CYMEDICA Orthopedics IntelliHab User Manual
  1. Manuals
  2. Brands
  3. CYMEDICA Orthopedics Manuals
  4. Medical Equipment
  5. IntelliHab
  6. User manual

CYMEDICA Orthopedics IntelliHab User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
CyMedica Orthopedics®
IntelliHab™ System
User's Manual
Read this manual carefully before operating the IntelliHab System
Customer Service
1-844-CYM-2014
Please visit www.cymedicaortho.com for more information on the IntelliHab System.
IH-0090-001
Rev. L
03/2022
IH-0090-001, Rev. L Page 1 of 66

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the IntelliHab and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for CYMEDICA Orthopedics IntelliHab

Summary of Contents for CYMEDICA Orthopedics IntelliHab

  • Page 1 CyMedica Orthopedics® IntelliHab™ System User’s Manual Read this manual carefully before operating the IntelliHab System Customer Service 1-844-CYM-2014 Please visit www.cymedicaortho.com for more information on the IntelliHab System. IH-0090-001 Rev. L 03/2022 IH-0090-001, Rev. L Page 1 of 66...

  • Page 2: Table Of Contents

    5. IntelliHab OPERATING INSTRUCTIONS ..........22 Charging and Storing the IntelliHab Controller ......22 Wearing the IntelliHab Conductive Garment ......23 Operating the IntelliHab Device for NMES Treatment ..... 25 Operating the IntelliHab device as a bilateral system (2 garments and one controller) ............31 03/2022 IH-0090-001, Rev.
  • Page 3 10.1 Required mobile device characteristics & internet ....40 10.2 Mobile app updates ..............42 10.3 Additional IntelliHab mobile app security measures ....42 10.4 Your healthcare provider viewing of your IntelliHab app data 10.5 Data security precautions ............43 PHYSICIAN INFORMATION ..............44 11.
  • Page 4 12. TECHNICAL SPECIFICATIONS .............. 54 12.1 Waveform Information ............54 12.2 Compliance Declaration ............56 12.3 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ..................56 12.4 FCC and IC ................62 12.5 Wireless Quality of Service and Coexistence ......63 12.6 Recommendations for Safe Wireless Connections ....

  • Page 5: Introduction

    Retardation or prevention of disuse atrophy 2. Evaluation of joint mobility by measuring and recording range of motion The IntelliHab System is indicated for adults of 22 years of age and older. 03/2022 IH-0090-001, Rev. L Page 5 of 66...
  • Page 6 Use environment The IntelliHab system is a prescription device in the USA and is intended for use in accordance with the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

  • Page 7: Safety Information

    SAFETY INFORMATION EXPLANATION OF SYMBOLS The following symbols are used in this user’s manual, and on the device packaging, or on the device or accessory labeling. Symbol Description Reference Number for Symbol Reference number; part number ISO 15223-1:2012(E) 5.1.6 Lot number ISO 15223-1:2012(E) 5.1.5 Serial Number...
  • Page 8 Temperature Limitation ISO 7000:2014-0632 Pressure Limitation ISO 7000:2014-2621 Keep the device away from sunlight ISO 15223-1:2012(E) 5.3.2 Keep the device dry ISO 15223-1:2012(E) 5.3.4 Do not iron device ISO 7000:2014-3113 Do not machine wash device ISO 7000:2014-3123 Do not use bleach to clean device ISO 7000:2014-3124 Do not tumble dry device ISO 7000:2014-3109...
  • Page 9 IP22 Protection against medium-sized IEC 60529 Edition 2.1 foreign bodies with a diameter > 12 2001-02 mm; Protection against vertically falling water drops when enclosure tilted up 15° Type BF applied parts IEC 60417.1-2004-5333 Lead wires comply with IEC 60417.1-2004-5035 performance standard for electrode lead wires (21 CFR part 898) Product...

  • Page 10: Definitions

    3.2 DEFINITIONS • Applied Parts – Part of the medical equipment, which is designed to come into physical contact with the patient, or parts that are likely to be brought into contact with the patient. For example, the electrodes are an example of an applied part. •...

