RehaStim, RehaMove Operating Manual Ver 1.3 Dec 2009

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RehaStim, RehaMove - Operating Manual -

Table of Contents Part I General Description

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1 Declaration ... of Conformity 1 2 Description ... of the RehaStim 2 3 Indications ... and Counter Indications 2 4 Adverse ... Effects 3 5 User... Safety 3 6 Warning ... Notices 5 7 Precautionary ... Measures 6 8 Default ... Values and Adjustment Ranges of Stimulation Parameters 8 9 Technical ... Specifications 8 10 Maintenance ... and Service Instructions 10 11 Service ... Information 10

Part II Control Elements and Accessories of the RehaStim

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1 Operating ... and Connection Elements 15 2 Accessories ... 17

Part III RehaMove - Motion Training with FES

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1 Notes ... on Therapy with RehaMove 22 2 Safety ... Measures 23 3 Preparations ... 24 4 RehaMove ... Leg training 25 5 RehaMove ... Arm training 31 6 Select ... a Program in the Therapist Menu 37 7 Customize ... a Program 38 8 Test... or customize current 40 9 Create ... a new Program from a Template 42 10 Available ... Templates 44 11 Finishing ... a Stimulation Session 49

Part IV Software for General Stimulation

51

1 Therapy ... instructions for General Stimulation 51 2 User ... Safety 51 3 Sequence ... Stimulation- Operation by Client 51 4 Gait... Sequence - Operation by Client 53 5 Gait... Training- Operation by Client 55 6 Use... External Trigger 57 7 Choose ... program in therapist menu 59 HASOMED GmbH

Contents

II

8 Customize ... a Program 60 9 Test... or customize current 63 10 Create ... a new Program from Template 64 11 Templates ... for gait training and gait sequence 67 12 Finishing ... a Stimulation Session 69

Part V Fault indication

70

1 Errors ... in the RehaStim 70 2 Errors ... in the RehaMove 71

Part VI Declaration of Warranty

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Part VII Address of manufacturer

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HASOMED GmbH

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RehaStim, RehaMove - Operating Manual -

1

General Description

1.1

Declaration of Conformity

EG-KONFORMITÄTSERKLÄRUNG entsprechend Anhang II der Richtlinie 93/42/EWG über Medizinprodukte EC DECLARATION OF CONFORMITY according to annex II of the Council Directive 93/42/EEC concerning medical devices

Wir:

We:

HASOMED GmbH

HASOMED GmbH

Paul – Ecke –Straße 1

Paul – Ecke – Straße 1

39114 Magdeburg

39114 Magdeburg

erklären in alleiniger Verantwortung,

declare under our sole

daß das Produkt / die Produkte:

responsibility that the product/s:

funktioneller Elektrostimulator

functional electrical stimulator

Typ

type

RehaStim

RehaStim

RehaMove

RehaMove

den einschlägigen Bestimmungen der

meet the provisions of the

Richtlinie 93/42/ EWG über

Council Directive 93/42/EEC

Medizinprodukte entsprechen.

concerning medical devices which apply to them.

Magdeburg, Sept. 1st 2005 Dr. P. Weber Managing Director of HASOMED GmbH

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HASOMED GmbH

General Description

1.2

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Description of the RehaStim

The RehaStim is a portable electrical stimulation device that generates impulses, on up to 8 channels simultaneously, to activate paralysed muscles via surface electrodes. The RehaStim can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications. It can be used on its own or in conjunction with a motion trainer as RehaMove. Numerous parameters for the power and time related progression of the stimulation can be adjusted individually for each channel. The parameters and operational conditions are presented on a graphical touch display screen which makes interaction with the device easy. The stimulator can be applied to functional electrical stimulation tasks of all kinds. In addition, the stimulator software and hardware have been especially prepared for a specific rehabilitation system as RehaMove using a movement exerciser. The RehaStim stimulator is certified according to the EU guidelines EN60601-2-10 for medical technical devices and systems.

