Ossur i-Limb Quantum User manual

i LIMB®HAND
Instructions for Use


EN | Instructions for Use 
DE | Gebrauchsanweisung 
FR | Notice d’utilisation 
ES | Instrucciones para el uso 
IT | Istruzioni per l’uso 
NO | Bruksanvisning 
DA | Brugsanvisning 
SV | Bruksanvisning 
EL | Οδηγίε Χρήση 
FI | Käyttöohjeet 
NL | Gebruiksaanwijzing 
PT | Instruções de Utilização 
PL | Instrukcja użytkowania 
CS | Návod k použití 
TR | Kullanım Talimatları 
RU |    
JA | 取扱説明書 
ZH | 中文说明书 
KO | 사용 설명서 
AR |   

3
a












b

4















5
ENGLISH
REGULATORY MARKINGS
Consult instructions for use
Class II equipment - provides double isolation to protect against electric shock
IP22 Protected against solid foreign objects of .mm diameter and greater and protected
against splashing water.
Serial Number
The unique serial number for i-limb™ quantum devices is a "M" with a 6 digit
alpha/ numeric number.
The unique serial number for i-limb™ ultra devices is a "U" with a 6 digit
alpha/ numeric number.
The unique serial number for i-limb™ access devices is a "A" with a 6 digit
alpha/ numeric number.
WEEE Compliance: This marking on the product, packaging, accessories or literature
indicates that the product contains electronic components and/or batteries that should not
be disposed of in regular waste at the end of its usable life. To prevent possible harm to the
environment or human health from uncontrolled waste disposal users are requested to
separate these items from other types of waste and recycle them responsibly to support
sustainable reuse of material resources. Users should contact their local government office
for information on how these items can be recycled or disposed of in an environmentally
sound manner.
To protect natural resources and to promote material reuse, please separate batteries and
electrical components from other types of waste and recycle them through your local, free
electronic parts return system.
Manufacturer and year of manufacturing (YYYY)
European Conformity
BF Applied Part

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INSTRUCTIONS FOR USE
ILIMB HAND
The i-Limb®hand is referred to as “the device” in the following document. This document provides information on
the indications for use, and handling of the device. It is intended for the user of the device. The device may only be
configured and fitted by a qualified practitioner authorized by Össur after completing the corresponding training.
These “Instructions for Use” relate to: i-Limb Quantum, i-Limb Ultra, i-Limb Access, analog electrodes, magnetic
charger port, mains and car charger.
PRODUCT DESCRIPTION
The i-Limb hands are a range of prosthetic hands consisting of individual motorized digits, stall detection and
a proprietary control app for Apple iOS devices (Fig. a). The product label can be found on the side of the device.
(Fig. b). The device is assembled as part of your prosthesis together with a socket custom made for you by your
clinician.
Users can choose from a selection of automated grips and gestures to help complete their daily tasks. Depending
on model, grips can be customized and automated for additional control. An overview of available control options
can be found in the features comparison table below:
Features comparison
i-Limb Quantum i-Limb Ultra i-Limb Access
Control options
Gesture control Yes - -
App control Yes Yes Yes
Muscle control Yes Yes Yes
Proximity control Yes - -
Grips available   
My grips  - -
Speed boost Yes Yes Yes
Powered thumb rotation Yes Yes -
Vari-grip Yes Yes -
Natural hand mode Yes Yes -
While digits are not controlled individually, automated grips allow i-Limb hands users to move certain digits for
pinching an object or make a gesture. Training is required to fully utilize the i-Limb hand and fully understand all
the functional benefits.
INDICATIONS FOR USE
Individuals with upper limb absence.
CONTRAINDICATIONS
None known.
INTENDED USE
Individuals with upper limb absence with the potential to use an upper limb prosthesis.