  • Page 11: Contraindication

    3.3 CONTRAINDICATION Do not use this device on patients who have a cardiac • pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death. 3.4 WARNINGS Do not apply stimulation across the chest, because the introduction of electrical current into the chest may cause heart rhythm disturbances, which could be lethal.
  • Page 12 17. No modification of this device is allowed. 18. Use this device only with the leads, electrodes, electrode gel, and accessories recommended by CyMedica Orthopedics indicated in this User’s Manual document. 19. Do not use this device while connected to high frequency surgical equipment.

  • Page 13: Precautions

    11. Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer. 12. Portable powered muscle stimulators such as the IntelliHab device should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
  • Page 14 15. Do not allow any foreign bodies (soil, water, metal, etc.) to penetrate the IntelliHab device and the battery compartment. 16. Do not use the IntelliHab Conductive Garment in proximity of fire or excessive heat sources due to the risk of fire. Make sure that the electrodes cover the connectors on the garment before use to avoid shocking, skin irritation, and burns.

  • Page 15: Adverse Reactions

    INTELLIHAB SYSTEM COMPONENTS The IntelliHab system consists of a NMES control unit, NMES conductive garment, universal USB charging cable, NMES electrodes, electrode gel, and electrode covers. The user interface is controlled by a proprietary 03/2022 IH-0090-001, Rev.

  • Page 16: Intellihab Controller

    4.1 IntelliHab Controller The IntelliHab controller is the stimulation generator that is operated through the IntelliHab Mobile App. By using therapy controls via the IntelliHab Mobile App, the controller sends the selected therapeutic program to the electrodes on the body. The controller has a single...
  • Page 17 Bluetooth, indicating the mobile IntelliHab Mobile App and the mobile device are ready to deliver stimulation treatment. In the OFF position, the LED light on the IntelliHab controller will no longer illuminate. The controller will be off and will not deliver treatment.

  • Page 18: Range Of Motion Sensor Pod

    4.2 Range of Motion Sensor Pod The IntelliHab range of motion sensor is used to evaluate the full movement potential of the knee joint, including its range of flexion and extension. The sensor pod must not be removed from the garment.

  • Page 19: Electrode Gel

    Replace electrodes every 20 to 30 sessions or sooner, if needed. When utilizing stimulation at intensity levels of 60 or higher, replace electrodes more frequently to minimize risk of skin irritation or burn. Electrodes are reusable if they are clean, without any sign of visible damage, dryness, and still tacky.

  • Page 20: Intellihab System Replacement Part Numbers

    Electrode 4.6 IntelliHab System Replacement Part Numbers Please visit the CyMedica Orthopedics shop page at https://store.cymedicaortho.com to order replacement electrodes and supplies. Contact CyMedica Orthopedics (1-844-CYM-2014) if you have any questions about online ordering. 4.7 Conductive Garment Electrodes: Placement Instructions Your garment is provided with pre-installed electrode wires with protective caps covering the metal conductive pins.
  • Page 21 Position a new electrode of the same size so the sticky side of electrode is facing up while the attachment side is facing down. Firmly place the electrodes within the electrode outlines on the garment. Plug in the new electrode all the way so that the metal pin end is completely covered.

  • Page 22: Intellihab Operating Instructions

    To charge the controller, undock it from the garment and attach the supplied USB charging cord to a standard 5V wall adapter charger. Plug the small, micro-USB end of the USB cable into the side of the IntelliHab controller. While charging, the LED light (near the USB charging port) will blink blue until fully charged.

  • Page 23: Wearing The Intellihab Conductive Garment

    5.2 Wearing the IntelliHab Conductive Garment The IntelliHab NMES device is designed to specifically target and activate two important muscles of the quadriceps: the vastus medialis oblique (VMO) muscle located near the inner part of the upper knee area, and the rectus femoris (RF) muscle located at the top-middle part of the thigh.
  • Page 24 Pull garment strap 1 over the electrode flap and attach to the garment as shown. Wrap the calf side flap over the top of the leg. Pull garment strap 2 over the calf flap and attach as shown. Verify the front knee opening fits comfortably around the knee.

