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Onward ARC-EX Instructions For Use Manual

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  • Page 1 System (Professional) Instructions for Use English...
  • Page 2 This page is intentionally left blank...
  • Page 3 A paper version of these Instructions for Use can be requested at no additional cost by contacting ONWARD. New versions of these Instructions for Use will be made available on the ONWARD® website and can be found at the following link: Caution: Federal law restricts this ONLY www.onwd.com/resources...

  • Page 4: All Rights Reserved

    The Bluetooth® word mark and logos are including but not limited to consequential registered trademarks owned by Bluetooth SIG, damage(s) caused reliance Inc. and any use of such marks by ONWARD information contained herein. Medical is under license. Drawings herein are for illustration purposes only.

  • Page 5: Setup And Use

    System (Professional) Essentials for Setup and Use English...
  • Page 6 This page is intentionally left blank...
  • Page 7 Condensed setup and use instructions for the following included in this guide: For Healthcare Professionals: Using ARC System in the rehabilitation center Refer to the Instructions for Use (IFU) in the rest of this document for comprehensive instructions. ONWARD ® Support Contact: USA toll-free: +1 (866) 217 0817 Phone EX ®...
  • Page 8 Charger (ARC PRO app) Stimulator Charger 1m/39.4 inches) Electrodes “Power” button Turn On the Professional Stimulator and the Programmer by pressing the “Power” button. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 9 Programmer battery status (top per Step 2 above. bar): Place the Stimulator on a flat surface with the ARC Professional logo readable at the top. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 10 To create a PIN, press “Set a lock type” to go to the Programmer Settings and set the PIN code. Refer to Professional IFU section 6.1 for additional details. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 11 Enter Patient information. iii. Select “Save”. Or, select an existing Patient profile. To edit a Patient profile, select the Patient and then select “Edit patient”. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 12 Serial Number on the back of the Stimulator. ii. If the correct Stimulator Serial Number is not listed, select “Search devices”. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 13 If they match, press “Pair’’ in the Programmer AND press the “Select” button on Stimulator (in any order). Refer to IFU section 6.3.5 for additional details. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 14 Or, select an existing program. To edit a program, select the program and then select “Edit program”. Refer to Professional IFU section 6.3.6 for additional details. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 15 Set Active Electrode Placement: In the designated fields labeled 1,2,3,4, choose where on the back of the neck you will place the Active Electrodes (maximum 4). For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 16 They should look like the screenshot Return Electrode you want to use for a below: specific channel. ii. Link the Return Electrodes by clicking icon. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 17 On the Patient’s body, locate areas of Electrode placement for both Active and Return Electrodes that you previously inputted in step 12 in the “Channels” screen. Return Electrodes (rectangular) For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 18 Electrodes should not be removed from their • Active Electrodes (round) on C3 and C6 liner or from the skin by the lead wires. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 19 Splitter Box (grey A-B-C-D). Replicate configuration in “Channels” screen precisely (e.g., Return Electrode A left iliac crest, Return Electrode B right iliac crest). For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 20 Ensure Stimulator is placed on a flat surface. Do not hold the Stimulator or place it on your lap during the therapy duration. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 21 · Frequency: 0.2 Hz – 100 Hz · Carrier Frequency: 5 kHz or 10 kHz Refer to Professional IFU section 6.5.1. for additional details. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 22 Refer to Professional IFU section 6.5.3 for additional details. Confirm you are ready to start stimulation by pressing “Yes” in the pop-up window. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 23 If stimulation creates discomfort, consider reducing Amplitude. Note: If the connection to the Programmer is lost, you can increase/decrease Amplitude from the Stimulator buttons. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 24 3 seconds. If stimu- lation is already paused, press and hold the “Select” button for 3 seconds. Then, press “End session’’. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
  • Page 25 Return all components to the provided Case. Clean and charge Stimulator and Programmer if necessary. Refer to Professional IFU sections 6.6.2 and 6.6.3 for additional details. For ONWARD Support, contact: USA toll-free: +1 (866) 217 0817 USA: +1 (617) 488 8642 support@onwd.com...
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  • Page 27 System (Professional) Instructions for Use English...
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  • Page 29: Table Of Contents

