College Park Espire Classic Plus User manual

Classic Plus, Classic, and Basic
Espire™Elbow
user guide

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.
WHAT’S INCLUDED WITH YOUR DEVICE
Espire Elbow System
Welcome to the Espire Elbow system from College Park Industries. The following pages will cover
everything you need to know about the elbow operation. If you have any questions, concerns or
comments, please contact your prosthetist.
This User Guide covers instructions for 3 types of elbow models:
Product Description
Espire Classic Plus – Mechanical elbow with manual lock and forearm counterbalance for lift
compensation. Body-powered elbow operation. Includes wired connection points at the proximal
and distal ends of the elbow for easy connections to input and output devices.
Espire Classic – Mechanical elbow with manual lock and forearm counterbalance for lift
compensation. Body-powered only.
Espire Basic – Mechanical elbow with manual lock and forearm spring assist for lift compensation.
Body-powered only.

User Guide Espire Elbow | 2
Features
Classic Plus Classic Basic
Elbow Joint Control mechanical mechanical mechanical
Terminal Device Control electronic/ mechanical mechanical mechanical
Elbow Lock mechanical mechanical mechanical
Lift Compensation counterbalance counterbalance spring assist
TECHNICAL SPECIFICATIONS
SPECIFICATIONS
Weight Limit 25 lb (11.3 kg)
Flexion Angle (preset control) -5 - 135⁰
IP Rating
Protected from touch by fingers and objects greater than 12 millimeters. Protected from water
spray less than 15 degrees from vertical.
BATTERY CLASSIC PLUS ONLY
The Espire Classic Plus has a built-in battery compartment which could be used to house a battery.
The charging port and switch may be located near this compartment. Your prosthetist can instruct
you on how to use it properly.

3 | Espire Elbow - User Guide
MANUAL LOCK
MANUAL LOCK OVERVIEW
The Espire features a mechanical locking mechanism that can be locked or unlocked while under
load, with a maximum holding limit of 25lbs.
The manual lock cable is attached to the upper elbow assembly, near the midline. The lock can
be engaged every 10 degrees (13 positions). A strain-relief is included to reduce the likeliness of
damage due to excessive pull on the lock cable. The lock cable may or may not be attached to your
harness.

User Guide Espire Elbow | 4
Pull on the lock cable to
engage/disengage the lock.
Lock response will vary by
the amount of force applied.
Standard Lock-Unlock A strong cable pull (clicking sound) disengages or re-
engages the lock.
Temporary Unlock A light cable pull (no click) unlocks the elbow joint
temporarily. Releasing the cable tension re-engages
the lock.
Note: When unlocking the elbow, the weight on the elbow may have to
be temporarily removed in order for the lock to disengage.

5 | Espire Elbow - User Guide
THE COUNTERBALANCE / SPRING ASSIST
COUNTERBALANCE AND SPRING ASSIST OVERVIEW
Depending on which model you are using, the Espire will include either a
counterbalance or spring assist mechanism:
Espire Model Lift Compensation Aid
Hybrid, Classic Plus, Classic Counterbalance
Basic Spring Assist
Both the counterbalance and spring assist aid in flexion and extension of the Espire Elbow.
Dierent amounts of tension are necessary based on the elbow’s overall length, the weight
of the terminal device, and the type of clothing worn.
Adjustment Dial Location
The adjustment dial may be located on either the inside or outside of your elbow. Refer to the
arrows on the dial to perform your adjustments. The dial looks identical for both counterbalance
and spring assist; however, these mechanisms adjust in opposite directions (see opposite).
Note: Adjustments are easier to make when the forearm is flexed.
Caution: Be aware that if the adjustment dial is at maximum tension and the arm is raised to a
horizontal level, the elbow could suddenly flex.
Caution: To prevent injury, users should ensure the elbow is in the maximum flexed position
when donning or dong.
ADJUSTMENT DIAL
Example: left arm with medial
adjustment location

User Guide Espire Elbow | 6
COUNTERBALANCE ADJUSTMENT
Direction Adjustment Result
Turn the dial backward 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 forward to decrease the
counterbalance weight.
Note: Elbow will spring back if it exceeds the
minimum adjustment.
Supports less
load on the elbow
SPRING ASSIST ADJUSTMENT
Direction Adjustment Result
Turn the dial forward to increase the spring
assist 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 backward to decrease the spring
assist weight.
Note: Elbow will spring back if it exceeds the
minimum adjustment.
Supports less load
on the elbow

7 | Espire Elbow - User Guide
MAINTENANCE AND TROUBLESHOOTING
TROUBLESHOOTING
▪Perspiration can diminish the performance of myoelectrodes (Classic Plus only). Remove the prosthesis
and wipe down the inside of the socket with a clean cloth, including the electrodes.
▪The inside of the socket may be cleaned with mild soap and water or isopropyl alcohol.
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 handle this device
unsupervised. Take caution when using this device around pets that may cause damage to the
device.

User Guide Espire Elbow | 8

9 | 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.
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. 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.
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 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
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: 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.

User Guide Espire Elbow | 10
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: 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 certified prosthetist and have the prosthesis inspected for any damage.
Caution: holding objects
Do not exceed the maximum holding limit of 25 lbs (11 kgs).
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.
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
prosthesis 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 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.

11 | Espire Elbow - User Guide
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.
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.
Complies with Standards
No. Version
ISO 22523 External limb prostheses and external orthoses – Requirements and test methods 2006
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 )
Temperature limit. ISO 15223-1
Reference
no. 5.3.7
Storage humidity range. ISO 15223-1
Reference no. 5.3.8

User Guide Espire Elbow | 12
Symbol Definition Source
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
Medical device manufacturer. ISO 15223-1,
Clause 5.1.1
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.
Info: Basic information regarding this product.
Caution: Possible risk of accident or injury.
Warning: Possible risk of severe accident or injury.

13 | Espire Elbow - User Guide
NOTES

User Guide Espire Elbow | 14

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
788 INS UG ESC 190313
MADE IN THE USA
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800.728.7950 |586.294.7950 |college-park.com