1.3

Indications and Counter Indications

Functional electrical stimulation (FES) is an established method of electrotherapy and widely applied for impaired extremities due to diseases or accidents. However, the RehaStim could also be used for therapeutical electrical stimulation. The RehaMove is a specialised system that has integrated the RehaStim specifically for exercise training. Indications of use Clients interventions can have a variety of goals such as : - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Maintaining or increasing range of motion Absolute counter indications These counter indications absolute exclude clients from applying the RehaMove: Cardiac pacemakers: Functional electrical stimulation must not be used in people with cardiac pacemakers. Pregnancy: Pregnant women must be excluded from stimulation treatment since possible adverse effects are unknown and have not yet been scientifically investigated. Fractures: Unhealed fractures in the following areas restrict the patient from using the RehaMove until the fracture is stable: - in the lower extremities, if you want to do leg training with the RehaMove. - in the upper extremities, shoulder girdle or upper ribs, if you want to do arm training. Additional counter indications for Arm training: - unability to keep humeral head into glenohumeral joint utilizing electrically evoked contraction of the supraspinatus - grade 3 tear of either rotator cuff. HASOMED GmbH

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Relative counter indications Denervated muscles: The RehaMove can not be used to evoke contractions in denervated muscles in extremities. Severe Spasticity: In most cases, spasticity will not disqualify an individual from using the RehaMove. A stretching program may be necessary prior to therapy along with modified therapy settings to reduce the likelihood of spasms occurring. Limited Range of Motion/ Heterotopic Ossification: - for leg training: clients can be positioned in their chair to accommodate for minor limitations in joint ranges. However, a minimum of 100 degrees of hip and knee flexion is recommended. - for arm training: the client can be positioned in their chair to accommodate for minor limitations in joint ranges: However, a minimum of 90 degrees of shoulder flexion and 100 degree of elbow flexion is recommended. Severe Osteoporosis: Mild to moderate osteoporosis is prevalent in the majority of the SCI population and in itself does not represent an immediate exclusion from the therapy. If the osteoporosis has progressed so that there is an increased risk of fractures, the therapy should be adjusted to account for the degree of osteoporosis. Dysaesthetic Pain Syndrome: In some cases the pain syndrome may worsen making the stimulation and the therapy may be too uncomfortable to continue. Pressure sores or open wounds in area of treatment. Implants: Recently (< 3month) implanted plates, pins, screws and other hardware underneath or near the muscle groups which are to be stimulated. Epilepsy: Clients who suffer from epilepsy may have to be excluded from stimulation treatment since possible adverse effects are unknown and have not yet been scientifically investigated. Additional relative counter indications for Arm training: - Implanted stimulators such as vegus nerve, phrenic, cardiac, cochlear, diaphragmatic stimulators. - Malignancy. Allergies to electrode gel: If the client is aware to have an allergy to electrode gel, please consult your medical supplier for alternatives.

1.4

Adverse Effects

Skin irritations or chemical burns may occur if there is insufficient contact between the skin and electrodes or if the parameters have been adjusted incorrectly. Therefore when using stimulation for the first time, check the area underneath the electrodes after 2 minutes! If you find that there is bad electronic contact, please use contact gel available from medical suppliers. In known allergies against electrode material, be careful when making your choice. Electrodes must not be placed on excoriations or gashes.