    System markings 3.2 Warnings 1.4 Abbreviations and definitions 3.3 Precautions 1.5 Manufactured by 3.4 Potential adverse reactions 1.6 ONWARD customer contact for USA 3.5 Incident reporting 1.7 Warranty 1.8 End User License Agreement 4 Components 1.9 Additional supporting material 4.1 ARC...
  • Page 30 Contents 5.6 Electrodes 6.4.1 Channel configuration, skin preparation and Electrode placement 6 ARC System Instructions 6.4.1.1 Channel configuration 6.1 Setting up the System prior to first use 59 6.4.1.2 Skin preparation and Electrode Placement 6.2 ARC Therapy session 6.4.2 Setting up the Splitter Box and 6.3 Prepare Stimulator 6.3.1 Collecting the components...
  • Page 31 6.6.4 Storing the ARC System 9.2.2 Radio frequency interference 7 Cybersecurity 10 Troubleshooting 7.1 Protecting access to the Programmer 10.1 ONWARD Support 7.2 Wireless security measures 10.2 ARC Stimulator troubleshooting 7.3 Guidelines for secure use 10.2.1 Stimulator does not turn on 7.4 Log files...
  • Page 32 Contents 10.2.8 How do I factory reset 10.3.10 How can I unlock the Programmer a Stimulator? if I lost my PIN code? 10.2.9 How do I change the language 10.3.11 Can I install other apps on of the Stimulator? the Programmer? 10.3 ARC Programmer troubleshooting 10.3.12 Can I use the Programmer while...

  • Page 33: Introduction

    USA: +1 (617) 488 8642 The tablet on which ARC PRO app is installed Email support@onwd.com and the Electrodes are distributed by ONWARD. Refer to the original manufacturer instructions provided in the ARC System package for more specific information not included in this document.

  • Page 34: Explanation Of Symbols In Package Labeling And System Markings

    1 Introduction 1.3 Explanation of symbols in package labeling and System Translation markings European Authorized Medical device EC REP Representative Quantity Bluetooth® European CE mark indicating Reference Number the year of authorization and the Notified Body identification code Ingress Protection USA federal law restricts this The first numeral refers to the device to sale by or on the order of...
  • Page 35 1 Introduction Keep dry and protected from Read Instruction for Use moisture Temperature limitation Manufacturer storage, handling, and transport, where x = minimal value, Country of manufacture y = maximum value. Temperatures outside of the stated range for each device can cause damage Date of manufacture Humidity limitation for storage, handling, and transport, where...

  • Page 36: Abbreviations And Definitions

    1 Introduction something happens. A Frequency 15 Volt direct current of 1 hertz means that something Separate collection for electrical happens once a second. and electronic equipment waste is Instructions for Use required This is the curved superior Unique Device Identification border of the ilium, the largest number...
  • Page 37 1 Introduction The Patient environment is ONWARD ONWARD Medical N.V. defined as the 1.5 m/5 feet Patient Milliampere area around the Patient and environment A milliampere (also milliamp) applies only while stimulation is 1/1000 of an Ampere. is being delivered.

  • Page 38: Manufactured By

    Europe: +31 40 288 2830 potentially compromised, and the warranty is void. Email support@onwd.com Website www.onwd.com 1.8 End User License Agreement 1.6 ONWARD customer contact System User License for USA Agreement (EULA) is outlined in the EULA documentation included in the ARC System Company ONWARD Medical INC.

  • Page 39: Arc Ex Intended Use

    2 ARC Intended Use 2 ARC Intended Use 2.3 Intended users 2.3.1 Rehabilitation Professional (RP) 2.1 Intended use and indications for use The Rehabilitation Professional is a licensed clinician or therapist who defines and/or The ARC System is intended to deliver supervises rehabilitation training sessions programmed transcutaneous electrical spinal and/or guides the rehabilitation process for a...

