College Park Espire Elbow Pro User manual

user guide
Pro and Hybrid
Espire™Elbow

1 | Espire Elbow - User Guide
WELCOME
INTENDED USE
Federal Law restricts that the Espire Elbow system is to be purchased, configured and fit only by a
board-certified prosthetist, licensed by the state in which they practice.
The operations contained in this document are intended for operator use.
Intended Use Statement
The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The
Espire elbow processes the User’s input signals to activate and control powered elbow movement.
WHAT’S INCLUDED WITH YOUR DEVICE
Espire Elbow System (2) 10.8 V Smart
Lithium Ion Batteries
Espire Elbow
Battery Charger

User Guide Espire Elbow | 2
TECHNICAL SPECIFICATIONS
Specifications
Weight Limit 25 lb (11.3 kg)
Maximum Lifting Force 10 lb
Flexion Angle (preset control) -5 - 135⁰
Speed (preset control) 135⁰/sec
Mode of operation Continuous
Device Operation – internally powered
Battery (removable) Smart Li-Ion
10.8 V, 3,000 mAh
Time to full charge 3.5 hours
Charger 100-250 VAC, 24 V, 2.5A DC
Environmental Use Conditions
Charging (temperature) 32F to 113F (0C to +45C)
Operating (temperature) 41F to 104F (5C to 40C)
Storage & Transport (temperature) -4F to 140F (-20C to +60C) *
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 before using. The device must be brought up to the operating
temperature, allow the device to sit for 15 minutes.
IP Rating
Protected from touch by fingers and objects greater than 12 millimeters. Protected from water
spray less than 15 degrees from vertical.

3 | Espire Elbow - User Guide
POWERING ON THE ESPIRE ELBOW
The power button is located on the underside of the Espire 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-colored
light on the LED indicator will flash for 1 second.
The system may also be configured with an external switch for turning the Espire Elbow on and o.
Pressing the switch will also turn the system on or o.
Feature Description
Power Button Press and hold for 4 seconds to turn Espire ON or OFF
Elbow LED Indication - Power
Color Indicator Status
Multi-Color Blink Power ON or OFF
Power Button

User Guide Espire Elbow | 4
LED INDICATOR
The Espire Elbow features a single, multi colored LED Indicator located on the
center 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.
Feature Description
Power Button Press and hold for 1 second to indicate
the battery status
Espire Elbow All LED Indications
Color 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 College
Park)
Blue Solid Bluetooth Connection

5 | Espire Elbow - User Guide
BATTERIES AND CHARGING
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 College Park Industries manufactured Espire Elbow battery pack and the
provided battery charger with the Espire Elbow system. 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.
BATTERY INSTALLATION AND REMOVAL
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 college park 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 first and apply. The batter cover clip will “click” into place
when seated.
BATTERY CHARGER
Espire Elbow systems are supplied with a Smart Charger for the lithium-ion battery. The charger
is recommended for daily use and will assure that the battery will receive 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 dierent A/C adapter than the one provided with your battery charger may cause
damage to the Espire battery or battery charger.

User Guide Espire Elbow | 6
CHARGING THE BATTERY
Charging the Espire Elbow Battery
1. Place the charger on a flat, 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 first be removed from the battery bay.
Remove the battery cover via 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.
Battery Charger LED Indications
Color Indicator Battery Status
Green Blinking Charging
Green Solid Fully Charged
Red Solid Error

7 | Espire Elbow - User Guide
RECALIBRATION USING THE RESET BUTTON
RECALIBRATION OVERVIEW  FOR USERS WITH AC
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.
HOW TO RECALIBRATE
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 flex any muscles at this time
Feature Description
Reset Button Press and hold for 1 second to begin “At Rest” calibration
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 will
play to signify the end of the “At Rest” calibration. If unsuccessful, a failure
tone will play, and you should repeat “At Rest” calibration.
Reset Button

User Guide Espire Elbow | 8
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
Feature Description
Reset Button Press and hold for 4 seconds to begin “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 flexion and extension)
at a comfortable but deliberate level. If successful, a success tone will play to signify the end of the
“Strong Signal” calibration. If unsuccessful, a failure tone will play, and you should repeat “Strong
Signal” 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.