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REQUIRED DEVICES
The My i-Limb and Biosim apps can be downloaded from the Apple Store. The two apps require an Apple iOS
device supported by the manufacturer, e.g. an iPhone or iPad. See the Apple Store for device compatibility.
SAFETY INSTRUCTIONS
Warnings
i-Limb Hand:
– The end user is the intended operator of the device and is responsible for its use.
– The i-Limb hand does not provide sensation, heat and moisture cannot be felt. The i-Limb hand is for low to
moderate impact activities only.
– Do not use without an approved cover.
– Do not use with a damaged cover.
– Do not disassemble componentry or modify in any way.
– Do not service or perform maintenance when in use.
– Do not carry objects using only the tips of the digits. Carry objects by evenly distributing weight across the
digits, as close to the knuckles and palm of the hand.
– Do not use for heavy lifting.
– Do not use with machinery with moving parts that may cause personal injury or damage.
– Do not use for extreme activities that may cause injury to a natural hand.
– Do not expose to vibration.
– Do not expose to excessive or high forces, particularly on the fingertips and on the side of the digits.
– Do not expose to water.
– Do not expose to excessive moisture, liquids, dust, high temperatures, or shock.
– Do not use in hazardous environments.
– Do not expose to high temperatures.
– Do not expose to flames.
– Do not use in or expose to explosive atmospheres.
– The electrode, magnetic charger port, DC port and switch block are an APPLIED PART.
– The electrode may contain nickel
Batteries:
– Do not cut or modify battery wires.
– Do not bend or exert excessive pressure on the battery.
– Do not pierce the battery.
– Do not disassemble battery.
– Do not expose to high temperatures.
– Do not incinerate batteries.
– Do not alter battery terminal wires.
– Do not short circuit the battery.
– Do not store batteries inside a vehicle.
– Dispose of batteries in accordance with US, European or local regulations.
Precautions
i-Limb Hand:
– Users must comply with local regulations on the operation of automobiles, aircraft, sailing vessels of any kind
and any other motorized vehicle or device. It is entirely the user’s responsibility to seek confirmation that they
are physically and legally able to drive using the i-Limb hand and to the fullest extent permitted by law.
– Only use with approved Össur accessories and tooling.
– Damaged covers must be replaced or repaired by a qualified Össur technician or technical partner.
– Maintenance, repairs and upgrades may only be performed by qualified Össur technicians and technical
partners. Össur will provide upon request information to assist service personnel in repair of device.
– Do not use an i-Limb device to operate electronic devices connected to a mains outlet, as this may affect
EMG signal.

8
– It is not recommended to use your device whilst undergoing specific investigations or treatments when in
close proximity of other medical electrical equipment.
– Do not use while charging is in progress.
– Only use with gloves supplied by Össur.
– Always use with gloves to avoid risk of electrostatic build-up and discharge.
– Do not use oil-based lotions on the skin, e.g. Vaseline.
– Do not expose electrode to dirt or fluids.
Batteries:
– Only Össur batteries should be used with this device.
– Only use the Össur charger to charge Össur batteries.
– Internal batteries must not be replaced by the end user.
– Batteries are to be replaced annually by service personnel only.
Do not use your i-Limb hand if the battery has visibly ballooned or swelled. Contact your clinician and do as follows:
• discontinue the charging process immediately
• disconnect the battery
• remove to a safe area
• leave and observe for minutes
• replace with new battery
• do not re-use
• dispose of any leaking batteries in an appropriate manner
If the device will not be used for a longer period of time, it is advisable to remove the battery from the prosthesis.
Contact your clinician for this to be completed.
SAFE USE GUIDELINES
– Push the thumb to the side. Hold handles or similarly shaped objects securely in palm near the base of the
fingers. Move the thumb to the side so that it doesn’t block the index from closing (Fig. ).
– Do not block the index finger from closing around thinner objects. The object will be less secure within the
i-Limb hand if the digits are not able to conform around its shape (Fig. ).
– Hold objects close to palm with all fingers fully closed. Ensure all digits are fully closed around objects (Fig. ).
– Do not hold objects with fingertips or side of the fingers (Fig. ).
– Position objects close to the knuckles when pulling/pushing (Fig. ).
– Do not pull or push objects with fingertips (Fig. ).
– Push up with fully closed fist with force at knuckles (Fig. ).
– Do not push up on fingers (Fig. ).
POWER
A fully charged device can be used for up to  hours, depending on use.
To charge the i-Limb hand, remove it first from the residual limb. Depending on model, turn either off or to
standby by moving power switch to the left position(Fig. , ).
Magnetic Charging Port
The magnetic charging port allows the battery to be charged, the power switched on/off and the remaining battery
level to be monitored in one place (Fig. ).
If your i-Limb has an internal battery and supports magnetic charger port, please follow these steps:
Turning the Device On and Off
– Press switch on charge port for  second and release to turn on/off.
– When turned on: the display will fully light up and then dim to a low level.
– When turned off: the display will fully light up and then switch off.