  • Page 40: Safety Information

    Refer to Section 6.3.1 for more details. 3.1 Contraindications Never attempt to modify or repair the • The ARC System should not be used on System. Contact ONWARD for any patients with active implantable devices or technical support. wearable defibrillators.

  • Page 41: Electrode Placement

    3 Safety Information Electrode placement Interaction with the ARC System during use and charging • Stimulation should not be applied near the thorax or trans-thoracically because the • Do not touch both the Active and Return introduction of electrical current into the Electrodes at the same time during heart may cause cardiac arrhythmias or stimulation (signaled by the yellow light...

  • Page 42: Precautions

    3 Safety Information Use and storage environment Cleaning • Do not use within 1 m/40 inches of shortwave • Failure to follow cleaning instructions or microwave therapy equipment. Using or using cleaning agents other than as the ARC System in close proximity to such described in section 6.6.2 can affect the equipment may produce instability in the safety and performance of the System.

  • Page 43: Potential Adverse Reactions

    3 Safety Information • Keep Electrodes separated. They must Use and storage environment not overlap or touch once attached to the • Store the Electrodes at room temperature Patient’s skin at the target location. recommended original manufacturer instructions. Patient selection precautions •...

  • Page 44: Incident Reporting

    3 Safety Information 3.5 Incident reporting the ARC System. • Do not use the ARC System if there is an If, during use of the ARC System , you have ongoing bladder infection or fever. reason to believe that a serious incident has occurred, report it to the manufacturer (refer Electrical stimulation...

  • Page 45: Components

    4 Components Stimulator Professional The shipping box contains the ARC Case and (referred to as Stimulator) the Electrodes. (REF:EXSTM01PRO) 4.1 ARC System package Stimulator intended to generate The ARC System is packed in a Case and and deliver electrical consists of the ARC Stimulator, Splitter stimulation Box, Extension Cables, Stimulator Charger,...
  • Page 46 4 Components Extension Cables Programmer (REF: EXPRG01PRO) (REF: EXCBL0105 and EXCBL0110) The Programmer is an • 4 short Extension off-the-shelf tablet that Cables (50 cm / 19.7 is pre-installed with the inches long) PRO app and is protected by a case. •...
  • Page 47 4 Components System (Professional) Instructions for Use (this document) (REF: EXIFU01PROEN) electronic version System (Professional) Instructions for Use can also be found on the ONWARD website: www.onwd.com/resources (Additional languages also available).

  • Page 48: Electrodes

    4 Components 4.2 Electrodes Electrodes are accessories to the ARC System and are provided together with their original manufacturer instructions. Table 2. Electrodes Pack of 4 Active Electrodes Pack of 4 Return Electrodes (round, REF 879100) (rectangular, REF 895240) Each Electrode Each Electrode...

  • Page 49: Arc Ex System Description

    5 ARC System description 5 ARC System Description 5.1 ARC System Overview The ARC System consists of a Programmer The Programmer communicates with the Stimulator that allows the user to define or control that generates delivers stimulation programs through a dedicated electrical stimulation to the Electrodes (Active clinician software application.