9 | Espire Elbow - User Guide
COUNTER BALANCE ADJUSTMENT
HYBRID ELBOW ONLY
COUNTER BALANCE OVERVIEW
The counter balance assists in flexion 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.
COUNTER BALANCE ADJUSTMENT
Direction Adjustment Result
Turn the dial backward to increase the
counter balance weight
Supports more load on the elbow
Turn the dial forward to decrease the
counter balance weight
Supports less load on the elbow
Counter Balance Dial

User Guide Espire Elbow | 10

11 | Espire Elbow - User Guide
MAINTENANCE AND TROUBLESHOOTING

User Guide Espire Elbow | 12
TROUBLESHOOTING
Caution: The Espire Elbow should never be serviced while connected to the end
user. Ensure that the device is disconnected and powered o before any service or
maintenance is performed. This device should never be serviced while in use. Never
let children use this 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. Wipe down the inside of the
prosthetic socket with a clean cloth, including the electrodes. The inside of the socket may also be
cleaned with mild soap and water or isopropyl alcohol.
▪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.

13 | Espire Elbow - User Guide
INTENDED USE AND SAFETY
INTENDED USE
Intended Use Statement
The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The
Espire elbow processes the User’s input signals to activate and control powered elbow movement.
Intended Users
The Espire Elbow is intended for use only by the individual being fit with the device. The
manufacturer does not approve use by any other person/s. This device is intended to be fit,
fabricated and set up only by board-certified prosthetists, licensed by the state in which they
practice.
SAFETY
Legend of Symbols
Note: Possible technical damage.
i
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 below can lead to damage or malfunction of the
product. Follow the safety instructions and stated precautions in this document.
Only start up the product in accordance with the information contained in the supplied documents.
Safety Instructions
i
Info: Use on airplanes
Airlines may not permit the use of this device on their aircraft. Check with your airline before travelling
to ensure this device is allowed for use on the plane.
i
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.

User Guide Espire Elbow | 14
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 authorized. The Espire Elbow and damaged
components may only be opened or repaired by certified College Park 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: 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, ...) 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 certified prosthetist and have the prosthesis inspected for any damage.
Caution: Lifting objects
Do not exceed the active lift limit of 10lbs (4.5Kg)
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 and
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.

15 | Espire Elbow - User Guide
Caution: Water and Humidity
The electrical and mechanical systems of your Espire Elbow are not water-resistant. You must prevent
water 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
prothesis for any reason, immediately switch o all components and stop using or charging them.
Please contact your certified prosthetist immediately to 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 authorized test center. For maximum safety and convenience,
College Park recommends that, at the very least, a specialist evaluate the need for any adaptations to
the car (such as by installing a steering fork). It is indispensable to ensure that the driver can operate
the vehicle without any risk with the Espire Elbow turned o. 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. Please check with your doctor or prosthetist before attempting to operate a motor
vehicle with this device, otherwise the Espire Elbow is not approved for use whiling driving.
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 ME 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 utilized. 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.

