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Bioness H200 Wireless User Manual

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Summary of Contents for Bioness H200 Wireless

  • Page 1 User’s Guide...
  • Page 2 Email: international@nl.bioness.com Website: www.bioness.com Rx Only (US Only) H200 Wireless, Bioness, the Bioness Logo and LiveOn are trademarks of Bioness Inc. ® ® ® in the United States or other countries. | www.bioness.com ©2018 Bioness Inc. 612-00964-001 Rev. A 03/2018...
  • Page 4 Bioness web site at: https://www.bioness.com/Patents.php Disclaimer Bioness Inc. and its affiliates shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc. products. Bioness Inc.

  • Page 5: List Of Symbols

    List of Symbols Caution Warning Double Insulated (Equivalent to Class II of IEC 536) Type BF Applied Part(s) Non-Ionizing Radiation Date of Manufacture Manufacturer This Product Must Not Be Disposed of with Other Household Waste Refer to Instruction Manual/ Booklet Re-Order Number Lot Number Serial Number...

  • Page 6: Table Of Contents

    Radio Frequency (RF) Communication ............. 11 Travel and Airport Security ................12 Electromagnetic Compatibility ................13 Warnings and Cautions ................13 Chapter 4: H200 Wireless System Kit ..........15 Contents ......................15 Chapter 5: H200 Wireless Orthosis ............19 Flexor Support ....................20 Extensor Wing ....................
  • Page 7 Preparing Your Skin ................... 50 Wetting/Attaching the Cloth Electrodes ............. 51 Putting on the Orthosis ..................53 Chapter 9: Operating the H200 Wireless System ....... 59 RF Communication Features ................59 Turning On the System ..................59 Turning Off the System ..................59 Testing Stimulation in the Orthosis ..............
  • Page 8 Chapter 10: Removing the Orthosis ............ 67 Chapter 11: Maintenance and Cleaning ..........69 Daily Maintenance and Storage ................ 69 Charging ......................69 Battery Replacement: H200 Wireless Control Unit ..........69 Battery Replacement: H200 Wireless Orthosis ..........71 Cleaning ......................71 Disinfecting ......................72 Chapter 12: Electronic Registration of Replacement Parts....
  • Page 9 User's Guide...

  • Page 10: Chapter 1: Introduction

    The H200 Wireless System delivers electrical stimulation to the nerves of the muscles that control the hand. The H200 Wireless System may help to improve hand function and assist with tasks of daily living.
  • Page 11 • Start, stop, and pause a stimulation program. • Communicate Control Unit battery status, RF communication errors, and Control Unit hardware/software malfunctions. Caution: Do not put on or operate the H200 Wireless System before being properly fitted by a trained clinician. User's Guide...

  • Page 12: Chapter 2: Safety Information

    • Reduction of muscle spasm. • Re-education of muscles. Contraindications • Do not use the H200 Wireless System where a cancerous lesion is present or suspected. • Do not use the H200 Wireless System if you have a cardiac pacemaker, implanted defibrillator, or implanted metallic device in the forearm or hand intended for the H200 Wireless use.

  • Page 13: Warnings

    Warnings • The H200 Wireless Orthosis is to be worn only on the affected forearm and hand of the patient for whom it is fitted. It should not be worn by anyone else or on any other part of the body.

  • Page 14: Precautions

    (bradycardia). • Use caution if you have suspected or diagnosed epilepsy. • Talk to your doctor before using the H200 Wireless System if you have any one of the following medical conditions in the affected arm: •...
  • Page 15 Orthosis. Do not turn on the H200 Wireless System until the Orthosis is on the arm and the wing is closed. • Turn off the H200 Wireless System when at a refueling place. Do not use the H200 Wireless System near flammable fuel, fumes, or chemicals.
  • Page 16 • Do not use the H200 Wireless System without the cloth electrodes. • Be sure the H200 Wireless cloth electrodes are wet and securely attached to the electrode bases before use. • Wet the H200 Wireless cloth electrodes before use and after every three to four hours of use.
  • Page 17 User's Guide...

  • Page 18: Chapter 3: Environmental Conditions That Affect Use

    The antenna for each transmitter must not be near to or operating in conjunction with any other antenna or transmitter. Portable and mobile RF communications equipment can affect the H200 Wireless System. Chapter 3 - Environmental Conditions that Affect Use...