  • Page 50: Arc Ex Stimulator

    5 ARC System description 5.2 ARC Stimulator The Stimulator is an internally powered device The numbers in the descriptions below equipped with a rechargeable battery. It correspond to the part of the Stimulator generates and delivers electrical stimulation to depicted in Figure 2. the Electrodes, based on commands received from the ARC PRO app (via the ARC...
  • Page 51 5 ARC System description LED status indicators to indicate the status of battery level, Bluetooth® connection to the Programmer, and electrode impedance status: •Battery •Bluetooth® •Impedance Status Lightbar to display device states (e.g., stimulation on, error, etc.). Indicators, sounds, the lightbar, and the notification area (screen) on the Stimulator help users determine ARC System state and Table 3 summarizes the feedback provided by the Stimulator.
  • Page 52 5 ARC System description Message on Stimulator Light indicator Sound type State notification area Control from app Bluetooth icon is on No sound Stimulator is lightbar: white light around connected to the the “Power” button PRO and ready to start stimulation Program ready Lightbar: white light around No sound...
  • Page 53 5 ARC System description Message on Stimulator Light indicator Sound type State notification area Charging: Charging: [value]% Battery icon on No sound Charging in progress. Please note that this message is only shown for 30s when starting charging and upon pressing Select button Charging: 100%...
  • Page 54 5 ARC System description Message on Stimulator Light indicator Sound type State notification area Stimulation: Program ready Lightbar: white light around No sound Stimulator is Start the “Power” button and performing a pre- yellow light above stimulation check Stimulator output port and stimulation will start in a few seconds.
  • Page 55 5 ARC System description Message on Stimulator Light indicator Sound type State notification area [Time elapsed] Lightbar: blue light all along No sound Stimulation ongoing Pause the bar up to the ending while controlling above of the Stimulator stimulation from output port where light is PRO app yellow...
  • Page 56 5 ARC System description Message on Stimulator Light indicator Sound type State notification area Paused Lightbar: dashed white Stimulation Stimulation is paused paused sound Resume Stop 3s Stopped Lightbar: white light around Stimulation Stimulation has been Final Amp: the “Power” button off sound stopped from...
  • Page 57 A system error has occurred. Note error code displayed. Turn the Stimulator off and on again. If problem persists, please contact ONWARD and be prepared to share the error code. For more details on the error codes, refer to section 10.2.2.

  • Page 58: Arc Ex Splitter Box

    System description 5.3 ARC Splitter Box The Splitter Box contains eight sockets for The Splitter Box manufactured by ONWARD Extension Cables. Four connect to Active is used to connect the Stimulator to the (round) Electrodes (1-4 red number) and four Extension Cables.

  • Page 59: Arc Ex Extension Cables

    The Extension Cables are used to connect the The manufacturer of the Programmer tablet Splitter Box to the Electrodes. A black ring is Samsung. The ONWARD ARC PRO app indicates which side of the Extension Cable is delivered pre-installed on the tablet. Refer should be connected to the Electrode.

  • Page 60: Electrodes

    PALS Electrodes manufactured by Axelgaard and distributed Electrode pad – placed on the skin. by ONWARD. Placed directly on the skin, they Lead wire – connected to the Extension deliver transcutaneous electrical stimulation Cable (end with the black ring). stimulation via the Stimulator.

  • Page 61: Arc Ex System Instructions

    6 ARC System instructions 6 ARC System Instructions via the Programmer): Confirm or change language: App · language can be changed at any time This section provides instructions for use of the System in a medical center environment in the ARC PRO app settings.

  • Page 62: Arc Ex Therapy Session

    Programmer will not be accessible anymore and you will need 1. Prepare the ARC System and Patient for to contact an ONWARD representative the rehabilitation session. for assistance. 2. Set up the Electrodes and stimulation ·...
  • Page 63 Programmer. The Power button of the stop using the ARC System and contact Programmer is the left-most button on the ONWARD. side of the Programmer when Programmer is oriented per Figure 6. Collect all necessary components: Power ˢ...

  • Page 64: Starting The Arc

    Prepare 6 ARC System instructions Wait 2.5 hours before using the Note Stimulator if stored below 5°C/41°F or above 40°C/104°F. If the ARC Programmer battery is low, it may disconnect or fail Note to communicate with the ARC Stimulator. Do not use expired Electrodes because they might not adhere Note properly to the skin.

  • Page 65: Arc Ex Pro App Settings

    Programmer settings to phone, website URL, and email address. unpair the Stimulator if needed. • ONWARD Privacy Policy available in the provided link. • Extract logs. A button to extract the logs recorded by the ARC System.

  • Page 66: Patient Profile Management

    Prepare 6 ARC System instructions 6.3.4 Patient profile management to 50 Patient profiles. You can choose to sort the Patient profiles Patient profiles are displayed and can be either alphabetically or chronologically (the managed in the “Patient List” screen below last profile used will appear at the top of the (Figure 7).

  • Page 67: Select Or Create Patient Profile

    Prepare 6 ARC System instructions 6.3.4.1 Select or create Patient profile If the desired Patient profile is not in the Patient List, create the Patient profile to be able to Select the desired Patient profile by clicking proceed with the session. on the corresponding line of the list.

