PowerDot PD-02 Operator Instructions Manual
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PowerDot PD-02 Operator Instructions Manual

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PowerDot PD-02 Muscle Stimulator
Operator's Instructions For Use
 

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Summary of Contents for PowerDot PD-02

  • Page 1   PowerDot PD-02 Muscle Stimulator Operator’s Instructions For Use  ...

  • Page 2: Intended Use

    Android mobile devices. Indications for Use PowerDot PD-02 stimulator is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor mobile application) or by patient/lay operator in a home environment (when operated from PowerDot Patient mobile application).

  • Page 3: Safety Guidelines

      Safety Guidelines 1. Counter-indications Do NOT use PowerDot PD-02 for the patients with the following conditions:  Cardiac stimulator (pacemaker), implanted defibrillator or other implanted electronic device. Such use could cause electric shock, burns, electrical interference or death. ...
  • Page 4 6. Co-existence and Environmental Safety Measures  Do not use PowerDot PD-02 in the areas where an explosion hazard may occur. An explosion hazard may result from the use of flammable anesthetics, skin cleansing agents and disinfectants as well as in the oxygen-rich environments.
  • Page 5  Do not use PowerDot PD-02 in the close proximity of medical devices such as MRI, CT, diathermy, X-Ray as well as RFID equipment (e.g. electromagnetic security systems) as those could alter the current generated by PowerDot PD-02, cause tissue damage, and can result in severe injury or death.
  • Page 6    For reasons of hygiene, each patient must have their own set of electrode pads. Do not use the same electrodes on different patients.  Contaminated electrode pads or hydrogel can lead to infection. • Use of electrode pads with degraded hydrogel can result in burns to the skin. •...
  • Page 7   PowerDot PD-02 Device & Accessories Power/Stimulation indicator Multifunction button Micro USB connector (dual function: connects either leads or charging cable) Charging indicator Female magnetic pad connector Lead cable with two female magnetic connectors  ...
  • Page 8   Power/Stimulation Indicator (1): Can be either WHITE (when the PowerDot is on or on standby mode) or ORANGE (when it’s being used for stimulation). Multifunction Button (2) Modes: Multifunction Button carries out these PowerDot functions: Multi-function Button PowerDot Initial State...
  • Page 9   Electrode Pads (7,8): PowerDot supports 3 types of electrode pads – 5.5 cm (2.2”) diameter round pads, 4.5 cm (1.8”) diameter round pads and 9x5 cm (3.5”x2”) rectangular pads. PowerDot pads use unique skin biocompatible hydrogel with superb conductive qualities and adhesiveness.
  • Page 10 Multifuncti ion Button to tu urn off the Powe erDot. Activating g PowerDot Before PowerD Dot PD-02 can b be used for mu scle stimulation n, it must be ac tivated from wi ithin your Pow erDot Doctor App.
  • Page 11 Attach PowerD Dot PD-02 devic ce female magn netic connector to the male sna ap on the rectan ngular pad; Make...
  • Page 12 Scheduled sessions’ parameters, listed above, can be always changed/re-adjusted if required. Before commencing the stimulation, PowerDot Doctor App will be asking to turn on PowerDot PD-02 device (or devices) which you are planning to use for the current stimulation session (please make sure the device has been previously activated via Devices screen).
  • Page 13 02(s) used in currently active session and re-connecting to PowerDot(s) being used in the newly selected session. Home Screen Control (8) – helps you to navigate back to PowerDot Doctor App Main Menu screen, so you could select another patient and initiate a new stimulation session.
  • Page 14 You can use both sides of a single safety film to attach one set of PowerDot electrode pads (one side for the rectangular pad and the other for the two round pads).
  • Page 15   Intensity Adjustment Guidelines For TENS programs or less demanding NMES programs, you are generally required to progressively increase the stimulation intensities until you see muscle twitches or feel comfortable sensation. For the majority of NMES stimulation programs, that use powerful muscle contractions, the efficacy of the treatment can be proportional to the maximum number of fibers being recruited, and, therefore, it is often required to adjust your stimulation intensity to the maximum levels the patient can comfortably endure.
  • Page 16 5-6 hours of continuous usage. The battery will last for at least 500 charging cycles. If you plan to store PowerDot PD-02, unused, for longer than six months, charge it to at least 50% every six months. In the PowerDot Doctor App, the current battery charge level is displayed at the Stimulation and is also available on the Devices screen.
  • Page 17   Stimulation Protocols Stimulation protocols, accessible to doctors from PowerDot Doctor App, based on their intended use, can be divided into 3 main groups: NMES Rehabilitation Protocols Disuse Atrophy Protocol Name Indication For Use Retarding disuse atrophy Disuse Atrophy* Description Targeting slow twitch (Type I) muscle fibers to facilitate increases in muscle volume after long periods of immobilization or diminished movement.
  • Page 18   (3-8) (30-50) (9-24) (1.5-6) (160-320) (15-30) Maintaining or increasing range of motion Increase Range of Motion* Targets increase in range of motion by creating contraction and movement in the antagonist muscle, thus causing maximum stretch of the problematic muscle. 2/0.5 (3-8) (30-50)
  • Page 19   (30-50) (240-432) Shoulder Subluxation Prevention and retardation of atrophy Targets stimulation of Deltoid and Supraspinatus muscles as prevention and treatment for atrophy of the sub-dislocated shoulder. 3/1.5 (6-10) (30-50) (6-10) (1-5) (160-320) (20-30) Back-Trunk Stabilization* Muscle re-education Targets stabilization of trunk and back muscles by stimulating abdominal or lumbar muscle groups. Suits patients with insufficiency in the bank and trunk due to long term pain or neurological disorder.
  • Page 20   TENS Pain Management Protocols By Type of Pain Protocol Name Indication For Use Acute Pain Post-surgical and post-trauma acute pain Description High frequency TENS is a popular choice for the management of acute pains. Adjust pulse width to patient pain sensitivity level. Frequency, Hz Burst Parameters Pulse Width, uS...
  • Page 21   For treating lower back pain resulting from chronically contracted lumbar paravertebral muscles. Low frequency stimulation alleviates pain by stimulating muscles to release the endorphins. In addition, muscle twitches also increase local blood circulation. (1-8) (160-320) (15-60) Symptomatic relief and management of chronic, Lumbosciatica intractable pain Sciatica...
  • Page 22   Muscle Pain Symptomatic relief and management of chronic, intractable pain Post-surgical and post-trauma acute pain Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities For treating all kinds of muscle pains. This protocol uses pulse width modulation, which creates undulating sensation and is generally more comfortable than constant pulse width stimulation.
  • Page 23   Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities For treating torticollis pain: a sharp pain in the neck, often accompanies by considerable reduction of the mobility of the cervical region.
  • Page 24   50-150 Hz at 2 sec (50-150 Hz at 2-5 sec) (32-160) (10-40) Frequency Modulated TENS, Medium Range Symptomatic relief and management of chronic, intractable pain Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities This protocol can be used for treatment of various chronic pain conditions such as arthralgia, epicondilitis, lower back muscle pains etc.
  • Page 25   Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities Mixed Frequency TENS is more comfortable and convenient form of High Frequency Conventional TENS. Also commonly referred as Hans Stimulation.
  • Page 26   Targets decrease in muscular tension. Provides effect of wellbeing and relaxation. 420 (for each 7,5,3 phase) (1-10) (160-432) (15-36) (300-720) Increasing local blood circulation Circulation Massage Helps to get rid of heaviness sensation and uncomfortable body tensions via increasing blood circulation in the target areas. 120 (for each 1,3,5,7,5,3,1, phase)