1.5

User Safety

Please read the manual carefully before using this device! Caution should be exercised during the treatment of individuals with the following conditions: Version 1.3 / December 2009

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General Description

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Patients with ANY implanted medical device. Patients with suspected or diagnosed heart problems. Patients with suspected or diagnosed epilepsy. Patients with history of hip or knee dislocation/subluxation Caution should be used in the presence of the following: a. history of uncontrolled autonomic dysreflexia; b. history of lower limb stress fractures; c. history of severe spasticity or spastic response to application of electrical stimulation; d. when there is a tendency to hemorrhage following acute trauma or fracture; and e. following recent surgical procedures when muscle contraction may disrupt the healing process. Additional Cautions for Upper Extremity Ergometry: - A history of upper limb stress fractures. - Uncontrolled hypertension Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

The treatment must only be carried out after an introduction by a doctor or therapist. The treating doctor must be kept informed about changes in the ailment/disability and of any new ailments. All accessories which are not provided by HASOMED GmbH and which the user wants to connect to the interfaces of the unit, must verifiably meet the according EN specifications (e.g. EN60601-1 for electrical medical devices and EN6950 for data processing devices). Furthermore all combinations must meet the system standard EN60601-1-1. For queries please contact the technical support at HASOMED GmbH (manufacturer). The treatment can influence electrical monitoring devices (e.g. ECG) if they are simultaneously connected to the client. Do not use when user is simultaneously connected to a high frequency surgical unit, because this may lead to burns underneath the electrodes. Do not use near (within1.5m) devices with high frequency (HF) range electromagnetic radiation, such as micro- and short-wave devices or welding units. Do not put electrode cables into AC mains power outlets. Only the provided charger (TR 30RAM090) and plug must be used to charge this device. The safety and effectiveness of the treatment depend on the appropriate use of the device. Inappropriate use of this device is dangerous.

HASOMED GmbH

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1.6

RehaStim, RehaMove - Operating Manual -

Warning Notices If the documentation is not clear about the use of this device in a particular way or on the connection of this device to another device then the manufacturer or an expert is to be contacted to ensure that the users safety is not put at risk.

If the device is used in conjunction with the movement therapy machine as part of the RehaMove system, only the provided connection parts (cables, electrodes etc.) must be used. If the patient’s blood pressure or heart rate reaches a level that the clinician considers a compromise to safety, or if the patient feels faint or nauseated, the session should be stopped immediately and appropriate medical action should be taken. If the patient begins to feel light-headed or nauseated, stop the treatment immediately. Some medical conditions can be aggravated by physical activity. If symptoms of a medical condition occur during or after a therapy session, consult your clinician immediately. If directed by the clinician, the patient’s blood pressure and heart rate should be monitored during the therapy session. The long-term effects of chronic electrical stimulation are unknown. The long term effects of electrical stimulation on a pregnant individual (mother and baby) are unknown. Stimulation should not be applied over the carotid sinus nerves, particularly in clients with a known sensitivity to the carotid sinus reflex. Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias. Stimulation should not be applied transcerebrally. Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc. Stimulation should not be applied over, or in proximity to, cancerous diseases. Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner. Powered muscle stimulators should be kept out of the reach of children. Children should only use this device under adult supervision. Never leave the RehaMove unattended when children are present. The arm crank should not be used unless continuous assistance is available as while using this device it may not be possible for the patient to stop the therapy while their arm(s) / hand (s) are secured.

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General Description

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Safety instructions for electrode use: Skin must always be clean, dry and free from lotion. When Electrodes begin losing adhesion, gently rubbing one or two drops of water onto gel surface (Re-hydrate Gel) may extend usage. If not, replace with new Electrodes. In the USA Federal Law restricts the device to sale by, or on the order of, a physician or other practitioner licensed to use the device. Do not apply to broken skin. Should a skin rash or a skin burn occur, immediately discontinue use and contact your clinican Do not stimulate while driving or operating machinery. Do not exceed 0.1 watts/cm². Adjust stimulator according to stimulator or/and clinician instructions for your treatment. For your safety an comfort, turn off the stimulator before you attempt to remove electrodes from your skin. Always lift Electrodes from the edge not the leadwire. Always replace Electrodes to “ON” side of the storage liner. Always store and seal Electrodes in the original package in a cool place. Never submerge Electrodes. Using Hot or Cold packs for long periods of time can cause adhesive separation. Only one driver per Electrode (Single Patient Use). Replace Electrodes when they show wear or tear.

