Steeper Espire Classic Plus User manual

Espire™Elbow
Classic Plus, Classic and Basic
User Guide

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WELCOME
Intended Use
The Espire Elbow system is to be purchased, configured and fitted by a
qualified prosthetist.
The operations contained in this document are intended for the end user.
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 Steeper Group. 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:
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.
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 25lb/11.3kg
Flexion Angle (preset control) -5° - 135°
Environmental Use Conditions
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
Protected from touch by fingers and objects greater than 12
millimetres. Protected from water spray less than 15° 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.

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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/11kg.
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.
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.
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
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 next page).
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 inside
(medial) adjustment location

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Counterbalance Adjustment
Direction Adjustment Result
Turn the dial posteriorly (backwards) 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
Spring-assist Adjustment
Direction Adjustment Result
Turn the dial anteriorly (forwards) 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 posteriorly (backwards) to
decrease the spring-assist 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
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, dry
cloth, including the electrodes.
• The inside of the socket may be cleaned with mild soap and a damp cloth or
isopropyl alcohol. All soapy residue must be removed from the socket.
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.
INTENDED USE AND SAFETY
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.
The Espire Elbow system is to be purchased, configured and fitted only by a
qualified prosthetist.
Indications for use of the Espire Classic Plus, Classic, or Basic elbow
systems include the following:
• Adequate limb length to allow for appropriate socket fit at a level above the elbow.
This would include trans-humeral, shoulder disarticulation and fore quarter
• Adequate muscle activity and range of motion of shoulder joint to adequately
control a body-powered prosthetic device
• Appropriate sound side limb dexterity or assistive device to position and lock
elbow system for use where necessary
• Adequate muscle activity for myoelectric control (Classic Plus only)
• Adequate cognitive ability to master technology and input requirements of device
(Classic Plus only)
• The patient is able and willing to participate in training for use of the myoelectric
control of the prosthesis (Classic Plus only)
• Access to a qualified prosthetist for fitting and servicing of the elbow system
• Able and willing to charge power source on a daily basis (Classic Plus only)
Contraindications for use of the Espire Classic Plus, Classic, or Basic
elbow systems include the following:
• Any condition that prevents socket fitting, 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)
• Significant deformity of remaining limb that would impair the ability to operate
body-powered devices
• Specific environmental factors—such as excessive moisture or dust, or inability to
clean or maintain the prosthesis

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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 below can lead to damage
or malfunction of the product. Follow the safety instructions and stated
precautions in this document.
Safety Instructions
Please ensure you are fully aware of all the safety instructions before leaving the clinic.
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 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: 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: holding objects
Do not exceed the maximum holding limit of 11kgs/25lbs.
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.
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 o. 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: 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.

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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. If such use is necessary, any equipment needs to be
agreed appropriate with their Prosthetist and/or Steeper.
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 )
Symbol Definition Source
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
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.
Indicates that this item is a medical device
MD

MADE IN THE UK
©2020 Steeper Group
All rights reserved.
Steeper Group, Unit 3 Stourton Link,
Intermezzo Drive, Leeds, UK, LS10 1DF
Steeper Group
Unit 3 Stourton Link, Intermezzo Drive
Leeds, LS10 1DF
Tel: [phone]
Email: [e-mail]
SteeperUSA
8666 Huebner Road, Suite 112
San Antonio, TX 78240
Tel: [phone]
Email: [e-mail]
STPPR147 Issue 1 November 2020