  • Page 19: Travel And Airport Security

    System. The H200 Wireless System will likely set off the security alarm. Be prepared to remove the H200 Wireless System so that security can scan it, or ask for the system to be scanned if you do not want to remove it. You may want to carry a copy of your H200 Wireless System prescription.

  • Page 20: Electromagnetic Compatibility

    (EMC) in accordance with International Electrotechnical Committee (IEC) 60601-1-2. The tables in the Appendix provide information regarding the EMC testing and guidance for safe use of the system. The H200 Wireless System should be configured and used in accordance with the instructions provided in this guide.
  • Page 21 CISPR (International Special Committee on Radio Interference, International Electrotechnical Commission) emission requirements. • Do not use the H200 Wireless System within three feet of short wave or microwave therapy equipment. Such equipment may produce instability in the stimulation output by the Orthosis.

  • Page 22: Chapter 4: H200 Wireless System Kit

    • H200 Wireless Cloth Electrodes • Cloth Electrode Mesh Bag • H200 Wireless FPL Panel • Large Thenar • Wrist Inserts • H200 Wireless User's Guide System Charger Set • User's Reference Card H200 Wireless Orthosis Chapter 4 - H200 Wireless System Kit...
  • Page 23 Regular H200 Wireless Cloth Large Electrodes Control Unit Neck Strap Control Unit Wrist Strap Control Unit Belt Pouch Orthosis Wrist Strap Wrist Insert Large Thenar H200 Wireless Cloth Electrode FPL Panel Mesh Bag User's Guide...
  • Page 24 H200 Wireless Orthosis The H200 Wireless Orthosis is available in right and left configurations, and in three sizes: small, medium, and large. H200 Wireless Control Unit The H200 Wireless Control Unit communicates wirelessly with the Orthosis to control the Orthosis and monitor system status.
  • Page 25 User's Guide...

  • Page 26: Chapter 5: H200 Wireless Orthosis

    Chapter H200 Wireless Orthosis The H200 Wireless Orthosis generates the electrical stimulation used to open and close your hand and move your thumb. The Orthosis has an integrated radio frequency stimulation unit and five stimulating electrodes. The electrodes have been predetermined by your clinician and configured with fitting panels.

  • Page 27: Flexor Support

    The H200 Wireless Orthosis features: (See Figure 5-2) • A flexor support • An extensor wing • A spiral end • A status light • A stimulation light • Audio alerts • A rechargeable battery and charging port Extensor Wing...
  • Page 28 Orthosis flexor support. The FPL panel fills excess space in the region of the #5 electrode base. See Figure 5-4. FPL Panel Electrode Base #5 Figure 5-4: Orthosis Flexor Support with an FPL Panel Chapter 5 - H200 Wireless Orthosis...

  • Page 29: Extensor Wing

    Extensor Wing The extensor wing delivers electrical stimulation to the nerves of the muscles that extend your hand. The extensor wing features: (See Figure 5-5) • Two electrode bases: #1 and #2 • A wing release handle • A wing arm Extensor Wing Wing Arm Electrode Base #1...

  • Page 30: Wing Arm

    The wing arm is used to close the extensor wing. See Figure 5-7. When the wing arm is pushed down, the extensor wing clicks. The extensor wing is sufficiently closed when no more clicking can be heard. Extensor Wing Arm Wing Figure 5-7: Orthosis Wing Arm Chapter 5 - H200 Wireless Orthosis...

  • Page 31: Fitting Panels

    Fitting Panels If your fitting panels detach from your Orthosis, please follow the directions below on how to reattach the fitting panels. Extensor Fitting Panel 1. With the Orthosis wing open, align the extensor fitting panel to the extensor wing. See Figure 5-8. 2.

  • Page 32: Spiral End Of The Orthosis

    The spiral end features: (See Figure 5-10) • A thenar • A wrist bridge • A trigger button • An Orthosis wrist strap attachment ring • An Orthosis wrist strap attachment bar Chapter 5 - H200 Wireless Orthosis...

  • Page 33: Thenar

    The snap on the thenar is for the cloth electrode placement. When the Orthosis is positioned correctly, the thenar cloth electrode should rest at the base of your thumb. See Figure 5-11. CAUTION: Do not operate the H200 Wireless System without a thenar cloth electrode in place. Trigger Button...

  • Page 34: Trigger Button

    The wrist strap attachment ring is for hooking the wrist strap to the Orthosis. See Figure 5-10. Wrist Strap Attachment Bar The wrist strap attachment bar is for securing the Orthosis wrist strap around the wrist. See Figure 5-12. Chapter 5 - H200 Wireless Orthosis...