98
Checking the Battery Charge Level Status
– The battery charge level is shown by the bars when the power is on.
– Each bar of light shows a % charge level. The number of bars lit up shows how much power is left in the
battery.
– When the battery level reaches %, the red low battery warning will light up (Fig. ). The light will shine for
minutes, and then the device will turn itself off.
NOTE: an emergency reserve of power remains available, to turn on and release the device from an object,
ensuring the safety of the user.
Charging the battery
WARNING: Do not wear an i-Limb hand when the battery is charging.
– Plug the mains charger into the power outlet. Attach the magnetic charger to the charger port on the
prosthesis.
– When in standby, the charger unit will display a faint green light.
– When charging is in progress, a red light is displayed.
– When fully charged a green light is displayed.
– Charging time: minutes to  hours.
– A car charger is also available.
External Battery
– If you have external batteries, remove the batteries from your prosthesis and insert into the charger base unit
(Fig. ). Connect the charger base unit with the power cable. Plug the power cable into the power outlet.
– The charging state is indicated on the back of the base unit:
– Middle light on: Charger is plugged in
– nd and th lights flashing green: batteries are charging
– nd and th lights solid green: batteries are charged
– st and th red lights on: battery fault, unplug and try again. If lights continue to illuminate, contact your
clinician.
Power Supply
CAUTION: Only use the Össur power supply to charge Össur batteries.
Manufacturer: PowerSolve
Model No.: A
Input: -Vac, - Hz, .A Max
Output: .VDC, A
CONTROLLING THE ILIMB HAND
Identifying the Device Number:
The device number can be found proximal to the thumb base (Fig. ). For extra small hands, or those with
a flexion wrist, the number is located within the chassis.
When connecting your i-Limb hand with the My i-Limb app, the device number will be displayed on the connection
screen. Selecting the number connects the app to your i-Limb hand. Alternatively, when connected to the app your
device number is displayed in the ‘about’ section.
Gesture Control (available only on i-Limb Quantum hands)
Enables an automated grip to be accessed through a smooth motion of the prosthesis in one of four directions
(forward, back, left or right). The grips programmed for each direction are customized to the user’s requirements
using the My i-Limb app.

10
To access gesture control:
. Hold i-Limb hand parallel to the ground (elbow bent to °)
. Maintain an open signal until index finger twitches
. Move the i-Limb Quantum hand (within  second) in direction assigned to the desired grip
. The i-Limb Quantum hand will adopt the grip
. To exit the grip, hold an open signal until the hand exits the grip
Default setting for gesture control is hold open, however it can alternatively be accessed using co-contraction. This
is changed using the My i-Limb app.
App Control (available on all i-Limb hands)
An automated grip can be accessed at the touch of an icon on the My i-Limb app. These are called quick grips. The
i-Limb hand will exit the grip when the icon is tapped again or by selecting another grip icon to enter.
Muscle Control (available on all i-Limb hands)
Triggers are specific muscle signals that can be used to access an automated grip. There are  potential muscle
triggers: hold open, double impulse, triple impulse and co-contraction.
You can use the app to activate and program muscle control.
Proximity Control (available only on i-Limb Quantum hands)
Grip Chips are small Bluetooth devices which change the function of the i-Limb Quantum hand when the hand
comes close to them.
To use Grip Chips, make sure the i-Limb hand is not connected to the My i-Limb app.
Proximity is accessed by holding the i-Limb hand fully opened near (cm/ ”) to a Grip Chip. Wait until the grip is
accessed, which may take up to  seconds. To exit a grip accessed via proximity control, give a long open signal.
Double tapping a Grip Chip activates the grip. Quickly tap a Grip Chip twice, just like double-clicking a computer
mouse. The LED on the Grip Chip flashes once when tapping is successful.
NOTE: a  second pause between each double tap is required. The pause prevents the grip chip from incorrectly
detecting multiple taps in a very short period of time. This can cause the hand to enter a grip and then immediately
exit it again.
The i-Limb must be fully open/digits stalled open for proximity or tapping to be successful.
The individual Grip Chips are programmed using the My i-Limb app and can be reprogrammed by the user at any
time.
ILIMB HAND COVERS
Donning a Cover
To don a cover, bring i-Limb hand into the position shown in figure  and turn the hand off. The position can also
be achieved using the don/doff quick grip.
Donning the i-Limb Skin Active, i-Limb Skin Contour and i-Limb Skin Natural covers:
. Line up cover with the fingers of the i-Limb hand, and slide cover downwards.
. When the fingers are mostly donned, pull the thumb opening over the thumb (Fig. ).
. Slide the remainder of the cover over the i-Limb hand (Fig. ).
. Make sure each digit tip is fitted to the cover.
. Do not pull the cover too tightly over the hand.
Donning the i-Limb Skin Match cover:
. Spray the outer surface with isopropyl alcohol (Fig. ).
. Invert the cover to the level of the finger openings (Fig. ).

