counterbalance weight.
Note: Elbow cannot be
over-adjusted. In this
direction, it will simply
reach maximum
flexion.
Supports more load on the
elbow
Turn the dial anteriorly
(forwards) to decrease the
counterbalance weight
Note: Elbow will spring
back into flexion according
to how much spring lift
assist is put into the
system if it exceeds the
minimum adjustment.
Supports less load on the
elbow

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users 15
Maintenance and Troubleshooting
5
5.1 Troubleshooting
Caution: The Espire Elbow should never be serviced while connected to the end-
user. Ensure that the device is disconnected and powered off before any service or
maintenance is performed. This device should never be serviced while in use. Never
let children handle this device unsupervised. Take caution when using this device
around pets that may cause damage to the device.
If the Espire Elbow system becomes unresponsive or control becomes erratic, try
the following:
• Turn the system o, wait several seconds and power back on.
• Perspiration can diminish the performance of myoelectrodes. Remove the
prosthesis and wipe down the inside of the socket with a clean, dry cloth
including the electrodes.
• Ensure that all visible wire connections are secure, and no wires have become
entangled or frayed.
• Make sure the battery has sucient charge. If the battery is too low, swap it
with an extra, fully charged battery. Ensure that the battery is fully inserted into
the Espire Elbow.
• Recalibrate the system (for prostheses with A/C myoelectrodes only).

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users16
Intended Use and Safety
6
6.1 Intended Use Statement
The Espire Elbow is to be used exclusively for external prosthetic ttings of the upper
limbs. The Espire Elbow processes the user’s input signals to activate and control
powered elbow movement.
6.2 Intended Users
The Espire Elbow is intended for use only by the individual being tted with the
device. The manufacturer does not approve use by any other person/s. This device
is intended to be tted, fabricated and set up only by a qualied prosthetist.
6.3 Indications and Contraindications
Indications for use of the Espire Pro or Hybrid elbow system include the
following:
• Adequate limb length to allow for appropriate socket t at a level above
the elbow. This would include elbow disarticulation, transhumeral, shoulder
disarticulation and forequarter
• Adequate muscle activity for myoelectric control (if utilised)
• Adequate cognitive ability to master technology and input requirements of
device
• The patient is able and willing to participate in training for use of the
myoelectric control of the prosthesis (if utilised)
• Access to a qualied prosthetist for tting and servicing of the elbow system
• Able and willing to charge power source on a daily basis
Contraindications for use of the Espire Pro or Hybrid elbow system include
the following:
• Any condition that prevents socket tting, such as a complicated wound or
intractable pain which precludes socket wear
• Inability to tolerate the weight of the prosthesis
• Inability to produce muscle or body movement necessary for operation of
the terminal device(s)
• Specic environmental factors—such as excessive moisture or dust, or
inability to charge the prosthesis
• Extremely rural conditions where maintenance ability is limited

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users 17
Intended Use and Safety
6
Legend of Symbols
Note: Possible technical damage.
Info: Basic information regarding this product.
Caution: Possible risk of accident or injury.
Warning: Possible risk of severe accident or injury.
Caution: Failure to follow the safety instructions that follow can lead to damage or
malfunction of the product. Follow the safety instructions and stated precautions in
this document.
6.4 Safety
Info: Use on aircraft
Airlines may not permit the use of this device on their aircraft. Check with your
airline before traveling to ensure this device is allowed for use on the plane.
Info: Disposal
These products may not be disposed of with household waste in some jurisdictions.
Disposal that is not in accordance with the regulations of your country may have
a detrimental impact on health and the environment. Please observe the
information provided by the responsible authorities in your country regarding
return and collection processes.
Caution: Battery Damage
Damage can occur to the battery when dropping, knocking, crushing, vibrating or
puncturing. Avoid damaging lithium batteries and devices. Always inspect for signs
of damage, such as hissing, leaking, cracking/bulging and smoking before use.
Immediately remove a device or battery from service, and place away from
flammable materials if any of these signs are present. In the event of battery
damage, immediately and carefully remove battery and please contact your certified
Prosthetist regarding safe disposal and replacement. In the event of contact with
the skin rinse immediately and contact medical care immediately.
Safety Instructions
Please ensure you are fully aware of all the safety instructions before leaving the
clinic.

