Rehabtronics HSST1 Forearm FES & NMES nerve stimulator User Manual Hand Stimulator

Rehabtronics Inc. Forearm FES & NMES nerve stimulator Hand Stimulator

User Manual

HAND STIMULATOR USER MANUAL HS-IFU-EN Revision A (DRAFT 15-08-05) YYYY-MM
1 Table of Contents Introduction .................................................................................................................................................. 4 Device Description .................................................................................................................................... 4 List of Symbols .......................................................................................................................................... 5 Safety Information .................................................................................................................................... 7 Contraindications .................................................................................................................................. 7 Warnings ............................................................................................................................................... 7 Precautions ........................................................................................................................................... 8 System Components ..................................................................................................................................... 9 The DOCK ................................................................................................................................................ 10 DOCK Setup ......................................................................................................................................... 10 Changing Outlet Adaptors ................................................................................................................... 11 The STIM ................................................................................................................................................. 12 The HMS .................................................................................................................................................. 13 Pairing a New STIM or HMS ................................................................................................................ 13 The GARMENT ......................................................................................................................................... 14 Selecting a GARMENT ......................................................................................................................... 15 The ELECTRODES ..................................................................................................................................... 16 The WRIST-SUPPORT ............................................................................................................................... 17 STIM User Interface .................................................................................................................................... 18 Status Bar ................................................................................................................................................ 19 Main Menu .............................................................................................................................................. 20 STIM INTENSITY ................................................................................................................................... 20 FES MODE............................................................................................................................................ 21 EXERCISE MODE .................................................................................................................................. 22 DEVICE SETUP...................................................................................................................................... 23 Factory Reset .......................................................................................................................................... 24 Using the Hand Stimulator System ............................................................................................................. 25 Overview ................................................................................................................................................. 25 Charging the STIM and HMS ................................................................................................................... 26 GARMENT & ELECTRODES Fitting ........................................................................................................... 27 Preparing the Arm ............................................................................................................................... 27 Wetting the ELECTRODES.................................................................................................................... 28
2 Attaching the ELECTRODES to the GARMENT ..................................................................................... 28 Positioning ELECTRODES in the GARMENT ......................................................................................... 29 Fitting the GARMENT .......................................................................................................................... 31 Using the WRIST-SUPPORT ................................................................................................................. 32 Configuring Stimulation Intensity ........................................................................................................... 33 Resetting Intensities ............................................................................................................................ 33 Adjusting Intensities ............................................................................................................................ 34 Functional Stimulation ............................................................................................................................ 35 Controlling Stimulation by Tapping .................................................................................................... 36 Controlling Stimulation by Head-Motion ............................................................................................ 37 Exercise Programs ................................................................................................................................... 38 System Cleaning and Maintenance ............................................................................................................. 39 General System Maintenance ................................................................................................................. 39 DOCK Cleaning & Maintenance .............................................................................................................. 39 STIM and HMS Cleaning & Maintenance ................................................................................................ 39 ELECTRODES Cleaning & Maintenance ................................................................................................... 40 GARMENT Cleaning & Maintenance ....................................................................................................... 41 Disposal Information ................................................................................................................................... 42 Troubleshooting .......................................................................................................................................... 43 Physical Reactions ................................................................................................................................... 43 Pain or Discomfort .............................................................................................................................. 43 Allergic Reactions ................................................................................................................................ 43 Skin Irritation....................................................................................................................................... 43 Device Use Troubleshooting ................................................................................................................... 44 General Troubleshooting .................................................................................................................... 44 STIM Error Messages .......................................................................................................................... 44 Technical Information ................................................................................................................................. 45 General Specifications............................................................................................................................. 45 Environmental Specifications .............................................................................................................. 45 Electrical Component Specifications ................................................................................................... 45 Stimulation Specifications ....................................................................................................................... 46 Wireless Specifications ........................................................................................................................... 47 Electromagnetic Compatibility ................................................................................................................ 48
3 Contact & Reordering Information ............................................................................................................. 51
4 Introduction Device Description The Hand Stimulator is a system designed to non-invasively stimulate the nerves of the forearm that control hand opening and closing. It is indicated for use by patients suffering from reduced hand-function due to conditions such as stroke, spinal-cord injury or other central nervous system disorders. Individuals suffering from these conditions can use the Hand Stimulator for any of the following purposes:  Functional Stimulation o Actively initiate hand-grip and hand-open stimulation to assist with tasks of daily living  Rehabilitation & Therapy o Improvement and/or maintenance of hand-function and range-of-motion o Prevention and/or reduction of disuse atrophy o Increase blood-circulation in the hand and forearm o Reduce muscle spasm o Muscle re-education CAUTION: The Hand Stimulator is intended to be used only under the direction and/or supervision of a licensed healthcare professional.
5 List of Symbols The following table lists the symbols that are used on the Hand Stimulator labels and in this manual: Symbol Definition Application to the Hand Stimulator System Warning Important information or instructions that should be observed to avoid potential injury or damage to the device. Operating Instructions Instructions for use can be referenced detailing operating instructions. Follow Instructions for Use The instructions for use contain critical instructions necessary to use the device safely. IP22 Ingress Protection Rating The STIM and HMS enclosures are protected against dripping water (e.g. light rain) and ingress of finger-sized objects. Non-Ionizing Radiation Emitter The STIM and HMS components use low-energy radio frequencies. Model Reference (Catalogue/Re-order Number) Reference the accompanying model number next to this symbol when re-ordering components. Lot/Batch Number Reference the accompanying batch number next to this symbol if contacting support. Type BF Applied Part Components that make patient contact have a degree of protection against electric shock. European Authorized Representative The contact information accompanying this symbol can be used to contact a representative in the European Community. Waste Electrical and Electronic Equipment (WEEE) Do not dispose electronics with regular household waste. Consult local waste management authorities to determine the acceptable means to dispose of electronic equipment.
6 Symbol Definition Application to the Hand Stimulator System Double Insulated (Class II) The DOCK power-supply adaptor does not require a safety ground connection. Do Not Iron or Press Do not iron the fabric of the GARMENT. Do Not Tumble Dry Do not tumble dry or hot-air dry the GARMENT after washing. Hand Wash Only Hand wash the GARMENT only. Do not use a washing machine. Do Not Bleach Do not use bleach when washing the GARMENT. Arm/Disarm A button on the STIM that toggles arming and disarming of the stimulator.