  • Page 25: Operating The Intellihab Device For Nmes Treatment

    Select download/install. Important: Follow the prompts to complete your profile. STEP 2: Pair the IntelliHab controller to your smart device You must pair your IntelliHab controller with your smart device (smart phone or tablet) before starting a treatment. See section 10.1 for required mobile device characteristics and internet connections.
  • Page 26 What do the different illuminated colors on the power button mean? Once you begin use, the LED light on the IntelliHab controller will glow • yellow when a treatment is in progress and will blink yellow when the treatment is in progress and is outputting energy.
  • Page 27 When the controller is blinking white, controller is not connected to Bluetooth and the treatment is paused. When powered off, the LED light on the IntelliHab controller will turn • off. The controller will be off and will not deliver treatment. After...
  • Page 28 The top section of the IntelliHab Mobile App will display a Dashboard Ring of your weekly progress. Each day you will be asked to conduct two 20-minute treatment sessions and a range of motion test.
  • Page 29 Once the intensity levels are set, tap ‘Start Therapy’ to begin your 20- minute treatment session. The IntelliHab NMES treatment program is 20 minutes long. 03/2022 IH-0090-001, Rev. L Page 29 of 66...
  • Page 30 Once treatment is complete, this screen will be displayed: Recommended Usage IntelliHab therapy is recommended to be used twice a day for a minimum of 5 days per week. Each session of NMES therapy is 20 minutes. The therapy is recommended...

  • Page 31: Operating The Intellihab Device As A Bilateral System (2 Garments And One Controller)

    5.4 Operating the IntelliHab device as a bilateral system (two garments and one controller) The bilateral IntelliHab system is indicated for treatment of both left and right knees. Only one controller is needed for use with both garments. Once the device has been paired using either garment, it is not necessary to pair the other garment.
  • Page 32 In the IntelliHab Mobile App Range of Motion test, tap ‘Save’ when you have reached your maximum extension. 03/2022...
  • Page 33 In the IntelliHab Mobile App Range of Motion test, tap ‘Save’ when you have reached your maximum flexion. It is important to not over-exert your range of motion beyond your comfort limits and to follow any instructions that your healthcare provider may have given to you.

  • Page 34: When To Use Your Intellihab System

    IntelliHab System to help maintain healthy joint function and manage further knee pain. How frequently you should use IntelliHab will depend on your specific condition and improvement rate. As a general guide, we would recommend you continue to use the IntelliHab System as shown above. IntelliHab SYSTEM TROUBLESHOOTING...
  • Page 35 To pause the stimulation, momentarily press the on/off button on the IntelliHab controller. To stop the stimulation, press and hold the on/off button on the IntelliHab controller for 2 seconds to turn off the device.
  • Page 36 Troubleshooting Table Problem Possible cause Solution Check the IntelliHab controller connection to the Loose connection dock Battery discharged Recharge IntelliHab controller The Controller is not responding Bad connection Verify the connection of lead wires to electrodes Defective electrode Replace the defective electrodes...

  • Page 37: List Of Error Messages

    CyMedica Orthopedics Customer Service can be reached at 1-844 -CYM- 2014. Please contact Customer Service if you need assistance setting up, using, or maintaining the IntelliHab System or to report any unexpected operation or events. When returning any products, please include your name, address, phone number, and Return Material Authorization (RMA) number provided by Customer Service.

  • Page 38: Repair

    CyMedica Orthopedics Customer Service. Do not attempt to repair any part of the CyMedica Orthopedics IntelliHab System. Never dismantle the IntelliHab controller due to risk of electric shock. CyMedica Orthopedics, Inc. declines all responsibilities for any damages or consequences resulting from unauthorized attempts to open, modify, or repair the stimulator.

  • Page 39: Operating Conditions

    45 minutes prior to operating the device. 9.5 Transportation and Storage Conditions The IntelliHab device should be transported and stored in temperatures between -13°F and 158°F (-25°C and 70°C), atmospheric pressures between 50 and 106 kPa and relative humidity between 10% and 90%.