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users18
Intended Use and Safety
6
Caution: Manipulation of system components
Independent changes and/or modifications to system components may lead to
faulty control or malfunction of the Espire Elbow, resulting in a risk of injury. No
modifications on your Espire Elbow except those described in this information
document are authorised. The Espire Elbow and damaged components may only be
opened or repaired by certified Steeper Group technicians.
Caution: Penetration of dirt and humidity
The penetration of dirt and humidity may lead to faulty control or malfunction of
the Espire Elbow and result in a risk of injury. Ensure that neither solid particles nor
liquids can penetrate the Espire Elbow.
Caution: Mechanical overloading
External mechanical influences or loads, such as impacts and vibration, can lead to
faulty control or malfunction of the Espire Elbow and result in a risk of injury. The
Espire Elbow should not be subjected to mechanical vibrations or impacts.
Caution: Thermal overloading
Extreme temperature conditions can lead to faulty control or malfunction of the
Espire Elbow and result in a risk of injury. Avoid areas outside the specified
operating temperature range. The operating temperature range must be between
5 °C and 40 °C (41.0 °F and 104.0 °F).
Caution: Magnetic interference
The Espire Elbow and connected components can malfunction when near high-
tension power lines, transmitters, transformers, or other sources of strong
electromagnetic radiation (such as security systems for goods in department
stores). This can result in a risk of injury. The electrodes should be set to as low a
sensitivity as possible. If corresponding malfunctions occur repeatedly, please have
the electrode settings checked by your prosthetist.
Caution: Lifting objects
Do not exceed the active lift limit of 4.5kg/10lbs

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users 19
Intended Use and Safety
6
Caution: Improper use
Any type of excessive strain, overload or improper use may lead to faulty control
or malfunction of the Espire Elbow, resulting in a risk of injury. The Espire Elbow
was developed for everyday use and must not be used for unusual activities. These
unusual activities include, for example, sports with excessive strain and/or shocks
to the wrist joint (pushups, downhill mountain biking, etc.) or extreme sports (free
climbing, paragliding, etc.). Do not use when swimming or in wet environments.
Careful handling of the prosthesis and its components not only increases their
service life but, above all, ensures your personal safety. Should the prosthesis be
subjected to unusual stresses (such as a fall), immediately contact a qualified
prosthetist and have the prosthesis inspected for any damage.
Caution: Consequences of product deterioration
Wear and tear on system components can lead to malfunction of the Espire Elbow,
resulting in a risk of injury. Follow the specified service intervals. The service life
of this device is 2 years for device, parts, and accessories. Battery packs should be
rotated in use of device, allowing a battery pack to not be used for more than 3
months can degrade the service life.
Caution: Water and Humidity
The electrical and mechanical systems of your Espire Elbow are not waterresistant.
Water must be prevented from entering the Espire Elbow. Be careful not to let
water run over the top of the prosthetic glove and enter the Espire Elbow as well
as the terminal device. If water enters the inside of the prosthesis for any reason,
immediately switch off all components and stop using or charging them. A qualified
prosthetist must be contacted immediately to assess the device and avoid further
damage.
Caution: Risk of accident while operating a vehicle
An upper extremity amputee’s ability to drive a vehicle is determined on a case-by-
case basis. Factors include the type of fitting (amputation level, unilateral or
bilateral, residual limb conditions, design of the prosthesis) and the amputee’s
abilities. All persons are required to observe their country’s national and state
driving laws when operating vehicles. For insurance purposes, drivers should have
their driving ability examined and approved by an authorised test centre. For
maximum safety and convenience, Steeper Group recommends that, at the very
least, a specialist evaluate the need for any adaptations to the vehicle. It is
indispensable to ensure that the driver can operate the vehicle without any risk with
the Espire Elbow turned off. Driving with the Espire Elbow turned ON may present a
risk if the Espire Elbow inadvertently moves due to unintentional muscle
contraction or other causes. A doctor or prosthetist should be consulted before
operating a motor vehicle with this device; otherwise the Espire Elbow is not
approved for use while driving.

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EspireTM Elbow Pro & Hybrid User’s Guide - For Users20
Intended Use and Safety
6
Caution: Too close to HF communication devices (e.g. mobile phones, Bluetooth
devices, WIFI devices)
If too close to HF communication devices, interference with internal data
communications can result in malfunctions of the product. This can lead to a risk of
injury. Therefore, keeping the following minimum distances from these HF
communication devices is recommended.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Espire Elbow, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Caution: EM Disturbances
Do not use the Espire Elbow near active HF SURGICAL EQUIPMENT and the RF
shielded room of an EM SYSTEM for magnetic resonance imaging, where the
intensity of EM DISTURBANCES is high. High levels of Electro Magnetic
disturbances may cause system to stop functioning properly, either not responding
to input signal(s) or no movement of the joints.
Caution: Overheating of drive unit
Continuous use of the Espire Elbow over a longer period (e.g. frequent lifting and
lowering) can lead to overheating of the drive unit. Touching overheated
components can result in painful situations. Caution should be exercised during use
by patients having skin with decreased heat sensitivity. In case of overheating, the
performance of the Espire Elbow is impaired and the full lifting force can no longer
be utilised. The activities must be discontinued until the drive unit has cooled. After
cooling, the full functionality is restored.
Caution: Risk of pinching where the elbow joint bends
Ensure that fingers and other body parts are not in this area when bending the
elbow joint.
Caution: Unsupervised Use
It is not recommended for children to operate this device without the supervision of
an adult. Use extreme caution around small children and household pets.