  • Page 35: Status Light

    Orthosis Wrist Strap Attachment Bar Wrist Strap Figure 5-12: Wrist Strap Attachment Bar Status Light The status light communicates system status and error messages. See Table 5-1. Stimulation Light The stimulation light communicates whether stimulation is on, off, or paused. See Table 5-1.

  • Page 36: Audio Alerts

    Table 5-1: H200 Wireless Orthosis Displays Audio Alerts The Orthosis will beep when: • The H200 Wireless System is turned on/off • The Orthosis stimulation unit malfunctions • Stimulation is turned on/off or paused Chapter 5 - H200 Wireless Orthosis...

  • Page 37: Rechargeable Battery And Charging Port

    Orthosis. See Figure 5-13. Charging Port Figure 5-13: H200 Wireless Orthosis Charging Port Note: While charging please make sure the orthosis is not lying on it's side, causing the trigger button to be pressed continuously. This will cause the system to reset and turn off.

  • Page 38: Chapter 6: H200 Wireless Control Unit

    Chapter H200 Wireless Control Unit The Control Unit is used to: • Turn on/off the H200 Wireless System • Test stimulation in the Orthosis • Select a stimulation program • Turn on/off or pause stimulation • Adjust the stimulation intensity level •...
  • Page 39 Mute Button Wireless Orthosis Audio Alerts Top: Select Program 1 Program Selection Buttons Bottom: Select Program 2 Stimulation Test Test Stimulation in the H200 Wireless Orthosis Button Table 6-1: Control Unit Operating Button Functions Visual Description Definition Display On/Off Button Flashes Green...

  • Page 40: Indicators And Digital Display

    Figure 6-2: Control Unit Digital Display and Indicators. The Control Unit indicators show: (See Table 6-3) • Control Unit status • Stimulation program selected • Control Unit low battery • RF communication status Chapter 6 - H200 Wireless Control Unit...
  • Page 41 Indicator Description Definition Control Unit Status Indicator Control Unit Low Battery Flashes Yellow Control Unit Charging Error; Control Unit Status Indicator is Electronic Registration Error; Control Steady Red Unit Hardware/Software Error Program 1 Indicator is Green Program 1 Selected Program 2 Indicator is Green Program 2 Selected RF Communication Indicator RF Communication Error...

  • Page 42: Audio Alerts

    Control Unit Fully Charged Table 6-4: Control Unit Digital Displays Audio Alerts The H200 Wireless Control Unit beeps to indicate: • Electronic registration was initiated, successful, or unsuccessful. • The H200 Wireless System was turned on/off. • A program has ended and stimulation has stopped.

  • Page 43: Charging Port

    Charging Port The Control Unit is powered by a single rechargeable NiMH AAA battery. CAUTION: Use only a battery supplied by Bioness Inc. The Control Unit charging port is located at the bottom of the Control Unit, under the flexible cover. See Figure 6-3.

  • Page 44: Chapter 7: H200 Wireless Stimulation Programs

    Chapter H200 Wireless Stimulation Programs The H200 Wireless System supports Functional Training, Neuroprosthesis, and Motor Neuromodulation programs designed to open and close the hand. Functional Training programs are designed to exercise your hand. They consist of repetitive opening and/or closing motions with a relaxation pause between each motion.
  • Page 45 User's Guide...

  • Page 46: Chapter 8: Setup Instructions

    Setup Instructions Charging the H200 Wireless System It is important to charge your H200 Wireless System daily and for at least four hours before a fitting/programming session. Bioness recommends charging the Control Unit and the Orthosis at the same time.
  • Page 47 6. If the Orthosis is charging, the status light on the Orthosis will alternately flash yellow and green . See Table 8-2. Caution: Use only the charger included in your H200 Wireless System Kit. Use of any other charger could damage the system. User's Guide...
  • Page 48 Battery Charging Display Horizontal Green Line in Digital Battery Fully Charged Display Status Light is a Steady Red Charging Error Table 8-1: H200 Wireless Control Unit Charging Displays Orthosis Display Description Definition Status Light Alternately Flashes Battery Charging Yellow and Green...

  • Page 49: Checking The System Components

    • Make sure your Orthosis and Control Unit are charged. Do not use your H200 Wireless System if a component appears to be damaged. If you have any questions about your H200 Wireless System, contact the Bioness Client Relations Department at 800.211.9136, Option 3 (in the United States) or...

