NHS ODFS Pace V1 User Instruction Manual Download Page 1

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Model: ODFS

Pace V1

Model: ODFS

Pace XL V1

Software: V1.4

The output of this device has a physiological effect.

The device should only be supplied and set up by a trained clinician.

This instruction manual is intended for the end user and should be supplied to

them by the clinician.

Read the instructions and precautions before use.

USA only:

Rx Only

…a confident choice

USER INSTRUCTION MANUAL

Odstock Dropped Foot Stimulator

Summary of Contents for ODFS Pace V1

Page 1: ...he device should only be supplied and set up by a trained clinician This instruction manual is intended for the end user and should be supplied to them by the clinician Read the instructions and preca...

Page 2: ...Controls and Connectors 20 Operating Guide 21 25 User Accessible Menu 26 27 Auto Turn Off 28 The Correct Movement For Dropped Foot Correction 29 Electrode Placement 30 31 Setting Stimulation Level 32...

Page 3: ...3 Technical Information Technical Specification ODFS Pace XL 47 Wireless Information ODFS Pace XL 48 Electromagnetic Compliance 49 52 Notes 53 54 Regulatory Representatives 55 6...

Page 4: ...er the supervision of clinical staff trained in its use by Odstock Medical Limited or their agents The ODFS Pace XL should be used as part of an integrated treatment plan Users should receive gait re...

Page 5: ...es of the Stimulator or OML GOOD Pause start button Test button Display Indicator light Battery compartment on the back Electrodes socket plastic pin Footswitch socket metal pin Control knob on off ou...

Page 6: ...ng for a carabiner The belt clip is easily removable reducing the overall size if the ODFS Pace XL is carried in a pocket Use a ball point pen or other similar tool to press the release button through...

Page 7: ...ed foot for both adult and paediatric individuals Other movement deficits can be addressed by stimulation of additional muscle groups singularly or in conjunction with the correction of dropped foot f...

Page 8: ...rse effects on heart rhythm or blood pressure Open or infected wounds Stimulation should not be applied over open wounds or over swollen infected or inflamed areas or skin eruptions Stimulation should...

Page 9: ...ical Limited All battery technologies carry a very small risk of explosion if used incorrectly Do not use or recharge a battery if it is damaged or swollen in any way Do not charge non rechargeable ba...

Page 10: ...ons or decreased electromagnetic immunity of this equipment and result in improper operation Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result...

Page 11: ...tegrity of their skin that is in contact with the electrodes lead footswitch or stimulator each time the device is used If pressure marking occurs remove the cause of the pressure and recommence use o...

Page 12: ...lation during pregnancy has not been established Prescribed user The device should only be used by the user that the system has been prescribed for Keep out of reach of non intended users Only use as...

Page 13: ...r accessories excluding electrodes have been stored at the minimum 20 C or maximum 70 C storage temperatures allow at least 10 minutes in ambient temperature before use This time may be required follo...

Page 14: ...have taken all foreseeable steps through design and testing to ensure this device is safe and reliable there remains a small risk of stimulation not being delivered when required This could lead to a...

Page 15: ...d of with other household waste Your ODFS Pace XL and accessories can be returned to Odstock Medical Limited for appropriate disposal The CE mark indicates that the ODFS Pace XL complies with the Euro...

Page 16: ...tshire UK enquiries odstockmedical com Do not use if the packaging is substantially damaged Proceed with caution and check components for damage prior to use Do not store outside of specified temperat...

Page 17: ...t button LOT Batch number SN Unique serial number of the stimulator REF Odstock Medical Limited stimulator reference number EC REP European authorised representative Light flashes on the ODFS Pace XL...

Page 18: ...battery cover securely by sliding it on to the back of the ODFS Pace XL casing Prior to replacement of the battery cover check the battery compartment for loose items that may cause a short circuit or...

Page 19: ...he footswitch is placed on the underside of the supplied insole For a wireless set up ODFS Pace XL the footswitch and footswitch lead would be replaced by a wireless accessory Stimulation electrodes e...

Page 20: ...are cycled by pressing the pause button In walk mode a long beep is given for entering active mode and a shorter higher pitched beep is given for exiting active mode When the pause mode is entered th...

Page 21: ...charged as soon as is practical At the end of useful battery life a beep will sound every 30 seconds Your clinician will have set the ODFS Pace XL to turn on at either 1 50 or the last used level befo...

Page 22: ...ement The pitch of the click will go up and down as the output is turned up and down When 50 is reached an extra high pitch beep is heard This allows the user to know when they have reached the normal...

Page 23: ...l change to a play symbol on the screen If in walk mode the screen will also display WALK and the ODFS Pace XL will respond to the footswitch If in exercise mode the screen will change to the exercise...

Page 24: ...er prolonging battery life Lost wireless footswitch connection If communication is lost between the ODFS Pace XL and the wireless footswitch upon entering active mode the screen will display No W FS U...

Page 25: ...to set timings without the need of a footswitch If your clinician has set an exercise mode for you the method of entering exercise mode is different for ODFS Pace and ODFS Pace XL For the ODFS Pace e...

Page 26: ...control knob to select the chosen options Note when the mode is changed from WALK to EXERCISE the output level is reduced to 1 When the mode is changed from EXERCISE to WALK the output level is reset...