  • Page 68: Edit Or Delete Patient Profile

    Prepare 6 ARC System instructions Save the Patient profile by tapping “Save” Save or cancel your changes by tapping on on the right of the bottom bar. You need to the corresponding button on the bottom fill in all the required information to be able bar.
  • Page 69 Prepare 6 ARC System instructions At this point, the Patient’s anonymous ID will i. Select the “Device ID” on the Programmer appear on the top bar. Ensure that the correct screen that matches the Serial Number on Patient profile has been selected. the back of the Stimulator.
  • Page 70 Prepare 6 ARC System instructions Once the Stimulator is connected, the following If this is the first time you are connecting information will appear on the top bar. this Stimulator with this Programmer, pair Stimulator with Programmer: i. Visually confirm that the 6-digit passkey on the Programmer screen matches the 6-digit number in the notification area of the Stimulator screen.

  • Page 71: Stimulation Program Management

    Prepare 6 ARC System instructions • The Battery level of the Stimulator and the To edit or delete programs, follow the option to disconnect from the Stimulator. instructions in the following sections. • The Bluetooth Signal Strength between the The ARC PRO app allows you to manage up Stimulator and the Programmer.

  • Page 72: Select Or Create A Stimulation Program

    Prepare 6 ARC System instructions 6.3.6.1 Select or create a stimulation pro- If the desired stimulation program is not in the “Program List”, create a new one as described gram below. Select the program by clicking on it. Once a program is selected, the “Program Details”...
  • Page 73 Prepare 6 ARC System instructions To make the start of the stimulation less abrupt iii. You can always cancel program creation when starting or resuming stimulation: by tapping on “Cancel” on the left of the bottom bar: ˢ A longer Ramp-Up Duration means a slower build-up to the set Amplitude, which can be more comfortable for the Patient when setting higher Amplitudes.

  • Page 74: Edit Or Delete A Stimulation Program

    Prepare 6 ARC System instructions 6.3.6.2 Edit or delete a stimulation program A program cannot be deleted once it has been used in a session. It Note All Programs can be: can, however, be updated with new stimulation parameters as needed. ˢ...

  • Page 75: Set Up

    Set up 6 ARC System instructions 6.4 Set up 6.4.1.1 Channel configuration Once you have selected a stimulation program 6.4.1 Channel configuration, skin (as described in section 6.3.6, the “Channels” screen is displayed (Figure 14). In this screen preparation and Electrode placement you need to define the Channels and Electrode Therapy is electrical spinal cord configuration.
  • Page 76 Set up 6 ARC System instructions Recommended starting setup • Select Return Electrode A for Channels 1 and 2. • Return Electrodes: • Click the icon between Return A: Left iliac crest Electrodes A and B B: Right iliac crest They should look like the screenshot below: •...
  • Page 77 Set up 6 ARC System instructions Determine and set Electrode placement: Select and link the Return Electrodes for each enabled channel: Set “Return Electrodes” placement: in • Select the field corresponding to the Return the designated fields labeled A,B,C,D, Electrode you want to use for a specific choose over which bony structures you will channel.

  • Page 78: Skin Preparation And Electrode Placement

    6 ARC System instructions Set up 6.4.1.2 Skin preparation and Electrode Please note that the frontal view Placement digital representation Note of a mannequin shows Return Refer to sections 3.2 and 3.3 Electrodes, while the back view WARNINGS and PRECAUTIONS related shows the Active Electrodes.
  • Page 79 Set up 6 ARC System instructions Place Electrodes prepared skin, ii. Apply Electrode pad center to skin first, ensuring they are securely attached to the then smooth down Electrode pad edges. skin. iii. Ensure Electrodes are securely attached to skin. Recommended starting setup •...