1110
. Ensure the fingers are straight and not bunched.
. Align the cover finger holes with the digits of the hand (Fig. ).
. Pull down onto digits of the i-Limb hand.
. Place thumb opening over thumb digit.
. Pull the cover carefully over the remainder of the i-Limb hand, without applying too much pressure on the
thumb (Fig. ).
. Check the cover for bunching and make sure the cover tips are fully fitted to the digit tips.
. Check the function of the i-Limb hand and ensure full opening and closing is possible and the digit tips align.
Doffing all Covers
. Bring the i-Limb hand into the same position as for donning and switch off/ to standby.
. Pull the cover upwards on each digit to release.
. Carefully ease the full cover off, without applying too much pressure on the thumb.
. Continue to pull cover upwards, until fully removed.
CLEANING
Cleaning instructions
The i-Limb hand covering, electrode surface and magnetic charger port can only by cleaned with a soft damp cloth
and mild soap.
Clean the electrode surface regularly.
Clean the cover with isopropyl alcohol once a week to help with disinfection.
NOTE: do not submerge the i-Limb hand, cover, electrode surface or magnetic charger port in water. Do not use
any strong chemicals.
TECHNICAL SPECIFICATIONS
Voltage Range  – . V
Max. Current  A
Battery Capacity Rechargeable lithium polymer .. V (nominal);
mAh capacity; ,mAh capacity
Max hand load limit (static limit) kg/ lb. (extra small)
kg/ lb. (small/ medium/ large)
Finger carry load (static limit) kg/  lb. (extra small)
kg/ lb. (small/ medium/ large)
Time from full open to full close . seconds
Expected service life  years
Device weight
(Quantum and Ultra)
Note: Titanium digits add an
additional g/ .lb.
per hand
Extra small Small Medium/ large
QWD g/ .lb. g/ .lb. g/ . lb.
WD g/ .lb. g/ . lb.  g/ . lb.
Flexion g/ .lb. g/ . lb.  g/ . lb.
Friction g/ . lb.  g/ . lb. g/ .lb.

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Device weight
(Access)
Note: Titanium digits add an
additional g/ .lb.
per hand
Extra small Small Medium/ large
QWD g/ .lb. g/ .lb. g/ . lb.
WD g/ .lb. g/ . lb.  g/ . lb.
Flexion g/ .lb. g/ . lb.  g/ . lb.
Friction g/ . lb.  g/ . lb. g/ .lb.
LIST OF PARTS
i-Limb Quantum
Code Description
PLA i-Limb Quantum QWD RHXS
PLA i-Limb Quantum QWD LHXS
PLA i-Limb Quantum QWD RHS
PLA i-Limb Quantum QWD LHS
PLA i-Limb Quantum QWD RHM
PLA i-Limb Quantum QWD LHM
PLA i-Limb Quantum QWD RHL
PLA i-Limb Quantum QWD LHL
PLA i-Limb Quantum Flexion RHXS
PLA i-Limb Quantum Flexion LHXS
PLA i-Limb Quantum Flexion RHS
PLA i-Limb Quantum Flexion LHS
PLA i-Limb Quantum Flexion RHM
PLA i-Limb Quantum Flexion LHM
PLA i-Limb Quantum Flexion RHL
PLA i-Limb Quantum Flexion LHL
PLA i-Limb Quantum WD RHXS
PLA i-Limb Quantum WD LHXS
PLA i-Limb Quantum WD RHS
PLA i-Limb Quantum WD LHS
PLA i-Limb Quantum WD RHM
PLA i-Limb Quantum WD LHM
PLA i-Limb Quantum WD RHL
PLA i-Limb Quantum WD LHL
PLA i-Limb Quantum Friction RHXS
PLA i-Limb Quantum Friction LHXS
PLA i-Limb Quantum Friction RHS
PLA i-Limb Quantum Friction LHS