7 Safety Information Contraindications  Do not use the Hand Stimulator System if a pacemaker or any other critical medical electrical equipment is in use. There is a remote chance that Hand Stimulator System may interfere with such devices.  Do not use the Hand Stimulator System if fractures or dislocations of the fingers, wrist or elbow are present. Use of the Hand Stimulator System with these conditions may complicate the existing injury.  Do not use the Hand Stimulator System on areas where a cancerous lesion is present or suspected. Electrical stimulation over cancerous lesions may complicate the condition. Warnings  The long term effects of chronic electronic stimulation are unknown. Discontinue use and consult a medical professional if any adverse effects are experienced.  Never attempt to use the Hand Stimulator to stimulate parts of the body other than the hand and forearm. Stimulation to other areas such as the head, neck or torso can result in serious injury or death.  Do not use the Hand Stimulator on, or close to injured, swollen, infected, or inflamed areas of the skin. Doing so may complicate the existing condition or prolong healing.  Long term use can cause skin irritation. Discontinue use if you experience skin pain or a rash on your arm that doesn't fade within 1 hour.  Interference is possible between the Hand Stimulator and other electrical equipment. o Do not use the device with any surgical equipment, or while near diagnostic equipment such as MRI, CT and ultrasound machines. o Do not use the device within 1 meter of any shortwave or microwave therapy equipment, as this may affect the performance of the Hand Stimulator.  Do not use while driving, operating machinery, or during any activity in which involuntary muscle contractions may result in injury.  Do not immerse the STIM, HMS or DOCK in water. Doing so may result in electrical shock and damage to the device.  Never attempt to disassemble, modify or repair any components of the system. Doing so may result in electrical shock and damage to the device.  Do not use if any component is visibly damaged. Wires, connectors and enclosures should be inspected for defects, breaks and obstructions before every use.  Do not probe under the GARMENT with fingers or other objects while the STIM is actively stimulating. Doing so may result in electrical shock.
8  Do not use the Hand Stimulator while sleeping.  The Hand Stimulator is to be used only with GARMENT, ELECTRODES, DOCK and POWER-SUPPLY components supplied by Rehabtronics Inc. Precautions  Safety of powered muscle stimulators for use during pregnancy has not been established.  Caution should be used for users with suspected or diagnosed heart problems, epilepsy or osteoporosis. Consult a physician prior to use.  Caution should be used over areas of the skin which lack normal sensation.  Some patients may experience skin irritation or hypersensitivity due to electrical stimulation. The irritation can usually be reduced by using an alternate electrode placement or by changing the stimulation parameters. If problems persist, discontinue use.  Electrode placement and stimulation setting should be based on the guidance of a medical professional.  Keep the Hand Stimulator out of the reach of children not prescribed to use the device. Children prescribed to use the device should do so only under adult supervision.  Muscle soreness may occur, much like during regular exercise. Limit the amount of usage per day according to exercise-related soreness.  Hand function may change while using this device. Use caution while attempting new activities.  Replace the GARMENT and ELECTRODES if they show signs of advanced wear and tear within suggested replacement period.  Autonomic Dysreflexia can occur while using the device in people with spinal cord injury above T6 level.  Extended use can reduce tenodesis grip in users with spinal-cord injuries.  When using the STIM between users, the intensity setting should be reset to minimum between users.  Do not share the GARMENT or ELECTRODES between users.  Do not use the Hand Stimulator continuously beyond four hours at a time. Remove the Garment and allow skin to ventilate between uses. If any skin redness or inflammation is noticed, do not begin using the Hand Stimulator again until the skin has fully recovered.  Do not store or operate the Hand Stimulator in conditions outside those listed in the Technical Information section of this manual. Doing so can damage components.  Electrical and wireless components of the Hand Stimulator System require special precautions for electromagnetic compatibility and immunity. Refer to Electromagnetic Compatibility tables in the Technical Information section of this manual for details.
9 System Components GARMENT (see page 13) - Used to position the ELECTRODES, and hold the STIM - Includes optional thumb-strap - Available in three sizes for both left and right arms WRIST-SUPPORT (see page 16) - Optional GARMENT accessory used to support the wrist DOCK (see page 9) - Used to charge the STIM and HMS - Optionally used to pair different STIM and HMS units - Includes a dedicated power-supply and interchangeable wall-outlet adaptors. ELECTRODES (see page 15) - Wettable electrode pads for use with the GARMENT - Comes in packaged sets of four (3 large and 1 small) HMS (see page 12) - “Head Motion Sensor” - Optional accessory, for use with the STIM - Worn over the ear - Allows stimulation to be controlled by movements of the head STIM (see page 11) - Used to configure and activate stimulation when connected to a GARMENT
10 The DOCK STIM CRADLE Connection for a STIM unit. POWER LED Glows green when the DOCK is receiving power. HMS CRADLE Connection for an HMS unit. POWER INPUT Connection input to the POWER-SUPPLY. PAIRING BUTTON Pairs connected STIM and HMS so they can work together. POWER-SUPPLY (Rehabtronics Part No. DE02) Suppliers power to the DOCK from a local AC power outlet. OUTLET ADAPTORS Common types of international adaptors can be interchanged to fit the shape of local power-outlets. DOCK Setup To setup the DOCK, simply connect the included POWER-SUPPLY adapter to the DOCK’s POWER INPUT, and plug in the POWER-SUPPLY to a local 100-240V AC power outlet. When properly plugged-in, the DOCK’s POWER LED will glow green. A B C E D F G A B C D E F G
11 WARNING: Do not attempt to modify or substitute the included POWER-SUPPLY. Doing so may result in electrical hazards. If a replacement adaptor is required, see “Contact and Re-Ordering Information” at the end of the Manual. WARNING: The DOCK is intended for indoor use only. Keep dry and away from extreme temperatures. Changing Outlet Adaptors The DOCK’s POWER-SUPPLY includes interchangeable OUTLET ADAPTORS, allowing it to fit the most common international outlets. The instructions below describe how to exchange OUTLET ADAPTORS: 1. Remove the current OUTLET ADAPTOR by pressing the “PUSH” button and twisting the adaptor. 2. Line up the arrows of the new OUTLET ADAPTOR and POWER-SUPPLY as shown. 3. Twist on the new OUTLET ADAPTOR until it clicks into place.