User Guide Espire Elbow | 16
Caution: Operating the product near active implanted systems
When operating the product, there is a risk of temporary influences of active implantable systems (e.g.
pacemakers, defibrillators etc.) because of electromagnetic interference of the product.
When operating the product in the immediate vicinity of active implantable systems, ensure that the minimum
distances stipulated by the manufacturer of the implant are observed.
Make sure to observe any operating conditions and safety instructions stipulated by the manufacturer of the
implant.
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.
Warning: Using with Other Equipment
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.
Warning: Use Only Specified Equipment
Use of accessories, transducers and cables other than those specified or provided by the manufacturer
of this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Warning: Operation of Equipment in Hospitals
The Espire elbow was designed for use in residential environments (home, restaurants, etc.) not
hospitals or industrial areas. If device is used in environments such as hospitals or industrial areas, user
might have to relocate to operate device appropriate so that is away from other HF radio devices.
EMC Compliance – Specific Mitigations
The Espire Elbow was tested to the listed standards at the appropriate levels for Home Health Care
Equipment below to ensure safety of the product regarding immunity and emissions. All devices
maintained their performance during and after the tests were completed.
This device complies with part 15 of the FCC rules. Operation is subject to the following two
conditions. (1) This device may not cause harmful interference. (2) This device must accept any
interference received, including interference that may cause undesired operation.
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject
to the following two conditions: (1) this device may not cause interference, and (2) this device must
accept any interference, including interference that may cause undesired operation of the device.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio
exempts de licence. L’exploitation est autorisée aux deux conditions suivantes: (1) l’appareil
ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d’en compromettre le onctionnement.

17 | Espire Elbow - User Guide
Definitions of symbols used in this device and its packaging
Symbol Definition Source
Consult instructions for use. BS EN ISO 15223-1: 2012 Reference no. 5.4.3
Keep dry. BS EN ISO 15223-1: 2012 Reference no. 5.3.4
This product contains electrical and electronic
components that may contain materials which, if
disposed with general waste, could be damaging to the
environment. Residents of the European Union must
follow specific disposal or recycling instructions for this
product. Residents outside the European Union must
dispose or recycle this product in accordance with local
laws or regulations that apply.
IS EN 50419:2006 Reference no. Fig. 1
Caution: Federal (USA) law restricts this device to sale
by or on the order of a physician.
USA Code of Federal Regulations
21 CFR Part 801 § 801.109(b)(1)
Refer to instruction manual/booklet. IEC TR 60878 Ed. 3.0 b:2015
The requirements for accreditation and market
surveillance relating to the marketing of products;
Medical Device Directive.
765/2008/EC 768/2008/EC MDD 93/42/
EEC Articles 4,11,12,17, Annex II )
Type BF applied part. 765/2008/EC 768/2008/EC MDD 93/42/
EEC Articles 4,11,12,17, Annex II )
IEC 60601-1
IEC 60878
ISO 9687:2015
Reference no. 5334
Temperature limit. ISO 15223-1
Reference no. 5.3.7
Storage humidity range. ISO 15223-1
Reference no. 5.3.8
Protection against solid foreign objects of 12.5 mm
diameter and greater, and protection against vertically
falling water drops when tilted up to 15 degrees.
IEC 60601-1, Table D.3, Symbol 2
Bluetooth® wireless or enabled technology. Trademarks of Bluetooth Special Interest Group
(SIG)
Complies with Australian Radio communications
requirements.
AS/NZS 4417.1:2012
Medical device manufacturer. ISO 15223-1, Clause 5.1.1
21 CFR Part 15
Meets FCC requirements per 21 CFR Part 15.
Federal Communications
Commission

User Guide Espire Elbow | 18
Battery is recyclable - follow local recycling & reclaiming
procedures.
ISO 7000 Reference
no. 1135
China RoHS Mark I logo. Product does not contain
toxic and hazardous substances or elements above
the clip level in any material or application including
those exempt from the requirements of the EU RoHS
Directive.
SJ/T11364-2006
Subject to recycling under the Waste Disposal Act. Environmental Protection
Administration, R.O.C.(Taiwan)
Note: Possible technical damage.
i
Info: Basic information regarding this product.
Caution: Possible risk of accident or injury.
Warning: Possible risk of severe accident or injury.

EMERGO EUROPE
Prinsessegracht 20, 2514 AP The Hague, Netherlands
COLLEGE PARK INDUSTRIES, INC
27955 College Park Dr. Warren, MI 48088 USA
Australian Sponsor
EMERGO AUSTRALIA
Level 20, Tower II, Darling Park, 201 Sussex Street,
Sydney, NSW 2000 Australia
765 INS UG ESP 190208
MADE IN THE USA
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800.728.7950 |586.294.7950 |college-park.com