1312
PLA i-Limb Quantum Friction RHM
PLA i-Limb Quantum Friction LHM
PLA i-Limb Quantum Friction RHL
PLA i-Limb Quantum Friction LHL
PLA i-Limb Quantum Ti QWD RHS
PLA i-Limb Quantum Ti QWD LHS
PLA i-Limb Quantum Ti QWD RHM
PLA i-Limb Quantum Ti QWD LHM
PLA i-Limb Quantum Ti QWD RHL
PLA i-Limb Quantum Ti QWD LHL
PLA i-Limb Quantum Ti Flexion RHS
PLA i-Limb Quantum Ti Flexion LHS
PLA i-Limb Quantum Ti Flexion RHM
PLA i-Limb Quantum Ti Flexion LHM
PLA i-Limb Quantum Ti Flexion RHL
PLA i-Limb Quantum Ti Flexion LHL
PLA i-Limb Quantum Ti WD RHS
PLA i-Limb Quantum Ti WD LHS
PLA i-Limb Quantum Ti WD RHM
PLA i-Limb Quantum Ti WD LHM
PLA i-Limb Quantum Ti WD RHL
PLA i-Limb Quantum Ti WD LHL
PLA i-Limb Quantum Ti Friction RHS
PLA i-Limb Quantum Ti Friction LHS
PLA i-Limb Quantum Ti Friction RHM
PLA i-Limb Quantum Ti Friction LHM
PLA i-Limb Quantum Ti Friction RHL
PLA i-Limb Quantum Ti Friction LHL
i-Limb Ultra
Code Description
PLA i-Limb UltraPT QWD RHXS
PLA i-Limb UltraPT QWD LHXS
PLA i-Limb UltraPT QWD RHS
PLA i-Limb UltraPT QWD LHS
PLA i-Limb UltraPT QWD RHM
PLA i-Limb UltraPT QWD LHM
PLA i-Limb UltraPT QWD RHL
PLA i-Limb UltraPT QWD LHL
PLA i-Limb UltraPT Flexion RHXS

14
PLA i-Limb UltraPT Flexion LHXS
PLA i-Limb UltraPT Flexion RHS
PLA i-Limb UltraPT Flexion LHS
PLA i-Limb UltraPT Flexion RHM
PLA i-Limb UltraPT Flexion LHM
PLA i-Limb UltraPT Flexion RHL
PLA i-Limb UltraPT Flexion LHL
PLA i-Limb UltraPT WD RHXS
PLA i-Limb UltraPT WD LHXS
PLA i-Limb UltraPT WD RHS
PLA i-Limb UltraPT WD LHS
PLA i-Limb UltraPT WD RHM
PLA i-Limb UltraPT WD LHM
PLA i-Limb UltraPT WD RHL
PLA i-Limb UltraPT WD LHL
PLA i-Limb UltraPT Friction RHXS
PLA i-Limb UltraPT Friction LHXS
PLA i-Limb UltraPT Friction RHS
PLA i-Limb UltraPT Friction LHS
PLA i-Limb UltraPT Friction RHM
PLA i-Limb UltraPT Friction LHM
PLA i-Limb UltraPT Friction RHL
PLA i-Limb UltraPT Friction LHL
PLA i-Limb UltraPT Ti QWD RHS
PLA i-Limb UltraPT Ti QWD LHS
PLA i-Limb UltraPT Ti QWD RHM
PLA i-Limb UltraPT Ti QWD LHM
PLA i-Limb UltraPT Ti QWD RHL
PLA i-Limb UltraPT Ti QWD LHL
PLA i-Limb UltraPT Ti Flexion RHS
PLA i-Limb UltraPT Ti Flexion LHS
PLA i-Limb UltraPT Ti Flexion RHM
PLA i-Limb UltraPT Ti Flexion LHM
PLA i-Limb UltraPT Ti Flexion RHL
PLA i-Limb UltraPT Ti Flexion LHL
PLA i-Limb UltraPT Ti WD RHS
PLA i-Limb UltraPT Ti WD LHS
PLA i-Limb UltraPT Ti WD RHM
PLA i-Limb UltraPT Ti WD LHM