12 The STIM DISPLAY The display screen for the user interface. NAVIGATION BUTTONS Used to navigate menus and options of the DISPLAY’s user interface. DOCK/GARMENT CONNECTION Allows the STIM to be connected to either a DOCK or a GARMENT. ARM/DISARM BUTTON Toggles arming and disarming. Arming is required for stimulation. Disarming will disable all stimulation. NOTE: The STIM must be connected to a GARMENT to arm. ON/OFF BUTTON Press and hold to turn the STIM on and off. NOTE: To conserve batteries, the STIM will automatically turn off after more than 10 minutes of no activity or movement. C D A E B A B C D E
13 The HMS DOCK CONNECTION Allows the HMS to be connected to a DOCK. STATUS LED Used to monitor the status of the HMS. Will flash dim green when the HMS is powered on. ON/OFF BUTTON - To turn on, press and hold until the STATUS LED glows green. - To turn off, press and hold until the STATUS LED glows yellow. Pairing a New STIM or HMS NOTE: The STIM and HMS units supplied with a system kit will come pre-paired. This section is only applicable if pairing different STIM and HMS units, or for troubleshooting purposes should a STIM and HMS be failing to communicate. In order for a STIM and HMS to communicate, they must first be paired. To pair a STIM and HMS, insert both into the DOCK and press the PAIRING BUTTON. The pairing progress can be monitored according to the table on the right. NOTE: Pairing a STIM and HMS only has to be performed once. Successful pairing is saved automatically. NOTE: A STIM can only be paired with one HMS at a time. The pairing process will overwrite any previous pairings. STIM Display Meaning Pairing is in progress Pairing successful Pairing error A B C A B C
14 The GARMENT THUMB-STRAP Detachable strap that allows the THUMB electrode to be placed against the heel of the thumb. STIM-HOLDER Holds the STIM while in use. WRIST-SUPPORT SLOT A slot for inserting the optional WRIST-SUPPORT accessory. STRAPS Velcro straps for tightening and securing the GARMENT. CLASPS Clasps for threading each of the STRAPS. PLACEMENT AREAS Stitched areas indicate recommended placement areas for each of the ELECTRODES. ELECTRODE LEADS Moveable leads can be relocated in the PLACEMENT AREAS and contain a socket for attaching ELECTRODES. WARNING: Do not share the GARMENT between users. A C B D E F G BOTTOM VIEW TOP VIEW A B C D E F G
15 WARNING: Do not machine-wash or tumble-dry the GARMENT. Doing so may irreparably damage the GARMENT. For washing instructions refer to the “GARMENT Cleaning & Maintenance” section of this manual. Selecting a GARMENT The GARMENT is available for either left or right arms in three sizes – small, medium, and large. System kits will include all different types, and hence the preferred type must be selected as follows: 1. Check the GARMENT labels and select only the ones specific to the affected arm (either left or right). 2. Try on each size of GARMENT to select the appropriate size that covers as much of the forearm as possible without interfering with elbow or wrist movement. 3. Note the re-order (REF) number on the label of the selected GARMENT for re-ordering purposes. For re-ordering information see “Contact and Reordering Information” at the end of this manual. L = Left Arm R = Right Arm Re-Order Number
16 The ELECTRODES GARMENT SNAP Allows connection to GARMENT ELECTRODE LEADS. FABRIC PAD Cotton pad holds water to conduct and distribute stimulation pulses. LARGE ELECTRODE 4.2cm in diameter. Intended for placement over large areas of the forearm. SMALL ELECTRODE 2.2cm in diameter. Intended for stimulating smaller areas, such as those required for thumb-close stimulation. CAUTION: Do not use soaps or detergents on the ELECTRODES. Doing so may result in skin irritation and have unknown effects on stimulation performance. WARNING: Do not share ELECTRODES between users. IMPORTANT: Replace ELECTRODES after two (2) weeks of daily use, or sooner if significant odors or discoloration is observed. See “Contact and Reordering Information” at the end of this manual. A B C D A B C D
17 The WRIST-SUPPORT GARMENT INSERT Extended portion that inserts into the GARMENT’s WRIST-SUPPORT SLOT. HAND-CRADLE U-shaped portion wraps around the palm of the hand STRAP A Velcro strap for holding the HAND-CRADLE to the hand. See “Using the WRIST-SUPPORT” section on page 31 of this manual for instructions on using the WRIST-SUPPORT.A B C A B C
18 STIM User Interface All of the Hand Stimulator system’s functions for configuring and activating stimulation are accessed through the STIM’s user interface. This section describes in detail how to navigate the user interface, and the available options.
19 Status Bar The STIM’s user interface contains a persistent Status Bar at the top of the DISPLAY that indicates the present status of the device. STIM Battery Status Icon Icon Meaning [image] Charged - Fully charged Discharging - Partially charged [image] Low Battery - Less than 10% charge remaining Audio Status Icon Icon Meaning Enabled - Audio is enabled Disabled - Audio is disabled Stimulation Status Icon Icon Meaning [image] Disarmed – All stimulation functions are disabled. Allows settings to be configured without a GARMENT. Armed (Standby) – STIM is connected to a GARMENT and ready to start stimulating. Active (Stimulating) – STIM is sending stimulation pulses to the ELECTRODES. HMS Status Icon Icon Meaning HMS Not Connected - Tap the STIM to control FES mode. HMS Connected - An HMS is detected and FES mode will respond to head-motion detections.  Indicates the wireless connection strength between the STIM and the HMS.  Is a battery meter for the HMS, similar to the STIM Battery Status Icon. STIM Battery Status Icon Audio Status Icon Stimulation Status Icon HMS Status Icon
20 Main Menu When the STIM is turned on by pressing and holding the ON/OFF BUTTON, a Main Menu is presented with the following four options: Menu Option Description STIM INTENSITY* Adjust stimulation intensities to the electrodes controlling hand-open, hand-close and thumb-close. FES MODE* Functional Electrical Stimulation. Manually control hand-open and hand-close stimulation. EXERCISE MODE* Timer-based stimulation programs that automatically cycle between hand-open and hand-close stimulation. DEVICE SETUP Settings to configure the user interface. *NOTE: STIM INTENSITY, FES MODE and EXERCISE MODE stimulation functions require the STIM to be connected to a GARMENT and armed for stimulation. STIM INTENSITY Selecting the STIM INTENSITY option from the main-menu will access the following sub-menus: Sub-Menu Description Instructions Resets all electrode stimulation intensities to OFF. Press twice to perform reset. Press any other NAVIGATION BUTTON to cancel. Adjust the stimulation intensity to the electrode controlling hand opening, or turn it OFF. Use the and buttons to adjust the intensity. Adjust the stimulation intensity to the electrode controlling hand closing, or turn it OFF. Use the and buttons to adjust the intensity. Adjust the stimulation intensity to the electrode controlling thumb closing, or turn it OFF. Use the and buttons to adjust the intensity. NOTE: Increasing intensities requires the STIM to be connected to a GARMENT. The person wearing the GARMENT will be able to feel the adjusted intensity. CAUTION: If sharing a single STIM between users, use the “reset” feature to reset all electrode intensities to ‘OFF’ between users.