  • Page 50: Wetting/Attaching The Cloth Electrodes

    H200 Wireless System. For optimal stimulation, the skin under the Orthosis should be clean and healthy.To prepare the skin: 1. Remove any jewelry from your hand, wrist, and forearm. 2. Clean the skin where the cloth electrodes will touch with a wet washcloth. If any lotions are on the skin, clean the skin with soap and water.
  • Page 51 5. Match each cloth electrode to its corresponding electrode base. See Figure 8-5. Electrodes Base #1 Electrode Base #2 Electrode Base #3 (Thenar) Electrode Electrode Base #4 Base #5 Figure 8-5: Electrode Bases #1- #5 6. Snap cloth electrode #3 to the thenar. Note: The #3 large cloth electrode is for large thenars only.

  • Page 52: Putting On The Orthosis

    Caution: Use only cloth electrodes supplied by Bioness Inc. Caution: The cloth electrodes are to be used by no more than one individual patient. They are for single patient use only.
  • Page 53 To put on the Orthosis: 1. Position the Orthosis on a stable surface, and place your hand in the spiral end of the Orthosis. The Thenar (with attached Thenar Cloth Electrode) should rest at the base of your thumb. See Figure 8-7. Thenar Figure 8-7: Positioning the Thenar 2.
  • Page 54 3. Place your forearm in the Orthosis Flexor Support. See Figure 8-9. Flexor Support Figure 8-9: Positioning the Flexor Support 4. Place your hand on top of the Wing Arm and grasp under the Extensor Wing with your fingers. 5. Pull the Extensor Wing out while pushing down on the Wing Arm. See Figure 8-10.
  • Page 55 6. Attach the hook on the Orthosis Wrist Strap to the Wrist Strap Attachment Ring. See Figure 8-11. Wrist Strap Wrist Strap Attachment Hook Ring Figure 8-11: Attaching the Wrist Strap Hook 7. Bring the Wrist Strap under the wrist. Make sure the cushion on the Wrist Strap is touching the wrist.
  • Page 56 9. Bring the Wrist Strap over the Attachment Bar and press to fasten. Warning: Do not turn on stimulation until your Orthosis is completely set up and correctly attached to your arm. Caution: Do not wear the Orthosis without the cloth electrodes. Caution: Do not pull down on the Wrist Strap.
  • Page 57 User's Guide...

  • Page 58: Chapter 9: Operating The H200 Wireless System

    Testing Stimulation in the Orthosis The stimulation test button is for testing whether the Orthosis is positioned correctly on the arm. The button is located on the side of the Control Unit. See Figure 9-1. Chapter 9 - Operating the H200 Wireless System...
  • Page 59 On/Off Button Mute Button Trigger Button Program 1 Button Program 2 Button Intensity Adjustment Stimulation Test Buttons Button Figure 9-1: Control Unit Operating Buttons To test stimulation in the Orthosis: 1. Make sure the system is in standby mode. The trigger button should not be lit.

  • Page 60: Selecting A Stimulation Program

    Control Unit or the trigger button on the Orthosis. • The Control Unit will beep. • The Control Unit trigger button will flash yellow. • The Orthosis stimulation light will flash yellow rapidly. Chapter 9 - Operating the H200 Wireless System...

  • Page 61: Pausing/Resuming Stimulation

    Note: Some of the programs contain rest periods. A rest period will last for at least one minute. During a rest period, stimulation will turn off and the Orthosis stimulation light will flash yellow slowly. The Control Unit trigger button will continue to flash yellow. Pausing/Resuming Stimulation Functional Training and Motor Neuromodulation Programs may be programmed to run from 5 minutes to 120 minutes, as determined by your clinician.

  • Page 62: Open Hand

    Orthosis, to start stimulation. Your fingers will close and your thumb will open. There should be a gap between your thumb and the side of your index finger. Chapter 9 - Operating the H200 Wireless System...

  • Page 63: Stopping Stimulation

    2. While your fingers and thumb are in this position, place the object you want to grip into the gap. 3. After several seconds, your fingers and thumb will close around the object. 4. When you are ready to release the object, press the Control Unit trigger button or the trigger button on the Orthosis a second time.

  • Page 64: Muting/Unmuting The System Audio Alerts

    Types of Audio Alerts Muting Allowed Faulty electrode contact Changes in software state Power supply detected Charging error Software/Hardware error Battery depletion threshold reached Orthosis electronic registration successful/unsuccessful Table 9-1: Types of Audio Alerts Chapter 9 - Operating the H200 Wireless System...
  • Page 65 User's Guide...