1.7

Precautionary Measures Clients with an implanted electrical device (e.g. cardiac pacemaker) must not be treated with electrical stimulation. In necessary cases, a doctor or an expert medical engineer must be consulted in advance and carry out a risk analysis before making any decision.

If the stimulator is to be used near the ribcage, consider and analyse the risk of cardiac fibrillation. Do not use when user is simultaneously connected to a high frequency surgical unit because this may lead to burns underneath the electrodes. Electrodes must not be placed on excoriations or gashes. Do not use near (e.g. <1.5m) an HF-range or micro-wave device because that may cause variations of the initial values of the stimulator. Do not use near (<1m) working mobile phones or radio/ wireless transmitting sets. For the correct operation, electrostatic loadings are to be avoided. Protect the device from water. If the device falls into water do not use it any longer and contact manufacturer for further instructions. Store the device in the original packaging to protect it from damage and dirt. Do not pass the device on to other people. HASOMED GmbH

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Users should be always accompanied by an assistant. Safety of powered muscle stimulators for use during pregnancy has not been established. Caution should be used for patients with suspected or diagnosed heart problems. Caution should be used for patients with suspected or diagnosed epilepsy. Caution should be used in the presence of the following: a. When there is a tendency to hemorrhage following acute trauma or fracture; b. Following recent surgical procedures when muscle contraction may disrupt the healing process; c. Over the menstruating or pregnant uterus; and d. Over areas of the skin which lack normal sensation. Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium, or alternate electrode placement. Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner. Powered muscle stimulators should be kept out of the reach of children. Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer. Portable powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.

Version 1.3 / December 2009

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General Description

1.8

Default Values and Adjustment Ranges of Stimulation Parameters

1.8.1

Features

8

duration of the stimulation 20µs to 500µs incremented in steps of 10µs impulses (pulse width): current:

20mA to 130 mA incremented in steps of 5 mA

number of channels:

2 modules with 4 channels each (running parallel constantly)

Stimulation frequency:

10 to 50 Hz in steps of 5 Hz

voltage reserve:

150V

operation time:

about 2 to 2.5 hours with medium stimulation parameters (with a load of 1100Ohm and 100nF)

charging time for integrated about 3.5 hours battery High user safety: Electrode connections are tested before stimulation starts Emergency stop button for unexpected sudden danger 1.8.2

General Stimulation Parameters

Parameter

Minimum

Maximum

Increment

Default value

Zero angle

0°

360°

10°

90°

Ramp

0 pulses

21 pulses

1 pulse

3 pulses

1.8.3

Reference values (can be changed but not saved individually for each user)

Parameter

Maximum

Increment

Default value

Cadence (in rpm) 0 rpm

50 rpm

5 rpm

20 rpm

Pulse width

500 µs

10 µs

20 µs

1.9

Minimum 20 µs

Technical Specifications

RehaStim alone device)

(stand

Size and Weight: Length

13,5 cm

Width

15 cm

Height

7 cm

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Shipping weight

5 kg

Power Supply: Power Source(s) :

AC and/or Akku

Method of Line Isolation

Current - TR 30RAM090 nach EN60601-1, - SANYO, NiMh, C= 2700 mAh,

Power connection

100-240 VAC 50-60 Hz

Power input

max. 150 W

Environment conditions: · In use

0 °C to 40 °C

· Transporting/storing

-20 °C to +60 °C

· Relative humidity

0 to 85% Rh, not condensating

Stimulator / Controller Display / interface

Touch-sensitive LCD

Communications

USB / RS232

Operating system

custom software

Maximum voltage output

154 V

Maximum channels

number

of 8

Current output per channel

20

Waveform type

Biphasic, charged balanced

Duration of the stimulation 20 impulses (pulse width):

130mA incremented in steps of 5 mA 500µs incremented in steps of 10µs

Stimulation frequency:

10 to 50 Hz in steps of 5 Hz

Degree of protection

Type BF Applied Part

RehaMove (consists of RehaStim and Motorized Ergometer) RehaStim see above Motorized Ergometer Size and Weight: Length

60 cm

Width

56 cm Version 1.3 / December 2009

HASOMED GmbH

General Description

Height

100cm

Shipping weight

leg trainer 31 kg leg and arm trainer 38 kg

10

Power Supply: Power connection

115V~, 50/60Hz

230V~, 5/60Hz

Power input

130VA

130VA

Protective type

IPXO

Classification

protection class I, Type B

Medical device according to IIa German Act on Medical devices Environment conditions: · In use

0 °C to 40 °C

· Transporting/storing

-20 °C to +60 °C

· Relative humidity

0 to 85% Rh, not condensating

1.10

Maintenance and Service Instructions

Cleaning the stimulator To clean the stimulator use normal detergent. Do not use spray cleaners. Use a semi-moist cleaning tissue. For cleaning the MOTOmed viva2, please refer to its user manual. Maintaining the Stimulator accumulator To maintain the stimulator accumulator, please every three months - let it discharge completely until the stimulator turns off automatically - then recharge it fully. Maintaining the technical safety The manufacturer recommends for the stimulator RehaStim a maintenance interval of 2 years in order to guarantee the safety standards for further use. For this please send your RehaStim to the manufacturer at your own account. HASOMED will examine the adherence to the technical parameters and the function of the monitoring elements.

1.11

Service Information

At the end of the list of programmes in the therapist menu you find the service information.

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Service information window

Service options

Service menu The service menu is contained in the list of available programs in the therapist menu in the program selection window. The service information window contains service relevant data: - the software version - the state of the battery in % and the current battery voltage - the zero angle of the device which has been adjusted during introduction Press OK if you want to enter the service menu. Service options In the service options window select what you want to do: - change the reference angle/ "Zero angle" at the RehaMove (see chapter Zero angle), or - reset the RehaStim to factory defaults (see chapter Reset to Default/ Factory settings). - read ID of your Stimulator (see chapter Read Stimulator ID) - upgrade your stimulator software under "Prog. Update" (see chapter Program Update). Use the arrow keys to scroll up and down between options and press OK to select one.

1.11.1 "Zero angle" The "zero angle" is the RehaMove calibration off-set value used to shift the actual physical zero point of the pedal angle sensor. The standard zero angle is defined as the sensor angle in a certain position. It is recommended to check the zero angle - if the MOTOmed viva2 cockpit/controller has been exchanged or - if the stimulator was moved to a different MOTOmed viva2. Warning! The zero angle is a device specific parameter and not part of the individual parameters. This means that any changes to this variable will affect other parameter sets too: Changing the zero angle for RehaMove arm training affects all RehaMove arm training programs. Changing the zero angle for RehaMove leg training affects all RehaMove leg training programs.

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General Description

Service options

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To check your RehaMove reference angle/ "zero angle" In the service options window select - Zero A. leg for checking the reference angle for RehaMove leg training - Zero A. arm for checking the reference angle for RehaMove arm training. Use the arrow keys to scroll up and down between options and press OK to select one.

Adjust zero angle

Adjust "zero angle" for RehaMove leg training The RehaMove leg training zero angle/ reference position is defined as the MOTOmed viva2 leg pedal position: - right foot pedal is in horizontal position + - right foot pedal points towards the patient (= backward). To test the zero angle: 1. Start MOTOmed viva2 leg trainer, choose cadence of 0 or 1 rpm. The window shows the default zero angle at the right side. In the left corner the current value from the sensor is constantly written. 2. Let the viva 2 run and watch the current angle value in the left corner change. Read the value the viva 2 tells you in the reference position (see above). If this value is not the same as the default zero angle at the right side, change the value at the right side to read value. The zero angle is adjusted correctly when both values in this window are the same the very moment the pedal is in the reference position. Confirm with OK. 3. Please be aware that changing the zero angle affects all programs. Save only when you are sure. If you are not sure, contact the manufacturer. Then the zero angle test is finished.