21 FES MODE The “Functional Electrical Stimulation” (FES) mode allows manual control of hand-open and hand-close stimulation in one of two ways, depending on whether a paired HMS is detected:  If a paired HMS is detected, the STIM will respond to head-motion detected by the HMS.  If there is no HMS detected, the STIM will respond to physical taps. While in FES MODE, the STIM will cycle between the following states in response to either physical taps or head-motion detections: FES MODE State Description Relax (no stimulation) This is the default state when FES MODE is first started. [image] Hand-Open Stimulation Electrical pulses are delivered to the hand-open electrode, causing the fingers of the hand to open. [image] Hand-Close Stimulation Electrical pulses are delivered to the hand-close and thumb-close electrodes, causing the hand to close. NOTE: Hand-Open and Hand-Close states require the STIM to be connected to a GARMENT, and armed for stimulation. NOTE: To conserve battery-life the DISPLAY will turn off when the STIM is left in any of the above states for a prolonged period. The DISPLAY will turn back on if any button is pressed, or if the relax/open/close state is changed by a tap or head-motion.
22 EXERCISE MODE EXERCISE MODE contains two timer-based programs: Program Description Condition muscles of the forearm and hand by automatically cycling between relax (no stimulation), hand-open stimulation, and hand-close stimulation. Promote blood circulation in the forearm and hand by automatically cycling between relax (no stimulation), hand-open stimulation, and hand-close stimulation at a low intensity. The following table describes the EXERCISE MODE interface: Interface Instructions Select Program Use the up/down navigation buttons to select the preferred program. Start Program Press the button to start the program. Stimulation will begin, and a timer will begin counting down from 20 minutes. NOTE: The STIM must be connected to a GARMENT and armed for the program to begin. Pause Program Press the button to pause the program. This will stop stimulation and pause the timer. Press the button again to un-pause and resume stimulation and timer countdown. Stop Program Stop the program by pressing the button. Stimulation will stop, and the timer will be reset. Panic Protection In addition to the instructions for pausing and stopping exercise programs described above, the STIM can also be immediately disabled at any time by either: a) Removing the STIM from the GARMENT, or b) Forcibly hitting the STIM.
23 DEVICE SETUP Selecting the DEVICE SETUP option from the main-menu allows access to the following device settings: DEVICE SETUP Menu Purpose Instructions Audio Setting Enable or disable audible beeps.  Use the ‘<’ and ‘>’ navigation buttons to select the preferred audio setting. Tap Sensitivity Adjust the tapping force required to cycle hand-open/close/relax in FES mode.  Use the ‘<’ button to make the STIM less sensitive to taps (harder tap required)  Use the ‘>’ button to make the STIM more sensitive to taps (softer tap required).  The current setting can be tested by tapping the STIM. The dot will flash green if the tap was hard enough for the STIM to detect it at the current sensitivity setting. HMS Mode Select the preferred head-motion detection pattern for use in FES mode.  Use the ‘<’ and ‘>’ navigation buttons to switch between head-motion patterns.  The currently selected pattern can be tested by donning a connected HMS and performing the selected head-motion. The dot will flash green when selected head-motion patterns are detected. Hand Reorient the DISPLAY and NAVIGATION BUTTONS according to the affected arm.  Use the ‘<’ and ‘>’ buttons to select left or right hand orientation, respectively. The DISPLAY and NAVIGATION BUTTONS will re-orient automatically. Usage Log Displays statistics on the amount of time stimulating.  The Usage Log screen with automatically record and update the following information: o Hand Open – The total amount of time spent stimulating the hand to open. o Hand Close – The total amount of time spent stimulating the hand to close. o Total Cycles – The total number of times the hand has been stimulated through open/close/relax cycles.
24 Factory Reset The STIM settings and Usage Log statistics can be reset to their original out-of-the-box settings as follows: 1. Select DEVICE SETUP from the STIM main-menu. 2. Navigate to the Usage Log screen. 3. Press and hold the button, and while still holding the button press the button. A confirmation screen will appear. 4. From the confirmation screen, press to confirm the reset, or press to cancel.
25 Using the Hand Stimulator System Overview This section describes the steps for using the Hand Stimulator system. Below is an overview of the steps and references to the pages of this manual where detailed instructions are given: 1. Charge the STIM and HMS (page 25) 2. Prepare the Arm (page 26) 3. Wet ELECTRODES and attach them to the GARMENT (page 27) 4. (If necessary) Reposition ELECTRODES in the GARMENT (page 28) 5. Fit the GARMENT over the ARM (page 30) 6. Configure preferred stimulation intensities (page 32) 7. Activate stimulation by selecting either of the following modes: a. FES Mode (page 34) – Manually control stimulation of hand-opening and hand-closing b. EXERCISE Mode (page 37) – Timer-based automatic stimulation programs
26 Charging the STIM and HMS To charge the STIM and HMS, simply insert them into their cradles in the DOCK as shown in the image below: The charging status can be monitored by observing the STIM’s DISPLAY and the HMS’s STATUS LED according to the following table: CHARGING STATUS Charging in Progress Charging Complete Charging Error STIM STIM’s DISPLAY shows an animated battery indicating the current charge progress STIM’s DISPLAY shows full battery and green checkmark STIM’s DISPLAY shows an error message HMS HMS’s STATUS LED alternately flashes green and yellow HMS’s STATUS LED is solid green HMS’s STATUS LED is solid red NOTE: STIM and HMS units can be charged separately or simultaneously. It is recommended that either component, when not in use, be placed in the DOCK to avoid battery depletion.