  • Page 80: Setting Up The Splitter Box And Stimulator

    6 ARC System instructions Set up 6.4.2 Setting up the Splitter Box and ii. End of Extension Cable(s) without the black ring to the Splitter Box. Stimulator ˢ Round Electrodes are Active Electrodes Refer to sections 3.2 and 3.3 and should be connected to the Active Elec- WARNINGS and PRECAUTIONS related trodes Sockets of the Splitter Box (red 1, 2, to to the interaction with the ARC...
  • Page 81 Set up 6 ARC System instructions Clip the Splitter Box (using the built- in clip) to a place, such as on the neck of the Patient’s shirt, where the Extension Cables can reach the Electrodes without restricting arm movement (Figure 17). Figure 17.
  • Page 82 6 ARC System instructions Set up different Extension Cable lengths are available (1m and 0.5 m/39.4 inches and 19.7 inches). Note Choose the most convenient length to reach the different Electrode’s placement without restricting the Patient’s arm movement. Ensure secure connection of: •...
  • Page 83 Set up 6 ARC System instructions Navigate to “Stimulation” screen by: i. Selecting “Save and continue” in the “Channels” screen ii. Selecting “Confirm” after confirming Electrode placement You need to have at least one enabled Note channel to be able to continue.

  • Page 84: Train

    6 ARC System instructions Train Train Refer to sections 3.2 and 3.3 WARNINGS and PRECAUTIONS related to to the interaction with the ARC System during a therapy session. 6.5.1 Stimulation Waveform configuration Adjust the stimulation parameters in the Figure 21. Example of “Stimulation” screen “Stimulation”...
  • Page 85 Train 6 ARC System instructions Frequency Pulse width Carrier frequency Current Amplitude Biphasic Monophasic Time Figure 22. Definition of Stimulation Parameters current is delivered within the pulse. The For each channel, you can program the charge is balanced with a subsequent following stimulation parameters (Figure 22): “charge-balance pulse”...
  • Page 86 6 ARC System instructions Train Amplitude (mA): Frequency (Hz): [0.2 Hz – 100 Hz] [Biphasic 0 mA – 250 mA; Monophasic Frequency refers to how many times 0 mA – 100 mA] the pulse repeats itself per second. Increasing Amplitude refers to the greatest absolute value of the negative phase of Increasing Frequency will increase the pulse, also known as the intensity.

  • Page 87: From The Arc Ex Pro App

    Train 6 ARC System instructions Once the stimulation parameters have been Stimulation start will not be available until set, the ARC PRO app provides the following the parameters are adapted to resolve the feedback in case the stimulation cannot be above feedback (simultaneous pulses across started due to simultaneous pulses across channels and safe stimulation limits).
  • Page 88 6 ARC System instructions Train Confirm you are ready to start stimulation ˢ Adjust the stimulation Amplitude from the by pressing “Yes” in the pop-up window. Programmer by pressing the “+” and “-” buttons for each channel to change the stimulation intensity.
  • Page 89 Train 6 ARC System instructions after several therapy sessions, ˢ You may pause the stimulation from consider making following Programmer pressing “Pause parameter adjustments, in order as stimulation” or by pressing the “Select” needed until effective parameters button on the Stimulator. are identified: i.
  • Page 90 6 ARC System instructions Train iii. Pressing the “Select” button on the Stopping the stimulation will stop it entirely and Stimulator once and then pressing it again you will have to restart a stimulation program and holding it for 3 seconds. If stimulation is from the beginning.

  • Page 91: Controlling Arc Ex Therapy From

    Train 6 ARC System instructions 6.5.2.2 Controlling ARC Therapy from the ˢ Increase / Decrease the Amplitude using Stimulator the two-buttons with arrows signifying When the Stimulator is connected with the “Increase” and “Decrease”. PRO app (on the Programmer), you can ·...

  • Page 92: Impedance Status

    Train 6 ARC System instructions 6.5.3 Impedance Status Select button Increase/Decrease Impedance Status refers to the resistance buttons of the skin and other body tissues to the flow of current produced by the Stimulator. The Impedance Status shown on the ARC app indicates the following: •...
  • Page 93 Train 6 ARC System instructions • “-”: the Impedance Status of the System is not measurable as the stimulation Amplitude is set to 0 mA. This means the channel is currently not delivering any current and the Impedance Status is not relevant.
  • Page 94 Train 6 ARC System instructions Whenever the Impedance Status changes If Impedance Status still does not improve: during the session, the ARC System will • Add drops of water to the gel surface of the compensate to maintain the desired current Electrodes.