Adjust zero angle

Adjust "zero angle" for RehaMove arm training The RehaMove arm training zero angle/ reference position is defined as the MOTOmed viva2 arm handle position: - right arm handle is in horizontal position + - right arm handle points towards the patient (= backward). To test the zero angle: 1. Start MOTOmed viva2 arm trainer, choose cadence of 0 or 1

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rpm. The window shows the default zero angle at the right side. In the left corner the current value from the sensor is constantly written. 2. Let the viva 2 run and watch the current angle value in the left corner change. Read the value the viva 2 tells you in the reference position (see above). If this value is not the same as the default zero angle at the right side, change the value at the right side to read value. The zero angle is adjusted correctly when both values in this window are the same the very moment the pedal is in the reference position. Confirm with OK. 3. Please be aware that changing the zero angle affects all programs. Save only when you are sure. If you are not sure, contact the manufacturer. Then the zero angle test is finished. If you want to check the adjustments once more, use LED cables and start a program with few channels, e.g. Ri. 2 Ch. Test whether the lights shine at the correct positions. Note: When you reset your stimulator to the default /factory settings (see chapter Reset to Default/ Factory settings), the zero angle is not reset!

1.11.2 Reset to Default/ Factory Settings Service options To re-establish the RehaStim factory default settings, in the service options window select Defaults..

Service options

Use the arrow keys to scroll up and down between options and press OK to select. Reset the RehaStim to factory defaults In order to reactivate the factory default values, press OK. All defaults settings are re-established - apart from the unit individual zero angle (see chapter "Zero angle"). The zero angle is not reset! However this eliminates all changes or customizations you made!

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General Description

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1.11.3 Read Stimulator ID Service options In the service options window select Read ID.. Use the arrow keys to scroll up and down between options and press OK. Service options

The stimulator ID is visible. After a few seconds the screen returns to Service options.

1.11.4 Program Update Service options In the service options window upgrade your stimulator software under "Prog. Update". Please contact manufacturer for a software upgrade and upgrade instructions. Service options

Use the arrow keys to scroll up and down between options and press OK.

HASOMED GmbH

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2

Control Elements and Accessories of the RehaStim

2.1

Operating and Connection Elements

Picture1: Front view with control elements

With the main switch the stimulator is turned on and off. The device is operated with a graphic LCD touch screen. Depending on task and status, the touch screen displays specific readouts and switch elements. The stimulator is powered from an internal battery. When charging use only the provided battery charger! While the battery is being charged the charge light (LED) will shine yellow. Stimulation is still possible during charging. When stimulation is carried out, the stimulation light (LED) shines yellow. If an error occurs, this light shines red (see chapter Fault Indication).

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Control Elements and Accessories of the RehaStim

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Picture 2: Back view with interface elements

There are 4 connection points for the electrode cables, each cable connecting two channels. The RehaMove interface (SPI/RS232) should be connected to the corresponding device. The emergency stop button must be connected to the corresponding interface. With it the user can immediately turn off the stimulation in the case of an emergency. The USB interface is used to connect the stimulator to a computer for software updates.

HASOMED GmbH

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2.2

RehaStim, RehaMove - Operating Manual -

Accessories

The stimulator and its accessories were delivered to you in a transport case.

Picture: RehaStim accessories

Its contents are described below: - 1 stimulator RehaStim - 1 emergency stop button - 4 electrode cables - 1 power supply for the stimulator - 1 cable to connect the movement exerciser and RehaStim - 1 USB connection cable to PC - 4 sets of electrodes separately: - bracket with bolt to fix the stimulator onto the movement therapy machine

Picture: RehaStim with connected accessories

Version 1.3 / December 2009

HASOMED GmbH