27 GARMENT & ELECTRODES Fitting Preparing the Arm The skin over which the GARMENT is fitted must be clean, healthy, and free of obstructions. Perform the following preparation steps prior to fitting: 1. Ensure the skin is healthy and free of any cuts, irritations, infections, or other injuries. 2. Ensure the skin is clean and free of any lotions, ointments or other cosmetics. 3. Remove any personal items such as jewelry, watches, bracelets, etc. from the affected arm. 4. If necessary for the ELECTRODES to make contact with the skin, trim any excess arm hair from the areas over which the ELECTRODES will be placed. CAUTION: Ensure the skin is clean and free of any ointments, lotions and cosmetics. The presence of other substances can have unknown effects on stimulation delivery. WARNING: Do not use over irritated, injured or infected skin. Doing so may complicate existing injuries or infections.
28 Wetting the ELECTRODES The ELECTRODES must be wet with clean water prior to connecting them to the GARMENT. This is done as follows: 1. Inspect the ELECTRODES prior to use. If there is significant discoloration, bad odors, or any noticeable separation of materials, discard and use a new set instead. For re-ordering information “Contact and Reordering Information” at the end of this Manual. 2. Soak ELECTRODES in clean, room-temperature water. Ensure the FABRIC PADS have absorbed as much water as possible. 3. Squeeze ELECTRODES lightly to remove excess water. The ELECTRODES should be as wet as possible, without dripping water. CAUTION: Use only clean water to wet ELECTRODES. Using dirty water or any other liquid can result in skin irritation and unknown stimulation performance. Attaching the ELECTRODES to the GARMENT Once the ELECTRODES have been wet, they can be snapped into the sockets at the ends of each of the GARMENT’s ELECTRODE LEADS: 1. Snap the SMALL ELECTRODE into the socket of the GARMENT’s THUMB LEAD. 2. Snap the remaining three LARGE ELECTRODES in to the sockets of the remaining leads. CAUTION: Ensure all four ELECTRODES are attached to the GARMENT prior to use. Wearing the GARMENT with missing ELECTRODES can cause discomfort and skin irritation. CAUTION: Ensure each electrode is securely snapped into the GARMENT sockets. Loose connections can result in intermittent stimulation delivery, or STIM error messages.
29 Positioning ELECTRODES in the GARMENT The underside of the GARMENT has stitched areas indicating the common placement areas for each of the ELECTRODES. The GARMENT’s ELECTRODE LEADS each have a fabric tab, allowing the ELECTRODES to be moved to different positions. CAUTION: Use care when re-positioning ELECTRODES so as not to stress or damage the underlying cables. THUMB electrode placement area NEUTRAL electrode placement area HAND-CLOSE electrode placement area HAND-OPEN electrode placement area Use fabric tabs to re-position ELECTRODES
30 The following figure illustrates the approximate areas of the arm corresponding to each of the PLACEMENT AREAS: Using the THUMB-STRAP to Place the THUMB Electrode In addition to the THUMB electrode placement area indicated on the GARMENT, the GARMENT also comes with a detachable THUMB-STRAP that allows the THUMB electrode to be placed against the heel of the thumb. THUMB NEUTRAL HAND-CLOSE HAND-OPEN Suggested placement areas for ELECTRODES in GARMENT Corresponding ELECTRODES contact areas on the arm THUMB NEUTRAL HAND-OPEN HAND-CLOSE
31 Fitting the GARMENT Once all four ELECTRODES are wet and attached to the GARMENT, the GARMENT can be fitted on the arm as follows: 1. Loosely thread the GARMENT’s STRAPS through the CLASPS, creating a wide “sleeve” shape. 2. With the GARMENT’s STIM HOLDER on top, insert the arm through the GARMENT. 3. Tighten and secure the STRAPS so that the ELECTRODES are pressed firmly against the skin, and the GARMENT does not twist or slide on the arm. CAUTION: Do not over-tighten to the point of restricting blood-flow to the hand.
32 Using the WRIST-SUPPORT The WRIST-SUPPORT is an optional GARMENT accessory used to support the wrist in a neutral position. It should be used only if the person wearing the GARMENT requires wrist support. To use the WRIST-SUPPORT, simply insert the long end into the GARMENT’s WRIST-SUPPORT SLOT. Conditions that may require the WRIST-SUPPORT: Unsupported, the wrist is held in a naturally flexed position With the WRIST-SUPPORT: Wrist is supported in a neutral position
33 Configuring Stimulation Intensity Resetting Intensities Prior to configuring STIM intensities, it is recommended that all settings be first reset to “OFF”. This should be done in either of the following situations: o If the STIM is being used for the first time o If the STIM is being shared between users, such as in clinical settings Resetting all intensities to “OFF” is accomplished as follows: 1. Turn the STIM on by pressing and holding the ON/OFF BUTTON. 2. Select “STIM INTENSITY” from the Main Menu. 3. Press the button at the screen asking if you would like to reset intensities. 4. A screen will ask to confirm the reset. o Press to confirm. o Press any other navigation button to cancel. 5. If confirmed, the DISPLAY will show a green checkmark indicating that all intensities have been successfully reset to ‘OFF’.
34 Adjusting Intensities IMPORTANT: If sharing the STIM between users, intensities should always be reset between users prior to following these instructions (see previous section). NOTE: Increasing intensities requires the STIM to be connected to a GARMENT, allowing the person wearing the GARMENT to feel the effects as the intensity is adjusted. Stimulation intensity can be adjusted individually to the HAND-OPEN, HAND-CLOSE and THUMB ELECTRODES as follows: 1. Wet the ELECTRODES and fit the GARMENT according to the instructions in the previous sections. 2. Insert the STIM into the GARMENT’s STIM-HOLDER. 3. Turn the STIM on by pressing and holding the ON/OFF BUTTON. 4. Press the button to arm the STIM. 5. Select “STIM INTENSITY” from the Main Menu. 6. Use the button to access the “HAND OPEN”, “HAND CLOSE” and “THUMB CLOSE” screens. 7. Use the button to gradually increase the intensity of stimulation to the each electrode, until the desired hand-response is achieved. CAUTION: Do not increase to painful levels. The desired hand-response should be achievable without pain or discomfort. If significant discomfort is experienced without achieving the desired response, reposition the electrode to another location in the PLACEMENT AREAS and try again. NOTE: In most cases, effects will not be felt until the setting has increased beyond 5. NOTE: Stimulation can be stopped at any time by pressing the button. NOTE: Not all circumstances require thumb stimulation. If thumb stimulation is not needed, the THUMB-CLOSE screen can be left at a setting of ‘OFF’.