1514
PLA i-Limb UltraPT Ti WD RHL
PLA i-Limb UltraPT Ti WD LHL
PLA i-Limb UltraPT Ti Friction RHS
PLA i-Limb UltraPT Ti Friction LHS
PLA i-Limb UltraPT Ti Friction RHM
PLA i-Limb UltraPT Ti Friction LHM
PLA i-Limb UltraPT Ti Friction RHL
PLA i-Limb UltraPT Ti Friction LHL
i-Limb Access
Code Description
PLA i-Limb Access QWD RHXS
PLA i-Limb Access QWD LHXS
PLA i-Limb Access QWD RHS
PLA i-Limb Access QWD LHS
PLA i-Limb Access QWD RHM
PLA i-Limb Access QWD LHM
PLA i-Limb Access QWD RHL
PLA i-Limb Access QWD LHL
PLA i-Limb Access Flexion RHXS
PLA i-Limb Access Flexion LHXS
PLA i-Limb Access Flexion RHM
PLA i-Limb Access Flexion LHM
PLA i-Limb Access Flexion RHL
PLA i-Limb Access Flexion LHL
PLA i-Limb Access WD RHXS
PLA i-Limb Access WD LHXS
PLA i-Limb Access WD RHS
PLA i-Limb Access WD LHS
PLA i-Limb Access WD RHM
PLA i-Limb Access WD LHM
PLA i-Limb Access WD RHL
PLA i-Limb Access WD LHL
PLA i-Limb Access Friction RHS
PLA i-Limb Access Friction LHS
PLA i-Limb Access Friction RHM
PLA i-Limb Access Friction LHM
PLA i-Limb Access Friction RHL
PLA i-Limb Access Friction LHL
PLA i-Limb Access Ti QWD RHS

16
PLA i-Limb Access Ti QWD LHS
PLA i-Limb Access Ti QWD RHM
PLA i-Limb Access Ti QWD LHM
PLA i-Limb Access Ti QWD RHL
PLA i-Limb Access Ti QWD LHL
PLA i-Limb Access Ti Flexion RHS
PLA i-Limb Access Ti Flexion LHS
PLA i-Limb Access Ti Flexion RHM
PLA i-Limb Access Ti Flexion LHM
PLA i-Limb Access Ti Flexion RHL
PLA i-Limb Access Ti Flexion LHL
PLA i-Limb Access Ti WD RHS
PLA i-Limb Access Ti WD LHS
PLA i-Limb Access Ti WD RHM
PLA i-Limb Access Ti WD LHM
PLA i-Limb Access Ti WD RHL
PLA i-Limb Access Ti WD LHL
PLA i-Limb Access Flexion RHS
PLA i-Limb Access Flexion LHS
PLA i-Limb Access Friction RHXS
PLA i-Limb Access Friction LHXS
LIST OF MAIN COMPONENTS
Part Code Description
PLA Magnetic Charger Base
PLA Magnetic Charger Plug
PLA Magnetic Charger Car
SAA Battery mAh
SAA Battery mAh
PLA Electrodes Compact Hz  mm
PLA Electrodes Compact Hz  mm
PLA Electrodes Compact Hz  mm
PLA Electrodes Compact Hz  mm
PLB Electrodes Remote Hz  mm
PLB Electrodes Remote Hz  mm
PLB Electrodes Remote Hz  mm
PLB Electrodes Remote Hz  mm
PLA Digital Electrode Remote