Page 27: ...s required Exercise mode can still be used when in airplane mode Steps logger My steps The MY STEPS screen gives the total number of steps taken with the stimulated leg MY STEPS can be reset by the us...

Page 28: ...28 Auto Turn Off Auto turn off If the ODFS Pace XL is paused and not used for more than 4 hours the device will automatically turn off The output level maybe require adjustment when turned on again 3...

Page 29: ...e from catching Stimulation enables heel strike and maintains control of the ankle as the foot is lowered to the ground preventing foot slap Because heel strike occurs with a degree of eversion weight...

Page 30: ...oot lifting slightly higher than the inside If the correct movement is not produced first try increasing the stimulation level a little If this is unsuccessful the position of the active electrode is...

Page 31: ...r the widest part of the muscle at the front of the leg approximately three finger breadths below the tibial tuberosity the knobbly bump at the front of the leg just below the knee and one fingers bre...

Page 32: ...test button Observe that the indicator light flashes You may feel the sensation of stimulation While the indicator light is flashing increase the output level by turning the control knob clockwise Inc...

Page 33: ...ever it is better to learn to find the electrode placement by understanding the anatomy of your leg and how to move the electrodes to create the correct movement Building up use of stimulation When fi...

Page 34: ...d foam insole with the black disc of the footswitch stuck to the insole Soft foam insoles are not recommended as they may move in the shoe The insole allows the footswitch to be moved from shoe to sho...

Page 35: ...or a rash of any kind Do not shave the skin as this may cause many tiny abrasions If long hairs prevent reliable skin adhesion trim the hairs with scissors or a beard trimmer All electrodes are for s...

Page 36: ...imes and then leave for a few seconds to dry This rehydrates the electrode and also removes any debris from the surface If this is not successful in restoring the stickiness replace the electrodes Ele...

Page 37: ...joining of accessories in the user accessible menu Wireless joining mode is accessed within the user accessible menu The menu structure is shown below The wireless joining mode can be accessed from t...

Page 38: ...ess footswitch after the remote control has been joined If JOIN REMOTE is selected all previous network settings will be erased irrespective of whether a remote control device is joined or not Spare o...

Page 39: ...lete all wireless accessories from the network and starts the process of joining a new wireless footswitch CREATE NETWORK is accessed through the advanced wireless options menu With the stimulator tur...

Page 40: ...n water Do not clean with solvents Remove any debris within the battery compartment by hand Ensure that debris does not get between the battery contacts and battery terminals Electrodes To clean elect...

Page 41: ...ectrode lead becomes stiff or cracked they should be replaced Remove the battery if the device is not used for an extended period of time Maintenance The ODFS Pace XL does not need maintenance beyond...

Page 42: ...stimulation electrodes 3 4 weeks See expiry date Elasticated tubular bandage 3 months N A ODFS Pace XL pouch 2 years N A Cork insoles 3 months N A Foam insoles 1 year N A PP3 Battery 9V non rechargeab...

Page 43: ...both x ray machines and metal detectors ODFS Pace XL users Like all radio telemetry devices the ODFS Pace XL and wireless accessories should not be used while flying Set the ODFS Pace XL to airplane...

Page 44: ...his triggers the stimulator consider moving the position of the footswitch in the shoe to a more suitable location Refer to page 34 2 No stimulation but the LED light flickers and the screen indicates...

Page 45: ...incorrectly inserted Change battery orientation Battery cap not removed Remove battery cap Battery contacts damaged Return to supplier Stimulator faulty Return to supplier Impact or water damage Retu...

Page 46: ...initial fitting by a registered FES clinician The warranty will default to the date of purchase if the warranty registration form is not received within 3 months Warranty s are not transferable The wa...

Page 47: ...5 to 40 C Electrodes 5 to 27 C 1 month Electrodes 0 to 40 C 1 month Alkaline Battery 5 to 30 C Lithium Battery 0 to 35 C System excluding above items 20 to 70 C Relative humidity Electrodes 35 to 50 S...

Page 48: ...heel event Co exsistence and interference The system has been stringently tested in a range of scenarios showing that it is not susceptible to interference However there is no guarantee that other wir...

Page 49: ...magnetic emissions The ODFS Pace XL is intended for use in the electromagnetic environment specified below The customer or user of the ODFS Pace XL should ensure that it is used in such an environment...

Page 50: ...ors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 6100 4 4 No connection to main...

Page 51: ...ned by an electromagnetic site survey a should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Note 3 At...

Page 52: ...ransmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800MHz to 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 20 1 20 2 30 10 3 79 3 79 7 27 100 12 0 12 0 23 0 For transmitters...

Page 53: ...53 Notes 6...

Page 54: ...54 Notes 6...

Page 55: ...ms should be reported via local representative If in doubt please contact Odstock Medical Limited for advice Enquiries should be initially directed to your local distributor If in doubt please contact...

Page 56: ...ry District Hospital Salisbury Wiltshire SP2 8BJ United Kingdom Registered Company No 5532620 Copyright Odstock Medical Limited 2008 2021 Revision 4 0 Manual Product Code 11 003 0079 QF 019 44 0 1722...

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NHS ODFS Pace V1, User Instruction Manual

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