35 Functional Stimulation The STIM has a dedicated mode for functional electrical stimulation (FES), which allows manual control over hand-opening and hand-closing stimulation. This control is accomplished by either physically tapping the STIM, or by executing head-motion patterns with the HMS. NOTE: this section assumes that the following pre-requisite steps have already been taken:  The ELECTRODES are wet and the GARMENT has been fitted according to the instructions in the previous sections (see page 27).  The STIM has been inserted into the GARMENT’s STIM-HOLDER and is turned on.  Stimulation intensity has been configured to desired levels (see page 33). CAUTION: Hand function may change as a result of using the Hand Stimulator. Use caution when engaging in activities that depend on controlled hand function. WARNING: Do not use while driving, operating machinery, or during any activity in which involuntary muscle contractions may result in injury.
36 Controlling Stimulation by Tapping Functional stimulation control by tapping the STIM is achieved as follows: 1. Check that there is no HMS connected to the STIM. The top right of the DISPLAY’s Status Bar should show “TAP”. If “TAP” is not shown in the Status Bar, check that any nearby HMS unit has been turned off. [image] 2. Press the button to arm the STIM. The Stimulation Status icon at the center of the DISPLAY’s Status Bar should be solid gray . 3. Select “FES MODE” from the Main Menu. [image] 4. Tap the STIM to cycle between hand-opening, hand-closing and relax (no stimulation). NOTE: Stimulation can be stopped at any time by pressing the button. Adjusting the Tap Sensitivity To adjust how sensitive the STIM is to taps, do the following: 1. Select “DEVICE SETUP” from the STIM’s Main Menu. 2. Press the button until the “TAP SENSITIVITY” screen is reached. 3. Use the and buttons to adjust the tap sensitivity: Press the button to make the STIM less sensitive (harder tap required) Press the button to make the STIM more sensitive (softer tap required) NOTE: The current setting can be tested by tapping the STIM. The dot on the screen will flash green if the tap was hard enough for the STIM to detect it at the current sensitivity setting.
37 Controlling Stimulation by Head-Motion To control functional stimulation using movements of the head, follow the instructions below: 1. Turn on the HMS by pressing and holding the ON/OFF BUTTON until the STATUS LED glows green.  After a moment, the STIM’s DISPLAY should indicate that an HMS has been detected, and the connection-strength should be visible at the top-right of the Status Bar. 2. Don the HMS over the preferred ear. 3. Set the preferred pattern by selecting “DEVICE SETUP” from the STIM’s Main Menu, and then navigating to the “HMS Mode” screen. 4. Use the and navigation buttons to switch between head-motion patterns. There are four detection patterns available:  (1) Down-Up – Nod the head down then return to normal  (2) Up-Down – Nod the head up, then return to normal  (3) Right-Left – Turn the head to the right, then return to normal  (4) Left-Right – Turn the head to the left, then return to normal NOTE: The currently selected pattern can be tested by performing the selected head-motion. The dot on the screen will flash green when selected head-motion patterns are detected. 5. Press the STIM’s button to arm the STIM. The Stimulation Status icon at the center of the DISPLAY’s Status Bar should be solid gray. 6. Return to the Main Menu and select “FES MODE”. 7. Hand-opening, hand-closing and relax (no stimulation) can now be cycled by executing the head-motion pattern selected in step 4.
38 Exercise Programs The Hand Stimulator system contains two passive, timer-based exercise programs: Program Stimulation Behavior Uses STRENGTH Automatically cycles between relax (no stimulation), hand-open stimulation and hand-close stimulation at the currently configured intensity settings. - Condition muscles of the forearm and hand - Increase or maintain range-of-motion CARDIO Automatically cycles between relax (no stimulation), hand-open stimulation and hand-close stimulation at 30% of the currently configured intensity settings. - Promote blood circulation to the forearm and hand NOTE: Both programs run for a maximum of 20 minutes per session, but can be stopped or paused at any time. CAUTION: Do not exceed one 20 minute session per day unless instructed otherwise by a medical professional. WARNING: Muscle soreness may occur, much like during regular exercise. Limit the amount of usage per day according to exercise-related soreness. If pain is experienced, immediately discontinue exercise and contact your medical professional. Use the exercise programs as follows: 1. Select “EXERCISE MODE” from the STIM’s Main Menu. 2. Use the and buttons to select either the “STRENGTH” or “CARDIO” screens. 3. Use the button to ensure that the STIM is armed. The Stimulation Status icon at the center of the Status Bar will be solid gray 4. Press the button to start the exercise. Stimulation will begin to cycle automatically, and the timer will begin to countdown. 5. Pause the exercise at any time by pressing the button. This will stop stimulation and pause the timer. Press the button again to resume the exercise. 6. Stop the exercise at any time by pressing the button. This will stop stimulation and reset the timer.
39 System Cleaning and Maintenance General System Maintenance The following general maintenance guidelines should be followed to ensure safe and effective use of the Hand Stimulator system:  Inspect all components prior to use. Do not use any components show signs of damage.  Do not store or operate any of the system components outside their specified operating and storage conditions (see “General Specifications” section of this manual).  All system components can be cleaned of surface debris as necessary by wiping with a soft cloth dampened with clean water. WARNING: Do not perform any cleaning or maintenance while the equipment is in use. Ensure components are powered off prior to following any of the cleaning instructions in this section. DOCK Cleaning & Maintenance Cleaning the DOCK can be performed as necessary to remove surface debris and prevent obstruction of the STIM CRADLE and HMS CRADLE. If there is noticeable dirt, dust or other substance accumulating on the surface or within either of the STIM or HMS cradles, perform the following: 1. Unplug the DOCK. 2. Wipe the DOCK’s outer surfaces with a soft cloth dampened with clean water. 3. Use compressed air to dislodge any obstructions from the STIM and HMS cradles. STIM and HMS Cleaning & Maintenance The STIM and HMS can be cleaned, as needed, by simply wiping with a soft cloth dampened with clean, warm water. If low-level disinfecting is required, such as in clinical settings, the STIM and HMS can be wiped with a cloth soaked with 70% isopropyl alcohol (IPA) solution. Continue to wipe as necessary to ensure all surfaces are kept wet with the solution for at least three (3) minutes. WARNING: Do not immerse the STIM or HMS in water or any other liquid. Doing so can permanently damage the electronics. When not in use, it is recommended that the STIM and HMS be stored in the DOCK. This will prolong the battery life, and ensure that the STIM and HMS are fully charged when next used.