  • Page 95: Prompt Interruption Of Stimulation

    “Power” or the “Select” button on the Stimulator: Power button Select button Figure 25. Prompt interruption of Stimulation by Unplugging Splitter Box, Issues with pausing or stopping stimulation should be reported to ONWARD. Figure 24. Prompt interruption of Stimulation with Power or Select Buttons.

  • Page 96: End Session

    6 ARC System Instructions End Session 6.6 End session Check skin for integrity and irritation. Should a skin rash or skin burn occur, immediately discontinue use and wait 6.6.1 Turning off the system until skin is healed before using of ARC System.

  • Page 97: Cleaning And Disinfection

    End session 6 ARC System instructions 6.6.2 Cleaning and The Stimulator, the Splitter Box, and the Extension Cables may be disinfected using disinfection wipes or cloths saturated (but no dripping) with 70% isopropyl alcohol per instructions: Refer to section 3.2 WARNINGS related System cleaning...

  • Page 98: Arc Ex Programmer

    End Session 6 ARC System Instructions 6.6.3.1 ARC Programmer Charging can take up to 8 hours depending on the initial charge level of Charging the Programmer: Charge the battery. When the charging session Programmer according tablet is complete, the Stimulator’s sceen will manufacturer’s user manual.

  • Page 99: Storing The Arc

    End session 6 ARC System instructions Charging is recommended at this time. Note, however, that the Stimulator will continue to run until the battery is too low to prevent further use, which will be signaled on the Stimulator by an error sound, the dashed orange lightbar, and the blinking battery icon.

  • Page 100: Cybersecurity

    A proprietary algorithm that detects if the PIN code is lost, the Programmer will and prevents an unauthorized user from not be accessible anymore and you will need attempting to pair with the Stimulator. to contact an ONWARD representative for assistance.

  • Page 101: Guidelines For Secure Use

    If you suspect any security issue, please contact an ONWARD representative. 7.4 Log files The ARC System generates protected logs. Only ONWARD representatives have access to the log files. If access to the logs is required, please contact an ONWARD representative.

  • Page 102: Maintenance And Service

    Per the may be released by ONWARD. manufacturer, gently rubbing one or two Only ONWARD representatives are allowed to drops of water onto the gel surface may perform ARC System updates, over-the-air, increase Electrode adhesion.

  • Page 103: Technical Information

    9 Technical information 9 Technical Information 9.1 Specifications Table 4. Specifications Characteristic Values Expected service life 3 years Mode of operation Continuous operation mode Wall adapter input voltage 100 - 240 V (AC) Wall adapter input frequency 50/60 Hz Wall adapter output voltage 15 V (DC) Wall adapter input current 1.5 - 0.8 A...
  • Page 104 9 Technical Information Dimensions 235 x 190 x 55 mm Memory Flash 32 MB Wireless cpability and performances Technology: (adaptive frequency hopping) Transmit Power: +8.7 dBm (max) Operating Frequencies: 2.40 - 2.48 GHz Receiver Sensitivity: -95 dBm Recommended maximum operational distance: 3 m Latency/throughput: 100 bytes of data within 0.5 s...
  • Page 105 9 Technical Information Biphasic Stimulation Pusle Amplitude range 0 mA- 250 mA (1 mA steps) For load impedance range from 150 Ohms to 500 Ohms Note: At higher load condition the output capability may be reduced. Intra-burst Pulse Repetition Frequency 10000 Hz or 20000 Hz Intra-burst Pulse Width 50 µs or 100 µs...
  • Page 106 9 Technical Information Length of Splitter Box cable 150 cm / 59.1 inches Length of the Extension Cables 50 cm/19.7 inches and 100 cm/39.4 inches Temperature: Environmental ranges Usage: +5 to +40°C Storage (Within Case): -25 to +70°C Transport (Within Case): -25 to +70°C Humidity: Usage: 10 to 90% humidity (non-condensing) Transport &...