  • Page 27: Basic Troubleshooting

    DURING PRE-STIMULATON SET UP, POWERDOT(S) CANNOT BE FOUND (OR ARE NOT CONNECTED) . Check out Devices screen and make sure that PowerDot device you’re trying to use is in the list of active devices. Make sure your PowerDot is turned on (the white light is on in the device).

  • Page 28: Powerdot Warranty

    PowerDot Warranty PowerDot PD-02 is covered by a worldwide warranty of 2 years, which comes into effect on the date of purchase of the device (proof of purchase is required). The warranty does not apply to the electrode pads and carry cases. Within the warranty period, manufacturer will replace your faulty PowerDot or accessories at no charge (except shipping &...

  • Page 29: Technical Specifications

      Technical Specifications All electrical specifications are given for an impedance of 1000 Ω per channel. Battery: 2x Lithium Polymer (LiPo) rechargeable 3.7 V, 210 mAh Charging Input: 5V through USB Type C connection (custom USB charging cable is provided as part of the package), I/P rating: 5Vdc 1-2.1A Stimulation Channels: 2 independent, optically isolated...
  • Page 30 CISPR EMISSION requirements. PowerDot PD-01 has been tested to the compliance with the following Emission and Immunity standards: Emission: STANDARD...

  • Page 31: Bluetooth Connectivity

    Apple iPad devices. Secure Pairing Your PowerDot is paired with your iPad using secure 8 digit numeric code which, by design, prohibits any other mobile phones or wireless devices to connect to your PowerDot. Secure pairing takes place during PowerDot activation process (see Activating PowerDot above) and, once your PowerDot becomes active, numeric activation code is written into PowerDot’s flash memory and gets verified by your PowerDot Doctor...
  • Page 32   Like any wireless device, PowerDot PD-02 emits very low levels in the radio frequency (RF) interval, and, is therefore not likely to cause any interference with nearby electronic equipment (e.g. radios, computers, telephones, etc.). PowerDot PD-02 is designed to withstand foreseeable disturbances originating from electrostatic discharges, mains supply magnetic fields, or radio frequency transmitters.

  • Page 33: Used Symbols

      Used Symbols Serial Number Stand by Attention Direct Current (DC)     IMPORTANT NOTE : (For Portable Device Configuration) FCC Radiation Exposure Statement: This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment for body- worn configuration in direct contact to the phantom.
  • Page 34     EU Only Symbols: This symbol on your PowerDot unit is to indicate conformity with the requirements of the Medical Device Directive (94/42/EEC) Manufacturer EU Authorized representative Internally powered device Class II with Type BF applied parts Product subject to WEEE regulations concerning separate waste collection...

  • Page 35: Manufacturer & After-Sale Service

    Altenhostrasse 80, 66386, St. Ingbert, Germany Electromagnetic Compatibility (EMC) PowerDot PD-02 is designed to be used in home healthcare environments in accordance with the EMC safety standard IEC 60601-1-2 (4 Edition) and with limitations, defined by the warnings and precautions in this manual (e.g.
  • Page 36   with frequent voltage interruptions (when charging from the wall adapter). To support consistent and reliable charging, the usage of uninterrupted power supply (UPS) is highly recommended, if operating in such environments. The following device function is considered essential to the safety of the user: ability to maintain consistent stimulation intensity (amplitude), pulse frequency and pulse waveform (both shape and width). ...

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