40 ELECTRODES Cleaning & Maintenance Between uses, ELECTRODES can be maintained as follows: 1. Disconnect ELECTRODES from the GARMENT. 2. Rinse ELECTRODES with clean water. 3. Squeeze out excess water, and allow ELECTRODES to air-dry. 4. When not in use, store the ELECTRODES in a dry, ventilated area. CAUTION: Do not use soaps, detergents, or other chemical cleaners on the ELECTRODES. Doing so may cause skin-irritation, or affect stimulation. CAUTION: Do not store ELECTRODES wet. Allow the ELECTRODES to fully air-dry prior to storing. The ELECTRODES are intended to be replaced regularly to prevent bacterial or other buildup, or degradation of materials. ELECTRODES should be replaced in either of the following cases: 1. If there is significant discoloration, bad odors, or any noticeable separation of materials; or, 2. After two (2) weeks of daily use. CAUTION: Inspect ELECTRODES prior to use. Damaged or dirty electrodes will affect stimulation efficacy, and hence should be replaced regularly. For re-ordering information see “Contact & Reordering Information” at the end of this manual.
41 GARMENT Cleaning & Maintenance The GARMENT can be washed by hand as necessary in a solution of mild laundry detergent and warm water. 1. Remove the STIM from the GARMENT. 2. Remove all ELECTRODES from the GARMENT. 3. Fill a sink or medium-sized basin with clean warm water and a small amount of mild, unscented laundry detergent. 4. Submerse the GARMENT in the soapy water and gently agitate by hand for 2 to 5 minutes. 5. Rinse the GARMENT under running warm water, and lightly squeeze - but do not twist or wring - until there is no sign of residual detergent. 6. Lightly squeeze out any excess water and dab-dry using a clean towel. 7. Hang the GARMENT on a clothes-line or drying rack, and allow time to air-dry. CAUTION: Do not use bleach, fabric-softener, or any other products. CAUTION: Handle the GARMENT with care. Do not twist, wring the GARMENT. CAUTION: Air-dry only. Do not tumble-dry or hot-air dry the GARMENT. The GARMENT is intended to be replaced regularly, as the fabrics and electronics are subject to wear. The GARMENT should be replaced in either of the following cases: 1. If there noticeable damage to materials; or, 2. After eight (8) weeks of daily use. For re-ordering information see “Contact & Reordering Information” at the end of this manual.
42 Disposal Information Rehabtronics Inc. considers the environment in all aspects of the product lifecycle, from design and engineering to packaging and recycling. We recommend that customers dispose of their used Hand Stimulator components in an environmentally sound manner. It is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment. The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your waste equipment for recycling, please contact your local city office, your household waste disposal service or the shop where you purchased the product. CAUTION: Do not dispose of electronic components with normal household waste. Contact your local waste-management services for information on how to best dispose of electronic equipment.
43 Troubleshooting Physical Reactions Pain or Discomfort If used as directed, the Hand Stimulator should not cause any pain. Mild discomfort may occur during use of the Hand Stimulator system. In most cases, however, such discomfort is easily remedied. The following table describes possible sources of discomfort, and the appropriate actions to take: Source of Discomfort Recommended Action Increase in sensitivity to stimulation over time Decrease stimulation intensities to comfortable levels. If discomfort persists, discontinue use and consult your healthcare professional. Change in arm physiology over time (e.g. weight change, change in muscle mass…) If the arm’s physical characteristics change, stimulation intensities and electrode positions will have to be adjusted to compensate. Refer to the instructions in this manual for configuring stimulation intensities and electrode placements. Fatigue or soreness following prolonged use Discontinue use until symptoms have cleared. If symptoms do not dissipate within a day of ceasing use, consult your healthcare professional. IMPORTANT: Use of the Hand Stimulator is intended to be directed or supervised by a healthcare professional. WARNING: If persistent pain is experienced, discontinue use immediately and contact your healthcare professional. Allergic Reactions All the Hand Stimulator materials have been selected and tested to ensure they are biocompatible, hypoallergenic, and free of any toxic substances. All system components are constructed from materials commonly used in medical devices such as polyester, cotton, silicone, and ABS/PC plastic to ensure freedom from allergic reactions. Nevertheless, if allergic reaction to materials is suspected, discontinue use immediately and contact your healthcare professional. Skin Irritation Some reddening and indentation of the skin under electrodes is normal following a period of use, and further mild skin irritation may be experienced depending on factors such as the environment, duration of use, and patient skin-sensitivity. The following guidance should be followed to mitigate possible skin irritation:  Limit wearing the GARMENT to a maximum of 4 hours a day.  Periodically remove the GARMENT when not stimulating to allow the skin time to ventilate uncovered.  If any sort of skin irritation develops, discontinue use until the symptoms have cleared.
44  If irritation does not clear within an hour of removing the GARMENT, contact your healthcare professional. WARNING: If persistent skin irritation is experienced that does not clear within an hour of removing the GARMENT, discontinue use and contact your healthcare professional. Device Use Troubleshooting General Troubleshooting Issue Recommended Action(s) Device performance issues or unanticipated behavior. Discontinue use and contact customer support. (see “Contact and Reordering Information” at the end of this manual) STIM Error Messages The following table lists possible error messages that may appear on the STIM’s DISPLAY, and the recommended actions to take: DISPLAY Message Potential Cause(s) Recommended Action(s) A red X and a number - An internal hardware diagnostic test has failed Recharge the STIM and HMS in the DOCK. If the same error screen persists, take note of the number displayed and contact Rehabtronics support (see “Contact and Reordering Information” at the end of this manual). “Check Electrodes” Or “Impedance Error” - ELECTRODES are not making good contact with the skin - ELECTRODES are not sufficiently wet - ELECTRODES are not properly snapped into the GARMENT Check that all ELECTRODES are sufficiently wet and pressed against the skin. Reattach the ELECTRODES to the GARMENT, ensuring that they are securely snapped to the sockets. “Put Stim in Garment” - STIM is not in GARMENT - STIM has been dislodged from the GARMENT Check that the STIM is firmly pushed into the GARMENT’s STIM HOLDER.