  • Page 107: Exposure

    9 Technical Information 9.2 Exposure Table 5. Electromagnetic Emissions 9.2.1 Electromagnetic interference Type of Electromagnetic Take precautions against risks Test Basic Environment - electromagnetic interference (EMI) between standard Guidance the ARC System and other electronic devices and Test that may be reasonably foreseen to be present Level(s) during specific...
  • Page 108 9 Technical Information The ARC System was tested for electromagnetic compatibility (EMC) in accordance with International Electrotechnical Committee (IEC) 60601-1-2 standards. Table 6 describes the electromagnetic environment for which the device has been tested and is safe to use. Table 6. Electromagnetic Immunity Immunity Test IEC 60601 Compliance Electromagnetic Environment –...
  • Page 109 9 Technical Information Immunity Test IEC 60601 Compliance Electromagnetic Environment – Test Level (s) Guidance Electrical fast transient/burst IEC 61000-4-4 Professional healthcare ± 2 Kv (100kHz rep.) Home healthcare Surge IEC 61000-4-5 Applicable to charging mode only, (Line-Line) ± 0,5 kV, ± 1 kV while AC/DC adapter connected to the MAINS supply.

  • Page 110: Radio Frequency Interference

    9 Technical Information There are currently no known devices or other sources that can potentially cause interference problems. This ARC System complies with part 15 of the FCC Rules. Operations is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this Note device must accept any interference received, including interference that may cause undesired operation.

  • Page 111: Troubleshooting

    10.1 ONWARD Support If the Stimulator encounters an event that request your attention, the light bar will For additional support, contact an ONWARD illuminate in dashed orange, an error tone will representative: sound and the stimulation will be interrupted if...

  • Page 112: Stimulator Shows A "See Cables" Error

    Error in temperatur detection is paused, press the Select button on the Stimulator for 3 seconds. If the issue persists, E008 Audio file unretrievable please contact an ONWARD representative. E009, E010 Versions compatibility error 10.2.5 The Stimulator is either not E013...

  • Page 113: The Stimulator Shuts Down Unexpectedly

    Programmer or when controlling problem and error message persist, contact stimulation, make sure the Stimulator and an ONWARD representative with the error Programmer are within 3 meters/10 feet of message at hand. each other to improve connectivity. If the problem persists, turn off or remove Wi-Fi 10.2.8 How do I factory reset a...

  • Page 114: Arc Ex Programmer Troubleshooting

    If this still does not solve the issue, try turning the Stimulator off and back on. with Stimulator If the problem persists, contact an ONWARD You will be notified of lost connection between representative for assistance. the Stimulator and Programmer through feedback on the Stimulator and on the Programmer.

  • Page 115: I Cannot Connect To The Stimulator

    Charger (please refer to section 6.6.3) described in section 10.3.13. and wait a few minutes before turning it on. For If the problem persists, contact an ONWARD more details, refer to the tablet manufacturer’s representative for assistance. user manual. If the problem persists, please contact an ONWARD representative.

  • Page 116: The Battery Of The Programmer Depletes Within A Few Hours

    Be aware that the screen consumes the most can customize or change such values for you. power. If you feel that battery longevity has Please contact an ONWARD representative for significantly degraded since you first started more information on settings you would like to using the Programmer, please contact an have changed.

  • Page 117: Can I Use The Programmer While

    10 Troubleshooting 10.3.12 Can I use the Programmer while app (three horizontal lines in the top-right navigation bar). Refer to section 6.3.3. charging it? You can use the Programmer while charging it, however, during delivery of therapy, the Programmer shall be charged only at a distance of 1.5m/5 feet from the Patient.

  • Page 118: Disposal

    11 Disposal 11 Disposal Before disposing of the ARC System, contact an ONWARD representative to delete the PRO app from the Programmer and to permanently remove data beyond recovery. Electrical devices are recyclable material and should not be disposed of with houshehold waste.
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  • Page 120 P/N EXIFU01PROEN Rev 5 Issue date 2024 - 12 -18...

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