  • Page 40: Replacement Parts Ordering Information

    Electrodes will last longer if used and stored according to instructions on electrode packaging. The IntelliHab controller and sensor in the NMES conductive garment is a piece of electronic equipment and may include substances that can damage the environment.
  • Page 41 The use of the IntelliHab Mobile App requires your mobile device, such as phone or tablet, to have internet access through cellular data or WiFi connections. In addition, the Bluetooth connection needs to be enabled on your device. IntelliHab Mobile App needs to be downloaded from the App Store (Apple) or Google Play (Android) on your device.

  • Page 42: Mobile App Updates

    10.3 Additional IntelliHab mobile app security measures When you create a profile in the IntelliHab Mobile App, you are required to enter a valid email address and password to create your account. The password management in the App provides security for setting a minimum of an eight-character alphanumeric password to allow you to login to your profile to view your data.

  • Page 43: Data Security Precautions

    IntelliHab controller ID and your App entered date of birth with your healthcare provider. 10.5 Data security precautions In the App Store (Apple) or Google Play (Android), search for “IntelliHab” and be sure to select the App with the icon shown...

  • Page 44: Physician Information

    CyMedica Orthopedics® IntelliHab™ System User’s Manual PHYSICIAN INFORMATION 03/2022 IH-0090-001, Rev. L Page 44 of 66...

  • Page 45: Clinical Study Summary Pivotal Usa Trial

    CLINICAL STUDY SUMMARY Pivotal USA Trial The aim of this clinical study was to evaluate the safety and effectiveness of the CyMedica neuromuscular electrical stimulation (NMES) therapy, a home- based electrotherapy device as a non-surgical therapy for knee pain relief and joint functional recovery in patients with knee osteoarthritis.
  • Page 46 The pain assessments included Pain Visual Analog Score (VAS) for a subject’s nominated activity, VAS for a general knee pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and Knee Injury and Osteoarthritis Outcome Score (KOOS) JR pain subscale. Secondary objectives- Secondary objectives were to gain knowledge and evidence of knee functional outcome improvement in subjects using the CyMedica NMES therapy as compared to those assigned sham treatment.
  • Page 47 Analysis of data Descriptive statistics was conducted for the primary and secondary • endpoints at baseline and weeks 4 through 12. Chi-Square test was utilized to compare the number and proportion of • subjects who achieved 30% or greater improvement from baseline in knee pain (treatment responders) as measured by VAS Nominated Activity with an associated 95% confidence interval.
  • Page 48 In the PPTC treatment NMES group, clinically meaningful improvements in knee pain, stiffness, and function and statistically significant difference against the sham group’s results were demonstrated in the Treatment NMES group at week 12 consistently, across multiple endpoints, see Tables A and B below. In addition, the Patient Global Impression of Change (PGIC) survey results confirmed an overall patients’...
  • Page 49 12. Between group differences also started at week 4 and continued to week 12. The largest differences between the Treatment and Sham groups were observed at week 12. In addition to the endpoints that reached statistical significance, those that did not reach significance still trended in favor of the treatment arm. Table A- Summary of Treatment NMES Group against the Sham Low Voltage Group, Comparison of Treatment Responder Rates at Week 12 Treatment...
  • Page 50 Table B- Summary of Treatment NMES Group against the Sham Low Voltage NMES Group, Comparison of Percentage Change from Baseline or PCFB at Week 12 Treatment NMES Sham Low P-value (N= 106, ITT, n= Voltage NMES (t-test) 45, PPTC) (N= 50, ITT & PP) PCFB PCFB - ITT...
  • Page 51 Isometric Quadriceps Strength The isometric quadriceps strength at week 12 improved by 64.7% (PCFB) in the ITT Treatment NMES group and 81.5% (PCFB) in the PPTC. A dependent Mean t-test demonstrated a statistical difference within the treatment NMES group at week 12 compared to the baseline for both ITT and PPTC groups (p= 0.0006 for ITT Treatment NMES group and p= 0.0001 for PPTC).
  • Page 52 Some uncertainty is acceptable in clinical trials and is weighed against potential benefits and potential risks. The following list includes a list of potential uncertainties resulted from the IntelliHab NMES treatment clinical study. 1- Conclusions about the effectiveness are based on an analysis of a...
  • Page 53 in a subgroup of compliant patients. Other secondary endpoints including , VAS , and VAS in the treatment NMES group did not General Walk Rest demonstrate statistically significant difference against the sham group. 3- The study Statistical Analysis Plan (SAP), including the analysis for missing data was finalized and released prior to study unblinding, but after study enrollment initiation.