45 Technical Information General Specifications Environmental Specifications Operating Conditions Temperature: +5 °C to +40 °C. Relative Humidity: 15% to 93% (non-condensing) Pressure: 70 kPa to 106 kPa Storage Conditions Temperature: +15°C to +25 °C. Relative Humidity: < 50% (non-condensing) Pressure: 70 kPa to 106 kPa Transport Conditions (up to 48 hours) Temperature: -25 °C to +70 °C Relative Humidity: 5% to 100% (non-condensing) Pressure: 70 kPa to 106 kPa Electrical Component Specifications System Component DOCK STIM HMS Model Number HSDK1 HSST1 HSHM1 Equipment Usage & Type Non Transit-Operable Portable Equipment Class II ME Equipment Transit-Operable Body-Worn Equipment Transit-Operable Body-Worn Equipment Mode of Operation Continuous Continuous Continuous Applied Part Type N/A BF Applied Part BF Applied Part Means of Supply Mains Isolation Direct plug-in adaptor N/A (battery-powered) N/A (battery powered) Power Specifications Mains Powered AC Input: 100 – 240 VAC, 0.5 - 0.3A, 50 – 60 Hz DC Output: 6 VDC, 2.5A MAX Internally Powered 3.7V, 310 - 330 mAh Rechargeable Lithium Ion Battery Internally Powered 3.7V, 45 - 55 mAh Rechargeable Lithium Ion Battery
46 Stimulation Specifications The following table provides technical details of the stimulation pulses delivered by the Hand Stimulator system: Stimulation Characteristic Hand Stimulator Specification Waveform Phase Asymmetrical, Biphasic Waveform Shape Rectangular Maximum Output Voltage (±10%) 20V @ 500 Ω 80V @ 2 kΩ 150V @ 10 kΩ Maximum Output Current (±10%) 40 mA @ 500 Ω 40 mA @ 2 kΩ 0mA @ 10 kΩ (fault state) Pulse Width 250 µsec (primary), 500 µsec (secondary) Pulse Duration 750 µsec Pulse Frequency 30-31 Hz Maximum Current Density (across smallest electrode) 1.74 mA/cm2 r.m.s @ 500 Ω Maximum Power Density (across smallest electrode) 5.24 mW/cm2 @ 500 Ω
47 Wireless Specifications The following table details the wireless specifications for the STIM and HMS: Operating Frequency Range 2403 – 2481 MHz Operating Frequencies Uses 3 randomly-selected frequencies assigned to each unit Data Rate 1 Mbps Maximum Transmit Power 4 dBm Modulation Scheme GFSK Modulating Signal Type Binary Data Modulation Baud Rate 1 MHz Modulation Bandwidth 160 kHz deviation around the carrier Receiver Bandwidth 160 kHz around the selected frequency RF Frequency Channels 79 Channels Channel Spacing Minimum 20 MHz, Maximum 25 MHz Antenna Type Antenova; -1.9 dBi Average Gain; 0.8 dBi Peak Gain Transceiver Duplex Scheme Time Division Duplexing Bit Error Rate Less than 0.1% Packet Error Rate Less than 5% Receiver Sensitivity -86 dBm at 0.1% Bit Error Rate Command Delay Maximum 1 Second Transmitter Duty Cycle Less than 0.05% Operating Range Up to 5 meters This device complies with Part 15 of FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of this device. Changes or modifications to this equipment not expressly approved by Rehabtronics Inc. could void the user’s authority to operate the equipment. NOTE: The Federal Aviation Administration rules require that all radio-transmitting devices be turned off during flight. This device complies with the Canadian Interference-Causing Equipment Standard #3 (ICES-003). This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
48 Electromagnetic Compatibility WARNING: The Hand Stimulator System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used. WARNING: Use of any system components other than those specified or supplied by Rehabtronics Inc. may result in increased emissions or decreased immunity of the equipment, and may cause the system to be non-compliant with the electromagnetic compatibility requirements of IEC 60601-1-2:2007. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Hand Stimulator System and all its system components are intended for use in the electromagnetic environment specified below. The customer or the user of the Hand Stimulator System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions CISPR 11 Group 1 The equipment uses 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 11 Class B The equipment is 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 61000-3-2 Class A Voltage Fluctuations / Flicker Emissions IEC 61000-3-3 Complies Recommended separation distances between portable and mobile RF communications equipment and the Hand Stimulator System The Hand Stimulator System and all its system components are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Hand Stimulator System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the components of the Hand Stimulator System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.12 0.12 0.24 0.1 0.37 0.37 0.74 1 1.17 1.17 2.34 10 3.69 3.69 7.38
49 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Hand Stimulator System and all its system components are intended for use in the electromagnetic environment specified below. The customer or the user of the Hand Stimulator System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors 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 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines Test N/A for input/output lines Mains power quality should be that of a typical commercial/residential or hospital environment. Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth ±1 kV line(s) to line(s) ±2 kV line(s) to earth Mains power quality should be that of a typical commercial/residential or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 UT = 240 Vac, 120Vac <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial/residential or hospital environment. If the user of the equipment requires continued operation during power mains interruptions, it is recommended that the equipment be powered from an uninterruptible power supply or a battery. Power frequency magnetic field (50 Hz/60Hz) IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial/residential or hospital environment.
50 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Hand Stimulator System and all its system components are intended for use in the electromagnetic environment specified below. The customer or the user of the Hand Stimulator System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of known RF transmitting devices and equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
51 Contact & Reordering Information For device support, or to reorder components, contact Rehabtronics Inc. via any of the following channels: Web: www.rehabtronics.com Email: support@rehabtronics.com Phone: 1-866-896-727 Mailing Address: Rehabtronics Inc. #4352, 10230 Jasper Avenue Edmonton, Alberta, Canada T5J 4P6 If reordering components, please refer to the model (REF) number as indicated in the table below, or on the component labels: System Component Re-Ordering System Component Model (REF) / Re-order Number Recommended Re-order Interval (component service life) Dock HSDK1 4 years Stim HSST1 4 years HMS HSHM1 4 years Electrode Set HSE1 2 weeks Garment (small) HSGS1 8 weeks Garment (medium) HSGM1 8 weeks Garment (large) HSGL1 8 weeks Rehabtronics Inc. declares that the CE marked device is in compliance with the applicable essential requirements of the Council Directive 93/42/EEC. For device feedback within the European Economic Community, use the following contact information: For inquires or re-ordering outside North-America or Europe, contact your local Hand Stimulator distributor. For health-related concerns, contact your health care professional.

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