  • Page 66: Chapter 10: Removing The Orthosis

    Removing the Orthosis To remove the Orthosis: 1. Press the Control Unit On/Off button to turn off the H200 Wireless System. 2. Carefully unfasten the Wrist Strap and slide it away from the Wrist Strap Attachment Bar. See Figure 10-1.
  • Page 67 Wing Arm Wing Release Handle Figure 10-2: Opening the Extensor Wing Flexor Support Figure 10-3: Removing the Flexor Support User's Guide...

  • Page 68: Chapter 11: Maintenance And Cleaning

    Chapter Maintenance and Cleaning Daily Maintenance and Storage 1. Store the H200 Wireless cloth electrodes in the cloth electrode mesh bag or where they can air dry. 2. Check the system components for signs of wear and damage. 3. Replace any components that appear old, worn, or damaged. Contact the Bioness Client Relations Department 800.211.9136, Option 3 (in the United...
  • Page 69 Figure 11-1: Replacing the Control Unit Battery Caution: Use only a battery supplied by Bioness Inc. Caution: Use of a non-rechargeable AAA battery can damage the H200 Wireless Control Unit. Remove the old battery, and properly dispose of it according to your local environmental regulations.

  • Page 70: Battery Replacement: H200 Wireless Orthosis

    (outside of the United States). Cleaning General Instructions All H200 Wireless System Kit components may be cleaned as needed or weekly by carefully wiping them with a damp cloth. Use water. Do not use detergents or other cleaning agents, unless otherwise specified below.

  • Page 71: Disinfecting

    3. As needed, use additional saturated disinfectant wipes or cloths to keep the components surface wet for 3 minutes. Note: Be sure to follow the Bioness instructions for the specified contact time to ensure an effective bacteria kill. Orthosis...
  • Page 72 (in the United States) or your local distributor (outside of the United States). System Kit Carrying Case The H200 Wireless System Kit carrying case may be cleaned and low-level disinfected using CaviCide (if available) or 70% isopropyl alcohol (IPA) per the following ®...
  • Page 73 Note: Be sure to follow the Bioness instructions for the specified contact time to ensure an effective bacteria kill. Note: Do not use other cleaning/disinfecting agents such as a diluted bleach mixture, or other disinfecting wipes. Bioness has not tested these products' effectiveness on the H200 Wireless components.

  • Page 74: Chapter 12: Electronic Registration Of Replacement Parts

    This section describes the steps to electronically register a replacement Control Unit or Orthosis. Note: When registering a replacement component, make certain that there are no other H200 Wireless systems within 3 meters (10 feet) of the components being registered. Registration Setup 1.
  • Page 75 3. If necessary, connect the components to the System Charger set, and plug the System Charger into a power outlet. 4. Locate the System ID Number (for example, A334) on the existing system component. The System ID Number is on the back of the Control Unit and under the extensor wing of the Orthosis.
  • Page 76 Note: Components can only be successfully registered once. Additional attempts will generate an error indication. 6. After registration is complete, turn on your H200 Wireless System. If the Control Unit is registered to the Orthosis, the Orthosis will turn on.
  • Page 77 User's Guide...

  • Page 78: Chapter 13: Troubleshooting

    • Change the cloth electrodes. • Contact the Bioness or your local distributor. Frequently Asked Questions When charging the H200 Wireless System, how will I know when the batteries are fully charged? • When the Control Unit is fully charged, a green horizontal line will appear in the Control Unit digital display.
  • Page 79 • A charging error has occurred. Reconnect the System Charger Y cable. If the problem persists, contact Bioness or your local distributor. When I turn on the H200 Wireless Control Unit, it beeps and the RF communication indicator flashes red. The status light and stimulation light on the Orthosis are not lit.
  • Page 80 Control Unit hardware or software malfunction has occurred. • Turn off the Control Unit and turn it back on. • If the problem persists, stop using the system and contact Bioness or your local distributor. Chapter 13 - Troubleshooting...
  • Page 81 My hand is not moving satisfactorily, and the H200 Wireless System is not indicating any errors. The Orthosis may not be positioned correctly. • Turn off the Control Unit. • Make sure the cloth electrodes are wet and your hand/arm are clean.
  • Page 82 Control Unit. Then press the trigger button on the Orthosis, to start the registration process. After I fully charged the H200 Wireless System, I disconnected the System Charger and then immediately reconnected it. The charging indications appeared again on the Control Unit and Orthosis. Are the components fully charged or do I need to repeat the charging process? •...