  • Page 54: Technical Specifications

    13 TECHNICAL SPECIFICATIONS 12.1 Waveform Information Treatment NMES: Cy-Motion Therapy Program Pulse shape Monophasic Treatment 20 minutes duration Frequency 50 pps Pulse width 5 ms Duty cycle Work cycle 12 s Relaxation 10 s time Work cycle – consists of 5 cycles of oscillating contractions per Work cycle muscle group Relaxation time is 1.4s–...
  • Page 55 Full output, Voltage across 10,000Ω load Rated Outputs – STRENGTH NMES Parameter 500 Ω 2 kΩ 10 kΩ Output Voltage (V 9.2 V 16.4 V 21.3 V Output Voltage (V 64 V 96 V 111 V PEAK Output Current (I 18.3 mA 8.2 mA 2.1 mA...

  • Page 56: Compliance Declaration

    12.3 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions • The IntelliHab device needs special EMC precautions and must be installed and started according to the EMC information supplied in this manual. 03/2022 IH-0090-001, Rev. L Page 56 of 66...
  • Page 57 System testing was 40.0”. GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS IntelliHab is intended for use in the electromagnetic environment specified below. The customer or user of the IntelliHab System should assure that it is used in such an environment. Emissions test Compliance...
  • Page 58 0 % UT; 1 cycle operation during power mains variations on Battery powered interruptions, it is recommended power supply that the IntelliHab be powered from 70 % UT; 25/30 cycles input an uninterruptible power supply or a Single phase: at 0° lines battery.
  • Page 59 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The IntelliHab System is intended for use in the electromagnetic environment specified below. The customer or the user of the IntelliHab System should assure that it is used in such an environment. Electromagnetic environment IEC 60601 test...
  • Page 60 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE INTELLIHAB The IntelliHab System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IntelliHab can help prevent...
  • Page 61 RF COMMUNICATIONS EQUIPMENT AND THE IntelliHab The IntelliHab is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IntelliHab can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IntelliHab as recommended below, according to the maximum output power of the communications equipment.

  • Page 62: Fcc And Ic

    FCC RF Radiation Exposure Statement FCC ID: 2AU28-CY1000330 Model: IntelliHab The minimum distance of the radiating structure of this device, during normal operation, is 15mm from the body of the user (§2.1093). This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.

  • Page 63: Wireless Quality Of Service And Coexistence

    TDMA (time division) multiple-access schemes. The BLE maximum output power levels in IntelliHab are -1.1dBm. The BLE links used in IntelliHab have a range of up to 10 meters (between the mobile device and controller). Bluetooth Module: Texas Instruments CC2640R2F MCU targeting Bluetooth®...

  • Page 64: Recommendations For Safe Wireless Connections

    The coexistence of the IntelliHab wireless system has been tested for up to forty wireless and microwave devices near the 2.4 GHz band, including 5 IntelliHab systems operating simultaneously within a 50 meters radius. 12.6 Recommendations for Safe Wireless Connections The IntelliHab System utilizes encrypted Bluetooth wireless data transmission to protect information.

  • Page 65: Measurements Accuracy

    ‘Settings’ then tap ‘Bluetooth Pairing’. The App will walk you through connecting your controller to your mobile device. In the event that your IntelliHab Mobile App is not connecting to the internet, take the following steps: 1) Ensure that your Wi-Fi is enabled in your device settings and you are connected to a valid Wi-Fi connection.
  • Page 66 CyMedica Orthopedics 2120 East 6 Street Suite 8 Tempe, AZ 85281 USA 03/2022 IH-0090-001, Rev. L Page 66 of 66...

Table of Contents