1716
PLA Digital Electrode Compact
A i-limb skin active ultra Medium RH Clear
A i-limb skin active ultra Medium LH Clear
A i-limb skin active ultra Small RH Clear
A i-limb skin active ultra Small LH Clear
A i-limb skin active ultra Medium RH Black
A i-limb skin active ultra Medium LH Black
A i-limb skin active ultra Small RH Black
A i-limb skin active ultra Small LH Black
PLA i-limb skin active RH Extra Small Black
PLA i-limb skin active LH Extra Small Black
PLA i-limb skin active RH Extra Small Clear
PLA i-limb skin active LH Extra Small Clear
PLA i-limb skin contour RH Extra Small Clear
PLA i-limb skin contour LH Extra Small Clear
PLA i-limb skin contour RH Extra small Black
PLA i-limb skin contour LH Extra small Black
PLA i-limb skin contour RH Small Clear
PLA i-limb skin contour LH Small Clear
PLA i-limb skin contour RH small Black
PLA i-limb skin contour LH small Black
PLA i-limb skin contour RH Medium Clear
PLA i-limb skin contour LH Medium Clear
PLA i-limb skin contour RH medium Black
PLA i-limb skin contour LH medium Black
ENVIRONMENTAL CONDITIONS
Do not use, transport or store i-Limb hand outside of the boundaries in the table below:
Use Shipping Extended Storage
Temperature - °C to + °C -°C + °C -°C + °C
Relative Humidity  % to  %  % to  %  % to  %
Atmospheric pressure  hPa to  hPa  hPa to  hPa  hPa to  hPa

18
BLUETOOTH MODULES REGULATED INFORMATION
This device contains the following radio frequency transmitters:
Model Re Type and Frequency
Characteristics Effective Radiated Power
Bluetooth Low Energy
Dual Mode Module
Model BR-LE.-DA
FCC
Contains FCC ID:
XDULE-D
Canada
Contains IC: A-LED
Japan
Contains transmitter with
certificate number
(Dual Mode)
Version V. +ED (GFSK +
π/ DQPSK + DPSK) 
-MHz
Version V. (GFSK) 
-MHz
Adjustable Power (-dBm
to .dBm) short to
long range
ELECTROMAGNETIC COMPATIBILITY
WARNING: 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 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
and result in improper operation
In order to regulate the requirements for Electromagnetic Compatibility (EMC) with the aim to prevent unsafe
product situations, the BS EN --:/ IEC --:  standard has been implemented. This standard
defines levels of electromagnetic emissions for medical devices.
The Össur Myoelectric Prosthetic Devices are manufactured by Össur hf. conforms to this BS EN -- :/
IEC --:  standard for both immunity and emissions.
The i-Limb hand is suitable for use in any environment except where immersion in water or any other fluid is
possible, or where exposure to highly electrical and/or magnetic fields can occur (e. g. electrical transformers,
high-power radio/TV transmitters, RF surgical equipment, CT and MRI scanners).
Refer to further guidance below regarding the EMC environment in which the device should be used:
205-160268

1918
Guidance and manufacturer’s declaration – electromagnetic emissions
Össur Myoelectric Prosthetic Devices is intended for use in the electromagnetic environment specified below.
The customer or the user of the Össur Myoelectric Prosthetic Devices should assure that it each are used in
such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 
Not applicable
Battery Powered
Össur Myoelectric Prosthetic Devices use RF
energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 
Class B Össur Myoelectric Prosthetic Devices are suitable
for use in all establishments, including domestic
establishments and those directly connected to
the public low- voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC --
Not applicable
Battery Powered
Voltage fluctuations/ flicker
emissions
IEC --
Not applicable
Battery Powered

20
Guidance and manufacturer’s declaration – electromagnetic immunity
Össur Myoelectric Prosthetic Devices are intended for use in the electromagnetic environment specified below.
The customer or the user of the Össur Myoelectric Prosthetic Devices should assure that each are used in such
an environment.
Immunity test IEC 
test level
Compliance level Electromagnetic environment – guidance
Electrostatic discharge
(ESD)
IEC --
±kV contact
±kV air
±kV contact
±kV air
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least %.
Portable and mobile RF communications
equipment should be used no closer to
any part of the Össur Myoelectric
Prosthetic Devices, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter
Electrical fast transient/
burst
IEC --
Not applicable Not applicable
Battery Powered
Not applicable
Battery Powered
No Cables >m
Surge
IEC --
Not applicable Not applicable
Battery Powered
Not applicable
Battery Powered
Voltage dips,
short interruptions and
voltage
variations on power
supply
IEC --
Not applicable Not applicable
Battery Powered
Not applicable
Battery Powered
No Cables >m
Power frequency (/
Hz) magnetic
field
IEC --
 A/m  A/m
/ Hz
Battery Powered