  • Page 83: Quick Reference Troubleshooting

    Quick Reference Troubleshooting Control Unit Description Definition Control Unit Status Indicator Low Battery, H200 Wireless Control Flashes Yellow Unit Control Unit Charging Error; Control Unit Status Indicator Electronic Registration Error; Control is a Steady Red Unit Hardware/Software Error Program 1 Indicator is Green...
  • Page 84 Control Unit Description Definition Letter "U" Control Unit Unregistered Rotating Green Circle Control Unit Charging Horizontal Green Line Control Unit Fully Charged Left Orthosis Display Description Definition Flashes Green System On Flashes Yellow Low Battery Alternately Flashes Battery Charging Status Light Yellow and Green Battery Fully Charged;...
  • Page 85 User's Guide...

  • Page 86: Chapter 14: Technical Specifications

    • Mute button to mute audio alerts • Program selection buttons (1, 2) • Stimulation test button • Four status icons: H200 Wireless Control Unit, RF Communication Status, Selected Program (1, 2) • Digital display designates relative stimulation intensity Indications •...
  • Page 87 Operating 3.7 V Voltage Battery Type Proprietary rechargeable Li-Ion (Lithium Ion) 3.7 V, 280–350 mAh • H200 Wireless Orthosis status (fault, battery, charging) and Stimulation LEDs Indications • “Beeps” for audio alerts • Main body cover: Rilsan BZM 30 OTL •...
  • Page 88 300 grams 300 grams 300 grams Weight (10.58 oz.) (10.58 oz.) (10.58 oz.) H200 Wireless Orthosis Pulse Parameters Pulse Balanced Biphasic Waveform Symmetric Intensity (Peak) 0–80 mA, 1-mA resolution (positive phase) • Electrodes #1, #2, #3, #5: 13.1 mA rms...
  • Page 89 Voltage 5 V ± 5% Current 2400 mA Note: The H200 Wireless Control Unit and Orthosis can be used while charging if the Control Unit is not connected to the Clinician's Programmer. H200 Wireless Cloth Electrode Specifications Non-woven cloth Material Note: Use only cloth electrodes provided by Bioness Inc.
  • Page 90 Wireless Technology Description Wireless Link Specifications Frequency Band 2.4 GHz, ISM band Complies with FCC 15.247 (for U.S.) Transmission Power regulations/ETSI EN300-440 (For Europe) regulations. Transmitters Operating Frequency Band 2401–2482 MHz Type of Modulation Type of Modulating Signal Binary data message Data Rate [=Frequency of 250 Kbps Modulating Signal]...
  • Page 91 Wireless Technology Characteristics RF Frequency Channels 83 channels Channel Spacing 25 MHz. Antenna Type Integral, max gain: +1dBi. No antenna connector. Transceiver Duplexing Scheme Frequency Synthesizer <1 msec Setting Time Error Detection Probability A miss detection rate of the CRC-16 is about 1.2 x 10 .

  • Page 92: Chapter 15: Appendix - Emi Tables

    Guidance and Manufacturer’s Declaration Electromagnetic Emissions The H200 Wireless System is intended for use in the electromagnetic environment specified below. The customer or the user of the H200 Wireless System should assure that it is used in such an environment.
  • Page 93 Guidance and Manufacturer’s Declaration— Electromagnetic Immunity for All Equipment and Systems The H200 Wireless System is intended for use in the electromagnetic environment specified below. The customer or the user of the H200 Wireless System should assure that it is used in such an environment. Immunity Test...
  • Page 94 Immunity Test IEC 60601 Test Compliance Level Electromagnetic Level Environment— Guidance Voltage dips, short <5% U (>95% dip <5% U (>95% dip Mains power interruptions and in U ) for 0.5 cycle in U ) for 0.5 cycle quality should be voltage variations that of a typical on power supply...
  • Page 95 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The H200 Wireless System is intended for use in the electromagnetic environment specified below. The customer or the user of the H200 Wireless System should assure that it is used in such an environment. Immunity...
  • Page 96 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 H200 Wireless System is used exceeds the applicable RF compliance level above, the H200 Wireless System should be observed to verify normal operation.
  • Page 97 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the H200 Wireless System The H200 Wireless System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the...

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